FEDERAL COURT OF AUSTRALIA

Novartis Pharmaceuticals Australia Pty Ltd v Bayer Australia Ltd [2015] FCA 35

THE COURT ORDERS THAT:

1.    On or before 20 February 2015, the parties are to identify which parts of the reasons they contend should not be published because of confidentiality and file a proposed form of orders.

2.    The parties are to endeavour to agree the figure to be included in [366] of these reasons.

3.    If the applicant wishes to contend that costs should not follow the event, it should file and serve by 20 February 2015 a written submission of no more than three pages in support of that contention. If the applicant files such a written submission, the respondent is to file and serve by 28 February 2015 its written submission of no more than three pages in response.

4.    The proceedings be listed at 9.30 am on 6 March 2015 for the making of orders.

Note:    Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

REASONS FOR JUDGMENT

Introduction

1    These proceedings concern two medicines for the treatment, by intra-vitreal injection, of neovascular (wet) age-related macular degeneration (wet AMD or wAMD), a medical condition which results in loss of vision. Each medicine involves ongoing treatment.

2    Lucentis® (Lucentis), the Novartis product, has been available for sale in Australia since 2007. It is only available on prescription and is, and has been since 2007, administered only by ophthalmologists. Its active ingredient is ranibizumab and it is sometimes referred to by that name.

3    Eylea® (Eylea), the Bayer product, has been marketed and sold in Australia since 2012. It also is only available on prescription and is administered only by ophthalmologists. It too is administered via intra-vitreal injection. Its active ingredient is aflibercept and it is sometimes referred to by that name.

4    It is common ground that Lucentis and Eylea are in direct competition with each other as prescription-only medicines indicated for use in Australia for the treatment of wet AMD.

5    In February 2007, Lucentis was registered on the Australian Register of Therapeutic Goods and in August 2007 it was listed on the Schedule of Pharmaceutical Benefits (PBS Schedule).

6    On 7 March 2012, Eylea was registered on the Australian Register of Therapeutic Goods. On 1 December 2012, Eylea was listed on the PBS Schedule.

7    Novartis pleads that in approximately 46 acts of publication, which I list below, and in detailing conduct, Bayer made the following representations:

(a)    that in clinical use, in accordance with the approved dosage, the Novartis product, Lucentis, is administered monthly for all patients (First Representation);

(b)    that, for each and every patient, Lucentis will only be a clinically effective treatment if administered monthly (Second Representation);

(c)    that the Lucentis Product Information specified, without qualification, that it was to be administered monthly (Third Representation);

(d)    that in accordance with approved dosages, all Eylea patients receive fewer injections than all Lucentis patients (Fourth Representation).

In its reply submissions, Novartis said that the heart of the case centred on the Fourth Representation.

8    Bayer denies that the representations were conveyed but admits that, if they were, each is false — that is, an incorrect statement of fact — but denies that they were misleading or deceptive or likely to mislead or deceive.

9    Novartis claims that Bayer breached ss 18, 29(1)(a) and/or 29(1)(g) of the Australian Consumer Law, which sections were as follows:

18    Misleading or deceptive conduct

(1)    A person must not, in trade or commerce, engage in conduct that is misleading or deceptive or is likely to mislead or deceive.

(2)    Nothing in Part 3-1 (which is about unfair practices) limits by implication subsection (1).

Note:    For rules relating to representations as to the country of origin of goods, see Part 5-3.

    …

29    False or misleading representations about goods or services

(1)    A person must not, in trade or commerce, in connection with the supply or possible supply of goods or services or in connection with the promotion by any means of the supply or use of goods or services:

(a)    make a false or misleading representation that goods are of a particular standard, quality, value, grade, composition, style or model or have had a particular history or particular previous use; or

…

(g)    make a false or misleading representation that goods or services have sponsorship, approval, performance characteristics, accessories, uses or benefits; …

…

Section 29 was in Part 3‑1—Unfair practices: see s 18(2) above.

10    By way of example, the content of one of Bayer’s acts of publication, by baby banner (second form), was:

11    The central issues for decision are as follows:

(i)    Were the four pleaded representations conveyed by the acts of Bayer? As I have said, Novartis pleaded approximately 46 acts of publication and detailing conduct, occurring on various dates up to mid-May 2013, but with one further publication in June 2013;

(ii)    If so, was that conduct misleading or deceptive or likely to mislead or deceive, or false or misleading?

(iii)    If so, what is the appropriate remedy, if any? In particular, has Novartis proved that it suffered loss or damage because of Bayer’s conduct and, if so, in what amount, and is other relief, in the form of declarations, injunctions and corrective advertising, appropriate?

12    It is necessary to approach these issues with an appreciation of the context, in particular the regulatory context, and the identification of the relevant class of addressees and the education, training, experience and state of knowledge of a (hypothetical) reasonable member of that class.

The words used and the acts of publication

13    The acts of publication were alleged to have been by poster, which was a large banner designed to stand on the floor, being approximately 2.13 m wide and 2.19 m high; by baby banner which was smaller than a poster, say for a desk top, being approximately 40 cm wide and 95 cm high; by detailing conduct which meant the detailing, i.e. communications by Bayer company representatives with ophthalmologists and/or optometrists, during which the ophthalmologists and/or optometrists were shown Detail Aids (on an iPad), which included words in terms substantially similar to those otherwise complained of by the applicant Novartis; advertisements in the journal Clinical & Experimental Ophthalmology and in mivision magazine; and by displaying and disseminating an attendee workbook at the Eylea product launch events in Sydney, Melbourne, Brisbane and Adelaide. Bayer accepts that it published magazine advertisements, published and had on display certain posters and baby banners at meetings and events, and that its sales representatives engaged in certain detailing conduct with an electronic document on an iPad. It also accepts that it provided the attendee workbook.

14    The magazine mivision is a monthly industry publication which is provided as a free subscription to ophthalmologists and optometrists and their practices in Australia and New Zealand 11 times a year on the first Monday of every month (except for January). In September 2012 the audited distribution for the magazine was 7265, made up of optometrists and optical shops (3793 recipients), ophthalmologists (1176 recipients) and ophthalmologists’ practices and staff (216 recipients). The journal Clinical & Experimental Ophthalmology is a clinical journal produced by the Royal Australian and New Zealand College of Ophthalmologists (RANZCO) and distributed to RANZCO members, ophthalmologists, as part of their membership.

15    I next set out the words used of which complaint is made.

16    It is alleged that, by displaying a poster, Bayer published, amongst other words, the following words:

“EYLEA® HELPS YOU AND YOUR

PATIENTS WITH FEWER INJECTIONS

WHEN USED ACCORDING TO THE APPROVED

DOSAGE COMPARED TO MONTHLY RANIBIZUMAB 1, 2

                …

References: 1. EYLEA® Product Information. 2. LUCENTIS® Product Information.”

17    This was the form for the poster (first form), the baby banner (first form), the Detail Aid and the attendee workbook.

18    It is next alleged that Bayer caused advertisements to be published in the same form.

19    This was the form used for the advertisements (first form).

20    Another form (second form) is alleged as follows:

“EYLEA® FOR YOU AND YOUR PATIENTS

WITH FEWER INJECTIONS WHEN USED

ACCORDING TO THE APPROVED DOSAGE

COMPARED TO MONTHLY LUCENTIS®1, 2

                …

References: 1. EYLEA Product Information. 2. LUCENTIS Product Information.”

21    This was the form for the poster (second form), the baby banner (second form) (see [10] above) and the advertisements (second form).

22    The references to first form are to “Eylea helps …” (larger font) “when used …” (smaller font), and the references to second form are to “Eylea helps/for you and your patients …”, “when used … ” (same font).

23    Next I set out in chronological order the numbered acts of publication contended for by the applicant.

24    I note that the first form ceased to be published at or about the time Eylea was listed on the Pharmaceutical Benefits Scheme (PBS) and therefore became, practically, available for prescription. Novartis submitted that the first form applied at the critical time leading up to and through the national product launch, when minds were being won. On or about 15 May 2013, Bayer gave an undertaking that it would cease publishing or otherwise communicating the promotional material on a without admissions basis.

25    I consider at [227]–[233] below the disputed acts of publication.

The regulatory context

26    Under s 25(4) of the Therapeutic Goods Act 1989 (Cth) (the TGA), as in force at the relevant time, the Secretary had a discretion to register therapeutic goods after an evaluation under s 25. If the Secretary decided so to register the goods and they were “restricted medicine” as defined, he or she was required to approve product information in relation to the medicine. Section 3(1) of the TGA defined “product information” in relation to therapeutic goods to mean: “information relating to the safe and effective use of the goods, including information regarding the usefulness and limitations of the goods.”

27    Under s 7D(1) of the TGA, a form was approved for providing product information to accompany the application for registration in accordance with s 23(2)(ba) of the TGA. That form required product information set out under certain specified headings including clinical trials and dosage and administration.

28    Under the Therapeutic Goods Regulations 1990 (Cth) (the TG Regulations), by reg 9A the sponsor of therapeutic goods (specified in Part 1 of Schedule 10) must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a patient information document set out in Schedule 12 to the TG Regulations. By reg 9A(2), information must be provided in the primary pack in which the therapeutic goods are supplied or in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.

29    Schedule 12 to the TG Regulations provided, so far as relevant:

A patient information document about a medicinal product must be:

…

•    consistent with product information about the product.

A patient information document must include the following:

1. Identification

The name of the medicinal product, which is the name given to the product by the sponsor, including or followed by the non-proprietary name(s) of the active ingredient(s) and the dosage form or strength, or both, of the product.

A statement of the active ingredients expressed quantitatively and excipients expressed qualitatively, using their common names, in the case of each presentation of the product.

The pharmaceutical form and the contents by weight, volume or number of doses of the product, in the case of each presentation of the product, together with its identifying Australian Register number.

2. What the product is used for and how it works

The therapeutic indications, unless a competent authority determines that dissemination of such information may have serious disadvantages for the patient.

The pharmaco-therapeutic group, or type of activity, if there is a term that is easily comprehensible for the patient. If not, a simple description of what the medicinal product is for and how it works, in 1 or 2 sentences.

3. Advice before using the medicinal product

A list of factors that are useful to consider before taking the medicinal product, including, if appropriate:

•    contraindications, including consideration of whether the patient has experienced previous allergic reactions

•    precautions for use, taking into account the particular condition of certain categories of users, such as the elderly, children, infants, pregnant or breastfeeding women, persons with specific pathological conditions

•    potential effects of the medicinal product on the ability to drive vehicles or to operate machinery

•    interactions with other medicinal products or other forms of interaction (for example with alcohol, tobacco, foodstuffs) which may affect the action of the product

•    special warnings, such as effects on sensitivity to sun exposure.

4. How to use the medicinal product properly

The necessary and usual instructions for proper use of the medicinal product, in particular:

•    the dosage, together with an indication that this may not always apply and may be modified by the prescriber

•    the method and, if necessary, route of administration

•    the frequency of administration, specifying, if necessary, the appropriate time at which the medicinal product should or must be used

In addition, depending upon the nature of the therapeutic goods:

•    the duration of treatment, if it should be limited

•    the expected effect of using the medicinal product

•    what to do if 1 or more doses have not been taken

•    the way the treatment should be stopped, if stopping the treatment may lead to withdrawal or other adverse effects. …

30    In order for a medicine to be listed on the PBS, the company must lodge a submission with the Pharmaceutical Benefits Advisory Committee (PBAC) in accordance with the PBAC Guidelines: Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee. The Guidelines applicable at the relevant time ran for nearly 300 pages. The overview of a major submission required: section A to establish the context for the submission, including a description of the proposed drug, its intended use on the PBS, and the therapies that would be co-administered or substituted (the therapy likely to be most replaced by prescribers in practice being the “main comparator”); section B to provide the best available evidence comparing the clinical performance of the proposed drug with that of the main comparator, preferably from direct randomised trials, and details to be provided about the trials, the section concluding with a comparative therapeutic assessment of the proposed drug; section C to describe the methods used in pre-modelling studies to translate the results of the evaluation of the clinical studies to the context of the requested listing; section D to provide an economic evaluation focused on changes in health outcomes and in the provision of healthcare resources due to the proposed drug; section E to include financial analyses for the PBS/Repatriation Pharmaceutical Benefits Scheme and government health budgets; and section F (optional) to present any additional information of relevance to the major submission.

31    In the PBS Schedule the “dispensed price for maximum quantity” (the amount the Commonwealth government pays for the medicine so as to make it available at a government-subsidised price) was $1431.37 for Eylea and also for Lucentis. From 1 January 2013, the co-payment amount by a patient was $36.10 or, if the patient had a pensioner concession card, $5.90.

32    The Medicines Australia Code of Conduct edition 16 came into effect on 1 January 2010 (the Code). It stated it should be viewed as the minimum set of standards required to promote prescription products in Australia and did not in any way prohibit more stringent and comprehensive requirements being applied by individual companies. The Code complements the requirements of the TGA and the TG Regulations. Both Bayer and Novartis were members of Medicines Australia.

33    It was common ground that under the law in Australia it was illegal to advertise prescription-only medicines to the general public.

34    As I have said, Lucentis has been available for sale in Australia since 2007. It was approved by the Therapeutic Goods Administration and was registered on the Australian Register of Therapeutic Goods in February 2007. From August 2007, Lucentis was listed on the PBS Schedule.

35    The Product Information for Lucentis contained the following:

Treatment of Wet AMD

The recommended dose of Lucentis is 0.5 mg (0.05 mL) or 0.3 mg (0.03 mL) given as a single intravitreal injection.

Lucentis is given monthly. The interval between two doses should not be shorter than 1 month. Although less effective, treatment might be reduced to one injection every 3 months after the first three injections (e.g. if monthly injections are not feasible) but, compared to continued monthly doses, dosing every 3 months may lead to an approximate 5-letter (1-line) loss of visual acuity benefit, on average, over the following nine months. Patients should be evaluated regularly.

36    The Consumer Medicine Information for Lucentis stated:

The usual dose is 0.05mL or 0.03mL

(equivalent to 0.5mg or 0.3mg). The

interval between two doses should

not be shorter than one month.

If you are treated for wet age-related

macular degeneration, the injection is

given once a month. If given less

frequently, the full benefit may not

be obtained or benefits already

obtained might be lost (that is your

vision might be less sharp or even).

37    On 7 March 2012, Eylea was registered on the Australian Register of Therapeutic Goods.

38    Between March and April 2012, Bayer sales representatives attended an 8 week training course including training in relation to anatomy, macular degeneration and wet AMD treatment options. On 23 March 2012, there was a “Marketing strategy & activities 2012” presentation to Bayer sales representatives.

39    Between May 2012 and May 2013, there was detailing conduct.

40    Eylea was launched on 24 October 2012.

41    In December 2012, VIEW 1 and 2 year 1 trial results were published in Heier et al, ‘Intravitreal Aflibercept (VEGF Trap-Eye) in Wet Age-related Macular Degeneration’, Ophthalmology 2012; 119: 2537–2548. The summary objective, results and conclusions were stated as follows:

Objective: Two similarly designed, phase-3 studies (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD [VIEW 1, VIEW 2]) of neovascular age-related macular degeneration (AMD) compared monthly and every-2-month dosing of intravitreal aflibercept injection (VEGF Trap-Eye; Regeneron, Tarrytown, NY, and Bayer HealthCare, Berlin, Germany) with monthly ranibizumab.

…

Results: All aflibercept groups were noninferior and clinically equivalent to monthly ranibizumab for the primary end point (the 2q4, 0.5q4, and 2q8 regimens were 95.1%, 95.9%, and 95.1%, respectively, for VIEW 1, and 95.6%, 96.3%, and 95.6%, respectively, for VIEW 2, whereas monthly ranibizumab was 94.4% in both studies). In a prespecified integrated analysis of the 2 studies, all aflibercept regimens were within 0.5 letters of the reference ranibizumab for mean change in BCVA; all aflibercept regimens also produced similar improvements in anatomic measures. Ocular and systemic adverse events were similar across treatment groups.

Conclusions: Intravitreal aflibercept dosed monthly or every 2 months after 3 initial monthly doses produced similar efficacy and safety outcomes as monthly ranibizumab. These studies demonstrate that aflibercept is an effective treatment for AMD, with the every-2-month regimen offering the potential to reduce the risk from monthly intravitreal injections and the burden of monthly monitoring.

42    On 1 December 2012, Eylea was listed on the PBS Schedule.

43    The product information for Eylea contained the following:

Pharmacodynamic effects

…

In patients treated with EYLEA (one injection per month for three consecutive months, followed by one injection every 2 months), retinal thickness decreased soon after treatment initiation, and the mean CNV lesion size was reduced, consistent with the results seen with ranibizumab 0.5 mg every month.

Dosage regimen

The injection volume is 50 μL of EYLEA (equivalent to 2 mg aflibercept).

EYLEA treatment is initiated with one injection per month for three consecutive months, followed by one injection every two months. (See CLINICAL TRIALS for dosing experience).

The clinical trials referred to were the VIEW 1 and VIEW 2 studies, which were summarised at pages 5 to 8 of the Eylea product information.

44    The Consumer Medicine Information for Eylea contained the following:

The recommended dose of EYLEA

is 50 μL (microlitre).

The interval between two doses

should not be shorter than one

month.

If you are being treated for wet

AMD:

The injection is given once a month

for the first 3 months followed by

one injection every 2 months.

The witnesses

45    The applicant relied on the evidence of the following witnesses:

(a)    three affidavits of Ms Sweta Ghelani, affirmed 2 May 2013, 24 July 2013 and 30 August 2013;

(b)    two affidavits of Dr Benjamin Waterhouse, sworn 14 August 2013 and 13 March 2014;

(c)    two affidavits of Mr Paul Hodgkinson, sworn 23 August 2013 and 14 March 2014;

(d)    four affidavits of Mr David Moore, health economist, affirmed 26 August 2013, 10 January 2014, 17 March 2014 and 12 April 2014; and

(e)    three affidavits of Mr Tony Samuel, chartered accountant, affirmed 11 September 2013, 23 December 2013 and 17 March 2014.

46    The respondent relied on the evidence of the following witnesses:

(a)    an affidavit of Dr Allan Ared, optometrist, affirmed 28 June 2013;

(b)    two affidavits of Dr Paul Mitchell, retinal ophthalmologist, affirmed 28 June 2013 and 3 March 2014, the latter being supplemented by a report in the form of a letter to the respondent’s solicitors dated 10 April 2014;

(c)    two affidavits of Dr Andrew Crawford, ophthalmologist, affirmed 28 June 2013 and 21 February 2014, and a report in the form of a letter dated 24 March 2014;

(d)    an affidavit of Dr Jan Twomey, affirmed 8 November 2013;

(e)    an affidavit of Ms Emel Elibol, affirmed 8 November 2013;

(f)    an affidavit of Ms Radmila Grabovac, sworn 8 November 2013;

(g)    an affidavit of Ms Naomi Leonard, sworn 8 November 2013;

(h)    an affidavit of Ms Michele Doyle, sworn 8 November 2013;

(i)    an affidavit of Mr John Burstow, sworn 8 November 2013;

(j)    an affidavit of Mr Larry Hodges, affirmed 8 November 2013;

(k)    an affidavit of Ms Cecilia Martinek, sworn 8 November 2013;

(l)    two affidavits of Ms Susan Adams, affirmed 8 November 2013 and 19 December 2013;

(m)    an affidavit of Ms Alena Reznichenko, affirmed 8 November 2013;

(n)    an affidavit of Mr Andy Kuo, sworn 19 November 2013;

(o)    an affidavit of Dr Philip Williams, economist, sworn 17 February 2014; and

(p)    an affidavit of Mr Terence Potter, chartered accountant, sworn 14 February 2014.

47    Ms Ghelani was the marketing manager (wAMD) for Lucentis and had held that position since September 2012. In that role she was responsible for the oversight and coordination of the Lucentis marketing team. In July 2011, she began working as a member of the Lucentis cross-functional team in the role of Senior Brand Manager with her main responsibility being to optimise the commercial potential of Lucentis, including the development of marketing plans and sales material. In her affidavit of 24 July 2013, Ms Ghelani gave more detailed evidence of her experience as a pharmacist and in the marketing of pharmaceutical products. She has a Masters of Business (specialising in Marketing) from RMIT University, which she obtained in 2003. She said that as of April 2012, the International Council of Ophthalmology estimated on its website that there were approximately 763 ophthalmologists in Australia.

48    Much of her evidence was not controversial.

49    She gave her understanding of Lucentis as an anti-vascular endothelial growth factor (anti-VEGF) therapy and said that it was the only such therapy available for sale in Australia during the period 2007 to 2012. During the period 2007 to November 2012, Lucentis was the only anti-VEGF product available for sale in Australia which was registered on the Australian Register of Therapeutic Goods, listed on the PBS, and administered through intra-vitreal injection.

50    Ms Ghelani gave the monthly ex-factory sales of Lucentis by unit for the period January to November 2012. She then gave the sales figures for Lucentis for the period December 2012 to April 2013 following the launch of Eylea. It was in October 2012 that the Minister for Health announced that the proposed PBS listing for Eylea would be amended to allow the switching of existing Lucentis patients to Eylea. She also set out a table showing the relative market share (as measured by sales from wholesalers to pharmacies) for Lucentis and Eylea determined by reference to the data contained in a report by IMS, a company which provided industry market data. The figures for the monthly ex-factory sales of Lucentis by unit were substantially lower following the launch of Eylea and so was the share of the age-related macular degeneration (AMD) market in Australia held by Lucentis. A comparison of the monthly ex-factory sales of Lucentis by unit (vials) was 17,000 units in April 2012 against 8574 units in April 2013, and the market share for Lucentis in October 2012 was 99.9% (19,136 units) against 58.3% (9916 units) in February 2013, with Eylea having a market share in February 2013 of 41.7% (7090 units).

51    In her third affidavit, Ms Ghelani deposed that optometrists may detect evidence of wet AMD during a routine eye examination, and a patient who was having difficulty with their vision will often present to an optometrist, but optometrists may not diagnose or treat the condition. Consequently, they refer their patients to ophthalmologists who may make a diagnosis and then treat wet AMD, sometimes with intra-vitreal anti-VEGF injections such as Lucentis or Eylea. Both the Lucentis product information and the Eylea product information stated that the medicine must only be administered by a qualified ophthalmologist or physician experienced in administering intra-vitreal injections. The relevant entries on the PBS Schedule required that the intra-vitreal injections be administered by an ophthalmologist in order for reimbursement to be made. Consequently, Novartis focused its advertising, promotion and visits to optometrists on education in relation to identification of wet AMD, so as to facilitate diagnosis, and the importance of early referral to an ophthalmologist for definitive diagnosis and treatment as appropriate. For ophthalmologists, Novartis focused more directly on Lucentis and the science surrounding its features and would delve more deeply into the scientific literature in that regard.

52    Ms Ghelani deposed that after the initial scientific studies which established the safety and efficacy of Lucentis, many of the subsequent studies had attempted to determine whether, and the extent to which, the interval between injections of Lucentis could be extended beyond monthly.

53    In her oral evidence, Ms Ghelani said that most clinicians would know about the clinical trials in the product information document. She was speaking specifically of the ANCHOR and MARINA studies referred to in the Lucentis product information. She agreed that the exchange of scientific information with the clinician occurred very frequently. Ms Ghelani agreed that, in her perception, the ophthalmologists and optometrists she was visiting for Lucentis were aware in 2011 of Eylea on the horizon and that they were aware of clinical studies for Eylea either taking place or being reported as a precursor to the PBS launch of Eylea. Her understanding was that ophthalmologists and optometrists had their own sources of information about the coming of the Eylea product, including the obtaining by them of clinical study material and other scientific papers about aflibercept and its qualities. Before the first publication in issue in the proceedings, before July 2012, her understanding was that many ophthalmologists and optometrists already had a great deal of detailed information about the qualities of Eylea that was coming to market.

54    Ms Ghelani also agreed that Novartis’ marketing for Lucentis very regularly adopted the practice of footnoting a claim and the footnotes referred to product information documents as well as other clinical trials. She said whatever the claim, it must be supported by a form of evidence and it was usually either a clinical paper or the product information. It was her understanding that ophthalmologists and optometrists understood the procedure of footnoting product information documents.

55    More generally in relation to the product information document, her working assumption in her role was that the marketing of Lucentis had as one of its main facts that it conveyed to ophthalmologists what the approved product information document said about dosage and administration.

56    Ms Ghelani was taken in cross-examination to a Novartis marketing document prepared some time in the period April to July 2011 which contained the statement “A MONTHLY REGIMEN OF LUCENTIS DEMONSTRATED THE BEST VA OUTCOMES IN THE CLINICAL TRIALS”, with a footnote reference to a study published in 2009. She accepted that it was her understanding that the intention of the statement was to encourage a monthly regimen of Lucentis because it gave the best results and that if doctors took up the suggestion of a monthly regimen it would be good for sales as patients who are dosed monthly consume more vials and are materially more profitable to Novartis than patients who have intra-vitreal injections less frequently.

57    Ms Ghelani agreed that at the conferences there was a variety of information, including clinical studies and product information, which was available to conference delegates and that material was distributed as ophthalmologists or optometrists expressed an interest in it or they would sometimes pick it up. It was standard practice to have such material for people to pick up. As part of the Code, the product information must be available on the stand and the sponsor may also have available a clinical paper.

58    Ms Ghelani was taken to a Novartis document dated February 2013 referring to most clinics where clinicians practice (centres) having trialled aflibercept (at different rates), “mainly switching existing LUC[entis] patients not responding and/or patients who cannot be extended out further than 4–5 weeks [with or without] fluid on the retina”. Ms Ghelani accepted that in this analysis in the summary, the point was being made that two reasons were put forward for clinics switching existing Lucentis patients. She added there was a third reason given being extending out further than four or five weeks. She said that: “[i]n some cases as the extension occurs, sometimes the fluid returns. But in some cases clinicians may have wanted to extend the patient out further for other reasons, such as where they lived, or impact on carers to bring them into the clinic. So there potentially are other reasons other than purely efficacy.” She added it may be fluid was one of the reasons that the clinician did not want to extend the patients out but it may also be that the clinician just wished to extend the patient out further if they could and the clinician would have a clinical discussion with the patient around: “you might not get as great vision, but we’re going to extend you out to eight weeks because we know that you are coming from Dubbo into the clinic, and that’s a long way for someone to come for an injection in the eyeball.” She said her understanding of the reason an ophthalmologist would regard an existing Lucentis patient as not being able to be extended, and therefore should be switched, was that it could be the visual acuity outcomes were not as great or it could be fluid. She said that she knew that ‘treat and extend’ was the most predominant regimen in Australia and that had been verified by a number of quantitative sources of data as well, but accepted that she had not addressed that question or brought forward material to support it in her affidavits. In re-examination, she said that the Commonwealth’s drug utilisation sub committee in 2012 showed that in the first year, Lucentis patients were on 7.42 injections, which, she said, clearly indicated that those patients were not being dosed monthly. She also referred in re-examination to a touch responder pad of about 100 retinal specialists at a weekend conference, held usually in June of most years. Their response was that around 80% of clinicians used treat and extend, 10% use a PRN (i.e. as required) and the balance would be monthly.

59    She agreed that the marketing document attributed the switching as mainly being for the two reasons of non-responsiveness of Lucentis patients to Lucentis, on the one hand, and those who could not be extended without fluid on the retina on the other. She added another reason as well, being just simply not being able to extend the patient out. The same document set out qualitative feedback from the top ten prescribing doctors and in the headline stated that usage of aflibercept was mostly in non-responders and patients on four weekly Lucentis. Ms Ghelani said there were varying definitions as to what constituted a non-responder. She agreed that the reasons that Novartis was provided at the time by these clinicians were good clinical reasons for adopting Eylea as a treatment for wet AMD. The same document contained a statement that the sales of aflibercept for the first few months from December 2012 were identical to Lucentis at launch for the first few months from August 2007. The document also contained pages setting out “qualitative field insights and Novartis response”, being information that had become apparent to Novartis employees, predominantly the sales team, reporting back to Novartis. The document described three complaints and none of them was to the effect that Bayer’s advertising said of Lucentis that it was administered monthly for all patients. Ms Ghelani’s recollection was that there was no complaint at all about any reference to monthly Lucentis. In re-examination she was asked whether her thinking changed from the views there expressed and she said that what changed was that the switching did not just stop at patients at four weeks but patients at 5 to 11 plus weeks were being switched to Eylea and this was not anticipated: certainly people eight weeks and more were not anticipated by Novartis in its marketing assumptions. Novartis did not anticipate that clinicians would switch patients who had been extended and who were not having high volumes of injections.

60    Ms Ghelani was taken in cross-examination to a printout of the digital screens from the iPad sales aid deployed by sales and marketing representatives of Novartis in their meetings one-on-one with ophthalmologists and optometrists. She accepted that in Novartis’ promotion to ophthalmologists Novartis always put the particular mandatory statement as to the ANCHOR and MARINA trials, which involved Lucentis administered on a fixed monthly basis. The sales aid also included the statement “less than monthly dosing* can sustain VA improvements in some patients vs baseline at 12 months … *Lucentis® is given monthly. Although less effective, treatment might be reduced to one injection every three months after the first three injections (e.g. if monthly injections are not feasible).” Ms Ghelani did not accept that the iPad sales aid involved the regular frequent presentation to ophthalmologists of the proposition coming from Novartis that Lucentis was given monthly. She said she thought the page was about less than monthly dosing sustaining VA improvements but Novartis had “put the mandatory there because we want to be clear about what’s in our label”. She accepted that what she called “the mandatory” was something that appeared frequently and regularly in the sales aid iPad material that Novartis was providing to ophthalmologists in 2012 and 2013.

61    Ms Ghelani agreed that the Consumer Medicine Information for Lucentis included the words: “[i]f you are treated for wet age-related macular degeneration, the injection is given once a month. If given less frequently, the full benefit may not be obtained or benefits already obtained might be lost (that is your vision might be less sharp or even)” and was included in that Consumer Medicine Information at all times during 2012 and 2013.

62    Ms Ghelani was taken to a March 2013 report and accepted that, as there stated at that time, the uptake of Eylea in Australia was similar to Japan on the basis of comparing units and the uptake in Australia was similar to the United States on the basis of comparing patients. She accepted that the uptakes in Japan and in Australia in those initial months were similar and the uptakes in the United States and Australia were not dissimilar.

63    Subject to one exception, I accept Ms Ghelani’s evidence. In particular, I give weight to her understanding that most clinicians would know about the clinical trials in the product information document; that the exchange of scientific information with the clinicians occurred very frequently; her perception that the ophthalmologists and optometrists she was visiting for Lucentis were aware in 2011 of Eylea on the horizon and that they were aware of clinical studies for Eylea either taking place or being reported as a precursor to the PBS launch of Eylea; and her understanding that ophthalmologists and optometrists had their own sources of information about the coming of the Eylea product, including the obtaining by them of clinical study material and other scientific papers about aflibercept and its qualities, such that before 28 July 2012, the date of the first publication in issue in the proceedings, many ophthalmologists and optometrists already had a great deal of detailed information about the qualities of Eylea that was coming to market.

64    I also accept Ms Ghelani’s evidence as to the role of optometrists in relation to the detection of wet AMD, that is, that a patient having difficulty with their vision will often present to an optometrist, but optometrists may not diagnose or treat the condition. Consequently they refer their patients to ophthalmologists who may make a diagnosis and then treat wet AMD, sometimes with intra-vitreal anti-VEGF injections such as Lucentis or Eylea. This evidence is entirely consistent with that of Dr Ared, an optometrist called by the respondent. It establishes, and I so find, that any impact of the respondent’s conduct on optometrists is at best indirect because optometrists do not make any choice between Lucentis and Eylea. My finding is confirmed by Ms Ghelani’s evidence that Novartis focused its advertising, promotion and visits to optometrists on education in relation to identification of wet AMD, so as to facilitate diagnosis, and the importance of early referral to an ophthalmologist for definitive diagnosis and treatment as appropriate.

65    The exception to my acceptance of Ms Ghelani’s evidence, to which I have referred at [63] above, is that I do not accept that the Novartis sales aid was about less than monthly dosing sustaining VA improvements: in my opinion the statements in the sales aid should be taken as conveying, to those who read them, that the product information stated that Lucentis was given monthly and, although less effective, treatment might be reduced to one injection every three months after the first three injections (e.g. if monthly injections are not feasible).

66    Dr Jan Twomey was the medical director for Bayer Healthcare Pharmaceuticals, a division of Bayer, since August 2010. She graduated from medicine at Flinders University at the end of 1991. She had full general registration as a medical practitioner and had held this continuously since 1993. In 2004, she was appointed Acting Medical Director for the phase 1 clinical trials unit at GlaxoSmithKline Limited for a short period before holding the position of Associate Medical Director at Wyeth Limited, now part of Pfizer Limited. In August 2005, she was appointed Area Medical Director/Director of Global Clinical Operations for Australia and New Zealand at Schering Plough and held that position until February 2010. As Medical Director she was responsible for: Medical Affairs (which was responsible, amongst other things, for compliance review of all promotional material for pharmaceutical products); Medical Information (which was responsible for providing medical information requested by internal staff, healthcare professionals and consumers); Pharmacovigilance; Regulatory Affairs; and Clinical Operations.

67    Dr Twomey had ultimate autonomy and authority to review, reject and, if appropriate, approve marketing materials. She said it was her practice to approve marketing materials only if she was satisfied that they complied with all applicable Australian or New Zealand medical and compliance requirements, including the scientific veracity of any such campaigns. This involved ensuring such promotional materials met the relevant requirements set out in the Code and the TGA and the TG Regulations.

68    Dr Twomey said that clinical papers and academic articles formed an important part of the way that Bayer promoted prescription medicines, including Eylea, to doctors and educated doctors on the mechanism of action, efficacy and dosage strength and regimen for medicines. She said that part of the training of Bayer’s Eylea sales representatives included training given by Bayer’s medical affairs department on eye diseases and the structure and mechanism of action of Eylea, including the associated clinical trials and academic papers. As part of the training, sales representatives were instructed to take copies of clinical papers and academic articles to meetings with ophthalmologists or arrange for a copy to be sent to a doctor who asked for a paper or article the sales representative did not have to hand.

69    Dr Twomey listed a number of such clinical papers and academic articles which were referred to in the process of preparing the marketing materials for Eylea, including:

(a)    VEGF-Trap: A VEGF blocker with potent antitumor effects, 99(17) Proceedings of the National Academy of Sciences of the United States of America (2002), August 2002, Holash et al (2002) (Holash et al);

(b)    VEGF Trap complex formation measures production rates of VEGF, providing a biomarker for predicting efficacious angiogenic blockade, 104(47) Proceedings of the National Academy of Sciences of the United States of America (2007), November 2007, Rudge et al (Rudge et al);

(c)    Predicted biological activity of intravitreal VEGF Trap, 92 British Journal of Ophthalmology (2008), March 2008, Stewart et al;

(d)    VEGF Trap-Eye for Exudative AMD, Retinal Physician (2009), April 2009, Heier (Heier);

(e)    Binding and neutralization of vascular endothelial growth factor (VEGF) and related ligands by VEGF Trap, ranibizumab and bevacizumab, Angiogenesis (2012), February 2012, Papadopoulos et al (Papadopoulos et al);

(f)    Intravitreal aflibercept injection for neovascular (wet) age-related macular degeneration, 13(4) Expert Opinion on Pharmacotherapy (2012), March 2012, Ohr et al (Ohr et al);

(g)    Intravitreal aflibercept (VEGF Trap-Eye) in wet Age-related macular degeneration, 119(12) Ophthalmology (2012), December 2012, Heier et al (Heier et al, elsewhere referred to as the VIEW study);

(h)    Different antivascular endothelial growth factor treatments and regimens and their outcomes in neovascular age-related macular degeneration: a literature review, 0:1-11 British Journal of Ophthalmology (2013), August 2013, Lanzetta et al (Lanzetta et al);

(i)    Visual and anatomical outcomes of intravitreal aflibercept in eyes with persistent subfoveal fluid despite previous treatments with ranibizumab in patients with neovascular age-related macular degeneration, 33(8) The Journal of Retinal and Vitreous Diseases (2013), September 2013, Kumar et al (Kumar et al); and

(j)    Conversion to aflibercept for chronic refractory or recurrent neovascular age-related macular degeneration, American Journal of Ophthalmology (1 July 2013), Yonekawa et al (Yonekawa et al).

70    Dr Twomey said she was responsible for approving and overseeing the approval of the marketing and educational materials for the Eylea campaign. She said this included a wide range of materials. She summarised examples of some of those materials, all of which were approved either by her or by staff within the medical department acting under her supervision. Her summary included: the first Detail Aid (from about May 2012 to around late June 2013); the second Detail Aid (from or around late June 2013); a document titled ‘Attendee Workbook’ that was to be made available for ophthalmologists attending the Eylea product launches in Sydney, Melbourne, Brisbane and South Australia on 24 October 2012; various speeches and presentations made at the Eylea product launches on 24 October 2012; and a large pull-up banner for use by the territory managers. I have reproduced this banner at [110] below.

71    Dr Twomey gave her understanding of the term ‘me too’. She said it referred to a medicine that was a copy of an existing drug with only minimal differences — i.e. structurally very similar, with a very similar mechanism of action, dosing regimen, method of administration and therapeutic effect to the existing medicine. In particular, it offered no real clinical advantage or disadvantage over the existing medicine. She said that Eylea was not a ‘me too’ medicine in relation to Lucentis, in particular: it had a different active ingredient; it had a different mechanism of action; and it had a different dosing regimen.

72    In cross-examination, Dr Twomey agreed that the clinical papers she had listed — set out at [69](g), (h), (i) and (j) above — post-dated the particular set of marketing materials she had referred to in her affidavit and so were not referred to or considered for the purposes of approving those marketing materials. She said she had identified those four papers because they had been used in ongoing preparation of marketing materials.

73    Dr Twomey was asked about the term ‘me too’. She agreed it was a term used in pharmaceuticals but did not have a technical or fixed meaning. She agreed that one would not describe a generic drug as a ‘me too’ drug: it would be called a generic drug. She agreed that ‘me too’ was an expression used to describe similar drugs, but minds could legitimately differ in terms of the spectrum of similarity. She said that some people might have a different interpretation of whether a drug is ‘me too’ or not and agreed that the core concept was similarity and the area for different opinions was on the extent of similarity.

74    Very little of Dr Twomey’s affidavit evidence was challenged in cross-examination. There was some question as to how much of the materials for the Eylea campaign Dr Twomey approved or was responsible for approving. In her affidavit, at [39], she said she was responsible for approving and overseeing the approval of the marketing and educational materials for the Eylea campaign and said that she summarised examples in the following paragraphs. But the details of her approval or responsibility for or oversight of the approval of most of the material at issue in these proceedings was not tested. Her evidence was given in a matter of fact and responsive manner. I accept Dr Twomey’s evidence. In particular, I find that the emphasis of the training of Bayer’s sales representatives given by Bayer’s medical affairs department was on eye diseases and the structure and mechanism of action of Eylea, including the associated clinical trials and academic papers. I also find that Eylea was not a ‘me too’ drug in the sense that it was not relevantly the same as Lucentis: it had a different active ingredient; it had a different mechanism of action; and it had a different standard dosing regimen.

The Bayer sales representatives

75    I come now to the written and oral evidence of the sales representatives called by Bayer.

76    The first Bayer sales representative to give oral evidence was Ms Radmila Grabovac, the territory manager for the city of Melbourne and north-west Victoria. She had tertiary qualifications in business marketing. There were approximately 140 ophthalmologists in her territory and of those about 45 were injectors. She was given extensive product training on Eylea, and on anatomy and macular degeneration. She also gave evidence that she read textbooks on her own as well as having face-to-face training. She spent most of April and May 2012 in training including a few weeks in Sydney, training as a team with other territory managers. She also received training on how to use a presentation about Eylea on her iPad (Detail Aid). She said that she was aware that the proceedings involved a dispute about two pages of the Detail Aid (the disputed pages). She also referred to a database used by Bayer, called Cortex, to record sales calls. She said that whenever she made a sales call to an ophthalmologist or optometrist, she entered details of the call into Cortex. It was her practice to put in “the main crux” of her discussion with the doctor, anything interesting that they mentioned and the objective of the next call. She exhibited these notes to her affidavit. She said that she only used the Detail Aid in an arranged face-to-face meeting, called a “sit down call”, and then where she had the opportunity unless there was a time restriction or the ophthalmologist made it clear they were not interested in seeing it. She said that in the time between approximately May and September 2012 the only other information she had to use was the Eylea product information. After using the Detail Aid once or twice in the first or second call with a doctor, she did not generally use it again. Occasionally she used it to stress or explain a particular point in relation to clinical information or to answer administration questions on storage or vial size, for example. She estimated that the number of ophthalmologists to whom she showed the Detail Aid was between 63 and 72, but that figure may have been too high. She said it was rare for her to show the disputed pages to ophthalmologists, and an ophthalmologist would only have seen those slides by accident and in passing on one of the rare occasions when she opened the Detail Aid during the actual sales call instead of having it already open at the MOA (mode of action) tab where it was her practice to have the Detail Aid ready. She estimated that this would have happened with a maximum of 3 to 4 ophthalmologists. She did not think that any doctor would have seen only the disputed pages. Once the VIEW study clinical paper was published in December 2012/January 2013, she said it was her practice to build on the information about that study in the Detail Aid by referring to the actual VIEW study clinical paper and handing it out. She also handed out other clinical studies to ophthalmologists in sales calls. Those studies included: Ohr et al; Holash et al; Kumar et al; and Yonekawa et al.

77    In her oral evidence, Ms Grabovac said there was a national sales manager and there were eight representatives who reported to the national sales manager directly. Each of them worked solely in relation to the selling of Eylea. During her training she was not provided with a sales manual or any document identifying key selling messages and there were not key selling messages she took into the field. She was familiar with the phrase but said “we were not given key selling messages for the Eylea role”. She said she had a training manual that looked at anatomy, clinical papers, a lot of clinical information because “our role was to provide clinical information to doctors.” She disagreed that her role was to sell as many products as possible. She said there were no specific messages she was given to give the doctors regarding Eylea. The training was based around product information, the VIEW study, predominantly, and that was the main crux of the information that the sales representatives were giving to doctors. She denied that she had in mind when she met doctors in the field a key selling message or key selling messages in respect of Eylea. When taken to a reference to “key selling messages” in the notes of one of her sit down calls, on 10 May 2013, Ms Grabovac said “key selling messages” would have referred to reducing the burden for patients, which appeared in the VIEW study in several cases, reducing the burden for patients with less injections, and that would be supported with information, and perhaps she would have spoken about less visits and less chance of an adverse event, which was also highlighted and supported by the VIEW study and product information. She said she believed she would have spoken about key selling messages but there would have been a lot of other clinical information that was delivered and she believed that she spoke about the way the doctor treated and also the growth of his practice and how he managed patients. Ms Grabovac was next taken to another reference in her Cortex notes to key selling messages. She was asked what the key selling messages were and she said that to the best of her recollection “I would have assumed that it would be reducing — perhaps reducing the burden, which is also in the VIEW paper; providing, perhaps, less injections, as demonstrated in the VIEW study; perhaps less cost for the patient. And … Less visits … and less cost.” She agreed that the benefits she had identified all resulted from fewer injections. She agreed that one of her responsibilities was to grow sales. She also agreed that when she actually had a product, at the beginning of December 2012, she did have a sales target and one of her responsibilities was to achieve that sales target. She said she did not remember a clear marketing message being given based on anything outside the clinical information. She said she was told to discuss information that was in the product information and the VIEW paper because there was not a product for the first year. She denied that she had been seeking to convince ophthalmologists about the benefits of fewer injections of the product since at least May or June 2012. She said the discussion she had with ophthalmologists initially, from what she recalled, was information gathering, discussing the product information and developing relationships. She was taken to her Cortex notes for a sit down call on 3 July 2012 with an ophthalmologist. She agreed that what she did with that ophthalmologist, after discussing the MOA, efficacy and administration was to discuss the benefits of Eylea for patients and less injections. She agreed that what she was doing from July 2012, as one facet of what the role entailed, was laying the platform for future sales. She also agreed that one of the ways she sought to lay the platform was to impart the message of less injections. She said the comparison was with Lucentis, because in the VIEW study that was the comparison.

78    Ms Grabovac was next taken to a sit down sales call for an ophthalmologist on 21 May 2012. The notes recorded: “[w]ent through MOA, efficacy, admin and discuss benefits to the patient of less injections but with optimal treatment.” After first denying that she was seeking to convince ophthalmologists of the merits of Eylea over Lucentis, she accepted that that was one of the components of her discussions. She said she would never say to a doctor “Eylea helps you and your patients with fewer injections” without drawing reference to a clinical paper or product information because that was actually contrary to Medicines Australia. She agreed it was part of her task to talk about clinical equivalence based on the VIEW study because the VIEW study did demonstrate clinical non-inferiority to the current standard of treatment and it was equivalent in efficacy and safety.

79    Ms Grabovac said she called on optometrists on a couple of occasions only, although she went to lots of meetings where ophthalmologists were presenting to optometrists. She agreed that some optometrists wanted to know about treatment options for discussion with their patients. She also accepted that she spent time with an optometrist and she had a hope of a referral meeting. She said the reason there were referral meetings was not always about education of Eylea: it was relationship building and it was also educational support for doctors, ophthalmologists and their referrers. She accepted that she would be happy for optometrists to discuss the product because optometrists on occasion have close relationships with ophthalmologists.

80    Ms Grabovac was asked for her understanding on whether ophthalmologists were not in fact required to administer either Eylea or Lucentis in accordance with what was said about dosing in the product information. She was aware of the practice of treating other than on guidelines. She said this seemed to be the practice of therapy that was tailored specifically towards the needs of the patient in terms of interval. She needed to discuss Eylea treatment intervals on label which was what was approved in TGA guidelines. If the doctor chose to treat at different intervals, that was his or her choice. Some doctors did PRN, some did treat and extend, and some treated on label, whether it be monthly or two monthly. It was really a tailor-made approach for each patient based on the discussion and the evaluation the doctor would make with his or her patient. It was their choice how they treated their patient. Some had the discussion that they extended out over eight or 12 weeks. There was a range of practices.

81    In relation to the Detail Aid (iPad) Ms Grabovac’s evidence was that it was rare for her in sales calls to show the disputed pages (which were under the “Home” and “Summary” tabs). To the question whether the mode of action of Eylea was being explained to explain why there were fewer injections required with Eylea, Ms Grabovac answered “On occasion, yes”. She could not estimate the number of such occasions.

82    It is not a straightforward matter to evaluate Ms Grabovac’s evidence. Plainly she was nervous and uncomfortable giving evidence and volunteered that it was her first time in a court. Also she had some difficulties in understanding the more complex questions she was asked. On occasions she appeared reluctant to accept the obvious and was overly cautious in her answers. She was overly keen, in my view, to emphasise the informational aspects of her work rather than the selling of Eylea. But I find that she was truthful and I accept her evidence. In particular, I find that in her dealings with ophthalmologists and optometrists Ms Grabovac did not refer to fewer injections in the abstract but with reference to the product information, or a clinical paper, and the VIEW study paper once it became available. As to the disputed pages of the Detail Aid, I find that three or four ophthalmologists saw those pages in passing in the course of Ms Grabovac’s visits but in the context of the balance of the pages.

83    The second Bayer sales representative to give oral evidence was Ms Elibol. In her affidavit she said her sales territory was eastern Victoria. She replaced Ms Reznichenko as the Eylea territory manager for eastern Victoria when Ms Reznichenko was promoted. (Ms Reznichenko also gave evidence, which I consider below.) Ms Elibol said there were approximately 128 ophthalmologists in her territory and she shared approximately 15 of those with Ms Grabovac. She has a Bachelor of Science, a Diploma of Health — Medical Laboratory, and a Graduate Diploma in Business Systems. She said she had two weeks of training, including formal training from Bayer. She was shown how to use the Detail Aid on the iPad. From December 2012 to January 2013 she said the vast majority of her time spent with ophthalmologists and clinic support staff was spent answering logistical questions from doctors and clinic support staff such as: (a) How do I obtain Eylea? (b) How do I write a prescription for Eylea? (c) How many repeats do I need to prescribe? (d) How do I fill out the Medicare form? (d) What temperature is it stored at? and (e) What is Eylea’s shelflife/expiry date? Ms Elibol also annexed to her affidavit her Cortex notes. Her Cortex summary showed that she visited a total of 60 ophthalmologists and had at least one sit down call with each ophthalmologist during the period from 7 May 2012 to 21 June 2013. She said she did not recall using the Detail Aid at all during her first six months with Bayer from October 2012 to March 2013. She estimated she had used the Detail Aid approximately 3 to 4 times in sit down calls with ophthalmologists since March 2013. She did not recall ever using the “Summary” or “Home” tabs or the disputed pages within them. She said it was her practice only to use the Detail Aid in a reactive way, that is, if an ophthalmologist had a question. It was her practice to use the product information and clinical and academic papers about Eylea to answer any questions asked of her by ophthalmologists. She said she used the following clinical and academic papers as they became available: Holash et al; Ohr et al; Heier et al; Kumar et al; Yonekawa et al; and Lanzetta et al.

84    Ms Elibol estimated that approximately half the ophthalmologists in her territory injected for wet age-related macular degeneration. She said she did not conduct sales calls on optometrists and therefore did not show the Detail Aid to any optometrist.

85    In cross-examination, Ms Elibol was asked whether the statement “Eylea helps you and your patients with fewer injections” was the key marketing message for the sale of Eylea. She said she could not really answer that with a full yes or no because when she spoke about key messages she spoke about higher binding affinity, different molecule, that the eight weekly dose gave the same results as the four weekly dose. She said the key message of fewer injections with Eylea did not make sense to her. She said she would not discuss and say just there were fewer injections with Eylea. That needed an explanation. It depended entirely on the doctor and what the doctor was interested in: whether he or she wanted to know about the molecule, the mode of action, the trial design, the type of patients he was treating. The relevant transcript was as follows:

Q    … So what you needed to do in order for ophthalmologists to consider switching over to your company’s product, EYLEA, was to point to some key difference in the products which he or she might find persuasive, a persuasive reason to change their existing practices. Do you agree with that?

A     Because you mentioned key differences – I’ve pointed out key differences, because there has been patients that don’t respond to Lucentis that can respond to EYLEA because of difference in molecule design, difference in higher binding affinity, longer duration. So it’s - - -

Q     Yes. Yes. Longer duration – can I ask you about longer duration? … If you pointed out longer duration, what you’re pointing out is that there would need to be fewer injections, because it lasts longer? Is that right?

A     Yes, because it has got a higher binding affinity. It has got a lower dissociation constant … So once it binds, it doesn’t let go.

Q     Yes. So did – can I just suggest to you - - -?

A     But not in all patients. I’ve got to just – it’s not in all patients. It’s just what’s in the study…

Q     But you did point out from time to time, can I suggest to you, to ophthalmologists, that this product requires fewer injections than Lucentis?

A     Whenever I have pointed that out, it has been in reference to the VIEW trial or to the product information.

Q     Yes. Yes. Yes. I’m just asking whether you did point that out?

A     Yes. It’s in the trial – yes … It’s mentioned several times in the trial.

Q    Yes. But you did point it out regularly, did you not, in your interactions with ophthalmologists, that EYLEA meant fewer injections for the ophthalmologist’s patients?

A     Did I mention it regularly? … How would you define regularly? Sorry. Because I really concentrate on – I concentrate on my trial design, I talk about, again, the molecule design, it’s a human fusion protein, I – it’s level 1 evidence, the type of patients that were involved in the trial, how it might work for some patients where Lucentis doesn’t respond. So – I mean, I wouldn’t just go in there and just talk about fewer injections, fewer injections – it would have to come after a discussion.

Q    Yes. And you’re not saying, are you, to his Honour that you never told a single ophthalmologist that EYLEA meant fewer injections – “Helps you and your patients with fewer injections”?

A     Have I not – have I - - -

Q    You’re not saying, are you, that you never said that to an ophthalmologist?

A     No, I have said it.

…

Q     Just focusing on the words, “EYLEA helps you and your patients with fewer injections.” Is it your evidence, Ms Elibol, that that statement – just that statement, “EYLEA helps you and your patients with fewer injections,” is misleading?

A     Just that sentence, is that misleading? “EYLEA helps you and your patients with fewer injections.”

…

A     What’s my belief? Like, what I think it is?

Q     Yes. Yes?

A     “EYLEA helps you and your patients with fewer injections,” I would like to know what is that compared to, personally, myself, if I saw that statement. Fewer injections compared to what?

Q     Yes. Well – Lucentis?

A     Okay. Fewer – in what way, I would want to know. Like, fewer injections in what way? How do you – what do you mean by fewer injections? That’s what I would want to know.

Q     All right. Thank you. Because that statement may be misleading?

A     Well, it just wouldn’t - - -

…

Q     The statement, “EYLEA helps you and your patients with fewer injections,” just that statement?

A     And so don’t look at the other thing – when you used according to – don’t look at that?

Q     Yes. Yes?

A     It wouldn’t make sense to me.

Q     Right. Why?

A     Because I - - -

Q     Because you don’t know what it’s comparing it to?

A     Yes. Like – yes. Comparing it to and how dosing - - -

Q     All right. Well, just let me ask you this: it would be obvious, wouldn’t it – no. I will just leave that. I will leave that topic.

86    Ms Elibol was asked whether it was her understanding that a key message to communicate to physicians was that Eylea had comparable efficacy and safety to ranibizumab with fewer injections and she answered “Yes”.

87    Ms Elibol was asked whether she became aware of the summary results of the VIEW extension study soon after she started with Bayer. She said only from what she heard a few times from doctors from what they had heard from Novartis.

88    I found Ms Elibol to be a frank, forthright and truthful witness. I accept her evidence. In particular, I find that whenever she pointed out that Eylea required fewer injections than Lucentis it was with reference to the VIEW trial or to the product information. As to her use of the disputed pages, I find that she did not show the disputed pages to the ophthalmologists she visited and those ophthalmologists would not have seen those pages during her visits to them.

89    Ms Susan Adams was the third Bayer sales representative to give oral evidence. She was employed by Bayer as an Eylea territory manager between May 2012 and July 2013. Her territory was southern New South Wales and the ACT. Her customer base was made up of all the retinal specialists in her territory and some general ophthalmologists who managed patients with wet AMD. She has a Bachelor of Science and a Diploma of Education. She said she did not receive the same level of formal training as the rest of the team because she joined late and already had a very good knowledge of the treatment of wet AMD from her previous employment. She received an iPad with information about Eylea on it (Detail Aid) and she thought she received some training on the iPad but did not remember the details. She also exhibited to her affidavit her Cortex notes. She said that she made sales calls on 86 different ophthalmologists. She listed 24 where she was fairly confident that she did not show the Detail Aid to them and of the remaining 62 ophthalmologists she could not recall how many had seen the iPad presentation, although it was certainly not all. She said that the retinal specialists she dealt with were very well informed about Eylea and the timelines for its availability from data presented at congresses, international educational meetings and journal papers. She said their general reaction to Eylea was that they were pleased to have more than one drug available so as to have an alternative to Lucentis. She said she was told by some ophthalmologists that between “about 10% and 30% of their patients” were confined to monthly Lucentis and could not be “stretched out”. She was informed by retinal specialists that they were looking forward to the possibility of being able to extend treatment for these patients with Eylea. In relation to the Detail Aid she said to the best of her recollection she did not open the “Summary” tab but ophthalmologists may have seen pages under the “Home” tab when she was opening up the presentation, but that was rare and never intentional. To the best of her recollection, no doctor only saw the disputed pages. Ms Adams made a second affidavit as to her possession and use of the two baby banners.

90    In cross-examination, Ms Adams was first asked about the use of the poster and the baby banners.

91    As to her period in a sales role, she agreed that she had key performance indicators and agreed there were specific sales targets in terms of units sold. She agreed that one of the aspects of her job was to secure as many new or initiating patients to use Eylea and another aspect was to convince ophthalmologists to use Eylea instead of Lucentis with their existing cohort of patients. She said her approach was not to seek to achieve switches irrespective of whether the patients were being treated on a four weekly interval or an inject-and-extend basis or a PRN basis. She said she was not out to switch all patients, that was not her approach to the role. She agreed that in her training, her briefing from people from marketing involved discussion of such things as a key selling message. The witness was asked the following questions and gave the following answers:

Q     … the key selling message was that EYLEA helps you and your patients with fewer injections?

A     When used according to the approved dosage.

Q     Well, I – yes, I - - -?

A     Yes. It’s not just - - -

Q     I see you looking at the poster. My proposition, I – what I’m putting to you was that marketing people explained to you that the key selling message was that EYLEA – EYLEA’s key point of differentiation from Lucentis was that it involved delivery of fewer injections?

A     Compared to the standard of care, which is monthly Lucentis.

Q     Well, fewer injections than Lucentis?

Q     No, compared to the standard of care.

Q     Right. You knew, didn’t you, from your long experience in this very specific AMD field, that many ophthalmologists did not inject on a monthly basis beyond the initial three months. Correct?

A     Yes.

Q    Yes. Thank you. Many engaged in the inject-and-extend method?

A     Yes.

Q     Yes?

A     I would say there would be quite a few, yes.

Q     Yes. And extended their patients out for the interval between injections. Extended out - - -?

A     If appropriate, yes.

Q    - - - if appropriate, sometimes to eight or more weeks. Correct?

A     Yes.

92    Ms Adams agreed that there was a growing trend from 2007 that a greater number of ophthalmologists were treating the disease of wet AMD. There was a growing number of injectors. She agreed there was a cross-section of the ophthalmic community that injected with either Lucentis or Eylea. She agreed that in her experience many ophthalmologists would have professional relationships with particular optometrists who referred patients to them.

93    The following exchanges occurred:

Q    … now, Ms Adams, it was a constant theme of your interactions with ophthalmologists, wasn’t it, that EYLEA required fewer injections than Lucentis?

A     Yes, in the context of the VIEW study. Yes.

Q     Yes. And another aspect which could fairly be described as a constant theme of your interactions with ophthalmologists is that fewer injections had real benefits for both patients, carers and clinicians?

A    Yes.

Q     And when you said in the context of the VIEW study you thought that that study established that fewer injections were required?

A     When compared to – monthly with Lucentis, when compared to the standard of care, yes. Yes.

Q    You were looking at the poster when you gave that answer?

A     I’m looking at that. Yes.

Q     And reading out the third and fourth lines of the poster?

A     Yes. Yes.

Q     Right. When – in this market, for all practical purposes, given that although there was a drug called Avastin, it wasn’t PBS listed, when you used the expression “Fewer injections,” you were speaking, at least in many cases, to an educated audience of ophthalmologists. Correct?

A     Yes.

Q     And to your understanding, when you used the expression or words to the effect of fewer injections, it would have been obvious to them that you meant fewer injections compared to Lucentis, because it was the only other or the dominant alternative on the market, don’t you agree?

A     No. Compared to monthly Lucentis, because - - -

Q    Pardon?

A     No. Compared to monthly Lucentis, the ... required fewer injections.

Q     Yes. Yes. Sticking to the - - -?

A     You cannot apply that for all patients, because that’s the truth. You can’t say “EYLEA requires fewer injections” because every patient responds differently to the drug.

Q     Yes. Yes. But you routinely tell ophthalmologists that EYLEA required fewer injections than Lucentis, didn’t you?

A     No. When it’s dosed monthly.

Q     Are you able to point to any entry in your Cortex notes where you refer to fewer injections, which make it clear that you spelt out “When it’s dosed monthly”?

A     Probably not, because these notes are a summary. They were my summary. I was not aware anyone was going to be looking at them. And I know that I always use this in the context of the VIEW study. I’m not going to write that in every – every time I write a summary of the Cortex notes. So no, it won’t appear there.

Q    You knew, didn’t you, that the first year of the two VIEW studies had as part of the protocol that Lucentis was, in that first year, administered monthly?

A     Yes.

Q    Correct?

A     Yes.

Q     Yes. You also knew, based on your experience – I think you’ve already accepted this – that many ophthalmologists did not inject Lucentis on a monthly basis after the first three months?

A     Yes.

Q     Right. Thanks. Now, it’s the case, isn’t it, to your understanding, that there’s no legal requirement or obligation for ophthalmologists to administer according to or in line with the product information for a particular product? Do you agree?

A     Yes.

94    Ms Adams was asked a series of questions as to whether or not she had access to information about the second year of the VIEW studies and whether or not she discussed that information with the doctors on her calls. It appears that on at least one occasion a doctor was putting to Ms Adams what had been raised with him by the Novartis sales representative. The following exchange occurred concerning an entry in Ms Adams’ Cortex notes:

Q    The reference to the ... to the number of injections of Lucentis and EYLEA being the same is a shorthand reference by you to the results of the second year of the VIEW study, isn’t it? Because that’s what those results showed: similar outcomes for the same number of injections?

A     Yes. It could have been but, again, in the context, it would have been they were taking that second year in isolation and, again, that’s inappropriate. We need to look at the first year as well.

Q     And to the extent there was a differentiation in the first year, that was driven entirely by the protocol, wasn’t it, which mandated that Lucentis would only be injected monthly. Do you agree?

A     Which, ethically, was required because it is the standard of care; it is the best treatment regimen for Lucentis. It gives the best outcome.

Q     It wasn’t the typical treatment regimen, though, in Australia, was it?

A     It was the standard of care at the time the trial was set.

Q    The standard of care – you mean, by reference to product information?

A     Yes, and also evidence based as well. But yes, it was the standard of care at the time.

95    In my view, Ms Adams was a careful and impressive witness. I accept her evidence. In particular, I find that she did not say to the doctors she visited as a Bayer sales representative that, in the abstract, Eylea meant fewer injections for patients but spoke in terms of the product information and the VIEW study. I also find that any sighting by those doctors of the disputed pages of the Detail Aid were, at most, fleeting.

96    Ms Naomi Leonard was the fourth Bayer sales representative to give evidence. Her sales territory was Western Australia and, as of August 2013, the Northern Territory. Before her current role she had, amongst other things, been employed in various sales roles by Pfizer for twelve-and-a-half years and for five of those years she sold glaucoma medication. Before working in the pharmaceutical industry she was a registered nurse. In or around March to May 2012 she completed about eight weeks of training with the other Eylea territory managers employed by Bayer. During the course of the training she received an iPad containing information about Eylea (Detail Aid). She said that on or around 7 May 2012, she began visiting ophthalmology clinics with the Detail Aid and the product information for Eylea and two clinical papers: Ohr et al; and Holash et al. She referred also to leaving behind with ophthalmologists other clinical papers, those by Kumar et al and by Yonekawa et al. She also exhibited to her affidavit her Cortex notes. She used the Detail Aid both in desk calls, which were unscheduled meetings, and sit down calls, which were scheduled appointments. She estimated that she used at least part of the Detail Aid with about 48 of the 60 ophthalmologists she called on. She did not remember showing any ophthalmologist the disputed pages. She said that most of the doctors she saw only wanted to see how the molecule worked, the results of the VIEW study, and safety information. She said that to the best of her recollection, it was highly unlikely that any doctor saw just the disputed pages and no other pages of the Detail Aid. Her Cortex notes showed that she visited one optometrist, who worked in an ophthalmology clinic. She said it was likely she showed the Detail Aid to that optometrist. She could not be sure whether he saw the disputed pages.

97    In cross-examination, Ms Leonard accepted that her job was to sell a product for her company and it was all about differentiating Eylea from Lucentis. The following exchanges occurred:

Q     And it was important in your sales campaign, if EYLEA was to establish a foothold in the market, that it be differentiated in a clear and decisive way from Lucentis. Correct?

A     And that’s what it was developed for, yes.

Q    Yes?

A     Yes.

Q     And the VIEW studies really established that it couldn’t be differentiated for clinical efficacy or safety, because it was – the result showed non-inferiority, so you had to distinguish on some other basis other than clinical efficacy or safety ... suggest, and that was fewer injections?

A     Based on – yes, the efficacy – the efficacy having different end – different usage to times, so the eight weeks versus the four weeks, yes, that’s correct.

Q    Fewer injections?

A     Yes, that’s one of the – the differences.

Q     Yes. Well, it’s the principal difference, isn’t it? As presented by you to ophthalmologists in the field?

A    Yes, one of the differences, yes.

Q    It’s the principal, is – it’s the principal difference, isn’t it?

A     Yes, it’s – it’s – based on the VIEW data.

…

Q    Ms Leonard, you, in your interactions with ophthalmologists, thought that the VIEW study established that fewer injections were required with EYLEA than Lucentis and that’s what you told clinicians?

A    Yes, where appropriate. You know, depending on the patient.

98    Ms Leonard agreed that she had regular catch-up meetings with her national colleagues and had telephone hook-ups as well as physical catch-ups. She agreed that they discussed what key messages were resonating with ophthalmologists and she agreed that the key message which was resonating was fewer injections.

99    At the end of Ms Leonard’s cross-examination the following exchange occurred:

A     … We were discussing and had been given the information for efficacy and safety based on VIEW first year data. And, actually, most of the time, we had the other papers and product information.

Q     And when the VIEW study for the first year became available, you gave that     out?

A     Yes.

Q     And you said it demonstrated that EYLEA meant fewer injections?

A    When used according to the product information, yes.

Q     Yes?

A     Because it’s eight-weekly versus the four-weekly.

100    Ms Leonard gave her evidence in a frank, straightforward and truthful manner. I accept her evidence. In particular, I find that she did not say to the doctors she visited that, in the abstract, Eylea meant fewer injections for patients but spoke in terms of the product information, the VIEW study and the papers to which she referred in her evidence. I also find that any sighting by those doctors of the disputed pages of the Detail Aid were not isolated from the balance of the material in the Detail Aid.

101    Ms Michele Doyle was the fifth sales representative called by Bayer. Her territory, from 12 March 2012, was South Australia and Tasmania. Her responsibilities as a territory manager included promoting and selling Eylea for wet AMD, conducting educational meetings on the management of wet AMD and managing her territory to enable adequate coverage of all retinal specialists and their clinics. She said there were approximately 84 registered ophthalmologists in her sales territory. In Tasmania there were six retinal specialists and three general ophthalmologists who injected for wet AMD. In South Australia there were 29 injecting ophthalmologists. She had been a registered nurse for 20 years and after that she had also been a representative of a number of pharmaceutical and medical companies from 1988. She received eight weeks’ training in March and April 2012 along with other members of the Eylea sales team. She also received four days’ practical training from retinal specialists at the Adelaide Eye & Retina Centre and Hobart Eye Surgeons. She received training for an additional day at the Launceston Eye Institute. In her last week of training she was given an iPad by Bayer and an application known as the eDetailer was installed onto the iPad (Detail Aid).

102    Ms Doyle also exhibited her Cortex notes to her affidavit. According to that summary, she had sit down calls with 59 ophthalmologists from 7 May 2012 to 21 June 2013 inclusive. She said that all the ophthalmologists she called on to discuss Eylea told her that he or she had heard about Eylea at a conference they had attended overseas and that he or she was aware of the VIEW studies. She said the ophthalmologists she visited were aware of the VIEW studies before they had been published. She said she could not recall showing the disputed pages to any ophthalmologists. She said she did not like using those pages as she considered them to be too commercial. She said that she had observed that many doctors had made comments to the effect of “don’t show me the glossies” when she had attempted to show them the commercial advertising in a detail aid. Based on that experience, she said, she was aware that doctors were only interested in evidence-based medicine and clinical data showing the results. She gave as examples of the questions she was asked: “When is Eylea going to be available?”; “When is Eylea going to be PBS listed?”; and “I want to be able to switch my non-responders to Eylea, can I do that?” After her initial appointments, she said, the subject matter of her discussions with ophthalmologists moved from Eylea’s product characteristics and the results of the VIEW studies to more practical issues. She gave as examples: why Eylea was not approved for switch patients until just before the launch in October 2012; the letter or email written by Dr Beaumont saying that there was an increased risk of stroke for patients over 85 using Eylea; and when Eylea was first PBS listed, Medicare only reimbursed patients for three injections in the first six months. Bayer covered the cost of the fourth injection until Medicare changed its policy, which took a number of months.

103    Ms Doyle said it was also her practice to refer to the following materials in sales calls with ophthalmologists: the Eylea product information and clinical papers as they became available, including the Ohr et al, Heier et al, Kumar et al and Lanzetta et al papers.

104    In cross-examination, Ms Doyle was taken to her experience of product launches and differentiating the product from any existing product. She said that success of a product launch involved not only differentiating the product but it also involved credibility, product knowledge, knowledge of the diseased state and good communication with the prescriber. She agreed that there needed to be good clear communication of a good clear message about the product. The following exchanges occurred:

A    … The sales department, obviously, always work closely with marketing. Marketing obviously set the – the selling message and it’s up to the sales force to interpret and – and put it forth to the prescriber.

Q     And that’s – I take it that answer occurred here in the context of your interaction with the marketing department – the identification by the marketing department of the message to be taken forward by the sales team?

A     Always based on the results of the VIEW study.

Q     Yes. Yes?

A     So based on the VIEW study, equal efficacy, equal safety as Lucentis but fewer injections.

Q     Thank you. Now – and that, in a nutshell, is the message you sought to take into the market?

A     In – yes.

105    Ms Doyle agreed that her key roles were to promote and sell Eylea for neovascular wet AMD.

106    She agreed that in theory one would expect ocular nurses, orthoptists and optometrists to discuss with ophthalmologists the benefits of Eylea. She said, however, that from her experience that was not how it worked. As far as the orthoptists and ocular nurses went, her selling job was made easy. When she first got out in the field, everybody knew about Eylea because the retinal specialists had heard about it from overseas conferences and they would come back and talk about it. They were waiting for it. She discounted the effect of the mivision magazine. She said she did not visit optometry rooms. She said that it was the specialists who advertised their clinics to optometrists because they knew it was the optometrists who referred patients to them. She said she believed it was important for optometrists to learn about the benefits of Eylea. Optometrists should know what options were available for their patients. She agreed that it was important for optometrists to know about the particular benefits of Eylea because she would expect them to discuss those benefits of that treatment with their patients.

107    Ms Doyle said she found the Bayer marketing department very different from marketing departments in other companies. At Bayer, there had never been the hard push, the hard sell or the single selling message. She said that she had not discussed at the meetings between members of the marketing and sales departments selling messages but obviously she had discussed the benefits of Eylea, all based on the clinical studies. She agreed that the principal benefit as she understood it was the fewer injections proposition. She said that she did not remember as a topic selling messages being part of what was said at meetings with the marketing department of Bayer. By this she meant there was never a session on selling messages but there was discussion about selling messages.

108    In my assessment, Ms Doyle was a senior and experienced representative with the additional qualification of many years’ experience as a nurse. She was frank and direct in her answers to questions. I accept her evidence. In particular, I find that she did not say to the doctors she visited that, in the abstract, Eylea meant fewer injections for patients but spoke in terms of the VIEW study. I also find that she did not show those doctors the disputed pages of the Detail Aid and they did not thereby see them.

109    The sixth Bayer sales representative to give oral evidence was Mr John Burstow. He had been an Eylea territory manager since March 2012. His sales territory included Southern Queensland, northern New South Wales and the cities of Cairns, Mackay, Rockhampton and Gladstone in northern Queensland. He has an applied science degree and was studying for an MBA. He was completely new to the field of ophthalmology when he started as a territory manager. The induction training that he was given lasted for eight weeks. It included training about general ophthalmology, the history of macular degeneration, Eylea and other treatment options for wet AMD. He was given an iPad and was able to access information about Eylea on the iPad via the eDetailer software application (Detail Aid). He also exhibited to his affidavit his Cortex notes. He said he used the Detail Aid in sit down calls. He had sit down calls, to his recollection and according to his Cortex notes, with 48 ophthalmologists between 7 May 2012 and 21 June 2013. He did not recall ever using the disputed pages. Initially, the only other material that he referred to was the product information for Eylea. As various clinical papers and review articles relating to Eylea were published, it was his practice to discuss them in his sales calls with ophthalmologists and leave a copy behind if requested. The clinical papers and review articles included those by Heier et al, Lanzetta et al, Kumar et al and Yonekawa et al. He visited a total of four optometrists and had at least one sit down call with each during the period 7 May 2012 to 21 June 2013. He estimated that he showed two of those four optometrists the Detail Aid. He did not recall ever using the disputed pages with the optometrists. On 3 and 4 August 2012 he attended the Queensland RANZCO conference on the Gold Coast.

110    In cross-examination, the following exchange took place:

Q     … you knew, didn’t you, that the protocol – tell me if I’m using the wrong language – but the VIEW 1 and VIEW 2 studies had a protocol which required Lucentis to be, for the purposes of the trial, administered on a monthly basis?

A     Yes, that’s correct. For the first 12 months.

Q     The first year. You knew in practice, didn’t you, from your work in the field and your education that, in fact, a lot of clinicians, in fact, use Lucentis on an inject-and-extend basis?

A     I would say there’s a lot who use it to the label who do use it monthly but there are some who use it less than monthly for a number of reasons.

Q     Yes?

A     But, yes, there are certainly – who follow the guidelines, the recommended dosing schedule and others who use it less frequently.

Q     Yes. Yes. Either inject-and-extend or PRN?

A     Yes. But there are a lot who treat to the label as well.

Q    I know. You’ve said that three times. I’m asking you about inject-and-extend and PRN?

A     Yes. There’s certainly clinicians who do that as well.

111    Mr Burstow was then asked questions about the sheet which was the approved artwork for a large pull-up banner, and about the banner itself, the banner being displayed at the meeting of the Queensland branch of RANZCO on 3 and 4 August 2012. The sheet was as follows:

112    He was asked and answered as follows:

Q     … where on the sheet does it indicate that the VIEW study mandated, as part of its protocol, that – for the purposes of the trial, Lucentis was to be injected monthly?

A     Well, you can see the treatment design.

Q    Pardon?

A    So if you look at the top right – sorry, top left-hand box, you will see the study design. And you can see down the bottom right-hand corner in that box you’ve got ranibizumab and you can clearly see “Administer” .5 milligrams Q4, which every doctor would understand to be a monthly treatment.

Q    Yes. Yes. But where does it say that that was mandated by the protocol of the study?

A     Well, I guess, to my understanding that is the design of the trial so - - -

Q     No. But - - -?

A     - - - you know, that’s clearly showing the design of the trial, which every clinical paper would do – would have a methodology and, you know, you can clearly see the different four arms – the four main arms of the trial.

Q    Yes. But is there anything else on this page which you say indicates that the protocol for the study - - -?

A     Monthly, yes - - -

Q     - - - dictated - - -?

A     Well, you can see prove non-inferior, it’s a monthly ranibizumab - - -

Q     Yes. Yes. But - - -?

A    - - - up the top, again, like I said, in the top left-hand box.

Q     Yes?

A     The box next to it, the top right-hand box, you’ve got the 94 per cent box which – down the bottom – says, again, Q4, which is understood as monthly.

Q    Yes?

A     So, yes, there’s quite a few, actually.

Q    Yes. But where does it say here that the study required, as part of its scientific protocol, that Lucentis only be injected monthly in the first year?

A     Yes. Well, to me, it clearly identifies that in the top left-hand box. So you’ve got – I will take it – I will take you through it. So you’ve got – all the patients are randomised, one to one to one, and then you’ve got an aflibercept arm and then you’ve got a ranibizumab arm.

Q     Yes?

A     And then you can clearly [see] that. Then the aflibercept was divided into three groups and two milligrams administered monthly, .5 milligrams administered monthly and then 2 milligrams administered Q8.

Q    Yes. Yes. Yes?

A     And then you’ve got, in the ranibizumab arm, .5 milligrams administered, you know, Q4, so monthly as well. So every clinician – I would, you know, be very comfortable to say – who attended that meeting would read that – would have a 100 per cent clear idea about that’s the monthly treatment for Lucentis.

Q     Yes. Yes. I’m not asking about whether it was a monthly treatment. Where does it show - - -

…

that that was mandated by the protocol of the study?

A    Are you asking me – so you get my point it’s clear that it was monthly. Are you asking me - - -

Q    Where does it indicate that - - -?

A     Why it was designed or - - -

Q    - - - that was a requirement of the study?

A     I go back to that same box.

Q     Right. Okay?

A     You know, so every patient is in one to one to one, they’re either in four groups – they’re in the EYLEA two milligrams monthly, .5 monthly, two milligrams over eight weeks after three monthly injections or the ranibizumab group, Lucentis, .5 monthly.

113    He was then asked questions about whether, by the time of the Queensland RANZCO conference, the results of the second year of the VIEW 1 and 2 studies were known to Bayer. He agreed that by the time of the conference, the results of the second year of the VIEW 1 and 2 studies might have been known but said they were not published. The essence was as follows:

Q     … Are you in a position, Mr Burstow, to explain why this information shown on the pull-up screen omitted any reference to the second year of the VIEW 1 and VIEW 2 studies, given that the results were known to Bayer by that time?

A     Sure. I guess in Australia we have a very strict, you know, code of compliance with what we can talk about and not talk about. And, you know, studies, you know, once the results are known they have to go through – you know, be published and there’s a process in which that takes – so, I guess, at that moment we were able to use, you know – at that time, we were able to use, you know, the VIEW 52 week’s data and then, you know, as we have done now, you know, we incorporate the 96 week data as well. Additionally to your question, the second part of that data – so the 96 – that second year which you’re referring to wasn’t, you know, I guess – the design protocol wasn’t something that’s probably, you know, similar to how the doctors would use a drug in Australia. So, you know, at the time of the conference, that’s the only data which we could actually put forward, because the rest of it wasn’t published. And, you know, that’s the gold standard of treatment, you know, which the trials were comparing to, so that’s what we had to present at that time.

…

What Mr Burstow said on this issue of compliance was his understanding.

114    Mr Burstow agreed that it was important, in his opinion, that the benefits of Eylea be explained to optometrists as well as ophthalmologists. In his opinion, it was important for the optometrist to understand the drugs that were being used to manage the patients and build the relationship with the ophthalmologist as well so they could co-manage the patients. He agreed that there was a lot of co-management that happened in Queensland where optometrists and ophthalmologists were working closely together with particular patients and part of their working relationship involved discussing between themselves different available treatments for a particular ophthalmic issue. That was one of the reasons why time was invested by Bayer in facilitating referral meetings and education meetings between ophthalmologists and optometrists.

115    Mr Burstow was asked the following questions and gave the following answers:

Q    And one of the reasons you take the baby banners along to those meetings is because so far as you understood it, they captured quite succinctly the key benefit of EYLEA?

A     Yes, it’s just, I guess, raising awareness of EYLEA.

Q     Yes?

A     Initially, you know, a lot of ophthalmologists – sorry, optometrists were really interested in the drug, so we’re keen to get some information about it.

Q     Yes. Yes. But the message on the banners, you understood to be the – no, I withdraw that. You certainly were of the view, weren’t you, that the principal benefit of EYLEA was that it would permit fewer injections which would reduce the patient burden than would be involved with Lucentis?

A     I think that’s a key – a key point amongst sellers.

Q     Yes?

A     Yes.

Q     Yes. It’s – but really is the key – was the key point, wasn’t it, in the whole campaign, the fewer injections message?

A     I wouldn’t say it’s the only key, but I would say it’s an important, you know, point.

Q     It’s one of the most, if not the most, important benefit, isn’t it, as you understood it?

A     Yes, it’s an – it’s an important point, you know, amongst others.

Q     But well, because, this is correct isn’t it, because fewer injections ease the burden for patients and that was a very powerful message, as you understood it?

A    Yes, that is, absolutely.

Q     Yes. And that’s the message you took around Queensland as you sought to promote this new product that there are great benefits, particularly for patients, but also for carers and doctors with fewer injections. And the product used, if you wanted fewer injections, was EYLEA. Do you agree?

A     Yes, we took that message, but we also took other messages as well.

Q     Yes. But what I’ve put to you is one of the central messages?

A     It was certainly one of the central messages amongst others, as I said.

Q     Yes?

A     Yes.

116    Mr Burstow was taken to one of his Cortex notes in relation to a sit down call with an ophthalmologist on 20 May 2013. The note read, in part:

… he has used but has not seen much of a difference btw both drugs – asked to explain – we discussed VIEW trials show no diff btw outcomes just that these outcomes can be achieved with less injections – he has been able to extend a few pxs out a bit further but still early days, discussed molecule design, mathematical model and reasons why it lasts longer in the eye, discussed medicare resolution and can px monthly if required – flexibility

The cross-examination was as follows:

Q    … That’s not atypical summary of the type of discussion you had with many of the ophthalmologists you saw in the course of the campaign?

A     I guess it’s hard to say that they’re all similar, like every conversations, quite different.

Q     Yes. But the general thrust of what you recorded - - -?

A     Of that conversation?

Q     Yes, is – was not unusual type of discussion you would have in the context of your interactions with ophthalmologists?

A     Yes, absolutely, you know, amongst other things. It’s obviously, I guess to me, what I’m saying there is – yes, the doctor is not seeing any efficacy differences, but, you know, then I’m obviously talking about you can achieve the same efficacy with less injections, you know, which is what is reflected within the VIEW trials.

Q     Yes. All right. Now, there was a bit of a concern, wasn’t there, around the time of the PBS listing. I don’t know whether it was before or after, perhaps you will be able to know better than me. There was a bit of a concern, wasn’t there, that some – probably after the PBS listing actually, that – that some doctors were finding they had to – had to inject EYLEA more frequently than once every eight weeks and – but that the PBS approval only allowed the subsidised price on a eight week cycle rather than a six week cycle, correct?

A     Do you mean after the initial three monthly loading doses?

Q     Yes. Yes?

A     Yes. There was some doctors who found that and now, you know, Medicare has, you know, the PBS system has – has – has changed all that.

Q     Yes. So the – and that was a bit of an issue, wasn’t it, across the – around the count[r]y. You understood it, including in your own region, where doctors were reporting that well, they actually got a finding that they were needing to inject having switched to EYLEA or initiated with EYLEA - - -?

A     Yes.

Q     - - - or finding they had to inject more frequently than once every eight weeks after the initial three month period?

A     Yes, there was – there was some doctors who found that.

Q     Yes?

A     I guess within medicine, you know, every patient is – is different. The VIEW trials were set up with naïve patients, so they – they hadn’t ever been treated before.

Q     Yes?

A     Whereas a lot of these doctors initially were obviously switching existing patients who had maybe potentially years of treatment, you know, chronic patients, you know, I guess the – the most severe sufferers and they potentially needed some more aggressive therapy within the eight week period.

Q     But some of the naïve patients, the doctors were finding that eight weeks was not sufficient even with some of the naïve patients?

A     There were – there were some.

Q     Yes. Yes?

A     And I guess, you know, that even reflected in the VIEW trials, you know, 95 per cent were able to – to achieve that.

Q     Yes?

A     But there’s still that five per cent.

117    Mr Burstow agreed that most doctors would understand that a comparison in relation to the number of injections was with Lucentis.

118    Mr Burstow gave his evidence competently, responsively and truthfully. I accept his evidence. In particular, I find that he did not say to the doctors he visited that, in the abstract, Eylea meant fewer injections for patients but spoke in terms of the VIEW study. I note that the form of questioning of Mr Burstow included as an abstract proposition that Eylea would permit fewer injections, which is not the same thing. I also find that he did not show the doctors he visited during his sit down calls the disputed pages of the Detail Aid and they did not thereby see them.

119    The seventh sales representative called by Bayer was Mr Larry Hodges. He had been employed as an Eylea territory manager sales representative since March 2012. Previously he had worked for Allergan in a sales capacity, where he developed relationships with ophthalmologists prescribing drugs for use in the treatment of glaucoma. He had also previously worked as a sales associate for Eli Lilly Australia between 2002 and 2006, and as a medical representative for that company from 2001 to 2002. He has a Bachelor in Health Sciences. He was one of the two Eylea territory managers in Queensland. His territory included the Brisbane CBD and ran north to Cairns, including the Sunshine Coast, Bundaberg and Townsville. There were approximately 90 ophthalmologists in his territory. He received about eight weeks’ training in total after first starting work with Bayer. The training was a combination of home study and sessions at head office. He also spent time at two or three ophthalmology surgeries observing the clinical process of treating patients with injections for wet AMD. In early May 2012, he was given an iPad containing a Detail Aid in relation to Eylea. He was trained on how to use the Detail Aid.

120    Mr Hodges exhibited his Cortex notes to his affidavit. Those notes showed that he visited a total of 75 ophthalmologists and he had at least one sit down call with each person. He said in around May to August 2012 he first visited the ophthalmologists in his territory to gather information about their practices and establish relationships with them. Most of the ophthalmologists he visited, he said, made comments to him which showed they knew aflibercept had been launched in the United States a year earlier, were aware of the clinical trials for aflibercept and were waiting for its introduction in Australia. He estimated about three of the ophthalmologists he visited saw the disputed pages on the Detail Aid. He said that no doctor would only have seen the disputed pages as part of his presentation of the Detail Aid. He said that in his experience ophthalmologists were high level technical customers who kept up-to-date with developments in their field. He said the available information about Eylea and Lucentis was already known to most of them when he began making sales calls in May 2012. At that time, the questions he got on Eylea were about efficacy and safety, or “Does it work?” and “How safe is it?”

121    As clinical trials were published, Mr Hodges took the papers with him and discussed them with the ophthalmologists and left them a copy after his sales calls. They included the Kumar et al and Yonekawa et al papers.

122    He said that all of the 17 optometrists to whom he made sales calls were clinical optometrists working in ophthalmology practices. He also met regularly with other members of the clinical teams in ophthalmology practices including orthoptists and ocular nurses. In relation to the eight or nine optometrists with whom he would have used at least part of the Detail Aid, he did not believe any of them saw the disputed pages.

123    In cross-examination, Mr Hodges agreed that he was trying to convince, as part of his job, as many ophthalmologists as possible to use Eylea in respect of both any new patients those doctors had and any existing patients those doctors had. He agreed that one of the benefits of both Eylea and Lucentis was that, because of the relative ease of administration through injection, a broader cross-section of ophthalmologists was able to deliver the treatment for the disease. He agreed he had an interest in the context of promoting Eylea also to try and convince some ophthalmologists who were not injecting, or who were thinking of injecting, to begin doing so and to do so with Eylea. He agreed that he saw real value in marketing Eylea and speaking to its benefits to optometrists as well as ophthalmologists in practices where there were both. Mr Hodges agreed that he certainly appreciated by the time he started with Bayer the need for a clear message or communication about the merits of a new product compared to any established product on the market. He was taken to one of his Cortex notes of a sit down call with an ophthalmologist on 10 May 2013 which read:

used eDetailer to position eylea’s ability to reduce burden. stated that he is using. starting to feel they are the same. used the efficacy page to show they get the same results in different ways. eylea less frequently leading to better patient and clinical outcomes.

The questions and answers which followed were in essence:

Q     … Your pitch, if [I] can – you understand that word, your pitch, you know that expression, I take it.

A    Yes.

Q    Your pitch was same results but with fewer injections. Correct?

A     Partially.

Q     Pardon?

A     Partially.

Q    Right. I’m not suggesting that was the entirety of your pitch, but your pitch to him, as recorded in this note, for example, was what I put to you, wasn’t it? Fewer results with less frequent or fewer injections – sorry, same results but with less frequent injections or fewer injections. Correct?

A     What’s your question? I’m sorry.

Q     The pitch, as recorded in this note, was same results but with fewer injections, with benefits to patients. Correct?

A     That’s the correct – that’s correct.

Q     Right. And that was typical of your pitch to many of the ophthalmologists who you visited throughout Queensland. Correct?

A     Not correct.

Q    Not correct. All right. It was similar, wasn’t it, to your general pitch to ophthalmologists throughout Queensland?

A     I don’t really have a pitch as you’re stating.

Q     All right. Okay?

A     I think, if I understand what you’re saying – is that there’s a message or a pitch that I go in with. And I don’t work like that. So - - -

Q     All right. Well, I will come back to that. Thank you for that. Do you see your note for the next visit? Sorry. So you thought this ophthalmologist, MD, because of what he said to you – and as you recorded it in the third and fourth line – you see what you record in the third and fourth line – you saw that he might be wavering, for example, in relation to his views about your product. Correct?

A     No.

…

Q     Okay. You see in the third line he has told you – this is your record of what he told you – you stated that he is using – now, that, I take it, is EYLEA, correct? And he’s starting to feel they are the same. Do you see that? They - - -?

A     That’s correct.

Q     That they - - -?

A     I see.

Q     You were referring to EYLEA and Lucentis, correct?

A     That’s correct.

Q    You didn’t need to say Lucentis because everybody knew, to your understanding, that there are really only two products in the game. Correct?

A     That’s correct.

Q     The one which had been around for about five years and EYLEA, correct?

A     That’s correct.

…

Q     He said what we agree you’ve recorded there, he’s starting to feel they are the same, and you’ve responded to that – according to your note – by seeking to differentiate between the two in terms recorded in the next sentence. Correct?

A     Correct.

…

Q     Yes. So to distinguish EYLEA from the existing product, there had to be something else able to be pointed to to differentiate or to mark out your product from the existing product. Correct?

A     That’s correct.

Q     And what it was is captured in that sentence, “Less frequently, leading to better patient and clinical outcomes.” That’s what you used to differentiate the product?

A     I use many different things to differentiate the product.

Q     You didn’t use efficacy, did you?

A     No, I didn’t.

Q     No. And you didn’t use safety? … and you used injection frequency?

A     In these – in this small set of notes there’s injection frequency.

Q     Yes. Yes?

A     But I use many different things to differentiate EYLEA.

Q     Yes?

A     So in this brief synopsis that you’re pulling here - - -

Q    The principal point of differentiation which you used generally in your field visits to differentiate the two products was injection frequency. That’s what I suggest to you?

A     Is that a question? I’m sorry.

Q    Yes?

A     No. That’s not correct.

Q     You regularly used the difference in injection frequency to differentiate the products in your field visits, didn’t you?

A     Say that again.

Q     You regularly used difference in injection frequency to differentiate the products in your field visits, didn’t you?

A     Amongst other things, yes.

Q     Yes. And I’m putting to you that that was – that difference being injection frequency, was the predominant point of differentiation you pointed out in your field visits?

A     Not correct.

Q     Pardon?

A     Not correct.

Q     It was – if it was one of a number of points of differentiation, it was an important point of differentiation from your point of view, wasn’t it?

A     I would agree with that.

Q     Yes. And being important, I take it, you pointed it out to your customers. Correct?

A     Yes, amongst other things.

Q     Yes. But being important, can I suggest to you, you always pointed it out to your customers?

A     That would be incorrect.

Q     Would it? So there was an important – are you saying to his Honour that as an experienced, successful sales representative, you had a view that injection frequency was an important point of differentiation, but you didn’t always draw that to the attention of the people you visited?

A     That’s correct.

Q     Right. In the overwhelming majority of cases you did though, didn’t you?

A     Amongst other things, yes.

Q     Thank you. Now, just staying on this note at the bottom of 156, you say:

Go over differences with Mark on next visit. Really bring home difference in treatment burden due to lower injection rate in most patients.

Can I suggest to you that whilst you have identified differences, plural, in your note, the one you have singled out is injection frequency. Do you see that?

A     Yes.

Q    And you agree that’s a fair reading of your note?

A     Yes.

Q     Yes. And the reason you singled that one out is because in your mind that was the most important point of differentiation or difference between the two products?

A    Not correct.

Q     No. Some of the other differences you have in mind in your answers, things like benefits to patients, easing the burden on carers, easing the burden on practices, are they the differences – examples of the other differences you had in mind and pointed out?

A     That amongst the mechanism of action against efficacy - - -

Q    Yes?

A     Yes, yes.

Q     Yes, but - - -?

A     So numerous.

Q     Sorry, so you’re saying the three I identified – easing the burden on patients, easing the burden on carers that have to – and easing the burden on practices – they were three of the other points you had in mind together with mechanism and action?

A     That’s correct.

Q     Yes. Now, those three points, the first of those three points – easing the burden on patients, easing the burden on carers and easing the burden on practices – all follow, don’t they, logically, from fewer injections?

A     I would agree with that.

Q     Yes. It’s really another way of expressing the fewer injections message, isn’t it, in that they are the consequences of fewer injections; correct?

A     I wouldn’t put it that way.

Q     Well, they are the consequences of fewer injections, aren’t they?

A     Yes, they - - -

Q     That patients are less burdened?

A     They would be. That’s correct.

Q     That carers are less burdened?

A     Yes.

Q    And that practices are less burdened?

A     I would agree with that.

Q     Yes. They’re not the consequence of anything else other than fewer injections, are they?

A     I would agree with that.

Q     And so when you pointed out in your visits – and I accept you say you didn’t do it all the time – but in many cases when you were pointing out the importance of fewer injections, you would also point out the benefits of easing the patient burden, easing the carer burden, and easing the burden on a practice; correct?

A     Correct.

Q     And those last three points really reinforce the attractiveness of fewer injections; correct?

A     That’s correct.

…

Q     Yes. That message of fewer injections with the benefits of easing patient care, easing carer burden, easing burden on practices, that, from a seller’s perspective, or a marketing or selling perspective, was a very, very powerful message in support of the product you were promoting; correct?

A     I would agree with that, amongst other things.

124    I have set out this transcript at some length in order to illustrate the point Mr Hodges was asked about lower injection rate or fewer injections in the abstract without context. This was made clear in two ways. First, later in the cross-examination the following exchanges took place:

Q     All right. What I’m suggesting to you is that the message which is encapsulated in this – the second half of that column:

Keep focused on the saving that EYLEA will offer patients with less injections, such as lower risk of endothermic injection anxiety and less travel.

That was typical of the message you communicated to the ophthalmologists and optometrists to whom you were trying to sell this new product?

A     Well, if you put – if you just look at that second half, then yes. But if you look at the entire thing, there’s other – you can’t just go into a doctor with – with these doctors with just the message there’s fewer injections. You can’t do that. You really have to talk about safety, you really have to talk about efficacy, its effectiveness, how it works.

Q    Yes?

A     So you just can’t go into a doctor and say, “Less injections.” I’m sorry.

Q     Yes. All right. I accept that. Thank you. And when you – so there’s a broader context – and when you talk to the doctors about safety, you said that the VIEW study showed no difference in adverse outcomes, same safety profile?

A     Yes.

Q     Right. That’s - - -?

A     That would be one part of the conversation.

Q    One part. And another part would say clinical efficacy, the same results achieved in different ways?

A     Yes.

Q     Correct?

A     Yes.

Q     And then you would come to this, would you not, but fewer injections with all of these benefits. Correct?

A     Using the VIEW data, which demonstrated that. Yes.

125    Secondly, in re-examination Mr Hodges was asked about his answer “Partially” at the beginning of the extract of his cross-examination I have set out above. His answer was as follows:

EYLEA was – gives the same results with fewer injections. So everything that I do is based on the clinical data, so the PI or the VIEW trials. So it’s a case of looking at the efficacy, and in the VIEW studies you had different arms – some arms of the EYLEA product was monthly, just as the Lucentis product, and there was ... was eight weeks, so when you look at the efficacy across the different arms, they’re similar, so the results show that you get the same results with efficacy if you were to treat monthly with Lucentis or EYLEA, but you also get the same results if you treat bi-monthly with EYLEA that you would get if you treated with Lucentis. So then you – there’s other things that you discussed as well. The mechanism of action, its binding affinity to the molecule, the fact that it binds on both arms, so you can’t just go in and talk to these – they’re really highly technical doctors – just with a – you can’t do a pitch, because then you lose your credibility, you lose your integrity, and once you’ve lost that, you – you won’t be visiting these doctors …

126    In my opinion, Mr Hodges was an impressive witness who considered his answers with appropriate care. I accept the truth of his evidence. In particular, I find that Mr Hodges did not refer in his communications with doctors to “Eylea means fewer injections” in the abstract but did so by reference to the product information or the VIEW trials. I also find that three of the ophthalmologists he visited saw the disputed pages on the Detail Aid but that those doctors did not see only the disputed pages as part of Mr Hodges’ presentation of the Detail Aid.

127    The eighth Bayer sales representative called was Ms Cecilia Martinek. She joined Bayer as an Eylea territory manager in New South Wales on 5 March 2012. Prior to joining Bayer she worked at Biogen Idec for 8 months as an area business manager. Before that she was at Allergan for almost 5 years as a territory manager working in the field of glaucoma and dry eye. Her customers at Allergan were ophthalmologists. She was a medical representative at AstraZeneca between 2003 and 2006. She has a Bachelor of Science, majoring in Pharmacology and her postgraduate studies included a certificate in marketing. Her territory was Chatswood, the inner and outer west of Sydney, parts of the Hills District, Orange and Dubbo. There were approximately 61 injectors in her territory.

128    She spent her first two months at Bayer, in March and April 2012, in training. She also did preceptorships, educational sessions, with ophthalmologists which continued past the training period. She went to ophthalmology clinics to get deeper insight, particularly into how the retinal specialists worked, and watched them give injections for wet AMD.

129    During the course of her training she was given an iPad containing a presentation on Eylea (Detail Aid). In the week beginning 7 May 2012 she began visiting ophthalmologists and other clinic staff with the Detail Aid and the recently released Eylea product information.

130    She exhibited her Cortex notes to her affidavit. Those notes showed she visited a total of 72 ophthalmologists and had at least one sit down call with 58 of them.

131    She said that after her first appointments she recalled that academic and clinical papers about Eylea started to become available. She recalled using the Holash et al paper and the Ohr et al paper in her discussions. The VIEW paper was published in January 2013. Her practice was to discuss these documents with the ophthalmologists and talk to some of the key points. It was also her practice, she said, to leave these documents with ophthalmologists so they could review them in their own time. Since then there had been some studies, such as Kumar et al in 2013, that she had discussed and left behind with ophthalmologists.

132    After the VIEW paper was published she rarely used the Detail Aid. She estimated the number of ophthalmologists who saw at least part of the Detail Aid would be nine. She did not think the disputed pages were helpful as, given her experience presenting to ophthalmologists, they did not speak to what was relevant. In her estimation perhaps 1 to 2% of the nurses or other medical staff she showed the Detail Aid to saw the disputed pages. She did not use the disputed pages with ophthalmologists.

133    Ms Martinek said the ophthalmologists in her territory had been using Lucentis for five years when she started to visit them. She understood that they were highly skilled and qualified professionals, with a sophisticated level of technical knowledge and practical experience. Even for those she showed the Detail Aid to, she did not need to show it twice, particularly after the VIEW data was published. In the two or three months leading up to the PBS listing of Eylea in 2012, it was her experience during appointments that generally ophthalmologists were more interested in practical issues such as whether Eylea could be used in switch patients, when it would be PBS listed and how many injections would be reimbursed by Medicare.

134    She said she had no sales calls with optometrists recorded on Cortex. She did not specifically target optometrists because they could not prescribe Eylea. Her only contact with optometrists was through referral meetings and optometrists working in ophthalmology clinics.

135    In cross-examination, Ms Martinek agreed that product differentiation was important in selling and marketing and when asked whether that was particularly important in the case of a new product being launched into a market where there was a well-established incumbent, she replied that most important was the evidence and what the evidence showed and the differentiation that the evidence showed. She said that the objective of her job at Bayer with Eylea was to present the evidence for Eylea: doctors were interested in the evidence and that was the objective, in her recollection. She said that education was a big part of her role. The outcome was to sell or convince ophthalmologists to use Eylea rather than Lucentis.

136    Ms Martinek, in my view, gave her evidence frankly, truthfully and efficiently. I accept her evidence. I note she was not asked questions in any detail about her dealings with ophthalmologists. I find she relied on the product information and later on the VIEW study as well in her communications with ophthalmologists. I also find she did not show the disputed pages to ophthalmologists and they would not have thereby seen those pages.

137    The ninth and last sales representative called by Bayer was Ms Alena Reznichenko. She had been a sales representative at Bayer since 12 March 2012. From 12 March 2012 to 22 October 2012 she was employed as the territory manager for eastern Victoria. Her territory included the parts of Melbourne east of Victoria Parade, out to Heidelberg, north to Albury and down to Wonthaggi and Mornington. She preceded Ms Elibol as territory manager for this territory. On 23 October 2012, she was promoted to the role of medical advisor. From January 2013 she was the medical advisor for Eylea. On 16 September 2013, she was promoted to the role of medical affairs manager, so that other medical advisers reported to her as well.

138    Before working at Bayer, she was a manager and senior clinical optometrist at the Epworth Eye Centre for three years. Prior to that she was a dispensing optician at Optik Eyecare for one year. Prior to that she was a consultant and medical advisor for the Royal New Zealand Foundation of the Blind for four years. She also practiced as an ophthalmologist for five years in Russia. She has a Diploma in Medicine, a Masters of Science in Medicine (specialising in Ophthalmology), a Bachelor of Optometry, a postgraduate certificate in Public Health and a Bachelor of Science in Software Engineering.

139    She said she received eight weeks’ training at Bayer when she started as a territory manager. During her training, she spent one and a half days training with Associate Professor Wilson Heriot in his ophthalmology practice. Towards the end of her training she was given an iPad by Bayer and received training on how to operate the Eylea detailing aid (Detail Aid). She exhibited her Cortex notes to her affidavit.

140    She used the Detail Aid in sit down calls. The Cortex notes showed she had at least one sit down call with 68 ophthalmologists. She said it was likely that she showed the Detail Aid to each of the 68 ophthalmologists with whom she had a sit down call. She said, based on her experience as an ophthalmologist, the scientific material meant more when speaking to ophthalmologists. The ophthalmologists she visited showed the most interest in the information in the MOA tab. She rarely used the Detail Aid during subsequent sit down calls with an ophthalmologist. The discussions she had with the ophthalmologists she visited focused on the scientific material.

141    She estimated that she showed the pages under the “Home” and “Summary” tabs (including the disputed pages), to approximately 50% of the ophthalmologists who saw the Detail Aid. If she had ever shown the disputed pages she said she would always have shown other pages from the Detail Aid.

142    Ms Reznichenko said that, in addition to using the Detail Aid, she always brought copies of the product information for Eylea with her to meetings with ophthalmologists. If she had not met with the ophthalmologist before, it was her practice to give to, and leave with, him or her a copy of the product information. The results of the VIEW studies (the Phase 3 clinical trials conducted using Eylea) had not yet been published when she was visiting ophthalmologists and she did not recall any other clinical papers being available. She did not conduct sales calls on optometrists.

143    In cross-examination, she accepted that she received some material from the Bayer marketing department as part of her two-month training program with other sales representatives. The following summarises her evidence:

Q    … Did it – did it involve, for example, some suggested key messages about the product which might be useful in the – in the interaction with the future customers?

A     Yes, and those key messages, they were all taken from the PI, from the product information.

Q     Yes. What – yes?

A     So they were the attributes of the product.

Q     Yes. And the key message that was communicated by the marketing department to you, in the course of your – your training, was that EYLEA meant fewer injections for doctors and patients. Correct?

A     That’s correct, because EYLEA means fewer injections.

Q     Thank you. And that crisp message, “EYLEA means fewer injections,” formed – I’m not suggesting it was the only thing you said to ophthalmologists when you visited them, but that was the clear message that the marketing department had suggested could be imparted?

A     That wasn’t the only message.

Q     No?

A     Fewer injections, it’s one of attributes of EYLEA. EYLEA has many more other attributes.

Q     Yes?

A     And they are all taken from the clinical trials which is described in the product information.

Q     But the – and other messages include benefits to patients, benefits to carers, benefits to eye practices. Correct?

A     What do you mean?

Q     That EYLEA - - -?

A     What other – yes.

Q     - - - would deliver benefits to patients. Benefits to their carers, benefits to practices because of the need for fewer injections. Correct?

A     I don’t understand what you’re saying. You’re asking me the other messages imply, that’s what you say.

Q     Yes. All right?

A     Can you just rephrase that.

Q     Yes. Did the marketing department press upon you that – or did you understand – that fewer injections would mean benefits for patients?

A     As an ophthalmologist, I see that.

Q     Yes. And benefits for their carers, in terms of losing the burden of getting them – those who need assistance, getting them to and from surgery?

A     You could make that assumption, yes.

Q     Yes. And benefits to practices, either by reducing the burden of injections or opening up the opportunity for more patients?

A     For other patients to receive timely treatment.

Q     Yes?

A     Yes, you can make that assumption as well.

Q     And those benefits, those three benefits, benefits for patients, benefits for their carers, and benefits for practices were all, can I suggest to you, features of EYLEA which you understood?

A     These benefits come out of effect that EYLEA requires fewer injections, as described by the protocol of a study as described by the product information.

Q     Yes?

A     Which is approved by the Therapeutic Goods Administration.

Q     Yes?

A     Yes.

Q     But those – you certainly, when you went out in the field speaking to ophthalmologists and optometrists, identified to them those benefits. Correct?

A     I will just correct you, that I did not speak with optometrists.

Q     Okay. Yes?

A     I spoke with ophthalmologists, and I did communicate that EYLEA requires fewer injections when used according to the label.

Q     Yes?

A     Yes.

144    Ms Reznichenko made clear in re-examination what she meant by the expression “according to the label”. The relevant questions and answers were as follows:

Q     Ms Reznichenko, in one of your answers you said that you communicated to ophthalmologists that EYLEA requires fewer injections when used according to the label; what does the expression “according to the label” mean in the way you used it in that answer?

A     EYLEA is approved to be used in Australia every two months following three loading monthly injections. That’s what the label of EYLEA says.

Q     And when you use the word “label” what are you referring to?

A     That’s what it’s approved by the Therapeutics Goods Administration which is the registration board of Australia - - -

Q     Yes?

A     - - - that registers products in Australia for the use.

…

Q     So is there a physical thing called a label that you’re referring to?

A     So when a product is tested and you do clinical trials, then that information is submitted to the Therapeutics Goods Administration, which is the TGA for short, and the TGA assesses all the information and then approves a certain label of application of a product which is the indication of how it’s going to be used. And EYLEA has been approved to be used every two months following three monthly injections, and that’s based on the clinical trial information. So that’s considered to be label of EYLEA which is - - -

Q     And when you use the word “label” are you referring to a physical document? Something on a piece of paper?

A     Yes. Which is the product information. Each pharmaceutical product in Australia has a product information, and that’s where the label is stated.

145    Ms Reznichenko was self-evidently a highly qualified witness. She had an impressive grasp of the subject matter. I accept her evidence. In particular, I find that she did not say that Eylea meant fewer injections in the abstract but referred to the product information and the clinical trials there described. As to the use of the disputed pages, I find Ms Reznichenko showed those pages to approximately 50% of the ophthalmologists who saw the Detail Aid but that those pages were shown with the other pages from the Detail Aid.

146    In respect of the sales representatives taken together, I find that although there were selling messages, those messages did not include “Eylea means fewer injections” in the abstract but in connection with the product information and the clinical trials and, later, the VIEW study.

147    As to the Cortex notes themselves, in my view the relatively infrequent references to “fewer injections” did not qualify or derogate from the context in which those references were made, as I have set out above.

148    Mr Kuo’s affidavit was formal and concerned the Cortex material. It is not necessary to summarise his evidence. He was not required for cross-examination.

The expert witnesses

149    On this branch of the case the experts were called by the respondent Bayer.

150    Professor Paul Mitchell had practiced as a medical retina specialist since 1983 and estimated that since 2007 he had treated approximately 800 patients for wet AMD. As at June 2013, he was treating approximately 450–500 patients for wet AMD with either Lucentis or Eylea. That number was expanding by around three to five new patients per week. Professor Mitchell’s clinic, and Professor Mitchell as Principal Investigator, had enrolled patients into many of the major pivotal trials testing different drugs for wet AMD, including ranibizumab and aflibercept. He had also been involved in academic work in relation to wet AMD and stated that he was one of a few Australian experts on the occurrence, risk factors and treatment for wet AMD. Professor Mitchell’s evidence was that once he had defined and diagnosed whether the patient had wet AMD he determined whether the patient was likely to respond to treatment. Once he had decided that treatment was appropriate for the particular patient, the next decision was which agent/drug to use. The decision as to whether to treat with Lucentis or Eylea, Professor Mitchell said, was based on:

(a)    his experience using the drug on patients in terms of the responsiveness and the treatment burden of the drug. He had treated patients with Lucentis since 2007 and with both Lucentis and Eylea since December 2012 and had gained considerable understanding about the two drugs from observing his patients’ responses to treatment. He drew on this understanding and knowledge and applied it to the particular patient he was treating in terms of choosing which drug should be used;

(b)    what he had learnt from the peer-reviewed medical literature about wet AMD, including the data from the randomised clinical trials. He had experience in having patients enrolled in some of those studies, including the VISION, ANCHOR SUSTAIN and VIEW 2 trials. He said he knew the literature very well and used what he had learnt in those studies to guide his decisions about which drug to prescribe and administer for individual patients. He said that ophthalmology was very much an evidence-based speciality. He, like other ophthalmologists, relied on the peer-reviewed evidence about the safety and efficacy of drugs;

(c)    the product information for Lucentis and Eylea. He had read this on numerous occasions and knew the contents;

(d)    potential durability/duration of action of the drug;

(e)    any credible reports of adverse events in the use of either of the drugs.

Professor Mitchell’s understanding was that both general ophthalmologists and retinal specialists adopted a somewhat similar decision-making process to his own, except that many did not have the same level of academic background knowledge that he had. He gave the basis of his understanding, being his regular collaboration with colleagues and discussions with them as to what they were doing in practice in relation to wet AMD, which confirmed to him that they adopted a relatively similar decision-making process to that used by him, and other ophthalmologists’ discussion of their practices at symposia, conferences and College and Society meetings which he attended. In particular, his colleagues asked questions at those events which indicated that they had reviewed and understood the medical literature about wet AMD and that this peer-reviewed literature played a substantive role in their decision-making processes, as it did in his.

151    Dr Andrew Crawford had training and experience as a general ophthalmologist and had managed wet AMD patients since 1999 using most of the techniques available at the relevant times. Once intra-vitreal injection treatment became well established in Australia he sought relevant training and commenced to perform injections at the end of 2010, continuing ever since. The decision-making process that he followed as a matter of practice when deciding whether to prescribe and administer Lucentis or Eylea was as follows:

(a)    he gathered information about the use, efficacy, burdens and hazards of each drug. The sources of information that he relied on included, in no particular order:

(i)    medical literature, especially reputable peer-reviewed journals. He evaluated items in the medical literature by their content and also by the reputation and affiliation of their authors;

(ii)    medical conferences and meetings, where he also evaluated presentations by that content and by the reputation and affiliation of presenters;

(iii)    discussion with his peers;

(iv)    auditing of his own patients’ outcomes;

(v)    information disseminated by pharmaceutical companies including product information, advertising materials and presentations by sales and scientific representatives;

(b)    he also gathered information about the specific pathology presented by the patient and the progress of the pathology once treated;

(c)    he also gathered information from the patient;

(d)    he combined the information from (a), (b) and (c) in order to make an individualised recommendation for treatment to each patient. The recommendation might be revisited from time to time during treatment if he believed that clinical progress suggested that an alteration would be beneficial or if the patient changed their attitude to treatment.

152    In cross-examination, the evidence of Professor Mitchell and the evidence of Dr Crawford on these points was not challenged. I accept their evidence. Novartis accepted, and I find, that ophthalmologists were aware of the dosage regime of Lucentis and Eylea set out in the product information I have set out at [34] and [42] above, respectively.

153    Professor Mitchell confirmed that he published fairly extensively in the area of wet AMD and that probably no one in Australia or possibly globally had been as prolific in terms of publications. He qualified this answer by referring to Professor Robyn Guymer in Melbourne and said that she could have more publications in this particular field than he had. It was put to Professor Mitchell that he was atypical amongst retinal specialists in terms of the extensive list of his publications and his international profile but he said that in terms of the clinical aspects of treating patients he was the same as most other retinal specialists and he spent a lot of time talking to his colleagues and he was among many others who treated the large number of people who developed macular degeneration. He agreed he was a full-time academic so that put him apart from some others but said clinical practice was a fair component of his work. In re-examination he made it clear that his clinical practice was about 60% of his work, seeing patients for most of three days a week.

154    He confirmed that he was an investigator in the VIEW 1 and 2 trial and he had, he thought, 11 patients in that study. He said the VIEW trial was divided into two studies as mandated by the United States Food and Drug Administration: the VIEW 1 was conducted in the United States and the VIEW 2 in the rest of the world, including Australia, so his patients were in the VIEW 2 trial.

155    In relation to the Australia and New Zealand Journal of Ophthalmology, Professor Mitchell said it was the only local peer-reviewed publication specialising in ophthalmology. He said the Journal went to all members of the Australia and New Zealand College of Ophthalmologists approximately once a month. He agreed it was an important publication and that most practitioners would look through it each month when they got it. He agreed that sometimes there would be a supplementary edition of the Journal in the month prior to a conference whereby Fellows received a copy of the abstract journal which covered the abstracts from the papers being presented at the national conference. They received it when they registered for the conference. He said the mivision magazine was not peer-reviewed and was more like a trade magazine.

156    Professor Mitchell was taken to slides he used at the national product launch of Eylea. He was first taken to a slide presenting the 52 weeks results in terms of the primary efficacy endpoint. He said that the VIEW studies were non-inferiority studies: aflibercept was being compared to ranibizumab and the aim of the study was to demonstrate that aflibercept was non-inferior to ranibizumab in terms of efficacy for the primary endpoint, which was preventing a serious loss of vision. That primary endpoint was chosen because it was the same in the Lucentis pivotal studies: the ANCHOR and MARINA studies. Professor Mitchell was taken to the slides which followed, dealing with clinical equivalence and safety. He was taken to slide 29 on which he said were the conclusions which, in a limited time, were important to highlight. They were as follows:

VIEW Studies: Conclusions

•    Aflibercept 2mg given every 2 months* was shown to be noninferior to ranibizumab 0.5mg given monthly

•    Aflibercept 2mg every 2 months* provided similar efficacy to ranibizumab 0.5mg monthly in maintaining vision (95.3% vs. 94.4%, avoiding a 3-line loss, respectively)

•    Results of secondary endpoint analyses of aflibercept and ranibizumab treatments were comparable

•    Aflibercept and ranibizumab also had similar safety profiles

*After 3 initial monthly doses

(Footnotes omitted.)

Professor Mitchell said the first bullet point gave an overview and the second bullet point gave the specifics.

157    Professor Mitchell said that the VIEW studies did have aflibercept given every month as one of the arms of the trial but because there was no difference between monthly and two monthly, they had done the comparison for two monthly. Professor Mitchell agreed that there were three aflibercept protocols, two different doses and two different regimens, and there was the one protocol for Lucentis, which was protocol dictated, and it was also because it was the result of the pivotal ANCHOR/MARINA studies which treated patients monthly.

158    Professor Mitchell was asked about his understanding of the phrase ‘me too’. He agreed it was not a scientific term or a term with a technical scientific definition. He agreed that minds could legitimately differ in terms of the relative significance of particular criteria such as mode of action, mode of administration, efficacy and safety and that minds could legitimately differ as to the degree of similarity between two products within any one criterion.

159    I accept Professor Mitchell’s evidence. Plainly he was eminently qualified and gave his evidence in a clear and frank manner.

160    I have set out above the parts of Dr Crawford’s affidavit evidence which I consider to be significant. I also note that he annexed to his second affidavit a second report dealing with further questions he had been asked concerning: detailing in the period May 2012 to June 2013 and discussions with Bayer representatives in that period; ‘me too’ pharmaceuticals and his understanding of that phrase and whether, in his opinion, Eylea was a ‘me too’ pharmaceutical in relation to Lucentis; medical literature; events; and referrals. There was also in evidence a short letter Dr Crawford wrote to the respondent’s solicitors on 24 March 2014 stating that his opinion in relation to the ‘me too’ issue was based upon knowledge of published, peer-reviewed studies that described the results of trials where patients had been treated sequentially with Lucentis then Eylea and direct clinical experience of patients under his treatment who had been switched from ranibizumab to aflibercept, or vice versa, with differences in clinical outcome.

161    In cross-examination, Dr Crawford was asked questions about the Yonekawa trial to which he had referred in his 24 March 2014 letter and agreed it involved a modest number of patients and was a retrospective study which involved limitations.

162    Dr Crawford was also asked about the VIEW 1 and VIEW 2 studies and agreed that they were important but he said that he did not believe there was a leading study of Lucentis and Eylea.

163    Dr Crawford was asked about a presentation he had given at a referral meeting attended by optometrists in which he used a series of slides, one of which referred to “reduced injection burden” in respect of Eylea. He said reduced injection burden referred to the VIEW study. He agreed it was a point the Bayer sales representatives had no doubt raised in meetings with him.

164    As to ‘me too’ drugs, Dr Crawford agreed that while a generic was an exact copy, a ‘me too’ may be a drug that was similar but different and minds could legitimately differ as to the extent of similarity required for somebody to form a view that a particular drug was a ‘me too’.

165    Dr Crawford was taken to the statement in his second report: “… the clinically effective outcome of each drug has been shown to be different if administered sequentially to the same patient.” He said that statement was not in his slide presentation because the VIEW trial did not sequentially administer the two drugs to the same patient so that answer could never have been contained in his summary of the VIEW trial data.

166    Dr Crawford emphasised in his evidence that he was a general ophthalmologist and not an academic ophthalmologist and that his practice was in the clinical, not the academic, sphere. Having said that, he gave his evidence in a direct and straightforward manner and I accept it.

167    Dr Ared was an optometrist and had nearly 20 years of experience as a clinical optometrist in direct patient care. He did not directly treat patients with wet AMD but had been co-managing patients with wet AMD with his ophthalmology colleagues for over five years. He had not been involved with clinical trials in relation to wet AMD and he had not been involved in any academic work in relation to wet AMD. He was not permitted to prescribe or administer Lucentis or Eylea as an optometrist. His understanding was that only ophthalmologists were permitted to prescribe and administer intraocular injections with anti-VEGF therapy such as Lucentis and Eylea. He said he did not himself treat patients who had wet AMD other than to co-manage the patient. In deciding whether to refer a patient who presented with symptoms of wet AMD, Dr Ared said his referral decision was based on a patient’s signs and symptoms. He determined a patient’s signs and symptoms by taking a detailed patient history and undertaking a clinical examination. For that purpose he used a diagnostic eye scanning imaging instrument known as an OCT (Optical Coherence Tomography). He said that information about patient treatment options came to him by way of a number of sources such as: direct reports from a treating ophthalmologist, industry meetings, magazines and trade exhibitions, company-sponsored continuing education evenings, ophthalmic literature articles and independently peer-reviewed randomised clinical studies. He drew on those sources of information when making a decision about whether a patient needed a referral for wet AMD.

168    Dr Ared said he did not attend any of the meetings where the relevant materials were displayed nor did he see any of the advertisements in the mivision magazine.

169    In cross-examination, Dr Ared agreed that there was a broad section of optometrists in terms of age, experience and interest. He said that ophthalmology, like all disciplines of medicine, was becoming a more sub-specialised profession, and the role of the optometrist was becoming a bit like a GP for eye care. He said that he did not treat wet AMD but he detected and referred, or diagnosed and referred. He agreed that many of his patients would ask about what treatments were available but said it was not his role as an optometrist to suggest to them what they may or may not end up with at their consultation with the specialist. He said the standard of care would be to get them to the ophthalmologist and then the ophthalmologist could have that discussion with the patient. Dr Ared accepted that if a patient of his asked him what the range of treatments available was, he would tell them and he would not be breaking any legal requirement or medico-legal requirement he was aware of in telling them that information. He said he could discuss the treatment options and he could tell the patients the various modalities but really it was trying to get the patient to the specialist. If he were asked by a patient whether the injection was just a one-off or did the patient have to keep having an eyeball injection and how frequently, he would answer that question by telling them it was up to the specialist to tell you how often. Dr Ared agreed that in the areas of practice where he also dealt with ophthalmologists, he also discussed developments in the field, new treatments and new drugs with them. He agreed that the role optometrists play in the broader eye care profession was valued by ophthalmologists, especially because in Australia the optometrists saw 80% of the patients for initial primary care.

170    I accept Dr Ared’s evidence. It is relevant to identifying the relevant class of addressees. It throws light on the relationship or interrelationship between optometrists and their work and ophthalmologists and their work.

Consideration

171    I have set out the four pleaded representations at [7] above.

172    For the reasons which follow, I accept that there is a class of addressees and the relevant class is ophthalmologists who are qualified to prescribe and inject Eylea and Lucentis.

173    Professor Paul Mitchell, whose expertise I accept, said he was not aware whether the prescription of Eylea and Lucentis was formally restricted to ophthalmologists but in practice only ophthalmologists prescribed those drugs because the PBS authority prescription forms required a statement from a medical practitioner that the patient had neovascular AMD and evidence to support that diagnosis, which was typically photographs from a fluorescein angiogram, that needed to be sent to Medicare, and other details of the clinical aspects of wet AMD cases. Such a diagnosis required specialist training that only ophthalmologists would have. For similar reasons, in practice in Australia Lucentis and Eylea were only administered by ophthalmologists.

174    To similar effect was the evidence of Dr Andrew Crawford, whose expertise I also accept, who said that Lucentis and Eylea could be prescribed by any medical practitioner but PBS benefits were only available from ophthalmologist prescriptions and therefore, in practice, only ophthalmologists tended to prescribe Lucentis and Eylea. Similarly, in practice administration of Lucentis and Eylea was only by, or directly under the control of, ophthalmologists.

175    In my opinion, the relevant class of addressees is ophthalmologists, as it is they who prescribe either Lucentis or Eylea. I accept that optometrists have an important role in referring the patients they see to an ophthalmologist but on the evidence they do not participate in or affect the prescription decision. I accept the applicant’s submission that the Court should infer that optometrists were targeted in the way they were because Bayer assessed that there was real value to it in doing so, notwithstanding that optometrists do not prescribe or inject Eylea, but this does not mean that that targeting had a relevant effect. That is, it is correct to say that the words used were directed at and were seen by optometrists as well as ophthalmologists but this was of no relevant consequence. The effect on optometrists was an effect of general awarenesss of Eylea as a newly available drug for the treatment of wet AMD by intra-vitreal injection. I refer here in particular to the evidence of Dr Ared at [167]–[170] above as to his practice of provisional diagnosis and referral to an ophthalmologist. Any such understanding did not affect an ophthalmologist in deciding whether to prescribe Eylea, either at all or in preference to Lucentis: see my findings in relation to the ophthalmologists’ decision-making processes at [150]–[152]. Any effect of the words used on an hypothetical optometrist was too general or diffuse to be taken into account in terms of the representations conveyed, causation or loss. I therefore accept the respondent’s submission that because the evidence does not support the conclusion that optometrists had either a direct or indirect role in the process of selection of Eylea, rather than Lucentis, as the medicine with which to treat a particular patient, optometrists should not be regarded as a relevant part of the audience. I find that optometrists did not suggest or advocate that an ophthalmologist should prescribe a particular wet AMD drug for the patient as part of any referral of a patient. I therefore refer to the class of addressees as ophthalmologists. I include in this class not only the approximately 25–50% of ophthalmologists who prescribed and injected the wet AMD drugs but also those likely to prescribe and inject such drugs, Lucentis or Eylea. The length of experience will, of course, vary but in each case the ophthalmologist will be a highly trained and knowledgeable specialist doctor making a serious decision and taking into account factors similar to those of which Professor Mitchell and Dr Crawford gave evidence.

176    My general observation is that the pleaded representations seek to give to the words used in any of the forms involved in the acts of publication (the words used) a meaning of invariability which the words do not convey to their audience, particularly given the inherent variability of patients and their conditions and the professional judgment involved. The gist of the First Representation is “for all patients”; of the Second Representation is “for each and every patient”; of the Third Representation is “without qualification”; and of the Fourth Representation “all Eylea patients” and “all Lucentis patients”.

177    In construing the words used and deciding whether the representations were conveyed, I take into account the evidence adduced by Bayer as to how an ophthalmologist would decide to prescribe and administer one of these drugs to a patient. I also take into account that ophthalmologists were aware of the respective dosage regimes of Lucentis and Eylea: see [152] above. A high level of interest in and awareness of the relevant scientific information is also evidenced by a series of letters Bayer sent to ophthalmologists in response to enquiries made by them to Bayer sales representatives as to particular aspects of the operation of the medicine. I have also taken into account that the words used were comparative rather than unilateral so there is no room for resort to notions of mere advertising puffery. The same approach is required by the specific nature of the words used. I accept the submission of the applicant that I should proceed on the basis that the words were put forward deliberately and with some precision. I also accept the submission of the applicant that those who engage in comparative advertising ought take particular care to ensure that the comparisons are accurate because errors made in comparative advertising may have a greater potential to mislead ‘consumers’ than statements made in unilateral advertisements.

178    In addressing these issues I have consciously avoided poring over the material divorced from the context in which it would have been seen and have assessed the words used in the circumstances in which they were read and seen, perhaps fleetingly, by their audience. The posters were displayed at professional meetings of ophthalmologists where other medical and scientific information about both Eylea and Lucentis was also available. These professional meetings were primarily scientific presentations of interest to ophthalmologists where both Novartis and Bayer promoted their products by reference to scientific and clinical material. Each of the advertisements was published in issues of either mivision or the Journal of Clinical & Experimental Ophthalmology. Baby banners were generally displayed at seminars for optometrists where the only ophthalmologists who attended were those presenting. The Detail Aid was used in some of the detailing visits, as set out above. Within the Detail Aid only 1 page within the “Home” tab (not being the first page) and 1 page within the “Summary” tab (not being the first page) contained the words about which Novartis complains. The attendee workbook was an eight page booklet available at the launches in Sydney, Melbourne, Brisbane and Adelaide, page eight of which contained the material about which Novartis complained.

179    I have also taken into account the principles in the authorities relied on by the parties, as follows.

180    At the forefront of the applicant’s submissions was Australian Competition and Consumer Commission v TPG Internet Pty Ltd [2013] HCA 54; (2013) 250 CLR 640 (TPG Internet). That case concerned an offer to consumers of an attractive price for the ADSL2+ service which TPG Internet Pty Ltd (TPG) supplied. The advertisements prominently displayed the offer to supply broadband internet ADSL2+ service for $29.99 per month. Much less prominently, the advertisements qualified this offer, stating that it was made on the basis that the ADSL2+ service was available only when bundled with a home telephone service, provided by TPG through landline technology, for an additional $30 per month (with a minimum commitment of six months). In addition, there was a setup fee of $129.95, plus a deposit of $20 for telephone charges. The primary judge upheld the Australian Competition and Consumer Commission’s claim that the advertisements were misleading and deceptive by reason of the disparity between the prominent headline offering the service at an attractive price and the less prominent terms qualifying that offer. The primary judge found that TPG’s target audience consisted of “the broad class of Australian consumers around mainland capital cities who were users or potential users of broadband internet services”. The primary judge found that there should not be imputed a high level of knowledge about broadband internet to the ordinary or reasonable consumer. The target audience included first time users of ADSL2+ services, the primary judge found, and the ordinary or reasonable consumer would not have any starting assumption as to whether TPG’s offering was of a separate or bundled service, and would rely on the advertisement for information as to the service offered. The primary judge found that each advertisement had the same dominant message namely: “Unlimited ADSL2+ for $29.99 per month.” The ordinary or reasonable consumer taking in only the dominant message would have the impression that the entire cost of the service was $29.99 per month, with no other charges and no obligation to acquire another service and the balance of the advertisement which contained that information was not given sufficient prominence to counter the effect of the headline claim. The dominant message was false because to acquire unlimited ADSL2+ for $29.99 per month, the consumer was also obliged to rent a home telephone line from TPG and to pay an additional $30 per month for it. The bundling condition operated to double the headline advertised monthly charge and for many consumers would involve the acquisition of a service extra to the service they were interested in acquiring. In those circumstances, the primary judge concluded that the information about TPG’s bundling condition needed to be quite clear and prominent if it was to correct the misleading impression of the message. Similar findings were made about the setup condition. The primary judge imposed a pecuniary penalty of $2 million, amongst other orders.

181    On appeal to the Full Court of the Federal Court, all but three of the primary judge’s findings of misleading conduct were set aside and the pecuniary penalty was reduced to a total of $50,000 in respect of the findings of infringement which were upheld. The Full Court held that the revised television advertisement, initial and revised radio advertisements, initial and revised newspaper advertisements, initial and revised online advertisements and public transport advertisements were not misleading. The High Court held that their Honours’ conclusion reflected differences in point of principle with the approach taken by the primary judge, particularly in relation to the primary judge’s view that the “dominant message” of the advertisements was of critical importance in determining whether they were to be characterised as misleading.

182    The High Court held, Gageler J dissenting, that the Full Court erred in setting aside the findings of the primary judge as to the extent of TPG’s contraventions of the Trade Practices Act 1974 (Cth). The primary judge’s assessment of the appropriate pecuniary penalty of $2 million was restored.

183    After noting, at [39], that there must be a sufficient causal link between the conduct and the error on the part of persons exposed to it, French CJ, Crennan, Bell and Keane JJ said, at [45], that the Full Court erred in holding that the primary judge was wrong to regard the “dominant message” of the advertisements as of crucial importance. Further, the Full Court erred in failing to appreciate that the tendency of TPG’s advertisements to mislead was not neutralised by the Full Court’s attribution of knowledge to members of the target audience that ADSL2+ services may be offered as a “bundle”. At [47], the plurality distinguished Parkdale Custom Built Furniture Pty Ltd v Puxu Pty Ltd (1982) 149 CLR 191 (Parkdale) on the basis, first, that TPG’s target audience did not consist of potential purchasers focused on the subject matter of their purchase in the calm of the showroom to which they had come with a substantial purchase in mind. The audience could not have been expected to pay close attention to the advertisement; certainly not the attention focused on viewing and listening to the advertisements by the judges obliged to scrutinise them for the purposes of the proceedings. Secondly, the plurality said, at [48], the Full Court did not recognise that the tendency of the advertisements to mislead was to be determined not by asking whether they were apt to induce consumers to enter into contracts with TPG, but by asking whether they were apt to bring consumers into negotiation with TPG rather than with one of its competitors on the basis of an erroneous belief engendered by the general thrust of TPG’s message. Thirdly, the plurality said, at [51], this was not a case where the tendency of TPG’s advertisements to lead consumers into error arose because the target audience might be disposed, independently of TPG’s conduct, to attend closely to some words of the advertisements and ignore the balance. The tendency of TPG’s advertisements to lead consumers into error arose because the advertisements themselves selected some words for emphasis and relegated the balance to relative obscurity. The Full Court erred in failing to appreciate the implication of its finding that “many persons will only absorb the general thrust”, which was to recognise the effectiveness of the selective presentation of information by TPG. The plurality said at [52]:

It was common ground that when a court is concerned to ascertain the mental impression created by a number of representations conveyed by one communication, it is wrong to attempt to analyse the separate effect of each representation. But in this case, the advertisements were presented to accentuate the attractive aspect of TPG’s invitation relative to the conditions which were less attractive to potential customers. That consumers might absorb only the general thrust or dominant message was not a consequence of selective attention or an unexpected want of sceptical vigilance on their part; rather, it was an unremarkable consequence of TPG’s advertising strategy. In these circumstances, the primary judge was correct to attribute significance to the “dominant message” presented by TPG’s advertisements.

(Footnote omitted.)

Justice Gageler dissented, not because he disagreed with the statements of legal principle of the plurality but because he could not read the reasons of the Full Court of the Federal Court as having ignored them: see [72].

184    In my opinion, while accepting, of course, the statements of principle by the High Court in TPG Internet, there is no real similarity between the facts and circumstances of that case and those of the present case. First, the class of addressees is entirely different. Secondly, the content of the material in question is quite different as I do not read the present materials as having a separate dominant message. In part this is because of the form of the representations but also because of their meaning. Thirdly, the circumstances in which a member of the class of addressees would or might be influenced by the material is very different from a representation apt to bring a ‘consumer’ into negotiation with Bayer rather than with Novartis on the basis of an erroneous belief engendered by the general thrust of Bayer’s message. Fourthly, due account must be taken of the different media involved: multimedia, including television and radio, in TPG Inernet compared with print (or its equivalent in the case of the Detail Aid) in the present case. I do not therefore accept the importance placed by Novartis on [55] of TPG Inernet which concerned the drawing of an inference of an effect from a representation made in terms apt to create a particular mental impression and intended to do so.

185    The applicant also referred to Australian Competition and Consumer Commission v Jewellery Group Pty Ltd [2012] FCA 848; (2012) 293 ALR 335 (Jewellery Group); Apotex Pty Ltd (formerly GenRx Pty Ltd) v Les Laboratoires Servier (No 2) [2008] FCA 607; (2008) 77 IPR 1 (Apotex); and Sidhu v Van Dyke [2014] HCA 19; (2014) 251 CLR 505 (Sidhu).

186    Jewellery Group related to six catalogues and a flyer which promoted 44 separate items of jewellery the subject of the proceedings. There was dual pricing, consisting of “strikethrough/sale pricing” and “was/now pricing”. The applicant’s case was that by making the statements of price in respect of each of the items of jewellery in the catalogues and the flyer, the respondent represented that consumers would save an amount of money, being the difference between the strikethrough price and sale price or the “was” price and the “now” price if the items were purchased during the relevant catalogue sale period. Justice Lander considered the audience, which he held to be very wide and to consist of aware and unaware customers, and the representation or representations conveyed by the catalogues and the flyer which, his Honour said at [26] required considering the words used in the advertisements in their context and in their entirety, and giving those words a fair and reasonable meaning. It was not appropriate to give the words a strained, false or unreasonable meaning. Rather, the words ought to be understood in their ordinary sense. The words would not be studied closely by the reasonable reader, Lander J said, but they would be read by that reader for the purpose of determining what it was that the retailer was offering. If the words were qualified in any way, then that qualification must be recognised and given effect to as an ordinary and reasonable reader would. The words may have more than one meaning. If they did, the question to be determined was whether each meaning that was reasonably open amounted to a representation that was misleading or deceptive, or likely to mislead or deceive. The applicant Novartis also relied on the following paragraphs, [61]–[62], where Lander J said:

I also reject the respondent’s second contention, namely that the applicant failed because it did not lead any evidence from a consumer from the class of persons to whom the representations were made (that is readers of the catalogues and the flyer) that the consumer understood the dual pricing in the catalogues and the flyer as the applicant contended. The respondent contended that the evidence it led from Mr Murphy, the chief executive officer of the respondent, was that he was not aware of any consumer complaints concerning the respondent’s pricing, which meant that the applicant’s failure to call any evidence as to the understanding of the audience leads to the conclusion that the applicant’s case was bound to fail.

The applicant is not bound to call the evidence contended for by the respondent, but may of course do so if the evidence is available and if the applicant considers that the evidence would assist the court in reaching its decision as to whether the representations amount to misleading or deceptive conduct: [Taco Co of Australia Inc v Taco Bell Pty Ltd (1982) 42 ALR 177] at 202 per Deane and Fitzgerald JJ. The applicant is entitled to ask the court to make a finding as to what a reasonable member of the class of persons identified by the court would make of the advertisement and would understand the representation contained in the advertisement to mean. The court must determine, objectively, the representation that was conveyed, and whether the representation is misleading or deceptive, or likely to mislead or deceive. Evidence that members of the public have actually been mislead (sic) is neither conclusive nor necessary: [Australian Competition and Consumer Commission v Ascot Four Pty Ltd (2008) 250 ALR 467; [2008] FCA 1295] at [90] and [97] per Mansfield J; [Ascot Four Pty Ltd v Australian Competition and Consumer Commission (2009) 176 FCR 106; [2009] FCAFC 61] at [34](iii); Parkdale at CLR 198–9 per Gibbs CJ; Taco Co at 202 per Deane and Fitzgerald JJ. The applicant proceeded on that basis. It follows then that the evidence led by the respondent from Mr Murphy is not dispositive.

I accept these statements of principle.

187    As I understood it, the point sought to be derived by Novartis from Apotex was that advertisements containing representations may be found to mislead or deceive or be likely to mislead or deceive medical practitioners. I accept that. Everything depends on the facts.

188    I also note that, for example, in relation to the stamp representations in Apotex, Bennett J held at [57] that the sections of the public to whom the representations were directed were medical practitioners (doctors), pharmacists and patients: no reason was advanced, her Honour said, to subdivide those groups into any subclasses or areas of specialisation. Her Honour went on to assess the reactions or likely reactions of the members of each class to whom the conduct was addressed: see [59]–[63] and [65]–[81] in relation to doctors and pharmacists.

189    In relation to the advertisements held misleading or likely to mislead medical practitioners, Bennett J held, at [119]–[120], that reference to “improved stability” in the first whole-page advertisement represented that there was a genuine improvement or benefit, or superior product performance of new Coversyl over its generic substitutes and that this was a reason for the doctor to prevent generic substitution. The other representations in the first whole-page advertisement were not misleading as alleged.

190    For the second whole-page advertisement, Bennett J held that the reference to “now indicated for stable coronary artery disease” was misleading and, by linking that statement to perindopril arginine (new Coversyl), the advertisement represented that perindopril erbumine was not so indicated and that also amounted to a misrepresentation as perindopril erbumine had been so indicated since 2005.

191    As I have said, I accept, of course, that representations may mislead or deceive medical practitioners. I note, however, that Bennett J at [130], in relation to the second whole-page advertisement, referred to ordinary and reasonable doctors, including general practitioners not specialised in hypertension and the mechanisms of blood pressure regulation, and was not satisfied that ordinary and reasonable doctors would generally have been aware of the Europa study and so discount the message otherwise conveyed by the advertisement. That is not the position in the litigation with which I am concerned.

192    Sidhu was referred to, first, for its citation of Gould v Vaggelas (1984) 157 CLR 215 at 236, where Wilson J, with whom Gibbs CJ and Dawson JJ agreed, speaking of an action in deceit, said:

If a material representation is made which is calculated to induce the representee to enter into a contract and that person in fact enters into the contract there arises a fair inference of fact that he was induced to do so by the representation.

Secondly, the respondent relied on Sidhu in relation to the second of four reasons given by the plurality for concluding that the respondent in that case discharged her onus of proof. The second reason was that it was not necessary that the conduct of the party estopped should be the sole inducement operating on the mind of the party setting up the estoppel. As elaborated on by Gageler J in a separate concurring judgment, the respondent did not need to establish that the belief to which she was induced by the appellant’s representations was the sole or predominant cause of the course of action or inaction she took but, in the language of Rich, Dixon and Evatt JJ in Newbon v City Mutual Life Assurance Society Ltd (1935) 52 CLR 723 at 735, she did need to establish that the belief was a “contributing cause”.

193    The respondent relied on AstraZeneca Pty Ltd v GlaxoSmithKline Australia Pty Ltd [2005] FCA 1645. That case concerned Seretide advertisements which included text such as “Imagine if you had the power to totally control asthma …” and “Symptomatic Patients” – “Looking for control?12 Switch to Seretide”. The target audience was general practitioners: see [39]. The claim, set out at [7] of the judgment, was that in each of the Seretide advertisements, the respondent made representations to the effect: (1) that all or virtually all asthma patients will achieve 100% control or total control of all asthma symptoms by using Seretide; (2) alternatively, that a majority (i.e. greater than 50%) of all asthma patients will achieve 100% control or total control of all asthma symptoms by using Seretide; (3) alternatively, that a sufficiently high proportion of all asthma patients will achieve 100% control or total control of all asthma symptoms by using Seretide to justify the use of the brand slogan “Seretide Total Control”; (4) that 41% of all patients taking part in the study known as the “Gaining Optimal Asthma Control” study published in the American Journal of Respiratory & Critical Care Medicine in 2004 (GOAL Study) achieved 100% control of all asthma symptoms by using Seretide; (5) alternatively, that 41% of all patients taking part in the GOAL Study achieved “total control” (as that term was defined in the Seretide advertisements) of all asthma symptoms by using Seretide; (6) that 71% of all patients taking part in the GOAL Study achieved “well controlled asthma” (as that term was defined in the Seretide advertisements) of all asthma symptoms by using Seretide; and (7) that the patient results of the GOAL Study identified in (4), (5) and (6) (sic) would be achieved or would be likely to be achieved in clinical practice.

194    At [112], Edmonds J said that a difficulty for AstraZeneca’s case was that it led no evidence to suggest that general practitioners relied on the information/representations made in advertisements of the kind comprising the Seretide advertisements, and appearing in publications of the kind in which some of those advertisements appeared, to prescribe medication for those of their patients suffering from the symptoms of asthma. Indeed, such evidence as was led indicated that general practitioners placed no reliance on such advertisements in prescribing medications for their patients with symptoms of asthma: that they would merely regard such advertisements as part and parcel of wider marketing campaigns undertaken by drug companies to promote their products, and not as a source of information by reference to which they prescribed medications for their patients. At [113], Edmonds J said that the evidence indicated that general practitioners relied on sources of information, including their own familiarity with and experience in the form of patient acceptance and results achieved in prescribing Seretide, other than any representations conveyed by the Seretide advertisements, as a basis for prescribing medication to their patients suffering from the symptoms of asthma. Seretide was first available in Australia from August 2000 and had been extensively prescribed prior to the publication of the Seretide advertisements. At [114], Edmonds J said that in the absence of any evidence that any representations conveyed by the Seretide advertisements would be relied upon by general practitioners in prescribing medication for their patients suffering from the symptoms of asthma, it was impossible to find any causal connection between the conduct complained of and any inferential error or erroneous assumption of the kind suggested. That would be sufficient, Edmonds J said, to dispose of AstraZeneca’s case. At [123], Edmonds J said this:

Even assuming that one or more of the representations complained of can be made out as being conveyed by the GOAL Mailer, the logical causal connection between the representations and the inferred error is so tenuous that it is not possible to arrive at any finding that the representation is false and misleading. This conclusion is supported by the following matters:

(1)    The balance of the advertisement, viewed as a whole, …

(2)    The qualifying footnotes at all levels …

(3)    The truth of the extract from the GOAL Study, with or without the omitted words …

(4)    The audience to which the advertisements was directed …

(5)    The prescribing practises of GPs …

(6)    The experience of GPs in dealing with asthma symptoms and their familiarity and experience in dealing with Seretide and Symbicort …

I understood Bayer to be submitting that there were factual similarities between the case before Edmonds J and the present case.

195    I accept whether or not the relevant audience was or was likely to be led into error must be an evidence-based conclusion rather than a conclusion based simply on the fact that advertising is taking place. In my opinion, Novartis’ proposition that advertising seeps through to ophthalmologists may be accepted but it does not follow that it affects ophthalmologists in deciding to prescribe a drug for the treatment, by intra-vitreal injection, of wet AMD.

196    As to Novartis’ proposition that the Court need only conclude that it is “reasonably open” that a representation is conveyed, Bayer submitted that the issue was not a lawyer’s test but the effect or likely effect of conduct on the minds of the relevant class of recipients of the communication and whether the misconceptions or deceptions alleged to arise or to be likely to arise were properly to be attributed to the ordinary or reasonable members of the relevant class: Campomar Sociedad, Limitada v Nike International Ltd [2000] HCA 12; (2000) 202 CLR 45 (Nike) at [105]. Bayer also submitted that a Full Court of this Court had made clear that the issue could not be considered in the abstract but needed to be considered from the perspective of the section of the public to whom the promotional material was directed, namely, ophthalmologists. In that respect Bayer relied on Apotex at [32] and Astrazeneca Pty Ltd v GlaxoSmithKline Australia Pty Ltd [2006] FCAFC 22; [2006] ATPR 42-106 at [35], [42] and [49]. I agree.

197    In Nike, at [105], the High Court said that in an assessment of the reactions or likely reactions of the “ordinary” or “reasonable” members of the class of prospective purchasers of a mass-marketed product for general use, the court may well decline to regard as controlling the application of s 52 those assumptions by persons whose reactions are extreme or fanciful. The initial question which must be determined was whether the misconceptions, or deceptions, alleged to arise or to be likely to arise were properly to be attributed to the ordinary or reasonable members of the classes of prospective purchasers.

198    I have already considered Apotex. The paragraph relied on by the respondent, Bayer, makes the point, in the context of that case, that it was the doctor who made the initial decision whether to permit substitution of a generic product for a branded product and the pharmacist who then decided, if permitted to do so, whether to substitute a generic product for a branded product.

199    In Astrazeneca Pty Ltd v GlaxoSmithKline Australia Pty Ltd [2006] FCAFC 22; [2006] ATPR 42-106 at [42] the Full Court viewed each of the flyers and the advertisements as marketing documents directed by the respondent to ordinary or reasonable members of the community of general practitioners throughout Australia in the context of the product and sales history which the Court had set out. The Full Court was unable to find that any of them made the representations alleged and which I have set out above in relation to the first instance decision of Edmonds J. Earlier, at [35], the Full Court said that such representations as may have been made in the flyers and the advertisements were not made to identified individuals nor to the public at large. What the Full Court said, at [49], does not involve any question of principle but was a finding as to the flyers or advertisements in question. I also observe that, at [52], the Full Court noted the primary judge’s reference to AstraZeneca’s omission to lead evidence to the effect that general practitioners relied upon the representations said to be made by the respondent in prescribing medication for use by the asthma sufferers. The Full Court observed that the lack of such evidence would not be determinative of a case for alleged contravention of s 52.

200    I test the matter by reference to the steps identified by Gordon J in Australian Competition and Consumer Commission v Telstra Corporation Ltd [2007] FCA 1904; (2007) 244 ALR 470 at [14]–[15], where her Honour said that a two-step analysis is required. First, it is necessary to ask whether each or any of the pleaded representations is conveyed by the particular events complained of: Nike at [105]; National Exchange Pty Ltd v Australian Securities and Investments Commission [2004] FCAFC 90; (2004) 49 ACSR 369; (2004) 61 IPR 420 at [18] per Dowsett J (with whom Jacobson and Bennett JJ agreed); Astrazeneca Pty Ltd v GlaxoSmithKline Australia Pty Ltd [2006] FCAFC 22; [2006] ATPR 42-106 at [37]. That is, do the events singularly or collectively convey any of the representations? Second, it is necessary to ask whether the representations conveyed are false, misleading or deceptive or likely to mislead or deceive. This is a “quintessential question of fact”: Australian Competition and Consumer Commission v Telstra Corporation Ltd [2004] FCA 987; (2004) 208 ALR 459 at [49]. Her Honour was concerned with ss 52, 53(aa) and/or 53(c) of the Trade Practices Act.

201    I also refer to Parkdale, at 199, where Gibbs CJ said with reference to s 52:

… the section must in my opinion by regarded as contemplating the effect of the conduct on reasonable members of the class. … What is reasonable will or [sic] course depend on all the circumstances. The persons likely to be affected in the present case, the potential purchasers of a suite of furniture costing about $1,500, would, if acting reasonably, look for a label, brand or mark if they were concerned to buy a suite of particular manufacture.

The conduct of a defendant must be viewed as a whole. It would be wrong to select some words or act, which, alone, would be likely to mislead if those words or acts, when viewed in their context, were not capable of misleading. It is obvious that where the conduct complained of consists of words it would not be right to select some words only and to ignore others which provided the context which gave meaning to the particular words. The same is true of acts.

See also per Mason J at 209. I take the former of the propositions stated by Gibbs CJ to mean that the seriousness or importance of the purchase to the purchaser is relevant to the assessment of the respondent’s conduct.

202    In my opinion, a reasonable member of the class of addressees would not have understood the words used by Bayer to have the meanings of any of the four alleged representations (see [7] above) and none of the pleaded representations was conveyed by the particular events of which the applicant complains. This is not to say that ophthalmologists are immune or effectively immune from the effects of advertising but that they will, first, understand and, secondly, be affected by advertisements in the light of their training, knowledge and experience. I do not accept that a reasonable member of the class of addressees would stop at the words “fewer injections”. Nor do I accept that there is any material difference between the first form and the second form of the words used. In each case a reasonable member of the class would read the words as a single claim. In my view, the font size and colour difference in the first form is minor and insignificant in relation to the content, grammar and placing of the words the subject of those differences. These are factual matters and decided cases can only provide examples of what the courts have found to be conveyed in different factual circumstances.

203    As to the First Representation, in my opinion the words used do not mean that in clinical use, in accordance with the approved dosage, Lucentis is administered monthly for all patients. I am not persuaded that the (hypothetical) reasonable member of the class of ophthalmologists would take from the words, in context, the meaning of this alleged representation. In my opinion, the words used would be understood to mean, in accordance with the product information, that Lucentis is given monthly: the words say nothing, in my view, about Lucentis being administered in practice monthly for all patients, which is the gist of this alleged representation. The First Representation depends on an inference as to clinical practice which does not find a foothold in the language of the publication and which I do not draw. Neither do I draw the inference that the language refers to all patients. This allegation, correctly in my view, takes the words “in accordance with the approved dosage” to qualify both Eylea/aflibercept and Lucentis/ranibizumab.

204    As to the Second Representation, in my opinion the words would not be understood to mean that for each and every patient Lucentis will only be a clinically effective treatment if administered monthly. The words used are addressed ultimately to an ophthalmologist and I would not take them as having the meaning that for every patient Lucentis would only be a clinically effective treatment if administered monthly. There is no basis for concluding that the (hypothetical) reasonable ophthalmologist would proceed on the basis that each one of his or her patients was relevantly identical. I am not satisfied that such an ophthalmologist would assume that each and every one of their patients would require the same frequency of injection. Furthermore, Lucentis had been available for sale in Australia since 2007. The product information stated: “Lucentis is given monthly. The interval between two doses should not be shorter than 1 month. Although less effective, treatment might be reduced to one injection every 3 months after the first three injections (e.g. if monthly injections are not feasible).” In my opinion, such an ophthalmologist would understand the words used in light of that experience, including the product information of which he or she was aware so far as concerns the dosage regime: see [152] above. The question is an objective one so I do no more than note that if there was an ophthalmologist who had a different understanding, whether from recently becoming an “injector” or otherwise, he or she did not give evidence.

205    As to the Third Representation, my conclusion is the same and for similar reasons. This representation accepts that the words used direct the reader’s attention to the Lucentis product information but puts that those words misstate the effect of that product information, that is, that Lucentis was to be administered monthly “without qualification”. I am not satisfied that the (hypothetical) reasonable ophthalmologist would understand the words on the basis that the product information specified that Lucentis was to be administered monthly without qualification. I am not persuaded that such an ophthalmologist would consider that the words used stated that the product information would so specify, given the inherent variability of cases. Ophthalmologists are aware of the dosage regime in the product information: see [152] above. In my opinion, such an ophthalmologist would understand the words used in light of his or her experience, including his or her awareness of the product information. If there was an ophthalmologist who had a different understanding, whether from recently becoming an “injector” or otherwise, he or she did not give evidence.

206    As to the Fourth Representation, in my opinion this involves propositions in relation to the Second Representation and the Third Representation which I have rejected. First, I would not conclude that the (hypothetical) reasonable ophthalmologist would proceed on the basis that each one of their patients was relevantly identical. Secondly, Lucentis had been available for sale in Australia since 2007 so it is unlikely that such an ophthalmologist would consider that all Lucentis patients were alike and that the approved dosage was fixed. Thirdly, such an ophthalmologist was aware of the dosage regimes set out in the product information for Lucentis and Eylea respectively and understood what product information was. Fourthly, such an ophthalmologist would know that he or she had and exercised professional judgment by reference to the particular patient and the condition of that patient from time to time. In my opinion, such an ophthalmologist would understand the words used in light of his or her knowledge and experience. In summary, in my view the words do not mean that in accordance with approved dosages every Eylea patient receives fewer injections than every Lucentis patient. The thrust of the pleaded Fourth Representation is that the words used misstate the effect of the product information by misstating that the product information means that all Eylea patients receive fewer injections than all Lucentis patients. In my view such an ophthalmologist would not read the words used as so misstating the effect of the product information and as operating to deny professional judgment and the inherent variability of patients and their conditions.

207    The words “monthly Lucentis” were a key theme in the applicant’s representation case but, in my opinion they do not, in context, have the meaning that Lucentis is always injected monthly. Further, “monthly Lucentis” was a description applied to Lucentis in material produced by Novartis. The Lucentis product information indicated that it was to be given once a month, as did the ‘patient information document’ which was included in every box of Lucentis. Novartis also produced a brochure which referred to a “monthly regimen of Lucentis” demonstrating the best visual acuity outcomes in the clinical trials. The versions of the e-detailer in use by Novartis from July 2012 onwards contained multiple pages with the headline: “Rapid and sustained improvements in vision with monthly injections”. I accept Bayer’s submission that a comparison of the Novartis e-detailer with the Bayer Detail Aid shows that the concept of “monthly” Lucentis is given much more prominence in the Novartis e-detailer. As I have said, at [202] above, neither am I satisfied that the words “Eylea helps you and your patients with fewer injections” would have been read as by themselves bearing a meaning without the words which immediately followed them, whether in the first form or in the second form. I consider the meaning is the same and the form constitutes a single statement, notwithstanding the differences in the size and colour of the characters.

208    I have considered the applicant’s emphasis on the written materials of the respondent’s marketing department. The approach of the applicant in its written submissions was to place great emphasis on what Bayer’s marketing department developed as a strategy and to do so before focussing on the words, in context, of the alleged misrepresentations. The addressees would not, of course, have been aware of this material. Thus, contrary to the submissions on behalf of the applicant, it does not seem to me to be of overwhelming significance “that there was a key message imparted by the marketing department to the sales team and that that key message coincided with the first two and most prominent lines of the advertisements that were placed … in a variety of different publications”. So far as concerns the written representations of which Novartis complains, I prefer to read the words used in the context in which they were used rather than place weight on material that was not communicated to the addressees. So far as concerns the detailing, the one-on-one communications between the sales representatives and the ophthalmologists, I prefer the direct evidence of the sales representatives, both as to what they said and the context in which they said it. The marketing material was of course useful to the applicant for the purpose of cross-examining the respondent’s sales representatives but it rose no higher than that. I do not draw any Jones v Dunkel inference from Bayer’s failure to call the marketing personnel. Also, as I have set out at length, I accept the evidence of the respondent’s sales representatives.

209    One example of the marketing material emphasised by the applicant is a document prepared for Bayer by Ipsos Healthcare (International Custom Healthcare) dated 11 May 2012 and entitled “Developing and Optimizing Detail Aid for VEGF Trap Eye Communication”. The business objectives were described as being “To develop, test and refine the EYLEA detail aid, which will be used to optimise Bayer Healthcare’s communication strategy thus maximising its successful launch” and the research objectives were to “Evaluate the detail aid and make improvements with the objective of supporting the brand position and promoting uptake of VEGF Trap Eye vs. competing agents” and “Build a storyline/detail aid flow that best helps support the winning positioning”. The methodology was to interview 12 ophthalmologists described as being either retinal surgeons, specialists or ophthalmologists with a sub-speciality in retina. The key findings were stated to be simplicity, patient orientated outcomes, and data issues. Under “A simple story is needed” it was said: “The compelling story behind the product is essentially a simple one, care must be taken to avoid over-complicating the core brand story and diluting it.” Then, hightlighted as the key message to communicate to physicians was: “EYLEA has comparable efficacy and safety to ranibizumab with fewer injections”. The authors recommended amending the MOA section to further simplify the story”: the recommendations were that a summary of the MOA could be included in the dosing section to provide context to its inclusion; detail currently included in the opening section could be moved to an appendix or be part of a leave piece for those desiring further information – only the most scientifically minded would be interested; and if the MOA section was to be shown in full it required further context. Comparision to the MOA of ranibizumab would highlight the relevance of stronger binding and fewer injections.

210    I have set out this material at some length because the applicant relied on it strongly. However, in my view, what was recommended cannot be a substitute for; the results of the recommendation, the Detail Aid as in fact used, with its two disputed pages; or the circumstances in which the Detail Aid was deployed; and the context in which the disputed pages were seen. It would be a mistake, in my opinion, to conduct the objective exercise of giving meaning to the representations from this starting point.

211    I turn now to a bundle of documents on which Novartis placed great emphasis. I should say by way of preface, although nothing turns on it, that I do not accept that these documents were belatedly produced by Bayer, as submitted by Novartis, if by that it is intended to mean that Bayer was under an obligation to produce these documents earlier.

212    First was a document entitled “Marketing strategy & activities 2012, Field Force Training 23 March 2012 - Sydney”. The document is of some 80 pages. The key messages were stated to be: the market opportunity in wAMD in Australia is significant; regulatory approval granted; reimbursement expected by October 2012; relationships with stakeholders established; patient familiarisation and patient support programs well underway; and organisational build up of capabilities newly completed. The following pages deal with: Unique market — major opportunity; Sales Development wAMD market 2007–2011; Actual patient numbers for wAMD from Medicare Australia confirm our estimations; In Australia, patients are mainly seen & treated in private practices; In Australia, optometrists play an important role in the referral process; Australia has the highest treatment rate, with 95% of eyes that will receive treatment after diagnostic: Australian physicians have a high rate of “treat and extend” (47% versus 53% for “fixed intervals”); In Australia, visual acuity and evolution is mainly measured in “letters lost”; In Australia, Lucentis leads the market with almost 90% injection shares; There is a high frequency of injections in Australia with injections performed every ~8 weeks in year 1; XXXXXXXXXXXXXXXXXX XX XXX XXXXXX XXXXX XXXXXX XXXX XXXXXX XXXXXXXX XXXXXXXXX XXX XXXX XXXX XXXX XXXXXXXXX XXXX XXXXXXX XXX XXXXXXXXXX XXXX XXXX XXXXX XXXXXXXXX XXXX XXXXXXXXXX XXXXXXXXX XXXXXXX XXX XXX XXXXXXXXX XXXXXXX XXX XXXXX XXXXX XXXXXXX XX XX XXXX XXXX XXXXX XXXX XXXX XXXXXX XXXXXXXX XXXXXX XXXX XXXXXX XXXXXXXXXX XXXXX XX. There was then a tactical plans overview with a key activities timeline for 2012 and key marketing activities. Many pages later, following the page titled “Promotional Materials”, there is reference to: product information and consumer medicine information; reprints of published papers including those by Papadopoulos et al and Ohr et al; Research Review; CLM — Focus on e-detailer; and Sneak Preview … There is then a section entitled “Special Projects” and within that some pages directed to product familiarisation programs (PFP). The Overview referred to: Ophthalmologists in Australia are asking for access to EYLEA; The PFP is an unique opportunity to provide Eylea to treaters prior to reimbursement under controlled condition; The PFP will generate early prescriber experience with EYLEA ensuring treaters trial the drug prior to reimbursement; Establish Byer’s leader image despite new comer to the market; Ensure good sales from day 1 as patients will be prescribed reimbursed product as of listing; Objective: maximise uptake of EYLEA upon PBS listing; From drug availability (1 July 2012?) until PBS listing (1 Oct 2012); Limit 10 pts per prescriber under MA Code; Maximise prescriber enrolment (~200) to maximise patient numbers; 1500-2000 patients in PFP prior to PBS launch; Territory Managers will enroll (sic) retina specialists and ophthalmologists with retina interest and ensure clinic staff buy in; Marketing agency developing materials & forms; External data management; and DHL distribution. On the sixtieth page of the document there is a reference to “Every second month administration: less frequent injections and cost”. There is then a reference to “Narrative wheel workshop (11 Jan 2012)” where there appears: “The cross functional team developed a draft core story for EYLEA that will be the foundation for all communication” and, on the next page: “The workshop team identified responses to key issues and interests of each audience”. The former page includes a reference to “Current treatments help sustain vision but require monthly injections in the eye” and, in relation to Eylea, “It is a significant improvement that delivers the benefits seen with existing treatments but requires less frequent injections.” The latter, at least under the legible wheel, included similar words but also a statement: “All information is contained in the PI”.

213    The next Bayer document from the marketing department entitled “Other resources” dated 20 April 2012 contains a summary of Lucentis trials. Under the heading “Pivotal Trials” ANCHOR/MARINA were described as: three monthly injections followed by monthly injections for one year; nearly all patients with monthly injections maintained vision (lost less than 15 letters) for up to 2 years and vision improved by at least 15 letters in up to 40% of patients. Up to 42% achieved 20/40 or better at 2 years.

214    The third Bayer document from the marketing department was entitled “Q&A and objection handling”, dated 20 April 2012. One of the possible questions was “Year two data shows no difference to Lucentis”, with one of the suggested answers being “It is off label for us to discuss”.

215    The fourth Bayer document from the marketing department was entitled “Key Selling Messages Q2-Q3 2012” dated 20 April 2012. It contains a similar “Narrative wheel workshop (11 Jan 2012)” to the one which I have referred to above. It also repeats, with reference to the VIEW studies, although not on every page, “Dosing: Fewer injections”.

216    The fifth Bayer document from the marketing department was a “Marketing Update”, dated 8 June 2012. It contained a responder pad survey of attendees at the Australian and New Zealand Society of Retinal Specialists conference in relation to their anti-VEGF treatment pattern and also a responder pad survey of current practices against the question “If EYLEA was introduced, estimate the decrease in current injections vs Lucentis”.

217    The sixth Bayer document from the marketing department was entitled “Cycle Meeting: Marketing update”, dated 19 September 2012. A key message was stated to be “Predictable: less frequent dosing”. There were other references in the document to less frequent injections, one of which was followed by a statement suggesting that the VIEW trials provided evidence for the assertion.

218    The seventh Bayer document from the marketing department was entitled “Market overview and competition”, dated 7 February 2013. XXXXXXXXXX XXXXXXX XXXXXXXXXX XXXXXXXXXX XXXXXXXXXX XXXXXXXXXX XXXXXXXXXXX XXXXXXXXXX XXXXXXX XXXXX XXXXXXXXXX XXXXXX XXXXXX XXXXXXXX XXXXXX XXX Answers were suggested with reference to the clinical studies, including the VIEW trials.

219    The eighth Bayer document from the marketing department was entitled “Session 4: 2013 Tactical Plans”, dated 7 February 2013. Nothing of significance was said to flow from this document.

220    The ninth Bayer document from the marketing department was entitled “Strategy and Messaging” and dated 7 February 2013. It contains a reference to a key message of “Predictable: less frequent dosing” but contains frequent and extensive references to the VIEW studies. One page was entitled “Burden of Treatment with Current Standard of Care – Lucentis”, stating that a “fixed” regular administration of Lucentis was supported by the findings from pivotal trials: once monthly and referred by name to the various trials. The next page was headed “Reduced Burden of Treatment with EYLEA®” and referred to a predictable regimen with fewer office visits for treatment and other associated tests.

221    The tenth and last Bayer document from the marketing department was entitled “Cycle Meeting: Marketing Update” dated 18 March 2013. The first substantive slides dealt with the awareness of Eylea among respondents in Australia and the Eylea market share two months post launch. It referred to an overall higher rating than Lucentis; differentiated from Lucentis on “therapeutic effect for 8 weeks” and “lower number of injections”. The next page referred to the top messages recalled for Eylea including “labeled dosing”; 31% do not recall discussing about “fewer visits” and 77% about “no requirement for monitoring between injections”. The other relevant page was a reference on page 30 of this 50 page document to all of the following being Eylea’s key selling messages: Eylea maintains eyesight with a lower cumulative risk of injection related adverse events; unique MOA; and reduce burden and a predictable treatment.

222    In my opinion, these internal marketing materials of Bayer were remote from what I have found to have been said by the Bayer sales representatives to ophthalmologists.  I do not find there was a single isolated key selling message in those materials. Nor do I find that those materials prove the intention of Bayer to convey an isolated message of fewer injections or that there was an intention to mislead by publishing that message. These marketing materials were not put to the witnesses called by Bayer and no application was made by Novartis to recall any of those witnesses for that purpose.

223    I do not accept the submission put by Novartis that “fewer injections” became the bedrock for the promotion of Eylea from the first half of 2012 and into 2013, nor the associated submission that unsurprisingly the key message was squarely represented in the impugned publications. Neither do I accept that the “fewer injections” message was deployed divorced from the context of the product information, for each of Lucentis and Eylea, and the VIEW studies, which is the burden of the applicant’s written submissions at [38]–[42]. The basis for my conclusion will be apparent from the review in these reasons of the evidence of the Bayer sales representatives. In particular, in that connection, I do not accept the construction of the evidence of Ms Reznichenko for which Novartis contends at [38] of its written submissions. As I have set out at [143]–[145] above, Ms Reznichenko’s evidence was that only one of the attributes of Eylea was fewer injections and all of these were taken from the clinical trials described in the product information.

224    I reject the submission put on behalf of Novartis that “the consistent and central message” inculcated in the sales representatives was one of “fewer injections”, which message was not tethered to the product information. As I have said, that submission is inconsistent with the evidence of the Bayer sales representatives and is also inconsistent with the tenor of the Cortex notes which were a more or less contemporaneous summary of their individual communications with ophthalmologists and optometrists.

225    In my opinion, messaging or dominant messaging should not be used as a substitute for the meaning conveyed by the words used, by which I mean all of the words used in their context. TPG Internet does not require or support that approach. Neither, in my view, do the other authorities relied on by the applicant Novartis. The starting point for a conclusion based on dominant messaging, as explained in Telstra Corporation Ltd v Optus Communications Pty Ltd [1996] FCA 1035; (1996) 36 IPR 515 at 524, is that a false dominant impression is conveyed: see also Singtel Optus v Telstra [2004] FCA 859 at [40], on which the applicant Novartis relied. Global One Mobile Entertainment Pty Ltd v Australian Competition and Consumer Commission [2012] FCAFC 134 at [84]–[106] concerned television advertisements to consumers of mobile telephone premium services. Further, the form and terms of the advertisements were quite different to the impugned publications in the present case.

226    I have also taken into account the particular circumstances of each act of publication as set out above at [23] and [178].

227    I next deal with the disputed acts of publication of which there were nominally six, those numbered 7, 12, 23, 29, 36 and 46 in the table at [23] above.

228    As to 7, alleged to be a poster (first form), Novartis relies on the oral evidence of Ms Adams and Ms Martinek. Bayer contends that it displayed the baby banner (first form) at the Eylea product launch at Four Points by Sheraton, Sydney on 24 October 2012. In her first affidavit, Ms Adams deposed that she attended the official launch on that date in Darling Harbour but did not recall “whether there were any baby banners on display at that meeting.” In her oral evidence, Ms Adams agreed that it was conventional for Bayer to make use of marketing materials on significant occasions where there were lots of ophthalmologists being gathered and, although she could not recall any posters being used at all, she could not give a reason why the poster would not have been on display at the launch. Her evidence was she could not recall it being used. Ms Martinek’s oral evidence was that she thought the big poster was there at the launch of Eylea and she could not think of any rational reason why it would not have been there. I find that a poster, rather than a baby banner, was used by Bayer. It is not necessary to decide whether a baby banner was used as well at this launch on 24 October 2012 as there is no allegation of such an act of publication.

229    As to 12, a baby banner (first form) at the Eylea launch event in Brisbane on 24 October 2012, Novartis relies on the evidence of Mr Hodges, one of the two Eylea territory managers in Queensland. Mr Hodges attended the Eylea launch meeting on 24 October 2012. He annexed to his affidavit a copy of a baby banner which he deposed he thought was displayed at the launch meeting. In cross-examination, he agreed that he used the baby banner and took it to the product launch. In my opinion, it is more probable than not that the baby banner (first form) was displayed at the launch meeting on 24 October 2012 and I so find.

230    As to 23, a baby banner at the Tasmanian RANZCO meeting, Novartis relies on the affidavit of Ms Doyle, employed by Bayer as the territory manager, ophthalmology for South Australia and Tasmania. She attended the RANZCO meeting on 1 and 2 February 2013 and she recalled a large Eylea branded banner set up behind the trestle table at Bayer’s trade booth at the conference. She was responsible for setting up the booth. In her oral evidence, Ms Doyle said there was not a big poster at the trade booth but her recollection was that the Eylea baby banner was displayed, sitting on the trestle table. I find that a baby banner was displayed and it was the baby banner in the second form given the date of this event, that is, 1 to 2 February 2013.

231    As to 29, a baby banner at the Luxottica educational meeting in Darling Harbour, Novartis relies on the affidavit and oral evidence of Ms Adams, at the time an Eylea territory manager. Ms Adams deposed to having attended the April 2013 Luxottica educational meeting and to displaying a baby banner on a registration table outside the lecture room. I find that a baby banner was displayed. On the evidence, I am not able to say which form of baby banner was used at this meeting: Ms Adams had both forms in her possession; she could not recall which form she used; and as at April 2013 there was no reason for her to prefer one over the other.

232    As to 36, a baby banner at an educational meeting for Luxottica optometrists, Novartis relied on the affidavit of Ms Elibol, at the time an Eylea territory manager in eastern Victoria. She deposed to attending an educational meeting for Luxottica optometrists on 10 April 2013 and setting up a baby banner, she cannot recall in which form, inside the meeting room on a table located at the front right of the room. I find that a baby banner was displayed and it was probably the baby banner in the second form given the date of this event, 10 April 2013.

233    As to 46, a baby banner at the Luxottica educational meeting in the ACT, Novartis relies on the affidavit evidence of Ms Adams, at the time an Eylea territory manager in southern New South Wales and the ACT. She deposed in her first affidavit that she attended a meeting held by the Luxottica optometry group in or about June 2013 and said: “I cannot recall where I placed a baby banner.” In her second affidavit, she made clear that she did use the baby banner at that meeting but she could not recall which baby banner she used. I find that a baby banner was displayed and it was the baby banner in the second form since Ms Adams gave evidence that her understanding was that there was one baby banner that she should not use, which was replaced with one that she could use.

234    Since I have found the representations were not conveyed, it is not necessary to consider the question of whether or not the conduct was misleading or deceptive or likely to mislead or deceive. Nevertheless I should deal with the submissions in the alternative, that is, on the basis that the representations were conveyed.

235    Bayer admitted that, if conveyed, the representations were false but were not misleading or deceptive or likely to mislead or deceive. This raises two questions, one in relation to s 18 and another in relation to s 29.

236    As to the s 18 question, Bayer submitted in effect that even if the representations were conveyed, and accepting for this purpose that they were incorrect, the conduct, in the circumstances, did not lead, and was not capable of leading, a reasonable member of the class of addressees into error: see Australian Competition and Consumer Commission v Dukemaster Pty Ltd [2009] FCA 682 (Dukemaster) at [10(1)] and the authorities there cited by Gordon J. I consider each of the four representations in turn. As to the First Representation, in my opinion no (hypothetical) reasonable member of the class of ophthalmologists was or could have been led into thinking that in clinical use Lucentis was administered monthly for all patients. As to the Second Representation, in my opinion no such member of the class of ophthalmologists was or could have been led into thinking that for each and every patient, Lucentis would only be a clinically effective treatment if administered monthly. As to the Third Representation, in my opinion no such member of the class of ophthalmologists was or could have been led into thinking that the Lucentis product information specified, without qualification, that it was to be administered monthly. As to the Fourth Representation, in my opinion no such member of the class of ophthalmologists was or could have been led into thinking that in accordance with approved dosages, all Eylea patients received fewer injections than all Lucentis patients. My reasons for so concluding that the reasonable member of the class was not led and was not likely to have been led into error by the conduct are the level of training, information and experience and the nature of the decision-making brought to bear on the very serious nature of the question of prescribing an expensive drug for injection into a patient’s eyeball to retain vision. I rely here particularly on the evidence of Professor Mitchell and Dr Crawford. I find that a reasonable member of the class of ophthalmologists had a high level of training, knowledge and expertise. Secondly, I find that the prescription by ophthalmologists of a drug for injection into a patient’s eyeball was serious, complex and specific to the condition and needs of the particular patient. It is also expensive, although not to the prescriber or, except to a limited extent, to the patient. Thirdly, I do not accept that ophthalmologists considering prescribing a drug for injection into a patient’s eyeball would consciously or unconsciously take into account, even as a contributing factor, the slogan or message contended for by the applicant Novartis. Rather, I find an ophthalmologist would make his or her own decision based on their own experience with the relevant studies and articles and what they knew from their experience. I find also that clinical data, what they heard at overseas conferences with their peers, and their awareness of the VIEW clinical trials would have been the cause or causes of the prescription of Eylea to the exclusion, as a contributing cause, of the impugned conduct. I find that the decision-making of specialist doctors in these circumstances would not have been altered or affected by a sentence in any or in all of the impugned publications.

237    Similarly, I am not persuaded that Novartis suffered loss because of the conduct of Bayer. I am not persuaded that a reasonable member of the class of addressees did, or was likely to, prescribe Eylea rather than Lucentis by reason of the impugned conduct, assuming the representations were conveyed and were false. I approach the question of “by reason of” in ss 236 and 237 of the Australian Consumer Law, set out at [246] below, by reference to whether or not the impugned conduct was a contributing cause. I repeat what I have said in [235] above. I find that the decision-making of specialist doctors in these circumstances would not have been altered or affected by a sentence in any or in all of the impugned publications. I find that the impugned conduct was not and was not likely to have been a contributing cause in the prescription of Eylea.

238    As to the s 29 question, this arises because s 29(1)(a) and s 29(1)(g) each refer to a false or misleading representation. Thus Bayer’s admission that, if conveyed, the representations were false may mean, on the present hypothesis that the representations were conveyed, that Bayer would have breached s 29, assuming causation. Any additional work done by these provisions was only lightly developed in argument. This is against the background, as Gordon J noted in Dukemaster at [14], that the vast majority of cases that discuss an alleged breach of the predecessor provision couple it with a breach of s 52 (now s 18) and deal with the “false or misleading” and “misleading or deceptive” aspect of the conduct mutatis mutandis.

239    For those reasons, and in light of my findings on other issues, it is not appropriate to deal with the particular s 29 questions extensively but I shall indicate my views in a summary way.

240    Novartis submitted in its written closing submissions on this question that the making of a false representation will amount to a contravention of s 29(1) without the need to establish separately misleading or deceptive conduct. Bayer did not seem to dispute this. Bayer submitted, assuming everything else against it, that Novartis had not advanced specific submissions in support of its contention that one or more of the representations was a representation “that goods are of a particular standard, quality, value, grade, composition, style or model or have had a particular history or particular previous use” (within the meaning of s 29(1)(a)), or that the goods “have sponsorship, approval, performance characteristics, accessories, uses or benefits” (within the meaning of s 29(1)(g)). Bayer submitted that the First and Fourth Representations were not within the ambit of s 29, since those representations were directed to the conduct of doctors in clinical practice, not any quality or characteristic of Lucentis. The Third Representation was not within the ambit of s 29, since it was a representation directed to what the product information document provided with the goods specified, not any quality or characteristic of Lucentis. As to the Second Representation, Novartis had not specified the way in which s 29 was alleged to apply to that representation. In its written reply submissions Novartis submitted that the First, Second and Fourth Representations related to the frequency with which Lucentis was injected, which was an attribute, or performance characteristic, of Lucentis, citing Instant Colour Pty Ltd v Canon Australia Pty Ltd [1996] FCA 763. The term “particular quality” in s 29(1)(a) extended to include the attributes and properties of the goods, citing Nick Scali Ltd v Super A-Mart Pty Ltd [2011] FCA 751 at [14]–[16]. Similarly, a “performance characteristic” signified something that the goods can do, or something that can be done with the goods, citing Australian Competition and Consumer Commission v Pest Free Australia Pty Ltd [2004] FCA 527. Finally, the Third Representation was a representation that Lucentis had a particular approval within the meaning of s 29(1)(g).