FEDERAL COURT OF AUSTRALIA

GlaxoSmithKline Australia Pty Ltd v Pharmacor Pty Ltd [2014] FCA 1202

THE COURT ORDERS THAT:

1.    The parties are to confer forthwith as to the precise form of the preliminary discovery orders to be made to accord with my reasons published today.

2.    The application be stood over until 9.30 am on 13 November 2014.

3.    Costs reserved.

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

REASONS FOR JUDGMENT

1    By originating application filed on 31 October 2014, GlaxoSmithKline Australia Pty Ltd (GSK) has applied under r 7.23 of the Federal Court Rules 2011 (Cth) (the Rules) for orders that Pharmacor Pty Ltd (Pharmacor) give discovery and inspection to GSK of:

    the sections of Modules 3.2 and 5.3 of the Common Technical Document (CTD) that were lodged with the Therapeutic Goods Administration (TGA) as part of Pharmacor’s applications to include their OSTEOMOL 665 PARACETAMOL products (ARTG Nos. 227075 and 227076) (Pharmacor Products) on the Australian Register of Therapeutic Goods (ARTG);

    the results and methodology of any dissolution, bioavailability and efficacy studies for the Pharmacor Products not reported in the sections of the CTD;

    documents recording or reporting the reasons for the Department of Health's decision to approve the Pharmacor Products for inclusion on the ARTG;

    correspondence between Pharmacor and the TGA in respect of the similarity or bioequivalence of the Pharmacor Products to GSK’s modified release paracetamol products; and

    marketing and promotional material for the Pharmacor Products (including product and consumer medicine information sheets, brochures and flyers).

2    GSK also seeks an order that Pharmacor provide to GSK a sample of at least 50 tablets of each of its Pharmacor Products that correspond to each of Pharmacor’s ARTG registrations 227075 and 227076 (together with the material described at [1] above, the Materials).

3    GSK relies upon the affidavits of Ian Stanley Pascarl, solicitor for GSK, sworn 31 October 2014, 5 November 2014 and 7 November 2014 in supports of its application. The application is opposed by Pharmacor. It relies on the affidavits of Benjamin Lee Miller, solicitor for Pharmacor, affirmed 4 November 2014, 5 November 2014 and 6 November 2014 and the affidavit of Susan Magdalene Walters, an expert consultant in pharmaceutical regulatory affairs, scientist and pharmacist, affirmed 5 November 2014.

4    GSK contends that there is reasonable cause to believe that it may have a right to obtain relief in this Court from Pharmacor. The potential entitlement to relief, including injunctive relief, declarations and damages, is said to arise from inter alia:

    Pharmacor’s alleged representations in contravention of ss 18 and 29 of the Australian Consumer Law (set out in Sch 2 of the Competition and Consumer Act 2010 (Cth)) (ACL) to the TGA that its Pharmacor Products are bioequivalent to, or interchangeable with or substitutable for, the GSK products;

    Pharmacor’s alleged actual or anticipated promotion of the Pharmacor Products in contravention of ss 18 and 29 of the ACL to pharmacists and consumers; and

    Pharmacor’s alleged potential infringement of the claims of the patent referred to below.

5    GSK also relies on s 23 of the Federal Court of Australia Act 1976 (Cth) (FCA) to justify the orders sought in relation to the provision of samples.

The Products and Activities of GSK and Pharmacor

6    GlaxoSmithKline Consumer Healthcare Investments (Ireland) (No. 2) Ltd is the patentee of Australian Patent No. 2001260212 entitled “Composition” (the Patent). The invention claimed in the Patent is a bilayer sustained release oral paracetamol tablet with a stipulated dissolution rate(s).

7    GSK is the exclusive licensee and markets and supplies two sustained release paracetamol products in Australia, each of which is a commercial embodiment of the invention claimed in the Patent and registered on the ARTG. These products are:

    Panadol Back & Neck Long Lasting (ARTG 78493); and

    Panadol Osteo (ARTG 116619).

8    Panadol Back & Neck Long Lasting has been promoted and sold in Australia since May 2001 (from about May 2001 to about April 2005, under the brand name Panadol Extend). Panadol Osteo has been promoted and sold in Australia since 2005.

9    Panadol Osteo has been since about April 2005 included on the Schedule of Pharmaceutical Benefits (PBS). Panadol Osteo is currently the only modified release oral paracetamol product listed on the PBS.

10    Panadol Osteo releases paracetamol at a rate which ensures that therapeutically active plasma paracetamol concentrations are rapidly attained and maintained until up to 8 hours after administration.

11    A therapeutically active in vivo plasma paracetamol concentration is generally accepted to be a concentration of 4µg/ml or greater.

12    Panadol Osteo is an effective product because longer lasting pain relief is obtained whilst taking fewer doses of tablets, when compared to immediate release 500mg paracetamol tablets. For convenience, in the discussion below I will refer only to Panadol Osteo in terms of GSK’s products.

13    Pharmacor is the sponsor of the following registered and over-the-counter (OTC) modified release oral paracetamol products:

14    These Pharmacor Products have the same specific indication on the ARTG as Panadol Osteo, namely:

Effective relief from persistent pain for up to 8 hours. Effective for the relief of persistent pain associated with osteoarthritis and muscular aches and pains such as backache. Provides effective temporary relief of pain and discomfort associated with: headache, tension headache, cold and flu, period pain, toothache and pain after dental procedures. Reduces fever.

15    Pharmacor has applied to have the Pharmacor Products listed on the PBS as from 1 December 2014 on the basis of the TGA’s registration. According to a letter dated 23 September 2014 from Ashurst, solicitors for Pharmacor, to GSK’s solicitors, Pharmacor has commenced its marketing efforts concerning the Pharmacor Products. Further, it has stated that it will be taking orders for and selling the products for delivery on and from 1 December 2014.

16    Pharmacor asserts that whilst the Pharmacor Products are bioequivalent to Panadol Osteo, the Pharmacor Products are differently formulated to Panadol Osteo and do not infringe any of the claims of the Patent.

17    This application is brought as a matter of urgency on the basis that Apotex Pty Ltd, the Respondent in related proceedings VID 571 of 2014 on 27 November 2014 is likely to seek to be released from its current undertaking not to launch its own modified release paracetamol product in Australia due to a material change in circumstances constituted by Pharmacor launching (if not restrained) the Pharmacor Products on 1 December 2014.

18    Until the launch of a product by AFT Pharmaceuticals Pty Ltd in about October 2012, the GSK products were the only modified release paracetamol products registered on the ARTG for supply in Australia. As I have said, Panadol Osteo is currently the only modified release paracetamol product listed on the PBS. The marketing and promotion of Panadol Osteo by GSK has been targeted at doctors who prescribe the product for the treatment of osteoarthritis (the PBS market), pharmacists supplying Panadol Osteo either on prescription or over the counter, and consumers. Promotional activities include the placement of advertisements in medical journals and trade publications, direct contact between GSK’s sales representatives and general practitioners and a marketing presence at trade shows and conferences. In around 2010, GSK began distributing newsletters to patients with osteoarthritis who signed up to a "PANADOL OSTEO Information Programme". Patients were given the option of joining the program by signing a form left by GSK in doctors’ waiting rooms and pharmacies. Members of the PANADOL OSTEO Information Programme receive a regular newsletter with articles regarding osteoarthritis and advice for treating and managing the condition. Since around May 2013, GSK has significantly increased direct consumer marketing and promotion of Panadol Osteo. GSK currently markets and promotes Panadol Osteo directly to consumers through television advertisements, advertisements published in digital media, hard copy brochures and other point of sale materials distributed in pharmacies and through GSK’s own websites.

Whether GSK has insufficient information to decide whether to commence proceedings

19    GSK asserts that it does not have sufficient information to decide whether to commence proceedings against Pharmacor. In order to make that decision, it says that it requires further information in respect of the alleged bioequivalence and efficacy of the Pharmacor Products to Panadol Osteo and the way Pharmacor intends to promote the Pharmacor Products.

20    The Materials (which include sample tablets) sought are relevant to the question of whether GSK has a right to commence proceedings against Pharmacor.

21    GSK says that as the Pharmacor Products claim to be generic versions of Panadol Osteo, it is highly likely that in order to obtain ARTG registration for the Pharmacor Products, Pharmacor was required to submit some form of bioequivalence data for evaluation by the TGA in support of its application.

22    GSK says that differences in release profiles can have implications with respect to onset and duration of pain relief. If the Pharmacor Products are not bioequivalent to Panadol Osteo, they are unlikely to provide adequate therapeutic plasma concentrations for a full eight hours.

23    GSK is concerned that if a patient who usually receives Panadol Osteo has this switched to a Pharmacor Product, there is a real danger that such patients who receive inadequate pain relief (less than the 8 hours to which they are accustomed) will perceive their new medication to be ineffective. As a consequence, these patients may take further doses or turn instead to non-steroidal anti-inflammatory drugs (such as ibuprofen) (NSAIDs). NSAIDs, with their more serious side effects and added cost, are considered to be less safe at high doses or for long term use, particularly in the frail or elderly.

24    Differences in release profiles can also entail different toxicokinetic behaviour following overdose, which would require hospitals to be aware of such differences and have appropriate overdose procedures and guidelines to deal with the different product.

25    Furthermore, if Pharmacor supplies Pharmacor Products in conjunction with representations that its Pharmacor Products are "bioequivalent" to Panadol Osteo and remains silent on differences between the Pharmacor Products and Panadol Osteo, or authorises such representations and silence by others, GSK is concerned that consumers will mistakenly believe that the Pharmacor Products are identical to Panadol Osteo, which it says they are not.

26    It is appropriate to make some general observations concerning bioequivalence. Bioequivalence can be assessed by comparing the in vitro properties of a product such as dissolution rate or in vivo pharmacokinetic properties of the product measured in healthy volunteers or patients, such as the:

    Cmax: the maximum plasma "active ingredient" concentration reached within the body after the product is consumed;

    AUC0-t: the area under the curve formed by plotting plasma "active ingredient" concentration versus time, from the time the product is administered to a particular time "t". The area under the curve (AUC) measures the amount of active ingredient released, and is a measurement of the bioavailability of the active ingredient; and

    AUC0-inf: the area under the plasma "active ingredient" concentration versus time curve, from the time the product is administered to time infinity, that is, the total active ingredient released from the product over time.

27    One way of assessing "bioequivalence" is by using the 90% confidence interval approach; normal statistical analysis would use 95% or a p value of 0.05; I make that point to demonstrate the increased imprecision in the comparison by using such an interval. The confidence interval approach measures the size of the difference between the respective pharmacokinetic characteristics of the two products being compared. The 90% confidence interval is satisfied if the ratio of test to reference compound primary pharmacokinetic variables such as Cmax, AUC0-t, or AUC0-inf lie within the range of 0.8 to 1.25.

28    But according to the evidence led by GSK, in the case of a modified release paracetamol product, the most important pharmacokinetic properties are not Cmax or AUC alone. Rather, they are also:

    the time taken to reach a therapeutically active plasma paracetamol concentration of 4µg/ml or greater (that is, an indication of how quickly pain relief is provided); and

    the duration of time over which a therapeutically active plasma paracetamol concentration of 4µg/ml or greater is maintained (that is, an indication of how long pain relief lasts).

29    The AUC of two modified release paracetamol products may be the same, but the respective products may be different in:

    the time taken to reach a therapeutically active plasma paracetamol concentration of 4µg/ml or greater; and

    the duration of time over which a therapeutically active plasma paracetamol concentration of 4µg/ml or greater is maintained.

30    Bioequivalence is a predictive tool. According to GSK, only a clinical efficacy trial can provide evidence of therapeutic equivalence. I will put to one side for the moment any subtleties or difference in language (if any) between bioequivalence and therapeutic equivalence.

31    As I have said, GSK considers that as the Pharmacor Products claim to be generic versions of the GSK Products it is highly likely that in order to obtain ARTG registration for the Pharmacor Products, Pharmacor was required to submit bioequivalence data for evaluation by the TGA in support of its application.

32    GSK is concerned that as a result of Pharmacor’s representations to the TGA that its products are bioequivalent or interchangeable with or substitutable for GSK’s products, consumers will mistakenly believe that the Pharmacor Products are identical to and interchangeable with or substitutable for GSK’s products, which it says they are not.

33    According to Pharmacor’s evidence of Mr Miller, Pharmacor’s application to the TGA was submitted with relevant data for evaluation by the TGA. But nowhere does he provide precise detail of the nature of the information that was supplied to the TGA by Pharmacor in support of its application for registration other than to refer in the most general terms to the fact of three clinical studies being provided and a reference to an in vitro test.

34    According to GSK’s evidence of Mr Pascarl, in making its assessment as to whether a generic product is bioequivalent to a prior registered product, the TGA relies entirely on the information provided by the generic applicant in support of its application for registration. The TGA does not conduct its own tests. I accept this for present purposes. Further, GSK asserts that the information provided by Pharmacor to the TGA may have relied on in vitro studies, not clinical studies. I do not accept this in light of Mr Miller’s later affidavits which state that some clinical studies were provided. According to GSK, dissolution data without more cannot predict the in vivo characteristics of the Pharmacor Products, in particular the onset and duration of action. Further, even if AUC data was provided, that alone may not be sufficient to demonstrate that the Pharmacor Products have the same onset and duration of action as Panadol Osteo. Without any of the supporting information on which Pharmacor’s assertion to the TGA as to bioequivalence is based, GSK considers that it cannot be confident that the Pharmacor Products are therapeutically equivalent to Panadol Osteo.

35    GSK says that the Materials (which include sample tablets) sought are directly relevant to whether GSK has a right to commence proceedings.

36    GSK says that information as to the dissolution rate of the Pharmacor Products will enable GSK to determine whether the Pharmacor Products are equivalent to Panadol Osteo in a clinical therapeutic sense. If the Pharmacor Products are not so equivalent, then GSK may have the right to seek relief, including injunctive relief, for a contravention of the ACL.

37    GSK intends to conduct in vitro dissolution tests on the sample Pharmacor Product tablets provided using the USP type III apparatus (reciprocating basket) with 250ml of 0.1M HCl at 37C set at a cycle speed of 15 strokes/minute. The dissolution results from the samples will undergo in vivo modelling simulation to verify the alleged equivalence to Panadol Osteo and therapeutic efficacy of the Pharmacor Products under appropriate laboratory conditions. GSK also says that these parameters for GSK’s proposed in vitro dissolution tests are the most appropriate parameters to use to compare the Pharmacor Products to Panadol Osteo as they are the parameters cited in the Patent and were the parameters used in connection with GSK's application to register its modified release paracetamol products on the ARTG.

38    Finally, I note that in Pharmacor’s affidavit material, reference has been made to GSK’s use of the term “bioequivalence”. But the examples relate to the alleged bioequivalence of a novel product to a prior registered originator product. According to GSK, they are not directly relevant. In the case of the Panadol Osteo examples, the reference to bioequivalence is preceded by a pharmacodynamics section which explains the outcomes of the efficacy studies of Panadol Osteo versus regular Panadol. Each of the GSK examples refers to bioequivalence:

    based on clinical studies carried out in humans; and

    in particular contexts such as “with respect to dose-corrected AUC(0-t)”, or “in the extent of absorption of paracetamol”, not equivalence in all pharmacokinetic parameters that are relevant to a modified release product.

39    In the case of the examples given, the drugs referred to are not modified release products and are not single active ingredient products.

40    Pharmacor’s reference to these examples does not take the matter far in relation to the issues that I have to decide.

Rule 7.23 – Principles

41    Rule 7.23 of the Rules provides:

7.23    Discovery from prospective respondent

(1)    A prospective applicant may apply to the Court for an order under subrule (2) if the prospective applicant:

(a)    reasonably believes that the prospective applicant may have the right to obtain relief in the Court from a prospective respondent whose description has been ascertained; and

(b)    after making reasonable inquiries, does not have sufficient information to decide whether to start a proceeding in the Court to obtain that relief; and

(c)    reasonably believes that:

(i)    the prospective respondent has or is likely to have or has had or is likely to have had in the prospective respondent’s control documents directly relevant to the question whether the prospective applicant has a right to obtain the relief; and

(ii)    inspection of the documents by the prospective applicant would assist in making the decision.

(2)    If the Court is satisfied about matters mentioned in subrule (1), the Court may order the prospective respondent to give discovery to the prospective applicant of the documents of the kind mentioned in subparagraph (1)(c)(i).

GSK must comply with paras (a), (b) and (c) of r 7.23(1) before it can ask the Court to exercise its discretion under subrule (2) to order the prospective respondent to give discovery of the documents of the kind mentioned in r 7.23(1)(c)(i). Further, if the requirements are satisfied, the Court may nevertheless exercise its discretion to refuse preliminary discovery.

42    GSK also seeks to justify the orders sought, particularly in relation to the samples, under s 23 of the FCA.

43    The principal debate before me between GSK and Pharmacor has concerned whether r 7.23(1)(a) has been satisfied. Rule 7.23(1)(a) requires that the prospective applicant “reasonably believes” that it “may have the right to obtain relief in the Court” from the prospective respondent.

44    The following principles are not in dispute:

    First, for the belief to be reasonable, mere assertion or conjecture is not sufficient.

    Second, there must be some evidence that inclines the mind towards the matter of fact in question.

    Third, GSK does not have to establish every element of the foreshadowed cause of action. Uncertainty as to one element might be compatible with holding the requisite reasonable belief, but uncertainty as to a number of such elements may be sufficient to undermine the reasonableness of the required belief.

    Fourth, the terms of r 7.23 are to be construed beneficially so as to be given the fullest scope that its language will allow.

    See generally ObjectiVision Pty Ltd v Visionsearch Pty Ltd [2014] FCA 1087 at [31]-[38] per Perry J; Optiver Australia Pty Ltd v Tibra Trading Pty Ltd (2008) 169 FCR 435 at [47]-[48] per Heerey, Gyles and Middleton JJ; St George Bank Ltd v Rabo Australia Ltd (2004) 211 ALR 147; [2004] FCA 1360 at [26] per Hely J; Apache Northwest Pty Ltd v Newcrest Mining Ltd (2009) 182 FCR 124 at [2] per Moore and Gilmour JJ and [26] per Flick J; AstraZeneca AB v Alphapharm Pty Ltd [2014] FCA 9 at [33]-[35] per Besanko J and Reeve v Aqualast Pty Ltd [2012] FCA 679 at [65] per Yates J.

45    Generally, under r 7.23 I only have to be satisfied that GSK “reasonably believes” that GSK “may” have the right to obtain relief in this Court from Pharmacor. As I say, only a reasonable belief is required. Further, that belief is only that GSK may have the right to relief. It is not required to be shown that the belief is that GSK would have such right to relief.

GSK’s Submissions

46    GSK's principal reasons as to why it says it reasonably believes it may have a right to obtain relief against Pharmacor have been set out in Davies Collison Cave Law's letter to Ashurst dated 10 October 2014. That letter states:

... our clients have reasons to believe that they may have the right to obtain relief in the Federal Court from your client including pursuant to the Australian Consumer Law (ACL).

The basis for that belief is as follows:

1.    Your client has represented to the Therapeutic Goods Administration (TGA) and the Pharmaceutical Benefits Advisory Commission (PBAC) that your client's OSTEOMOL 665 PARACETAMOL products (ARTG Nos. 227075 and 227076) (Pharmacor Products) are bioequivalent to our client's PANADOL OSTEO and PANADOL BACK & NECK products (GSK Products) (letters from you to Phillips Ormonde Fitzpatrick dated 30 July 2014 and 5 September 2014).

2.    The Pharmacor Products are specifically indicated for exactly the same indication as the GSK Products, namely "Effective relief from persistent pain for up to 8 hours. Effective for the relief of persistent pain associated with osteoarthritis and muscular aches and pains such as backache. Provides effective temporary relief of pain and discomfort associated with: headache, tension headache, cold and flu, period pain, toothache and pain after dental procedures. Reduces fever."

3.    Our clients infer, from the matters set out above, that your client has sought to have the Pharmacor Products listed on the Schedule of Pharmaceutical Benefits (PBS) as a "new brand" of PANADOL OSTEO.

4.    By applying to list the Pharmacor Products as a "new brand", your client is, in effect, representing that the Pharmacor Products may be interchanged or substituted with PANADOL OSTEO.

5.    Our clients reasonably believe, from the matters set out above, that your client has and/or will promote the Pharmacor Products as being "bioequivalent to", "interchangeable or substitutable with" and/or "as good as" the GSK Products or with reference to similar statements suggesting the same (Statements).

6.    Our clients infer, from the matters set out in your letter to our client of 30 July, that your client claims that the Pharmacor Products are bilayer tablet products which comprise equal amounts of paracetamol in the immediate release layer and sustained release layer and do not have an in vitro paracetamol dissolution profile within the constraints of claim 1 of Australian Patent No. 2001260212 (212 Patent).

7.    The GSK Products are commercial embodiments of the invention claimed in the 212 Patent. The Patent clearly explains the advantages of the claimed formulations over a bi-layer tablet formulation comprising equal amounts of paracetamol in the immediate and sustained release layers (see, for example, page 17 of the 212 Patent).

8.    If the matters set out in numbered paragraphs 6 above are correct, our clients believe that the Pharmacor Products cannot be considered to be "bioequivalent to", "interchangeable or substitutable with" and/or "as good as" the GSK Products.

9.    In those circumstances, the Statements (and the representations made to the TGA and PBAC referred to above (Representations) would contravene section 18 and 29(a) and (g) of the ACL and our clients would be entitled to, amongst other things, injunctive orders restraining your client from making the Statements and the Representations and damages for the loss our clients have suffered as a result of those Statements and Representations.

47    Section 18 of the ACL provides that:

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).

48    Paragraphs 29(1)(a) and (1)(g) of the ACL provide that:

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…

49    GSK also contends in the alternative, although this is not set out in the letter of 10 October 2014, that it reasonably believes it may have a right to obtain relief against Pharmacor in relation to infringement of the Patent. If the Pharmacor Products are bioequivalent to Panadol Osteo, in terms of how GSK would perceive bioequivalence, then GSK contends that Pharmacor may arguably have infringed the Patent.

50    This is an alternative case. Its primary case is that there is no bioequivalence, hence the contentions in its letter dated 10 October 2014. Its alternative case is that if it is wrong on its primary case and there is such bioequivalence, then it is likely that there has been or is threatened to be an infringement of the Patent. In other words, in GSK’s universe, as it views the concept of bioequivalence and where there are only these two possibilities, it reasonably believes that it may have a claim. Pharmacor on the other hand contends for the third possibility, which is the scenario where there is bioequivalence but no infringement. In how it or the TGA views the concept of bioequivalence, it says that this was an appropriate characterisation of its product. Accordingly, it says that there is no ACL claim against it. Moreover, there is no actual or threatened infringement of the Patent.

51    On one view, accepting for the moment that there is this third possibility, it might be said that of the three possibilities, two of these three possibilities may give rise to a claim that GSK could make against Pharmacor. In any event, GSK also has a response to this third possibility. Even if it is assumed that the products are “bioequivalent” and that there has been no infringement, nevertheless that does not make the products substitutable or interchangeable. If Pharmacor markets and supplies the Pharmacor Products to pharmacists, consumers and the like to the effect that the “products are bioequivalent as approved by the TGA” then it may be engaging in a half-truth scenario or misleading or deceptive conduct by omission or silence on the basis that such conduct will conceal or omit to make reference to key differences between the Pharmacor Products and Panadol Osteo.

52    For the reasons that follow, in my view GSK has satisfied the elements of r 7.23(1)(a) in relation to this last possibility but no other potential claim.

Pharmacor’s submissions

53    Pharmacor’s principal submission is that GSK has not demonstrated the requisite reasonable belief that it may have a right to obtain relief against Pharmacor.

54    First, it is said that GSK has led no evidence to establish the existence of that belief or its reasonableness. It says that GSK relies upon mere speculation or conjecture. In particular, it is said that there is no evidence to support the proposition that Pharmacor has made or will make the various representations or statements alleged by GSK. Nor is there any evidentiary basis for GSK's assertion that those representations or statements, if made, would be false or misleading. It is said that no evidence has been led, for example, to attempt to establish that the Pharmacor Products are not in fact "bioequivalent to", "interchangeable or substitutable with" or "as good as" the GSK products as alleged. It is said that the Patent does not provide any such evidence. Further, it is said that there is no evidence that a tablet falling outside the parameters claimed in the Patent would, when compared with a tablet falling within the claims, make any relevant material difference when given to a patient. It is said that GSK's case is based on assertion, with no evidence to incline the mind in favour of any right to relief.

55    Pharmacor has also filed substantial affidavit material seeking to justify the merits of its argument that GSK has no claim against it. Although interesting, I am not at this stage dealing with the merits of any claim or Pharmacor’s defences thereto other than to the extent of determining whether GSK has a reasonable belief that it may have a right to obtain relief. Pharmacor has also gone so far as to refer to some of the very material it has placed before the TGA. Of course, GSK has no access to this at this stage; this material is what is being sought by this application.

56    There are a number of responses to Pharmacor’s primary contention as follows.

57    At the core of Pharmacor’s position is the submission that GSK has not demonstrated any reasonable belief that the Pharmacor Products are not “bioequivalent” to Panadol Osteo in relation to how the TGA has used the concept of “bioequivalent”. I accept this submission. Although there is some difference in the material as to what is meant by “bioequivalent”, it seems to me that in terms of how the TGA has used that term, there is no proper basis for contending that the Pharmacor Products have not properly or accurately been assessed so as to accord with how the TGA has used that characterisation.

58    GSK has made a number of submissions suggesting that “bioequivalence” can be differently assessed and characterised. Indeed, it has gone so far as to inject into that characterisation concepts that relate to therapeutic equivalence. But even accepting such submissions, it does not show any basis for saying that the TGA’s characterisation of bioequivalence between Panadol Osteo and the Pharmacor Products is not on all fours with how the TGA has used such a concept.

59    Second, it is said that GSK can have no reasonable belief that it may have the right to obtain relief from Pharmacor in respect of representations alleged to have been made to the TGA. It is said that as part of its application to the TGA, Pharmacor submitted relevant data which was evaluated and assessed by the TGA. It is said that the TGA made its own assessment of that data and determined to its satisfaction that the Pharmacor Products were bioequivalent to Panadol Osteo. It is said that in doing so, the TGA performed its statutory function. It is said that there is no evidence at all of any misrepresentation or material non-disclosure made by Pharmacor to the TGA or any reliance thereon by the TGA.

60    I accept this submission. The general process followed by the TGA appears to be as follows.

61    The TGA publishes guidelines on its website at https://www.tga.gov.au/industry to assist sponsors to prepare applications. In respect of OTC medicines these guidelines are the Australian Regulatory Guidelines for OTC Medicines (ARGOM).

62    The ARGOM provides information as to the registration process applicable to OTC medicines, including:

(a)    TGA regulatory requirements for the preparation and submission of an application and the data required in support of an application;

(b)    the TGA's pre-market evaluation and assessment processes, including:

(i)    the rounds of assessment undertaken by the TGA;

(ii)    the use of expert statutory scientific advisory committees;

(iii)    the issuing by the TGA of evaluation/assessment reports of quality, nonclinical and clinical evaluators as required;

(iv)    the processes by which the TGA can seek further information from applicants (referred to as "section 31 requests") and applicants’ responses;

(v)    the processes involved in the TGA's making a request for expert advisory committee review and advice;

(c)    the Secretary's determination of whether to approve or reject the application; and

(d)    the Secretary's finalisation of the decision, including notifying the applicant of the Secretary's decision and entering the goods on the ARTG once regulatory requirements are met.

63    In the course of evaluating an application for registration of a generic medicine, including evaluating the supporting data to determine if bioequivalence of the medicine has been demonstrated with a reference medicine, the Secretary may seek independent expert advice to assist in his or her evaluation from a number of statutory advisory committees (which are established under the Therapeutic Goods Regulations 1990 (Cth)). The relevant committee from which the TGA can seek independent expert advice in evaluating an application in the case of OTC medicines is the Advisory Committee on Non-prescription Medicines (ACNM). This committee is comprised of experts in pharmacy, medicine (including in particular fields of medicine), clinical pharmacology, drug quality (including bioavailability and bioequivalence), preclinical toxicology, clinical studies, drug safety and drug development. The ACNM can also enlist assistance and advice from sub-committees. It is not apparent that the ACNM met or reported on the Pharmacor Products.

64    On completion of an evaluation, the Secretary decides whether to accept or reject the application for registration, based on evaluation of the information in the applicant's submission, including the data in support of that submission, any advice received from advisory committees and other information obtained during the evaluation phase. In the case where product information is required to be submitted for evaluation by the Secretary in relation to a medicine, the Secretary is required to evaluate that product information and notify the applicant of the approved product information in respect of that product when the product has been approved for registration.

65    Pharmacor has asserted that in accordance with these procedures, the TGA evaluated Pharmacor’s application and assessed the data submitted by Pharmacor. It is said that the TGA made its own assessment and determined to its satisfaction that the Pharmacor Products were bioequivalent to Panadol Osteo, applying the applicable regulatory standard.

66    In my view, there is a doubt in the material as to what process was in fact followed by the TGA in evaluating the Pharmacor Products. The material before me suggests that the TGA may not have referred the application for registration to the relevant committee/subcommittee(s). Nevertheless, even if it did not, any such deficiency (if there be one) does not provide a reason to believe that there has been any relevant misrepresentation or non-disclosure to the TGA by Pharmacor or any mischaracterisation of the Pharmacor Products as being bioequivalent to Panadol Osteo in the sense of how that term has been used by the TGA.

67    Pharmacor generally stresses the independence of the TGA in its assessment. But accepting that to be so, the TGA is nevertheless reliant upon accurate and complete information from Pharmacor. But in my view there is no reason to doubt that Pharmacor has provided such accurate information to the TGA as required of Pharmacor in order for the TGA to carry out an adequate assessment of bioequivalence.

68    Third, Pharmacor says that GSK can have no reasonable belief that it may have the right to obtain relief from Pharmacor in respect of representations made to the Pharmaceutical Evaluation Branch of the Department of Health (PEB). It is said that this is because the relevant representation as to bioequivalence was made by the TGA (not Pharmacor) to the PEB and that such a representation was true. It is said that the representation was that the TGA approved the Pharmacor Products as being bioequivalent to Panadol Osteo, which it in fact did.

69    Again, there was little dispute as to the procedures followed.

70    On 25 August 2014, Pharmacor applied to the PEB for listing of the Pharmacor Products on the PBS pursuant to the relevant provisions of the National Health Act 1953 (Cth). That application included a copy of a notification by the TGA that the TGA had determined to its satisfaction that the Pharmacor Products were bioequivalent to Panadol Osteo.

71    The website of the Department of Health, Pharmaceutical Benefits Scheme explains that the TGA's notification concerning bioequivalence is required by the PEB:

The following information must be received by the Listing Unit ... :

Brand Equivalence Statement (applies to New Brands only). New brands must be listed with an equivalence indicator. In order for a brand equivalence indicator to be included in the entry for the new brand, it is the sponsor's responsibility to request a statement from the TGA indicating that it is appropriate for an equivalence indicator to be shown in the PBS Schedule, and against which other brands. This advice must be received by the Listing Unit by the deadline. It is suggested the statement be requested from the TGA towards the end of the evaluation process to ensure that the TGA has sufficient time to provide the advice prior to the listing deadline.

72    It is apparent that any notification or representation made as to bioequivalence to the PEB was made by the TGA rather than Pharmacor. There is no evidence that the TGA was the cat’s paw of Pharmacor. Further, there is no evidence that the TGA made any representation to the PEB of anything other than the accurate statement that the TGA had determined to its satisfaction that the Pharmacor Products were bioequivalent to Panadol Osteo.

73    In my view, there is no basis for saying that GSK might have a claim against Pharmacor in relation to any representation made to the PEB. Further, any representation made by the TGA to the PEB was accurate.

74    Fourth, it is said that even if Pharmacor had made representations to the TGA or the PEB as alleged by GSK (and assuming they were misleading) then those representations were not made “in trade or commerce” so as to attract the operation of ss 18 or 29(1)(a) or (1)(g) of the ACL.

75    Given the conclusions set out above, strictly it is unnecessary to deal with this aspect. But if I am wrong, I also accept Pharmacor’s submissions in this respect in any event.

76    Concrete Constructions (NSW) Pty Ltd v Nelson (1990) 169 CLR 594 (Concrete Constructions) establishes that the phrase “in trade or commerce” refers not to “the immense field of activities” in which corporations may engage in the course of carrying on some overall trading or commercial activity, but rather to the central conception of trade or commerce (see at 603-604 per Mason CJ, Deane, Dawson and Gaudron JJ).

77    Generally, representations made to statutory authorities as required by legislation in order to satisfy a statutory condition or to “procure” an exercise of statutory power are outside the scope of “in trade or commerce”. They are not of themselves in the course of a trading or commercial relationship or bear a trading or commercial character. The relationship is rather “a relationship between a regulator and a regulated industry or business” (Village Building Co Ltd v Canberra International Airport Pty Ltd (2004) 139 FCR 330 at [51] per French, Sackville and Conti JJ; Glueck v Stang (2008) 76 IPR 75; [2008] FCA 148 at [32]-[33] per Lindgren J; Interpharma Pty Ltd v Commissioner of Patents (2008) 107 ALD 342; [2008] FCA 1283 at [14] per Sundberg J and Gold & Copper Resources Pty Ltd v Newcrest Operations Ltd [2013] NSWSC 281 at [109], [116]-[118] per Stevenson J).

78    GSK asserts that such authorities do not deny its argument that any representations made by Pharmacor to the TGA or the PEB were “in trade or commerce”. It says that the above cases are distinguishable. GSK says that in the present case, Pharmacor’s representations made to the TGA and the PEB were a necessary part of its ultimate objective to market and supply its product for profit to pharmacists, medical practitioners and the ultimate end user. But even accepting this to be correct, that does not establish that the conduct of Pharmacor vis a vis the TGA was “in trade or commerce” as such; likewise in terms of the conduct of Pharmacor vis a vis the PEB. GSK relied upon some observations in Brown v Riverstone Meat Co Pty Ltd (1985) 60 ALR 595 at 607 per Wilcox J, but in my view such observations are not of assistance; they pre-date Concrete Constructions.

79    GSK has not established that it is reasonably arguable that Pharmacor’s conduct vis a vis either the TGA or the PEB was “in trade or commerce”. Alternatively expressed, GSK has not established a reasonable belief as to this element of any claim based under ss 18 or 29(1)(a) or (1)(g) of the ACL in relation to any alleged representations made by Pharmacor to the TGA or the PEB.

80    Fifth, it is said that GSK has no reasonable belief that it may have the right to obtain relief from Pharmacor in respect of its promotion of the Pharmacor Products to pharmacists and/or consumers in contravention of ss 18 and 29(1)(a) and (1)(g) of the ACL. It is said that the evidence led by Pharmacor establishes that no false or misleading representations will be made to pharmacists or consumers, and that GSK has no basis for suggesting otherwise.

81    It is this aspect of the matter that in my view GSK has made out. GSK has a reasonable belief as to a potential claim based upon the half-truth scenario or misleading or deceptive conduct partly constituted by silence or omission. I reject Pharmacor’s submissions on this aspect.

82    GSK says that Pharmacor has or will promote the Pharmacor Products as being "bioequivalent to", "interchangeable or substitutable with” or "as good as" the GSK Products or similar statements suggesting such a comparison; it is said that such statements will or are likely to contravene ss 18 and 29(1)(a) and (1)(g) of the ACL.

83    It is appropriate to summarise the evidence as to how Pharmacor intends to promote and supply the Pharmacor Products.

84    Pharmacor says that the only statements that it will make to pharmacists and consumers in supplying and promoting the Pharmacor Products are to the effect that the TGA has approved these products as being bioequivalent to Panadol Osteo and that the PEB has approved the Pharmacor Products to be interchangeable or substitutable with Panadol Osteo. Let me elaborate.

85    First, the Pharmacor Products are to be marketed in packaging which has been approved by the TGA and submitted by Pharmacor as part of its application for PBS Listing. It is said that there will be nothing on the packaging of the Pharmacor Products which makes any reference to the Pharmacor Products' bioequivalence to Panadol Osteo.

86    Second, the Pharmacor Products will be supplied to pharmacists together with product information approved by the TGA under s 25AA of the Therapeutic Goods Act 1989 (Cth).

87    Third, if any consumer medicine information is to be supplied inside any pack of the Pharmacor Products, it will make no reference to the Pharmacor Products' bioequivalence to Panadol Osteo.

88    Fourth, apart from the statements referred to in [84] and [89], Pharmacor does not propose to promote the Pharmacor Products:

    by referring in general terms to the "bioequivalence", "equivalence" or "similarity" of the Pharmacor Products to Panadol Osteo (or use similar expressions);

    by referring in general terms to the "interchangeability" or "substitutability" of the Pharmacor Products to Panadol Osteo (or use similar expressions); or

    by claiming or asserting that the Pharmacor Products are "the same as", "identical to" or "as good as" Panadol Osteo (or use similar expressions).

89    Fifth, Pharmacor proposes to ensure, in all marketing and promotional material for the Pharmacor Products, that:

    any reference to "bioequivalence" of the Pharmacor Products to Panadol Osteo, is made using the phrase "approved by the TGA as bioequivalent to PANADOL OSTEO" or a similar expression referring to its correct regulatory status; and

    any reference to "interchangeability" or "substitutability" of the Pharmacor Products for Panadol Osteo is made using the phrase "listed on the PBS as interchangeable with or substitutable for PANADOL OSTEO" or a similar expression referring to its correct PBS listed status.

90    It is said that such statements will not only be literally true, but are consistent with pharmacists' understanding in respect of "bioequivalence", "interchangeability" and "substitutability".

91    Further, the evidence of Dr Walters was to the effect that Australian pharmacists:

    understand that pharmaceutical products listed on the PBS as being equivalent to another brand include a "brand equivalence" indicator (being superscript 'a' or 'b' located immediately before the brand names of a particular strength of an item);

    understand that in the context of a medicine listed on the PBS as interchangeable with another brand, an 'a' flag indicates that the TGA has approved the medicines as being bioequivalent or therapeutically equivalent;

    understand that in order for a new brand to be listed on the PBS with a brand equivalence indicator, the TGA must have provided a statement to the PBS that it has determined that the products are bioequivalent;

    understand that if a new brand of a medicine is marked as brand equivalent on the PBS against another medicine, the TGA has assessed and approved the new brand as equivalent to the brand against which the equivalence indicator is applicable; and

    identify alternative generic brands for a medicine when dispensing medicines by conducting searches using prescribing software, which contains information as to the brands listed on the PBS that have a brand equivalence indicator indicating that the brands can be interchanged.

92    Let it be accepted that the proposed promotion by Pharmacor of the Pharmacor Products to pharmacists and consumers will involve references to “bioequivalence” between the two products using the phrase “approved by the TGA as bioequivocal to Panadol Osteo” and references to brand equivalence. Let it also be assumed that such statements are literally true in the sense of being accurate descriptions of the TGA’s and PEB’s descriptions (as distinct from the objective truth of such characterisations). Yet that does not deny the realistic scenario of misleading or deceptive conduct or false representation being constituted by a half-truth or by omission.

93    First, there are at least two potential classes to consider, viz, pharmacists and the end users or consumers. End users or consumers may take such a statement “approved by the TGA as bioequivocal to Panadol Osteo” as meaning that the Pharmacor Products are interchangeable or substitutable with Panadol Osteo. They may take such a statement to mean or imply that the Pharmacor Products deliver all the same benefits as Panadol Osteo. They may not understand fully what “bioequivocal” entails and any imprecision in that concept, let alone know how the TGA have used that concept. They may readily conclude complete interchangeability, substitutability and identical benefits without any discrimination whatsoever. Moreover, such promotions and understanding may be fortified by the imprimatur and gravitas of the phrase “approved by the TGA as bioequivocal …”. Further, pharmacists may understand the subtlety of such a phrase in terms of how the TGA have used the phrase “bioequivocal”, but they may not. Alternatively, they may gloss over relevant distinctions. As Dr Walters observed:

40.    In my practice as a pharmacist, I identify alternative generic brands for a medicine when filling prescriptions by conducting searches using prescribing software, which contains information as to the brands listed on the PBS that have a brand equivalence indicator indicating that the brands can be interchanged. This is a surrogate for consulting the PB schedule itself. If I have time (which is not likely) I can also identify alternative brands of medicines that are bioequivalent by conducting a search on the PBS website at http://www.pbs.gov.au/pbs/home, by active ingredient or original brand, then looking for 'a' or 'b' in the "Available brands" field. I understand that brands marked 'a' can be substituted for others marked 'a', and those marked 'b' can be substituted for others marked 'b' but brands marked 'a' cannot be substituted with brands marked 'b'. Based on my interactions with my colleagues who are community pharmacists, my knowledge and experience of prescribing practices and my observation of the practices of other community pharmacists, I understand that other community pharmacists in Australia identify alternative generic brands of a medicine in the same way as I have described above.

41.    In order for a new brand to be listed on the PBS with a brand equivalence indicator in the entry on the PB Schedule, the TGA must have provided a statement to the PBS that it has determined that the products are bioequivalent. This requirement is set out on the PBS website at http://www.pbs.gov.au/info/industry/listing/elements/listing-unit-requirements, a copy of which is annexed at Annexure SMW-7.

42.    Therefore, if a new brand of a medicine is marked as brand equivalent on the PBS against another medicine, I understand that the TGA has approved the new brand as equivalent to the brand against which the equivalence indicator is applicable. Based on this approval, I dispense medicines that are brand equivalent (provided that the patient consents and the prescriber has not annotated the prescription 'Brand substitution not permitted') and believe there is no significant difference in safety or efficacy between the brands. Based on my interactions with my colleagues who are community pharmacists, my knowledge and experience of dispensing practices and my observation of the practices of other community pharmacists, I understand that other community pharmacists in Australia identify interchangeable generic brands of a medicine in the same way.

Accordingly, once there is this “brand equivalence”, flowing from the TGA’s characterisation of bioequivalence, pharmacists are likely to treat the products as, for all relevant purposes, the same and to supply or promote them to consumers accordingly.

94    Second, although such representations or statements may not appear on actual packaging, nevertheless broader promotions and marketing material are likely to contain such representations or statements. Further, the material suggests that promotional material may either be targeted directly at the end user or targeted at pharmacists who will then so promote to the end user. There is another class of persons being medical practitioners who may be the potential targets of such representations, but I do not need to consider them further for present purposes.

95    In terms of looking at potential classes of persons and how they might understand the relevant promotional material, as I say the intended audience or potential classes are either pharmacists or actual or potential consumers of the Pharmacor Products. Where there is a dispute as to the effect of conduct on a class of persons, such as consumers who may range from the gullible to the astute, what is considered is whether an ordinary and reasonable member of that class would be or was likely to be misled or deceived (Google Inc v Australian Competition and Consumer Commission (2013) 249 CLR 435 at [6]-[9] per French CJ, Crennan and Kiefel JJ). Further, in considering the hypothetical ordinary and reasonable member of the relevant class, one considers the dominant message conveyed (Australian Competition and Consumer Commission v TPG Internet Pty Ltd (2013) 250 CLR 640 at [20], [40] and [45] per French CJ, Crennan, Bell and Keane JJ). Further, where general injunctive relief is being sought, all that may be required to be shown is that the relevant statement has a tendency to lead persons of the relevant class into error; contrastingly, if an individual damages claim is being made, causation, including reliance questions, needs to be specifically addressed. Moreover, the question is whether there is a real rather than a remote possibility of the member of the relevant class being misled or deceived. For completeness, I have not separately addressed whether the proposed statements made or to be made by Pharmacor are fact or opinion, putting to one side the functional utility of such a division (cf Forrest v Australian Securities and Investments Commission (2012) 247 CLR 486 at [38] per French CJ, Gummow, Hayne and Kiefel JJ). Pharmacor did not advance any separate argument based upon any such division.

96    Third, the potential half-truth scenario or misleading or deceptive conduct by omission or silence might arise in circumstances where:

    the products are “bioequivalent” in one sense of that term, but not “bioequivalent” in another sense of that term;

    the products are “bioequivalent” whatever the sense of the term, but are not completely interchangeable or substitutable because they each deliver different therapeutic or other benefits;

    the products are “brand equivalent” in one sense of that term, but not “brand equivalent” in another sense of that term;

    the products are “brand equivalent” whatever the sense of the term, but are not completely interchangeable or substitutable because they each deliver different therapeutic or other benefits.

97    In terms of principle:

    One looks at the relevant course of conduct as a whole in light of the surrounding facts and circumstances (Butcher v Lachlan Elder Realty Pty Ltd (2004) 218 CLR 592 at [109] per McHugh J (dissenting in the result but not the principle)).

    Silence is to be assessed as a circumstance like any other (Demagogue Pty Ltd v Ramensky (1992) 39 FCR 31 at 32 per Black CJ).

    A practical approach may be to consider whether there is a reasonable expectation of disclosure as an aid to the necessary factual enquiry, but this is not to be taken as any reformulation of the statutory test (Miller and Associates Insurance Broking Pty Ltd v BMW Australia Finance Ltd (2010) 241 CLR 357 at [20]-[21] per French CJ and Kiefel J).

98    Generally, there is evidence before me suggesting that the Pharmacor Products differ from Panadol Osteo, notwithstanding the TGA’s ascription of bioequivalence and the PEB’s ascription of brand equivalence.

99    Pharmacor has been at pains to point out that the Pharmacor Products do not infringe claim 1 of the Patent. It was not in dispute that, contrastingly, Panadol Osteo satisfies all integers of claim 1. Indeed, Pharmacor asserts that there is no material before me which suggests that GSK has a reasonable belief as to even a potential claim for infringement or threatened infringement of the Patent. But to so assert bespeaks that Pharmacor accepts that there is a difference between the Pharmacor Products on the one hand and Panadol Osteo on the other hand. But notwithstanding this, it wants to take the stance (indeed overly subtle and nuanced from GSK’s perspective) that its products are “bioequivalent” and “brand equivalent” to Panadol Osteo. When pointed out that such ascriptions may conceal rather than reveal any true differences, it sought refuge in the proposition that it was using such “labels” in the sense of “as approved or used by” the TGA or the PEB. That enabled it, of course, to say that its promotions and representations to pharmacists and consumers were literally true. That may be so. But that is no answer to the half-truth scenario or misleading or deceptive conduct constituted partly by silence or omission. The question is whether GSK has reason to believe that there are arguable differences between the products such that Pharmacor’s literally true representations to pharmacists and consumers may arguably amount to half-truths or misleading or deceptive conduct by omission in the context of the “positive statements”. Let me address the Patent for the moment to highlight the difference in the products and also to deal with part of an alternative case put by GSK along the lines that if bioequivalence existed, then the Pharmacor Products are likely to fall within claim 1 of the Patent.

100    Pharmacor rightly points out that claim 1 of the Patent has, as integers, the immediate release phase in one layer as within a stipulated percentage range by weight of total paracetamol in admixture with a matrix forming polymer, and within another stipulated percentage range by weight of total paracetamol in like context in the sustained release phase in the other layer. Further, claim 1 stipulates that the relevant composition (the bilayer tablet having an immediate release phase of paracetamol and sustained release phase of paracetamol) is to have an in vitro paracetamol dissolution profile with certain percentage release constraints within three periods of 15, 60 and 180 minutes; the dissolution profile is to be determined using the USP type III apparatus, reciprocating basket, with 250ml of 0.1M HCl at 37C set at a cycle speed of 15 strokes/minute, although the detail thereof does not matter for present purposes.

101    Pharmacor has then drawn my attention to the only precise evidence before me concerning an analysis of the Pharmacor Products as compared with Panadol Osteo. In “Confidential Exhibit BLM-10” to the affidavit of Mr Miller affirmed 6 November 2014 (BLM-10), there is a dissolution profile comparison between the Pharmacor Products and Panadol Osteo. The in vitro testing conditions are comparable to those described in claim 1 of the Patent. Moreover, the dissolution profiles for the three periods of 15, 60 and 180 minutes referred to earlier are contained within a broader reported data set contained in BLM-10. Without unnecessary elaboration given the confidential nature of the material, it is sufficient to say that BLM-10 on its face demonstrates that the Pharmacor Products fall outside the integers of claim 1. Moreover, there is no other material before me suggesting otherwise. GSK asserts that BLM-10 only deals with one (and perhaps an out of date) batch. Be that as it may, that is the evidence. To assert potential infringement beyond BLM-10 is to engage in speculation. GSK asserts that if the TGA has found bioequivalence, then somehow infringement may be inferred. Such reasoning is speculative, in some sense it is a non-sequitur (given the different concept and ascertainment of bioequivalence), and moreover it is negated to some extent by BLM-10. Moreover, GSK previously sought and obtained documents from Pharmacor, including BLM-10, and reviewed the same prior to its letter of 10 October 2014 sent to Pharmacor seeking preliminary discovery. Its letter then made reference only to the ACL claims. One can infer that GSK took the view, having reviewed the earlier material, that a realistic potential infringement claim was not in the frame.

102    In summary, one can accept on Pharmacor’s own case that the Pharmacor Products are different, in a meaningful way, from a product satisfying the integers in claim 1 of the Patent, that is, Panadol Osteo.

103    Further, notwithstanding the TGA’s assessment of bioequivalence, such an assessment also does not rule out significant differences between the Pharmacor Products and Panadol Osteo.

104    The concept of “bioequivalence” as used by the TGA has a degree of imprecision and variability. One view is that the phrase may be aligned with an equivalence of “safety and efficacy”, themselves imprecise concepts (see the Guidelines on efficacy and safety aspects of OTC applications published by the TGA in October 2012). Further, there may be different meanings (see for example the US FDA guidelines).

105    Further, bioequivalence is usually established using only in vitro dissolution tests. A correlation between in vitro release characterisation (established by in vitro dissolution testing) and in vivo bioavailability parameters may assist to demonstrate that in vitro dissolution testing can act as a proxy for in vivo behaviour. Nevertheless, such correlation analysis is not a necessary part of establishing bioequivalence between different products. Such bioequivalence can be established from in vitro data alone, rather than individual in vitro data for each particular product being also required to be separately correlated with in vivo bioavailability parameters for that product. But not to use in vivo analysis or secondary correlation analysis does demonstrate some fluidity in the concept of bioequivalence and may conceal different performance characteristics. There is evidence that in vitro dissolution data without more may not predict in vivo characteristics. Now there is some evidence that the TGA has received from Pharmacor some clinical studies, but their contents and how they have been used is unclear.

106    Further, two products may be treated as bioequivalent even though they differ in release controlling excipients or mechanisms if they show similar in vitro dissolution profiles. This demonstrates some fluidity in the concept of bioequivalence and may conceal different performance characteristics.

107    Further, bioequivalence usually compares the metrics and variables AUC0-t, AUC0-inf and Cmax, but as I have referred to earlier and as Mr Pascarl points out in his affidavit of 5 November 2014 at [21]-[22]:

21.    However, in the case of a modified release paracetamol product, the most therapeutically important pharmacokinetic properties are not Cmax or AUC alone, rather, they are also:

(i)    the time taken to reach a therapeutically active plasma paracetamol concentration of 4µg/ml or greater (that is, an indication of how quickly pain relief is provided); and

(ii)    the duration of time for which a therapeutically active plasma paracetamol concentration of 4µg/ml or greater is maintained (that is, an indication of how long pain relief lasts).

22.    It may be the case that the AUC of two modified release paracetamol products is the same, but the respective products’:

(i)    time taken to reach a therapeutically active plasma paracetamol concentration of 4µg/ml or greater; and

(ii)    duration of time for which a therapeutically active plasma paracetamol concentration of 4µg/ml or greater is maintained,

are quite different.

108    Further, even accepting that only variables Cmax, AUC0-t and AUC0-inf are used, because the confidence intervals used are at the 90% level, there can be considerable width in the range permitted of these variables, but nevertheless still establishing bioequivalence. As Mr Pascarl points out, “the ratio of test to reference compound primary pharmacokinetic … variables… lies within the range of 0.8 to 1.25…”.

109    Further, bioequivalence may not demonstrate therapeutic equivalence for the reasons explained by Mr Pascarl, although I accept that there is a debate in the evidence as to this.

110    Generally, GSK’s position is that notwithstanding the ascriptions of “bioequivalence” and “brand equivalence” by the TGA and PEB respectively and given that Panadol Osteo falls within claim 1 of the Patent and the Pharmacor Products may not, there is at least a reasonable belief to the effect that:

    the products may have different clinical effects;

    different release profiles between the different products may result in different pain relief effects.

111    Further, Mr Pascarl gave evidence based upon information from Mr Peter Thanopoulos, Director of Regulatory Affairs and Quality at GSK, that:

7.    If a bi-layer tablet containing 665mg of paracetamol split 50-50 between an immediate release formulation layer and a sustained release formulation layer has an in vitro dissolution profile which over an initial time period releases a greater amount of paracetamol than either PANADOL OSTEO or than the dissolution profile parameters in claim 1 of the Patent, then I would expect that such a tablet would be unlikely to provide up to 8 hours of pain relief (like PANADOL OSTEO) because so much paracetamol would be released initially (when compared to PANADOL OSTEO or the parameters in claim 1 of the Patent) and a relatively smaller amount of paracetamol would be available to the patient during the latter part of the 8 hours.

8.    Conversely, if such a tablet has an in vitro dissolution profile which over an initial time period releases a lesser amount of paracetamol than either PANADOL OSTEO or than the dissolution parameters in claim 1 of the Patent, then I would anticipate that such a tablet would not provide such rapid onset of pain relief as PANADOL OSTEO.

112    Now a query was raised as to whether this was borne out by other evidence before me. It is inappropriate and unnecessary to elaborate further. It suffices to say that this may be a triable issue. But at present I only need to consider whether there is the requisite reasonable belief. Pharmacor made the point that Mr Pascarl’s evidence is hearsay and that Mr Thanopoulos is less expert than Dr Walters. But all of that goes to weight rather than to negate any reasonable belief.

113    The specification of the Patent also demonstrates that there can be bioequivalence between two products and yet there can be different pharmacokinetic properties. In the discussion of example 2, there was bioequivalence with respect to AUC, yet significant differences in Cmax between the products, differences in the rates of attainment of therapeutic serum concentrations and periods of maintenance of mean serum levels. In the discussion of example 3, there was bioequivalence with respect to AUC, yet significant differences between the variables for each product concerning Cmax, Cmin and the fluctuation index. Interestingly, in discussing example 3 there was also a discussion of Tylenol Extended Relief, being a 650mg bilayer sustained release tablet (see also pp 1-2) where there were equal amounts of paracetamol in an immediate release layer and a sustained release layer. A steady state biostudy conducted for Tylenol showed a higher fluctuation index than for the sustained release tablet of formulation D; if one infers that the products were bioequivalent in one sense, which seems reasonable, nevertheless they may have different fluctuation indexes. The FI metric is important; a low FI number (i.e. < 1) is considered a safer product. I have been elliptical in how I have expressed this as I have sought to avoid publishing confidential information about the Pharmacor Products.

114    In summary, in my view GSK has a reasonable belief that Panadol Osteo has different therapeutic effects to the Pharmacor Products. If there are such differences, then it seems to me that the promotion and representations proposed to be made by Pharmacor to pharmacists and consumers may mislead by just making the literally true statements of “bioequivalence as approved by the TGA” or “brand equivalence as approved”, without disclosing relevant differences. Pharmacor cannot hide behind the TGA’s or PEB’s labels or ascriptions, particularly as Pharmacor initiated or procured them. Moreover, the apparent objective of Pharmacor is to use these equivalence labels to compete with GSK and to gain market share at GSK’s expense. Pharmacor no doubt wants to tread the fine line of saying that there is bioequivalence but no infringement of the Patent. It may be correct, but that does not deny the force of GSK’s point concerning the half-truth scenario. Finally, no point was taken on any entitlement to relief (in terms of injunctive relief) if the half-truth scenario was established. In my view r 7.23(1)(a) has been established in relation to such a potential claim.

Patent infringement

115    GSK has been provided with, but has now returned limited dissolution data on Pharmacor Product tablets. It was not known whether the tablets were samples of the Pharmacor Products to be offered commercially in Australia. That data was used by Pharmacor to support an argument that the Pharmacor Products do not infringe any claims of the Patent.

116    For the reasons set out earlier ([100]-[101]), in my view GSK has not established the requisite reasonable belief in relation to such a potential claim.

GSK’s enquiries

117    GSK has made various requests to Pharmacor for production of the Materials. The requests have been refused. Extensive correspondence about the terms under which any of the Materials might be provided culminated in the acceptance by GSK on 30 October 2014 of the terms offered by Pharmacor but the subsequent withdrawal of that offer by Pharmacor later the same day.

118    Further, GSK has made an FOI application to the TGA on 10 October 2014. The TGA has advised that they are processing GSK’s request but the next step in the process is that Pharmacor will be given an opportunity to object to production. This process is likely to take at least 6 weeks. Sponsors of generic medicines may object to production of documents sought pursuant to an FOI request on the ground that the information contained in the documents covered by the request is commercial in confidence. The TGA may uphold such an objection.

119    Further, GSK has written to the Acting Secretary for the Department of Health seeking reasons for the decision to register the Pharmacor Products on the ARTG.

120    In my view, GSK has made the requisite reasonable enquiries.

121    Further, as at the date of its application, I accept that after making reasonable enquiries of Pharmacor and the TGA, GSK does not have sufficient information to decide whether or not to commence proceedings against Pharmacor in relation to the half-truth scenario. Further, in my view, GSK reasonably requires further information of the kind sought in the Materials in respect of the alleged bioequivalence and efficacy of the Pharmacor Products to Panadol Osteo and the way Pharmacor intends to promote the Pharmacor Products. Further, although I have found that GSK does not have reason to believe that it has a claim concerning the representations per se made to the TGA, nevertheless material provided to the TGA would be relevant to assessing the characteristics and performance of the Pharmacor Products of themselves.

122    Pharmacor also submits that GSK has not relevantly made "reasonable inquiries" as required by r 7.23(1)(b) because GSK appears at an earlier point in time to have sought samples of Pharmacor Products for purposes extraneous to considering whether to commence proceedings against Pharmacor for contraventions of ss 18 and 29(1)(a) and (1)(g) of the ACL, namely, to make a submission to the TGA in relation to the regulatory status of the Pharmacor Products. Of course, preliminary discovery may be refused on the basis of the Court's lack of satisfaction as to the purpose for which the documents are being sought (see Stratford Sun Ltd v OM Holdings Ltd (2009) 74 ACSR 698; [2009] FCA 1245 at [68] per Siopsis J). But in the present case, I am satisfied that GSK is now seeking the Materials for the legitimate purpose to determine whether to institute proceedings against Pharmacor.

Pharmacor’s control of material

123    GSK believes that Pharmacor is likely to have the Materials in its control. The documentary Materials formed part of Pharmacor’s submission to the TGA for registration of the Pharmacor Products. Further, Pharmacor has previously offered samples of the Pharmacor Products to GSK. I accept that Pharmacor has the Materials in or under its control.

Other matters

124    Pharmacor contends that the requirements of r 7.23(1)(c) have not been satisfied. Rule 7.23(1)(c) requires that the prospective applicant reasonably believes that the inspection of the documents sought would assist in making the decision. Pharmacor submits that GSK has not complied with r 7.23(1)(c) because many of the Materials the subject of GSK's application have no relevance to bioequivalence to, or interchangeability or substitutability with, Panadol Osteo. It is said that the scope of the documents sought travels well beyond what would be necessary even on GSK's case. I do not accept this submission. No content to this submission has yet been provided by Pharmacor, but I will hear counsel further before pronouncing any order.

125    Pharmacor also contends that even if the Court was to consider that any of GSK's case under r 7.23(1)(a) rises above mere assertion or speculation, this would be an appropriate case in which to refuse preliminary discovery in the exercise of the Court's discretion. In Benchmark Certification Pty Ltd v Standards Australia International Ltd (2004) 212 ALR 464; [2004] FCA 1489 at [128], Emmett J said:

Even if there were some basis for conjecturing as to the possibility of a right to relief, I do not consider, in the exercise of discretion, that it is appropriate to make an order for discovery having regard to the uncertainty as to all of the relevant elements on the material presently before the court.

(see also Specsavers Pty Ltd v Canstar Blue Pty Ltd [2010] FCA 1153 at [55] per Edmonds J).

126    In my view, uncertainty is inherent in the preconditions to be established under r 7.23(1)(a) in order to justify preliminary discovery. If such a precondition has been satisfied, I accept that I have a discretion to refuse relief nevertheless. But I do not see a proper basis to refuse preliminary discovery in this case based upon some more general assessment of uncertainty in terms of the elements of r 7.23(1)(a).

Conclusion

127    In my view, GSK is entitled to an order for preliminary discovery in relation to the ACL claims dealing with the half-truth scenario or misleading or deceptive conduct concerning the proposed promotion and supply of the Pharmacor Products to pharmacists or consumers.

128    I will discuss with counsel the form of orders to be made.

Associate:

Dated:    12 November 2014