FEDERAL COURT OF AUSTRALIA

Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd (No 4) [2024] FCA 678

ORDERS

THE COURT ORDERS THAT:

1.    By 4:00 pm on Monday, 19 August 2024, the Applicants/Cross-Respondent give discovery and inspection of documents within the category set out in the Annexure to these Orders by:

(a)    filing and serving a verified list of documents in accordance with r 20.17 of the Federal Court Rules 2011 (Cth); and

(b)    producing to the Respondents/Cross-Claimants' solicitors electronic copies of the documents within Part 1 of that verified list of documents.

2.    In the event that the Applicants/Cross-Respondent adduce evidence from one or more of the inventor(s) of the patent in suit as to the research and development process undertaken to arrive at the invention claimed in any of claims 1, 2, 5, 7, 8, 33, 37, 38, 39, 40, 42, 45, 46 and/or 49 of the patent in suit in unamended form and/or in the form set out in Schedule A to the Second Further Amended Statement of Claim dated 19 March 2024, then at the time of serving that evidence, the Applicants are to give discovery and inspection of Documents (as defined in the Annexure to these Orders) recording or evidencing research and/or development and/or experimental work on the invention the subject of any such claims, being limited to Documents created or dated from 27 August 2002 up to and including 27 August 2004.

3.    The discovery and inspection referred to in Order 1, and any discovery and inspection given pursuant to Order 2, is to be given in accordance with the electronic discovery protocol agreed between the parties dated 3 August 2023.

4.    The Respondents’ discovery application is otherwise dismissed.

5.    The costs of the Respondents’ discovery application be costs in the cause.

Annexure

CATEGORIES FOR DISCOVERY ON INVALIDITY

In this document, the following terms have the following meanings:

Control has the meaning given in Schedule 1 to the Federal Court Rules 2011 (Cth) (FCR).

Document has the meaning given in Schedule 1 to the FCR, and includes all Documents in the Control of the Pfizer Group.

Filing Date means 26 August 2005.

Patent means Australian Patent No. 2005280034.

Pfizer Group means the Cross-Respondent and related companies within its corporate group.

1.    All Documents created or dated before the Filing Date concerning the production of etanercept or “TNFR-Ig” as described in Example 16 of the Patent, relating to one or more of the following matters:

(a)    the cell line and/or expression system;

(b)    the seed density;

(c)    the medium in the perfusion bioreactor;

(d)    the medium the production bioreactor, including feed media and/or supplementation;

(e)    the culture conditions in the production bioreactor, including pH, temperature, osmolality and chemical inductants;

(f)    any change in culture conditions in the production bioreactor, including the timing and magnitude of any change; and

(g)    the maximal possible viable cell density if no change in culture conditions were implemented.

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

REASONS FOR JUDGMENT

BURLEY J:

1    This judgment concerns the respondents’ application for non-standard discovery by categories in patent infringement and revocation proceedings in accordance with Federal Court Rules 2011 (Cth) (FCR) r 20.15. Two categories of discovery are sought. The first seeks production of all research and development documents created from 27 August 2002 until 27 August 2004. The second seeks production of documents relating to inutility of the patent in suit. The precise form of the discovery sought is set out in the schedule to these reasons.

2    The proceedings were commenced by the applicants, seeking declarations and orders arising from the alleged infringement of patent no 2005280034 which is entitled “Production of polypeptides”. The eight respondents are from different corporate groups who are separately represented. However, for present purposes it is not necessary to distinguish between them as each is in the same interest insofar as the present application is concerned. They advance a cross-claim alleging that the claimed invention is invalid for: want of novelty, lack of inventive step, lack of clarity, lack of definition, insufficiency, failure to disclose best method, lack of fair basis, inutility and false suggestion and misrepresentation.

3    The applicants rely on an affidavit affirmed by Daniel Posker which annexes correspondence and a declaration given by Dennis Drapeau. The respondents rely on no evidence in support of their application.

4    The proceedings have been listed for hearing over three weeks in September and October 2025. Affidavit evidence is due to be filed in December this year, with responsive evidence in April next year. It is large-scale commercial litigation. The patent infringement suit concerns the manufacture and use of etanercept, which is a biological medicine useful in the treatment of autoimmune diseases. The applicants (Pfizer) have made and sold etanercept under the brand name ENBREL for many years; see Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd [2017] FCA 285 at [1]. The parties are represented by senior and junior counsel. The proceedings are at a relatively early stage. Pleadings have closed, but the parties are not due to file their evidence in chief until December this year.

5    Category 1 of the discovery sought is characterised by the respondents as discovery of the type contemplated in Wellcome Foundation v VR Laboratories (Aust) Pty Ltd [1981] HCA 12; (1981) 148 CLR 262. The respondents contend that evidence of research and development can play a crucial role in the Court deciding whether an invention is obvious and to the ground of lack of utility. They refer to a number of recent and elderly cases to support that proposition in relation to the ground of lack of inventive step.

6    The applicants oppose such discovery on the basis that it is not directly relevant to any of the respondents’ pleaded cases. They submit that the pleaded case makes a bare allegation of obviousness based on common general knowledge alone and otherwise pleads a myriad of Patents Act 1990 (Cth) s 7(3) combinations. The patentee’s research and development documents are, they submit, not directly relevant to any of these.

7    The respondents’ case concerning lack of inventive step is pleaded by reference to several alternative routes and permutations within those routes. If the claims are entitled to their earliest potential priority date, then the invention is said to lack an inventive step by reason of:

(1)    the common general knowledge alone;

(2)    the common general knowledge together with 6 identified prior art documents, each considered separately;

(3)    three different combinations of those 6 prior art documents; or

(4)    any of (1) – (3) in combination with two further prior art documents.

8    If an alleged deferred priority date applies, the respondents contend that the invention claimed lacks an inventive step with yet another set of permutations of common general knowledge and prior art being:

(5)    all of the combinations in (1) – (4); or

(6)    two further identified prior art documents; or

(7)    any of the further combinations in (5) together with the two identified in (6).

9    Without being too precise, the combinations and permutations identified in (1) – (7) add up to over 80 variations of common general knowledge and items of prior art. It is not a picture of compliance with s 37M of the Federal Court of Australia Act 1976 (Cth). When Mr Cooke SC, together with Mr Larish, who represents the first to third respondents, was taxed on this excessive number of permutations, he readily and properly conceded that there were too many and that his client would limit the number. He undertook to do so in several months.

10    Recent cases have addressed the modern applicability of the passage in Wellcome, including Schutz DSL (Australia) Pty Ltd v VIP Plastic Packaging Pty Ltd (No 14) [2011] FCA 1159 at [8] – [11]; DSM Nutritional Products LLC v Suntory Holdings Ltd [2013] FCA 675 at [17]; BlueScope Steel Limited v Dongkuk Steel Mill Co Ltd [2017] FCA 1537; 135 IPR 1 at [30] – [38] and Teva Pharma Australia Pty Ltd v Boehringer Ingelheim Pharma GMBH & Co. KG [2019] FCA 625 at [14] – [15].

11    In Teva, Moshinsky J surveyed those cases and adopted the reasoning of Beach J in BlueScope Steel, where his Honour noted that modern principles of discovery have superseded the Compagnie Financière et Commerciale du Pacifique v Peruvian Guano Co (1882) 11 QBD 55 “line of enquiry” applied in Wellcome, such that documents broadly referred to as inventor’s notes and the like may be accepted to be relevant to the question of inventive step, but of secondary significance only: Teva at [16]. I respectfully agree with that proposition. The requirement under FCR rr 20.14 and 20.15 is that documents must be “directly relevant to the issues raised by the pleadings or in the affidavits” in order to be discoverable.

12    Further, s 37M of the Federal Court of Australia Act sets an overarching purpose in civil practice and procedure that was not explicit when Wellcome was decided. It requires the court to be astute to the quick, inexpensive,and efficient disposition of cases. That course applies to considerations arising in relation to discovery.

13    The primary test under s 7(2) of the Patents Act is whether a person skilled in the relevant art would have found the invention obvious. This an objective test, based on the imputed skills and knowledge of a notional person, which is a remove from the steps taken by the inventors themselves.

14    The relevance of Wellcome style discovery will vary from case to case. In the event that the patentee chooses to give evidence of the inventive steps involved leading to the invention, then the relevance of such documents is likely to be elevated. In other cases, there may be particular indications that the inventors took a certain route to the invention that warrant the provision of discovery.

15    However, in the present case, the pleading is focussed on the state of the common general knowledge and the welter of combinations of prior art documents said to be relevant to the Patents Act s 7(3) case. Given the number of permutations and items of prior art pleaded, it may be said that the lack of inventive step case takes something of a poorly focussed, scattergun approach. The relevance of the inventor’s own path to the invention is truly secondary. Indeed, the pleading gives no inkling that it is relevant at all. In that context, the pleading provides some support for the criticism advanced by the applicants that category 1 is no more than an exercise in fishing. Although there is no evidence that it would be oppressive to grant discovery, it is implicit that additional work will be required, not only on the part of the applicants in producing documents, but also the respondents in absorbing and assimilating. If adduced in evidence, there will be more work because that evidence must be considered and answered. Furthermore, in the event that arguments are put forward, they must be considered by the Court. All of this adds to the cost of the proceedings.

16    I am not persuaded that an order for discovery sought in category 1 is warranted. I do not rule out that discovery would be required if the patentee puts evidence of the inventors’ steps or if other circumstances arise. For instance, in the event that the patentee does give evidence from the inventors, then I will order that they give full discovery in accordance with category 1. This is an example where a practical solution is that it is suitable to consider the position after the evidence of the applicants has been given. Ms Cochrane SC, who appears for the applicants together with Ms Evetts, accepts that, in the event that such evidence is provided, that discovery must be given in the accordance with category 1 at the same time. Orders will be made to that effect.

17    Nor do I consider the fact that the respondents also rely on lack of utility adds support for the discovery sought. That ground is pleaded on the basis that the claimed invention does not meet the promise of the invention to provide improved protein production and/or a reduction in ammonium and/or lactate. Those promises are said not to be met on the basis of the disclosure of the specification, because the claims are not limited to include media containing any particular amount of ammonium and/or lactate and the claims do not require the production of any amount of polypeptide (respondent’s particulars of invalidity, particular 18(b)). It is difficult to see, at this point in time, how the production of documents in accordance with category 1 is anything other than speculative.

18    Category 2 seeks discovery of all documents created or dated before the filing date of the patent concerning the production of etanercept or “TNFR-Ig” as described in Example 16 of the patent, “Production of TNFR-Ig using Medium 9”, including, but not limited to seven listed matters in subparagraphs (a) – (g).

19    In paragraph 16(b) of their particulars of invalidity, the respondents plead that the patentee did not describe the best method of producing a polypeptide (in the unamended claims) or TNFR-2:Fc (in the proposed amended claims), because the best method is purportedly described in Example 16, being a culmination of research and experiments in Examples 1 – 15. However, Example 16 is said to be deficient, or to omit certain information which may be inferred to be known to the patent applicant at the time of filing the patent application.

20    Specific examples are given, including:

(a)    the CHO cell line (or expression system);

(b)     the “high density” of the seed in the perfusion bioreactor;

(c)    the medium used in the perfusion bioreactor, and whether any media from that bioreactor was introduced into the production bioreactor with the seed culture;

(d)    the characteristics of the media used to produce TNFR-2:Fc;

(e)     whether and when the cell culture was supplemented with feed media and any other nutrients during the production bioreactor step, and the time(s) and details of any supplements; and

(f)    other relevant details of that production bioreactor step, including volume of the bioreactor, the pH, temperature, osmolality, oxygenation level and the time(s) at which amount(s) of chemical inductants are added.

21    The respondents submit that the relevant approach to determining whether the requirement of best method under s 40(2) of the Patents Act is met is for them to identify the information not disclosed in the patent, indicate whether it was common general knowledge and then explain the importance of the information and any burden (on the person skilled in the art) arising from the non-disclosure. This approach broadly accords with the requirements set out in GlaxoSmithKline Consumer Healthcare Investments (Ireland) (No 2) Limited v Generic Partners Pty Limited [2018] FCAFC 71; (2018) 264 FCR 474 (Middleton, Nicholas, Burley JJ) at [186] – [192]. They submit that it will be relevant to obtain documents conforming with category 2 to assess whether Example 16 does disclose the best method, or whether matters which are not disclosed in that example were known to the patentee.

22    The applicants submit that category 2 is fishing, and that the broader disclosure of the patent supports its case that the best method is indeed disclosed. In this regard, the applicants rely particularly on paragraph 11 of the statement of Dr Denis Drapeau, one of the co-inventors of the patented invention, who says, in response to an apparently similar complaint made in what I understand to be European proceedings, challenging the grant of a patent cognate to the present patent, that:

…While indeed only Example 16 fully describes and establishes the success of the presently claimed invention for producing TFNR-Fc, the full set of Examples provides evidence for the generalizability for different polypeptides of the claimed methods, in particular of the media characteristics we have described in granted claim 1. Furthermore, with regard to the allegation that the invention would not be sufficiently disclosed to be carried out by a skilled reader, I believe it is evident that Examples 1 – 17 collectively describe, in great detail, how the inventive medium characteristics and culture conditions were developed, what the important variables are and in particular, which media characteristics are particularly preferable…

23    At this stage it seems that the patentee agrees that Example 16, by itself, does not disclose the best method of performing the invention. They contend instead that relevant information for achieving that method is to be understood by the person skilled in the art from the whole of the specification, and in particular, from Examples 1 to 17 and the figures. Whether or not the specification does achieve that disclosure will be a matter for evidence.

24    However, the question of whether the patent applicant has disclosed the best method known to it within s 40(1)(a) of the Patents Act provides a safeguard against a patent applicant holding back information in its possession with a view to getting the benefit of a patent monopoly, without conferring on the public the full consideration for the grant of that monopoly: Pfizer Overseas Pharmaceuticals & Ors v Eli Lilly & Co [2005] FCAFC 224; 225 ALR 416 at [374] (French and Lindgren JJ) and [408] (Crennan J agreeing); see also Les Laboratoires Servier v Apotex Pty Ltd [2016] FCAFC 27; 247 FCR 61 (Bennett, Besanko and Beach JJ) at [64].

25    The respondents have a basis for contending that Example 16 is deficient in information. This has been pleaded and is to some extent supported by the evidence of Dr Drapeau. I am satisfied that the patent applicant may well have information to supply that deficiency and that discovery in accordance with category 2 is warranted. I do not consider that it is appropriate to delay the provision of that discovery, pending the provision of expert evidence in the case.

26    Although the hearing seems somewhat in the future, the timetable imposed on the parties is relatively tight and must be adhered to in order for the hearing date to be met. Accordingly, I decline to order discovery in accordance with category 1, but allow discovery in accordance with category 2, with amendments made to that category as follows.

27    Paragraph 2, in the third line, reads “including, but not limited to Documents relating to”. Those words should be deleted and replaced with the words “relating to”, so that the chapeau to paragraph 2 reads “All Documents created or dated before the Filing Date concerning the production of etanercept or “TNFR-Ig” as described in Example 16 of the Patent, relating to one or more of the following matters”.

28    Following this, in paragraph 2, are subparagraphs (a) through to (g). Subparagraph (g) should be amended by the deletion of the words “the viable cell density of the bioreactor, including” at the commencement of that paragraph should be deleted.

29    There has been a mixed result in the application. I will order that the costs of the application be costs in the cause.

Associate:

Dated:    18 June 2024

Schedule

CATEGORIES FOR DISCOVERY ON INVALIDITY

In this document, the following terms have the following meanings:

Claims refers to claims 1, 2, 5, 7, 8, 33, 37, 38, 39, 40, 42, 45, 46 and 49 of the Patent in unamended form and in the form set out in Schedule A to the Second Further Amended Statement of Claim dated 19 March 2024.

Claimed Invention refers to the alleged invention the subject of the Claims of the Patent. Control has the meaning given in Schedule 1 to the Federal Court Rules 2011.

Document has the meaning given in Schedule 1 to the Federal Court Rules 2011, and includes all Documents in the Control of the Pfizer Group.

Filing Date means 26 August 2005.

Patent means Australian Patent No. 2005280034.

Pfizer Group means the Cross-respondent and related companies within its corporate group.

Research and Development Documents means Documents recording or evidencing research and/or development and/or experimental work on the Claimed Invention.

1    All Research and Development Documents created or dated from 27 August 2002 up to and including 27 August 2004.

2    All Documents created or dated before the Filing Date concerning the production of etanercept or “TNFR-Ig” as described in Example 16 of the Patent, including, but not limited to Documents relating to one or more of the following matters:

(a)    the cell line and/or expression system;

(b)    the seed density;

(c)    the medium in the perfusion bioreactor;

(d)    the medium in the production bioreactor, including feed media and/or supplementation;

(e)    the culture conditions in the production bioreactor, including pH, temperature, osmolality and chemical inductants;

(f)    any change in culture conditions in the production bioreactor, including the timing and magnitude of any change; and

(g)    the viable cell density of the production bioreactor, including the maximal possible viable cell density if no change in culture conditions were implemented.

SCHEDULE OF PARTIES