Federal Court of Australia

Novartis AG v Pharmacor Pty Limited [2023] FCA 804

ORDERS

THE COURT ORDERS THAT:

Discovery

1.    By 4.00 pm on 17 August 2023, the applicants give discovery (by way of a reasonable search in accordance with r 20.14(3) of the Federal Court Rules 2011 (Cth) (the Rules)) and inspection of documents within the category set out in the Annexure to these orders (excluding any duplicates of any documents) by:

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

(b)    producing to the respondent's solicitors electronic copies of the documents within Part 1 of that verified list of documents.

2.    When providing inspection of the documents discovered in accordance with Order 1, the applicants may exclude any document in respect of which a claim of privilege is made over the whole document, and may redact any part of a document that contains a communication with respect to which a claim of privilege is made.

3.    The costs of an incidental to the interlocutory application filed on 7 July 2023 be reserved.

Separate Question

4.    By 4.00 pm on 19 July 2023, the applicants file and serve any affidavit evidence in support of the interlocutory application filed by the applicants dated 11 July 2023 (Separate Question Application).

5.    By 4.00 pm on 26 July 2023, the respondent file and serve any affidavit evidence in answer to the Separate Question Application.

6.    By 4.00 pm on 1 August 2023, the applicants file and serve:

(a)    any affidavit evidence in reply on the Separate Question Application; and

(b)    submissions on the Separate Question Application, limited to 5 pages.

7.    By 4.00 pm on 4 August 2023, the respondent file and serve submissions on the Separate Question Application, limited to 5 pages.

8.    The matter be listed for hearing of the Separate Question Application at 10.15 am on 11 August 2023, with an estimate of one hour.

Affidavit Evidence

9.    By 21 August 2023 the applicants file and serve their affidavit evidence in chief on their infringement claims.

10.    By 21 September 2023, the respondent file and serve its affidavit evidence in chief on its invalidity claims.

11.    By 21 November 2023 the respondent file and serve its affidavit evidence in answer on the infringement claims.

12.    By 21 December 2023, the applicants file and serve their affidavit evidence in answer on the invalidity claims.

13.    By 9 February 2024, the parties file and serve any affidavit evidence in reply on their respective claims.

14.    The parties provide a copy of the Draft Standard Instructions to Expert Witnesses in Patent Litigation dated 2 June 2023 (which was provided by the Court to the parties on 6 July 2023) to any expert witness the party proposes to file affidavit evidence from on the question of inventive step (obviousness) at the time of, or as soon as practicable after, retaining the expert.

Joint Expert Report

15.    On or before 16 February 2024, the parties:

(a)    confer regarding the parties' expert witnesses who shall participate in a joint expert conclave and prepare a joint expert report, and the preparation of a protocol which addresses the matters referred to in sections C and E of the draft document titled Practice Note: Joint Expert Reports dated 2 June 2023 (which was provided by the Court to the parties on 6 July 2023) (Protocol); and

(b)    provide an agreed list of conclave participants, together with an agreed Protocol, to the Associate to Justice Yates or, in the event of disagreement, a marked-up copy of the list of conclave participants and/or Protocol indicating the areas of disagreement.

16.    On the date that the list of conclave participants and the Protocol are finalised in accordance with Order 15 above, the parties provide a copy of the Protocol to the parties' conclave participants (as specified).

17.    From 1 to 15 March 2024, the parties’ expert witnesses (as specified) participate in a conclave, to be conducted in accordance with Part 7 of the Expert Evidence Practice Note (GPN-EXPT) and section E of the draft document referred to in Order 15(a).

18.    On or before 15 March 2024, the conclave participants produce a joint expert report that complies with section E of the draft document referred to in Order 15(a).

19.    The matter be listed for a pre-trial case management hearing, and for the determination of any disagreement on the matters in Order 15(b) above, on 19 February 2024 at 9.30 am.

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

Annexure

Discovery category

The following terms have the following meanings:

(a)    Date of Filing means 16 January 2003.

(b)    Document has the meaning set out in the Dictionary in Schedule 1 of the Federal Court Rules 2011 (Cth).

(c)    NEP inhibitor means a neutral endopeptidase inhibitor.

(d)    Novartis means Novartis AG, Novartis Pharmaceuticals Australia Pty Limited and related companies of either of them (separately, or together) and whether alone or together with any contractors, consultants or other third parties acting on their behalf.

1.     All Documents created during the period from 16 January 1998 to the Date of Filing recording or evidencing the description and/or evaluation of any pharmaceutical composition and/or method of preparing any pharmaceutical composition comprising:

(a)    valsartan (or a pharmaceutically acceptable salt thereof); and

(b)    an NEP inhibitor (or a pharmaceutically acceptable salt thereof); and

(c)    a pharmaceutically acceptable carrier,

in which the NEP inhibitor is sacubitril or sacubitrilat, and in which the valsartan (or a pharmaceutically acceptable salt thereof) and the NEP inhibitor (or a pharmaceutically acceptable salt thereof) are associated by non-covalent bonds.

REASONS FOR JUDGMENT

YATES J:

Introduction

1    The respondent, Pharmacor Pty Limited (Pharmacor), has filed a notice of cross-claim seeking revocation of claim 1 of Patent No 2003206738 (the patent) on which it has been sued for threatened infringement. Novartis AG is the patentee. Novartis Pharmaceuticals Australia Pty Limited (Novartis Australia) is recorded on the Register of Patents as the exclusive licensee of the patent. It is the sponsor in Australia of the product called Entresto.

2    By an interlocutory application filed on 7 July 2023, Pharmacor seeks an order for discovery against Novartis AG and Novartis Australia. In these reasons, I will refer (where appropriate) to both as one entity—Novartis.

3    The invention of the patent relates to, amongst other things, a pharmaceutical composition comprising a combination of valsartan (or a pharmaceutically acceptable salt thereof) and one of two specified neutral endopeptidase (NEP) inhibitors (or pharmaceutically acceptable salts thereof), and a pharmaceutically acceptable carrier.

4    Pharmacor’s application for discovery is directed to documents created in the period 16 January 1998 to 16 January 2003 (the filing date of the application for the patent) concerning, in general terms, a composition or the preparation of a composition containing valsartan (or a salt thereof) and an NEP inhibitor (or a salt thereof) as a single unit entity associated by non-covalent bonds.

5    Novartis opposes Pharmacor’s interlocutory application. However, Novartis does not oppose giving discovery by reference to a category of documents it proposes.

The complete specification

6    The complete specification discloses that valsartan is an angiotensin II antagonist. It interacts with, and binds to, AT 1-receptors on target cells. Angiotensin II antagonists can be used as antihypertensives and for the treatment of congestive heart failure, among other indications.

7    The complete specification discloses that NEP cleaves a variety of peptide substrates, including atrial natriuretic factors (ANF)—a family of vasodilator, diuretic, and antihypertensive peptides. The function of ANF is to maintain salt and water homeostasis, and to regulate blood pressure. ANF is rapidly inactivated in the circulation by processes that include enzymatic inactivation via NEP. There is evidence that NEP inhibitors potentiate ANF, lower blood pressure, and exert ANF-like effects.

8    The complete specification explains that the nature of hypertensive vascular diseases is multifactorial and that, under certain circumstances, drugs with different mechanisms of action have been combined. It does not follow, however, that combining drugs having different modes of action will yield advantageous effects. The complete specification teaches that there is a need for more efficacious combination therapy which has less deleterious side effects.

9    At pp 7 – 8, the complete specification says:

It has surprisingly been found that, a combination of valsartan and a NEP inhibitor achieves greater therapeutic effect than the administration of valsartan, ACE inhibitors or NEP inhibitors alone and promotes less angioedema than is seen with the administration of vasopeptidase inhibitor alone. Greater efficacy can also be documented as a prolonged duration of action ….

Further benefits are that lower doses of the individual drugs to be combined according to the present invention can be used to reduce the dosage, for example, that the dosages need not only often be smaller but are also applied less frequently, or can be used to diminish the incidence of side effects. The combined administration of valsartan or a pharmaceutically acceptable salt thereof and a NEP inhibitor or a pharmaceutically acceptable salt thereof results in a significant response in a greater percentage of treated patients, that is, a greater responder rate results, regardless of the underlying etiology of the condition. This is in accordance with the desires and requirements of the patients to be treated.

It can be shown that combination therapy with valsartan and a NEP inhibitor results in a more effective antihypertensive therapy (whether for malignant, essential, reno-vascular, diabetic, isolated systolic, or other secondary type of hypertension) through improved efficacy as well as greater responder rate. The combination is also useful in the treatment or prevention of heart failure such as (acute or chronic) congestive heart failure. It can further be shown that a valsartan and NEP inhibitor therapy proves to be beneficial in the treatment and prevention of myocardial infarction and its sequelae.

10    The complete specification discloses that an NEP inhibitor that is useful in the combination is a compound of “formula (II)” (which is identified and described) and the pharmaceutical salts thereof.

11    The complete specification also identifies a number of NEP inhibitors that are said to be within the scope of the invention.

12    The complete specification refers to active agents which, it is said, can be taken from The Merck Index or from exemplified databases, the content of which (the complete specification says) “is hereby incorporated by reference”. At p 8, the complete specification says:

Any person skilled in the art is fully enabled to identify the active agents and, based on these references, likewise enabled to manufacture and test the pharmaceutical indications and properties in standard test models, both in vitro and in vivo.

13    Claim 1 is:

1.     A pharmaceutical composition comprising:

(i)     the AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof;

and

(ii)    the NEP inhibitor N-(3-carboxy-1-oxopropyl)-(4S)-p-phenylphenylmethyl)-4-amino-2R-methylbutanoic acid ethyl ester or (2R,4S)-5-Biphenyl-4-yl-4-(3-carboxypropionylamino)-2-methyl-pentanoic acid or pharmaceutically acceptable salts thereof and a pharmaceutically acceptable carrier.

14    Plainly, claim 1 claims a composition which includes valsartan (or a pharmaceutically acceptable salt of valsartan) in combination with one of two identified NEP inhibitors (or a pharmaceutically acceptable salt of the chosen NEP inhibitor). The evidence before me is that the first identified NEP inhibitor—the ethyl ester—is known as sacubitril. The second identified NEP inhibitor is known as sacubitrilat.

15    Claim 1 does not specify, in terms, the particular dose of valsartan or of the NEP inhibitor in the composition. Further, it does not specify the molar or weight ratio between the two active ingredients or their ratio relative to the pharmaceutically acceptable carrier or any other component of the composition (it being noted that the complete specification makes clear that the word “comprising” is to be understood to imply inclusion, not exclusion).

16    Claim 1 does not limit, in terms, the salts that can be used in the composition (other than that they be pharmaceutically acceptable salts) or require that the same salt be used (if the two active ingredients are present as salts).

17    Claim 1 does not limit, in terms, the form of the two active ingredients (such as whether they must be in crystalline form, amorphous form or polymorphic form, or be present as hydrates, or have a supramolecular structure) or limit the way in which the two active ingredients are to be combined.

18    Claim 1 does not limit, in terms, the particular form of the pharmaceutical composition itself.

19    It is clear, however, that claim 1 is more limited in scope than the disclosures made in the complete specification by reference to the “invention”. Its limitation is to compositions that include valsartan (or a pharmaceutically acceptable salt thereof), one or other of the two identified NEP inhibitors (or their pharmaceutically acceptable salts), and a pharmaceutically acceptable carrier.

20    The complete specification includes a number of examples. Example 8 is: “Chronic effects of 4-[N-(3-carboxy-1-oxo-propyl)amino]-4-(p-phenylphenylmethyl)-3-methylbutanoic acid ethyl ester (AHU377) and valsartan individually and in combination, on arterial pressure in Dahl salt-sensitive and spontaneously hypertensive rats”. Example 8 appears to have been added to the complete specification by an amendment filed on 14 October 2019 and allowed on 16 January 2020. It reports on experiments that were performed to assess and compare the efficacy of the combination of valsartan and AHU377 administered as monotherapy in two models of hypertension.

Entresto

21    Novartis supplies a sacubitril/valsartan combination product called Entresto. Entresto contains a salt complex of the anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:2.5, respectively (trisodium [sacubitril-valsartan] hemipentahydrate or “TSVH”).

22    The evidence presently before me is that Novartis first synthesised TSVH in January 2006, following experimental work between March 2005 and January 2006. The TSVH complex is distinct from a combination of valsartan and sacubitril obtained by simply physically mixing sacubitril (or a sacubitril salt) and valsartan (or a valsartan salt). The components (the anionic form of sacubitril; the anionic form of valsartan; the sodium cations; and the water molecules) are held together in the complex by attractive forces, such as ionic bonding and hydrogen bonding. Covalent bonds exist between the atoms within the anionic form of sacubitril. Covalent bonds exist between the atoms within the anionic form of valsartan. However, covalent bonds do not exist between the components themselves. The components are said to be “associated by non-covalent bonds” or to have “non-covalent associations”.

Pharmacor’s products

23    Novartis alleges that Pharmacor threatens to infringe claim 1 of the patent by exploiting the products referred to in the statement of claim as the Pharmacor Generic Products. These products are identified by their registration numbers in the Australian Register of Therapeutic Goods.

24    Novartis’ case is that it would be an infringement of claim 1 to exploit a product that is a pharmaceutical composition in which the two active ingredients are the sodium salts of valsartan and sacubitril present as a mixture of two separate chemical entitles that are not covalently bonded.

25    Pharmacor contends that valsartan and sacubitril are present in the Pharmacor Generic Products as an amorphous mixture of valsartan, sacubitril and sodium. It contends that the valsartan and sacubitril are not separate. It contends that the mixture of valsartan, sacubitril, and sodium comprises a single unit entity associated by non-covalent bonds.

The challenge to the validity of claim 1

26    Pharmacor alleges that claim 1 of the patent is invalid on a number of grounds. Relevantly to the present application, Pharmacor alleges that the complete specification for the patent does not describe the best method known to Novartis AG of performing the alleged invention, and therefore does not comply with the form of s 40(2)(a) of the Patents Act 1990 (Cth) (the Act) that applies in this case.

27    In its amended statement of cross-claim (the cross-claim), Pharmacor pleads:

6.     Insofar as any of the Pharmacor Products … fall within claim 1 of the Patent (which is denied), the Patent does not disclose the best method of performing the alleged invention known to Novartis AG before 5 April 2007 (the Date of Grant) or, alternatively, at either 28 November 2006 or 28 July 2006 (the Dates of Amendment) or, alternatively, at 16 January 2003 (the Date of Filing) for the reasons pleaded in paragraphs 7 to 7B below.

7.        Before the Date of Grant or, alternatively, at the Dates of Amendment or, alternatively, at the Date of Filing, Novartis AG knew of each of the following:

(a)    a pharmaceutical composition containing a compound comprising non-covalently bound valsartan (or a valsartan salt) and a neutral endopeptidase (NEP) inhibitor (or a NEP inhibitor salt), and/or a method of preparing the foregoing;

(b)    further or in the alternative, a pharmaceutical composition containing a compound comprising non-covalently bound valsartan (or a valsartan salt) and sacubitril (or a sacubitril salt), and/or a method of preparing the foregoing;

(c)    further or in the alternative, a pharmaceutical composition containing a compound comprising non-covalently bound valsartan (or a valsartan salt) and sacubitrilat (or a sacubitrilat salt), and/or a method of preparing the foregoing.

Particulars

(a)     The matters in (a) to (c) above can be inferred from the contents of one or more of the following documents:

i.     U.S. Provisional Patent Application Nos. US 60/735,093 (filed 9 November 2005), 60/735,541 (filed 10 November 2005), 60/789,332 (filed 4 April 2006), 60/822,086 (filed 11 August 2006) and International Application No. PCT/US/2006/043710 (filed 8 November 2006), U.S. Patent Nos. 8,877,938 (filed 8 November 2006) and 9,388,134 (filed 23 June 2014).

ii.    Joint Claim Construction Brief, In re Entresto (Sacubitril/Valsartan) Patent Litigation, United States District Court for the District of Delaware, Case 1:20-md-02930-LPS, document no. 253 at pages 7 and 31 (filed 21 May 2021).

iii.     Declaration of Piotr H. Karpinski dated 9-7-2010.

(b)     Pharmacor may provide further particulars following discovery and evidence.

7A.     Before the Date of Grant or, alternatively, at the Dates of Amendment or, alternatively, at the Date of Filing:

(a)     the matters in paragraph 7(a) above;

(b)     further or in the alternative, the matters in paragraph 7(b) above;

(c)     further or in the alternative, the matters in paragraph 7(c) above,

were the best method of performing the alleged invention known to Novartis AG.

                    Particulars

(a)     Pharmacor repeats the particulars to paragraph 7 above.

7B.     Each of the following matters is not disclosed in the specification of the Patent:

(a)     the matters in paragraph 7(a) above;

(b)     further or in the alternative, the matters in paragraph 7(b) above;

(c)     further or in the alternative, the matters in paragraph 7(c) above.

8.     Further or in the alternative to paragraphs 6 to 7B above, insofar as the best method known to Novartis AG of performing the invention before the Date of Grant or, alternatively, at the Dates of Amendment or, alternatively, at the Date of Filing, is described in Example 8 (which is denied), Example 8 was not included in the complete specification before the Date of Grant or, alternatively, at the Dates of Amendment or, alternatively, at the Date of Filing.

Particulars

(a)    Example 8 was included in the specification by amendments applied for on 14 October 2019 (see letter on behalf of Novartis AG to Commissioner of Patents dated 14 October 2019) and allowed on 16 January 2020.

(b)    Example 8 does not describe the best method known to Novartis AG of performing the alleged invention in the Patent before the Date of Grant or, alternatively, at the Dates of Amendment or, alternatively, at the Date of Filing above.

(c)     Pharmacor may provide further particulars following discovery and evidence.

9.     The specification (in its present form, or otherwise in its forms before the Date of Grant) does not describe the best method known to Novartis AG of performing the alleged invention and therefore does not comply with section 40(2)(a) of the Act.

Particulars

(a)    Pharmacor repeats paragraphs 6 to 8 above and the particulars thereto.

(b)    Pharmacor may provide further particulars following discovery and evidence.

10.     In light of the matters set out in paragraphs 6 to 9 above, claim 1 is invalid and liable to be revoked.

28    In its defence, Novartis denies that the best method of performing the alleged invention is not disclosed in the complete specification. It admits having knowledge of the documents referred to in the particulars subscribed to paragraph 7 of the cross-claim at the dates referred to therein.

29    Novartis also admits that it knew the information in Example 8, referred to in paragraph 8 of the cross-claim, before the filing date (16 January 2003) and that Example 8 was not included in the complete specification before 5 April 2007, when the patent was granted.

30    Otherwise, Novartis alleges that the allegations in paragraphs 7(a), (b), and (c); 7A(a), (b), and (c); 7B(a), (b), and (c); and 8 of the cross-claim are “vague and embarrassing” and makes no admission in respect thereof beyond the express admissions it has made.

31    Importantly, Novartis does not plead, in its defence, the best method that was known to it at any of the times pleaded in paragraph 6 of the cross-claim or identify where, in the complete specification, the best method is disclosed.

32    Further, Novartis contends that it is for Pharmacor to identify in its cross-claim the particular pharmaceutical composition within claim 1 that it says is the best method of performing the invention known to Novartis AG at the filing date.

33    Pharmacor accepts that the pharmaceutical compositions and methods of preparing them referred to in paragraph 7 of the cross-claim are only identified in general terms. It contends that, nevertheless, it can be reasonably inferred from the documents it has particularised that the contents of those documents were known to Novartis not only at the dates pleaded in paragraph 6 of the cross-claim, but before those dates. Further, as the documents, on their face, appear to be expressed as a culmination of efforts, it can be reasonably inferred that Novartis knew of earlier, and other, relevant pharmaceutical compositions and methods of preparing them. Pharmacor contends that, absent Novartis’s engagement, in its defence, with the allegations in paragraph 7 of the cross-claim, a sufficient basis have been provided to seek discovery from Novartis directed to the ascertainment of Novartis’s knowledge of the matters alleged in that paragraph.

The application for discovery

34    Pharmacor seeks discovery of the following category of documents:

1.    All Documents created during the period from 16 January 1998 to the Date of Filing recording or evidencing Novartis' knowledge and/or awareness (including but not limited to the description and/or evaluation) of any composition and/or method of preparing any composition comprising:

(a)    valsartan (or a salt therof); and

(b)    a NEP inhibitor (or a salt thereof),

associated by non-covalent bonds.

35    “Documents” is given the extended meaning given in the Dictionary in Sch 1 to the Federal Court Rules 2011 (Cth).

36    In support of its opposition to the interlocutory application, Novartis relies on an affidavit made on 12 July 2023 by its solicitor, Mr Collins. Mr Collins’ affidavit annexes correspondence passing between the solicitors for the parties. Mr Collins also deposes to a number of matters on information and belief, based on statements made by Dr Denis Barbier.

37    Dr Barbier is the Principal Patent Attorney for Novartis AG. He has worked in the Patent Department of Novartis AG (or one of its corporate affiliates) since 1 June 2004. He is primarily responsible for providing instructions to Novartis’ solicitors in relation to this proceeding.

38    Dr Barbier informed Mr Collins that the phrase “associated by non-covalent bonds”, as used in Pharmacor’s proposed category, is “vague and nebulous” and “renders the boundaries of … [the] category unclear”. Mr Collins’ affidavit does not divulge any further information as to why Dr Barbier holds these views.

39    Dr Barbier informed Mr Collins that the reference to “a NEP inhibitor”, as used in Pharmacor’s proposed discovery category, is to a broad class of agent (a neutral endopeptidase inhibitor). According to Dr Barbier, over 100 different compounds were known before the filing date to be NEP inhibitors.

40    Dr Barbier informed Mr Collins that he (Dr Barbier) is not aware of Novartis having undertaken searches to identify whether it had synthesised or evaluated a combination of valsartan and any NEP inhibitor, other than sacubitril or sacubitrilat, before the filing date. Dr Barbier informed Mr Collins that undertaking such searches would entail significant time, expense, and difficulty. Dr Barbier offered three reasons.

41    First, as already noted, a large number of compounds were known to be NEP inhibitors as at the filing date. Each compound could be known by multiple different chemical names or code names.

42    Secondly, the chemical names of large molecules, such as NEP inhibitors, are often long and complicated. Potentially, difficulties might be encountered in searching for documents falling within the category.

43    Thirdly, the reference to “all documents” refers to documents falling within a period that is now between 21 and 25 years ago. There are a number of potentially relevant custodians of these documents in the United States of America and in Switzerland. Further, many of Novartis’ primary records for this period are stored in off-line hard drives, which would need to be reviewed. Further still, the documents would cover a large number of handwritten documents, such as laboratory notebooks, that would not be text searchable.

44    It would seem that Dr Barbier did not provide Mr Collins with any information as to the time it would take to carry out appropriate searches or the expense to undertake that work.

45    Novartis also relies on an “affidavit” made by Dr Barbier himself on 12 July 2023. The document has been signed by Dr Barbier but not sworn or affirmed by him at the time of the hearing. I was informed by Senior Counsel for Novartis that this is being attended to. Pharmacor raised no objection to me receiving the document in this form as evidence in the interlocutory application.

46    In that “affidavit”, Dr Barbier describes the supramolecular complex of valsartan and sacubitril in the Entresto product (i.e., TSVH). Dr Barbier says that, while he understands expressions such as “non-covalent associations” and “associated by non-covalent bonds” when used to refer to the interactions between the components in this supramolecular salt complex, it is not apparent to him what other combinations of valsartan and sacubitril Pharmacor intends by referring, in its proposed category, to a composition comprising (a) valsartan (or a salt thereof) and (b) an NEP inhibitor (or a salt thereof), “associated by non-covalent bonds”.

47    Dr Barbier’s “affidavit” does not add to the information he provided to Mr Collins on why searching for the documents in Pharmacor’s proposed category “would entail significant time, expense, and difficulty”.

Analysis

48    At the time that Novartis AG applied for the patent it was required by s 29 of the Act to file a patent request accompanied by a complete specification. Section 40 of the Act required the complete specification to disclose the best method known to Novartis AG of performing the invention. This obligation is not in dispute.

49    Paragraphs 6 to 10 of the cross-claim, and paragraphs 6 to 10 of the defence thereto, raise, as a triable issue, the question whether Novartis AG complied with this obligation. As I have noted, in its defence Novartis has not identified the best method known to it of performing the invention at the filing date. It has simply denied that it failed to disclose the best method in the complete specification at any of the dates pleaded in paragraph 6 of the cross-claim.

50    On the basis of the pleadings, I am satisfied that an appropriate order for discovery of documents, directed to ascertaining Novartis AG’s state of knowledge, at the filing date, of the best method of performing the invention, is warranted for the just resolution of this aspect of the proceeding. There is a question, however, as to whether the scope of the category of documents that Pharmacor seeks is too broad.

51    Novartis AG’s obligation was to disclose the best method of performing the invention. The invention claimed in claim 1 is limited to compositions that include (1) valsartan (or a pharmaceutically acceptable salt thereof); (2) one of the two identified NEP inhibitors—sacubitril (or a pharmaceutically acceptable salt thereof) or sacubitrilat (or a pharmaceutically acceptable salt thereof); and (3) a pharmaceutically acceptable carrier. Although I have referred to the absence of certain other characteristics in the definition of the invention, the invention, as claimed in claim 1, is limited by these three characteristics.

52    Pharmacor’s category is not limited to documents concerning compositions that include, as the NEP inhibitor, sacubitril or sacubitrilat, or their pharmaceutically acceptable salts. It submits that it should be given the broader discovery it seeks with respect to documents concerning compositions that include any NEP inhibitor or the salt of any NEP inhibitor. It points to the broader discussion of the “invention” in the complete specification and, by reference to various statements by the Full Court in Sandvik Intellectual Property AB v Quarry Mining & Construction Equipment Pty Ltd [2017] FCAFC 138; 348 ALR 156 (Sandvik) (particularly at [95] and [115]), argues, in substance, that the requirement to disclose the best method of performing the “invention” is not limited to the invention as claimed.

53    I am not persuaded that the statements in Sandvik on which Pharmacor relies support that contention. The category of documents should be limited to compositions in which the NEP inhibitor is either sacubitril or sacubitrilat, or their salts.

54    Moreover, the category should be limited to compositions possessing the other characteristics of the composition claimed in claim 1, namely that the composition be a “pharmaceutical” composition; that the salts of valsartan or sacubitril or sacubitrilat be “pharmaceutically acceptable” salts; and that the composition include a “pharmaceutically acceptable carrier”.

55    At the hearing, there was considerable debate about the meaning of the expression “associated by non-covalent bonds” as used in Pharmacor’s description of the category. Despite Dr Barbier’s view to the contrary, I am satisfied that it is sufficiently clear that Pharmacor’s use of this expression in describing the category is directed to the association between valsartan (or its salts) and the NEP inhibitor (or its salts). I do not understand Pharmacor’s reference to “associated by non-covalent bounds” to be directed to the bonds between atoms within valsartan or to the bonds between atoms within the NEP inhibitor. Even so, the description of the category can be modified slightly in this regard to remove any doubt about that matter.

56    Another difficulty attending use of the expression “associated by non-covalent bonds” that was raised in argument was whether, by use of that expression, the category would cover: (a) a mere physical combination or mixture of valsartan and the NEP inhibitor; or (b) a composition where valsartan and the NEP inhibitor are “separate”. As the argument developed, Pharmacor indicated that the category should cover both such compositions.

57    Novartis contended that construing the proposed category in that way would be beyond Pharmacor’s pleading of its cross-claim, where Pharmacor bases its case (on Novartis AG’s alleged failure to disclose the best method of performing the invention) on Novartis AG’s knowledge of compositions “comprising non-covalently bound valsartan (or a valsartan salt) and a neutral endopeptidase (NEP) inhibitor (or an NEP inhibitor salt), and/or a method of preparing the foregoing” before the filing date (and other dates). Novartis contended, further, that the description of Pharmacor’s proposed category should be amended to specifically exclude: (a) a mere physical combination or mixture of valsartan and the NEP inhibitor; and also (b) a composition where valsartan and the NEP inhibitor are “separate”. It also contended that the description of Pharmacor’s proposed category should be amended to delete the expression “associated by non-covalent bonds”, having regard to Dr Barbier’s evidence to which I have referred.

58    I accept that Pharmacor’s pleaded case is limited to Novartis AG’s alleged knowledge of a pharmaceutical composition containing valsartan (or a valsartan salt) and an NEP inhibitor (or an NEP salt) that are “non-covalently” bound. However, after I expressed the view that I did not see that uncertainty was introduced by use of the expression “associated by non-covalent bonds”, Novartis withdrew its objection to the category being described by reference to the expression, as well as its contention that specific words of exclusion should be incorporated in the description.

59    Another objection to Pharmacor’s proposed category is its reference to “Novartis’ knowledge and/or awareness”. Novartis contends that this reference renders the category “too broad for the purpose of a best method case”. It contends that the reference to “Novartis’ knowledge and/or awareness” should be deleted and the category limited to compositions that record or evidence that Novartis had synthesised or evaluated the composition, or had performed a method of preparing the composition.

60    In the course of argument, Pharmacor proposed a revision to the description of the category in this regard. I am persuaded that Pharmacor’s revised formulation should be adopted. I am not persuaded that the category should be limited as Novartis proposes.

61    The final matter in dispute is whether discovery should be ordered against both Novartis AG and Novartis Australia. Novartis contends that, as only Novartis AG’s knowledge (as the patent applicant) is relevant, discovery should only be ordered against it. I do not accept that submission. Both Novartis AG and Novartis Australia should be ordered to give discovery.

Disposition

62    Orders will be made accordingly, as well as other orders that will progress the preparation of the matter for hearing. As the parties have each had varied success, it seems to me that the costs of the interlocutory application should be costs in the cause. Nevertheless, I am prepared to hear the parties on that question. To that end, I will reserve the question of costs.

Associate:

Dated:    14 July 2023