Federal Court of Australia
AstraZeneca AB v Pharmacor Pty Ltd (No 3) [2026] FCA 565
File number: | NSD 2359 of 2025 |
Judgment of: | DOWNES J |
Date of judgment: | 6 May 2026 |
Catchwords: | PRACTICE AND PROCEDURE – patents – amendment application to include invalidity ground concerning failure to disclose best method – amendment refused – other amendments allowed |
Legislation: | Patents Act 1990 (Cth) s 70(3)(a) Federal Court Rules 2011 (Cth) rr 16.02(1), 20.11 |
Cases cited: | Aljazeera International (Malaysia) SDN BHD v Hun [2026] FCAFC 22 AstraZeneca AB v Pharmacor Pty Ltd (No 2) [2026] FCA 414 AstraZeneca AB v Pharmacor Pty Ltd [2026] FCA 88 Novartis AG and Another v Pharmacor Pty Ltd (No 3) (2024) 186 IPR 24; [2024] FCA 1307 Novartis AG v Pharmacor Pty Limited [2023] FCA 804 |
Division: | General Division |
Registry: | New South Wales |
National Practice Area: | Intellectual Property |
Sub-area: | Patents and associated Statutes |
Number of paragraphs: | 45 |
Date of hearing: | 2 April 2026, 4 May 2026 |
Counsel for the Applicants: | Mr N Murray SC, Ms M Evetts and Ms S Yates |
Solicitor for the Applicants: | Corrs Chambers Westgarth |
Counsel for the Respondent: | Mr J Cooke SC, Mr D Larish and Ms J McKenna |
Solicitor for the Respondent: | Maddocks |
ORDERS
NSD 2359 of 2025 | ||
| ||
BETWEEN: | ASTRAZENECA AB First Applicant ASTRAZENECA PTY LTD ABN 54 009 682 311 Second Applicant | |
AND: | PHARMACOR PTY LIMITED ABN 58 121 020 835 Respondent | |
AND BETWEEN: | PHARMACOR PTY LIMITED ABN 58 121 020 835 Cross-Claimant | |
AND: | ASTRAZENECA AB Cross-Respondent | |
order made by: | DOWNES J |
DATE OF ORDER: | 6 may 2026 |
THE COURT ORDERS THAT:
1. The Cross-Claimant has leave to file an Amended Notice of Cross-Claim, Amended Statement of Cross-Claim, Amended Particulars of Invalidity and Amended Defence containing the amendments substantially in the form identified as being allowed in the reasons delivered on 6 May 2026.
2. Any such amended documents be filed and served by 8 May 2026.
3. The Cross-Claimant pay the Applicants’ costs thrown away by the amendments.
4. The costs of the Cross-Claimant’s interlocutory application accepted for filing on 18 March 2026, including the application to amend that interlocutory application, be the Applicants’ costs in the cause.
Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.
REASONS FOR JUDGMENT
DOWNES J:
Overview
1 The relevant background appears in AstraZeneca AB v Pharmacor Pty Ltd [2026] FCA 88 (AstraZeneca (No 1)), and the defined terms in that judgment are adopted in these reasons. That decision concerns the hearing of an application for an interlocutory injunction on 6 February 2026 (first hearing date). On 16 February 2026, orders were made which included the grant of the interlocutory injunction substantially in the terms sought by AZ.
2 It is relevant to observe that:
(1) this proceeding has been set down for trial commencing on 31 August 2026, which is less than four months away;
(2) the listing for trial on a relatively expeditious basis occurred on the basis of the pleadings as they then were on the first hearing date;
(3) AZ has provided an undertaking as to damages which extends to any damage suffered by third parties, such as the Commonwealth, as part of the price for the injunction which it obtained;
(4) it is in the interests of any affected third parties that a trial occurs, and a decision be handed down, as soon as is reasonably practicable;
(5) it is also in the interests of AZ that a trial occurs, and a decision be handed down, as soon as is reasonably practicable so as to minimise its exposure on the undertaking as to damages;
(6) as Pharmacor wishes to launch its generic product as soon as possible, it is in the interests of Pharmacor that a trial occurs, and a decision be handed down, as soon as is reasonably practicable;
(7) the Patent will expire on 22 October 2027;
(8) AZ contends, and Pharmacor accepts, that a trial commencing on 31 August 2026 is no longer feasible if the amendments are allowed. Whether such a position pertains to a scenario where only some, but not all, of the proposed amendments are allowed is yet to be determined.
3 By its application, Pharmacor seeks to expand the grounds on which it alleges that certain claims of the Patent are invalid. As to this, the proposed Amended Particulars of Invalidity define “Asserted Claims” as claims 1, 2, 3 and 16 of the Patent.
4 The interlocutory application by Pharmacor to amend its Notice of Cross-Claim, Statement of Cross-Claim, Particulars of Invalidity and Defence was heard on 2 April 2026 (second hearing date). At that hearing, Pharmacor also pressed an application to withdraw any admission made in its Defence in relation to the validity of the extension of the term of the Patent, and applied to set aside a Notice to Produce served by AZ (which latter application failed). Further background is found in AstraZeneca AB v Pharmacor Pty Ltd (No 2) [2026] FCA 414.
5 At the second hearing date, the amendment application was adjourned part-heard. The sole matter left to be addressed on the amendment application at that time was for AZ to make submissions in answer arising from any documents produced by Pharmacor pursuant to the Notice, and for Pharmacor to make submissions in reply: see AstraZeneca (No 2) at [24].
Application to adduce additional evidence
6 At the resumed hearing of the amendment application on 4 May 2026 (being a date which was nominated by the parties) (resumed hearing), Pharmacor sought leave to rely on additional affidavit evidence. Although reliance on the additional evidence was opposed by AZ by its written submissions, that opposition was not pressed at the hearing. However, AZ maintained that the evidence considered as a whole, including the additional evidence, did not contain an adequate explanation for the delay in advancing the PTE allegation at an earlier time. That submission is addressed below.
Application to amend the interlocutory application
7 At the resumed hearing, Pharmacor sought leave to rely upon an amended interlocutory application and an updated version of the Amended Particulars of Invalidity which added additional particulars to Pharmacor’s proposed best method ground. The new particulars relate to three documents which comprise more than 100 pages.
8 There was no evidence to explain why the documents referred to in these additional particulars could not have been ascertained with due diligence prior to the second hearing date. The obvious inference is that Pharmacor, with the benefit of AZ’s submissions at the second hearing date, has decided to improve upon its proposed best method case. This course of action has resulted in further costs being incurred by the parties, including extending the duration of the resumed hearing.
9 It is not in the interests of justice to permit Pharmacor to amend its application and to expand its proposed best method case in this way, especially in light of the matters addressed in [2] above. To the contrary, it would impede the just, quick and efficient resolution of this proceeding. The amendment application was adjourned part heard because of Pharmacor’s failed application to set aside the Notice and for the limited purpose of addressing the matters in AstraZeneca (No 2) at [24]. Had that not occurred, judgment on the amendment application would have been delivered before now and the matter would be progressing to trial. The adjournment was not to facilitate a reopening and revision of the application to plead the best method case, or to expand upon that case.
10 For these reasons, the application to amend the interlocutory application, and to add further particulars to the proposed best method case, is refused.
The proposed amendments
11 The proposed amendments which are opposed by AZ will be addressed in turn. Otherwise, the amendments which were not challenged by AZ will be allowed. This includes the withdrawal of the invalidity attack on the basis of lack of novelty which was addressed in AstraZeneca (No 1) at [27]–[51].
Obviousness
12 By its amendment application, Pharmacor seeks to amend its Particulars of Invalidity as follows:
D. Lack of Inventive Step
4. The alleged invention as claimed in each of the Asserted Claims is not a patentable invention within the meaning of section 18(1)(b)(ii) of the Patents Act in that it did not involve an inventive step when compared with the prior art base as it existed before 20 May 2002.
Particulars
(a) The alleged invention as claimed in each of the Asserted Claims lacks an inventive step in the light of the common general knowledge as it existed in the patent area before 20 May 2002 considered together with WO 128, being information that the person skilled in the art could, before 20 May 2002, be reasonably expected to have ascertained, understood and regarded as relevant, by reason that:
(i) the Asserted Claims do not:
A. involve one or more of a technical advance, difficulty overcome or barrier crossed;
B. further or in the alternative, satisfy the selection principles summarised in Ranbaxy v Warner-Lambert (2008) 77 IPR 449 at [105];
(ii) further or in the alternative, the person skilled in the art armed with WO 128 together with the common general knowledge would be directly led as a matter of course to try the alleged invention claimed in the Asserted Claims in the expectation that it might well produce a useful result.
(b) Further particulars may be provided, including after discovery.
13 Prior to the first hearing date, Pharmacor reserved the right to run a classical obviousness case at trial. AZ was therefore on notice at an early stage in the proceeding that such a case might be advanced. Further, the delay by Pharmacor in applying to make these amendments is not significant.
14 While it may be accepted that these amendments will add to the issues which need to be addressed by the experts and the parties prior to trial, and at the trial itself, and bearing in mind the matters in [2] above, I am satisfied that the proposed amendments to the Particulars of Invalidity and any associated documents should be allowed.
PTE allegation
15 By proposed amendments to its Statement of Cross-Claim, Pharmacor seeks to advance the PTE allegation, being in substance that:
(1) in the request to extend the term of the Patent pursuant to s 70 of the Act, BMS asserted that FORXIGA is “a mixture of dapagliflozin… together with propylene glycol… and water” and therefore contains dapagliflozin, also described as “the compound dapagliflozin” (Asserted Pharmaceutical Substance);
(2) FORXIGA does not contain or consist of the Asserted Pharmaceutical Substance including because it contains the substance “dapagliflozin propanediol monohydrate” (DPM), being a complex of dapagliflozin, propylene glycol and water, and the DPM complex is a different substance to the Asserted Pharmaceutical Substance;
(3) s 70(3)(a) of the Act was not satisfied for these reasons and the extension of term of the Patent was wrongly granted as a consequence.
16 The documents produced by Pharmacor pursuant to the Notice reveal that, in May 2025, the issue of the alleged disconformity between the substance contained in FORXIGA (DPM) and the claims of the Patent was considered by Mr Balu Falke, an employee of a company within the same corporate group as Pharmacor who works in the in-house intellectual property team. He said that Pharmacor and his company rely on the advice of external legal advisers in relation to Australian law. Mr Falke prepared a memo which considered “[t]he basis for PTE invalidation”. Mr Falke’s unchallenged evidence is that he did not have in mind the s 70(3)(a) argument when he wrote the memo, and that, to his knowledge, no-one at his company or Pharmacor had considered the s 70(3)(a) argument prior to it being raised by Pharmacor’s solicitors on 19 February 2026.
17 Mr Falke’s memo was provided to Pharmacor’s solicitors, and the decision of Yates J in Novartis AG and Another v Pharmacor Pty Ltd (No 3) (2024) 186 IPR 24; [2024] FCA 1307 was addressed in an internal email within the firm between a partner and senior associate. The email cited passages of Novartis which referred to s 70(3) of the Act. However, both the partner and the senior associate gave unchallenged evidence to the effect that, prior to 6 February 2026, no-one at Pharmacor and none of Pharmacor’s legal representatives had considered the s 70(3)(a) argument now sought to be advanced by Pharmacor.
18 While it may be accepted that there are other people within Pharmacor who have an interest and involvement in this litigation in addition to Mr Falke (as the number of recipients of an email advice of 19 February 2026 from Maddocks suggests), and while Pharmacor was a party in the Novartis case, I consider that it is unlikely that those people would have considered advancing the s 70(3) argument in this case without raising it with their external legal advisers, and it is also unlikely that they would have raised it with solicitors other than those who are on the record for Pharmacor in this matter, being Maddocks. Based on the evidence, it was not so raised.
19 For these reasons and contrary to the submissions advanced by AZ, the evidence adduced by Pharmacor is therefore sufficient to demonstrate that, while consideration was given by Pharmacor and its solicitors to at least some of the underlying facts which could be pleaded in favour of the PTE allegation, there was no real recognition before 6 February 2026 that there might be an argument available to Pharmacor that s 70(3)(a) of the Act had not been satisfied.
20 Once such an argument was recognised as being a tenable one, Pharmacor acted promptly to apply to amend its case to make the PTE allegation.
21 While it may be accepted that these amendments will add to the issues which need to be addressed by the experts and the parties prior to trial, and at the trial itself, and bearing in mind the matters in [2] above, I am satisfied that the proposed amendments to the Statement of Cross-Claim and any associated documents should be allowed so that the PTE allegation may be advanced by Pharmacor.
Failure to disclose best method
22 As an alternative to the PTE allegation, Pharmacor seeks to amend its Particulars of Invalidity to include the following (all of which paragraphs are underlined in the proposed particulars):
F. Best Method
6. The matters pleaded at paragraphs 7 – 10 below are in the alternative to the allegations at paragraphs 4A – 4H of the Amended Statement of Cross-Claim.
7. Insofar as a “compound having the structure [being the chemical structure of dapagliflozin]” in the Asserted Claims includes a complex of dapagliflozin, before the filing date of the Patent (15 May 2003), the patent applicant (Bristol-Myers Squibb Company (BMS)) knew of a method of performing the claimed invention which involved a complex of dapagliflozin (Complex Method).
Particulars
(a) This can be inferred from the proximity in dates between the filing date of the Patent and the dates of each of the following:
(i) US patent no. US 6,774,112 B2 (US 112) entitled “Amino acid complexes of C-aryl glucosides for treatment of diabetes and method” and filed by BMS on 8 April 2002, which discloses a method for preparing a complex of dapagliflozin in the form of a crystalline amino acid complex. The complex has the structure of the preferred compounds of “formula IA” as set out in column 3 of US 112 and claimed in claim 5.
(ii) US patent application publication no. US 2008/0004336 A1 (US 336) entitled “Crystal structures of SGLT2 inhibitors and processes for preparing same” and filed by BMS on 20 June 2007, which discloses methods for preparing complexes of dapagliflozin, in particular the complex dapagliflozin S-propanediol (also known as S-propylene glycol) monohydrate. The complex has the structure of “compound Ia” as set out in [0006] of US 336 and claimed in claim 5.
(iii) International patent application publication no. WO 2008/002824 A1 (WO 824) entitled “Crystalline solvates and complexes of (IS) -1, 5-anhydro-L-C- (3-(phenyl) methyl) phenyl) -D-glucitol derivatives with amino acids as SGLT2 inhibitors for the treatment of diabetes” and filed by BMS on 21 June 2007 (with an earliest priority date of 28 June 2006), which discloses methods for preparing complexes of dapagliflozin, in particular the complex dapagliflozin S-propanediol monohydrate. The complex has a structure of “compound Ia” as set out on p 2 lns 13-14 of WO 824.
(iv) Australian patent application no. AU 2008228714 B2 (AU 714) entitled “Pharmaceutical formulations containing dapagliflozin propylene glycol hydrate” and filed by BMS on 21 March 2008 (with an earliest priority date of 22 March 2007), which discloses a method for preparing the complex dapagliflozin S-propanediol monohydrate. The complex has a structure that falls within the structure of “compound Ia (SC-3)”, as set out in [0005] of AU 714.
(v) BMS was a collaborator and investigator in the following AstraZeneca-sponsored phase II clinical trials (noting the drug code assigned to dapagliflozin propanediol monohydrate is “BMS-512148”):
A. study identifier MB102-003, commencing in April 2005, to assess the safety of, exposure to, and biological effects of “BMS-512148” in stable Type 2 diabetic subjects, as disclosed in AstraZeneca’s clinical trial database entry for the study located at
B. study identifier MB102-008, commencing in December 2005, concerning whether “BMS-512148” is effective in controlling blood sugar levels as determined by HbA1c and fasting plasma glucose in patients who have been diagnosed with Type 2 diabetes, as disclosed in AstraZeneca’s clinical trial database entry for the study located at
(vi) BMS applied to the Food and Drug Administration for regulatory approval of FARXIGA on 11 July 2013 by reference to clinical trials that studied inter alia the safety and efficacy of “BMS-512148”. For example, the phase III clinical trial commenced in September 2007 with study identifier MB102-013 studied the safety and efficacy of BMS-512148 as a monotherapy in subjects with Type 2 diabetes who have inadequate glycemic control with diet and exercise.
(vii) AstraZeneca was a sponsor and collaborator of the clinical trial with study identifier MB 102-013, as disclosed in AstraZeneca’s clinical trial database entry for the study located at
(b) Further particulars may be provided after discovery.
8. The Complex Method was the best method of performing the invention of the Patent known to BMS as at the filing date of the Patent (15 May 2003).
Particulars
(a) The Respondent / Cross-Claimant refers to and repeats the particulars to paragraph 7 above.
9. The specification of the Patent does not describe the Complex Method.
10. By reason of the matters in paragraphs 7 to 9 above, the Patent does not comply with s 40(2)(a) of the Act.
(Emphasis original.)
23 During the course of the resumed hearing, it was proposed by Pharmacor that the word “being” in the final line of paragraph 7 could be substituted for the words “which involved”. It was also proposed that, as a fall-back position, the best method case to be advanced would be confined to five complexes, being:
(1) an L-Phenylalanine complex of dapagliflozin (see further proposed particulars 7(a)(viii)(F) and 7(a)(x)(A)–(B));
(2) a D-Phenylalanine complex of dapagliflozin (see further proposed particular 7(a)(viii)(F));
(3) an L-Proline complex of dapagliflozin (see further proposed particular 7(a)(viii)(F));
(4) an ethyl acetate complex of dapagliflozin (see further proposed particular 7(a)(x)(A)–(B)); and
(5) a propanediol monohydrate (i.e. propylene glycol monohydrate) complex of dapagliflozin (see proposed particulars 7(a)(ii)–(vi) and further proposed particulars 7(a)(viii)(F)–(G) and 7(a)(x)(A)–(B)).
24 When I asked senior counsel which of these complexes is said to be the “best”, the response was “until we get their discovery, we don’t know” following which it was suggested that the best method case would be narrowed, and the particulars would be supplemented after discovery. This exchange makes plain that the current proposed plea is designed to cast a net wide to search for a best method case through discovery, which case is not able to be articulated with precision at present and is likely to be amended. In the circumstances described in [2] above, and as a general proposition, such a proposed course is untenable: see Aljazeera International (Malaysia) SDN BHD v Hun [2026] FCAFC 22 (Bromwich, Wheelahan and Owens JJ) at [112]–[114]. It is also contrary to the just resolution of the proceeding as quickly, inexpensively and efficiently as possible: see r 20.11 Federal Court Rules 2011 (Cth).
25 Further and leaving aside the fact that the list of five complexes above contains references to the further proposed particulars which were sought to be added after the amendment application was adjourned, a more fundamental difficulty with the proposed best method case is that it is not apparent how “a complex of dapagliflozin” could be alleged to be a method of performing the invention as claimed in the Asserted Claims. This is especially as, according to Pharmacor, the specification of the Patent does not refer to complexes at all.
26 Claims 1 and 2 of the Patent claim a compound, which compound is depicted in AstraZeneca (No 1) at [13], although I note that claim 1 identifies the compound and states “or a pharmaceutically acceptable salt, a stereoisomer thereof, or a prodrug ester thereof”. The compound in claims 1 and 2 is dapagliflozin.
27 Claim 3 of the Patent claims a pharmaceutical composition comprising a compound as defined in claim 1 or claim 2 and a pharmaceutically acceptable carrier therefor.
28 Claim 16 of the Patent claims a method for treating type II diabetes which comprises administering to a mammalian species in need of treatment a therapeutically effective amount of a compound as defined in claim 1 or claim 2 alone or in combination with another antidiabetic agent, an agent for treating the complications of diabetes, an anti-obesity agent, an antihypertensive agent, an antiplatelet agent, an anti-atherosclerotic agent and/or a hypolipidemic agent.
29 None of these claims refer in terms to a complex, or to a compound which is a complex.
30 Mr Fisher, a solicitor who acts for AZ and who has a Bachelor of Science majoring in Chemistry, gave this unchallenged evidence:
…The “Complex Method” is defined at paragraph 7 [of the draft Amended Particulars of Invalidity] as “a method of performing the claimed invention which involved a complex of dapagliflozin”.
Despite those pleadings, it is not clear to me what the Respondent alleges the “best method” of performing the invention of the Patent at the relevant date and known to BMS was, including because I do not know what the substantive content of the “Complex Method” is.
31 When senior counsel for Pharmacor was pressed about what the “Complex Method” is said to be, he submitted that “it’s a complex that has [the] dapagliflozin molecule as a constituent, and logically, it doesn’t matter what the other constituents in that complex are”. He also submitted that “the pleading is sufficient, at this stage, pre-discovery” and “it was sufficient for Yates J in the Novartis pre-discovery” (which I understood to be a reference to Novartis AG v Pharmacor Pty Limited [2023] FCA 804). He also submitted that this case is “on all fours” with Novartis.
32 The relevant claim in Novartis is addressed in that decision at [13], [14] and [19]. In essence, claim 1 in that case was to a pharmaceutical composition comprising valsartan (or a pharmaceutically acceptable salt of valsartan) in combination with one of two identified NEP inhibitors (or their pharmaceutically acceptable salts) and a pharmaceutically acceptable carrier.
33 The best method plea in Novartis identified the matters which were alleged to have been known by the patentee in these terms:
…
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.
34 It is therefore the case that the best method allegation advanced in Novartis was aligned with the invention as claimed in the relevant claim.
35 In that case, Yates J recognised that this was the extent of the obligation to disclose the best method, stating at [51] that:
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.
36 Further, having regard to the invention as claimed, his Honour considered that the category of documents to be discovered “should be limited to compositions in which the NEP inhibitor is either sacubitril or sacubitrilat, or their salts” and that “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”: see [53] and [54].
37 By contrast, claims 1 and 2 of the Patent claim a compound, and not a composition (unlike the claim before Yates J) or, indeed, a complex. The invention claimed in claims 1 and 2 of the Patent is limited to a compound (being dapagliflozin) or, in the case of claim 1, a pharmaceutically acceptable salt, a stereoisomer thereof, or a prodrug ester thereof.
38 While claim 3 of the Patent claims a pharmaceutical composition, this comprises a compound as defined in claim 1 or claim 2 and a pharmaceutically acceptable carrier therefor, and is so limited. However, when one has regard to what is alleged in paragraph 7 and the particulars, Pharmacor’s proposed best method case concerning claim 3 of the Patent is not to the effect that BMS knew of the best method of preparing any pharmaceutical composition comprising the compound dapagliflozin and a pharmaceutically acceptable carrier.
39 Similarly, while claim 16 of the Patent claims a method, which method encompasses administering the compound dapagliflozin in combination with another antidiabetic agent, an agent for treating the complications of diabetes, an anti-obesity agent, an antihypertensive agent, an antiplatelet agent, an anti-atherosclerotic agent and/or a hypolipidemic agent, Pharmacor’s proposed best method case concerning claim 16 is not to the effect that BMS knew of the best method of preparing or administering the compound dapagliflozin and one of these agents.
40 It is therefore not the case that this case is “on all fours” with Novartis. Rather, the proposed best method case sought to be advanced by Pharmacor bears little resemblance to the invention claimed in the Asserted Claims.
41 If Pharmacor was allowed to plead its proposed best method case, it would be liable to be struck out as it does not give AZ fair notice of the case it would have to meet at trial, and the issues that Pharmacor wants the Court to resolve are not identified, contrary to rr 16.02(1)(c) and (d) Federal Court Rules.
42 For these reasons, the application to amend insofar as it relates to the best method case will be refused. It is therefore not necessary to address the other arguments advanced by AZ in opposition to these amendments.
Conclusion and disposition
43 The application relating to the amendments to advance the proposed best method case will be refused. The other proposed amendments will be allowed.
44 As to costs, AZ seeks an order that it have its costs thrown away by the amendments, which Pharmacor does not oppose.
45 As to the costs of the amendment application, it is Pharmacor which is seeking an indulgence by applying to amend, and it did not succeed in its application to amend the interlocutory application. On the other hand, Pharmacor has succeeded in obtaining the amendments relating to obviousness and the PTE allegation. On balance, the appropriate costs order relating to the amendment application, and the application to amend the interlocutory application, is that AZ should have its costs in the cause.
I certify that the preceding forty-five (45) numbered paragraphs are a true copy of the Reasons for Judgment of the Honourable Justice Downes. |
Associate:
Dated: 6 May 2026