Apotex Pty Ltd v Les Laboratoires Servier

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FEDERAL COURT OF AUSTRALIA

Apotex Pty Ltd v Les Laboratoires Servier

[2013] FCA 1426

Citation: Apotex Pty Ltd v Les Laboratoires Servier [2013] FCA 1426
Parties: APOTEX PTY LTD ACN 096 916 148 v LES LABORATOIRES SERVIER and SERVIER LABORATORIES (AUST) PTY LTD
File number: NSD 51 of 2012
Judge: RARES J
Date of judgment: 24 December 2013
Corrigendum: 6 March 2014
Catchwords:

INTELLECTUAL PROPERTY – patents – patent claimed particular new pharmaceutical salt of substance – whether invention of new salt novel within meaning ss 7(1) and 18 of Patents Act 1990 (Cth) when two earlier patents in prior art made general claims for the substance “and its pharmaceutically acceptable salts” – whether earlier patents’ claims disclosed the invention to skilled addressee or lacked sufficient content – common general knowledge

INTELLECTUAL PROPERTY – patents – whether claimed invention obvious and involved inventive step within meaning of ss 7(2) and 10(1) of Patents Act 1990 (Cth) – whether problem/solution approach apposite – perspective of person skilled in the art as to whether selection of counter-ion to try in salt screen obvious

INTELLECTUAL PROPERTY – patents – whether claim in patent for pharmaceutical salt “and its hydrates” fairly based within meaning of s 40(3) of Patents Act 1990 (Cth) – where complete specification did not indicate how hydrates were part of invention or how made – construction of patent – whether construction approached from position of skilled addressee

INTELLECTUAL PROPERTY – patents – whether complete specification described best method known to the patentee of performing the invention within meaning of s 40(2)(a) of Patents Act 1990 (Cth) – where complete specification gave very general description of method leaving open many alternatives that left to chance whether a pharmaceutically acceptable salt would be produced – whether person seeking revocation must prove that the particular method that patentee failed to disclose is in fact a better method than the generalised method described in the specification

INTELLECTUAL PROPERTY – patents – statutory construction – whether expression “fraud, false suggestion or misrepresentation” in s 138(3)(d) of Patents Act 1990 (Cth) identifies three alternatives – meaning of “fraud”, “false suggestion” and “misrepresentation” in s 138(3)(d) – basis upon which patent construed as understood by Commissioner of Patents for purpose of revocation proceedings under s 138(3)(d) – onus of proof of falsity in the sense in which skilled addressee would understand the patent read as a whole

STATUTORY CONSTRUCTION – whether Court’s power to revoke a patent under s 138(3) of Patents Act 1990 (Cth) discretionary

Legislation: Patents Act 1952 (Cth) ss 100(1), 102, 105
Patents Act 1990 (Cth) ss 7, 7(1), 7(2), 18(1)(b), 40(2)(a), 40(3), 49(1), 59, 138, 138(1), 138(3)(b), 138(3)(d), 138(3)(f), Sch 1
Statute of Monopolies 1623 (UK)   
Cases cited:

Aktiebolaget Hässle v Alphapharm Pty Ltd (2002) 212 CLR 411 applied
Aon Risk Services Australia Ltd v Australian National University (2009) 239 CLR 17 applied
Apotex Pty Ltd v Sanofi-Aventis (2008) 78 IPR 485 applied
Apotex Pty Ltd v Sanofi-Aventis (2009) 82 IPR 416 applied

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Details
Case
[2013] FCA 1426
Decision Date

CaseChat Overview and Summary

Apotex Pty Ltd initiated proceedings against Les Laboratoires Servier, seeking to invalidate a patent held by Servier for perindopril arginine. The dispute centred on the validity of several claims within the patent, particularly focusing on whether Apotex’s generic perindopril erbumine tablets would infringe these claims. The matter was heard in the Federal Court of Australia, where Apotex argued that the patent was invalid due to various reasons, including insufficient disclosure of the best method of performing the invention. Servier, on the other hand, maintained that the patent was valid and enforceable, and sought to prevent Apotex from marketing its generic version of perindopril arginine.

The central legal issues the court had to address were whether the patent claims were sufficiently disclosed and whether they met the statutory requirements for patentability. Apotex argued that the patent did not comply with the disclosure requirements under section 40(2) of the Patents Act 1990 (Cth), particularly regarding the best method known to the applicant for performing the invention. Additionally, Apotex contended that certain claims within the patent were not supported by the specification and were therefore invalid. Servier defended the validity of the patent, asserting that all claims were properly disclosed and met the necessary statutory criteria.

The court found that Apotex had successfully demonstrated that the specification in the patent did not describe the best method known to the applicant of performing the invention, thereby failing to comply with section 40(2)(a) of the Act. This finding of invalidity, however, did not extend to all claims in the patent. Apotex’s other challenges to the validity of the patent, which constituted the majority of the evidence and arguments presented, were unsuccessful. Consequently, the court held that the patent was only partially invalid. The court will further consider the appropriate relief and costs to be awarded, taking into account the outcome of the validity findings and the extensive evidence presented by both parties.

Orders

Orders of the court

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Background

Background to the litigation

Claims 8-11 referred to descriptions of the invention in “the Examples”, but there were no examples set out in the patent and so those claims could not be sustainable.SOME GENERAL BACKGROUND In late 2006 Servier ceased to supply perindopril erbumine tablets under the Coversyl brand name and began selling perindopril arginine tablets under it instead. The perindopril arginine tablets are made by wet granulation and then packaged in HDPE bottles with a desiccant. They have a TGA approved shelf-life of three years when marked “store below 30°C”. Also in late 2006, Apotex began selling its perindopril erbumine tablets. Those are made by direct compression, marketed in Alu/Alu (or cold form foil) packaging and initially had a TGA approved shelf-life of two years when marked “store below 25°C”. Pharmacists can substitute Apotex’ perindopril erbumine tablets for patients who present prescriptions for Servier’s perindopril arginine tablets under the National Health Act 1953 (Cth). In 2007, the TGA approved a longer shelf-life of three years for Apotex’ perindopril erbumine tablets when marked “store below 25°C”. In January 2012, Apotex informed Servier that it had applied to the TGA for registration of generic perindopril arginine products on the Pharmaceutical Benefits Scheme once they were approved by the TGA. Apotex commenced these proceedings on 16 January 2012. Servier obtained an interlocutory injunction in March 2012 restraining Apotex from selling perindopril arginine effectively until final judgment. Apotex did not oppose that course. Apotex accepts that if claims 1, 2, 3, 4 and 6 of the patent are valid, it would infringe them. Servier does not seek relief on the basis of any apprehended infringement of claims 5 and 7 on the basis that Apotex does not allege that those two claims are independently invalid. The parties did not present argument about the detail of how the individual claims may be infringed, no doubt because of Apotex’ concession that if its invalidity arguments fail, unless further restrained, it will infringe the patent by going to market with its new generic. The parties called six experts in chemistry with expertise in pharmaceutical matters. There was no issue that each of these experts was appropriately qualified. I found their evidence of considerable assistance. I will very briefly summarise their qualifications which, however, are much more extensive and impressive than is necessary to record in these reasons. Apotex relied on Dr Peter Spargo, Dr Desmond Williams and Associate Professor Michael Perkins. Dr Spargo is currently a consultant. He had worked in the field of chemistry research and development in the pharmaceutical industry seeking to develop new chemical entity therapeutic agents since he began his career working for Pfizer Ltd in the United Kingdom in 1988. He had particular experience and expertise in solid form (including salt and polymorph) selection. Dr Williams is currently the program director, pharmaceutical science in the School of Pharmacy and Medical Sciences and supported researcher in the Sansom Institute for Health Research at the University of South Australia. He is also a registered pharmacist and chartered chemist. His experience included pharmaceutics (i.e. the formulation of drug substances, such as APIs, into drug products suitable for, and adapted to, effective delivery to the intended site within the human body). He had worked for a number of large pharmaceutical companies and had considerable experience in dealing with regulators, including the TGA, and has been a member of the pharmaceutical subcommittee of the TGA’s Advisory Committee on Prescription Medicines since 2005.

Evidence

Evidence Before The Court

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Decision

Reasons for decision

The parties spent considerable time debating whether Apotex’ generic erbumine salt tablets were entitled to their current shelf-life and the experts did not come to a joint position on this. However, it is not necessary to resolve this further dispute in an already over complex case.CONCLUSION Apotex has succeeded only in establishing that the specification in the patent did not describe the best method known to the applicant of performing the invention and so did not comply with s 40(2)(a). Accordingly, that raises the question of what relief should be granted under s 138(3) of the Act. Apotex’ many other challenges to the validity of the patent have all failed and those took up the bulk of the evidence and hearing. That failure should be reflected in costs. In addition, the parties should identify any errors or oversights in these reasons that may readily be corrected, including any argument or issue of substance that may not have been addressed so as to avert any unnecessary issue in any appeal. I will hear the parties on the question of relief and on costs.

Ratio Decidendi

Legal Principle Established

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