Warner-Lambert Company LLC v Apotex Pty Ltd

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FEDERAL COURT OF AUSTRALIA

Warner-Lambert Company LLC v Apotex Pty Ltd [2014] FCAFC 59

Citation: Warner-Lambert Company LLC v Apotex Pty Ltd [2014] FCAFC 59
Appeal from: Warner-Lambert Company LLC v Apotex Pty Ltd [2014] FCA 241
Parties: WARNER-LAMBERT COMPANY LLC, PF PRISM CV, PFIZER IRELAND PHARMACEUTICALS, PFIZER ASIA PACIFIC PTE LTD and PFIZER AUSTRALIA PTY LTD (ACN 008 422 348) v APOTEX PTY LTD (ACN 096 916 148)
File number: NSD 287 of 2014
Judges: ALLSOP CJ, JAGOT & NICHOLAS JJ
Date of judgment: 19 May 2014
Catchwords:

APPEAL – appeal against primary judge’s refusal to grant interlocutory injunction restraining alleged patent infringement – where application for interlocutory injunction based solely on threatened contravention of s 117(1) when read with s 117(2)(b) of Patents Act 1990 (Cth) – where primary judge not satisfied appellants had established prima facie case – where primary judge found that appellants’ case that pharmacists would not be deterred from engaging in product substitution was unsupported by evidence – whether primary judge erred in failing to give any weight to expert evidence called by appellants – whether such evidence was mere conjecture and assertion – whether conflict of expert evidence capable of resolution on application for interlocutory injunction – whether balance of convenience favoured grant of interlocutory injunction;

PATENTS – where application for interlocutory injunction based solely on threatened contravention of s 117(1) when read with s 117(2)(b) of the Patents Act 1990 (Cth) – where patent for method of use for pharmaceutical compound known as pregabalin in the treatment of pain – where respondent’s products indicated for the treatment of different condition – where respondent’s products capable of infringing and non-infringing use – whether respondent had requisite “reason to believe” for the purposes of s 117(2)(b) – significance of treatment indications – significance of approved product information – significance of respondent’s proposed written directions to doctors and pharmacists – whether prima facie case of threatened patent infringement – whether balance of convenience favoured grant of interlocutory injunction;

Held:  Appeal allowed; interlocutory injunction granted.
Legislation: Patents Act 1990 (Cth) s 117(1), 117(2)(b)
Therapeutic Goods Act 1989 (Cth) s 22(5)
Cases cited: Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (2013) 304 ALR 1
Australian Broadcasting Corporation v O’Neill (2006) 227 CLR 57
Beecham Group Limited v Bristol Laboratories Pty Limited (1968) 118 CLR 618
Generic Health Pty Ltd v Otsuka Pharmaceutical Co Ltd (2013) 100 IPR 240
House v The King (1936) 55 CLR 499
Shercliff v Engadine Acceptance Corporation Pty Ltd [1978] 1 NSWLR 729
Date of hearing: 9 May 2014
Place: Sydney
Division: GENERAL DIVISION
Category: Catchwords
Number of paragraphs: 103
Counsel for the Appellants: Mr R Cobden SC with Mr C Dimitriadis
Solicitor for the Appellants: Allens
Counsel for the Respondent: Mr DK Catterns QC with Mr NR Murray and Mr HPT Bevan
Solicitor for the Respondent: Ashurst Australia

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY

GENERAL DIVISION

NSD 287 of 2014
ON APPEAL FROM THE FEDERAL…
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Details
Case
[2014] FCAFC 59
Decision Date

CaseChat Overview and Summary

In the case of Warner-Lambert Company LLC v Apotex Pty Ltd, the appellants, members of the Pfizer group, sought an interlocutory injunction against the respondent, Apotex Pty Ltd, to prevent the alleged infringement of their patent for the use of pregabalin in the treatment of pain. The primary judge had previously refused the injunction, prompting the appeal. The central legal issues were whether the appellants had established a prima facie case for patent infringement and whether the balance of convenience favoured the grant of the injunction.

The court found that the primary judge had erred in his assessment of the existence and strength of the prima facie case, which influenced his decision on the balance of convenience. The court concluded that an interlocutory injunction should be granted, although not in the exact form requested by the appellants. The court examined the evidence, including expert testimony from Dr. Jackson, who highlighted the importance of the treatment indications and approved product information in determining the scope of the patent. The court also considered the respondent's proposed written directions to doctors and pharmacists, which were seen as significant in mitigating the risk of infringement. Ultimately, the court found that the appellants had established a prima facie case of threatened patent infringement, and the balance of convenience favoured the grant of the interlocutory injunction.

The final orders of the court included allowing the appeal, setting aside certain orders of the primary judge, and granting an interlocutory injunction against the respondent from supplying specific products containing pregabalin. The court also addressed the costs of the interlocutory application, the application for leave to appeal, and the appeal itself, ordering that these costs be borne by the appellants. The court provided a mechanism for parties to apply for a different costs order within specified timeframes.

Orders

Orders of the court

1. The appeal be allowed.

2. Orders 2 and 3 made by the primary judge on 14 March 2014 be set aside.

3. Until the determination of proceeding number NSD 763 of 2013 between the appellants and the respondent (the proceeding) or further order of a Judge of the Court, the respondent, whether by it servants, agents or otherwise, be restrained from supplying or offering to supply in Australia any of the following products:

(a) APOTEX-PREGABALIN pregabalin 300mg capsule blister pack (ARTG ID 193289);

(b) APOTEX-PREGABALIN pregabalin 150mg capsule blister pack (ARTG ID 193286);

(c) APOTEX-PREGABALIN pregabalin 75mg capsule blister pack (ARTG ID 193284);

(d) APOTEX-PREGABALIN pregabalin 25mg capsule blister pack (ARTG ID 193280);

(e) any other product containing pregabalin which is indicated for “adjunctive therapy in adults with partial seizures with or without secondary generalisation” (or any substantially similar indication) but is not indicated for the treatment of neuropathic pain (or any sub-category of neuropathic pain).

4. The costs of:

(a) the interlocutory application heard by the primary judge;

(b) the application for leave to appeal; and

(c) the appeal,

be the appellants’ costs in the proceeding.

5. Order 4 hereof be suspended for a period of 21 days.

6. Any party wishing to apply for a costs order different to order 4 hereof may file and serve a written submission (limited to 2 pages in length) within 7 days.

7. Any party wishing to reply to any such written submission is to file and serve a written submission in reply (limited to 2 pages in length) within 14 days.

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

Background

Background to the litigation

We consider that the primary judge erred in his assessment of the existence and strength of the prima facie case, which necessarily affected his assessment of the balance of convenience. We have therefore considered for ourselves whether the additional interlocutory relief sought by the appellants should be granted. For reasons which follow, we consider that there should be an interlocutory injunction although not in the precise form sought by the appellants. BACKGROUND The appellants are members of the Pfizer group of companies (the Pfizer group). The first appellant (Warner-Lambert Co) is the owner of the pain patent. The fifth appellant (Pfizer Australia), said to be Warner-Lambert’s exclusive licensee, markets and sells a pharmaceutical product called Lyrica™ (Lyrica) which contains pregabalin as its active ingredient. The primary judge accepted that Lyrica is one of the Pfizer group’s leading pharmaceutical products and its second biggest product by revenue in Australia. For convenience, unless it is necessary to distinguish between the two, we shall refer to Warner-Lambert Co and Pfizer Australia collectively as Warner-Lambert. Pfizer Inc, the ultimate parent of the Pfizer group, is a co-owner (with Northwestern University) of Australian Patent 677008 (the seizure patent) for (inter alia) the use of pregabalin in the treatment of seizures. The seizure patent is due to expire on 18 May 2018. Since 13 April 2005 Lyrica has been registered on the Australian Register of Therapeutic Goods (ARTG) for use for the treatment of neuropathic pain in adults (neuropathic pain indication) and as adjunctive therapy in adults with partial seizures with or without secondary generalisation (seizure indication). Pfizer Australia is the sponsor of each of those registrations. Given the scope of the ARTG registrations, Lyrica cannot be advertised for any other indication: see s 22(5) of Therapeutic Goods Act 1989 (Cth). Lyrica is manufactured and sold by Pfizer Australia in capsule form containing 25mg, 75mg, 150mg and 300mg dosages. Pfizer Australia promotes the sale of Lyrica in Australia for the neuropathic pain indication, but not for the seizure indication. On 19 September 2012 Apotex obtained ARTG registrations for various pharmaceutical products containing pregabalin as the active ingredient. These registrations were limited to the neuropathic pain indication and the seizure indication, and were obtained on the basis that the products are bioequivalent to Lyrica. The ARTG registrations obtained by Apotex were for products referred to as Apotex-Pregabalin (Apotex-Pregabalin) and various other products referred to as APO-Pregabalin, Terry White Chemists Pregabalin and ChemMart Pregabalin. The registrations for Apotex-Pregabalin include (but are not limited to) 25 mg, 75 mg, 150 mg and 300 mg capsules. The registrations for APO-Pregabalin, Terry White Chemists Pregabalin and ChemMart Pregabalin also include (but are not limited to) 25 mg, 75 mg, 150 mg and 300 mg capsules.

Evidence

Evidence Before The Court

The notice of appeal includes 12 grounds. Ground 1 asserts that the primary judge erred in concluding that there was no prima facie case or, alternatively, at best a weak case. Grounds 2-10 identify particular errors which the primary judge is said to have made that led to this conclusion. Grounds 11 and 12 are concerned with the balance of convenience. They assert:11.The primary judge erred in failing to find that the balance of convenience strongly favoured the grant of an injunction. The primary judge should have found:(a)that there was a strong prima·facie case;(b)that preservation of the status quo was appropriate;(c)that it was inappropriate for the Respondent to try to launch its product before successfully concluding its claim for revocation;(d)that the Applicants would suffer irreparable harm were an injunction not to be granted;(e)that the loss of sales to the Respondent as a result of an injunction would be insignificant and in any event quantifiable;(f)that the Respondent’s preparedness to submit to an injunction against supplying its “pain” product suggested the appropriateness of the further injunction sought; and(g)that the public interest favoured the grant of the injunction. 12.The primary judge erred in finding that Generic Partners Pty Ltd would be unable to enter the pregabalin market.Generic Partners Pty Ltd is, like Apotex, a supplier of generic medicines. THE EVIDENCE There was a large volume of evidence before the primary judge given by affidavit. There was no cross-examination. Having regard to the way in which the hearing before the primary judge developed (focusing on the non-PBS market for Lyrica) much of that evidence was of limited relevance. Some evidence of particular relevance to the primary judge’s ultimate conclusions is referred to below. Dr Jackson Dr Jackson is an experienced pharmacist who gave evidence for Warner-Lambert. He said he was well aware of Lyrica and that he had dispensed it frequently in the past. He said that in his experience medical practitioners (except those working in hospitals) mostly prescribed pregabalin using the brand name Lyrica and that the overwhelming majority of prescriptions for Lyrica are PBS prescriptions indicated for neuropathic pain. Dr Jackson said that he could not recall ever seeing a prescription for Lyrica for seizures. In his first affidavit Dr Jackson gave evidence that Schedule 4 medicines (which include pregabalin) can be prescribed for a non-ARTG registered indication (ie. “off-label”) so long as the prescription is made by a medical practitioner or any other health professional legally capable of making a prescription. He said that medical practitioners commonly rely on other sources of information and their own clinical experience when prescribing medicines for off-label uses. Dr Jackson also said:If a medical practitioner writes a prescription, whether PBS or non-PBS, for a particular pharmaceutical substance (whether or not a particular brand is specified), and the pharmacist is aware that there is an alternative brand of the same pharmaceutical substance registered on the TGA and available to the pharmacist, the pharmacist is entitled to supply that alternative brand. In doing so, the pharmacist would be expected to satisfy himself or herself that, as well as having the same active pharmaceutical ingredient, the medicine is the same dosage and that there is no evidence of a lack of bioequivalence to the prescribed brand. The active ingredient and dosage are recorded on the label and ordinarily also in the pharmacist's dispensing software. Pharmacists are regularly visited by representatives of generic suppliers who inform them when bioequivalent products are available, and most pharmacists also have dispensing software that specifically identifies bioequivalent products. It is a requirement under professional guidelines that patient consent is gained when generic substitution occurs.

Decision

Reasons for decision

The primary judge’s reasons are at Warner-Lambert Company LLC v Apotex Pty Ltd [2014] FCA 241 (the interlocutory judgment). Leave to appeal against the primary judge’s order refusing the interlocutory relief sought by the appellants was granted by order made on 9 April 2014. Although his Honour refused an interlocutory injunction in the terms sought, he did grant an interlocutory injunction (the pain injunction) restraining the respondent from (inter alia) supplying any product containing pregabalin which is indicated for the treatment of neuropathic pain in adults or any substantially similar indication with or without any other indication. This order was not opposed by the respondent and was in a form proposed by it and to which it was apparently willing to submit, subject, of course, to the appellants providing the usual undertaking as to damages. The primary judge was not satisfied that the appellants had demonstrated a prima facie case for the additional interlocutory relief they sought restraining the respondent from supplying any product containing pregabalin which is indicated for the treatment of seizures and that, even if they had, he considered that their case was at best a weak one. His Honour said that if he was wrong in concluding that the appellants had failed to establish a prima facie case or in holding that the case was at best weak, the balance of convenience in any event favoured the refusal of the application for the additional interlocutory relief. We consider that the primary judge erred in his assessment of the existence and strength of the prima facie case, which necessarily affected his assessment of the balance of convenience. We have therefore considered for ourselves whether the additional interlocutory relief sought by the appellants should be granted. For reasons which follow, we consider that there should be an interlocutory injunction although not in the precise form sought by the appellants. BACKGROUND The appellants are members of the Pfizer group of companies (the Pfizer group). The first appellant (Warner-Lambert Co) is the owner of the pain patent. The fifth appellant (Pfizer Australia), said to be Warner-Lambert’s exclusive licensee, markets and sells a pharmaceutical product called Lyrica™ (Lyrica) which contains pregabalin as its active ingredient. The primary judge accepted that Lyrica is one of the Pfizer group’s leading pharmaceutical products and its second biggest product by revenue in Australia. For convenience, unless it is necessary to distinguish between the two, we shall refer to Warner-Lambert Co and Pfizer Australia collectively as Warner-Lambert. Pfizer Inc, the ultimate parent of the Pfizer group, is a co-owner (with Northwestern University) of Australian Patent 677008 (the seizure patent) for (inter alia) the use of pregabalin in the treatment of seizures. The seizure patent is due to expire on 18 May 2018. Since 13 April 2005 Lyrica has been registered on the Australian Register of Therapeutic Goods (ARTG) for use for the treatment of neuropathic pain in adults (neuropathic pain indication) and as adjunctive therapy in adults with partial seizures with or without secondary generalisation (seizure indication). Pfizer Australia is the sponsor of each of those registrations. Given the scope of the ARTG registrations, Lyrica cannot be advertised for any other indication: see s 22(5) of Therapeutic Goods Act 1989 (Cth).

Ratio Decidendi

Legal Principle Established

Full text does not contain this section.