On 19 May 2014, the Full Federal Court issued a decision in Warner-Lambert Company LLC v Apotex Pty Ltd [2014] FCAFC 59. This case reinforces the dominant position of a pharmaceutical patentee when seeking interlocutory protection.

The case concerns an application by Warner-Lambert for an interlocutory injunction to stop Apotex from supplying the drug pregabalin in Australia. Warner-Lambert had to establish a prima facie case that the supply of pregabalin in Australia would constitute infringement by supply of Australian Patent No. 714980 under section 117 of the Patents Act 1990, and that the balance of convenience lay in granting the injunction.

Pregabalin is marketed by Pfizer Australia (under license from Warner-Lambert) under the brand name LyricaTM. It was registered on the Australian Register of Therapeutic Goods (ARTG) for the treatment of neuropathic pain in adults and as an adjunctive therapy in adults with partial seizures. AU714980 related specifically to the treatment of pain, claim 1 reading:

“A method of treating pain comprising administering a therapeutically effective amount of [pregabalin] to a mammal in need of said treatment.”

Apotex had limited the ARTG registration for their bioequivalent drug (Apotex-pregabalin) to the treatment of seizures and proposed sending all medical practitioners and pharmacists in Australia promotional material emphasising that the Apotex-pregabalin was not indicated for the treatment of neuropathic pain. They also gave an undertaking not to supply Apotex-pregabalin in hospitals and would not apply to list Apotex-pregabalin on the Pharmaceutical Benefits Scheme for neuropathic pain.

The primary judge granted an interlocutory injunction restraining Apotex from supplying any product containing pregabalin for the purposes treating neuropathic pain. However, a general injunction on the supply of pregabalin was not granted: Warner-Lambert Company LLC v Apotex Pty Ltd [2014] FCA 241, on the basis that Warner-Lambert had not established a prima facie case, or, if they had, the case was so weak as to weigh against them in the balance of convenience test. The primary judge considered that the promotional materials described above were significant.

Warner-Lambert appealed arguing that, notwithstanding the measures taken by Apotex, a doctor or pharmacist would still prescribe Apotex-pregabalin for the treatment of neuropathic pain, and that in this circumstance there was a prima facie case that infringement under section 117 would occur.

Section 117 of the Patents Act 1990 states:

“(1) If the use of a product by a person would infringe a patent, the supply of that product by one person to another is an infringement of the patent by the supplier unless the supplier is the patentee or licensee of the patent.

(2) A reference in subsection (1) to the use of a product by a person is a reference to:

(a) if the product is capable of only one reasonable use, having regard to its nature or design--that use; or

(b) if the product is not a staple commercial product--any use of the product, if the supplier had reason to believe that the person would put it to that use; or

(c) in any case--the use of the product in accordance with any instructions for the use of the product, or any inducement to use the product, given to the person by the supplier or contained in an advertisement published by or with the authority of the supplier.”

Warner-Lambert did not attempt to allege infringement under s117(2)(a) or (c). Thus, the question was whether there was a prima facie case that Apotex had “reason to believe” that Apotex-pregabalin would be used to treat neuropathic pain.

The Full Federal Court held that Warner-Lambert has established, at least on a prima facie basis that the seizure market was small and that pregabalin was used for a wide variety of pain states (not just neuropathic pain). They were not convinced that the Apotex evidence established that “off-label” prescribing for other indications (such as depression, anxiety and bipolar disorders) occurred on any significant scale.

In relation to the issue of the Apotex promotional materials, the Full Court held that whether Apotex had reason to believe that Apotex-pregabalin would be used for pain was a question of fact. Warner-Lambert had provided evidence that pharmacists would not be deterred by these materials from substituting Apotex-pregabalin based on the knowledge of bioequivalence. The Full Federal Court disagreed with the primary judge that this evidence was “unsupported by any evidence and is based on mere speculation and assertion” and considered that there was a true conflict of evidence which could not be resolved before trial.

In light of the above, the Full Federal Court held that Warner-Lambert had made out aprima facie case that Apotex would have reason to believe that Apotex-pregabalin would be used for the treatment of pain.

In relation to the balance of conveniences, the Full Federal Court gave significance to the following factors:

  • The introduction of Apotex-pregabalin threatened to disrupt Pfizer Australia’s (the Warner-Lambert licensee) well established market for the treatment of pain.
  • There was no evidence that the pain patent might be invalid.
  • Apotex had stated (e.g. in their promotional materials) that they only wished to supply Apotex-pregabalin for the seizure indication. On the basis that this market is small, the damage to Apotex in being kept out of the market would be relatively small.
  • In contrast, if Apotex-pregabalin were to be introduced and was used as a substituted for Lyrica, then this could result in a substantial reduction in sales.
  • Pfizer Australia could also be forced to reduce prices as a result of the introduction of Apotex-pregabalin resulting in further damage. It was significant that “If a permanent injunction is granted against Apotex following the final hearing, then it may be extremely difficult for Pfizer Australia to increase its prices back to their existing levels.”
  • Apotex had given an undertaking to not supply pregabalin in the hospital market and had thus demonstrated a willingness to “stay its hand”.
  • The full revocation and infringement proceedings had been set down for October 2014, meaning the period of any injunction was likely to be relatively short.

Not surprisingly, when looking at these factors together, the Full Federal Court felt that the balance of convenience favoured extending the interlocutory injunction to encompass all supply of pregabalin.

The Full Federal Court’s judgement illustrates how difficult it is for a pharmaceutical manufacturer to avoid an interlocutory injunction when attempting to introduce a generic substitute into the Australian market, particularly where the date for substantive proceedings has been set and the period of any injunction is likely to be short.

An interesting aspect is the contrast between the Full Federal Court’s position in considering the interlocutory injunction and the decision of the High Court of Australia inApotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd[2013] HCA 50 in relation to a permanent injunction reported here.

It was widely assumed as a result of the High Court decision that ARTG registration for indications other than that covered by the patent would avoid contributory infringement under section 117(b). However, the Full Federal Court’s decision makes it clear that whether there is “reason to believe” is a question of fact and that merely having an ARTG registration (and promotional literature) which excludes the patented subject matter may not be determinative of infringement. Of course the Full Federal Court was only concerned with whether there was a prima facie case of infringement and so it remains to be considered whether infringement under section 117(b) is established in light of substantive consideration of the evidence.