Warner-Lambert Company LLC v Apotex Pty Ltd [2014] FCAFC 59 (available here)

The Full Federal Court earlier this week allowed an appeal by Warner-Lambert Company LLC and the Pfizer group (together, Pfizer) to broaden the scope of an existing interlocutory injunction restraining Apotex Pty Ltd’s supply of pregabalin products in Australia.

The factual context of this decision indicates to the industry that there is now very little scope for successfully defeating an interlocutory injunction brought by pharmaceutical patent owners even in relation to products "skinny-labelled" for a non-patented indication.

Pfizer supplies pregabalin in Australia under the brand name Lyrica. Lyrica is Pfizer’s second biggest product by revenue, and is registered on the Australian Register of Therapeutic Goods (ARTG) 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). Lyrica was listed on the Schedule of Pharmaceutical Benefits (PBS) for neuropathic pain in circumstances where the condition is refractory to treatment with other drugs.

Apotex filed invalidity proceedings on 8 May last year seeking to revoke Pfizer’s Australian Patents 677008 (the seizure patent) and 714980 (the pain patent). The pain patent relates to methods of use of pregabalin and related compounds in the treatment of pain including, but not limited to, neuropathic pain. The challenge to the validity of the seizure patent has been resolved by consent on confidential terms.

Pfizer launched the interlocutory injunction proceedings having received notification that Apotex was preparing to launch its generic of Lyrica, Apotex Pregabalin. Apotex Pregabalin’s ARTG registration was limited to ‘adjunctive therapy in adults with partial seizures with or without secondary generalisation’ and not the pain indication.

Importantly, Apotex had already consented to an injunction in respect of neuropathic pain in adults, ‘or any substantially similar indication’. Further, it had previously given an undertaking not to supply pregabalin to hospitals until the determination of the infringement proceedings (being a substantial market for the pain indication, and where evidence showed doctors prescribe by the generic name ‘pregabalin’ rather than the product name, Lyrica). It had also informed Pfizer that it would not apply to list for neuropathic pain on the PBS, thereby removing the threat of a mandatory price drop in the reimbursed price for Lyrica under the PBS (which occurs when the first generic lists for a PBS reimbursed indication).

However, there remained a dispute in respect of the potential for off-label generic substitution by pharmacists when filling prescriptions for Lyrica. Pfizer argued under the contributory infringement provisions of the Patents Act that any such substitution would amount to an infringement of the pain patent. Pfizer submitted that as the seizure market for pregabalin is ‘practically non-existent’, Apotex should be taken to have reason to believe that pharmacists would supply Apotex Pregabalin to patients for pain relief, thereby infringing the pain patent.

At first instance (available here), Justice Griffiths was not satisfied that Pfizer had demonstrated a prima facie case for the additional interlocutory relief it sought. Second, His Honour held the balance of convenience favoured the refusal of the application for additional interlocutory relief.

Justice Griffiths placed weight on the fact that Pfizer had made its own unsuccessful attempt to have Lyrica listed on the PBS for the seizure indication in 2005 (evidencing that there was in fact a market for the seizure indication) and Apotex’s own commercial forecasting for Apotex Pregabalin. His Honour also noted evidence filed by Apotex on behalf of the Terry White pharmacy chain in relation to the unlikelihood of ‘off label’ dispensing.

The Full Court accepted Pfizer’s submissions that the primary judge had conducted ‘a preliminary trial of the proceeding’ at least in so far as His Honour rejected evidence filed by Pfizer on these key issues in favour of Apotex’s evidence.

In addition to other factual disputes, the Full Court held that whether or not Apotex had the requisite ‘reason to believe’ that pharmacists would be likely to substitute Apotex Pregabalin for Lyrica prescriptions in respect of neuropathic pain relief was not something that could be resolved before trial.

In relation to balance of convenience, the Full Court supported Pfizer’s application for additional interlocutory relief, giving considerable weight to the fact that it enjoyed a well established market for pregabalin for the treatment of pain which Apotex was threatening to disrupt.

The matter has been consolidated with the revocation proceedings, and listed for final determination in October this year.

This decision evidences an increasing trend from the Federal Court to grant interlocutory injunctions in favour of pharmaceutical patent owners, with the trade off of the subsequent infringement case receiving an early trial. Indeed, it is becoming difficult to see any circumstance of the threatened launch of a generic pharmaceutical in which a Court would decline to order an interlocutory injunction pending trial.