PTE Alert - interlocutory injunction refused in Tecfidera® dispute

Australia’s PTE system – the basics

Australia’s PTE scheme offers extensions of term of up to five years on patents that cover approved pharmaceutical substances. In order to be eligible for a PTE, the patent must disclose and claim one or more pharmaceutical substances per se, or disclose and claim one or more pharmaceutical substances produced by a process that involves the use of recombinant DNA technology. Additionally, at least one of these substances must be listed on the Australian Register of Therapeutic Goods (ARTG). Importantly, the PTE application must be based on the ‘first regulatory approval date’ of a relevant pharmaceutical substance, and at least five years must have elapsed between the effective filing date of the patent application and this first regulatory approval date.

Biogen International GmbH & Anor v Pharmacor Pty Limited

Biogen commenced infringement proceedings against Pharmacor on 5 August 2021, alleging that Pharmacor’s recently approved dimethyl fumarate products infringed Australian Patent No. 2000011572 ‘Utilisation of dialkylfumarates’. The ’572 patent received a PTE in 2014 which extended the term of the patent by 5 years to 29 October 2024. On 20 September 2021, Pharmacor cross-claimed in the proceeding, challenging the validity of a number of claims of the patent, and the validity of the PTE.

Biogen sought an interlocutory injunction preventing Pharmacor’s entry to the market pending conclusion of the litigation. That application was heard at the end of October and required an initial assessment by the Court of the strength of Pharmacor’s defence to infringement based on invalidity of the patent and the PTE.

Pharmacor’s PTE challenge raised an issue until now undecided in the Australian Courts – the scope and construction of an “EPC 2000” claim. This is a claim format specifically introduced into the European Patent Convention 2000 in 2007, allowing purpose limited product claims in the form “[product x] for use in the treatment of [disease y]”. Until now the Patents Office has treated EPC 2000 claims as covering a product suitable for the specified treatment, meaning that the purpose is not limited, and exposing the claim to validity challenges based on prior disclosures of the relevant product. At the interlocutory injunction hearing, Pharmacor argued that correctly construed, an EPC 2000 claim is limited by the stated purpose. As such, it is not a claim to a pharmaceutical substance per se, and so cannot provide the basis for a PTE. In the event the claims were construed more broadly Pharmacor pursued an alternative novelty case. Pharmacor also argued that the claim was not to a pharmaceutical substance per se because the claims were to a pharmaceutical preparation in the form of microtablets or micropellets.

In her first substantive patent judgment, Justice Rofe refused the interlocutory injunction application. The judgment was not published pending an opportunity for the parties to seek suppression of any confidential information in it. As such, we do not yet know the Court’s findings on the above issues. The reasons for judgment will be published on 23 December 2021, and will no doubt contain important lessons for patent litigators and prosecutors alike.

However at a more general level, Pharmacor’s successful resistance of an interlocutory injunction seems to at least widen the hole in what has been a largely impenetrable interlocutory injunction net for generics to date. In recent years, Courts hearing such applications have placed increasing emphasis on the strength (or lack thereof) of the infringement case when viewed in the context of the invalidity arguments. We assume that the strength of Pharmacor’s invalidity arguments was a key factor for the Court in this case too. Additionally, recent damages inquiry cases have highlighted the difficulties in establishing and quantifying the damage to a generic if an injunction is wrongly granted, with several judges sounding warnings to this effect in interlocutory injunction contexts. It may be that Rofe J’s judgment in this case indicates a further application of these principles to limit cases in which interlocutory injunctions will be granted in pharmaceutical cases.

Pearce IP will publish a summary with key takeaways from the judgment next week.

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the pharmaceutical, biopharmaceutical and life sciences industries.