In brief

In Biogen International GmbH v Pharmacor Pty Ltd [2021] FCA 1591, Pharmacor successfully resisted an interlocutory injunction sought by Biogen in circumstances where Biogen, as the moving party, was unable to demonstrate a sufficiently strong prima facie case of infringement because of a questionable term extension. This decision also highlights the Court’s reluctance to grant an interlocutory injunction in circumstances where the patentee intends to change the status quo by launching a new product which would affect the relevant market.

Background

Biogen sought urgent interlocutory orders to restrain Pharmacor from listing its generic dimethyl fumarate (DMF) products on the Pharmaceutical Benefits Scheme and launching it in Australia. Biogen alleged that Pharmacor would infringe Biogen’s patent relating to its DMF product, TECFIDERA. In response, Pharmacor cross-claimed alleging invalidity and asserted that the term extension for the patent was wrongly granted and should be removed.

Under Australian law, a party seeking an interlocutory injunction must show that in light of the strength of the prima facie case of infringement, the balance of convenience and justice warrants the grant of injunctive relief pending final hearing.

Prima facie case

Pharmacor admitted for the purposes of the interlocutory hearing that its products fell within a number of the asserted claims of the patent. However, her Honour agreed that Pharmacor’s challenge to the term extension was sufficiently strong, at a provisional level, to qualify the conclusion that Biogen had a prima facie case of infringement.

Biogen’s extension of term application was based on claims in the “EPC 2000” form of “substance X for use in the treatment of disease Y”. Justice Rofe found that these claims were purpose limited product claims, not claims to a pharmaceutical substance per se, as required for a patent term extension. As the patent would have expired (and hence could not now be infringed) but for the term extension, her Honour concluded that Biogen had not established a prima facie case of infringement.

Balance of convenience

Turning to the balance of convenience, her Honour considered, for the most part, that the factors were evenly balanced. In respect of damages, the calculation of loss for either party was of comparable complexity such that it was not possible, at the provisional level, to determine which damages calculation exercise would be more complex. However, one factor which weighed against the grant of the injunction was Biogen’s intention to launch its VUMERITY (diroximel fumarate) product, which it markets in the USA as superior to TECFIDERA. Her Honour considered this would have a profound effect on the DMF market in Australia which could significantly diminish the market in which Pharmacor could compete.

Decision

Having regard to the weakness of Biogen’s prima facie case and the balance of convenience, her Honour declined to grant the interlocutory injunction sought by Biogen. The validity of the term extension has yet to be determined at a final hearing, but it seems clear that if the case proceeds to a final hearing the court will hold that, like Swiss-style claims, claims in EPC 2000 form are not eligible for term extension in Australia.

Key lessons

• A patentee seeking interim injunctive relief must establish, at a provisional level, a sufficiently strong prima facie case of infringement.
• Generic companies seeking to resist an interim injunction must be able to establish a sufficiently strong invalidity case, at the provisional level, to qualify the patentee’s case on infringement.
  
• The Federal Court has expressed a preliminary view that claims of the kind “substance X for use in the treatment of disease Y” are purpose limited product claims and, therefore, are not product claims for a pharmaceutical substance per se as required for a patent term extension.