Pregabalin – Australia

On Feb 15, 2017,  Judge Nicholas J of Australian Federal Court has delivered decision in Apotex Pty Ltd v Warner-Lambert Company LLC (No 3) [2017] FCA 94 for the drug Lyrica ® (Pregabalin). The Australian Federal Court held that applying for Pharmaceutical Benefits Scheme (PBS) listing does not exploit a patent and it is not an infringement.

In October 2016, the Federal Court upheld the validity of all the claims of Patent No. 714980 (set to expire on Jul 16, 2017) in a challenge brought by Apotex Pty Ltd. The claims are directed to methods of treating pain using compounds including pregabalin.  The present judgement considers, amongst other matters, the form of injunctive relief to which Pfizer is entitled. Pfizer submitted that applying for PBS listing constitutes an infringement of the patent and sought an injunction to prevent Apotex from doing so before the expiry of the patent.

In this case, Apotex proposed to take steps during the patent term to apply for PBS listing for its generic pregabalin products, so that it was in a position to commence offering them for sale at subsidised prices under the PBS scheme once the patent expired.

Justice Nicholas characterized an application for PBS listing as a ‘mere preparatory step’ which may enable a generic supplier to exploit the invention after the expiry of the patent, without amounting to an ‘offer’ to sell or dispose of its products. Justice Nicholas also indicated that other preparatory steps taken by a generic supplier in anticipation of launch would not infringe a patent. Justice Nicholas accepted that an offer for sale during the patent term could amount to an act of exploitation even though the products would not be supplied until after patent expiry, and also noted that the word ‘offer’ should be construed broadly such that it could encompass an expression of a willingness to sell.