Federal Court expedites another pharma patent trial

Background

Celgene Corporation (Celgene) markets lenalidomide for a number of blood cancers including multiple myeloma.

Juno Pharmaceuticals Pty Ltd and Natco Pharma Ltd¹ (collectively, Juno) filed revocation proceedings in respect of certain claims of Celgene’s Australian Patent 715779 to various compounds including lenalidomide (Compound Patent). Celgene filed a cross-claim for infringement not only of the Compound Patent, but of seven additional patents directed to the marketed indications and other methods of treatment (MOT Patents). The earliest of the MOT Patents was due to expire in April 2023, the latest in August 2027.

Juno applied to strike out the cross-claim in respect of the MOT Patents, and to schedule an expedited trial in respect of the Compound Patent. At the time of the decision, the Compound Patent term had slightly more than 16 months left to run before expiry on 24 July 2022.

Key Issues

Beach J considered the competing efficiencies of expedition in light of the cross-claim engaging seven additional patents. First, Beach J considered whether the inventive step issues in respect of the Compound Patent and the MOT Patents might overlap. He determined that they would not, given the different nature of the inventions, and the fact that six years had elapsed between the priority date of the Compound Patent and the earliest MOT Patent.

Second, he considered arguments by Celgene that, even if the Court found the relevant claims of the Compound Patent to be invalid, it would not be possible for Juno to take advantage of that decision by launching its generic product before 24 July 2022 without infringing at least one of the MOT Patents.

Marketing a generic pharmaceutical product requires prior approval by the Australian Therapeutic Goods Administration (TGA). Furthermore, many pharmaceutical products are not commercially viable unless they are listed on the PBS, thereby making them available to the public at a government- subsidised price. A generic product can only be granted TGA approval and PBS listing for indications already approved for the reference product (in this case Celgene’s product). Celgene asserted that each of the on-label lenalidomide indications fell within the scope of at least one MOT Patent, so that removing one or more indication from the Juno product leaflet (and marketing the Juno product in accordance with that leaflet) could not avoid infringement entirely.

Secondly, his Honour considered Juno’s application to strike out parts of Celgene’s cross-claim. He rejected Juno’s strike out application because, while Juno could not launch without TGA approval, it was clear from the expedition application that it did intend to launch before expiry of the Compound Patent. Whilst Beach J considered the Celgene cross-claim to be “in some respects hypothetical”, it was “not sufficiently hypothetical to warrant summary disposition”. He noted that for the purposes of the strike out application before him he only needed to consider whether the parts of the cross-claim in question gave rise to a reasonable cause of action on their face. This contrasts with a summary dismissal application, which may require a determination that a party has no reasonable prospect of success.

Outcome

Beach J granted Juno’s application for an expedited trial on the Compound Patent, with the infringement claim on the later expiring MOT Patents to be dealt with on a different schedule. To Celgene’s argument that Juno should clear the way on all patents at the same time, his Honour pointed to the impracticality of doing this on an expedited basis, which would result in a lost opportunity for Juno to challenge the Compound Patent. In doing so, his Honour explicitly acknowledged that Juno’s objective ‘may not be fully met’ even if successful with respect to the Compound Patent.

In the decision, his Honour indicated his intention to deliver judgment within one month of the expedited trial, “all being well”.

Implications

The Federal Court is increasingly mindful of the commercial practicalities surrounding the timing of generic pharmaceutical launches, and the impact of regulatory frameworks affecting pharmaceutical approvals and reimbursement on the market. We observe a willingness by judges within the Court’s IP practice area to expedite proceedings where appropriate, particularly in the pharmaceutical patent sphere.  We consider this good news for litigants in general, and a positive sign of improvement to Australia’s reputation for patent litigation. Of course, the quid pro quo for expedition is compressed timeframes, particularly in the evidentiary stages. Strategic planning, well before litigation is commenced, can be essential in making the most of the expedited timeframe and meeting the expectations of the Court.

1. Pearce IP acted for Juno and Natco in this matter.