Pharmacia’s Dynastat patent expires before injunction ordered; but validity challenge means section 19 certification is still issued

by , | Apr 20, 2022

We recently reported on the decision in Pharmacia LLC v Juno Pharmaceuticals Pty Ltd [2022] FCA 92 in which the Federal Court found certain batches of Juno’s generic parecoxib products fell within the claims of Pharmacia’s patent.  The Court has now handed down its decision as to the form of orders to give effect to those earlier reasons.  While much of the decision relates to the specific facts of this case, the issue of a certification pursuant to section 19 of the of the Patents Act 1990 (Cth) (Act) is a timely reminder of potential cost implications for any entity involved in litigation on a patent that has previously been the subject of proceedings.

Consideration of declaration of infringement, injunction, costs

While the Court made declarations that certain batches of product considered during the trial fell within the scope of the patent, contrary to Pharmacia’s submissions no declaration of infringement was made.  Orders as to costs were deferred until after the quantum of any damages is dealt with.

As to the question of an injunction, although in the earlier decision Justice Burley had found that Pharmacia would be prima facie entitled to an injunction if there was infringement, notwithstanding the imminent patent expiry, by the time of this later decision, the patent had in fact expired, rendering an injunction futile, and so no injunction was granted.

Section 19 certification

Although it was not discussed in the reasons, the Court followed its usual practice of issuing a certification for the purposes of section 19 of the Act, that is, that the validity of certain claims of the patent were questioned unsuccessfully in the proceedings.  The consequence of such a certification is that in specified subsequent proceedings relating to these patent claims, the patentee will be entitled to ‘solicitor client’ costs (which will be higher than the ‘party party’ costs usually ordered) if successful.  While the issue is moot here given the expiry of the patent, patent challengers should be mindful of previous unsuccessful attacks on the same patent claims for this reason.  Moreover, given that the wording of section 19 arguably also covers infringement proceedings without a cross-claim for revocation, all generic pharmaceutical suppliers launching during a patent term would be well advised to check the existing litigation landscape on such patents.

Naomi Pearce

Naomi Pearce

Executive Lawyer, Patent Attorney & Trade Mark Attorney

Naomi is recognised as one of Australia’s leading patent lawyers in virtually every notable legal guide and directory.  Naomi is also Lawyers Weekly Women in Law Partner of the Year (SME Law) for 2021, and the Founding Principal of Pearce IP, which was recognised as the IP Team of the Year in the Australian Law Awards in December 2021.

Underpinning Naomi’s legal work is a deep understanding of the pharma/biopharma industries, resulting from 25 years’ experience including as VP of IP in-house at global pharma giants, Partner of a top-tier international law firm, and as the founding Principal of Pearce IP.

Kate Legge

Kate Legge

Special Counsel, Lawyer

Kate is an experienced IP and patent lawyer, providing IP leadership for pharmaceutical product development and commercialisation in global markets – from initial scoping through to post-launch.

She has developed and implemented global IP strategies over more than 15 years at multi-national pharmaceutical companies. She is an Australian qualified and registered legal practitioner, and has a Master’s degree in IP Law and a BSc in biochemistry.

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