Monday, June 12, 2023

Stay Pending Re-Examination Denied

Pfizer Canada ULC and Pfizer inc v uniQure BioPharma BV 2023 FC 629 Furlanetto J

2,737,094 / Modified Factor IX Polypeptide / HEMGENIX

Pfizer has a product that has undergone a Phase 3 clinical trial that would arguably infringe uniQure’s 094 patent. Pfizer therefore brought an action last fall challenging the validity of several key claims [5]. Shortly thereafter, uniQure filed a request for re-examination pursuant to s 48.1, allegedly in response to new prior art that was brought to uniQure’s attention during foreign proceedings involving Pfizer [10].

In this motion, uniQure sought a stay of Pfizer's impeachment action pending the outcome of the re-examination. There is no statutory bar to impeaching a patent that is under re-examination [42], so the decision to stay is discretionary, guided by the aim of “securing the just, most expeditious, and least expensive determination of the proceeding on its merits,” without unfairly prejudicing one of the parties [19]. In the result, Furlanetto J refused to stay the impeachment action, essentially because the outcome of the re-examination would not sufficiently simplify the impeachment proceeding to warrant a lengthy stay of up to a year.

The crux of uniQure’s argument was that the claims would likely change as a result of re-examination and it would be pointless to litigate claims that would no longer be in effect [21]. The Re-examination Board might cancel the existing claims or it might accept some or all of the amended claims proposed by uniQure. Moreover, uniQure undertook to not to defend the existing claims if the Board accepted any of its proposed claims [14].

However, uniQure acknowledged that the crux of the invention remained the same under the proposed claims [25]. Consequently, the attacks based on anticipation, obviousness and misrepresentation under section 53 would remain largely unaffected [25], [40]. The amendments certainly would not dispose of the litigation [25].

The arguments based on utility / overbreadth and patentable subject-matter might or might not be affected, depending on whether the Board accepted uniQure’s proposed claims and if so, which ones [25]–[27]. While uniQure argued that documentary discovery would be narrowed without the issues of utility and claim breadth [28], Furlanetto J found that discovery would not be significantly narrowed because the documents are issue were probably relevant to other issues put in play by the pleadings [29]-[32]. (This is aside from the question of whether the Board would adopt the proposed claims.)

Further, Furlanetto J pointed out that

[38] uniQure was and has always been free to choose its own litigation strategy. It was uniQure’s choice to wait to seek re-examination in Canada despite narrowing its claims elsewhere well in advance of the initiation of the Action. It cannot now claim prejudice from circumstances created in part by its own doing. There is also nothing preventing uniQure from making formal admissions in the Action to limit what it perceives as unnecessary areas of inquiry for discovery in view of positions it has taken in the re-examination.

Furlanetto J also found that uniQure would not be unfairly prejudiced if the action went ahead [25]–[37]. The wait for re-examination could be up to a year, and re-examination would have to have an impact that was “not. . . tenuous” to justify a stay of such length [41]. Consequently, Furlanetto J dismissed uniQure’s motion for a stay.

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