In Pfizer Canada ULC and Pfizer Inc. v. Uniqure Biopharma B.V., 2023 FC 629, the Federal Court denied uniQure’s motion to stay Pfizer’s impeachment action. uniQure had sought a stay until the Re-Examination Board issues a decision on uniQure’s request for re-examination of its own patent. The Federal Court determined that it would not be in the interests of justice to grant the stay.

Underlying Action

The underlying action concerns uniQure’s Canadian Patent No. 2,737,094, which claims a Factor IX protein for use in gene therapy to treat hemophilia B. The patent relates to uniQure’s HEMGENIX product.

Pfizer is seeking to impeach the patent. uniQure has defended and pleadings have closed. Trial will likely be scheduled to begin sometime in 2025.

uniQure’s Request for Examination

uniQure filed its re-examination request based on the claims of its patent as issued, then filed an amended claim set in reply to the Re-Examination Board’s first-stage determination of its request. The amended claims are narrower in some respects and, according to uniQure, potentially moot several of Pfizer’s inutility/overbreadth and unpatentable-subject-matter allegations. The timing of the re-examination request, filed one week after Pfizer commenced its claim, and well after uniQure had already narrowed its claims in other jurisdictions, was noted by the Court.

uniQure’s proposed stay would pause the action pending the determination of its re-examination request, which could be issued as late as April 14, 2024. 

The Motion for Stay

uniQure argued that the outcome of its patent re-examination request could change the claims and thus the scope of the impeachment action. The Federal Court disagreed, finding that the possible outcomes of the re-examination would not be a material enough to justify a stay.

The decision weighed numerous factors raised by the parties, but focused on the potential impact of the re-examination decision on the litigation. The Court noted that one of the possible outcomes was a rejection of the re-examination, in which case the claims would remain unchanged. Further, even if the Re-Examination Board were to amend the claims as requested by uniQure, the amendments would not be dispositive of the action. The crux of the purported invention would remain in the new claims and thus the allegations of anticipation and obviousness would be the same. In any event, the inventor’s course of conduct would remain relevant to the action.

As such, the Court found that the outcome of the re-examination would not materially effect the discovery steps that would take place while the re-examination is proceeding.

A Few Other Take-Aways

The decision commented on a few other important issues:

1. Conduct in other jurisdiction may be a relevant factor. The Court held uniQure to its apparent strategic choice of waiting to seek re-examination until litigation had commenced in Canada when it had sought re-examination earlier in other jurisdictions. According to the Court, uniQure “cannot now claim prejudice from circumstances created in part by its own doing”.
2. The Court was careful to distinguish the broad, discretionary interests-of-justice analysis for staying its own proceedings from the public-interest considerations that apply when deciding whether to enjoin another body’s proceedings, relying on the Federal Court of Appeal decision in Mylan Pharmaceuticals ULC v. AstraZeneca Canada Inc., 2011 FCA 312.
3. Re-making submissions previously made to Case Management Judges may lead to a “collateral attack” finding. In this case, uniQure had already argued in case management that allowing the action to proceed could lead to inconsistent positions. Faced with this argument, the Case Management Judge had already forced the action to proceed in any event.

A key take away for patentees who are seeking, or may have already sought, re-examination of their patents in other jurisdictions is that they should keep their Canadian patents in mind. Otherwise, patentees may find themselves in the difficult position of seeking re-examination and fighting an impeachment action all at the same time.