On April 26, 2021, the Federal Court granted Teva’s motion for a stay of the re-examination proceeding commenced by Pharmascience in respect of Canadian Patent No. 2,760,802 (802 patent) relating to glatiramer acetate (Teva’s COPAXONE and Pharmascience’s GLATECT): Teva Canada Innovation v Pharmascience, 2021 FC 367.
As previously reported, the Federal Court found the 802 patent valid and infringed in an action by Teva pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations against Pharmascience (the PMNOC Judgment). Pharmascience appealed and the appeal remains pending.
In September 2019, while the PMNOC action was ongoing, Pharmascience requested that the Commissioner of Patents re-examine the 802 patent. Re-examination of a patent is governed by sections 48.1-48.5 of the Patent Act. A re-examination proceeding is commenced if, following the filing of a request, a re-examination board determines that “a substantial new question of patentability” is raised.
Prior to the PMNOC Judgment, the Re-Examination Board (Board) issued a preliminary opinion that the claims of the 802 patent were invalid. Following the PMNOC Judgment, the Board issued a further preliminary opinion relying on Federal Court jurisprudence stating “that validity is to be determined based solely on the jurisprudence and the evidence”, without considering or being bound by the outcome of separate proceedings. The Board reiterated that the 802 patent claims and now the patentee’s proposed new claims were invalid. Teva filed the present motion for a stay of the re-examination proceeding which was required to be completed by May 29, 2021 until exhaustion of any appeals of the PMNOC Judgment. The Attorney General, on behalf of the Board, was added as a third party and consented to the motion.
The Court granted the stay until discontinuance, settlement, or conclusion of any appeal of the PMNOC Judgment, finding that Teva satisfied the three-part test as follows.
- Serious issue to be tried: The PMNOC Judgment supported the conclusion that Teva’s position on the merits is not frivolous or vexatious.
- Irreparable harm: The Court found that “subjecting Teva to duplicative litigation on the same issue, with the associated risk of inconsistent decisions”, and specifically the issuance of a re-examination decision prior to a final appellate decision, gives rise to irreparable harm. The Board’s preliminary opinions support the likelihood of an inconsistent result but this risk will be mitigated by the availability of the final appellate decision; until then, the Board faces a “moving target” and Teva and the patentee will not have the final decision in arguing issue estoppel and similar principles before the Board.
- Balance of convenience: The Court found that this factor favours granting the stay in view of the non-speculative harm to Teva described above and the public interest in avoiding inconsistent results. While the stay may delay the marketing of the Pharmascience product, that was only one possible outcome involving “a significant amount of speculation”.
The Court dismissed the request of the Attorney General to direct the Board to consider the application of issue estoppel and similar principles upon expiry of the stay. The Court concluded that the issue is already before the Board and should not be addressed by the Court “until it has a mandate to do so”, i.e. on appeal of the Board’s decision.
Pharmascience has not appealed.
Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.
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