The Court of Appeal recently determined that the institution of proceedings under the “new” PM(NOC) Regulations, is not re-litigation or an abuse of process where the same issues were already considered in proceedings under the “old” PM(NOC) Regulations.
Amgen had previously unsuccessfully asserted the 537 patent against generic pharmaceutical manufacturer Apotex under the former Regulations. When Amgen later sued Apotex for infringement of the 537 patent under the Patent Act, the Court dismissed the application as redundant, scandalous, frivolous or vexatious or otherwise an abuse of process. See our post about a related decision here.
In 2018, Amgen launched an action against Pfizer under section 6(1) of the “new” Regulations for infringement of the 537 Patent in relation to Pfizer’s proposed filgrastim biosimilar. In light of the decision in the earlier Apotex application, Pfizer argued that it was abusive for Amgen to benefit from the 24-month stay of any NOC issuance afforded by the amended Regulations and to institute yet another proceeding in view of the Court’s previous decisions concerning the same patent.
In dismissing Pfizer’s motion, the Prothonotary highlighted the major procedural changes brought on by the 2017 amendments, which permit examinations for discovery and proffering of live evidence at trial. Under the old Regulations, validity and infringement issues were entirely decided based on a paper record and therefore could not be conclusively determined.
Court of Appeal
On appeal, Court of Appeal, citing Sanofi, considered whether an attempt to re-litigate a claim already determined by the Court is made, and the negative impact allowing re-litigation would have on judicial economy, consistency and finality of decisions, and on the integrity of the administration of justice. Since the purpose under the former Regulations was simply to determine the narrow question of whether the Minister should be prohibited from issuing a NOC, the Court of Appeal concluded that institution of proceedings under the amended Regulations or Patent Act, in the face of determinations made under the previous Regulations, cannot constitute re-litigation or abuse of process within the meaning of Sanofi.
The Court of Appeal, however, did not close the door on Pfizer eventually arguing estoppel based on the Apotex litigation holding “it remains open to it to raise issue estoppel and abuse of process once Amgen’s action goes to trial.
The decision of the Court of Appeal can be found here.