2021 Year In Review & 2022 Trends To Watch: Pharmaceutical Patents

• Published date: 10 January 2022
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Biotechnology & Nanotechnology
• Law Firm: Lenczner Slaght LLP
• Author: Ms Jordana Sanft

In 2021, the Canadian pharmaceutical and life sciences industries were once again at the forefront of innovation, developing and commercializing new vaccines, drugs, and medical devices. The media continued to shine a light on the advances made to protect the public from COVID-19, including regulatory approvals for new mRNA and adenovirus vector vaccines. In the pharmaceutical patent litigation arena in particular, we saw some new trends develop. There were important developments in proceedings relating to pharmaceutical patents, advances in cases and legislative developments relating to the Patented Medicine Prices Review Board ("PMPRB") as well as judicial review applications and appeals in patent-related fields.

In this blog, we recap the top developments in the pharmaceutical patent space in Canada from 2021 and identify trends to watch for in 2022.

1. PMPRB

One of the biggest trends in 2021 was the focus on drug prices in Canada and the PMPRB. Not only were there important developments before the courts relating to excessive pricing and challenges to amendments to the PMPRB Regulations and PMPRB Guidelines, but there were also updates to legislative changes.

Alexion Pharmaceuticals Inc v Canada (Attorney General), 2021 FCA 157

In July 2021, the Federal Court of Appeal ("FCA") held that the PMPRB's decision regarding the alleged excessive pricing of the drug SOLARIS was unreasonable. The FCA reversed the finding of the Federal Court and granted Alexion's application for judicial review. The FCA held that the PMPRB's mandate is to control patent abuse, not regulate reasonable pricing. The FCA remitted the matter back to the PMPRB for redetermination. Alexion was awarded its costs on the appeal and below. On September 29, 2021, the Attorney General of Canada sought leave to appeal to the Supreme Court of Canada. Whether the SCC will grant leave is something to watch for in 2022.

Merck et al c Le Procurer General du Canada, 2020 QCCS 4541

In December 2020, the Quebec Superior Court held that two recent amendments to the PMPRB Regulations are unconstitutional and of no force and effect. The impugned amendments relate to ss. 4(4)a) and 4(4)b), which require patentees to account for discounts and rebates provided to third parties when reporting to the PMPRB. The Court held that the other amendments and the rest of the PMPRB Regulations were constitutionally valid. An appeal was filed to the Quebec Court of Appeal in January 2021. In December 2021 oral...