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Bristol-Myers Squibb and Pfizer succeed in high-stakes patent battle involving its blockbuster ELIQUIS® medicine against generic challengers

Date Closed

July 12, 2022

Lead Office

Toronto

On January 12, 2021, Justice Zinn of Canada's Federal Court released a decision in PM(NOC) litigation between patent owners Bristol-Myers Squibb Company (BMS) and Pfizer, and generics challengers Sandoz and Pharmascience Canada Ltd. The victory protects BMS’s/Pfizer’s ELIQUIS® market until 2031.

The case concerned a blockbuster anticoagulant drug jointly owned by BMS/Pfizer called ELIQUIS® (apixaban). Since its introduction to the market, ELIQUIS® has revolutionized the treatment of thromboembolic disorders and helped millions of patients worldwide. It is the fourth largest selling drug in the world, with global sales of almost US$9 billion in 2020 alone -- Canadian sales are C$500 million per year. ELIQUIS® is one of BMS’s most valuable medicines and a critical component of its business.

BMS/Pfizer have two patents that protect ELIQUIS®. One expires in June 2022 and one expires in February 2031.

Numerous generic manufacturers have challenged the ELIQUIS® patents under the new Patented Medicines Notice of Compliance Regulations.

The 3-week trial involving generic challengers Sandoz and Pharmascience was heard in September and October 2020 via ZOOM. Witnesses appeared by video from various locations across Canada, USA, and Europe.

Justice Zinn (Federal Court) found both patents valid and infringed, and thereby excluded Sandoz and Pharmascience from the Canadian market until February 2031. A loss would have resulted potentially in immediate generic market entry.

These cases have been closely watched in Canada, as they are among the first to proceed under the amended PM(NOC) regime and raised novel issues under Canadian patent law.

BMS and Pfizer, based in New York, are both leading biopharmaceutical companies with global reach and operations.

McCarthy Tétrault is acting for BMS and Pfizer with a team led by David Tait and Steven Mason, that includes Rebecca Crane, Sanjaya Mendis, Jamie Holtom, Laura MacDonald, Bohdana Tkachuk, and Christina Vincent.

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