Case information

Intellectual property — Patents — Medicines — Applicants’ patent invalidated on grounds of obviousness — To satisfy the “obvious to try” test, is the claimed invention itself, or experiments along the way leading to the invention that must be self evident? — In a multi step invention process, should the “obvious to try” analysis be applied at each experimental step or only to the entire gap between the state of the art and the inventive concept of the claim? — In an “obvious to try” analysis, can the notional skilled person apply knowledge learned at an earlier experimental step in the invention process to the direction and design of a later experimental step, despite the prohibition on using hindsight in the analysis?

Case summaries are prepared by the Office of the Registrar of the Supreme Court of Canada (Law Branch). Please note that summaries are not provided to the Judges of the Court. They are placed on the Court file and website for information purposes only.

The applicants (collectively “Amgen”) brought an action against the respondent Pfizer Canada ULC (“Pfizer”) under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93 133 after being served with a Notice of Allegation from Pfizer. Amgen is the owner of the 537 Patent in issue, listed on the Patent Register against Amgen’s biological drug, sold and distributed commercially as “Neupogen”, with the active ingredient being filgrastim. Filgrastim is used to treat neutropenia, a disorder in which the body cannot produce sufficient levels of white blood cells, usually experienced during the course of chemotherapy. The patent is related to a hematopoietic growth factor, made using recombinant genetic technology. Pfizer filed a New Drug Submission with the Minister of Health for the issuance of a Notice of Compliance for its filgrastim biosimilar “Nivestym” using Neupogen as the reference biologic drug, to receive regulatory approval. Amgen’s position was that the making, selling and distributing of Nivestym would infringe certain claims of its 537 Patent. Pfizer counterclaimed that the 537 Patent was invalid and void due to, inter alia, obviousness. The trial judge held that the 537 Patent was invalid for obviousness. This decision was upheld on appeal.