Pfizer seeks to invalidate a Canadian patent

Our Toronto office is acting as Canadian counsel to Pfizer Canada ULC and Pfizer Inc. (collectively “Pfizer”), the plaintiffs in a new patent impeachment proceeding in the Federal Court of Canada (T-1477-22). Pfizer is seeking to invalidate Canadian Patent No. 2,849,196 (the “196 Patent”), which is owned by the defendants, Amgen Research (Munich) GmbH and Amgen Inc. The 196 Patent relates to bispecific antibodies that target the human proteins CD3 and BCMA and are intended to cause cytotoxic T cells to kill BCMA-expressing cells, including multiple myeloma cells.  Pfizer has asserted in its Statement of Claim that the 196 Patent is invalid for indefiniteness, anticipation, obviousness, over breadth, insufficient disclosure, and wilful misleading.  

Pfizer’s action is a significant new patent proceeding in Canada, as it concerns a new class of antibody drugs for treating a common and incurable cancer, multiple myeloma. Antibody drugs are an important class of therapeutics, but patents covering them have rarely been litigated in Canada. Therefore, the case is expected to raise novel factual and legal issues for the court to resolve.  

In addition, the case has significant consequences for our client, as the 196 Patent presents a business risk for Pfizer’s planned launch of a new drug. Specifically, Pfizer wants to invalidate the 196 Patent to clear the way for its drug Elranatamab, a BCMA/CD3 bispecific antibody for treating multiple myeloma. Pfizer plans to market Elranatamab in Canada, pending a successful outcome in an ongoing clinical trial.