The Top Line
In Alexion Pharmaceuticals v Amgen, the Federal Court
upheld the validity of Alexion's eculizumab patent (CA810),
rejecting Amgen's claims of anticipation and obviousness, and
blocking its biosimilar BEKEMV from entering the market. Most
notably, the Court clarified that a prior art reference can legally
anticipate a patent if it explicitly and precisely incorporates
another document by reference, marking a potentially significant
evolution in Canadian anticipation law. However, on the facts, the
Court found that Amgen's cited references failed to disclose
eculizumab with the necessary specificity.
In a recent Federal Court decision dated May 12, 2025
(Alexion Pharmaceuticals, Inc v Amgen Canada Inc, 2025 FC 754), Alexion successfully defended
its Canadian Patent No. 2,645,810 (CA810) against allegations of
anticipation and obviousness and succeeded in preventing Amgen from
entering into the market with its eculizumab biosimilar.
