Federal Court Denies Plaintiff’s Request for Cell Culture Samples in Patent Infringement Claim

On February 10, 2025, the Federal Court (the Court) issued its decision in Bayer Inc. v Amgen Canada Inc., 2025 FC 264, dismissing Bayer Inc. and Regeneron Pharmaceuticals Inc.’s (the Plaintiffs) appeal of an order denying their request to compel Amgen Canada Inc. (Amgen) to produce samples of its cell culture media used in manufacturing Amgen’s biosimilar (ABP 938).

The Plaintiffs alleged that the cell culture process used to make ABP 938 would directly or indirectly infringe the claims in Canadian Patent No. 2,906,768, which describes and claims a cell culture medium comprising certain amino acids (putrescine and ornithine), among other things. Amgen agreed to produce certain samples of its cell culture medium. However, the Plaintiffs sought production of additional samples at various in-process steps to determine whether ornithine may be present as a result of a conversion process during manufacturing.

The hearing judge considered whether the Plaintiffs had discharged their burden under Rule 249 of the Federal Court Rules to demonstrate “a reasonable possibility that the proposed test will reveal something useful for the trier of fact”. The hearing judge found: (i) a lack of evidence supporting the ornithine conversion issue; (ii)  no evidence of a test that could identify the presence of ornithine in the ABP 938 cell culture media; and (iii) the notional existence of a potential test with no reasonable possibility of revealing ornithine in cell culture media did not establish that the production of the samples sought would assist the Plaintiffs or the trier of fact.

On appeal, the Court held that the hearing judge did not err in requiring the Plaintiffs to show that the requested samples had a reasonable possibility of providing something different from the cell culture media Amgen agreed to provide. The Court noted that identifying “a test” does not necessarily equate to a “useful test” for the purposes of assessing infringement by measuring ornithine in the cell culture media. The Plaintiffs must show that the samples have a reasonable possibility of revealing something useful to the trier of fact in assessing an issue in the proceeding; the Court concluded that the hearing judge was entitled to find that the Plaintiffs failed to discharge that burden based on the paucity of evidence.

The Court therefore dismissed the Plaintiffs’ appeal with costs.

Summary By: Amy Ariganello