Federal Court denies samples for testing infringement of biologic process patent
The Federal Court recently refused to order a defendant to produce samples of cell culture because there was no “reasonable possibility” that testing the samples would yield evidence of patent infringement. In pharmaceutical patent cases, testing samples of a defendant’s product – or samples from a defendant’s process – can lead to crucial evidence of infringement for trial. However, as seen in the Court’s recent decision, a defendant can resist producing samples where the plaintiff only proposes “speculative undefined tests”.
The action
Amgen Canada Inc. (Amgen) is seeking Health Canada’s approval to market a biosimilar of Bayer Inc.’s biologic drug EYLEA® (aflibercept). In response, Bayer Inc. and Regeneron Pharmaceuticals, Inc. (collectively Bayer) have brought a quia timet patent infringement action against Amgen under section 8.2 of the Patented Medicines (Notice of Compliance) Regulations. Bayer alleges that Amgen’s biosimilar aflibercept would directly or indirectly infringe Canadian Patent No. 2,906,768 (the 768 Patent). Amgen denies infringement.
Testing for infringement of the 768 Patent
Claim 1 of the 768 Patent claims, “A cell culture medium, which is serum-free, comprising 0.6 ± 0.09 mM ornithine and 0.714 ± 0.11 mM putrescine.”
To prove infringement of Claim 1 and other claims, Bayer proposed testing the concentration of ornithine in the cell cultures Amgen uses to manufacture its biosimilar aflibercept. Amgen had disclosed its cell culture process, including the composition of its cell culture medium. However, Bayer contended that infringing concentrations of ornithine may still be present in Amgen’s cell cultures because arginine, a component of Amgen’s medium, can convert to ornithine.
When Amgen refused to provide samples of its cell cultures for testing, Bayer moved for an order to compel samples under Rule 249 of the Federal Courts Rules.
Court refuses to order samples produced
In a September 17, 2024 decision, the Court dismissed Bayer’s motion to compel samples of Amgen’s cell cultures.
The Court first noted the language of Rule 249, which required Bayer to prove that the samples were “necessary or expedient for the purpose of obtaining information or evidence in full”. This requirement has been interpreted by the leading authority (Apotex Inc. v. Eli Lilly Canada Inc., 2013 FCA 45) as meaning that there must be “a reasonable possibility” that the proposed testing of the sample will reveal something useful for the trial judge.
The Court found that Bayer had not met its burden. The Court identified two issues with Bayer’s proposed testing:
- First, the Court rejected Bayer’s evidence that arginine could convert into ornithine in Amgen’s process. Bayer led two scientific articles showing that, under certain conditions, arginine can convert into ornithine. However, Bayer did not lead expert evidence to explain how that literature applied to Amgen’s cell cultures. By contrast, Amgen led expert evidence that the arginine-to-ornithine conversion described in Bayer’s literature could not occur in Amgen’s cell cultures (e.g., due to their temperature and pH).
- Second, Bayer had not identified the tests it would carry out and instead relied on Amgen’s expert evidence that it was possible to measure the concentration of ornithine in a sample. The Court found that “a notional, undescribed or theoretical test” does not establish a “reasonable possibility” of revealing something useful for the trial judge.
Finally, the Court considered the interests of Bayer, Amgen, and the trial judge. The Court found that having to obtain samples of cell culture would affect Amgen’s manufacturing process and “may jeopardize an entire production run”. By contrast, neither Bayer nor the trial judge was likely to benefit from Amgen producing samples, as Bayer’s “potential test” had no reasonable possibility of showing infringement of the 768 Patent.
Links
- Bayer Inc. v. Amgen Canada Inc., 2024 CanLII 117240 (FC)