The Top Line
The Federal Court in Bayer v Amgen offered key insights into the evidence needed to compel production of samples for testing. The Court balanced the “permissive approach” from prior caselaw with the overarching requirement that parties must demonstrate a “reasonable possibility” that the proposed testing will reveal something useful to the Court. Here, mere existence of testing methods on the samples without evidence of a specific test was not enough to meet the burden.
Background
In the underlying action (Bayer v Amgen, Federal Court File No. T-1919-23) the plaintiffs, Bayer and Regeneron, alleged that Amgen infringed a patent that claimed various compositions of cell culture media. The plaintiffs brought a motion under Rule 249 to compel production of samples of the cell culture used in the manufacture of Amgen’s aflibercept biosimilar. Since Amgen agreed to produce samples of its production medium and production feed medium, the only issue was whether it should produce representative samples of its cell culture from various steps in the culturing process.
Bayer and Regeneron argued that the cell culture samples were relevant to infringement, namely, to demonstrate the presence and concentration of the claimed ornithine component in Amgen’s cell culture medium. They did not lead any expert evidence, and instead relied on an admission by Amgen’s expert that there were test methods available that could test for the presence of ornithine in Amgen’s cell culture, although no such test or test conditions had been identified or described.
Key Findings
The principal dispute was the evidentiary threshold required to justify production of samples for testing. Bayer and Regeneron argued that the threshold was low, and was sufficiently met so long as a notional test can be said to exist — as admitted by Amgen’s expert — even if the test is not specifically identified, and there is no evidence of what it may entail or produce.
The Court disagreed. It declined to characterize the threshold as either “high” or “low” and instead indicated that it is “precise” – there “must be evidence” that the result of the testing has a reasonable possibility of revealing something useful to the trier of fact.
In this case, the evidence fell short of demonstrating how the testing had a reasonable possibility of assisting the Court. Reconciling its decision with the “permissive approach” discussed in Gilead, the Court held that while there is some flexibility in motions to compel, mere evidence of notionally or theoretically possible tests won’t cut it. There must be evidence that establishes a sufficient nexus between testing of [the samples] that may be conducted and the unadmitted allegations in the pleadings. From the Court’s perspective, the moving party’s reliance on a “notional test” without further evidence strongly suggested that this was primarily a fishing expedition.
Despite framing the threshold as “precise”, the Court also confirmed that parties do not need to lead evidence that the proposed tests are the only way to make their case, nor are they required to provide details of their tests or confirm if tests will be performed (citing Gilead). In other words, the key consideration is the potential relevance and utility of the proposed test to the issues in dispute, rather than particulars of how and whether the test will be conducted.
The Court also outlined key principles guiding Rule 249 motions, highlighting the need to balance the interests of the parties and the Court. The Court held, however, that a benefit to the Court was unlikely in this case, as the evidence did not show that the testing could reasonably shed light on the issue of infringement.
Finally, as part of its assessment of relevance, the Court acknowledged that assessing whether the requested samples ought to be compelled may involve preliminary determinations on the claim language and hence scope of the claims. This is routinely done in motions to compel in patent cases and not determinative of the ultimate claim construction by the trier of fact.
This article is intended as a timely legal update and does not constitute legal advice. For more information, contact a member of our Life Sciences team.