Federal Court of Appeal finds pre-litigation experimental testing is exempt from the Federal Court’s 2016 Notice re: Experimental Testing, even if the testing was done with future litigation in mind.

The reasons can be found here: Apotex Inc. v. Bayer Inc., 2020 FCA 71. These reasons were adopted in Teva Canada Limited v. Bayer Inc., 2020 FCA 72.

In these appeals, Bayer conducted experimental testing that it intended to use in future litigation. After commencing separate proceedings under the Patented Medicines (Notice of Compliance) Regulations, Bayer advised the defendants (Apotex and Teva) that it had conducted pre-litigation testing, and intended to rely on the results at trial. Apotex and Teva took the position that Bayer’s testing was inadmissible because Bayer had not complied with the Federal Court’s 2016 Notice Re: Experimental Testing.

The Notice specifies that for testing results to be admissible without leave, a party must give notice of the testing at least two months before the service of expert reports to which the testing relates, including notice of: (a) the facts to be proven by such testing; (b) the nature of the experimental procedure to be performed; (c) when and where the adverse parties’ counsel and representative(s) can attend to watch the experiment(s); and (d) when and in what format the data and test results from such experiment(s) will be shared with the adverse parties.

In response, Bayer brought motions asking the court whether leave was required to lead evidence of the testing, and, if so, whether leave should be granted. The Federal Court held that leave was not required. Apotex and Teva appealed.

On appeal, the Court held that the text, context, and purpose of the Notice, and the case law all supported the conclusion that compliance with the Notice was not required to lead evidence at trial based on testing conducted before litigation had commenced.

As drafted, the wording of the Notice contemplated only ongoing litigation. For instance, the Court noted that it was not possible to serve notice on “other parties” when those parties have not yet been identified in the course of litigation. If the Notice were intended to apply to pre-litigation testing it would have said so.

With respect to context, the Court noted that the listing of a patent on the patent register does not identify any specific company that might later seek approval to sell a generic version of the drug or trigger a timeline for litigation.

With respect to purpose, the Court held that the purpose of the Notice would not be frustrated if it did not apply pre-litigation. Moreover, Apotex and Teva were still free to argue that the testing evidence should be excluded or given little weight based on existing case law.

Finally, the Court decided not to answer the question of “whether a notice to the profession like the Notice in issue here is as a matter of law capable, even if by its terms it did apply, of modifying the rules governing the admissibility of evidence.”

For more information, please contact the McCarthy Tétrault Intellectual Property Litigation group in Toronto.