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FCA finds Notice to the Profession re: Experimental Testing does not apply to pre-litigation testing

On April 8, 2020, the Federal Court of Appeal (FCA) released a decision finding that the Federal Court Notice to the Profession re: Experimental Testing (Notice) does not apply to pre-litigation testing: Apotex v Bayer, 2020 FCA 71 (reasons apply equally to Teva v Bayer, 2020 FCA 72).

The Notice, which issued in May 2016, requires a party to a patent infringement or validity action intending to rely on evidence of “experimental testing conducted for the purpose of litigation”, to provide reasonable notice of the testing to the other parties. Such notice must include, among other information, “when and where the adverse parties’ counsel and representative(s) can attend to watch the experiment(s)”. The Notice further provides that unless the requisite notice is given, the party cannot lead the evidence without leave of the Court.

The decision was made in the context of two patent infringement actions brought by Bayer against each of Apotex and Teva under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations). Bayer had conducted testing in contemplation of possible future litigation at a time when no litigation in relation to the patent at issue was pending. Once litigation had commenced, Bayer informed Apotex and Teva of its intention to rely on the pre-litigation testing. Apotex and Teva took the position that, pursuant to the Notice, Bayer had to seek leave to lead the testing evidence as the requisite notice of the testing had not been provided. Bayer brought a motion for determination of (1) whether, under the Notice, it requires leave of the Court to lead evidence of pre-litigation testing, and (2) if so, whether leave should be granted. The motion judge answered no to the first question and found it unnecessary to decide the second. Apotex and Teva sought and were granted leave to appeal, and the appeals were heard together.

The FCA reviewed the motions judge’s decision on a correctness standard and dismissed the appeal. Justice Laskin, writing for the FCA, engaged in a textual, contextual and purposive approach to interpreting the Notice. In so doing he found that the text of the Notice includes several expressions that contemplate ongoing litigation and requirements that would be difficult to comply with outside of the litigation context. He agreed with the motion judge’s views regarding contextual and purposive factors, including the view that, in the context of the PMNOC Regulations, the mere listing of a patent on the Patent Register is not sufficient to trigger the application of the Notice, and noted that such factors did not detract from the conclusion flowing from the textual analysis of the Notice. Lastly, Justice Laskin observed that the Notice appears to be an attempt to codify the long-standing practice of the Court to exclude evidence of testing conducted only during litigation or trial without giving adverse parties notice and an opportunity to attend. He concluded that if the Notice was intended to apply to a practice outside of that which has been applied by the Court to date, the Notice would have said so expressly.

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