In public reasons released on 30 July 2018, the Federal Court dismissed the first motion for summary dismissal brought under Section 6.08 of the amended Patented Medicines (Notice of Compliance) (PMNOC) Regulations.(1) The court had previously dismissed the plaintiffs' attempts to stop or delay this motion until after the completion of examinations for discovery (for further details please see "Procedural decisions relating to Herceptin under amended PMNOC Regulations").
The underlying action for infringement concerned Amgen Canada's regulatory submission for approval of its biosimilar of Hoffmann-La Roche's Herceptin (trastuzumab). Amgen sought to dismiss the action regarding two of the four asserted patents, both of which contained use claims. Amgen argued that the plaintiffs' assertions that it would induce infringement did not have the slightest chance of success. Amgen's motion was dismissed.
The Federal Court held that, as per existing jurisprudence regarding the corresponding provision under the pre-amended PMNOC Regulations, striking an action pursuant to Section 6.08 remains an extraordinary remedy and the threshold is high. The moving party bears the onus of demonstrating that the claim is so clearly futile that it has not the slightest chance of success. As the hearing of the motion is not a hearing on the merits, the court's role is not to determine whether there has been an infringement or inducement. Rather, the court's role is to determine whether the plaintiff has raised an arguable case such that it is not plain and obvious that the action will fail.
The court also held that it should exercise a heightened level of caution in striking claims pursuant to Section 6.08, as the plaintiff is precluded from commencing a subsequent action for infringement, in contrast to summary dismissal under the pre-amended PMNOC Regulations.
The court held that it was not plain and obvious that the plaintiffs' claims had no chance of success. In respect of one of the patents, the court held that:
it was at least arguable that Amgen has done 'something more' within the meaning of the case law that a trial judge could ultimately consider to be the requisite influence leading to direct infringement by physicians and patients.
Further, the court held that there was an arguable case in relation to the balance of the test for inducement.
With respect to the second patent, the court found there was a debatable issue regarding proper claim construction, and that the plaintiffs had raised an arguable case to meet the test for inducement.
Accordingly, the motion was dismissed.
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(1) Genentech, Inc v Amgen Canada Inc, 2018 FC 694.
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