A Federal Court Order has issued on a motion to strike brought by Sandoz in four actions relating to infringement of rituximab patents. The Court’s treatment of the novel claims by Roche may be of interest to litigants under the current scheme of the PMNOC Regulations.
The Court declined to strike out claims for damages and an accounting of profits on the basis that, at law, such remedies are not available in such an action. In the absence of case law on whether these remedies are available under the current Regulations, and in view of the broad wording of section 6(4), the claims were novel and arguable. As pleaded, however, the claim for future damages and an accounting of profits, grounded on possible issuance of a notice of compliance and in the absence of any sales by Sandoz, was struck out as hypothetical. The plaintiffs may seek leave to amend should they become aware of material facts. Roche’s claim based on Sandoz’s past and present acts of infringement – pleaded as promotion and marketing of its proposed product in Canada – was permitted to stand.
The Court declined to strike paragraphs on the basis of Sandoz’s assertion that certain activities undertaken by it in the development and submission of information to Health Canada and provincial formularies fall within the exemption to infringement in section 55.2 of the Patent Act. For example, the allegation that Sandoz’s filing of its drug submission was an infringing act was a novel and arguable claim in light of the recent regulatory and statutory amendments. The scope of exempted activities was a matter for determination at trial.
Finally, the Court struck out paragraphs that Sandoz will act “in concert” with formularies and hospitals to infringe the asserted patent claims, with leave to amend with particulars. The allegation was novel but at least arguable, falling within the concept of infringement by common design recognized in the jurisprudence. Roche is required to plead particulars of all third parties asserted to be acting in concert with Sandoz and their conduct, such as how they are acting in concert with Sandoz, the nature of their tacit agreement or plan, and whether there is any alleged intention on the part of the third parties to infringe the patents.