The Federal Court has found that it is reasonably arguable that a claim for "a composition for use in the treatment of a disorder" may be directly infringed through the importation, manufacture and stockpiling of the composition. The Court distinguished these claims from pure "use of a composition for a treatment" claims, which can only be infringed by a generic manufacturer through inducing infringement.
The Court's decision concerns a pleadings amendment motion by Eli Lilly Canada Inc. and its co-plaintiffs (collectively, Lilly) in patent infringement actions against: (1) Apotex Inc.; (2) Mylan Pharmaceuticals ULC; (3) Teva Canada Limited; and (4) Pharmascience Inc. and Laboratoires Riva, all concerning generic versions of the plaintiffs' CIALIS tadalafil. The defendants began selling their respective generic products in Canada following the expiry of a patent (the 784 Patent) that had been successfully asserted in prohibition proceedings under the Patented Medicines (Notice of Compliance) Regulations (the PM(NOC) Regulations).
Lilly sought to amend its pleadings to claim that the generic defendants infringed the 784 Patent (prior to its expiry) by manufacturing, importing and stockpiling tadalafil for the treatment of ED, resulting in springboard damages.
The defendants contested the amendment by arguing that it was plain and obvious that the amended claim could not succeed. The crux of the defendants' argument was that the 784 Patent is a "use" patent, and that manufacturers can only be liable for infringement of "use" patents through inducing others to use the medicinal ingredient in the specified treatment. Manufacturers do not use medicinal ingredients for particular treatments — these acts are confined to patients and doctors. Since the generic manufacturers had not sold tadalafil prior to expiry of the 784 Patent, they argued that they cannot be liable for inducing patients and doctors to infringe that patent.
The Court rejected this argument on the basis that the defendants had conflated claims for a "use of a composition in a treatment" with claims for a "composition for use in the treatment". The former can only be infringed by manufacturers through inducing infringement, whereas the latter can be directly infringed by manufacturers through the manufacture of the composition for the purpose of treating the specified disorder. The Court held that such claims can be construed as claiming "vendible products" and therefore it is "arguable that a claim for a vendible product can be directly infringed by making, importing or stockpiling the product, even if no sales or use by a consumer have occurred".
As parties continue to dispute the need for proof of direct vs. induced infringement in actions for pharmaceutical patent infringement, the Court's reasons in this case should prove instructive when framing pleadings — including in actions under the new PM(NOC) Regulations, where the cause of action for infringement will typically be litigated before the generic comes to market. Although the Court did not construe the claims in issue on this motion, its willingness to distinguish between claims for "a composition for the treatment of a disorder" and claims for "the use of a compound for the treatment of a disorder" signals that parties should likewise distinguish between these types of claims in their pleadings and evidence.
The case is: Eli Lilly Canada Inc. v. Apotex Inc., 2019 FC 884
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