On a motion for leave to file reply expert reports, the Federal Court has reinforced the rule against case splitting and outlined the circumstances under which reply expert reports are permissible under the Federal Courts Rules. The Court concluded that none of the proposed reply reports put forward by Teva Canada Limited (Teva) in respect of patent validity issues were proper and dismissed the motion. Background This motion arose in the context of an…

In CanMar Foods Ltd. v TA Foods Ltd., 2019 FC 1233, the Federal Court interpreted and applied the new file wrapper estoppel provision, section 53.1 of the Patent Act, RSC 1985, c P-4, for the first time. While CanMar is not a life sciences case, the application of Canada’s new file wrapper estoppel provision has implications for patentees generally. In CanMar, the patentee contended that two elements of the claim at issue were non-essential. The Court reached the opposite…

The Government is moving forward with changes to the PMPRB intended to lower the prices of patented medicines in Canada in order to lay the foundation for National Pharmacare. The changes are set out in final amendments to the Patented Medicines Regulations that were released on Friday, August 9, 2019. The amendments will come into force on July 1, 2020. Once the amendments come into force, the PMPRB will use a different basket of price…

As we reported, the Budget Implementation Act, 2019 (BIA) paved the way for changes to the regulation of clinical trials and created a new class of “advanced therapeutic products” (ATPs) regulated by Health Canada. Health Canada is consulting on what it should consider in developing regulations for clinical trials and implementing the approval pathway for ATPs until August 30, 2019. Background The BIA received Royal Assent on June 21, 2019. The changes to clinical…

The Federal Court of Appeal has provided new guidance on the proper approach to the “patent pertaining” analysis used by the Patented Medicine Prices Review Board (PMPRB or Board), including on the identification of the medicine and the invention of the patent, in a case concerning Differin®. Having provided this guidance, the Court of Appeal set aside the judgment under appeal and remanded the final determination of whether or not the patent in question pertains to Differin® to the Board.…

The Federal Court recently confirmed that an infringement action under the Patent Act cannot be joined with an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations) while the Regulations prohibit the Minister from granting a NOC. The Court stated that an infringement action under the Patent Act could instead be brought in a separate proceeding. With cooperation between the parties and simultaneous scheduling of the trial of common issues, separate Patent Act…

On May 29, 2019, the federal government introduced Bill C‑100 to implement the new trilateral trade deal known as the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA), making Canada the first of the three member countries to introduce legislation that would ratify the treaty. CUSMA provides more protections for biologic and innovative pharmaceuticals under Canadian law. However, the treaty does not require the immediate adoption of these new protections and none of them…