The Federal Court has invalidated Health Canada’s decision to disclose records pertaining to a veterinary pharmaceutical product, Fortekor Flavour Tabs (Fortekor), pursuant to the Access to Information Act (the Act). Health Canada defended its decision on the
January 2020
Patent owner files its own pleading in a PM(NOC) action
The Federal Court granted leave to the United States of America (USA), in its capacity as co-owner of a patent, to file its own pleading in an action under s 6(1) of the Patented Medicines (Notice of Compliance) …
Health Canada Provides Guidance on Regulation of Software as a Medical Device (SaMD)
On December 18, 2019, Health Canada published a new Guidance Document Software as a Medical Device (SaMD): Definition and Classification (Guidance Document). The Guidance Document explains what products would be regulated as SaMD under the Food and Drugs …
Pharma in Brief: The 2019 Year in Review
In this article, the Pharma in Brief team curated the most significant topics we covered during 2019.
The Canadian pharma and life sciences space saw many developments in 2019. These included major policy initiatives and regulatory changes affecting the industry,…
Federal Court reinstates damages decision concerning prejudgment interest
The Federal Court has vindicated Lilly, reinstating a patent infringement damages decision that awarded Lilly prejudgment interest equal to its average annual rate of return during the interest earning period, on a compound basis. It found that Lilly’s real-world rate…