Health Canada releases updated Certificate of Supplementary Protection guidance

By Sarah Pennington, Paul Jorgensen and Kristin Wall on May 29, 2023 Posted in Pharmaceuticals and life sciences

On May 12, 2023, Health Canada announced the release of an updated version of the Guidance Document: Certificates of Supplementary Protection (CSP Guidance).  The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations (CSP Regulations) and to reflect changes to Health Canada’s administrative … Continue reading

The Ontario Superior Court dismisses a generic manufacturer’s claim for damages under section 8 of the PM(NOC) Regulations

By William Chalmers, David Yi and Allyson Whyte Nowak on May 4, 2023 Posted in Damages, Intellectual property, Life sciences and healthcare

The Ontario Superior Court (ONSC) has dismissed a claim for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations) brought by Apotex Inc. (Apotex) for lost sales of its Apo-Atomoxetine product. The Court conducted a purposive interpretation of the Regulations and found that Apotex did not meet the statutory requirements … Continue reading

Supreme Court denies leave to appeal in generic Statute of Monopolies case

By William Chalmers, Christopher A. Guerreiro and David Yi on May 4, 2023 Posted in Damages, Intellectual property, Life sciences and healthcare

On April 27, 2023, the Supreme Court of Canada dismissed an application by Apotex Inc. and Apotex Pharmachem Inc. (Apotex) for leave to appeal from a decision of the Ontario Court of Appeal (ONCA), dismissing its claim for damages in the Ontario courts under the Statutes of Monopolies and other novel causes of action. In the Courts below, Apotex … Continue reading

PMPRB Update: Federal Standing Committee on Health begins review of the Board

By Christopher A. Guerreiro and Kristin Wall on May 2, 2023 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

The Standing Committee on Health (HESA) has begun a study on the Patented Medicine Prices Review Board (PMPRB). HESA is made up of 12 Members of Parliament representing the four main parties in the House of Commons. In connection with this study, HESA has conducted two meetings to ask questions of witnesses regarding the PMPRB: The events … Continue reading

Bill C-47 introduces patent term adjustment: Proposed term to run concurrently with term of Certificate of Supplementary Protection

By Kristin Wall, Anna Wilkinson and Paul Jorgensen on May 1, 2023 Posted in Intellectual property, Pharmaceuticals and life sciences

On April 20, 2023, the federal government tabled legislation (Bill C-47) that would amend the Patent Act to bring, for the first time, a system of general patent term adjustment (PTA) into Canada. Canada is required under the Canada-United States-Mexico Agreement (CUSMA) to adopt a PTA system by 2025. The PTA system is intended to … Continue reading

U.S. Trade Representative cites Canada’s “IP problems” including pharmaceutical patent protection

By Paul Jorgensen and Kristin Wall on April 27, 2023 Posted in Intellectual property, Pharmaceuticals and life sciences

On April 26, 2023, the Office of the United States Trade Representative (USTR) released its 2023 Special 301 Report on intellectual property. The report keeps Canada on a Watch List of 29 U.S. trading partners that “merit bilateral attention to address underlying IP problems”.  The report is the USTR’s annual review of the global state of … Continue reading

Federal Court of Appeal rejects elevated standard of proof for induced infringement in paliperidone case

By Fortunat Nadima Nadima, Christopher A. Guerreiro and Kristin Wall on April 21, 2023 Posted in Intellectual property, Pharmaceuticals and life sciences

The Federal Court of Appeal (FCA) has allowed an appeal concerning induced infringement in an action under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The FCA found that the Federal Court (FC) had erred by applying an elevated causation requirement. The FCA also rejected an appeal by the generic from the finding that the patent was … Continue reading

Canada announces its first-ever national strategy for drugs for rare diseases

By Sarah Pennington, Paul Jorgensen and Kristin Wall on March 27, 2023 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

On March 22, 2023, Canada’s federal government announced its first-ever National Strategy for Drugs for Rare Diseases, including an investment of up to $1.5 billion over three years to help increase drug access and affordability.  Investments made as part of the National Strategy The lion’s share of the federal government’s investment – up to $1.4 … Continue reading

Federal Court launches IP Chamber pilot project

By Christopher A. Guerreiro and Kristin Wall on March 6, 2023 Posted in Intellectual property

The Federal Court has created a new, specialized Chamber of judges to be used for assigning intellectual property and competition law hearings. The Chamber formalizes the Court’s existing practice of endeavouring to assign judges with relevant IP expertise to preside over IP matters. It is intended to increase transparency and provide greater certainty regarding the … Continue reading

Higher costs awards coming to the Federal Court, including for pharma regulatory and IP disputes

By Chelsea Nimmo, Paul Jorgensen and Kristin Wall on February 26, 2023 Posted in Damages, Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

Higher costs awards for Federal Court litigation are on the horizon, with the Canadian government consulting on proposed amendments to the costs structure in the Federal Courts Rules (the Rules). The proposed amendments are intended to increase costs awards by approximately 25%.   The current costs regime Under the Rules, the Federal Courts can fix a … Continue reading