William Chalmers

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Patent term adjustment: Canada consults on proposed regulatory framework

By William Chalmers, Christopher A. Guerreiro, Anna Wilkinson and Kristin Wall on August 7, 2023 Posted in Intellectual property

On August 7, 2023, the Canadian Intellectual Property Office (CIPO) launched a consultation on proposed features of regulations on patent term adjustment (PTA) in Canada (the Consultation). The PTA system is intended to compensate patentees for “unreasonable delays” by CIPO in issuing a patent. The Consultation seeks feedback on proposals that would impact the length of … 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

Pharma in Brief: The 2022 Year in Review

By William Chalmers, Christopher A. Guerreiro, Paul Jorgensen and Kristin Wall on January 25, 2023 Posted in Damages, Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

Does 2022 already seem like a blur? The Pharma in Brief team is here for you with a summary of some of 2022’s most significant legal and regulatory developments in the Canadian pharmaceutical space. We also flag what to watch out for in 2023. The most significant legislative changes concerned the Patent Act and … Continue reading

Federal Court of Appeal overturns judicial review decision in data protection dispute

By William Chalmers, Christopher A. Guerreiro and Kristin Wall on January 12, 2023 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court of Appeal (FCA) has overturned a decision of the Federal Court (FC) that found the Minister of Health’s (Minister) analysis of the data protection provisions of the Food and Drug Regulations unreasonable. The FCA restored the Minister’s decision granting an NOC to Médunik Canada (Médunik) for its amifampridine product, RUZURGI. Background Catalyst … Continue reading

2022 Guide to Canada’s Pharmaceutical Intellectual Property Regime

By William Chalmers and Kristin Wall on July 25, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

Our 2022 Guide to Canada’s Pharmaceutical Intellectual Property Regime is a convenient all-in-one reference to the important legal and regulatory regimes governing pharmaceuticals in Canada. The Guide provides a detailed review of the key regimes, including: Data protection market exclusivity; The Patented Medicines (Notice of Compliance) Regulations (PMNOC), linking generic market access to patent rights; … Continue reading

Pharma in Brief: The 2021 Year in Review

By Kristin Wall, William Chalmers, Christopher A. Guerreiro and David Yi on January 9, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2021. Introduction In 2021, governments advanced major policy initiatives aimed at the COVID-19 pandemic and broader health priorities. These policy initiatives included reforms to the Patented Medicine Prices Review Board (PMPRB), the Patented Medicines … Continue reading

Federal Court quashes NOC in dispute over Data Protection Provisions

By William Chalmers, Christopher A. Guerreiro and Kristin Wall on June 9, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court has quashed a notice of compliance (NOC) issued to Médunik Canada (Médunik) for its amifampridine product, RUZURGI, over an issue concerning data protection for another amifampridine product. The Minister provided no reasons for its issuance of the NOC, and the Court found that the Certified Tribunal Record (CTR) outlining the decision-making process … Continue reading

Data protection upheld for subsequently approved combination drugs containing new chemical entities: Federal Court finds Minister of Health’s decision to deny generic ANDS filing is reasonable

By Kristin Wall and William Chalmers on August 6, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Summary On July 24, 2020, the Federal Court dismissed an application for judicial review brought by Natco Pharma (Canada) Inc. (Natco) in respect of a July 26, 2019 decision (Decision) by the Minister of Health (Minister). The Decision refused to accept Natco’s ANDS filing using Gilead Sciences Canada Inc.’s (Gilead) product DESCOVY as the Canadian … Continue reading

No leave required for experimental testing conducted prior to litigation

By William Chalmers and Pharma in Brief team on April 22, 2020 Posted in Intellectual property

The Federal Court of Appeal (FCA) has decided that the Federal Court’s Notice to the Profession regarding experimental testing (the Notice) does not apply to testing conducted in advance of litigation. As a result, parties wishing to lead evidence of pre-litigation testing at trial are not required to obtain leave of the Court. Background This … Continue reading

Ontario implements regulatory changes to streamline drug formulary listing and reduce government payments to pharmacies

By William Chalmers and Kristin Wall on December 19, 2019 Posted in Uncategorized

The Ontario Ministry of Health and Long-Term Care (the Ministry) has amended Regulations made under the Ontario Drug Benefit Act (ODBA) and the Ontario Drug Interchangeability and Dispensing Fee Act (DIDFA). The new Regulations are substantially similar to those originally proposed (as we reported). The intended effect of the amendments is to reduce technical requirements … Continue reading

Ontario reduces restrictions on ordinary commercial term benefits and private label products

By William Chalmers, Randy Sutton and Allyson Whyte Nowak on December 17, 2019 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

The Ontario Ministry of Health and Long-Term Care (the Ministry) introduced changes to regulations (collectively, the Regulations) made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA). These changes will remove the financial caps on ordinary commercial term (OCT) payments made by drug manufacturers to pharmacies and allow … Continue reading

Ontario consults on changes to streamline drug formulary listing and reduce government payments to pharmacies

By William Chalmers and Kristin Wall on November 10, 2019 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

The Ontario Ministry of Health and Long-Term Care (the Ministry) has proposed draft amendments to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Ontario Drug Interchangeability and Dispensing Fee Act. The proposed changes are intended to reduce technical requirements for listing a product on the Ontario formulary and align policies with industry … Continue reading

Stockpiling generic manufacturers may be liable for direct infringement of “composition for a use” claims

By William Chalmers and Daniel Daniele on November 7, 2019 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

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 … Continue reading