Corey McClary

Federal Court finds Minister of Health’s refusal to grant CSP based on the “Timely Submission Requirement” unreasonable

SUMMARY The Federal Court has granted Merck Canada Inc.’s (Merck) application for judicial review of a decision of the Minister of Health (Minister) denying a Certificate of Supplementary Protection (CSP) for Canadian Patent No. 2,670,892 (892 Patent) and the drug BELSOMRA (suvorexant). BACKGROUND A CSP provides patent-like rights and is intended to compensate patentees for … Continue reading

CSP Amendments to the PMPRB Regime: Jurisdiction of Patented Medicine Prices Review Board to Include Medicines Protected by Certificates of Supplementary Protection

By Corey McClary, Christopher A. Guerreiro and Kristin Wall on June 22, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

A suite of amendments to the Patent Act and the Patented Medicines Regulations (the Regulations) will soon require holders of Certificates of Supplementary Protection (CSPs) to report information to the Patented Medicine Prices Review Board (PMPRB) on substantially the same terms and conditions as would be reported by patentees. Regulations amending the Regulations, which will … Continue reading

Proposed amendments to the PM(NOC) Regulations: Patents claiming different salt forms of medicinal ingredients eligible for inclusion on the Patent Register

By Corey McClary, David Yi and Kristin Wall on April 25, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

On April 23, 2021, Proposed PM(NOC) Amendments [1] were published in the Canada Gazette, Part I. These amendments permit patents claiming different forms of a medicinal ingredient (e.g., salt forms) to be listed on the patent register and are intended to balance Proposed FDR Amendments [2] published on March 30, 2019 which allow generic manufacturers … Continue reading

Canada amends CSP Regulations, adding UK to list of “timely submission requirement” countries

By Morgan Westgate, Corey McClary and Kristin Wall on January 18, 2021 Posted in Uncategorized

Canada has added the UK to the list of countries that must be considered for the “timely submission requirement” in an application for a Certificate of Supplementary Protection (CSP). The change was implemented by an amendment to the CSP Regulations that came into force on January 6, 2021. Impact on “timely submission requirement” CSP eligibility … Continue reading

Pharma in Brief – Federal Court dismisses application for a prohibition order regarding prasugrel hydrochloride under the old PM(NOC) Regulations

By Corey McClary, David Yi and Allyson Whyte Nowak on August 13, 2018 Posted in Uncategorized

The Federal Court dismissed an application by Eli Lilly Canada Inc., Ube Industries, Ltd., and Daiichi Sankyo Company, Limited (the Applicants) seeking a prohibition order regarding Apotex’s generic version of Lilly’s EFFIENT® (prasugrel hydrochloride). While the Court rejected Apotex’s allegations of overbreadth, insufficiency, and non-patentable subject matter, it held that the claims were obvious. Background … Continue reading

Apotex request to re-open validity of esomeprazole patent denied

By Corey McClary and Kristin Wall on April 24, 2018 Posted in Intellectual property

The Federal Court dismissed Apotex’s motion to re-open the validity phase of the patent infringement action relating to esomeprazole (AstraZeneca’s NEXIUM®). Apotex had moved to re-open validity to allow the Court to adjudicate the issue of “overpromising” in light of the Supreme Court of Canada’s decision in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC … Continue reading

Federal Court of Appeal Provides Further Guidance on Inventive Concept

By Corey McClary and Brian R. Daley on December 6, 2017 Posted in Intellectual property

The Federal Court of Appeal has provided additional guidance on the framework for analyzing obviousness. In dismissing an appeal from the Federal Court, the Court of Appeal identified the search for an inventive concept as an “unnecessary satellite debate” and held that a more useful approach would be to construe the claims. Case: CIBA Specialty … Continue reading

Update on utility and the impact of the SCC decision in NEXIUM case

By Corey McClary and Kristin Wall on September 24, 2017 Posted in Intellectual property, Pharmaceuticals and life sciences

The impact of the Supreme Court’s landmark ruling in AstraZeneca Canada Inc. v Apotex Inc., 2017 SCC 36 (NEXIUM decision) rejecting the “Promise Doctrine” is taking shape in the Federal Court. As we reported, the SCC held that the level of utility required of a Canadian patent is driven by the claims of the patent … Continue reading