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Canada Patent Act

Smart & Biggar

Twice is not nice – second notice of allegation may be abusive

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On December 23, 2023, the Federal Court of Appeal (FCA) held that it was an abuse of process for Apotex to raise invalidity in defending actions under the Patented Medicines (Notice of Compliance) Regulations (Regulations)...more

Smart & Biggar

Federal Court finds PMPRB reasonably concluded Galderma’s patent claiming 0.3% adapalene “pertained to” 0.1% adapalene DIFFERIN

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On January 11, 2024, the Federal Court released its decision concluding that the Patented Medicine Prices Review Board (PMPRB or Board) was reasonable in its redetermination that the invention of Patent No. 2,478,237 (the 237...more

Davies Ward Phillips & Vineberg LLP

New Excessive and Unfair Pricing Provisions in Force in Canada’s Competition Act: Risk and Compliance Considerations

Canada’s Competition Act was amended effective December 15, 2023 to both (i) establish a new, more expansive framework for challenging anti-competitive conduct by dominant firms and (ii) specifically provide that it is an...more

Smart & Biggar

2023 Highlights in Canadian Life Sciences IP and Regulatory Law

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Eli Lilly v Teva, Pharmascience, Riva, Apotex, Mylan (tadalafil, CIALIS) – Following a summary trial, Lilly’s infringement actions were dismissed: composition claims directed to “a physiologically acceptable salt” of...more

Smart & Biggar

Federal Court declines to grant injunction for infringement of HUMIRA formulation patent

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On December 4, 2023, the Federal Court issued its public judgment and reasons in two patent infringement actions pursuant to s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations (“Regulations”) and two patent...more

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Canadian patents: Establishing “due care” after failure to pay a maintenance fee

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It has been four years since amendments to the Patent Act and Patent Rules were made, bringing the Patent Law Treaty (PLT) into force in Canada. The most consequential changes have proven to be the handling of missed...more

Smart & Biggar

Federal Court of Appeal dismisses appeal challenging amended basket of comparator countries in PMPRB Regulations

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On December 5, 2022, the Federal Court of Appeal (FCA) dismissed Innovative Medicines Canada (IMC) and sixteen innovative pharmaceutical companies’ appeal regarding the validity of the amended basket of comparator countries...more

Smart & Biggar

PMPRB finds ultra-rare drug PROCYSBI is excessively priced

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On September 1, 2022, a Panel of the Patented Medicine Prices Review Board (PMPRB) issued a decision that the price of Horizon Pharma’s PROCYSBI (cysteamine delayed release capsules) was and is excessive under sections 83 and...more

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Canada’s new patent claim fee rules: Alternative embodiments within a single claim

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Historically, claim fees have not been payable at any time during the pendency of a Canadian patent application or term of the patent. This changed on October 3, 2022, and the present article discusses strategies for...more

Smart & Biggar

Ontario Court of Appeal affirms dismissal of Apotex’s Statutes of Monopolies and Trademarks Act claims regarding olanzapine

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On March 8, 2021, the Ontario Superior Court of Justice dismissed Apotex’s claims against Eli Lilly (Lilly) under the Statute of Monopolies, Trademarks Act, and common law conspiracy relating to Canadian Patent No. 2,041,113...more

Smart & Biggar

Canadian Patent Law 2021: A round-up of interesting developments and court decisions

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2021 saw changes in Canadian patent legislation, and a variety of court decisions addressing rarely interpreted provisions of the Patent Act, early consideration of recently enacted provisions, and new takes on central tenets...more

International Lawyers Network

Understanding Privilege: Is Your Canadian Patent Agent Also A Lawyer?

In Canada, there are practising patent agents and trademarks agents who are not lawyers. They are not admitted to any bar of any province or territory in Canada and are not members of any law society. The College of Patent...more

Smart & Biggar

Regulatory amendments provide permanent measures to address therapeutic product shortages

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On September 1, 2021, Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) (the “Regulations”) were published in Part II of the Canada Gazette. These amendments are intended to provide...more

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FCA remits pricing decision on ALEXION’S SOLIRIS to PMPRB

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Update: On September 29, 2021, Canada applied to the Supreme Court of Canada for leave to appeal (Docket No. 39858). In September 2017, the Patented Medicine Prices Review Board (PMPRB or Board) decided (see article here)...more

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Federal Court of Appeal upholds decision finding Seedlings' LifeCard patent invalid and not infringed by Pfizer’s EpiPen

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On July 28, 2021, the Federal Court of Appeal (FCA) dismissed Seedling’s appeal from the Federal Court decision of Justice Grammond (2020 FC 1, previously reported), which concluded that certain claims of Seedlings' LifeCard...more

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PMPRB update: Revised compliance timelines for grandfathered and gap medicines and proposed regulatory amendments directed to CSPs

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Revised compliance timelines for Grandfathered and Gap medicines - On April 16, 2021, in view of COVID-19, the Patented Medicine Prices Review Board (PMPRB) reversed its position on compliance timelines for Grandfathered...more

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Federal Court of Appeal finds Minister of Health’s refusal to grant a CSP for SHINGRIX is reasonable

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In the first appellate decision relating to Certificates of Supplementary Protection (CSPs), the Federal Court of Appeal has allowed the appeal of the Minister of Health (the Minister), setting aside the lower court judgment....more

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Ontario Superior Court dismisses Apotex’s Statutes of Monopolies and Trademarks Act claims regarding olanzapine

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Update: Apotex has appealed. On March 8, 2021, the Ontario Superior Court of Justice granted Eli Lilly’s (Lilly) motion for summary judgment and dismissed Apotex’s claims under the Statutes of Monopolies, Trademarks Act, and...more

Smart & Biggar

Office Actions: Options to consider when you need an extension of time to respond to the Patent Office

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The extensive amendments to the Patent Act and Patent Rules that came into force on October 30, 2019 have complicated the practice for responding to an Office Action (i.e. an “Examiner’s Report”) issued by the Canadian Patent...more

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Innovators challenge final PMPRB Guidelines in new Federal Court application

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On November 23, 2020, Innovative Medicines Canada (IMC) and a number of research-based pharmaceutical companies commenced an application for judicial review (T-1419-20) of the final Patented Medicine Prices Review Board...more

Dickinson Wright

Patent Claim Construction Decision May Boost Patent Eligibility in Canada

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Those applying for Canadian patents will be pleased to learn of a recent decision by the Federal Court of Canada invalidating the patent office’s controversial problem-solution approach to patent claim construction. The...more

Smart & Biggar

JULUCA CSP application remitted to Minister of Health for reconsideration

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UPDATE: On January 13, 2021, the Minister of Health refused the application on reconsideration. Viiv sought but later discontinued a second application for judicial review (T-258-21). In a decision dated July 10, 2020,...more

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Federal Court strikes price calculation provision of amendments to Patented Medicines Regulations

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UPDATE: On September 10, 2020, the applicants (Innovative Medicines Canada and the company applicants) appealed Justice Manson’s decision (A-215-20). On September 21, 2020, the Attorney General of Canada cross-appealed. As...more

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Federal Court releases decision on validity of the Amending Regulations of the Patented Medicines Regulations

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UPDATE: See July 15, 2020 article here describing the decision in more detail. On September 10, 2020, the applicants (Innovative Medicines Canada and the company applicants) appealed Justice Manson’s decision (A-215-20). On...more

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Action under amended PMNOC Regulations not rendered moot by patent expiry

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On May 22, 2020, the Federal Court held that an action under the amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) relating to saxagliptin (ONGLYZA) would not be rendered moot by the relevant...more

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