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Articles by William Chalmers
Selon deux décisions rendues aux États-Unis, la reproduction d’œuvres aux fins d’entraînement de grands modèles de langage constitue une utilisation équitable - Partie 2 : Kadrey v Meta
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Patent term adjustment: Canada consults on proposed regulatory framework
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 the PTA term, in order to inform the development of draft amendments to the Patent Rules.
The Ontario Superior Court dismisses a generic manufacturer’s claim for damages under section 8 of the PM(NOC) Regulations
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 for damages.
Supreme Court denies leave to appeal in generic Statute of Monopolies case
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.
Pharma in Brief: The 2022 Year in Review
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 accompanying rules/regulations.
Federal Court of Appeal overturns judicial review decision in data protection dispute
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 Pharmaceuticals Inc. and KYE Pharmaceuticals Inc. (together, Catalyst) and Médunik filed NDSs for drugs containing amifampridine.
2022 Guide to Canada's Pharmaceutical Intellectual Property Regime
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.
Federal Court Quashes NOC In Dispute Over Data Protection Provisions
Canada: Federal Court Quashes NOC In Dispute Over Data Protection Provisions 14 June 2021 by William Chalmers , Christopher Guerreiro and Kristin Wall Norton Rose Fulbright Canada LLP Your LinkedIn Connections with the authors To print this article, all you need is to be registered or login on Mondaq.com.
Federal Court quashes NOC in dispute over Data Protection Provisions
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.
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 - Privacy - Canada
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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 | LexBlog
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 Reference Product. DESCOVY contains a combination of tenofovir alafenamide (TAF) hemifumarate and emtricitabine.
No Leave Required For Experimental Testing Conducted Prior To Litigation - Intellectual Property - Canada
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No leave required for experimental testing conducted prior to litigation
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 decision was rendered in the context of actions for patent infringement under the Patented Medicines (Notice of Compliance) Regulations. Bayer Inc.
Ontario Implements Regulatory Changes To Streamline Drug Formulary Listing And Reduce Government Payments To Pharmacies - Food, Drugs, Healthcare, Life Sciences
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Ontario implements regulatory changes to streamline drug formulary listing and reduce government payments to pharmacies
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 for listing a product on the Ontario formulary and align policies with industry standards and other provinces.
Ontario Reduces Restrictions On Ordinary Commercial Term Benefits And Private Label Products
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Ontario reduces restrictions on ordinary commercial term benefits and private label products
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 private label products to be listed as benefits or be designated as “interchangeable”.
Stockpiling generic manufacturers may be liable for direct infringement of “composition for a use” claims
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 be infringed by a generic manufacturer through inducing infringement.
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