Brian R. Daley

Firm/Organization: Norton Rose Fulbright

Blogs: Les Actifs créatifs, Pharma in Brief

Latest Articles

PMPRB extends consultation on new Draft Guidelines implementing amendments to the Patented Medicines Regulations

By Christopher A. Guerreiro, Kristin Wall & Brian R. Daley

December 10, 2019

The Patented Medicine Prices Review aboard (PMPRB) has extended the deadline for written submissions on new Draft Guidelines until January 31, 2020. Originally, the consultation was scheduled to run until January 20, 2020. Background As we reported, the Board proposed Draft Guidelines to replace its existing price-review practices, including the Compendium of Policies, Guidelines and Procedures. The changes are intended to implement the recent amendments to the Patented Medicines Regulations, which come into force…

Pharma in Brief

PMPRB launches 60-day consultation on new Draft Guidelines following amendments to the Patented Medicines Regulations

By Christopher A. Guerreiro, Kristin Wall & Brian R. Daley

November 21, 2019

Today, the PMPRB launched a consultation on Draft Guidelines intended to implement recent amendments to the Patented Medicines Regulations. The PMPRB also released a Q&A-style Consultation Backgrounder. Interested parties have 60 days, until January 20, 2020, to make submissions on the Draft Guidelines. Background As we reported, the Government released final amendments to the Patented Medicines Regulations on August 9, 2019. These amendments are scheduled to come into force on July 1, 2020…

Pharma in Brief

Federal Court of Appeal applies holistic approach to the “palpable and overriding error” standard of review

By Bianca Pietracupa, Christopher A. Guerreiro & Brian R. Daley

November 11, 2019

The Federal Court of Appeal has provided a detailed review of the proper approach to identifying palpable and overriding errors of fact or mixed fact and law in an appeal concerning the obviousness of two patents. The Court of Appeal concluded that when viewed as a whole, there was no reviewable error in the judgment and dismissed the appeal. Background The underlying action concerned a claim by Teva Canada Limited (Teva) for damages under section…

Pharma in Brief

Federal Court relies on foreign prosecution history in first application of file wrapper estoppel

By Colin Hyslop, Christopher A. Guerreiro & Brian R. Daley

October 6, 2019

In CanMar Foods Ltd. v TA Foods Ltd., 2019 FC 1233, the Federal Court interpreted and applied the new file wrapper estoppel provision, section 53.1 of the Patent Act, RSC 1985, c P-4, for the first time. While CanMar is not a life sciences case, the application of Canada’s new file wrapper estoppel provision has implications for patentees generally. In CanMar, the patentee contended that two elements of the claim at issue were non-essential. The Court reached the opposite…

Pharma in Brief

Government releases final amendments to the PMPRB’s Patented Medicines Regulations to lower the prices of patented medicines

By Christopher A. Guerreiro, Kristin Wall & Brian R. Daley

August 13, 2019

The Government is moving forward with changes to the PMPRB intended to lower the prices of patented medicines in Canada in order to lay the foundation for National Pharmacare. The changes are set out in final amendments to the Patented Medicines Regulations that were released on Friday, August 9, 2019. The amendments will come into force on July 1, 2020. Once the amendments come into force, the PMPRB will use a different basket of price…

Les Actifs créatifs

Après un second coup d’œil, la CAF confirme le rejet de demande en contrefaçon dans un litige portant sur des dispositifs médicaux ophtalmiques

By Brian R. Daley, Jonathan Chong & Vanessa Rochester

July 17, 2019

L’équipe aimerait remercier Roxanne Caron, étudiante, pour son aide dans la rédaction de ce billet. Juin 2019 Brevets – Contrefaçon et validité Dans TearLab Corporation c. I-MED Pharma Inc, 2019 FCA 179, la Cour d’Appel Fédérale (CAF) a confirmé le rejet de l’action en contrefaçon de brevet de TearLab contre I-MED. Le juge de la Cour Fédérale n’a commis aucune erreur manifeste et dominante en concluant que les revendications en cause étaient évidentes. La CAF…

Pharma in Brief

Federal Court of Appeal agrees that the PMPRB incorrectly applied the patent-pertaining analysis

By Christopher A. Guerreiro, Brian R. Daley & Kristin Wall

July 9, 2019

The Federal Court of Appeal has provided new guidance on the proper approach to the “patent pertaining” analysis used by the Patented Medicine Prices Review Board (PMPRB or Board), including on the identification of the medicine and the invention of the patent, in a case concerning Differin®. Having provided this guidance, the Court of Appeal set aside the judgment under appeal and remanded the final determination of whether or not the patent in question pertains to Differin® to the Board.…

Pharma in Brief

Competition Bureau publishes Final IP Enforcement Guidelines

By David Yi, Christopher A. Guerreiro & Brian R. Daley

March 18, 2019

On March 13, the Competition Bureau published a revised version of its IP Enforcement Guidelines (IPEGs). The IPEGs clarify the Bureau’s approach to conducting investigations of alleged anti-competitive activities that involve IP, including settlement of pharmaceutical patent litigation under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The revised IPEGs replace the earlier 2016 version. Sections 7.2 and 7.3 include a detailed explanation of the Bureau’s approach to litigation settlements under the Regulations, which can…

Pharma in Brief

Federal Court of Appeal upholds Health Canada’s requirement for additional information on testing data integrity

By Jonathan Chong & Brian R. Daley

August 21, 2018

The Federal Court of Appeal (FCA) has dismissed Apotex’s appeal arising from its application to end Health Canada’s requirement for additional information establishing the integrity of data from Indian drug manufacturing facilities. The FCA found that the Federal Court (FC) properly considered the evidence and that it did not err in finding that the decision to implement the requirement for additional information was not improperly motivated. Background This appeal arises from the third in a…

Pharma in Brief

Federal Court upholds patent validity and grants prohibition order against generic lisdexamfetamine in pre-CETA PM(NOC) application

By Jonathan Chong, Brian R. Daley & Jordana Sanft

July 16, 2018

The Federal Court dismissed Apotex’s action to invalidate the claims of Canadian Patent No. 2,527,646 (the 646 Patent), which was consolidated with Shire’s application to prohibit the Minister of Health from issuing a Notice of Compliance for Apotex’s generic version of VYVANSE® (lisdexamfetamine). Shire’s counterclaim for infringement in the action was dismissed but the Court granted the prohibition order against the Minister. Patent found to be valid Amphetamines are used to treat attention deficit and…

Brian R. Daley

PMPRB extends consultation on new Draft Guidelines implementing amendments to the Patented Medicines Regulations

PMPRB launches 60-day consultation on new Draft Guidelines following amendments to the Patented Medicines Regulations

Federal Court of Appeal applies holistic approach to the “palpable and overriding error” standard of review

Federal Court relies on foreign prosecution history in first application of file wrapper estoppel

Government releases final amendments to the PMPRB’s Patented Medicines Regulations to lower the prices of patented medicines

Après un second coup d’œil, la CAF confirme le rejet de demande en contrefaçon dans un litige portant sur des dispositifs médicaux ophtalmiques

Federal Court of Appeal agrees that the PMPRB incorrectly applied the patent-pertaining analysis

Competition Bureau publishes Final IP Enforcement Guidelines

Federal Court of Appeal upholds Health Canada’s requirement for additional information on testing data integrity

Federal Court upholds patent validity and grants prohibition order against generic lisdexamfetamine in pre-CETA PM(NOC) application

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