News & Analysis as of

Patent Litigation Patented Medicines

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Federal Court of Appeal affirms Minister of Health reasonable in concluding successor second person was entitled to benefit of NOA...

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On May 26, 2023, the Minister of Health determined that Biosimilar Collaborations Ireland Limited was entitled to the benefit of section 5 of the Patented Medicines (Notice of Compliance) Regulations (Regulations), including...more

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FCA dismisses appeal, patent not listable against STELARA SNDS

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As previously reported, the Federal Court (FC) dismissed Janssen’s application for judicial review of the decision of the Office of Submissions and Intellectual Property (OSIP) refusing to list Canadian Patent No. 3,113,837...more

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2022 Highlights in Canadian Life Sciences IP and Regulatory Law

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Below are highlights from the Rx IP’s team’s 2022 updates (see also our Top 10 Rx IP Update Reads of 2022): Contents: 1. Patent decisions on the merits 2. PMNOC Regulations: Fifth-year anniversary of major amendments,...more

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Federal Court of Appeal upholds invalidity of fampridine patent

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The Federal Court of Appeal (FCA) dismissed an appeal by Biogen and a cross-appeal by Taro from a decision of the Federal Court... dismissing two actions by Biogen under the Patented Medicines (Notice of Compliance)...more

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2022 mid-year highlights in Canadian life sciences IP and regulatory law

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In the first half of 2022, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to July and...more

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Federal Court finds Janssen’s macitentan combination therapy patent valid

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On May 31, 2022, the Federal Court released a decision by Justice Pallotta in a patent infringement action pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations in relation to macitentan...more

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Merck’s JANUVIA crystalline monohydrate DHP salt patent found valid

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In a patent infringement action brought under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations, in relation to sitagliptin phosphate monohydrate (Merck’s JANUVIA), Justice Furlanetto of the Federal...more

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Federal Court holds summary trial appropriate, Apotex and Pharmascience will induce infringement of paliperidone palmitate patent

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The Federal Court released a pair of decisions in patent litigation relating to paliperidone palmitate (Janssen’s INVEGA SUSTENNA): Janssen Inc v Pharmascience, 2022 FC 62 and Janssen Inc v Apotex, 2022 FC 107. Pharmascience...more

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Plaintiff cannot amend Statement of Claim more than 45 days after receipt of NOAs to plead infringement of further patents.

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On May 5, 2021, the Federal Court dismissed a motion by Biomarin Pharmaceutical Inc (Biomarin) to amend its Statement of Claim to allege infringement of two patents that had not been asserted within the 45-day deadline...more

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Federal Court of Appeal Upholds Decision Allowing Taro to Plead Validity Attacks beyond Notice of Allegation

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On June 9, 2021, the Federal Court of Appeal (FCA), following grant of leave to hear Sunovion’s appeal, dismissed Sunovion’s appeal from a Federal Court (FC) decision of Furlanetto J. (2021 FC 37) granting Taro leave to amend...more

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Federal Court of Appeal affirms prohibition order against Apotex regarding abiraterone

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As previously reported, in the final decision released under the pre-amended Patented Medicines (Notice of Compliance) Regulations (Regulations), the Federal Court granted a prohibition order relating to Canadian Patent No....more

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Janssen’s abiraterone acetate and prednisone combination therapy patent found invalid

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On January 14, 2020, the Federal Court released a decision by Phelan J. in patent infringement actions pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) relating to...more

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Federal Court finds silodosin formulation patent valid but not infringed

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On December 24, 2020, the Federal Court issued a decision in a patent infringement action pursuant to s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations relating to silodosin (Allergan’s RAPAFLO): Allergan...more

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Federal Court upholds validity of two patents pertaining to ELIQUIS

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On January 12, 2021, the Federal Court issued its public decision in four patent infringement actions pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations brought by Bristol-Myers Squibb...more

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Federal Court decision regarding glatiramer acetate finds one patent obvious and another valid and infringed

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On January 6, 2021, the Federal Court issued its decision in two patent infringement actions pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations involving Teva’s patents pertaining to the...more

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Final PMPRB Guidelines Released

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UPDATE: See our article here highlighting changes relative to the June 2020 draft Guidelines. This morning, the PMPRB released the final Guidelines operationalizing the amended Patented Medicines Regulations (Amended...more

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First decision on CSPs: SHINGRIX refusal remanded to Health Canada

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The first decision considering the scope and meaning of the provisions in the Patent Act relating to Certificates of Supplementary Protection (CSPs) has now been released.  Justice Barnes of the Federal Court in...more

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The Best of the Decade – Canadian Patent Law in the 2010s

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The 2010s saw many developments in Canadian patent law.  Establishment of a trade agreement with the European Union, ratification of an international IP treaty, implementation of a national IP strategy, and other domestic...more

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Patent owner named as defendant may file reply in actions under the PMNOC Regulations

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In an action commenced by Allergan against Apotex in respect of ulipristal (Allergan’s FIBRISTAL) under the Patent Medicines (Notice of Compliance) Regulations (PMNOC Regulations), an issue arose as to the appropriate...more

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Court declines to direct preliminary determination on interpretation of subsection 6(1) of PMNOC Regulations

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On November 7, 2019, Prothonotary Tabib dismissed Pharmascience’s motion for an order directing a preliminary determination of a question of law in the context of a patent infringement action brought by Teva pursuant to the...more

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Federal Court rejects Apotex’s invalidity allegations on claims for use of abiraterone acetate in combination with prednisone

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On October 29, 2019, the Federal Court issued its final decision under the pre-amended Patented Medicines (Notice of Compliance) Regulations: Janssen Inc v Apotex Inc, 2019 FC 1355. Justice Phelan granted Janssen’s...more

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Rx IP Update - June 2018

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Health Canada News - Health Canada issues updated guidance on PMNOC Regulations - Health Canada has issued updated guidance reflecting the September 21, 2017 amendments: Guidance Document: Patented Medicines (Notice of...more

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