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Canada Patent Infringement Pharmaceutical Patents

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Federal Court finds patent for concentrated methotrexate solutions obvious

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On March 26, 2024, the Federal Court dismissed Medexus and Medac’s action for patent infringement of Canadian Patent No 2,659,662 (the 662 Patent), finding the asserted claims invalid for obviousness: Medexus Pharmaceuticals...more

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Dexlansoprazole formulation patent invalid and not infringed by Apotex

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On February 7, 2024, the Federal Court dismissed Takeda’s action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations in relation to dexlansoprazole (Takeda’s DEXILANT). Justice Furlanetto...more

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FCA upholds inducement of infringement findings relating to paliperidone palmitate.

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As previously reported, the Federal Court released a pair of decisions relating to paliperidone palmitate (Janssen’s INVEGA SUSTENNA), finding in a summary trial that each of Pharmascience and Apotex would induce infringement...more

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LUMIGAN RC formulation patent found valid and infringed

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In a patent infringement action brought by Allergan and AbbVie under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (Regulations), in relation to 0.01% w/v bimatoprost solution for ophthalmic...more

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Canadian IP Litigation 2023: Year in Review

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The year 2023 witnessed several developments in Canadian IP litigation. From summary judgment finding its limits to the denial of a permanent injunction for the first time in almost three decades, several cases decided in...more

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Canadian Patent Law 2023: A Year in Review

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In our annual review of developments in Canadian patent law, we considered over 60 patent decisions reported last year. This article highlights statutory changes and a selection of interesting points addressed in the reported...more

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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

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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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Declaration of infringement does not preclude further NOA based on invalidity

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Update: Janssen has appealed after obtaining leave from the Federal Court of Appeal (A-229-23). On June 28, 2023, Manson J. of the Federal Court dismissed Janssen’s motion for summary judgment in actions relating to...more

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Obviousness of Lilly’s tadalafil (CIALIS) dosage form patent stands

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The Federal Court of Appeal has dismissed Lilly’s appeals of judgments that held Canadian Patent No. 2,371,684 (the 684 patent) claims invalid. The decision, Eli Lilly v Apotex, 2023 FCA 125, was issued on June 2, 2023....more

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Apotex’s section 8 claim for Apo-Atomoxetine dismissed

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On March 30, 2023, the Ontario Superior Court of Justice dismissed Apotex’s claim under section 8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) relating to Apo-Atomoxetine (Lilly’s...more

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Lilly’s CIALIS patent claims extending to “physiologically acceptable salt” found invalid for overbreadth and insufficiency

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On October 17, 2022, Justice St-Louis of the Federal Court granted a motion for summary trial brought by Teva, Pharmascience, Laboratoire Riva, Apotex and Mylan (the Defendants) and dismissed the underlying actions of Lilly...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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PM(NOC) Regulations: Five-year anniversary of major amendments

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September 21, 2022, marked the fifth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fifth year...more

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Sandoz granted leave to add new allegations on condition of trial adjournment and extension of 24-month stay

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In a decision rendered on August 17, 2022, the Federal Court granted Sandoz Canada Inc (Sandoz) leave to amend its Statement of Defence to add new allegations, contingent on an adjournment of the trial and an extension of a...more

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Federal Court finds Minister of Health reasonable in concluding JAMP not a ‘second person’ for its SIMLANDI biosimilar

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On August 17, 2022, the Federal Court, per Justice Fothergill, dismissed AbbVie’s applications for judicial review of the Minister of Health’s decisions that (1) JAMP was not a “second person” and therefore it was not...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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Janssen succeeds on infringement against Apotex in macitentan combination patent case

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In a public decision dated July 6, 2022 in an action under the Patented Medicines (Notice of Compliance) Regulations, Justice Pallotta of the Federal Court found that Apotex would infringe Janssen’s patent relating to...more

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Update on biosimilars in Canada – June 2022

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We provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, market access and competition) since our last update in October 2021....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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Federal Court of Appeal upholds validity of glatiramer acetate patent

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The Federal Court of Appeal (FCA) dismissed an appeal by Pharmascience from a decision of the Federal Court... which found Canadian Patent No. 2,760,802 (802 Patent) valid and infringed by Pharmascience’s proposed glatiramer...more

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2021 Highlights in Canadian Life Sciences IP and Regulatory Law

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In the fall of 2021, the Rx IP Update team celebrated its 20thyear of monthly updates on Canadian life sciences IP and regulatory law. Below are highlights from our team’s 2021 updates...more

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PM(NOC) Regulations: Fourth year following major amendments

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September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fourth year...more

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