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[Webinar] Cross-border IP strategies for IP owners and litigators - September 18th, 2:00 pm PDT

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Explore skinny labelling & obviousness in Canada and Australia - If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more

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[Webinar] Cross-border IP strategies for IP owners and litigators - September 12th, 12:00 pm GMT

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Explore skinny labelling & obviousness in Canada and Australia - If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more

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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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Biocon Settles with Bayer and Regeneron, Securing Canada Market Entry Date for Aflibercept Biosimilar

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On March 4, Biocon Biologics Ltd. announced it has signed a settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. regarding YESAFILI, Biocon’s proposed biosimilar to EYLEA (aflibercept)....more

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Federal Court of Appeal affirms paliperidone palmitate claims are not unpatentable methods of medical treatment

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In a 2022 decision involving Janssen and Pharmascience, the Federal Court found that the claims of Canadian Patent No. 2,655,335 (335 patent, relating to paliperidone palmitate (Janssen’s INVEGA SUSTENNA)) were not invalid...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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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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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 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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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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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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Minister of Health reasonable in deciding patent for Janssen’s STELARA was ineligible for listing against SNDSs

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On July 17, 2023, Justice Aylen of the Federal Court dismissed Janssen’s application for judicial review of the decision of the Office of Submissions and Intellectual Property (OSIP) refusing to list Canadian Patent 3,113,837...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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Supreme Court of Canada denies Apotex leave to appeal ONCA olanzapine Statutes of Monopolies decision

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As we previously reported, the Ontario Court of Appeal affirmed the lower court’s decision dismissing Apotex’s claims against Eli Lilly under the Ontario and English Statutes of Monopolies, Trademarks Act, and common law...more

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Supreme Court of Canada denies Pharmascience leave to appeal decision upholding the validity of two patents relating to ELIQUIS

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On March 30, 2023, the Supreme Court of Canada dismissed Pharmascience’s application for leave to appeal (Docket No. 40400) a decision of the Federal Court of Appeal (FCA) upholding the validity of two patents relating to...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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An Interview with Rachel Goode, Ph.D, about Biological Patent Thickets

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Kevin DeJong (Senior Editor) and Shweta Kumar (Editor) from the Big Molecule Watch recently interviewed Rachel Goode, Ph.D. to discuss an article she recently co-authored, “Biological patent thickets and delayed access to...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 rejects trial of common issues and allows pleadings amendment re: supply disruptions in abiraterone acetate amended...

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As previously reported, the Federal Court found Janssen’s Canadian Patent No. 2,661,422 (“422 patent”) – which relates to treatment of prostate cancer in humans by co-administration of abiraterone acetate (marketed by Janssen...more

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Federal Court of Appeal upholds obviousness finding re: Janssen’s abiraterone acetate and prednisone combination therapy patent

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As previously reported, the Federal Court found Janssen’s Canadian Patent No. 2,661,422 (the 422 patent) invalid on the basis of obviousness and dismissed its actions against Apotex, Dr. Reddy’s Laboratories, and...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 upholds validity of patent relating to paliperidone palmitate

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On August 23, 2022, the Federal Court issued its public judgment and reasons in two actions under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (the “Regulations”) relating to paliperidone...more

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Federal Court of Appeal upholds validity of two patents relating to ELIQUIS

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On August 4, 2022, the Federal Court of Appeal (FCA) dismissed Pharmascience’s appeal of a Federal Court decision upholding the validity of Canadian Patent Nos. 2,461,202 (the 202 patent) and 2,791,171 (the 171 patent)...more

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