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Patent Invalidity Notice of Compliance

Smart & Biggar

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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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 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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Federal Court finds invalidity allegations relating to patent for metformin formulations not justified

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On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of Health from issuing a notice of compliance to Generic Partners for its generic version of Valeant’s GLUMETZA,...more

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Apotex not permitted to plead promise-based invalidity grounds in Ontario section 8 lansoprazole action

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This motion arose in the context of a section 8 action in which Apotex claims damages for delay in the issuance of its notice of compliance for its generic lansoprazole product (Takeda's PREVACID), due to prohibition...more

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Shire’s VYVANSE patent valid, prohibition order issued

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On June 29, 2018, Justice Fothergill of the Federal Court granted Shire’s application under the pre-amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for an order prohibiting the Minister of...more

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RX IP Update - January 2017

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Apotex’s Infringement of AstraZeneca’s Omeprazole Formulation Patent Upheld - As previously reported, the Federal Court of Appeal, in a unanimous decision released on January 12, 2017 (2017 FCA 9), has affirmed the...more

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