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CETA PMNOC Regulations

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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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Amended PMNOC Regulations: First Anniversary Update

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As previously reported, the amended Patented Medicines (Notice of Compliance) Regulations (“Regulations”) came into force on September 21, 2017, heralding significant changes to the landscape for pharmaceutical companies in...more

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Rx IP Update - 2017 Highlights in Canadian Life Sciences IP

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The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...more

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Update on Biosimilars

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The following provides an update on biosimilars in Canada. Health Canada’s guidance on biosimilars - In November 2016, Health Canada issued a Guidance Document: Information and Submission Requirements for Biosimilar...more

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Publication of Final Regulations on Patent Linkage and Term Restoration

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On September 7, 2017, the Government of Canada published final pharmaceutical regulations flowing from CETA. According to an Order in Council, the new regulations will be in force on September 21, 2017....more

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Rx IP Update - July 2017

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Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more

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CETA Draft Regulations Published on Patent Linkage and Term Restoration – 15 Day Public Comment Period

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The government has published the long anticipated draft regulations regarding: - changes to the Patented Medicines (Notice of Compliance) Regulations [“PMNOC Regulations”], and - proposed Regulations to implement...more

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Rx IP Update - May 2017

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Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission - On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...more

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Rx IP Update - March 2017

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Tribunal dismisses Eli Lilly’s NAFTA challenge on promise utility doctrine - As previously reported, Eli Lilly submitted claims to international arbitration under the North American Free Trade Agreement (NAFTA) seeking...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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RxIP Update - 2016 Year in Review

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The following are highlights of developments in Canadian life sciences intellectual property and regulatory law in 2016, updating our 2016 mid-year highlights. 1. Substantive patent law developments - Utility and...more

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