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CETA Patents

Smart & Biggar

Federal Court of Appeal finds Minister of Health’s refusal to grant a CSP for SHINGRIX is reasonable

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In the first appellate decision relating to Certificates of Supplementary Protection (CSPs), the Federal Court of Appeal has allowed the appeal of the Minister of Health (the Minister), setting aside the lower court judgment....more

Smart & Biggar

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

Smart & Biggar

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

Smart & Biggar

Certificate of Supplementary Protection Regime: First Anniversary Update

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September 21, 2018 marked the first anniversary of the certificate of supplementary protection (CSP) regime. CSPs, which provide an additional patent-like protection term, are intended to partly compensate innovators for the...more

Smart & Biggar

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

Smart & Biggar

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

Smart & Biggar

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

Smart & Biggar

Rx IP Update - October 2017

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Pfizer obtains orders of prohibition on polymorphic form patent - On September 22, the Federal Court, in a pair of decisions, granted Orders of prohibition under the Patented Medicines (Notice of Compliance) Regulations...more

Mintz - Intellectual Property Viewpoints

Canada Institutes Certificates of Supplementary Protection for Approved Drug Products

On September 21, 2017, the Comprehensive Economic and Trade Agreement (CETA) signed between the European Union (EU) and Canada provisionally entered into force in Canada.  Among other things, this agreement seeks to harmonize...more

Smart & Biggar

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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Proposed amendments to the Canadian Patent Rules published for public consultation

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The Government of Canada has opened a public consultation on proposed amendments to the Canadian Patent Rules, running from August 1 to September 8, 2017. The changes relate principally to pending amendments to the Patent...more

Smart & Biggar

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

Bennett Jones LLP

Pharma and Biologics Disputes in Canada—Big Changes for Big and Small Molecule Litigation

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The patent litigation that propels generic and biosimilar products to market will soon change dramatically. July 15, 2017, marked the release of long-awaited proposed amendments to the Patented Medicines (Notice of...more

Smart & Biggar

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

Smart & Biggar

Bill C-30 passed Senate yesterday to usher in changes to Canadian pharma patent regulations

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Bill C-30 was passed by the Senate yesterday, May 11, 2017 without amendment. Bill C-30 is the bill that will implement the Canada-European Union Comprehensive Economic and Trade Agreement (CETA). As reported here, this...more

Smart & Biggar

Rx IP Update - February 2017

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Federal Court of Appeal rules on non-infringing alternatives and apportionment as defences to an accounting of profits from patent infringement - On February 2, 2017, the Federal Court of Appeal released a...more

Smart & Biggar

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

Smart & Biggar

Canadian IP law and practice in 2016: reviewing the highlights

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As the calendar turns the page from 2016 to 2017, we take the opportunity to review Canadian IP law and practice highlights from the past year....more

Smart & Biggar

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

Smart & Biggar

Rx IP Update - November 2016

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Federal Court of Appeal opines on the framework for analyzing obviousness-type double-patenting - On November 4, 2016, the Federal Court of Appeal dismissed Apotex’s appeal in Apotex Inc v Eli Lilly Canada Inc, 2016 FCA...more

Blake, Cassels & Graydon LLP

When the Dust Settles: An Update on Changes to Canadian IP Legislation

Canada is in the midst of a substantial overhaul of its intellectual property statutes and regulations that will have wide-ranging implications for patent, industrial design, trade-mark and copyright law as well as procedure....more

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