The Canadian Senate has passed Bill C-30 (the act intended to implement CETA), the final major stage of the legislative process. Bill C-30 will become law once it receives royal assent, which we expect to happen shortly.
May 12, 2017
The Government of Canada has published draft regulations pursuant to Vanessa’s Law that provide details regarding the Minister of Health’s powers to require tests, assessments and studies of a drug post-market authorization and set out additional reporting requirements for manufacturers based on the actions of foreign regulators.
May 08, 2017
Major reforms to Canada’s Patent Act are coming soon, including the implementation of patent term restoration (i.e., Certificates of Supplementary Protection (CSP)), which may extend the patent term of eligible pharmaceutical products by up to two years.
May 04, 2017
Health Canada has proposed regulations that will amend the Food and Drug Regulations to allow for importation of drugs that address an urgent public health need but have not yet received regulatory approval from Health Canada
May 02, 2017
The Federal Court of Appeal dismissed BMS’s appeal from the Federal Court’s finding that claims for the bisulfate salt of atazanavir were obvious, and provided guidance on the meaning of “inventive concept” and the application of the leading Plavix decisions to obviousness.
April 25, 2017
The Regulation respecting calls for tenders for certain medications covered by the basic prescription drug insurance plan (the Regulation) came into force on April 20, 2017.
The Federal Court of Appeal allowed Apotex’s appeal from the Federal Court decision that found Apotex was entitled to damages for misfeasance of public office and negligence in part, finding that Apotex was not required to mitigate its damages.
April 21, 2017
The Federal Court made factual findings relating to Teva’s damages for being delayed from entering the olanzapine market, rejected Teva’s argument that its damages should include a pipefill adjustment, and clarified evidentiary issues on fact witnesses and hearsay.
April 20, 2017
Health Canada has released a white paper setting out Health Canada’s decision to make certain clinical information from drug submissions and medical device applications available to the public following regulatory review.
April 11, 2017
The court granted Shire’s motion to partially consolidate an application pursuant to section 6 of the Regulations and an impeachment action with respect to the same patent.
April 03, 2017
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