The Patented Medicines (Notice of Compliance) Regulations regulations link the patent system to the regulatory regime for food and drugs in Canada.
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October 6, 2016
October 6, 2016
2014 FCA 68 - Innovator pharmaceutical companies should be cautious and think twice about how aggressively they defend their patents as they could potentially face paying more than 100% of actual damages as an award under section 8 of the PM(NOC) Regulations.
October 5, 2016
October 5, 2016
2015 FCA 286 - An attack on the Federal Court’s slight rewording of the obvious-to-try test has proven unsuccessful. The FC referring to a 'fair expectation of success'" was not a reviewable error.
August 22, 2016
August 22, 2016
2016 FC 720 - The FC bifurcated the issues of infringement and validity from any other section 8 issue in hopes that bifurcation would likely lead to a settlement of all the issues between the parties.
May 6, 2016
May 6, 2016
2015 FC 875 - The FC noted that the law is unsettled when it comes to determining the appropriate date for assessing obvious-type double patenting.
April 11, 2016
April 11, 2016
2015 FC 570 - The FC favoured the respondent’s "blinded expert" evidence in which the experts provided their opinions before knowing what was claimed in the disputed patents.
April 5, 2016
April 5, 2016
2015 FC 125 - The existing patent was invalid on the grounds of lack of utility for having made a promise of utility that could not be demonstrated nor soundly predicted, was anticipated by a previous patent of the applicant that claimed an overlapping dosage range, and was also therefore made obvious by the same previous patent.
February 17, 2016
February 17, 2016
2015 FC 1205 - A quirk in the PM(NOC) rules was resolved that could make the entry of generics into the market even slower if the generic tries to make post-filing amendments to its application.
October 7, 2015
October 7, 2015
Gilead Sciences, Inc v Canada (Health), 2015 FC 610 - Gilead's assertion that its patent is valid would be relitigating old issues and an abuse of PM(NOC) proceedings.
May 20, 2015
May 20, 2015
The proposed amendments would dispose of the product specificity requirement that was interpreted by the Federal Court of Appeal in paragraphs 4(2)(a) and 4(2)(b) of the PM(NOC) Regulations.
February 25, 2015
February 25, 2015
Eli Lilly Canada v Canada (Attorney General), 2014 FC 152 - This decision clearly states that a higher level of specificity is required to adhere to the Regulations than is required for an element to be claimed as a matter of claim construction.