PM(NOC)

The Patented Medicines (Notice of Compliance) Regulations regulations link the patent system to the regulatory regime for food and drugs in Canada.

October 21, 2016

FCA Clarifies Test for Obviousness-Type Double-Patenting

2016 FCA 119 - The FCA dismissed the appeal, which alleged that Canadian Patent No. 2,226,784 was invalid on the basis of obviousness-type double-patenting and for lack of utility due to no sound prediction. As a result, the ‘784 patent was upheld.
October 6, 2016

Pharmaceutical Patentees Could Face More than 100% of Actual Damages under PM(NOC) Regulations

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

“More or Less Self-evident” Remains the Standard in the Obvious-to-Try Test

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

FC Bifurcates Infringement & Validity Issues from Section 8 PM(NOC) Proceeding in Hopes of Settlement

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

Law Remains Unsettled Regarding Appropriate Date for Assessing Obviousness-type Double Patenting

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

FC Dismisses Prohibition Application – Favours Respondent’s “Blinded Expert” Evidence

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

Strike Two: Second Prohibition Application Regarding Mylan’s Proposed Tadalafil Tablets Denied

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

Data Protection Provisions Block Post-Filing NDS Amendments for Generic Drug

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

Relitigating Conceded Claims is an Abuse of PM(NOC) Proceedings

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.
September 15, 2015

FCA Rejects “Exact Matching” Requirement in PM(NOC) Regulations

Eli Lilly Canada Inc v Canada (Attorney General), 2015 FCA 166 - The FCA rejected the notion adopted by the Federal Court 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, bringing the law in line with Industry Canada proposed amendments.