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 21, 2016
October 21, 2016
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
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.
September 15, 2015
September 15, 2015
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.
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.
May 13, 2015
May 13, 2015
Lundbeck Canada Inc v Canada (Health), 2014 FC 1049 - How should overlapping expert costs be allocated? Three parties each sought a Notice of Compliance (NOC) for the same drug, and the innovator relied on much the same expert evidence in each proceeding but costs were not precisely allocated among the three proceedings.
March 24, 2015
March 24, 2015
Eli Lilly Inc v Mylan Pharmaceuticals ULC, 2015 FC 178 - Mylan did not infringe the ‘948 Patent because the Mylan’s tadalafil compound did not have the claimed particle size distribution and the formulation did not contain the claimed concentration of hydrophilic binder. The Court rejected two purposive arguments by Eli Lilly in favour of a more literal reading of the patent.
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.
December 22, 2014
December 22, 2014
The proposed amendments are said to clarify the patent listing requirements as they relate to single medicinal ingredients found in combination drugs and confirm Health Canada’s established practices which, in light of recent Federal Court and Federal Court of Appeal decisions, may need to change.
July 31, 2014
July 31, 2014
Allergan Inc v Apotex Inc, 2014 FC 567 - In terms of claim construction, this case shows the tension between construing claims based solely on the wording of the claims versus peering beyond the wording of the claims to distill an underlying invention.
July 3, 2014
July 3, 2014
Hospira Healthcare Corporation v Canada (Health), 2014 FC 179 - The Court determined that a pharmaceutical innovator benefiting from data protection has standing where that data protection is challenged.
May 26, 2014
May 26, 2014
Apotex Inc v Pfizer Canada Inc, 2014 FC 159 - The Court confirmed that bifurcation of a PM(NOC) proceeding is not limited to liability/damages, and held that “[i]t is open to the Court to bifurcate any issue which will result in the saving of time, cost and judicial resources.” The issue need not be a threshold issue determinative of the proceedings.
March 21, 2014
March 21, 2014
Sanofi-Aventis Canada Inc v Teva Canada Limited - 2014 FCA 69 - The Court stated that whether there can be recovery for unauthorized indications under section 8 of the PM(NOC) Regulations is a question of fact, and that the purpose of section 8 damages is to compensate generics for a delay caused by NOC Proceedings.
March 10, 2014
March 10, 2014
Pfizer Canada Inc v Apotex Inc, 2014 FCA 54 - The Court rejected Pfizer's argument that the trial judge did not properly apply the R. v. J.-L.J., 2000 SCC 51 case when assessing the admissibility of what Pfizer alleged were novel scientific theories put forth by Apotex’s expert.