PM(NOC)

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

May 20, 2015

PM(NOC) Amendments to Reverse Gilead and Viiv Decisions Regarding Product Specificity Requirement for Combination Drugs

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

Cobalt gets Overlapping Costs Reduced in PM(NOC) Proceeding

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

Mylan-Tadalafil does not Infringe Eli Lilly’s Formulation Patent in NOC Proceeding

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

Federal Court Upholds Gap between Claim Construction and PM(NOC) Product Specificity Requirement for Combination Drugs

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

Industry Canada to Amend PM(NOC) Regulations Respecting Patents Listed for Combination Drugs

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

Federal Court Prohibited Issuance of a NOC for Generic Version of Lumigan

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

Pharma Innovator Benefiting from Data Protection Has Standing in Proceeding Brought by Generic Challenging Minister’s Decision to Enforce that Data Protection Against the Generic

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

Federal Court Grants Motion for Bifurcating Determination of Start of Liability Period under s. 8 of the PM(NOC) Regulations

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

FCA Upholds Trial Court Ruling that Availability of Compensation under s. 8 of the NOC Regulations Is a Question of Fact

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

FCA Dismisses Pfizer’s Appeal Challenging Admissibility and Weight of Apotex Expert’s Testimony

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.