In AstraZeneca v Apotex, 2017 FC 726, the Federal Court issued its damages decision concerning Apotex’s infringement of a patent pertaining to AstraZeneca’s LOSEC (omeprazole) drug. This decision offers insight in the factual hurdles a generic must overcome to establish an ex post facto non-infringing alternative (NIA), and confirms that s. 8 damages are not available during a period in which a generic would be infringing a patent, as there is no compensable loss.… Continue Reading
The provisional application of CETA takes effect in Canada today, ushering in a new era for pharmaceutical patent litigation. As part of this implementation, amendments to the Patent Act, the Patent Rules and the PM(NOC) Regulations, as well as the new Certificates of Supplemental Protection (CSP) Regulations, came into force today. See our previous posts on the new PM(NOC) Regulations and CSP Regulations for key details about these new schemes.
The Government of Canada has announced that the amended NOC regulations will come into force on September 21, 2017. These amendments will implement sweeping changes to pharmaceutical patent litigation in Canada pursuant to obligations imposed under CETA. The changes will apply to proceedings commenced in respect of NOAs served on or after September 21, 2017.
In this decision (2016 ONSC 4966), the Ontario Court dismissed Apotex’s claim for damages under s. 8 of the NOC Regulations in the face of a motion to strike. Apotex’s other relatively esoteric claims were, however, left for another day. These claims include alleged false and misleading statements under s. 7 of the Canadian Trade-Marks Act, unjust enrichment, nuisance, and conspiracy. Pfizer failed to establish that these claims were doomed to fail. The high standard applicable on these motions was not met.
Apotex pursues Pfizer in the Ontario Court for alleged losses relating to Apotex’s delay in … Continue Reading
Last year we wrote about a trilogy of Federal Court decisions relating to Eli Lilly’s erectile dysfunction (ED) drug CIALIS® (tadalafil). While Lilly was successful in obtaining a prohibition order in the first proceeding, its latter two applications were dismissed. Mylan appealed the first order, and the Federal Court of Appeal (FCA) recently released its decision in Mylan Pharmaceuticals ULC v. Eli Lilly Canada Inc., 2016 FCA 119 dismissing Mylan’s appeal.
The FCA’s decision affirms the view that obviousness and obviousness-type double patenting validity challenges require distinct analyses, and that a patent’s disclosure cannot be referenced to vary the … Continue Reading
A recent decision of the Federal Court in Allergan Inc. v. Apotex Inc. et al. (2016 FC 344), relating to the drug Gatifloxacin, appears to have regressed the issue of expert “blinding” in patent cases. Expert “blinding” is a relatively recent trend in patent litigation where a litigant intentionally “blinds” its expert witness to certain issues and materials in an effort to afford their opinions a higher degree of credibility. In the Gatifloxacin decision, the Court appears to have endorsed expert “blinding” in patent cases as not only de rigueur but, perhaps necessary; while other recent decisions of … Continue Reading