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
On July 15, 2017, the Canadian government published (link) its proposed amendments to the NOC Regulations. These amendments will implement sweeping changes to pharmaceutical patent litigation in Canada pursuant to obligations imposed under CETA. There will be a 15-day comment period, after which, the amendments will be published in final form. The finalized amendments are expected to be in force around late September 2017. These revamped NOC Regulations will apply to Notices of Allegation (“NOAs”) served on or after the date the revamped NOC Regulations come into force.
Overall, the revamped NOC Regulations… Continue Reading
In Teva v. Pfizer Canada, 2017 FC 526, the Federal Court reaffirmed and reissued a judgment awarding Teva a section 8 damages award in excess of $125 million relating to the drug EFFEXOR XR® (venlafaxine). This decision offers insight into the legal limits on what inferences can be drawn about a generic’s ability to source sufficient drug supply in the but-for damages world.
The key issue at this redetermination was whether Teva would have had and could have had access to sufficient quantities of venlafaxine at the relevant time to support its notional sales in … Continue Reading
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
On October 30, 2014, the Supreme Court of Canada granted leave to Sanofi-Aventis’ (“Sanofi”) application for leave to appeal a decision of the Federal Court of Appeal (2014 FCA 68). By granting leave to Sanofi, the Supreme Court will now consider for the first time the correct interpretation of, and the correct legal framework applicable to quantifying section 8 damages under the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”).
The PM(NOC) Regulations strike a balance between the interests of innovative pharmaceutical companies and generic manufacturers, by requiring generic manufacturers to address innovators’ patents before receiving … Continue Reading