In Canada, innovator drug companies can protect their market exclusivity from generic copycats by asserting patents against the generic manufacturer in litigation under the PM(NOC) Regulations. Until now, the consequences of losing PM(NOC) litigation was the potential payment of damages to the generic whose market access was delayed by the litigation. These so-called “section 8 damages” are limited to the actual loss suffered by the generic during that specific period of delay. Public policy is such that the profits earned by the innovator during that period cannot, however, be disgorged pursuant to section 8 of the PM(NOC) Regulations.… Continue Reading
On July 2, 2014, Mr. Justice Rennie of the Federal Court released his judgment and reasons in Astrazeneca Canada Inc v. Apotex Inc., 2014 FC 638 dismissing AstraZeneca’s action for infringement and granting Apotex’s counterclaim for a declaration that Canadian Patent 2,139,653 (the “‘653 Patent”) is invalid. This patent relates to AstraZeneca’s successful drug NEXIUM® (esomeprazole).
Justice Rennie found the invention of the ‘653 Patent was novel and non-obvious, but nevertheless invalidated the patent for promising an improved therapeutic profile which was not soundly predicted.
While Justice Rennie canvassed a number of legal issues, his … Continue Reading
In a pair of simultaneously released decisions on June 13, 2014, Justice O’Reilly allowed Allergan’s applications (the “Applications”) prohibiting the Minister of Health from issuing NOCs to Cobalt (now “Actavis”) (2014 FC 566) and Apotex (2014 FC 567) to market their generic versions of LUMIGAN RC® until the expiry of Canadian Patent 2,585,691 (the “‘691 Patent”) in 2026.
Allergan was represented by Andrew Reddon, Steven Mason, Steven Tanner and Sanjaya Mendis of McCarthy Tétrault LLP.
Allergan originally marketed a 0.03% bimatoprost (“Bp”) containing formulation for treating glaucoma called LUMIGAN, … Continue Reading