AstraZeneca Canada Inc. v. Apotex Inc., 2011 FC 505 (T-1668-10); aff’d 2011 FCA 211 (A-180-11)
The Federal Court of Appeal has upheld a decision to deny an innovator pharmaceutical company's motion for an interlocutory injunction prior to the trial of an infringement action, scheduled to be heard in September 2013. The Court of Appeal deferred to the lower court's findings of fact, and found no reviewable error.
The action involves five of AstraZeneca's patents. Two of the patents had been involved in prior NOC applications: one was withdrawn on consent, the other was dismissed on June 16, 2010 on the basis that Apotex's allegations of invalidity were justified. Apotex obtained their NOC the following day. On July 13, 2010, Apotex confirmed its intention to launch its Apo-Esomeprazole product, and re-confirmed on July 26, 2010. Apo-Esomeprazole was listed on the drug formularies in Quebec, Nova Scotia, and New Brunswick in February, 2011. AstraZeneca brought their motion on March 11, 2011, four days after Apotex launched their product and announced it had commercial inventories available.
In the end, the Court found that AstraZeneca could not show irreparable harm as their potential damages are likely to be quantifiable and recoverable. Furthermore, the balance of convenience fell in favour of Apotex.
Justice Crampton made a few general observations relating to the tripartite test for an interlocutory injunction:
- Serious issue to be tried: prior decisions in NOC proceedings where the allegations of invalidity were justified will not create a presumption of invalidity. NOC proceedings are not res judicata of the issue in later actions.
- Irreparable harm: An applicant for an interlocutory injunction is permitted to make a profit and still suffer irreparable harm. The law does not require applicants to establish that they are likely to become unprofitable if the injunction they seek is not granted.
- Balance of convenience: The balance of convenience is not automatically awarded to a generic who has succeeded in a prior NOC proceeding. An innovator company may obtain an interlocutory injunction following a NOC proceeding where they satisfy the tripartite test. This is not contrary to the spirit of the NOC Regulations.
The full text of the decisions can be found at: