No Double Patenting, Claims Invalid, Patent Prohibition Orders Not Set Aside, No Section 8 Damages
Aventis-Pharma Inc. v. Pharmascience Inc. 2009 FC 915 (Zinn J.)

September 15, 2009

Gunars A. Gaikis for Aventis-Pharma Inc. and Aventis Pharma Deutschland GmbH
Donald H. MacOdrum for Pharmascience Inc. (“Pharmascience”)
Eric Peterson for the Minister of Health (“Minister”)

The Court was asked by Pharmascience to set aside two earlier orders of the Court which prohibited the Minister of Health from issuing a Notice of Compliance (“NOC”) to Pharmascience for ramipril. The orders of the Court were from two earlier applications wherein the Court granted orders of prohibition based essentially upon Pharmascience’s failure to establish that Canadian Patent No. 1,341,206 (the ‘206 Patent) was invalid on the basis of double patenting.

Years later, a patent infringement action was commenced against Apotex Inc. and Novopharm Limited for their sale of ramipril in Canada. After the trial of those actions, Justice Schneider found that claims 1, 2, 3, 6 and 12 of the ‘206 Patent are invalid, void, unenforceable and of no force or effect. Those same claims of the ‘206 Patent were the only relevant claims with respect to the orders of prohibition ordered by the Court in the instant cases.

As a consequence of the Court’s recent finding of invalidity of these claims of the ‘206 Patent, Pharmascience requested the Minister to issue the NOC for which it had previously applied for its ramipril capsules.

The Minister responded to Pharmascience’s request stating that it was not able to issue the NOC given the two earlier Court orders prohibiting the Minister from issuing the NOC. Specifically, there were remaining claims which were not declared to be invalid, therefore there was no declaration by the Court that the entirety of the ‘206 Patent is invalid and therefore the ‘206 Patent cannot be considered to be expired, which would otherwise have allowed the Minister to grant the NOC. 

The Minister further cited the PM(NOC) Regulations which would also prevent it from issuing the NOC as a result of the ‘206 Patent remaining on the patent list. As a consequence of this response, Pharmascience brought the instant motion seeking to set aside the two orders of prohibition previously granted by the Court and to dismiss the applications in those two matters.

When the motion came on for hearing, the Applicants informed the Court that an appeal of Justice Schneider’s judgment which found invalid a number of the claims of the ‘206 Patent had been filed, however they had no objection to Pharmascience being issued the NOC for ramipril. They took the position that it is unnecessary to set aside the orders of prohibition and that it would be unnecessary and inappropriate to dismiss the underlying applications. They speculated that Pharmascience was seeking to have the applications dismissed in order that it could take advantage of a claim for damages under Section 8 of the Regulations.

The Court determined that it was not plain and obvious that the orders of prohibition no longer prevented the Minister from issuing an NOC to Pharmascience. However, in order to come to the conclusion that the Minister ought no longer to be prevented from issuing the NOC, one must look behind the orders to the real issues that were determined and that were in dispute.

The Court was not persuaded that an order setting aside the prohibition orders is not necessary in order that the Minister may issue the Notice of Compliance. With respect to the timing of such an order, the Court stated that it saw no reason why an order setting aside these prohibition orders should be effective from any earlier date than the date of its new order. The Court further found that it would be improper to now set aside the findings of the Court in the two earlier applications wherein prohibition orders were issued and denied dismissing the applications. 

By:  Peter W. Choe, Gowling Lafleur Henderson LLP