The Federal Court of Appeal dismissed a motion brought by ratiopharm to set aside an order of the appellate court in Pfizer Canada Inc. v. Canada (Minister of Health), 2006 FCA 214, which had granted an order prohibiting the Minister of Health from issuing a NOC to ratiopharm for its generic version of the brand drug, Norvasc (amlodipine besylate), until the expiry of Pfizer Limited’s Canadian Patent 1,321,393.

Following the issuance of the prohibition order, ratiopharm was successful in an impeachment action: ratiopharm v. Pfizer Limited, 2009 FC 711, affirmed 2010 FCA 204, which declared the ‘393 Patent invalid on all grounds argued at trial, i.e. obviousness, utility, sufficiency, selection patent and section 53 of the Patent Act.

ratiopharm consequently brought a motion to set aside the earlier prohibition order on two grounds: (1) by reason of a matter that was discovered subsequent to the making of the order, and (2) on the basis that the order was obtained by fraud. ratiopharm additionally sought an order dismissing the prohibition proceeding, so it could bring a claim for section 8 damages.

In respect of the first ground, the Court concluded that the issue was moot due to the prohibition order having expired with the expiry of the patent and the fact that a NOC had issued to ratiopharm and it was on the market.  In any event, the Court held that a subsequent finding in an of invalidity in an impeachment proceeding did not qualify as a “new matter”.

In respect of the second ground, the Court held that in order for ratiopharm to succeed in having the decision set aside for fraud, ratiopharm must establish that fraud was committed in both the NOC proceeding in the Federal Court and in the Court of Appeal and that the fraud is material, ie., but for the fraud, the Court of Appeal would not have reversed of the Federal Court’s decision and granted prohibition. The Court held that ratiopharm fell short of establishing the required materiality.

Finally, the Court of Appeal made it clear that, except where an order was obtained by fraud, a subsequent decision invalidating a patent does not provide a basis upon which an earlier prohibition order should be set aside.  As such, absent fraud, a generic drug manufacturer who is prohibited from being issued a NOC cannot reach back and apply the finding of invalidity in a subsequent action so as to argue it is entitled to section 8 compensation.

For a copy of the decision, please see:
http://decisions.fca-caf.gc.ca/en/2011/2011fca215/2011fca215.html