Pfizer v. Ratiopharm: Invalid Patent Insufficient to Support Back-Claim Compensation

Generic drug companies have suffered a setback in the fight to claim compensation when they have been incorrectly kept off the market. The Federal Court of Appeal has refused to overturn a prohibition order against Ratiopharm, thereby disallowing Ratiopharm’s compensation claim, in spite of the fact that Pfizer’s patent is invalid.

Pfizer was initially successful in preventing the invalidation their Patent No. 1,321,393 (‘393 Patent) under the NOC Regulations. Then in 2006, Ratiopharm had another go at Patent ’393 and it was subsequently found that Pfizer had wilfully relied on fraudulent material in support of their patent. This allowed Ratiopharm to then market its generic version of Pfizer’s drug NORVASC.

Yet in order for Ratiopharm to claim compensation for the losses they incurred having been kept off the market by an invalid patent, according to s.8 of the NOC Regulation, Ratiopharm had to bring a motion to set aside the Court’s earlier NOC prohibition order. That is the main issue of this case.

Ratiopharm claims that because Patent ’393 has been found to be invalid, the initial NOC prohibition order should be overturned, as the order was obtained by fraud, and compensation should be allowed.

The Federal Court of Appeal decided, however, that for the order to be overturned, the fraud must have been committed in the proceedings in which that NOC order was made. Ratioparhm must establish that were it not for the fraud, the Court would not have reversed the Federal Court decision and issued the 2006 order.

Because Ratiopharm did not file a record of the proceedings which could establish that the original panel of judges were victims of fraud, and no perjured evidence and no forged documents were filed in the NOC proceedings, consequently, there was nothing to indicate that Pfizer had the intention to mislead during those specific NOC proceedings. As such, the prohibition order would not set aside on the basis of fraud.

We will now see whether Ratiopharm will appeal this to the SCC.