Ranbaxy held in generics battle with Pfizer

Following an appeal by Ranbaxy Laboratories (RL) the Court of Appeals for the Federal Circuit (CAFC) has upheld a preliminary injunction granted by the US District Court for the District of New Jersey, US, barring its subsidiary Ranbaxy Pharmaceuticals (RP) from marketing Quinapril HCl tablets (five, 10, 20, and 40 mg), a generic product marketed by Teva Pharmaceuticals in the US.

The preliminary injunction came as a result of a suit brought by Pfizer in March, claiming that the tablets, which Ranbaxy describes as 'the AB-rated generic equivalent of Pfizer's antihypertensive agent Accupril Tablets', infringe on US Patent No. 4,743,450 'literally and under the doctrine of equivalents'. The sale of Quinapril, which began in December 2004, was immediately halted following this initial injunction, but Pfizer states that 'other non-infringing formulations remain on the US market'.

'The court explained that its decision was based on a preliminary record and noted that claim construction, a legal issue, is subject to change based on a more developed factual record,' commented Jay Deshmukh, Ranbaxy's vice president of global intellectual property. 'Moreover, the preliminary injunction did not address the invalidity or enforceability of the '450 patent. Accordingly, Ranbaxy intends to vigorously challenge infringement, validity and enforceability of the patent in further proceedings before the district court.'

'This decision sends a clear message that the law does not encourage or excuse infringement of valid pharmaceutical patents by generic companies,' countered Jeff Kindler, vice chairman of Pfizer. 'The ruling also reinforces the importance of intellectual property protection to the development of new, life saving medicines.'

The case will now be argued at the District Court in New Jersey as Pfizer seeks damages for 'lost sales' and Ranbaxy seeks to assert its non-infringement case.