US court upholds stand against Ranbaxy, Teva

The US Court of Appeals for the Federal Circuit has upheld the preliminary injunction against Ranbaxy Laboratories Inc and Teva Pharmaceuticals USA Inc, barring the generics players from marketing Quinapril HC1 tablets (5, 10, 20, and 40 mg) in the US. The case would now be argued at the District Court in New Jersey.

The injunction on the $500 million drug had been given by the US District Court on a patent infringement suit filed by the innovator Pfizer Inc which sold it as 'Accupril'.

Pfizer had sued both Ranbaxy and Teva and claimed damages to the tune of $387 million due to lost sales of the drug in 2004.

"Today's decision sends a clear message that the law does not encourage or excuse infringement of valid pharmaceutical patents by generic companies," stated a release on Pfizer's website.

However, Jay Deshmukh, Ranbaxy's vice-president for Global Intellectual Property, said, "The preliminary injunction did not address the invalidity or enforceability of the patent.

Accordingly, Ranbaxy intends to vigorously challenge infringement, validity and enforceability of the patent in further proceedings before the District Court."

Teva, which had secured the 180-day exclusivity on Quinapril after a successful Para IV challenge, was marketing the drug while Ranbaxy manufactured it for the Israeli generics giant.

After the challenge by Pfizer, Teva waived its exclusivity leaving the field open to other generic manufacturers like Ranbaxy with Abbreviated New Drug Application (ANDA) approvals for the drug.

Refusing to call the latest court order a setback, a Ranbaxy spokesperson said, "We are going to aggressively go into litigation. It is a high-risk high-return game and part of our business model."

Asked if the court order on Quinapril would change the financial projections of the company "" it had been cited as the cause for decline in bottomlines in the company's quarter-end results, the spokesperson commented that they were not expecting any impact whatsoever on account of this.

Ranbaxy has in recent times emerged as one of the most aggressive patent challengers across the world with mixed fortunes.

It was sued a day before by Astrazeneca for 'willful infringement' of its $4 billion drug Nexium and has a litigation on with Pfizer on the largest prescription drug ever, Lipitor, in various parts of the world. The case for the $12 billion drug is coming up for hearing by the year-end.

DRUG PLAY

• Ranbaxy not expecting any impact on it's financial projections from the court order on Quinapril
• The injunction on the $500 million drug had been given by the US district court on a patent infringement suit filed by the innovator Pfizer Inc
• Pfizer had sued both Ranbaxy and Teva and claimed damages to the tune of $387 million due to lost sales of the drug in 2004
• Teva, which had secured the 180-day exclusivity on Quinapril after a successful Para IV challenge, was marketing the drug while Ranbaxy manufactured it for the Israeli generics giant