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Patent infringement of Pfizer drug — Ranbaxy to appeal against US court injunction

Our Bureau

New Delhi , March 30

RANBAXY Laboratories Ltd will appeal against the US District Court's preliminary injunction barring the Indian generics company and Teva Pharmaceuticals from selling quinapril tablets used for treating blood pressure in the US market as it was infringing Pfizer's patent for Accupril.

Pfizer had asserted that Ranbaxy's quinapril tablets, which have been marketed through an exclusivity relinquishment arrangement with Teva, were infringing its US patent both literally and under the doctrine of equivalents.

Accupril and the related Accuretic contributed about $665 million to the Pfizer's sales last year, with a major portion of the revenues coming from Accupril.

According to a statement issued by Pfizer, "The court held that Pfizer was likely to prevail in its patent infringement suit filed on January 28, 2005 against Teva and Ranbaxy, and ordered the preliminary injunction to prevent further sales of the Teva-marketed product, while Pfizer seeks a permanent injunction.

"The judge has also denied Ranbaxy's and Teva's request to stay the injunction. As a result of the ruling, Pfizer will seek damages resulting from lost sales."

Meanwhile, Mr Jay Deshmukh, Vice-President, Intellectual Property, Ranbaxy, stated that while Teva and RPI will comply with the preliminary injunction, they also will immediately file with the US Court of Appeals for the Federal Circuit an appeal to have the injunction lifted and a motion to expedite the appeal.

He added, "Ranbaxy Pharmaceuticals Inc, (the US subsidiary) is confident that it will, on appeal, be able to make a compelling argument in support of its non-infringement position."

Teva launched Ranbaxy's version of quinapril in December 2004 under its own label. The Israel-based generics company signed this agreement with Ranbaxy after losing a patent infringement suit involving the same Pfizer patent. It was then found that Teva's generic version of quinapril infringed the valid patent that expires in August 2007.

The New York-based company has argued that even Ranbaxy's version of the drug infringed the patent. Other companies such as Mylan Laboratories Inc and Par Pharmaceuticals also sell generic Accupril, but there are no litigations involving these products.

Analysts tracking the sector said this decision by the US Court would hurt Ranbaxy as the company was hoping to generate about $8-10 million from this product in the first year.

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