The Hindu Business Line : Setback for Dr Reddy's as Pfizer wins ruling

In a significant ruling, the US Court of Appeals for the Federal Circuit has reversed a lower court ruling and determined that the patent extension covering Pfizer's Norvasc (Amlodipine Besylate) is applicable to Dr Reddy's AmVaz (Amlodipine Maleate).

The Appeals Court has also said that allowing Dr Reddy's drug would be exploiting an unintended loophole in the law.

Norvasc is the world's top selling hypertension drug from Pfizer, with the global drug major holding patent rights till 2007.

Dr Reddy's had filed with the United States Federal Drug Authority (US FDA) to obtain approvals for its variant of Norvasc, for marketing AmVaz using the 505(b)(2) route of the US law.

Even as Dr Reddy's has not spelt out the total loss it could suffer owing to the legal battle, the pharmaceutical industry sources predict a tough time for Dr Reddy's since it has not seen a big product launch for close to two years. According to the spokesperson of Dr Reddy's, the legal expenses over the issue "could be in the range of $10 million, while the market opportunity lost has not been determined."

Responding to the development, Dr Reddy's Chief Executive Officer, Mr G.V. Prasad, said, "We are clearly disappointed by the court decision and had expected that the views expressed by the Chief Judge in the dissent would have been the position of the majority."

However, he said, "Despite today's ruling, we remain committed to investing the resources to create a sustainable US-based business of specialty products and new chemical entities as well as generic medicines."

Dr Reddy's ADR listed on the NYSE fell by 12.5 per cent on Friday to $25.45.

More Stories on : Corporate Disputes | Courts/Legal Issues | Pharmaceuticals

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