Pfizer's slams India's patent regime, says Indian standards are vague and malleable.

NEW DELHI: American drugmaker Pfizer Inc has slammed the patent regime in India, telling a domestic industry body in a letter that all patents that the company has managed to get in the country do not have any meaning.

The company's chief intellectual property counsel Roy F Waldron has replied to the Indian Pharma Alliance (IPA), which had questioned many of his assertions in a testimony before the US House Committee on Ways and Means in March, and stuck to his stance.

"The parlous environment for patent rights in India has set the ground to render each and every one of those cited Pfizer patents without meaning in the Indian legal environment," said Waldron, responding to the list of patents cited by the IPA to contest his claim that the intellectual property environment in India was deteriorating.

Waldron has also questioned the logic behind not holding Glivec patent valid in India, without directly referring to the Supreme Court judgement. "The Glivec product is one example of a product that had enhanced bioavailability over the prior art.

Anyone in the pharmaceutical sciences will tell you that developing forms of compound that have increased bioavailability is the holy grail for pharmacists...A drug that is more bioavailable is by definition a more therapeutically effective drug," Waldron said. To dismiss as 'evergreening', the absolutely critical area of pharma sciences is blithely to dismiss valuable work that millions of pharmacists and pharma scientists do everyday to meet the needs of patients, he added.

"India's chief reason and rationale for not complying with the full extent of its TRIPS (Trade Related Aspects of Intellectual Property Rights) obligations is related to preserving its domestic industry's exports markets," Waldron alleged in his letter.

The IPA, in its letter, had quoted a World Health Organisation statement of 2004 which had applauded India as a global leader in supplying HIV drugs and other essential medicines and urged the government to not give in to the TRIPS plus measure, which, it said, could impede access to medicines. On the grant of India's first compulsory licence to Natco for cancer drug Nexavar on grounds of "reasonably meeting requirements of the public and reasonably affordable price", Pfizer's IP counsel said "the standards here are so vague and malleable such that any non-Indian company would find itself on the other side of the argument every time".

The provisions (for grant of compulsory licensing) can be and have been so easily manipulated and abused such as to deprive a patentee of rights that for all intents force that company from competing in the Indian market, he added. The sharp comments on India's patent regime from Waldron late last month came after IPA alleged in May that he had misled the US committee by making factually incorrect statements.

Waldron, in his testimony in March, had urged the US government to review all available policy tools in light of India's deteriorating intellectual property environment besides sensitising government officials and raising concerns at bilateral and multilateral forums to send signals to the Indian government that such actions were not condoned. The testimony happened days before India's Supreme Court rejected Novartis' plea to grant a patent for its drug Glivec.

Source : timesofindia.indiatimes.com