Multinational drug-maker Pfizer and a key association of the Indian pharmaceutical industry have locked horns over the protection of intellectual property in India.

“Recent decisions underscore a pattern of deteriorating IP (intellectual property) protection in India that undermines our ability to compete fairly, and creates a business environment that is unpredictable and threatens patients’ access to innovative medicines,” Pfizer said.

Pfizer was reacting to the Indian Pharmaceutical Alliance’s (IPA) rebuttal of an earlier submission made by a Pfizer representative to a US trade sub-committee.

In a strongly-worded response, the IPA had has that the Indian patent regime did not discriminate between domestic and foreign companies. “It distinguishes only between innovation and discovery of new forms of known substances that do not result in the enhancement of efficacy,” it added.

Patent battles

Further, it said, there were voices of concern emerging in the US too on the high cost of treatment — a constant concern in a developing country like India.

India had amended its Patent Act in 2005, to protect product patents. Granting a patent gives the innovator 20 years of manufacturing and marketing exclusivity on the product. Companies also seek to protect their IP or data generated from research for the new product.

The amended Indian patent regime witnessed a spate of legal activity, including two significant judgments. Earlier this year, the Supreme Court dismissed Novartis’ plea for patent protection on its blood cancer drug Glivec, on the ground that it was not a new drug.

In another development, the Patent Office had issued the country’s first compulsory licence to Natco last year, allowing it to make a similar version of Bayer’s advanced kidney cancer drug Nexavar. Pfizer, too, is locked in litigation over its kidney cancer drug Sutent.

Pfizer testimony

The war of words between Pfizer and the IPA has been triggered by a written testimony from Roy F. Waldron, Pfizer Inc’s chief intellectual property counsel to a US trade sub-committee.

He had said that “the issuance of unwarranted compulsory licences, the unfair revocation of valid patents, and the denial of patentability of inventions in India “were areas of concern for US companies operating in India.

These measures weaken the competitiveness of US pharmaceutical companies in India, he said, adding that their concern was because other countries looked to India as a leader and India’s actions had wider repercussions.

“We have seen several countries adopt policies similar to India’s, which are leading to a worldwide deteriorating trend on intellectual property,” he said, urging the US government to protect intellectual property of US companies. The US government should review all available policy tools in the light of India’s deteriorating intellectual property environment, he suggested.