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US increases pressure on India over generics industry

Follows complaints from Pfizer about the country’s patent laws

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The US is to step up its pressure on the Indian generic drug industry following criticism from Pfizer of the country's intellectual property (IP) standards.

On a recent visit to India, US Secretary of State John Kerry is believed to have discussed the Obama administration's opposition to the country's generic drug policies, which analysts have warned could discourage pharma from investing in the country.

Indian patent laws, which do not consider new forms of a known substance to be innovative unless it improves efficacy, have stirred much controversy in recent years, following a number of high-profile cases of revoked patents. In April this year, Novartis' cancer drug Gilvec was denied patent protection; a case that followed similar defeats for Roche's hepatitis C drug Pegasys, Merck's asthma treatment Singulair, Gilead's HIV drug Viread and Pfizer's cancer drug Sutent.

During a subcommittee of the House Energy and Commerce Committee last week, chair Lee Terry outlined his concerns over India's IP policies, which he described as a “unfair and discriminatory” and a "threat" to the trade relationship between the US and India.

Speaking at the meeting, Pfizer's chief IP officer, Roy Waldron, argued that India's "unfair practices" have undermined Pfizer's "ability to innovate, create jobs and provide faster access to life-saving medicines". He claimed that the patent laws have had negative effect on Pfizer's ability to recoup R&D costs, "often exceeding $1bn".

"Since early 2012, India's policies and actions have undermined patent rights for at least nine innovative medicines. Many of these medicines have received patent protection in most countries across the world, suggesting that India is an outlier in recognising and enforcing patent rights. This is not only creating significant uncertainty in the market but it also undermines our ability to compete fairly in India, and our willingness to invest there."

Public health experts have argued that India's inexpensive generic drugs are vital to providing life-saving treatments around the world. Democrat Henry Waxman said: “Indian policies regarding IP and access to medicines can genuinely advance public health”, adding that the US's AIDS-relief programme PEPFAR relies heavily on Indian generics to supply medicines in the developing world.

In a move to address concerns, Indian ambassador to the US, Nirupama Rao, has offered US lawmakers an opportunity to discuss the issue of pharmaceutical IP.

"My senior colleagues at the embassy stand prepared to come and meet with your key officials or your constituents to engage in a friendly and substantive exchange of views so as to promote deeper understanding, and to seek mutually satisfactory solutions, in a spirit of friendship," said Rao in a letter to the US legislators, according to The Times of India.

"India has […] a well-settled, stable and robust intellectual property regime. The three main pillars of this regime are comprehensive laws, detailed rules to back them up, and strong enforcement mechanisms, including those for dispute resolution. In India, the IP framework is rooted in law.

"The full complement of our laws on patents, designs, trademarks and geographical indications is in place and these are in compliance with the Trade Related Intellectual Property Rights (TRIPs) of WTO,” she said.

2nd July 2013

From: Regulatory

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