India's "protectionist and discriminatory policies, which exploit US intellectual property (IP) to benefit its own industry," require "an equally bold response" from the US government, a spokesman for Pfizer has urged a US Congressional hearing.
Over the past year, the pharmaceutical industry has seen a rapid deterioration of the business environment in India, with the patent rights for at least nine innovative medicines having been undermined, Pfizer's chief intellectual property counsel Roy Waldron told the hearing, held by a subcommittee of the House Energy and Commerce Committee to discuss the issue: How India's Industrial Trade Policy is Hurting US Companies.
Many of these medicines have received patent protection in most countries around the world, suggesting that India is an outlier in recognising and enforcing patent rights, said Mr Waldron. But, he added, India's decisions threaten to set "a dangerous precedent" for other countries seeking to promote their own protectionist industrial policies, as the nation is often seen as a leader amongst emerging economies.
He also noted that, at the same time as India is rolling back protections for US innovators, its own drugmakers "enjoy unfettered access" to the US market, and have grown their US sales dramatically. "American companies should be afforded no less protection than their Indian competitors," he told the panel.
Mr Waldron went on to warn that India's "short-sighted" approach will do more harm than good for its own patients, innovators and economic development. "If India continues to erode IP rights and enact protectionist policies, the result could be significantly reduced foreign investment in India as well as delays in getting Indian patients access to the newest medicines."
"Moreover, such policies also promote an environment for India's own pharmaceutical companies that is hostile to the development of innovative medicines, including for diseases that are especially prevalent in India and its region, such as tuberculosis, diarrheal disease and waterborne illnesses," he added.
Opening the hearing, Representative Fred Upton, chair of the Energy & Commerce Committee, said that India has not been a battleground in the effort to protect IP in recent years, but that, "with recent developments, that may soon change."
India issued its first compulsory license last year and is considering issuing three more under the guise of making expensive cancer drugs available for the "urgent needs of public health" and for failure to manufacture the drugs in India.
But both these reasons suffer "fatal flaws." said Mr Upton. First, the domestic manufacturing requirement is "a clear violation of India's World Trade Organisation [WTO] national treatment obligations, and second, Indian companies are selling their generic versions at a cost that remains out of reach for most of India's population.
"Instead, only a few privileged citizens can afford these generic versions of patent-protected, US-research and developed pharmaceuticals, delivering all of the profit but none of the R&D pain to India's generic pharmaceutical manufacturers,” he said.
- Last month, the chairman of the Senate Finance Committee, Max Baucus, and the panel's Ranking Member, Orrin Hatch, wrote to Secretary of State John Kerry urging him to push Indian leaders on policies adopted by their government which "shut out US-made innovative products and transfer US intellectual property to its domestic industry."
"India is ignoring evidence from its own recent positive economic experience and is lapsing once again into protectionism. We cannot afford to sit back and watch as India adopts policies that adversely impact US innovative and creative industries, and threaten the greater stability of the international trading system," the Senators’ letter urges Mr Kerry.
