Congress Questions India Pharma Patent Practices
Last week a Congressional subcommittee held a hearing on India’s’ trade policies, and not surprisingly, much of the hearing focused on IP and pharmaceuticals. Big Pharma has been irate over India’s pharmaceutical patent policies for some time, alleging they lean toward favoring generic drug makers.
In recent years India’s Patent Appeals Board has issued a compulsory license to a domestic generic drug company when it deemed the price of a patented drug too high. It has revoked patents granted to several multinational pharmaceutical companies. And in January, India’s Supreme Court rejected Swiss drug maker Novartis’s patent application for the leukemia drug Glivec, saying it was not sufficiently innovative and amounted to “evergreening.”
Evergreening, which the pharmaceutical industry calls “life-cycle management,” describes a common practice in which drug companies make small changes to a patented drug, enabling them to apply for a new patent and extend the drug’s term of patented exclusivity.
The hearing last week was chaired by Representative Fred Upton, a Republican from Michigan, who called compulsory licenses “unfair and discriminatory.” Compulsory licensing is, in fact, legal under existing international trade agreements.
Witnesses at the hearing who spoke in support of the pharmaceutical industry included Roy Waldron [PDF], associate general counsel and chief intellectual property counsel of Pfizer, and Mark Elliot [PDF], executive vice president of the U.S. Chamber of Commerce’s Global Intellectual Property Center. Doctors without Borders’s director of policy and advocacy, Rohit Malpani, testified in support of India’s patent policies and their impact on public health.
Even before the hearing, however, 170 members of Congress sent a letter [PDF] addressed to Present Barack Obama and Secretary of State John Kerry alleging that India’s trade policies—especially those related to its patent policies—are discriminatory, And they asked the White House to address these issues with the highest levels of the Indian government.
And in May, Pfizer sent a letter to the U.S. Trade Representative in which the company alleged that India lacks a rule of law and urged the USTR to put pressure on the Indian government.
India, however, does not appear to be bowing to the wishes of the United States and the multinational pharmaceutical industry so quickly. “India has a well-settled, stable, and robust intellectual property regime,” India’s Ambassador to the United States, Nirupama Rao, wrote in a letter to U.S. lawmakers last month. “In India, the IP framework is rooted in law.”
She also noted that compulsory licensing and the India Patent Act are in accordance with provisions of the Trade Related Aspects of Intellectual Property Rights Agreement (commonly referred to as TRIPs) and the Paris Convention.
According to a report in The Times of India, the commerce department of India wrote to the U.S. Trade Representative, saying that India’s Patent Act “encourages genuine innovation by discouraging trivial, frivolous innovation, which leads to evergreening,” and suggested that the U.S. government also consider strengthening its patent laws to discourage “undesirable practices.”
