The Burrill Report


The Office of the United States Trade Representative is calling India to account in its latest “Special 301 Report,” an annual review of the state of intellectual property rights protection and enforcement by U.S. trading partners.

Despite what the trade representative called India's “limited progress” on improving its weak intellectual property rights legal framework and enforcement system in 2012, the office is keeping the country on its Priority Watch List, flagging it as a problem trading partner along with nations such as Algeria, China, and Russia.

India’s government during the past year invoked a compulsory license permitting a domestic company to manufacture a low-cost generic version of Bayer’s patented Nexavar and, more recently, rejected Novartis’ attempt to patent a new version of its cancer treatment Glivec. The actions have drawn criticism from industry and government officials alike.

In many areas, intellectual property rights protection and enforcement challenges are growing and “there are serious questions regarding the future condition of the innovation climate in India,” the Trade Representative says. Recent actions by the Indian government “have raised serious questions about the innovation climate in India and risk hindering the country’s progress towards an innovation-focused economy,” the Trade Representative said. “In the pharmaceutical sector, some innovators are facing serious challenges in securing and enforcing patents in India. The United States urges India instead to adopt policies that support both cutting-edge innovation to address important health challenges and a robust generic market.”

Jay Taylor, International Vice President for the Pharmaceutical Research and Manufacturers of America, says that the Trade Representative’s review will help garner high-level attention to the problems in India, but that the group would have liked to see a review issued earlier.

“The deteriorating protections for patented medicines in India have become increasingly concerning,” says Taylor. “Over the past year, the Government of India has issued several intellectual property decisions that have disproportionately impacted U.S. biopharmaceutical companies and a number of other innovative sectors. The IP regime in India has been structured and applied in ways that prop up local industries to the detriment of U.S. jobs and the world’s patients."

While the Trade Representative had sharp words for India, it also called attention to the problem of counterfeit drugs, especially in United States trading partner nations such as Brazil, China, India, Indonesia, Lebanon, Peru, and Russia. “For instance, in China, domestic chemical manufacturers that produce active pharmaceutical ingredients have avoided regulatory oversight by failing to declare that a bulk chemical is intended for use in pharmaceutical products,” the Trade Representative writes. “This contributes to China being a major source country for active pharmaceutical ingredients used in counterfeit pharmaceutical products.”

As demand for affordable medicines in developing economies grows, it is likely that conflicts between foreign governments and international pharmaceutical and biotech companies will only sharpen. Meanwhile, the Trade Representative writes that United States will work to strike a balance between enforcing trade agreements and making sure that its actions are “consistent with U.S. Government policies concerning intellectual property rights and health policy and do not impede its trading partners from taking measures necessary to protect public health.”


May 10, 2013
http://www.burrillreport.com/article-u_s_trade_representative_puts_focus_on_indian_ip_issues.html