News

U.S. pharmaceutical manufacturers say India has made a mockery of their drug patents. And when Prime Minister Manmohan Singh visits the White House on Friday, they want President Barack Obama to give him an earful about it.

If direct diplomacy doesn’t work — it’s a long shot, considering that Singh is a lame-duck leader scheduled to leave office in the spring — businesses are plotting tougher moves, including the possibility of taking the dispute to the World Trade Organization as early as next fall, industry sources say. In addition, their allies in Congress are pushing legislation to raise tariffs on India’s exports if the country doesn’t increase protections, even as its government considers requiring yet another U.S. company to turn over its patent to an Indian company for generic production.

“A line has been crossed here,” said Mark Elliot, the executive vice president of the U.S. Chamber of Commerce’s Global Intellectual Property Center — which launched a coalition with the National Association of Manufacturers to press the issue.

Criticisms over India’s lax intellectual property regime are not new, but U.S. drugmakers say their situation has gotten much worse of late.

Twelve times in the last three years, India’s government has denied or revoked pharmaceutical patents or approved generic versions of drugs before their patent terms expired. In April, the Indian Supreme Court ruled that the cancer drug Glivec, made by Novartis, wasn’t significantly more effective than alternatives and that its active ingredient was already known.

Drug manufacturers say India’s most egregious act came in March 2012, when its controller general of patents, designs and trademarks granted a compulsory license for local generics company Natco to sell a copy of Bayer’s Nexavar, which treats liver and kidney cancers, at a much lower price.

India’s laws allow such moves when its government decides a drug is exorbitantly priced. While a month’s supply of Nexavar, for example, sold for $5,000 in India, the same amount of Natco’s version goes for $160.

Public-health advocates have hailed India’s actions, saying they have provided access to medicines that would otherwise prove too costly in the developing world.

“Every country has the right to take steps to increase access to medicines and implement a patent system in line with its public health needs,” said Leena Menghaney, manager of Doctors Without Borders’ Access Campaign in India. “Even though India is acting completely within its rights, the country must now deal with unrelenting, unwarranted and purposely misleading attacks from the multinational pharmaceutical industry and U.S. government officials.”

Doctors Without Borders officials also defend India’s generic drug industry, arguing that, in the case of Glivec, India’s Supreme Court was stopping the practice of “evergreening,” or extending patents on existing drugs. They note that 80 percent of the HIV medication the organization uses to treat 280,000 patients in 21 countries comes from India.

“In a world where medicines are increasingly being patented, which blocks the production of more affordable generic versions, we’re going to see more and more people become sick or die because the medicines they need to stay alive are simply too expensive,” Menghaney said.

Drug manufacturers, though, have expressed frustration over what they see as roadblocks to a huge market.

“They’re gradually picking off one cancer drug or AIDS drug after another,” said Mark Grayson, a spokesman for the Pharmaceutical Research and Manufacturers of America.

Now the industry is watching to see if India will grant another compulsory license for the local manufacture of a leukemia drug called Sprycel, made by Bristol-Myers Squibb. A key Indian panel recommended this month that the government green-light the license — further evidence that India’s environment for advanced U.S. products is deteriorating, industry sources say.

“It just continues to show the pattern — what India’s doing in not recognizing innovation, or if they’re recognizing innovation, they’re taking away the fruits of that innovation,” Grayson said.

The pharmaceutical industry’s supporters in Congress asked the independent U.S. International Trade Commission to document India’s violations of intellectual property rights in a report due in the fall of 2014. It could address issues raised by a host of industries, including seed producers, movie studios and information technology firms.

Drugmakers could find the study useful as ammunition to urge U.S. Trade Representative Michael Froman to take the dispute to the World Trade Organization. The United States has two complaints against India pending with that body already — one on blocking U.S. agricultural exports and another over a solar power dispute.

The WTO’s agreement on intellectual property rights allows the local licensing and manufacturing of generics when a government decides that doing so is in the public interest. The provision is typically invoked to combat epidemics, not cancer, prompting the U.S. pharmaceutical industry to argue India is abusing its power under the agreement.

Rep. Lee Terry (R-Neb.) introduced a bill last week that would seek an alternative means of persuading India to change course. The bill, which won quick backing from India’s critics, would tie the country’s authority to export duty-free products to the U.S. under the Generalized System of Preferences, a program designed to help developing countries, to its efforts to increase intellectual property protections .

Terry’s measure is toothless right now because the program expired at the end of July, but Congress could retroactively reauthorize it as part of a larger trade measure this fall.

“This bill sends a strong signal to GSP beneficiaries, particularly countries like India that have systematically disregarded intellectual property protection standards in recent years,” Elliot said.

Read More: http://www.politico.com/story/2013/09/drug-companies-india-prime-minister-patents-97400.html