Governors from 14 states and a group of 18 industry organisations sent letters to President Obama this week protesting India’s IP policies ahead of his meeting with Singh.
In separate letters, sent this week, the politicians and business groups urged the president to use his meeting with Singh to address “protectionist policies” including revocations of patents and compulsory licences for certain medicines and mandatory local production of certain information technology and clean energy equipment.
In their letter to Obama on Tuesday, the Governors urged the president to “convey concerns regarding India’s trade and investment policies, which continue to threaten the intellectual property rights of US industry and induce barriers to trade". The governors were from Colorado, Ohio, Connecticut, Oklahoma, Georgia, Pennsylvania, Idaho, Tennessee, Kansas, Vermont, Maine, Washington, Maryland and Wisconsin.
The 18 industry organisations (see below), operating as the umbrella group the Alliance for Fair Trade with India (AFTI), wrote a separate letter to Obama on Wednesday. AFTI also released a statement denouncing India’s “protectionist policies".
In March, German pharmaceutical company Bayer lost an appeal against a compulsory licence issued to domestic generic competitor Natco for kidney cancer drug sorafenib. The compulsory licence was issued because the Indian government considered the drug, which costs $4,500 per month, unaffordable to most of the population. Natco’s generic version is now available for 97% less than the brand name price.
In a report in March, India’s Committee on Price Negotiation for Patented Drugs recommended further price controls and compulsory licences, concluding that many patented drugs are still “much beyond the reach of the general masses of the country".
India’s Supreme Court also recently rejected Novartis's patent for a salt form of the anti-cancer drug Glivec, ruling that the new formulation did not meet patentability requirements. Indian law limits "evergreening", a widespread pharmaceutical industry practice which extends drug patents on existing drugs.
A spokesman for Phrma, an industry group that represents brand name US drug companies, told Managing IP that the organisation believes India’s “anti-IP, mercantilist practices” may be in violation of the WTO’s TRIPs agreement.
But international medical humanitarian organisation Médecins Sans Frontières (Doctors Without Borders) said in a statement that India is “acting completely within its rights” despite “unrelenting, unwarranted, and deliberately misleading attacks” from multinational drug companies and US government officials.
“Indian policymakers and courts have taken steps that are entirely legal under international trade rules to keep medicines affordable, and should not be facing any retaliatory tactics whatsoever,” said Judit Rius, manager of MSF’s Access Campaign in the U.S.
“We rely on affordable medicines produced in India to do our medical work across the world, so we are very concerned about the pressure India is facing.”
According to the WTO’s list of disputes, no complaint has been brought against India regarding compulsory licensing. A spokesman for the WTO said the organisation could not comment because it must remain impartial. According to WTO policy, the WTO would not take any action in response to a complaint except to manage the dispute settlement procedure as laid out by members.
Dilip Shah, secretary general of the Indian Pharmaceutical Alliance, which represents generic manufacturers, also strongly disagreed with claims that India’s patent laws discriminate against foreign companies or are in violation of international treaties.
Shah argued that the critics of India’s decision to grant a compulsory licence for Bayer’s Nexavar fail to address the lack of access to the drug. According to Shah, Bayer had made the drug available to less than 2% of the target population.
“Bayer could not substantiate their claim that they were making the product available,” he said. “India has not deviated from international standards; the compulsory licence was granted through a full judicial process.”
Shah also took issue with the claim that India’s patent laws were in violation of TRIPS. He said a number of the drug companies have asked the US Trade Representative to file a complaint before WTO, which has so far declined to do so.
“Do you believe that the US pharmaceutical industry with such tremendous lobbying power would hesitate to push for an official complaint against India if the TRIPS agreement is violated?” he asked. “We asked a number of US-based international law academics to look at the issue, and they agreed that India’s patent laws did not violate TRIPS.”
Industry organisations that sent a letter to President Obama :
American Business Conference
American Foundry Society
Association of Equipment Manufacturers
Biotechnology Industry Association
California Manufacturers & Technology Association
CropLife America
Emergency Committee for American Trade
INDA, Association of the Nonwoven Fabrics Industry
Information Technology Industry Council
Motion Picture Association of America
National Association of Manufacturers
National Electrical Manufacturers Association
National Foreign Trade Council
Pharmaceutical Research and Manufacturers of America
Recording Industry Association of America
Solar Energy Industries Association
Telecommunications Industry Association
U. S. Chamber of Commerce