- India once again made the U.S. Trade Representative's priority watch list for failing to adequately enforce and protect patent rights. The U.S. pharma industry has lobbied for India to be included on the list over concerns the country's patent law benefits generic Indian drugmakers.
- But consumer advocacy groups view the India government's stance as protective of cheaper drugs and argue the pharma industry's efforts to strengthen intellectual property (IP) rights there will hurt access to affordable drugs.
- One of the fault lines underpinning this disagreement is differing interpretations of an international IP agreement. Under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, India maintains it can request a compulsory license to override patents during a public health emergency or in potentially respond to pricing and access issues. However, the USTR says that there is a "lack of clarity" around how these licenses should be issued.
The report from USTR, known as the Special 301 report, did acknowledge "positive steps" India has taken to prevent further erosion of IP. However, USTR noted India has failed to "address longstanding and systemic deficiencies in its IP regime."
Indian patent law has long been a source of contention for multinational biopharmaceutical companies. However, consumer advocates and humanitarian groups prize India's ability to manufacture cheap generic drugs which are instrumental in providing care to lower-income populations.
In a statement following the release of USTR's report, Doctors Without Borders (MSF) highlighted this issue. "It’s outrageous that the US government is once again attempting to stand in the way of India and other developing countries’ efforts to increase access to affordable, lifesaving medicines," MSF said.
"India’s policies save lives and are fully consistent with global trade rules. The US government should support countries, rather than penalize them, for not bowing to the persistent efforts of the multinational pharmaceutical industry to severely restrict generic competition in India and worldwide.”
India has become a generic manufacturing powerhouse and a global supplier, in part due to the dynamic on the ground in India. "Due to technological expertise, inexpensive labor and lack of governmental regulations regarding clinicals, India has become a very favorable place to make and develop drugs," said Daniel A. Scola, Jr., partner at the law firm Hoffman & Baron.
"Yet the IP system and the court system are not as favorable to patent owners and do not seem to have kept pace with the economics of making pharmaceuticals. Thus, a tension exists in India between developing and protecting that which you develop," Scola said.
Even as some pharma companies look to become more flexible in how they approach patents, India is usually left out. Earlier this year, GlaxoSmithKline said it would not seek patents in low income countries and would offer licenses to generic manufacturers for its drugs in return for a small royalty. India was not included, however.