Amid an ongoing rift with the US government, India last week issued a new policy about intellectual property, but opinions are divided over whether the move will appease the pharmaceutical industry, which has been pushing the Indian government to strengthen patent protection.
In a 29-page statement, the Indian commerce and industry ministry said its overarching goal is to bolster intellectual property as a “marketable financial asset and economic tool,” and create a “holistic” system that provides economic growth while protecting the public interest.
The policy emerges as the Indian government faces sustained pressure over patent protection. Toward that end, Indian Prime Minister Narendra Modi agreed to create a working group with the United States to review intellectual property issues shortly after taking office two years ago.
The US Trade Rep, meanwhile, recently kept India on its annual list of countries it believes does not sufficiently enforce patent rights. And global brand-name drug makers complain that laws and court rulings have made it easier for their generic rivals to sell lower-cost, copycat versions of their medicines.
But India’s new IP policy, which does not focus exclusively on pharmaceuticals, is carefully worded and, as a result, appears open to interpretation. For instance, one industry consultant, who specializes in the Indian prescription drug market, argued that the policy will not assuage global drug makers.
“This policy does not indicate India is changing its position when it comes to pharmaceutical patents,” said Vince Suneja of TwoFour Insight Group. “It’s basically, business as usual. I think this may be the last straw that tells the global industry that India is not changing for the foreseeable future … It falls well short of the types of changes that the industry would need to maintain their advocacy strategy.”
As an example, he pointed to language praising a World Trade Agreement that allows countries to issue compulsory licenses to a generic drug maker to copy a patented medicine without the consent of the brand-name drug company that owns the patent.
These licenses are contentious because drug makers argue that countries wield the threat of issuing a license in order to negotiate lower prices. Consumer and patient groups, however, maintain that licenses are legitimate for allowing access to medicines that would, otherwise, remain unaffordable.
The Indian policy states that existing intellectual property laws were either enacted or revised after the WTO agreement, and its laws and court decisions “provide a stable and effective legal framework for protection and promotion of intellectual property rights.”
The Pharmaceutical Research and Manufacturers of America, the industry trade group, appeared disappointed. In a statement, it said it looks forward to discussing the policy “and hope this will include meaningful reforms” to India’s intellectual property laws.
“We believe areas of the policy need to be strengthened to accelerate the reforms needed to foster medical innovation and enhance India’s global competitiveness,” the trade group added, although it was not specific about the changes it would like to see made to the policy.
One activist, however, took an opposing view. Tahir Amin, who is director of intellectual property at the Initiative for Medicines, Access & Knowledge, which has challenged the validity of patents that Gilead Sciences (GILD) filed in India for its Sovaldi hepatitis C medicine, believes the policy appeases India’s critics.
“It’s written in broad strokes,” he said. “The mantra is, basically, that intellectual property is good for all — that IP is the solution for all economic development … and will help India become a powerhouse. But there’s nothing that suggests there’s something wrong with the current IP system.”
He also argues that the wording is so nuanced that he believes what the government says about remaining in compliance with the WTO agreement is actually unclear. “I think it could be seen as friendlier to multinational” drug makers.
This marks the second time in recent weeks, by the way, that debate has erupted over India’s stance toward pharmaceutical patents. Earlier this year, the government denied assertions by business groups that it would revise its approach toward issuing compulsory licenses.