“And, no Mr Speaker, we have not yet claimed intellectual property right on Yoga,” said Prime Minister Narendra Modi in his recent address to the US Congress.

Though said in a lighter vein, the statement is a clear give away that the Prime Minister’s Office has its finger on the pulse of what bothers industry every time there is a top level India-US engagement.

This visit was no different, preceded by statements from health advocacy and pro-patient groups cautioning the Indian delegation against softening the stand on intellectual property rights (IPR). Coming against the backdrop of the IPR Policy unveiled by India a month ago, this visit assumed a greater significance. And its outcome is being closely watched by health groups and industry representatives, their IP orientation notwithstanding. Explaining some of the apprehensions, Third World Network’s KM Gopakumar says that the Policy has “kept the door open” for a possible review of existing IP laws. And the worry is whether New Delhi will accommodate American drug companies’ demands against compulsory licensing (CL) or for data exclusivity.

The Policy should have taken a calibrated approach, he says, since it’s been over 10 years since the Patents Act was amended. It should have looked at whether new patented medicines in the country are affordable or not. Whether steps taken in public interest have worked? And whether there still exists a threat perception to the country’s health security, he explains.

Referring to the IP debate around Gilead’s Hepatitis C drug sofosbuvir and the licences given to Indian drug companies to make less expensive versions, Gopakumar says, this happened because of pressure from healthcare workers to bring down the price on these innovative medicines. (Gilead’s price on sofosbuvir is $84,000 for 12 weeks.) Pointing to Bangladesh and Egypt, where there is no patent on this drug, he says, their governments and domestic companies are exploring new approaches in treatment. Since the Indian government’s stance is not clear, local drugmakers are taking the less risky step and entering into licensing agreements, he adds.

The Organisation of Pharmaceutical Producers of India’s (OPPI) President, Shailesh Ayyangar, says that the industry owes it to the country to bring in medicines. (OPPI largely represents multinational drug companies.)

“This is not about pleasing the Americans” or any other country, he said at a recent OPPI event. “This is for my nation and my scientists here,” he says, elaborating how countries like India can benefit from making incremental developments on medicines. At present, Section 3 (d) of the Patent Act disallows protection on incremental developments, unless if can prove greater efficacy than an existing medicine.

Reason for jitters

The CL concern is because India does not have a clearly-spelt-out stand and the ambiguity creates anxiety for people wanting to invest, he says. It is the sovereign right of any country to issue a CL during a public health emergency, and no one disputes that, he says. The concern is when it is used and how. It should not be for the commercial benefit of a third party, he says.

“Make no mistake,” says Ayyangar, generic medicines are a lifeline of every country even the US, as it keeps the cost low. But the generic industry exists only if innovative medicines are made, he says, explaining how an innovative patented drug is allowed a period of exclusive time to sell and recover its research cost, before it is opened up to competitors to make it.

The Policy should have also addressed marketing approvals given to a company by the Indian regulator on a drug that is patent protected by another company, says Krishna Sarma, Managing Partner with the Corporate Law Group. She also expresses disappointment on specialised courts for IP cases not getting a mention in the Policy. This would have meant speed in disposing cases, a criteria in the ease of doing business, besides bringing in greater domain knowledge, she explains.

Middle path

Making a practical suggestion, Komal Kalha, Senior Counsel, US Embassy, says that modifications to the law should be made after getting stakeholders to talk to officials so that the outcome is more comprehensive. That would take out the bickering, she says.

In fact, health advocacy groups too have asked the Government to bring in greater transparency and table a white paper in Parliament on its IP engagements with the US.

With IP being as divisive as it is, the Government may do well to take on board both suggestions and chart a middle path of consensus.

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