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Pharma patent regime may get stricter, say experts

Pharma patent regime may get stricter, say experts

In order to boost dollar inflows in pharma sector and establish stronger IPR regime, govt may affect patent amendments

The joint statement issued on September 30 by the US and India to establish an annual high-level Intellectual Property (IP) working group has inevitably led to a debate on whether the governmentwould bow down to the US pressure.

A section of the pharmaceutical industry feels that the government may give importance to increasing the dollar in-flows through foreign direct investments(FDI) rather than pushing the case of a “diluted” intellectual property rights (IPR) regime that the country followed so far.

According to an industry expert, the government may choose to bow to the US pressure since it is keen on having more foreign companies investing in India. “May be it will, given that unless we comply with the requirements from MNCs, investment is not going to come. We are WTO-compliant but still there are some provisions under Section 3 and compulsory licensing which is not in consonance with the global patent regime for the pharma sector. And the international lobby wants India to remove this,” said the expert.

Srividhya Ragavan, professor of law, University of Oklahoma College of Law, said in an emailed response, “Whether India will be cowed down by Pharmaceutical Research and Manufacturers of America (PhRMA) pressure is yet to be seen. But the recent events do show that there is pressure from PhRMA directly as well as indirectly to effectuate patent amendments. As a sovereign nation that is compliant with its trade obligations, India is not required to succumb to this pressure. Any ill-conceived amendment to the patent statute will affect either the government’s ability to facilitate access to medications, and/or result in low quality patents which in turn can affect the cost and access to those medications.”

Early last month, commerce and industry minister Nirmala Sitharaman had said the government will soon come up with a policy on IPR which will be open for public discussions.

Gopakumar Nair, IPR sub-committee chairman, Indian Drug Manufacturers’ Association (IDMA), said, “The discussions on IP are an ongoing process and every time the US trade representative or deputy trade representatives visit India, they threat us with some downgrading or other. This is on for quite some time. But what Nirmala Sitharaman said that we will have an IPR policy is a wrong advice. If a task force has been formed to look into IPR policy, it does not mean anything and is a general statement with no binding on anybody. What has been actually done is a task force has been constituted to draft a National IPR policy and according to me, the draft is not at all practicable. If it has to be made practicable, it has to be implemented through acts and rule.”

Ragavan said, “India does have an interest in increasing the in-flow of FDIs. However, several non-pharmaceutical companies had expressed the view that they were satisfied with the state of the intellectual property laws in India even during the International Trade Corporation (ITC) and the US Trade Representative (USTR) hearings in 2013. Plus, the Indian patent statute is fully TRIPS compliant and has facilitated inventions in all areas, including in pharmaceuticals.”

Taking cue of Sitharaman’s view, Milind Antani, partner — pharma and life science practice, Nishith Desai & Associates, said, “There has not been any further clarification after that statement that we have to make our IPR better. And if the government is considering any changes to the patent regime, it could be pertaining to the patentability exclusion provisions in the Indian Patent Act. Looking at the new government’s industry-friendly actions, focus on foreign investments and foreign companies, I expect patent regime to be at par with global regimes.”

Another industry expert said that the government must keep a balance between MNCsand local pharma companies. “Needless to mention that we want foreign investments to come into India but having said that we cannot neglect our own pharmaceutical industry.”

But on how soon India may have a new IPR policy, S V Veerramani, president, IDMA, said, “The government is currently reviewing it and will seek public views on it. There have been some initial discussionis on this.”
However, Antani feels a separate independent committee or a task force needs to be formed to look into these issues.

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