Recent Development on US pressure on Indian Patent Law

Source: IP Health, 4 Feb 2015

Michael Froman testified in a Congressional hearing on  27 January 2015 that the USTR has secured “commitments from India in the 2014 Trade Policy Forum on a broad range of IP issues of concerns to the United States and its stakeholders.” See the article here

US officials are demanding of the new government that they do something about the following to protect the investments and interests of US pharma companies:

Sec 3(d), basically India’s patentability criteria; freeze any moves on compulsory licensing which reduce the price of expensively priced patent medicines by allowing a competitor to sell the product; introduce data exclusivity that bars the drug regulatory authority from approving of a competitor’s product as long as exclusivity on data lasts; provide patent linkage which connects regulatory approvals to patent status which can not only undermine the bolar provision, and compulsory licensing in the patent law, but also make the Indian drug regulator the new patent police; and IP enforcement by the Indian courts who treat medicines differently and can deny injunctions demanded by MNCs.

While bringing in amendments to the Indian patent Act or interfering with the judiciary is not something the govt can do without attracting attention, but introducing new IP rules into the regulatory system and putting a moratorium on CLs in DIPP is something strongly rumoured to have been agreed to by a senior DIPP official and PM’s Office.

India civil society in a statement last week seemed to confirm what Froman said about securing commitments from the new Indian govt:

Statement of Indian groups:

Following the Prime Minister Modi’s talk at the US-India Business Council yesterday that “India is ready to accept suggestions made by a joint working group with the United States on intellectual property rights,” as quoted in Reuters, patients and civil society groups have responded:

“It is now clear that the Indian government is willing to sell the interests of Indian patients in order to please US based pharmaceutical companies. If this is the outcome of President Obama’s visit then the fears of Indian patient groups and civil society that this visit would adversely affect the health of millions are more than realised,” said Amit Sengupta, Convenor, Jan Swasthya Abhiyan.

“There are indications that the Indian government is changing its stand and taking a favourable view to the US-demand for data exclusivity and patent linkage. What is most troubling is that this move would only benefit foreign MNCs, leaving Indian generics in the lurch and risking the health of millions of patients in the bargain”, said Anand Grover, Director, Lawyers Collective.

Vikas Ahuja of the Delhi Network of Positive People added “Indian generic medicines are the life-line of millions of patients around the world. US pharmaceutical companies are threatened by our industry and now the Indian government also seems to be bending to their will. Access to affordable generics could be under serious threat if the US companies have their way”

“Acche Din for US companies, Modi is selling out on IPR” says Dinesh Abrol, Convenor, National Working Group on Patent Laws. “India is abandoning its well-considered stand that Indian IP policy and laws are TRIPS-compliant and have been devised to balance the public interest and innovators rights. It was a grave mistake to agree to discussing intellectual property as part of a bilateral setup – the US-India Working Group on IP is turning out to be an instrument for the protection of US companies. It is grossly troubling that our Indian CEOs were silent when the US government was pushing its IP practices as best practices for India to follow when they have already failed to promote genuine innovation in pharmaceuticals in the US.”

“It is bizarre that the Indian government is inviting US inputs on the draft IPR policy, why don’t we just hand it over to the US pharma industry, the ghost writers behind every US complaint report against India, such as the USITC or Special 301 reports, to give us their track-changes? The US will leave no opportunity to dismantle India’s pro-health laws and insert stronger IP barriers that will strangle generic supply. It would be a death-trap for cancer patients who will be denied affordable treatment into the forseeable future” commented Kalyani Menon-Sen, Campaign for Affordable Trastuzumab.

This entry was posted in Compulsory Licensing, Data Exclusivity, Patent linkage, Sec 3 (d), TRIPS, TRIPS plus. Bookmark the permalink.

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