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.

Posted in Compulsory Licensing, data exclusivity, Patent linkages, Sec 3 (d), TRIPS, TRIPS plus | Leave a comment

Next round of RCEP negotiations to be held in Pattaya, Thailand from 9-13 Feb

Posted in Regional Comprehensive Economic Partnership, TRIPS plus | Leave a comment

Natco Pharma ties up with Gilead on hepatitis C drugs

Source: Reuters

2 March 2015

(Reuters) – Natco Pharma Ltd said on Monday it has agreed a deal with Gilead Sciences Inc to supply generic copies of the U.S. drugmaker’s chronic hepatitis C medicines, including $1,000-a-pill drug Sovaldi, in 91 developing nations.

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Posted in Hepatitis - C, Voluntary License | Leave a comment

South Africa Awaits Patent Reforms With Hope, Concern

Source: IP Watch

2 March 2015

CAPE TOWN – South Africa’s new policy on patents could go to the Cabinet for approval soon, says Doctors without Borders (Médecins Sans Frontières, MSF), one of the organisations spearheading the Fix the Patent Laws campaign in the country.

The draft intellectual property policy has been circulated for comments since its release in September 2013.

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Posted in Fix the patent law, Intellectual Property, patent evergreening, Patent examination system | Leave a comment

No proposal to change patent law

Source: Business Standard

2 March 2015

India today ruled out amendment to the patent law, asserting that there are no gaps in protection of Intellectual Property Rights (IPR).

“There is no proposal to amend patent law… There is no proposal to anything to do with Indian Patent Act,” Commerce and Industry Minister Nirmala Sitharaman said while replying to questions in the Rajya Sabha.

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Posted in Indian Patent Law, IP Think Tank, US pressure on India | Tagged , , , | Leave a comment

Will a new US-led IP empire in India put access to medicines at risk?

Source: Financial Express

26 Feb 2015

Prof Brook K Baker, Professor of Law and Northeastern University, cautions that the Modi government’s accelerating flirtation with the US and its investors is dangerous to hundreds of millions of people worldwide whose lives depend on Indian generics

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January 26 was a bad day for people around the world who rely on Indian generic companies for access to affordable medicines of assured quality. In the 19th century, the British Empire imposed a patent regime on India designed to guarantee monopoly access to its inventors and industries. In the 21st century, the US Empire is attempting the same, and there are troubling signs that the new government, led by Prime Minister Modi, might fail to resist the IP takeover.

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Posted in data exclusivity, IPR policy, US pressure on India | Leave a comment

Are Sky-­High Prices For New Drugs Justified?

Source: Forbes

23 Feb 2015

Ask any pharmaceutical executive to justify the high price tags attached to most new drugs and you’re likely to hear a common refrain: Drug companies must charge lofty prices so they can make a sufficient return on investment, which they can then pour into research meant to yield new breakthrough products.

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Posted in Drug Pricing, R&D | Leave a comment

The Drug That Is Bankrupting America

Source: Huffington Post

19 Feb 2015

America is the land of breakthrough science — and health care scams. The two seem to go hand in hand in the case of the new hepatitis C virus (HCV) cure named sofosbuvir, sold under the brand name Sovaldi by the drug company Gilead Sciences. There is no question that Solvadi is a godsend — a lifesaver for millions of Americans, and perhaps someday for hundreds of millions of people around the world infected by Hepatitis C. Yet Sovaldi is also the poster child of a U.S. health care system that is being bankrupted by greed, lobbying and indefensible policies on drug pricing.

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Posted in Drug Pricing, Hepatitis - C, R&D | Leave a comment

Need political spark for India-EU FTA: EU ambassador

Source: Live Mint

19 Feb 2015

Need political spark for India-EU FTA: EU ambassador

Joao Cravinho said there was a move in India towards viewing trade as part of its integration towards global value chains. Photo: Priyanka Parashar/Mint

New Delhi: A “political spark” is required to get long-running talks on a free trade agreement (FTA) between India and the European Union (EU) moving, a senior European diplomat said on Wednesday, adding an agreement would help burnish India’s credentials among international investors looking to set up shop in Asia’s third largest economy and use it as a base for exports.

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Posted in EU-India FTA | Leave a comment