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

Should All Drugs Be Patentable? A Comparative Perspective

Source: Infojustice

Abstract: Although there has been substantial discussion of the proper scope of patentable subject matter in recent years, drugs have been overlooked. This Article begins to address that gap with a comparative perspective. In particular, this Article considers what is permissible under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as well as how India and Canada have utilized TRIPS flexibilities in different ways to properly reward developers of valuable new drugs, while also considering the social harm of higher prices beyond an initial patent term on drugs. Continue reading

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Pharma accused of restricting access to hep C drug in poor countries

Source: The Guardian

20 Mar 2015

hepatitis C patient given ribavirin at MSF clinic in Mumbai

A patient on treatment for hepatitis C at Médecins Sans Frontières’ clinic in Mumbai, India, receives a weekly supply of ribavirin, an older drug used to treat the viral infection. Photograph: Siddharth Singh /MSF

New drugs for hepatitis C are a major breakthrough but hugely expensive in rich countries. Pharma giant Gilead will allow cheap copies to be made for poor countries – but only for patients with proof of identification and citizenship and the drug supplies will be closely tracked

The battle over access to the new hepatitis C drug, Gilead’s sofosbuvir (and similar drugs coming along behind) is hotting up. There is angst even in the richest countries over the $1000 a pill price tag. It now looks as though Gilead is going to extraordinary lengths to ensure that cheaper versions, which it is permitting generic companies to make for poor countries, do not arrive in affluent world pharmacies.

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Posted in Hepatitis - C, Sofosbuvir | Leave a comment

Gilead is Criticized for Restrictions on Generic Hepatitis C Drug Deal

Source: The Wall Street Journal

20 March 2015

 In yet another fracas over Gilead Sciences and its hepatitis C treatments, Doctors Without Borders is harshly criticizing the drug maker over an agreement in which several generic companies will sell lower-cost versions of Gilead’s Sovaldi and Harvoni medicines in 91 developing countries. At issue is the effort Gilead is making to ensure its medicines are not sold in still other countries not covered by the deal.

The agreement, which Gilead announced last fall, is designed to forestall criticism over the price of its medicines, which in the U.S. cost $63,000 to $94,500, depending upon the drug and regimen. The medicines cure more than 90% of those infected and Gilead argues the cost is less expensive than hospitalizations or liver transplants. But the cost is considered out of reach in many countries.

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Posted in access to medicines, Drug regulation, Hepatitis - C, Sofosbuvir | Leave a comment

KEI EUROPE ASKS ROMANIAN GOVERNMENT TO ISSUE COMPULSORY LICENCES ON HEPATITIS C MEDICINES

Source: KEI Europe

19 Mar 2015

Geneva, Switzerland 18 March 2015. On 10 March 2015, Knowledge Ecology International Europe (KEI Europe), in collaboration with affiliate Knowledge Ecology International (KEI), submitted a request to Romanian Minister of Health, Nicolae Banicioiu, to petition the Court of Bucharest to issue compulsory licenses on patents necessary for the supply of low-cost hepatitis C virus (HCV) medicines. The request provides a legal basis, as well as an economic, medical and moral basis, for compulsory licences as the pathway to affordable treatment for the approximately 1 million Romanian citizens living with HCV.

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Posted in Compulsory Licensing, Generic drug, Hepatitis - C | Leave a comment

UNITAID NGO Delegation Expresses Strong Support for LDC Pharmaceutical Extension Request

Source: Ip-Health

The NGO delegation to the Board of UNITAID offers its strong support for the proposal of WTO least developed country Members to extend the transition period for enforcing protections for pharmaceutical related patents and clinical data “for as long as the WTO member remains a least developed country.”  The proposal, IP/C/W/605, was offered by Bangladesh on behalf of LDCs  at the 24-25 February 2015 meeting of the WTO TRIPS Council and will be taken forward at its next 1 June 2015 meeting.  In addition to seeking an unconditional extension of the current pharmaceutical transition period set to expire on 1 January 2016, the LDCs also seek a waiver from the General Council with respect to two additional transition measures, namely mailbox and exclusive marketing rights provisions under Articles 70(8) and 70(9) of the TRIPS Agreement. Continue reading

Posted in access to medicines, Drug Pricing, Generic drug, LDC Extension, LDCs, TRIPS | Leave a comment

Another investor-state dispute on horizon for India

Income Tax Dept slaps $1.6 bn tax demand on Cairn Energy; firm to file dispute notice

Source: Financial Express

March 11,2015

Income Tax Department has slapped a Rs 10,247 crore (USD 1.6 billion) tax demand on Cairn Energy Plc, which termed the action as “very disappointing” and said it would contest the order.

The tax demand relates to an alleged Rs 24,500 crore worth capital gains it made in 2006 while transferring all its India assets to a new company, Cairn India, and got it listed on the stock exchanges. Continue reading

Posted in Investment treaties, investor state dispute | Leave a comment

German comapany’s patent for asthma drug revoked

Source: Times of India

10 Mar 2015

MUMBAI: India’s Patent Office has revoked a patent on asthma drug, Spiriva (tiotropium bromide monohydrate) held by German major Boehringer Ingelheim on an opposition filed by generic company, Cipla. The patent was revoked on grounds that it lacks inventive step, fails to demonstrate therapeutic efficacy as well as requirements of Section 3 (d).

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Posted in Indian Patent Law, patent revocation, Sec 3 (d) | Tagged , , | Leave a comment