Pharma company Viiv’s attempt to secure patents for key HIV drugs dolutegravir and cabotegravir opposed in India

‘Patent opposition’ seeks to ensure availability of affordable generics

New Delhi/Geneva, 8 February, 2016—People living with HIV have opposed patent applications in India for two important HIV medicines, dolutegravir and cabotegravir.  Médecins Sans Frontières/ Doctors Without Borders (MSF) supports these ‘patent oppositions,’ which have been filed to challenge an attempt by ViiV Healthcare (a joint venture by Pfizer and GlaxoSmithKline) to obtain monopoly rights in India while several of its patent claims are questionable according to Indian patentability criteria.

The company has so far failed to make dolutegravir available in India for people who have run out of other treatment options. Cabotegravir is still in the clinical trial phase of development.   Continue reading

Posted in Evergreening, Indian Patent Law, Patent Opposition, Uncategorized | Leave a comment

India, EFTA look to restart stalled trade talks

Press Trust of India  | February 10, 2016

India and EFTA, a bloc of four European countries, will discuss resumption of talks for the proposed free trade agreement during a meeting here on Friday.

The trade talks between India and the bloc are stalled due to a host of issues, including intellectual property rights.

A parliamentary delegation of the European Free Trade Association, consisting of Switzerland, Iceland, Norway and Liechtenstein, will meet the commerce ministry officials on Friday to give a push to the trade negotiations.

The EFTA Parliamentary Committee, which was in Mumbai today, will also discuss closer bilateral economic relations with members of the Lok Sabha and the Rajya Sabha. Continue reading

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PhRMA Special 301 submission 2016

PhRMA Special 301 Submission 2016 insists that India remains on the Priority Watch List in the USTR Special 301 Report. PhRMA sees India’s progressive Patent Act of 2005 and IP environment as a legal and regulatory barrier to patentability of newer drugs. Also, it repeatedly pushes for the introduction of ‘Data Exclusivity’. Import duties and taxation policy on pharmaceutical products, drug price control policy and clinical research procedures too have been highlighted as key issues of concern.

The submission attempts to present that India’s IPR regime does not welcome pharmaceutical innovations, thereby restricting the access to medicines for Indian patients. PhRMA has high expectation from the draft IPR Policy and is hoping that it will bring Indian IP rules closer to global standards which will lead to foster innovation and investment.  Furthermore, PhRMA urges USTR ‘to provide an opportunity for a meaningful assessment of India’s IP regime through an Out-of-Cycle Review’, so that the U.S. government can evaluate India’s working on IP issues and ‘dedicate the required bilateral attention necessary to translate India’s commitment into substantive and real policy change in the IP.

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US pharma body slams Indian patent regime

Rupali Mukherjee, TNN | Feb 9, 2016

Mumbai: Criticizing India’s “weak” intellectual property rights (IPR) regime, PhRMA (Pharmaceutical Research and Manufacturers of America), which represents leading pharma and biotech companies in the US, has suggested India remain on the Priority Watch List in the 2016 Special 301 Report.

The Special 301 Report is an annual review of the state of IPR protection and enforcement in trading partners of US, and identifies challenges and opportunities facing US companies in foreign markets. The hearings on the issue will start in March. PhRMA said India’s “legal and regulatory systems pose procedural and substantive barriers at every step of the patent process, ranging from the impermissible hurdles to patentability, posed by Section 3(d) of Patents Act to the narrow patentability standards applied in pre-grant and post-grant opposition proceedings”.
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US wants bilateral treaty modelled on India’s FTAs with Japan & South Korea

Dipanjan Roy Chaudhury, ET Bureau | 9 Feb, 2016

NEW DELHI: A draft copy of the proposed India-US Bilateral Investment Treaty is not ambitious enough to attract American investors to India, feels Washington, which would rather prefer an agreement similar to the ones Delhi has signed with Japan and South Korea. “What India has proposed is not yet attractive enough for the US,” an American government source said.

India had shared a model text of the proposed treaty (BIT) with the US last year. The issue had come up for discussion at the US-India Trade Policy Forum (TPF) meeting in Washington last year, and bet over the past year, both sides held formal negotiations on BIT either in person or through video conferencing. Continue reading

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TPP: A new low

By Richard Trumka, The Hill| February 2, 2016

As a dozen nations gather in New Zealand this week to officially sign the Trans-Pacific Partnership (TPP), working families in the United States are sounding the alarm on a deal that would lower wages and ship even more jobs overseas.

The final text of the agreement, released in November, is even worse than we imagined, with loopholes in labor enforcement and rewards for outsourcing. Like its predecessor agreements NAFTA and CAFTA, the TPP is a giveaway to big corporations, special interests and all those who want economic rules that benefit the wealthy few. It is no wonder the presidential front-runners from both political parties oppose it.

It didn’t have to be this way. The labor movement supports trade. We know that opening up new markets to American products the right way can create jobs and lift up working people. But trade must be done under a fair set of rules that puts people ahead of profits. The TPP fails that test miserably.

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Biologic exclusivity provisions could scupper U.S. plan for TPP

By Matthew Driskill, FiercePharmaAsia |February 5, 2016

As expected and as FiercePharmaAsia reported in October 2015, provisions in the torturously negotiated Trans-Pacific Partnership (TPP) trade pact that deal with the exclusive period on biologics look set to derail plans to have the deal approved by the U.S. Congress as early as May or June.

Biologics, as the name implies, are made from biological material instead of chemicals and are one of the hottest areas in pharmaceutical development today.

They take years to develop and test and can costs tens of millions of dollars–or more–and drug companies say they need at least 12 years of exclusivity protection in order to make the treatments affordable and worth developing.

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