‘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
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
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.
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”.
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
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.