PhRMA Special 301 Submission 2016 – India 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 PhRMA Special 301 Submission 2016 – India 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.
Atty Mel Libre, Sunstar| Feb 6, 2016
IT WOULD have been like another working day in Auckland if not for the 5,000-plus protesters that created a commotion outside Sky City Hotel where ministers from 12 countries, including New Zealand, signed formally the Trans-Pacific Partnership (TPP).
TPP is a free-trade agreement between 12 Asia-Pacific countries: Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, the United States and Vietnam that primarily allows the free flow of goods and services sans tariff.
The signing of the agreement in New Zealand is an acknowledgment of its role as the driving force in its creation and growth – and having convinced the United States and Japan to join. It all started in 2001 when New Zealand and Singapore entered into an agreement, the Closer Economic Partnership (NZSCEP), a precursor to the Trans-Pacific Strategic Economic Partnership Agreement that further expanded to what is now TPP. The New Zealand initiative became bigger when President Barack Obama of the United States agreed to back it up.
The announcement about U.S. Trade Representative’s (USTR) ‘Special 301’annual report 2016 known for attacking progressive patent laws like those of India is out. USTR has been strategically using this report to create pressure on countries to enhance IPR protection beyond the TRIPS agreement. USTR has retained India in its “Priority Watch List” now consecutively for two years and has been pushing India to bring its IPR regime closer to their patent law that seeks to favour multi national pharma companies and restrict generic competition.
Thanks to the Indian patent law, generic competition has prevailed in the country and resulted in production of affordable life saving drugs. Ironically, US itself has failed to provide better and accessible healthcare to its people. Evergreening of patents and big pharma lobby has resulted in mounting prices for life- saving drugs especially for the treatment of Cancer, Hepatitis C in the US. Continue reading