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Alert: USPTO-Pfizer pushing for TRIPS Plus measures in India
The United States Patent and Trademark Office, in collaboration with the Pfizer Limited, is organizing a meeting in India for NGO's and the media titled “Intellectual Property and Innovation in the Pharmaceutical Industry” from 2:30-5:30 p.m. at the Taj President Hotel in Mumbai on September 9, 2009. The meeting is being organized with the assistance of the US
Embassy in India.
On the agenda are controversial TRIPS Plus measures such as Data Exclusivity and Patent Linkage which are designed to delay the registration of generic medicines by several years, besides seriously interfering with the implementation of public health safeguards such as compulsory licensing. Even if a company is given authority to produce a generic drug under a compulsory license, it still needs to register the drug with India’s drug regulator - the Drug Controller General of India or DCGI. The DCGI will be reduced to enforcing private commercial rights and will become in effect the “patent police”.
In addition, Data Exclusivity will undermine one of India’s most important legal safeguards – section 3(d) that seeks to prevent the patenting of new forms, combination, uses of known medicines. Even when a patent is rejected on a known medicine, “data exclusivity” will create a new patent-like monopoly by blocking the registration of generic medicines.
A study conducted by Oxfam of the impact of TRIPS-plus provisions in Jordan (which was forced to implement these provisions under a free trade agreement with the US) compared drug prices in Jordan as a result of data exclusivity with those in neighbouring Egypt that does not enforce these provisions. The study found new medicines for diabetes and heart disease between 2 and 6 times more expensive in Jordan. See http://www.oxfam.org.uk/resources/policy/health/bp102_trips.html
This meeting highlights several issues of concerns – among them is the fact that a US agency such as USPTO’s link with the US pharmaceutical companies. Pfizer has actively lobbied for patent linkage and Data Exclusivity in the past; going the extent of suing the Philippines FDA officials for starting the process of registration of a generic version of the medicine ‘amlodipine besylate’ just before the patent expired.
Pfizer incidently has just been fined a record 2.3 billion dollars in the US for unethical drug promotion. See http://www.newsdaily.com/stories/tre5813xb-us-pfizer-settlement/
In addition, Pfizer CEO is the Chairman elect of Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA is the business lobby comprised of US drug manufacturers who have actively pushed for both - Data Exclusivity and Patent linkage in developing countries including India. They were extremely successful in the past. On behalf of PhRMA, the US Government and United States Trade
Representative (USTR) negotiated a number of free trade agreements under which developing countries (Chile, Jordon) were forced to adopt such TRIPS Plus measures.
It is important to note that the most recent report of the UN Special Rapportuer on the RIght to Health has highlighted concerns with the adverse impact of such TRIPS-plus measures on access to treatment and has recommended that developing countries not adopt these. See http://daccessdds.un.org/doc/UNDOC/GEN/G09/127/11/PDF/G0912711.pdf?OpenElement.
Not surprising is the continued attack against India’s position against evergreening of patents. Therefore on the agenda is a discussion on incremental innovation and ever greening being led by Mr. Dominic Keating from the U.S. Embassy. However India and the US have very different patentability standards. While US is faced with a proliferation of patents on new uses, combinations and new forms of known medicines which is instrumental in keeping generics out of the market and lowering of patentability standards of novelty, non-obviousness and industrial application; India on the other hand strictly limits the patenting of known medicines and has rejected a number of such
applications related to several antiretrovirals, cancer medications.
The fact is that for incremental innovation by Indian companies the market and not patents is the driving force. This is borne out by the development of the three –in- one AIDS pill – one of the most revolutionary innovations in AIDS treatment for the developing world. That the individual compounds were not patented in India made combining them possible.
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