The patients groups and health NGOs who have filed a pre-grant opposition against Gilead Science's patent application on tenofovir disoproxil fumarate, feel that the recent decision of Gilead to sign non-exclusive license agreements with eight generic companies of India can prove harmful to the long term interests of the patient groups in ensuring affordable medicines to the needy.
The groups question the rationale behind running after Gilead when there is a strong case for rejection of its patent application in India. The public interest lawyers providing legal support to Indian Network for People Living with HIV/AIDS (INP+) and the Delhi Network of Positive People, who jointly filed the pre-grant opposition, argue that forming a salt (fumaric acid) out of an existing compound (tenofovir disoproxil), is a common practice within the pharmaceutical industry, and should not be considered a new invention. The scramble for marketing license can only weaken the chances of winning a pre-grant opposition, and thereby ensuring un-hindered low cost generic manufacturing and supply, they fear.
According to them, the apparently harmless license agreement has several in-built clauses that prevent the generic companies from supporting any move to oppose Gilead's 'patent' rights. "It prevents generic companies from having rights on any improvements, modifications or derivative works that they might work on Gilead's compound. Further, the agreement ensures that Gilead controls over the manufacturing and marketing channels of TDF world over, as formulators are required to source APIs only from licensed API manufacturers. The API manufacturers are bound by the agreement to provide raw material to only those companies that have license agreements with Gilead. The generic formulators are also to pay a royalty to Gilead," they explained.
The major problem with such agreements is that it allows a single pharmaceutical company to have a control over the manufacturing and marketing of an essential drug. Indian companies should have waited for the decision of the Patent Office on Tenofovir's patent status before jumping into such agreements, activists opined.
It is known that the license agreement requires the generic companies to assist Gilead on the issuing, maintenance and enforcement of the patents. In case of a patent infringement allegation, the generic company may be asked to assist Gilead in further proceedings and to lend its name to such actions or proceedings if required by law in order to help Gilead. The patient advocacy groups say that such actions may lead to a wrong precedence where trivial patent applications get approved due to lack of opposition from generic players. This would ultimately result in higher prices and monopoly control over marketing of essential medicines, they fear.
The patient groups had filed pre-grant opposition against patent application on TDF at the Delhi Patent Office on May 9, 2006.
Meanwhile, Gilead Sciences have stated that the move is entirely based on its partnerships with NGOs and patient groups and is intended at bringing down the cost of TDF. The non-exclusive licenses granted to Indian companies would enable them to sell TDF at the lowest possible price in 95 countries including India. Gilead itself has offered its branded TDF Viread at $1 per day and feels that the generic competition would drive the costs further down. Whatever be the cost, the generic companies who have license agreements with Gilead will have to pay 5 per cent of net sales of the product as royalty.