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Compulsory licensing
The Indian government has given private assurances that it will not grant licences allowing local firms to override patents and make cheap copies of drugs by big Western drug makers, a US business advocacy group said.
The Indian government has given private assurances that it will not grant licences allowing local firms to override patents and make cheap copies of drugs by big Western drug makers, a US business advocacy group said.
The comments were revealed in a submission last month by the US-India Business Council (USIBC) to the US Trade Representative (USTR), which is reviewing global intellectual property laws for an annual report identifying trade barriers to US companies, thus reports Reuters.
In a landmark move, the Indian Patent Office announced in March 2012 issued its first compulsory license to a domestic generic drug-maker. The decision effectively ends German pharmaceutical company Bayer AG's monopoly over an anti-cancer drug and authorises the production of a low-cost version for the Indian market, states http://www.ictsd.org/.
Compulsory licensing is when a government authorises a party other than the patent owner to produce the patented product or process, without the patent owner's consent. New Delhi's decision may pave the way for other Indian generic producers to ask for compulsory licenses on patent-protected medicines if the right-holders fail to supply the products at affordable prices and in sufficient quantities.
It could also potentially encourage other developing countries to use compulsory licensing for drugs for non-communicable diseases, which has until now mostly been limited to HIV drugs in these countries, experts say. India is the world's third-largest pharmaceutical drug producer by volume; in 2011 the domestic pharmaceutical market reached a record of US$12.2 billion in sales.
India only began issuing patents for drugs in 2005 in order to comply with the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). The TRIPS Agreement explicitly allows compulsory licensing as long as procedures and conditions set out in Article 31 of TRIPS are fulfilled.
Under Section 84 (1) of the Indian Patent Act, any person may request a compulsory license if, after three years from the date of the grant of a patent, the needs of the public to be covered by the invention have not been satisfied; the invention is not available to the public at an affordable price; or the patented invention is not "worked in," or manufactured in the country, to the fullest extent possible, adds the ICTSD website.
