India is drying up as a source of affordable versions of newer life saving medicines. The Indian Patent Office has since April 2005 started to publish and examine thousands of pending patent applications, a large number of which relate to essential medicines like antiretroviral used in the treatment of AIDS. Such newer drugs are under patent or pending patent grant in other important countries with generic production capacity, such as Brazil and Thailand, which are known for keeping prices of life saving drugs high and their availability low. If patents are granted too easily on such essential drugs in the country, it may herald the end of India's primordial role in producing generic affordable versions of high cost life saving drugs.
It is, therefore, important that the patentability standards, introduced by the Patent (Amendment) Act, 2005, which seeks to provide for novelty, non-obviousness and Section 3 (d) may result in proliferation in patent applications before the Indian Patent Office. Such applications may claim protection for minor, in some cases of obvious, variants of existing essential drugs, and if that are strictly implemented, it will be very difficult to ensure the widest possible access to affordable life-saving medicines in developing countries.
Meanwhile, according to Indian Drug Manufacturers Association, patent harmonization, which provides for a uniform law on patents for all the countries throughout the world, is a ploy by the United States to substitute the law of that country on all other countries. In a world where every country has a different Constitution, different commercial laws, different economic laws, it is just not possible to provide for a uniform patent law for the entire world. The Association feels that there is a need to remove all qualifying phrases from the Patents Act in order to bring in flexibilities available under the Trade Related Intellectual Property Rights Agreement (TRIPS).
Right of patent applicants under Section 11(A) (7), which states that 'on and from the date of publication of the application for patent and until the date of grant of a patent in respect of such application, the applicant shall have the like privileges and rights as if a patent for the invention has been granted on the date of publication of the application', is decried on the ground that such provision is not required under the TRIPS and benefits only the multi-national corporations.
Added to the foregoing, the compulsory licence procedure is too lengthy and complicated. It favours totally the patent holders, who are generally multi-national corporations. This minimizes the chances of getting a compulsory licence as a very low one because of protracted and high cost legal battle in the country.
The new patent regime for essential life saving drugs is balanced in favour of multi-national drug giants and hampering India's national campaign for access to essential life saving affordable medicines. This will, ultimately and potentially dilute India's role as the 'pharmacy of the developing world'.#