In India, The Indian Patents Act 1970 was implemented in 1972. It made pharmaceutical product innovations, as well as those for food and agro-chemicals, un-patentable in India. It allowed innovations patented elsewhere freely copied and marketed in India. Further, this Act restricted import of finished – formula, imposed high tariff rates and introduced strict price control regulation. This Act was not beneficial to the big foreign multinational organizations and was not in sync with the global patent system.
India being a member of WTO, it had to comply with the requirements under the TRIPS Agreement. As such the 1970 Act was required to be amended. The requirements were that a mailbox system be set up and Exclusive Marketing Rights (EMR) be allowed. Under the EMR, an international company would get exclusive rights to market a product in the field of pharmaceuticals and agricultural chemical products in the Indian market for a specified period (5 years). The mail box system is a box which received all applications for the patenting of pharmaceutical and agricultural chemical products. These provisions were included in the Patents Act through 1999, 2001 and 2002 amendments. The applications in the mail box were considered in 2005.
These amendments though far reaching, still did not bring the Indian Patents Act in full conformity with the global intellectual property system. This conformity was introduced through the Patents Amendment Act 2005. The main provisions of this Amendment Act are:
1. Product Patent:
The Act extends product patent protection in all fields of technology, i.e. drugs, food and chemicals. Earlier only process patent was allowed which limited patent rights. For example, a process patent was awarded to the way a cure for, say cancer, is manufactured and not for the cure. This allowed the other manufacturers to produce the same cure by some other method and hence not violate patent rights of the original manufacturer. But now after the 2005 Amendment, patent is awarded to the way cancer cure is manufactured and to the cure as well.
2. Compulsory Licensing:
This is a TRIPS compliant provision empowering the governments to check and control the misuse of patents. In spite of the existence of a patent, the govt can invoke the compulsory license to make available the patented product to the people in case of national emergency for public non-commercial use. The govt can also invoke compulsory licensing if it feels that the public requirements with regard to a patented product have not been met and the product is not available for the public at an affordable price.
3. Embedded Software:
The Act allows for patenting of embedded software
4. Other provisions:
The Act allows the patent holder to challenge the license so that he can block general production of his drug. Pre-grant and post-grant opposition clause has been provided. The Act also removes provisions relating to EMRs besides strengthening the provisions relating to national security to guard against patenting abroad of dual use technologies.
Patents Act 2005 provides that following items are not patentable:
A frivolous invention or one that claims anything contrary to established natural laws .
An invention the use of which would be contrary to morality or injurious to public health.
The mere discovery of a scientific principle or the formulation of an abstract theory.
The mere discovery of any new property or new use of a known substance or the mere use of a known process , machine or apparatus unless such known substance results in a new product or employs at least one new reactant .
A substance obtained by a mere admixture resulting only in the aggregate properties of the components thereof or a process for producing such substance.
The mere arrangement or rearrangement or duplication of known devices functioning independently of one another in a known way.
A method or process of testing applicable during the process of manufacture rendering the machine , apparatus or other equipment more efficient, or for the improvement or restoration of the existing machine, apparatus or other equipment for the improvement or control of manufacture .
A method of agriculture or horticulture.
Inventions relating to atomic energy.
The govt has clarified that the new patent regime will not affect the prices of 350 life saving drugs available in the market. This has been done considering the fact that 97% of the drugs available in the market are made off patent.These drugs therefore are not to be patented in India
BY:- Lavannia Pilla