Protection of Pharmaceutical Products
Pharmaceutical industry is a successful, technology driven industry that has seen steady growth over years. As research is inevitable and expensive in pharma industry, it becomes essential to safeguard its outcomes, which may be in the form of a new and innovative products or processes. The global liberalisation of economy is the primary reason for the flourishing of many industry sectors especially the pharmaceutical market and various research and development in the industry paving way to innovations, forces the sector to protect its inventions. Awareness about Intellectual property Rights is therefore necessary in protecting the rights of the owners and curbing infringement.
Patent Act, 1970 regulates Patenting system in India and lays down the criteria for granting a patent for an invention- viz newness or novelty, non-obviousness and usefulness. Patent system in India like several other developing countries, originally did not grant patents for pharmaceutical products. Likewise, there are some inventions which are excluded from patentability and listed as non-patentable under Section 3 of the Patent Act which include (i) Any process for the medicinal, surgical, curative, prophylactic or other treatment of human beings or animals, (ii)A substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance (iii) The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance, amongst others.
The Uruguay Round Trade Negotiations on General Agreement on Tariffs and Trade (GATT) included discussion on TRIPS and issues encompassing the Intellectual Property rights issue with regard to pharmaceutical industries. During the discussions, it was pointed out that countries at different levels of development should have their own right to decide whether to grant patent right to certain products. India had signed the General Agreement on Tariffs and Trade (GATT) on 15th April 1994, thus complying with TRIPS agreement. GATT was succeeded by the establishment of World Trade Organization (WTO), in which India is the founding member. Accordingly, in order to meet the TRIPS standards, many provisions of the Patents Act, 1970, were amended, including the object of patent protection and the patent term (granted for a minimum term of 20 years to any product or process that fulfils established criteria), amongst others. The provisions for patentability of pharmaceutical products were thus included to comply with the TRIPS obligations, effective from January 1, 2005.
The Patents Act also included provisions for Compulsory Licensing which enumerates that on completion of 3 years from the date of the sealing of a Patent, any interested person can make an application to the Controller for grant of a compulsory license for a patent on the following grounds: (1) that the reasonable requirements of the public with respect to the patented invention have not been satisfied; (2) that the patented invention is not available to the public at a reasonably affordable price; and (3) that the patented invention is not worked in the territory of India. The Act provides special provisions for compulsory licenses on notification by the Central Government, which may be issued in a circumstance of national emergency, extreme emergency, or a case of public non-commercial use, including public health crises, relating to AIDS, human immunodeficiency virus, tuberculosis, malaria, or other epidemics.
All these provisions had a significant impact on India’s pharmaceutical patent system as patents for drugs granted pharma companies the exclusive right over their patented formulations, allowing them to prevent others from using the same without license during the term of the patent.
After the introduction of product patent regime, a wide range of pharmaceutical products are being patented in India. This is particularly so considering that obtaining exclusivity by way of patents is often needed to protect the results of Pharmaceutical Research and Development, and to get returns for the huge investments made by Pharma companies in R&D.
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