By M.C. Linthoingambee
Patent is one of the major forms of Intellectual Property Rights (IPR) used in the pharmaceutical industry. Grant of patent in India is governed under the Patents Act, 1970.Significant changes like provision of product patents and increase in the term of patent to 20 years were introduced in the Indian patent law, after India signed TRIPS agreement in 1995. This review provides a brief overview of development of patent law in India as a consequence of the TRIPS agreement. Criteria of patentability and different types of pharmaceutical patents currently being granted in India are described with the aim to provide the fundamental knowledge of pharmaceutical patenting to the researchers.
India has one of the largest standing pharmaceutical industries in the world with the world market providing huge turnovers. As far as pharmaceutical products were concerned, over a period almost 85 per cent of medicines were supplied by multi-national corporations. Kefauver Committee of USA which deliberated extensively on the availability of medicines worldwide and the role of the multi-nationals pointed out in their report that the prices of antibiotics and other medicines in India were the highest in the world. The Indian people were virtually fleeced on the availability and affordability of medicines. Dr. Yusuf K Hamied, Chairman and Managing Director of Cipla Limited and a leading scientist in his recent Paper ‘Trading in Death’ has made strong observations on the new Indian Patent Law keeping the critical health scenario in India in view: “The truth is that health in India is in a permanent and perpetual crisis. The disease profile is as follows : 80 million cardiac patients, 80 million afflicted with mental illness, 60 million diabetics, 50 million asthmatics, 50 million hepatitis B cases, and one in three Indians is a latent carrier of TB. The World Bank has said that India will have 35 million HIV cases by 2015, or approximately half of all the AIDS cases in the world. Given these facts, the patent regime in this country should be devised so that the utmost priority is granted to securing the people’s rights of access to affordable and quality healthcare, without monopoly”.
Furthermore, more than half a million people in the world are unable to afford medicines. The severity of the price has increased and needs immediate attention. India being one of the largest developers of generic version of drugs has helped in exporting a series of drug to help treat patients in developing and underdeveloped countries. Several organizations like: Doctors Without Borders (MSF), Indian Red Cross Society, etc. has volunteered to supply medicines free of cost to patients dealing with the stress of unaffordable prices. The growing need for medicines is felt everywhere – Medicines guarantee much more than they are meant for. The growing increase in Research and Development has helped developed drugs which could treat a varied number of diseases and volatile epidemics. The Patent Law has helped guarantee a safe regime to give certain rights to large pharmaceutical companies to register the drug at their monopoly for a particular time after which the drug enters a public domain giving rights for various local pharmaceuticals to develop a generic version of the same drug. The patent system should be thought of as ?a carefully crafted bargain that encourages both the creation and the public disclosure of new and useful advances in technology, in return for an exclusive monopoly for a limited period of time. Patent law here gives the public client sufficient incentive to create and innovate, at the while ensuring that the public have access to the fruits of their endeavors. This clearly demonstrates how patent law can serve public interest. The public interest about the affordability of patent filing have been protected to a great extent which otherwise would have made the innovations lost.
Most of us are even unaware of this setback. There are less number of certified pharmacist who are qualified to selling medicines in the first place who had not obtained due license from the probable authorities. For every time we buy a medicine for a common cold, headache, etc we are not bothered to ask about its values and terms. But this ignorance has led to more payments and the lost of the local market flourishing in guaranteeing public health to the citizens of its own country. With the exception of a few, most Indian pharmaceutical companies are unfamiliar with the nuances of complex patent prosecution strategies. Research-based pharmaceutical companies, on the other hand, have firsthand knowledge of successfully designing and implementing, sophisticated patent prosecution strategies. Therefore, the first hurdle for the Indian pharmaceutical industry is unevenness in the domain knowledge on patents. One of the ways to overcome this is to learn the use of patents as a business tool.