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Indian IP laws: Troubled watersThursday, November 27, 2008 08:00 IST IPR, which globally stands for intellectual property rights, is a scholarly creation of law. The question is what for are we creating such a law? This should always be the basic jurisprudence that needs to be answered before enacting any possible amendment or launching a social public attack on any of the provision of the Patents Act, 1970. Legal provisions are neither made in the air nor enacted to please any particular lobby of the industry. They are made considering the larger benefit of the society. In any country, law needs to take care of the welfare of its citizens and protect interests of the entities dedicating their operations for the good and progress of the society. Any imbalance may trouble the water and Indian patent law is no exception to that. It is important for the government to enact a law balancing the need and well being of the citizens and commercial interest of companies to achieve a larger societal development. No company can attain market success without the support of society and no society can progress without the operational success of the companies. Both are dependent on each other and work for the good of each other, but it is always consumer (people) who drives the global market and success of any company. As per section 83(c) of the Patents Act 1970, the protection and enforcement of patent rights contribute to the promotion of technological innovation and transfer and dissemination of technology, mutual advantage of producers and technology knowledge in a manner conducive to social and economic welfare and balance rights and obligations. So, even Indian patent law is enacted to balance social interest and economic prosperity. One has to bear in mind that law cannot be uniform across the globe because of demographic, economic and social disparity. Unlike US and Europe, India is a nation of ultra economic and social disparity depicting wide contrast in living standards and cost of living among the different segments of society. Enacting a law for such a nation like India is always going to be a challenge. Developed countries and global companies should not only recognise the fact that enacting a patent law for such demographic landscape country was not an easy task but also should appreciate the Government of India for enacting the Patents Act, 1970 in the present form balancing the social demographic need and well being of its citizens and global need for patent protection for research-based and IP-driven investment companies. While enacting the Patents Act 1970, the Government of India also ensured that companies should not only utilise patent protection for securing market space in India but also work patents on commercial scale (see section 83(a)), instrumental in public health (see section 83(d)), and available in reasonable cost (see section 83(g)). In case of abuse of patent protection, the Indian patent law also has provisions for Compulsory Licensing (see section 84) and Revocation of patents for non-working (see section 85). Overall, the Government of India not only managed in balancing needs and challenges but also in framing world class patent law. Courting opinion Globally, pharmaceutical industry is bifurcated, based on their business operations, into pioneers and generics. Pioneers invest huge sums in world class infrastructure, hiring and retaining research scientists and incalculable time discovering and developing new drug products and further bringing to global market. But this nowhere guarantees commercial success for their new drug products. Mostly, the commercial fate of new drug products depends on market acceptability, after sales public and health (regulatory) reviews over safety and efficacy, and last but not the least introduction of other new drug products by the competitors. In other words, pioneers often ventures into commercially high risk investment, which may even lead bankruptcy in case of operational, financial and market failure. But why investments are made? And what pioneers expect for such investments? Such investments are made to discover new generation drugs for complex and life threatening diseases or for developing better and more effective substitutes for known drug therapies. Usually pioneers face more research failures than success and often want to transform research success into commercial success to recoup investments made on research operations (including failures) and importantly brining high returns to the investors to keep them funding in future research activities. Pioneers often secure their investments and market space by building strong IP and patent portfolios. Intellectual partiality rights (?) Government of India brought third patents amendment to the Patents Act, 1970 to keep trivial and frivolous pharmaceutical inventions out of patent protection to avoid chances for ever-greening. Particularly, amendment to section 3(d) precludes patent protection for mere discovery of new forms of a known substance, which lacks enhancement of the known efficacy of that substance. However, the patents act fails to define what qualify for enhancement of the known efficacy, whether any improvement in physiological property will be sufficient to suffice enhancement of the known efficacy or it needs to be clinically improved efficacy. Also, the Indian patent law has provision for pre grant opposition giving interested parties a unique statutory chance to oppose application for a patent before the grant of the patent. However, this provision is often misused to unnecessarily delay the application process. Particularly, section 3(d) and pre grant opposition are creating additional statutory barrier for research-based companies for securing patent protection for their incremental and stepwise pharmaceutical products. And the government's lack of clarity over what qualify for improved efficacy has further caused imbalance between the business interests of pioneers and generics, which in fact seems to creating a new definition for IPR - Intellectual Partiality Rights. If the government of India favours generics by keeping small improvements out of patent protection, then the government should also need to put down a clear guideline for what qualify for enhancement of the known efficacy. So that genuine incremental products can be awarded patent protection. In case, if the Government of India consider enhancement of the known efficacy in terms of clinically improved efficacy then it is important that the government should equally reward pioneers for conducting additional clinical studies, such as, making provisions for data exclusivity. Also, the pre grant opposition, which largely favours generics, should also have a provision for adjusting patent term, if the application process is delayed for a substantial period. This is important that the Indian patent law should balance the needs of pioneers and generics, and should work in the commercial interests of both for the larger benefit of society. (The author is managing partner of IP Feathers) 
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