COMPULSORY LICENSING vs DATA EXCLUSIVITY Indian pharmaceutical industry is under lens of global pharmaceutical companies after introduction of product

patent law under WTO-TRIPs agreement. Compulsory license is one of the aspects of TRIPS agreement where government of developing and underdeveloped countries allows non-patent holder to produce the patented products or process without consent of the patent owner. Data exclusivity is kind of a backdoor entry to monopoly protection. When the patent period has expired, or there is no patent on a product, data exclusivity will allow to act independently to delay the entry of any generic companies willing to enter the market until the period of data exclusivity is over. Data exclusivity right is a much stronger right than a patent. Unlike patent law, there are no exceptions or flexibilities allowed by governments to tailor the law to national circumstances. Government cannot provide the equivalent of a compulsory license, or data exclusivity may act as an obstruction to compulsory licensing of a patent on the same product by preventing marketing approval for a compulsory licensee. Data exclusivity very is attractive to research companies because unlike a patent, data exclusivity has no exceptions. No fees are incurred for application or maintenance of the data exclusivity right and there is more limited scope than exists in patent law for legal challenges. For these reasons pharmaceutical companies are strong supporters of data exclusivity regimes. In European Union it refers to eight year protection during which generic company cannot refer to the information of the original marketing authorization holder and marketing exclusivity refers to 10 year period after which generic products can be launched in the market. This duration is 5 years in US and 6 years in Japan and China. MNC are trying for 10 years of data exclusivity in Indian market. Because of the weak implementation of the Patent law under TRIPs, MNC companies are trying to get exclusivity in the Indian market through data exclusivity under Article 39(3) of TRIPs. Article 39(3) does not talk about Data Exclusivity at all, but only about unfair commercial use of their data in public or by other companies for marketing generic medicines. If such law is introduced in India, DCGI will be barred from relying on test data submitted by big pharmaceutical companies in granting marketing approvals to generic manufacturers. On the contrary it will ask generic drug manufacturers to undertake its own clinical trials and submit the data to DCGI to assess the quality, efficacy and safety of the generics. As these clinical trials are very complex, time

consuming and demand huge investment in R&D. Long incubation period undertaken by generic companies in conducting clinical trials will delay the process of launch of life saving drugs at affordable price by many years and this would lead to monopolization of the pharmaceutical giants. Recently we have witnessed the investment in R&D done by MNC like Eli Lily has found China more suitable than India. With lot of Indian companies having their research molecules in the pipeline, the weak implementation of the trade policies will in turn harm the Indian pharmaceutical industry. Many of the SSI or SMEs are not aware of the implications of data exclusivity and few semi-literate Indian pharmaceutical companies and researchers are clamoring for introducing data exclusivity. Introduction of data exclusivity, would adversely affect at least partially, the hitherto proven capabilities of Indian generic industry. Undoubtedly there will be a short term monopoly and adverse pricing scenario impacting public health interests. Being international pharmaceutical front runner in generics, India should do well to keep up its image as an IP/patent/data honoring participant rather than creating a hue and cry with regard to application of Data exclusivity. On one hand government is trying to protect the Indian pharmaceutical industry and providing affordable healthcare to the people of India by introducing Compulsory licensing and on the other hand by succumbing to the MNC by allowing Data Exclusivity is a complete mockery of Indian Patent Law and ridicules the national interest. India should try to learn from the mistakes of other countries like Jordan, who brought in Data exclusivity as a part of trade deal with the US. As per the study done by Oxfam, 103 medicines registered and launched in Jordan since 2001 at least 79% had no competition from a generic equivalent as a consequence of data exclusivity and the prices of these medicines under data exclusivity were up to 800% higher than in neighboring Egypt. India should not repeat others mistake or the effect of this would be felt far beyond India. India is the source of the vast majority of drugs used to treat AIDS and other life threatening disease in developing countries like Africa. Generic medicines produced in India have played a major part in reaching the more than 5 million people receiving treatment across the world. Previously, treating one HIV positive person for a year cost more than Rs 4lakh. But thanks to competition among generics from India, this treatment today costs just Rs 3,000. Any measure in the free trade agreement under TRIPs would have the effect of blocking competition would effectively be turning the clock back on access to medicines. -RASESH PADIA: 1ST year MBA Pharmaceutical Management, NMIMS, Mumbai