From the Desk of Patent Circle

It all started in 1995 when India became a founding member of the World Trade Organization (WTO) following the Uruguay Round of Multilateral Trade Negotiations including agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS), and that was the beginning of India’s commitment (or rather obligation) to bring its patent law in uniformity to minimum requirements as negotiated (or rather stipulated) under TRIPS agreement. But the move to leverage patent law to TRIPS minimum requirements was not as simple and straight as what it seems to be, drawing large wave of criticisms from political parties, NGOs, Industries, and public-health activities. In 1998, India was forced to bring Mail-box provision for pharmaceutical and agricultural chemical products following complaints brought by the US and European Communities within the WTO Dispute Settlement Mechanism as a result of violation of Articles 27, 65 and 70 of the TRIPS agreement. However, en-route to TRIPS obligation, India brought three amendments to existing patent law within a span of 10 years transitional period which finally ended on 31.12.2004. The first amended was passed in 1999 which brought provisions for Mail-box applications and Exclusive Marketing Rights (EMR) followed by second amendment in 2002 which along with important amendments amended definition of ‘invention’ and brought patent term in uniformity to TRIPS and also inserted provisions for Patent Cooperation Treaty (PCT). The third amendment brought in 2005 deleted provisions for Mail-box applications and EMR and introduced product patent protection in the field of pharmaceutical, chemical, biotechnology, and agro-chemical products. But the time gap between the second and third amendment concerned lots of public debates against the introduction of product patent in health-care sectors and also found Indian pharmaceutical sector divided on patent frontier, with a section of industry supporting product patent and other fearing abuse of product patent protection. The 2005 amendment amended section 3(d) to exclude the possibility of ‘ever-greening’ and also inserted definitional clause for ‘pharmaceutical substance’. But section 3(d) after amendment left many things unclear than clear, making scope of section 3(d) technically unexplained and legally vague. However, during parliamentary debate over the Patents (Amendment) Bill, 2005 issues regarding patentability of micro-organisms and definition of ‘pharmaceutical substance’ to mean “a new chemical entity (NCE)” or “new medical entity (NME)” were raised which Commerce and Industry Minister assured to refer to an Expert Committee for detailed examination. Accordingly, a Technical Expert Group on Patent Law Issues was set by the Government of India under the chairmanship of Dr. R.A. Mashelkar, Director General, Council of Scientific and Industrial Research to decide whether (1) it would be TRIPS compatible to limit the grant of patent for pharmaceutical substance to new chemical entity or to new medical entity involving one or more inventive steps; and (2) it would be TRIPS compatible to exclude micro-organism from patenting. The Expert Group consisting of Dr. R.A. Mashelkar, Prof. Goverdhan Mehta, Prof. Asis Datta, Prof. N.R. Madhava Menon, and Prof. Moolchand Sharma adopted a consultative approach before making recommendations and conclusion to the Government of India. The Expert Group consulted people from industries, NGOs, intellectual property attorneys, etc. through written submissions, presentations, etc. and also acknowledged the need for access of affordable medicines to Indian people at large, encouraging innovation by Indian industry, its current capabilities in R&D, and balancing of India’s obligation under international agreements with the wider public interest. On December 29, 2006 the Technical Expert Group of Patent Law Issues submitted its recommendations to the Government of India, concluding that granting patents only to NCEs or NMEs, thereby excluding modifications and variant of NCEs, and excluding micro-organisms per se from patenting would contravene the TRIPS provisions. The Expert Group further concluded that detailed guidelines should be formulated and rigorously used by the Indian Patent Office for examining (1) pharmaceutical patent applications to prevent the grant of frivolous patents and ‘ever-greening’; and (2) patent applications involving micro-organisms from the point of view of substantial human intervention and utility. In concluding its recommendations regarding NCEs or NMEs, the Expert Group explicitly distinguishes ‘ever-greening’ from ‘incremental innovation’; argued about the consequences in restricting patentability just to NCEs or NMEs; and examined the current level and R&D innovations of Indian pharmaceutical industry. In case of patentability of micro-organisms, the Expert Group argued about rapid growth of Indian biotech industry and India’s advantage and needs to reap the due of benefits from its rich bio-resources. Patent Circle gives thumbs-up to Dr. R.A. Mashelkar and team for quite pragmatic conclusion and unbiased recommendations. It is important for Indian industry to understand that incremental innovations are important for the keeping the pace of the development. Most of the time the discussions are always based around big market players like Ranbaxy and Dr. Reddy’s which are slowly becoming capable to invent new molecules but what about small players? Incremental innovations are very much necessary to keep small companies going in this globally competitive environment.