Six months have passed since the Department of Industrial Policy & Promotion (DIPP), ministry of commerce & industry, announced the constitution of a Technical Expert Group (TEG) to study all outstanding issues related to patentability of new chemical entities and microorganisms. The expert panel headed by Dr R A Mashelkar, director general, Council of Scientific and Industrial Research, has met thrice during this period and taken the views of various interests groups. The other experts engaged in this exercise are Prof. Goverdhan Mehta, Director, Indian Institute of Science, Bangalore; Prof. Asis Datta, Director, National Centre for Plant Genome Research, New Delhi; Prof. Madhav Menon, National Judicial Academy, Bhopal and Prof. Moolchand Sharma, Director, National Law Institute University, Bhopal. The expert group is to continue the sittings to decide whether it would be TRIPS (Trade-Related Intellectual Property Rights) compatible to limit the grant of patents for pharmaceutical substance to new chemical entity or to new medical entity involving one or more inventive steps. The Group will also study if it would be TRIPS compatible to exclude microorganisms from patenting. DIPP has not given any deadline to the TEG to finalize its recommendations. Meanwhile DIPP is in the process of fine-tuning the Patent Rules. The draft of the second amendment to the rules is to be finalized soon. With the Patent Act in place and the rules almost clear, what remains to be known is the government's stand on "patentability". The future of majority of the mailbox applications that are being processed by the Patent offices now depends on the recommendations of TEG on "patentability". The recommendation of the TEG is thus crucial for the R&D intensive pharmaceutical industry.
Given the importance of the final report of TEG and its possible implications in future drug patent filings, it is high time the DIPP asks TEG to speed up its study. Whatever be the outcome, the recommendations would help end the uncertainty and prepare the drug industry to face the rules of the land. Equal attention should also be given in finalizing the contents of the "user manual", which is to be circulated among the patent examiners. Clear instructions should be there in the manual about the exact meaning of the terms like "reasonable royalty", "mere new use" etc. The DIPP should realize that unless a proper blue print for uniform interpretation and implementation of Patent Laws are made, the decisions of the Patent Controller are going to be challenged more frequently in the court of law. While the Patent Act, as it stands now, addresses almost all the TRIPS flexibilities and provides sufficient safeguards to address public health concerns, what needs to be seen is the implementation of these safeguards in a fair and judicious manner.