After more than 20 months of constitution of the Technical Expert Group to study all outstanding issues relating to patentability of new chemical entities and microorganisms, Dr Mashelkar, chairman of TEG, submitted a half baked report last month. Appointment of such a high powered committee under the chairmanship of such an eminent scientist of the country was considered critical for the ongoing implementation of the new patent law in India which was notified in January 2005. The contents of the TEG report instantly became the target of sharp criticism from the domestic pharmaceutical industry. Objection to the recommendations is understandable considering the incompetent handling of such a vital issue affecting the Indian consumers and domestic pharmaceutical industry. The expert group was to decide whether it would be TRIPS compatible to limit the grant of patents to new chemical entities or to new medical entities involving one or more inventive steps. The Group was also expected to study whether it would be TRIPS compatible to exclude microorganisms from patenting. The future of majority of the mailbox applications that are being processed by various Patent offices in the country may depend on the recommendations of Dr Mashelkar on "patentability". These recommendations were thus, considered crucial for the future of R&D of Indian pharmaceutical industry.
Doha declaration on TRIPS agreement and public health confirmed the flexibilities allowed to WTO members to define patentability in the national laws. India can thus use this flexibility to protect public health and its generic industry as per the section 3(d). Unfortunately TEG report did not address the core issue the way it was directed and expected to do. Indian Pharmaceutical Alliance has already taken up the matter with the government by dispatching a letter to the commerce ministry and asking it to reject the report and its recommendations. IPA has stated that TEG ignored the terms of reference and extended the scope of its study. By ignoring the available evidence on interpretation of the TRIPS Agreement, the TEG has also failed to provide a reasoned analysis for its conclusion. Here, the key issue is pertaining to granting of patents to trivial modifications of existing molecules thereby allowing ever greening of patents. OPPI representing MNCs in India has been pressing long for extension of patent protection for incremental innovations. And Dr Mashelkar found nothing wrong in granting patents to incremental modifications to known chemical substances. Such a stand in the TEG report is surprising considering the background and positions held by the scientist in India's premier and apex research institution. TEGs recommendations seem to have been made on the premise that the Indian pharmaceutical industry is capable of "incremental innovations" only and therefore India should not limit patenting to "new chemical entity" or "new medical entity". This is gross underestimation of the potential of India's research based pharmaceutical companies. TEG report also goes against the public interest by favouring MNC lobby which has been long campaigning for monopoly pricing of so called new drugs in India.