Once again patentability of pharmaceutical substances is a subject of intense debate in the country after the government decided to accept the modified report of Dr. R. A. Mashelkar Committee. The government had set up a technical expert group (TEG) with Dr. Mashelkar as its chairman on April 5, 2005 on the twin issues of 'evergreening of patents' and 'exclusion of micro-organisms from patentability' as Section 3(d) of the amended Patent Act was ambiguous. TEG submitted the report to the government on December 29, 2006. There was strong objection to the report by public interest groups on the ground that important parts of the report were plagiarized from a submission before the TEG by the representatives of MNCs. Subsequently, Dr. Mashelkar resigned as chairman of TEG but the government persuaded him to re-examine the issues and submit a revised report. Now even in the resubmitted report, Dr. Mashelkar has not taken a clear stand on patentability of pharmaceutical substances. The report says while incremental innovation involving new forms of a known molecule with significantly enhanced efficacy need to be encouraged, it is important for the patent office to be vigilant about high standards of judging such innovations so that efforts of evergreening are scrupulously prevented. This statement leaves the issue where it was. It is not clear how one determine 'significantly enhanced efficacy' of new forms of an existing molecule.
Section 3(d) in the amended Patent Act itself is not very clear and that is why the government thought of appointing a TEG. Now, as the issue is back to square one after four years, it would be better for the concerned government departments to frame suitable guidelines for Section 3(d) instead of leaving the issue to judiciary for its varying interpretations. What is to be remembered now is the very objective and spirit of this Section. The government does not want any pharma company to unjustifiably profiteer from a product without incurring any significant research costs. There is no doubt that granting patent protection for pharmaceutical substances involving only incremental innovation is against the public interest as such research does not involve any huge expenditure or time line unlike in the case of a new molecule. A 20 years market exclusivity for any incremental innovation cannot be justified as powerful pharma companies charge any price on such products by strongly promoting them at the cost of patients. Currently, there is no price control on patented products. The case of Glivec is already well known. Dispute on patentability of this high priced cancer drug of Novartis is on for the last three years. Although it is a clear case of incremental innovation, Novartis is not willing to give up its claim for patent and now it has approached Supreme Court. Since the amended Patent Act was notified in 2005, there are over 60 cases where patent applications were opposed by generic companies on patentability. A good number of these applications were already rejected by the patent offices but there are many more in the courts. Doha declaration on TRIPS agreement and public health had 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).