The debate on patentability criteria is up on the fore again with the recommendations of the Technical Expert Group on Pharmaceutical and Microorganism patents, popularly known as the Mashelkar Committee, been recently accepted by the Indian government, in its present form. The report recommended that any attempt to exclude an entire class of inventions i.e. incremental pharmaceutical inventions would violate the mandate under Article 27 of TRIPS to grant patents to all inventions in all fields of technology. It asserted that limiting patent grant for pharmaceutical substance to a new chemical entity or to a new medical entity involving one or more inventive steps would exclude an entire class of technology of incremental innovations from patenting, even when they satisfy the basic criteria of patentability. It also says that it would not be TRIPS compliant to exclude micro-organisms from patenting.

Article 27(1) of the TRIPs Agreement reads:

• Patents shall be available for any inventions, whether product or process, in all fields of technology; and

• Patent rights shall be enjoyable without discrimination in the field of technology.

The report was first submitted to the government in December 2006, was withdrawn and resubmitted in March 2009. It contained the same conclusions as it did earlier, albeit backed by some additional technical and legal arguments. It had sparked a debate on Section 3(d) and incremental inventions when it first came up and with the acceptance of the Report in toto by the government, there are expectations that there might be a change in the patentability criteria in the Statute. This will have a bearing on the number of applications filed in India, the content of the specifications/claims as also the examination of the applications already filed. The applicants who have already filed for patents, may delay the filing of Request for Examination, or may file a divisional application to include incremental inventions.

Patenting of microorganisms is allowed in the Indian Patents Act vide Section 3(j), as a matter of exception when disallowing patents on plants and animals. This is desirable in the wake of flourishing biotechnology industry in India. The Patents Amendment Act, 2005 that brought about product patent regime in India also made major changes to make patent law compliant with TRIPS, including modifying the definition of patentability to prevent ever greening. ection 3(d) was accordingly revised to prevent inventions that do not result in enhancement of a known efficacy of a substance, or new uses of known substances that do not result in new product or employs at least one new reactant. 

The Report also mentions, “Every effort must be made to prevent the practice of ever greening often used by some of the pharma companies to unreasonably extend the life of the patent by making claims based sometimes on ‘trivial’ changes to the original patented product. The Indian patent office has full authority under law and practice to determine what is patentable and what would constitute only a trivial change with no significant additional improvements or inventive steps involving benefits. Such authority should be used to prevent ever greening.” It recommends that there be detailed guidelines for the Patent Office for the examination of applications for pharmaceuticals, so that the remotest possibility of granting frivolous patents is eliminated.