Even as the government accepts the revised report of the technical expert group on patent law issues, headed by RA Mashelkar, a key conclusion of the group has run into fresh controversy over the reasoning on which it is based. A globally-acknowledged Argentine patent expert, Carlos M Correa, who has been quoted in the report to support the group’s contention that patenting cannot be limited to new chemical entities, has disclosed that his views have been misinterpreted. This is an even more serious charge than the previous one (of plagiarising paragraphs from other documents to protect the commercial interests of multinational drug companies) that had forced the group to withdraw its original report. Regardless of how the group or its chairman responds to this allegation, the matter is serious enough for the government to take note; it should revisit its decision to approve the report.
The issue before the group was whether it would be compatible with the provisions of the global agreement on trade-related intellectual property rights (Trips) to limit patents for pharmaceutical substances to new chemical entities. (The other issue referred to the group concerned Trips and the exclusion of micro-organisms from patenting.) The group held that India is obliged to extend patent protection to incremental changes made to known medical entities which have significant therapeutic value. It argued that limiting the patentability of pharmaceutical substances to new entities amounts, prima facie, to ‘statutory exclusion of a field of technology’, which was not Trips-compliant. Mr Correa, on the other hand, feels that WTO-member countries enjoy flexibility and can deny patent protection to incremental innovations in pharmaceuticals that are non-inventive but the result of routine experimentation and known techniques. This line of argument has the backing of lobbyists who plead for the modification of the Indian Patent Act of 2005, to confine patents to new entities alone. The opposite viewpoint, proffered by the pharmaceutical sector, maintains that restricting patents to new entities may benefit companies having a ‘reverse engineering mindset’ but will not be in the long-term interest of the industry since it will discourage fundamental research to evolve new molecules.
The Mashelkar committee’s conclusion on micro-organisms — that their exclusion from patent protection would be violative of Trips — is equally contentious. The relevance of micro-organisms goes beyond the pharmaceutical sector to encompass, among others, agriculture, to improve the ability of crops and livestock to withstand pests and diseases. These microbes, billions in number, are an endowment of nature, and not the result of human endeavour. Their discovery or isolation should not, therefore, be entitled to statutory safeguards unless they have been significantly altered through human intervention.
Two arguments weigh in favour of dumping the Mashelkar report. First, its integrity is in question, on not one but two counts. And second, the pharmaceutical industry globally has been finding it increasingly difficult to come up with new molecules and breakthrough drugs; they have resorted therefore to extending the life of old patents by making minor changes to existing products. There is little or no public benefit from such activity, all that results is an increase in the price of drugs.