Mashelkar report draws health groups' ire again

With the government last week accepting the Mashelkar Committee Report on pharmaceutical patents, the stage is set for a new battle over patents and public health.
The report, which made headlines in 2007 for being plagiarised from a UK study funded by pharma companies, was re-submitted to the government a few months ago. It, however, carries the same conclusions as the last time, albeit with stronger reasoning.
The report notes that restricting grant of patent for a pharmaceutical substance to a new chemical entity (NCE) or new medical entity (NME) and excluding micro-organisms from the ambit of patents would not be compatible with Article 27 of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement of the World Trade Organisation.

The process of innovation is continuous, and incremental innovation based on existing knowledge and existing products is the norm rather than an exception, it says, adding, such incremental innovation with significantly better safety and efficacy standards should be encouraged.

In the same breath, however, the report says effort should be made to provide drugs at affordable prices and to prevent grant of frivolous patents.

Patient groups and bodies working to boost access to medicines are clearly not happy with the report and will be protesting against it.

In a letter to Union commerce & industry minister Anand Sharma on August 10, the National Working Group on Patent Laws had said that the recommendations of the Mashelkar Committee should be disregarded and appropriate amendments introduced in the amended Patent Act 1970. It claimed that frivolous and questionable patent claims are being filed by the industry and being granted by patent offices.

A New Delhi-based legal activist said incremental innovation, which the report eulogises, is a glorified term for ever-greening —- extending the patent monopoly by making trivial changes to an existing patent product. “We are seeing companies filing for patent applications for different forms of existing molecules,” the activist said.

Patents have been granted in India for Roche’s valganciclovir (treatment for eye infections), Schering-Plough’s pegylated interferon alfa-2b, Roche’s pegylated interferon alfa-2a (both for hepatitis C) and GlaxoSmithKline’s abacavir oral solutions for HIV, which, say legal activists, are new forms of known substances.

Some patent experts also quash the report’s claim that restricting patent grants to only NCE/NME will be against TRIPS. According to them, Article 1.1 of TRIPS says members are free to determine the appropriate method of implementing the provisions of the agreement within their own legal system.

In an earlier response to this newspaper, R A Mashelkar, prominent scientist and former director general of the Council for Scientific and Industrial Research (CSIR), under whose chairmanship the committee was set up, had said that if the obligation under TRIPS is to grant patents to all inventions and not to discriminate against technology, India cannot detract from the obligation.