New Mashelkar report has, well, little new

The Mashelkar committee report on pharmaceutical and micro-organism patents has reared its controversial head again.

The report, which made headlines in 2007 for being plagiarised from a UK-based report funded by pharma companies, was recently re-submitted to the government. However, it carries the same conclusions that were drawn the last time, albeit with a 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 Organization (WTO).

It says the process of innovation is continuous, and incremental innovations based on existing knowledge and existing products is a ‘norm’ rather than an exception. Thus, such incremental innovation with significantly better safety and efficacy standards should be encouraged.

In the same vein, it mentions that every effort should be made to provide drugs at affordable prices and to prevent grant of frivolous patents and ‘ever-greening’.

The committee was set up in 2005 under the chairmanship of scientist RA Mashelkar to look into two contentious patent provisions that were to be introduced in the Patent (Amendment) Bill, 2005, but held back as the government felt they wouldn’t comply with Trips.

Leading patients groups and legal activists say there will be strong opposition if the government accepts the committee’s recommendations.

Amit Sengupta, secretary of All India Peoples Science Network, said, “This committee was discredited on charges of plagiarism and now it has come out with same conclusions. There is basically no transparency in the report.”

According to a Mumbai-based patent expert, restricting pharma patent grants only to a NCE/MNE will not be against Trips, as Article 1.1 says that members shall be free to determine the appropriate method of implementing the provisions of the agreement within their own legal system.

But according to Mashelkar, the former director general of the Council for Scientific & Industrial Research (CSIR), although obligations under Trips can be implemented in any manner, they cannot be done away with. “If the obligation is to grant patents to all inventions and not to discriminate against technology, India cannot detract from these obligations,” he told DNA.

Mashelkar did not reply to references of lack of credibility that are being levied by activists.

Leena Menghaney, project manager-India, Medecins Sans Frontieres, an international medical and humanitarian aid organisation, said incremental innovation can be at the expense of investment in real therapeutic breakthroughs. “These medicines are similar to existing ones, and offer little in the way of therapeutic advantages.”

According to a New Delhi based legal activist, the Mashelkar report is paying lip service the concern of public health. “Incremental innovation is just a glorified term for ever-greening — extending the patent monopoly by bringing out trivial changes to an already existing patented product.”

The Delhi activist further says the report is clearly siding with pharma companies by reiterating that incremental innovations need a patent.

“India has several examples of incremental innovation, in the form of novel drug delivery systems (NDDS) which happen when a need is seen in the market. But they don’t call for patenting,” she says, adding that we need a situation wherein only NCEs are patentable.

Sengupta says we need strict patenting criteria so as not to patent small innovations. “We are seeing companies filing for patent applications for different forms of an existing molecule.”

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

“These are just examples of ever-greening and monopolistic tactics,” says the Delhi-based legal activist.