Recommendations made by a 5-member committee constituted by the Government of India on limiting drug patents have been questioned by public interest groups concerned about availability of cheap drugs in the country.

The committee headed by R A Mashelkar, former Director-General of the Council of Scientific and Industrial Research, has recommended that grant of patents in the country should not be limited to new chemical entities (NCEs) or new molecular entities (NMEs).

NCEs or NMEs are drugs that contain no previously patented active molecule or ion responsible for the physiological or pharmacological action of a drug.

In its report released recently, the Mashelkar Committee has said that limiting the grant of patents to NCEs or NMEs would not be TRIPS-compliant.

The committee has also recommended that only micro-organisms modified by substantial human intervention should be granted patents. Exclusion of micro-organisms per se from patent protection could be “violative” of TRIPS, the committee stated.

Indian patent law currently does not strictly limit patents to NCEs or NMEs. Neither does it impose a blanket ban on patenting of micro-organisms.

Many public interest groups as well as India’s Left parties want a stricter patent regime with patentability limited only to NCEs or NMEs. The demand is based on two related grounds:

• The country’s public health needs ample supply of affordable drugs, which can be provided by the domestic generic drugs industry.
• The adverse effects of misuse of patents on the generic industry should be prevented.

The Mashelkar committee has however opined that limiting the grant of patents to NCEs would be against the TRIPS agreement as well as national interest.

The committee said that though many Indian companies are investing in R& D, “it will be a decade before a critical mass is in place and results start accruing”. In these circumstances, restricting patentability to just NCEs would mean that most of the pharmaceutical product patents would be owned by multinational companies, the committee’s report said.

“Incremental innovations,” the committee’s report stated, “are sequential developments that build on the original patented product and may be of tremendous value in a country like India. Therefore, such incremental developments ought to be encouraged by the Indian patent regime.”

At the same time, the committee emphasised, efforts to extend a patent monopoly by making trivial changes to an existing patented product (`ever-greening' in pharma industry parlance) should be prevented.

The committee suggested that detailed guidelines should be formulated and rigorously used by the Indian Patent Office for examining the patent applications in the pharmaceutical sector so that “the remotest possibility of granting frivolous patents is eliminated”.

K M Gopakumar, patent expert with Centad, pointed that while the committee was right in emphasising the role of incremental innovations and the need to prevent frivolous patents, it had failed to answer the main question posed before it in its terms of reference: Would it be TRIPS- compatible to limit the grant of patent to a new chemical entity or to a new medical entity involving one or more inventive steps?

He also questioned the national interest argument used by the committee. The national interest perspective of the committee considered only the interests of a few big Indian pharmaceutical companies, he said. “There is no reference to public health concerns in the report.”

January 17 , 2007