India's Expert Group Says Denying Patents To Incremental Innovations Will Not Be TRIPS-Compliant; Evergreening To Be Scrupulously Prevented

MUMBAI - Putting to rest wide speculation about applicability of the controversial Section 3 (d) of the Indian Patents Act, which deals with the treatment of incremental innovations, the Mashelkar Committee report - set up to dwell on Indian patent law issues - has recommended that incremental innovations should be encouraged.

"Incremental innovations involving new forms, analogs, etc. but which have significantly better safety and efficacy standards, need to be encouraged," the report says.

The clause comes with a rider that states, "What is important, however, is for the patent office to be vigilant about setting high standards of judging such innovations so that efforts on "ever-greening" are scrupulously prevented."

Local media reports suggest that the committee's recommendations have been accepted by the Indian government.

The recommendations have been mostly appreciated by the global pharmaceutical companies that maintain that innovations are inventive in nature and if it meets the requirement of benefiting the patients, there is no ground to deny patent rights to a product.

The Mashelkar Committee came out with its first report in 2006, but was then asked to re-submit the recommendations considering "technical inaccuracies" that had crept in following charges of plagiarism.

Categorically backing rigorous guidelines for determining patentability of products and making them available at affordable costs, the committee has concluded that it would not be TRIPS compliant to limit granting of patents for pharmaceutical substance to new chemical entities only, since it prima facie amounts to a "statutory exclusion of a field of technology".

"However, every effort must be made to provide drugs at affordable prices to the people of India. Further, every effort should be made to prevent the grant of frivolous patents and 'ever-greening'. 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," the report says.

"The group had always supported incremental innovation if the real benefit accrued to the patient in the form of better delivery technology or any kind of better treatments," Tapan Ray, director general of the Organization of Pharmaceutical Producers of India told PharmAsia News. "We had also made our stand clear on not encouraging frivolous patenting," he added.

Ray cited an example whereby a drug that needs sophisticated cold chain systems can be made heat stable. "The benefit of the drug becoming easier to handle will accrue to the patient and so these incremental innovations should be allowed patents."

D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, the lobby that represents generic drug makers in India said Section 3(d) is more supportive on innovation and leaves out frivolous patents. "This is the real function of Section 3(d). It is not a section which is against innovation, rather it is supportive of innovations which "result in the enhancement of the known efficacy" of a substance," he said.

An independent observer however said that the Mashelkar Committee is a "please all" effort so that multinational companies and Indian generic drug companies can be kept happy.

Section 3(d) of the Indian Patent Act has been debated for many years as multinational companies have struggled to bring in their patented products (Also see "Insider Analysis From Nishith Desai Associates: Learning And Unlearning From Section 3(d) Of The Indian Patents Act (Part 2 of 2)" - Scrip, 29 Jun, 2009.).

"If everything is left open to the discretion of the Indian Patent Office, we will end with numerous litigations and much time will be lost in bringing drugs to the market. Section 3(d) still contains many doubtful points but is better understood than what we had before" he argued requesting not to be identified.

Shah criticized the multinational pharmaceutical lobby and said, "An impression has been created by some of the big pharma companies that because of section 3(d) any kind of incremental innovations will not get patents in India. This has been sold to the media through the challenges to section 3(d) by Novartis."

The report is seen by many as a boost to drug discovery research for Indian companies.

In what is seen as a boost to drug discovery research to Indian companies, the Mashelkar Committee, known as "The Expert Group," said: "The TEG noted that a few Indian companies, which had invested in discovery research, were beginning to see some success in building a pipeline of new molecules. However, these molecules are in early stages of evaluation and entry and success in the marketplace is still awaited. Overall, it seems, that at least as of now, restricting patentability to just NCEs would mean that most of the pharmaceutical product patents would be owned by MNCs."

Novartis has been battling for long with Indian companies, non-government organizations and the government to secure patent rights for its anti-cancer drug Glivec. In July, India's Intellectual Property Appellate Board turned down the Swiss companies plea on grounds of lack of enhanced efficacy among other issues (Also see "Novartis Suffers Setback As Indian Patent Appeals Board Strikes Down Glivec Patent" - Scrip, 5 Jul, 2009.).

[Editor's note: PharmAsia News will host a webinar Sept. 24 on the commercial and intellectual property implications in India after the patent of Novartis' Glivec was rejected for not demonstrating significantly enhanced efficacy.]

- Vikas Dandekar ([email protected])