‘We must look to avoid grant of frivolous patents at all costs’

With the government accepting the Mashelkar Committee Report on pharmaceutical patents, the stage is now set for a new battle over patents and public health.

The report, which made news in 2007, for allegedly being plagiarszed from a UK study funded by MNC pharma companies, currently carries the same conclusions that were drawn the last time, albeit with stronger reasoning.

It states that restricting grant of patent for a pharmaceutical substance to a new chemical entity (NCE) or a new medical entity (NME) and excluding micro-organisms from the ambit of patents would be incompatible with Article 27 of the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement of the World Trade Organization (WTO).

These conclusions have drawn protests from patient bodies that believe the report plays into the hands of MNCs and would not benefit patients.

In an email interview with DNA , eminent scientist RA Mashelkar, chairman of the committee, shares his views about the report, patents, and incremental innovations from Hanoi in Vietnam.

What does the government’s acceptance of your report mean to you?
I am happy that the government has accepted the report in toto. I am happy that despite the personal attacks, I showed the courage to stand by a report that was based on the most sound technical and legal arguments put forward by my colleagues in the committee, which comprised, besides our icons among scientists, two of our most eminent legal luminaries in India.

I am happy that the truth has finally prevailed and my stand has been vindicated. I am also happy that the government, after not accepting my resignation, showed patience for two years and full faith in my integrity.

How does the report address the issue of providing affordable medicines to our common citizens?
There should be no fears whatsoever on that count. We must avoid grant of frivolous patents at all costs, but this can be done by not breaking our commitment to international treaties, to which we are signatories.

There are fears that the government’s acceptance of this report will increase ‘ever-greening’— extending the patent monopoly by making trivial changes to an existing patented product.

As regards fears that the government’s acceptance of the committee’s interpretation will lead to evergreening, the report has made explicit recommendations regarding the rigorous criteria that the Indian patent offices should use to ensure that not a single frivolous patent is granted.

Several healthcare and legal activists feel that restricting pharma patent grants only to NCE/NME 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 systems.

This only means that ‘obligations’ under TRIPS can be implemented in any manner. But one cannot do away with the obligations themselves. In other words, if the obligation is to grant patents to all inventions and not to discriminate against technology, India cannot detract from them.

However, it can choose the specific mode that it wishes to use in implementing these ‘obligations’. But it has to comply with these ‘obligations’ in the first place, and Article 1.1 does not say otherwise.

Is patenting of drugs the only manner in which innovation can be rewarded?
There are a number of innovations that are emerging. So patenting of drugs will continue to be the mode of rewards, but the business models for rewards will change. The situation on discovery of molecules with entirely new chemical structures is pretty dismal. Last year, FDA approval for such category was given to only 21 molecules, as against about twice the number a decade ago!

Do you strongly support incremental innovations?
I am in support of incremental innovations that truly bring in significant benefits in terms of efficacy, safety, mode of delivery, etc, and not just trivial ones. The patent office can always set up its own benchmarks for novelty. No one can object to it. As Edison had said, we can always do better. And doing better happens incrementally in life, not by breakthroughs every day!