"Don't destabilise or create uncertainty on the IPR regime"

Dilip G. Shah: "Defining patentability is a flexibility provided in the TRIPS agreement."

Dilip G. Shah: "Defining patentability is a flexibility provided in the TRIPS agreement."   | Photo Credit: Photo: Sarah Hiddleston

Sarah Hiddleston

Dilip G. Shah, Secretary-General of the Indian Pharmaceutical Alliance who has had 40 years of experience in the pharmaceutical industry, answers questions on what type of pharmaceutical products should be eligible for patents in India; innovation in the Indian industry; and issues raised by the Mashelkar report, which has been withdrawn on account of `technical inaccuracies and plagiarism.' Excerpts from the interview conducted in Mumbai:

How do we define new chemical entity?

New Chemical Entity is not defined either in TRIPS or in Indian law, not even in United States patent law. Only the U.S. Food and Drug Association has defined NCE. Nowhere else is there a definition. This makes it clear that each country has the freedom to define in its own law what it considers to be a new chemical entity. This FDA definition is a good definition, which very clearly says that for any new inventive drugs you can submit a patent and any derivatives [small changes in form, usage] are not eligible.

The Mashelkar report concludes that India cannot limit patents to NCEs because that would contravene Article 27 of the TRIPS agreement. What is IPA's view?

The technical expert group has taken an interpretation of Article 27 without examining its nuances or considering practices followed by other WTO members such as Canada, or even taking note of the judgment of the WTO dispute settlement panel and appellate body [India-Patent Protection for Pharmaceuticals and Agricultural Chemical Products AB-1997-5, WT/DS50/AB/R, December 19, 1997]. Extensive volumes have been written on interpretations of Article 27, 7, and 8 and the Doha Declaration on public health.

Two commissions have also examined this. First, the United Kingdom Commission on Intellectual Property Rights (CIPR). Dr. Mashelkar was a member. Secondly, the WHO set up a commission on the same subject. Dr. Mashelkar was a member of this also. The commissions came to the same conclusion: defining patentability is a flexibility provided in the TRIPS agreement.

The absence of international patent law has led some countries to seek harmonisation in terminology of patent law at WIPO [World Intellectual Property Organisation] since the conclusion of TRIPS. Had TRIPS provided uniform patentability, there should be no need for the United States, European Union, and Japan to demand harmonisation.

Instead of examining the technical and legal issues of Article 27 and making use of available evidence, the Mashelkar group developed another set of criteria, which is purely political. This committee wasn't set up for that.

What were these criteria?

First, the report says they [the technical experts] want access to affordable medicines. But all it says is that every effort must be made to provide drugs at affordable prices to the people of India. But on how and who will make the drugs, there is nothing. You don't need an expert group to make this statement. This is a political statement.

Secondly, the report implies that not limiting patents to NCEs would encourage innovation by Indian industry. But in this you encourage only tweaking of molecules [manufacturing derivatives] instead of real innovation.

Thirdly, the report claims that Indian industry is capable of only incremental innovation. And as evidence for that, the Mashelkar group cites in Annexure IV of the report, 215 (not 339 as it would appear at first glance) patent applications for incremental innovations. But why are Indian companies doing this? If the U.S. permits incremental innovation and I am going to sell my product in the U.S., I will go by U.S. rules. So I will file applications for the U.S. market for incremental innovation. Concluding from this that incremental innovation is the only capability of the Indian industry is not true. It's not true for the simple reason that companies do not want to make any claims today on where they stand on the development of a new molecule. They treat it as a trade secret. But we have enough evidence that the Indian industry has the capability for original research. Between 1998 and 2004 there were 60 molecules in the pipeline. Only if you ignore this data will you come to the conclusion that we can only do tweaking of molecules! And by using that argument you will only perpetuate tweaking of molecules. If you block that route, you push companies to go for high-end research.

Fourthly, Dr. Mashelkar says he wants to balance India's obligations under international agreements with the wider public interest. But he is a scientist that is not his term of reference. He was asked merely to say whether this was TRIPS-compliant or not. Balancing obligations is a political decision.

What is your take on the fact that the Mashelkar group's conclusions are "borrowed without acknowledgement" from a paper funded by an association of multinationals?

That is not the issue. The issue is intellectual honesty. If Dr. Mashelkar did not agree with what was written in the WHO report or the U.K. CIPR report, which stated that "developing countries should not be deprived of the flexibility of defining their own patent systems," then why did he not record his dissent? Whether he quotes Shamnad Basheer or Frederick Abbot, that is not the issue.

What action should the government take?

Since Dr. Mashelkar has withdrawn the report on his own, we have to see what new evidence and analysis he produces. This will create a credibility gap. How is he going to substantiate any changes? Anything that he writes in the second report will be compared with the first. He gave explanations to journalists when they asked him why submissions like Frederick Abbott's were not included; he said that only documents with the secretariat were used. But all these documents were available with the secretariat. We submitted some of them. If evidence was available with him earlier, why did he not examine that, analyse it and put it in the report? He has created a very difficult situation for himself and other members of the committee. The Government should not let him withdraw this report. Leave it and close this chapter.

Do you think a new committee should be put together?

At this moment I think we need to give the present intellectual property rights regime a chance to work. Let it be implemented and we can take at least five years to assess, one its impact on public health, specifically the availability and prices of medicines; two whether patented medicines are brought into this country by the innovators; three, the impact on domestic industry and its ability to export; and four, what sort of R&D is taking place and whether Indian industry has moved to high-end research or not. Then evaluate which direction to take. Until that time there is no need to keep destabilising or creating uncertainty on the IPR regime.

This will not be acceptable to multinationals. So the government has to make a clear statement that we in India are taking a calibrated approach to IPR.

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