Interactive session on ‘Mashelkar Committee Report on Patent Laws’

The controversial report of the technical expert group on patent law issues (known as the Mashelkar Committee) was the subject of an interactive session organised by Centad in collaboration with the PHD Chambers of Commerce and Industry at the PHD Centre, Siri Fort, New Delhi, India, on February 24, 2007.

The Mashelkar Committee, headed by Dr R A Mashelkar, had been set up to look into the following facts: 

• Whether it would be TRIPS-compatible for India to limit grant of patents for pharmaceutical substances to new chemical entities or to new medical entities involving one or more inventive steps.
• Whether it would be TRIPS-compatible to exclude micro-organisms from patenting.

The committee came out with a much-disputed report in January 2007. Many public interest groups said that the report had been plagiarised from a study funded by a foreign multinational company.

It is against this background that Centad organised the interactive session ‘Mashelkar Committee Report on Patent Laws’ that was attended by various stakeholders including government representatives, academicians, activists and civil society members.

The inaugural session was addressed by Dr Murli Manohar Joshi, Chairman, Parliamentary Standing Committee on Commerce, I K Gujral, former Prime Minister of India, Nilotpal Basu of the Communist Party of India (Marxist), and D Raja, member, Communist Party of India.

Speakers in subsequent sessions were G Wakankar, Executive Director, Indian Drugs and Manufacturers Association, K M Gopakumar, Research Officer, Centad, Dinesh Abrol, Senior Scientist, NISTAD, and Dr Satyajit Rath, Professor, Indian Institute of Immunology.

In the inaugural session, the panellists discussed the political process involved in passing three amendments to the Indian Patent Act and the different views of various political parties. The Bill, which initially came up as an ordinance, was referred to the Standing Committee on Commerce.

Concerns regarding issues of access to medicines contained in it were brought to light by the National Working Group on Patent Laws, Left parties and civil society groups that said it had wide ramifications for ordinary people.

There were also appeals from developing and least developed countries, including a very touching appeal from African nations that said that since they depended on India for a large number of generic medicines, India should take a decision on the amendments only after due consideration. It was under these circumstances that the government decided to set up the Mashelkar Committee to look into the matter.

The Mashelkar Committee report was described as a “national shame”; a great embarrassment for the country especially in light of the fact that most developing countries look to India as a cheap source of generic drugs. The committee not only went into matters/questions that were never referred to it, it also said that some of the provisions of the already-amended Act should be done away with.

Panellists at the interactive session were of the opinion that the report should be rejected, the committee scrapped and a new joint parliamentary committee established. It was reiterated that the report should be rejected on substantive issues, not just on the issue of plagiarism.

On non-substantive aspects of the report, it was stated that the report reflected on how policy is made in the country. A reading of the 58-page report reveals that, apart from the annexures, it consists only of 10 pages that are divided into the two issues mentioned in the terms of reference. It is very clear that, in the guise of national interest, the interests of multinational companies are being served. The report’s conclusions were based on two key recommendations, and one can easily see that sweeping comments and conclusions were made without any proper justification. The policy did not reflect a consultative process.

In fact, the Mashelkar Committee report contradicted earlier reports and positions that Dr Mashelkar has taken.

On the issue of restricting the scope of patentability to new chemical entities or new medical entities, panellists at the session said that although India does not prohibit incremental modifications the bar is higher because of the ‘efficacy’ requirement. The TRIPS Agreement gives countries the flexibility and prerogative of deciding the level of the bar.

On the issue of limiting the scope of patentability with respect to pharmaceutical patents, it was stated that the government’s intention has always been to limit them to NCEs (New Chemical Entities). Section 3 (d) was introduced as transitionary; the government only wished to double-check, though its intention was clear.

If the scope of patentability is not restricted, this will allow for 20 years of monopoly for incremental modification, which is not justified. New drug delivery systems can be given process patents; product patents need not be given. However, the attempt now is to give product patents. Pharmaceutical companies should come out with data on research and development to justify their demands; incremental modifications to drug innovations do not involve the same expense.

Most companies justify their demands against restricting the scope of patentability on grounds of ‘defensive patenting’, that is, if they do not obtain a patent then someone else will and they will lose operating space. However, in India, there is no reason to implement patent laws based on such justifications. Patent law is not based on reciprocity but on a country’s socio-economic concerns. Though the law in other countries may be evaluated, it is not necessary to adopt them. The Philippines amended its patent law and almost copied Section 3 (d) of India’s Patent Act. Thus, Section 3 (d) is not unique; other countries are following it too.

The view taken in the Mashelkar report is that limiting patentability to NCEs would contradict Article 27 on grounds of discrimination. Speakers at the interactive session countered this by pointing out that there is a difference between discrimination and differentiation. This view was upheld by a WTO panel in the EC-Canadacase, and also by the Appellate Body. Further, as Article 27 prohibits discrimination on the three grounds mentioned, it means it will be possible to discriminate on other grounds.

Differentiation has already been made under the Doha Declaration; limiting the scope of patentability would be well within the Doha Declaration. Thus, the Mashelkar Committee would not be correct in stating that the Doha Declaration cannot be used. Also, the committee gave no reasons for reaching such a conclusion.

On the issue of limiting the grant of patent for pharmaceutical substances to new chemical entities or to new medical entities, if the recommendations of the Mashelkar Committee were adopted this would allow ever-greening. A micro-organism can be used for several activities, if patents are allowed, whereas they should only be for a particular use and not for all uses of the micro-organism. Moreover, the micro-organism is not a new invention but the discovery of an already existing element, and its patentability itself is questionable. However, the Mashelkar Committee did not consider these objections.

A view that emerged at the session was that there must be a definition for ‘micro-organism’. Common definitions of micro-organisms were discussed at the interactive session, as well as how they differed from the rest of the living world. Considering that plants and animals cannot be patented, if micro-organisms are excluded from such treatment then it would be necessary to define them. A formal biological definition is imperative.

See also ‘Mashelkar Committee Report: A Critique’