People's Democracy

MASHELKAR COMMITTEE REPORT 

Patently Wrong

Dinesh Abrol

DR R A Mashelkar, former director general of Council of Scientific and Industrial Research (CSIR) is currently in the eye of a big storm for being caught red handed by Chan Park of the Lawyers Collective HIV/AIDS Unit and Achal Prabhala, a researcher on intellectual property rights, for committing the crime of plagiarising the important conclusions of the report of the Technical Expert Group on Patent Law Issues from a paper prepared by Shamnad Basheer, Associate of Oxford Intellectual Property Research Centre, United Kingdom.

Chan and Achal charge the committee for compromising with the multinationals on the patent law issues and use the issue of plagiarism to make their case of the report having a clear multinationals’ connection. In his defense the stated claim of Dr Mashelkar, the chairperson of the Technical Expert Group on Patent Law Issues, which the government had set up on April 5, 2005 as per the directions of Indian parliament, is simple. He states that the “technical inaccuracy” is very unfortunate and is basically in terms of failure to acknowledge the source of eight to ten lines that have been extracted verbatim from Basheer’s paper. According to him this error crept in inadvertently at the hands of a sub-group that the committee had created for drafting the report. Forced by criticism from all over the world, Dr Mashelkar, left with no alternative, has responded by withdrawing his report. In the capacity of being the chairperson of the committee, he has also sought from the government a time of three months to resubmit the report.

CAUGHT RED HANDED, YET TAKING HIGH MORAL GROUND 

However, as Dr Mashelkar continues to hold that the committee stands firmly by its recommendations, the issue that concerns us is not just plagiarism but also the impropriety of response reflected in the attempt to take the high moral ground and to hide the real nature of interests being served by the recommendations being made on the concerned patent law issues. One cannot help but notice that there is an attempt to take the high moral ground by camouflaging the whole episode in terms of merely a “technical inaccuracy” creeping in to the report. The decision of Dr Mashelkar to withdraw the report is only to ensure that the best ethical practices for preparation and submission of a technical report are followed. He has even claimed that this is the first error in his distinguished career.

The fact of the matter is that this is not the first time that Dr Mashelkar has had to be reprimanded on his conduct on the concerned issues of patent laws. On May 22, 2005, in the columns of People’s Democracy, in the article published entitled “Govt Needs to Clarify”, it was brought out that how he had embarrassed the country by his conduct at the World Intellectual Property Organisation (WIPO) meeting held in Casablanca on February 15, 2005 where the issues connected with harmonisation of requirements of patentability were being discussed at the inter-governmental level. In this meeting, in the capacity of being the chairperson of the meeting, he had actively helped the developed countries to impose their stand on the developing countries. And this meant India going back on the position taken by her consistently over fifteen years on the issue of harmonisation of patentability requirements and ditching the rest of developing world. To contain the damages of the fall out of his embarrassing conduct the Indian government had to issue a clarification that the stand taken by him at the meeting was in his “individual” capacity. In the article published in People’s Democracy the government was warned and asked to clarify as to why it had chosen him to chair the Expert Group to recommend on the pending legislative issues arising out of the process of deliberations on the third patent amendment act concerning the definition of pharmaceutical substance and the determination of patentability in respect of micro-organisms?

THE NOVARATIS CONNECTION

Further, it has to be recognised that in the current instance what has not been emphasised enough in the media is the fact that the report plagiarises its important conclusion on the patentability of new chemical entities in the case of pharmaceutical substances from a paper sponsored by the multinational pharmaceutical companies. A Swiss lobby group called INTERPAT – whose chairman in India is Ranjit Shahani, vice chairman and managing director Novaratis India Limited – aided and supported the work of Shamnad Basheer from whose report Mashelkar committee has plagiarised. Novartis Switzerland is one of the 29 corporate funding sources of INTERPAT. It is no coincidence that Shahani also happens to be the elected president of Organisation of Pharmaceutical Producers of India (OPPI). In India the OPPI has been a votary of the acceptance of TRIPS proposals from the day one when they were mooted by the developed countries in the Uruguay Round of GATT Negotiations. 

To continue on the multinational connection of the Mashelkar Committee report, Novaratis India Limited is also the same company which happens to be fighting with cancer patients over the issue of patentability of its “new” salt. The patients are opposing Novaratis’ patent application for Gleevec, essential leukemia medicine, in India in the courts of Chennai for its adverse impact on the price of medicine. To give an idea of the nature of possible damage to the leukemia patients in India if the patent application under contestation in the case of Gleevec goes in favour of Novartis, we must compare the Indian companies’ prices of this drug with that of Novaratis. They are ten times cheaper than what Novartis is charging. As shown below, Novaratis is thus even a direct beneficiary of the findings of the report of Mashelkar committee. 

Experts consider the patent application filed by Novaratis to be an important example of one of the many possible ways of ever greening of patents, a mechanism which the multinationals would be able to use by filing patents on trivial and insignificant modifications to extend their monopoly over the markets of pharmaceuticals in India. If we view the issue of connection of Mashelkar Committee report from the point of view of the specific interests of Novaratis whose case is being fiercely fought in the courts of Chennai by the cancer patients and the Indian companies, the timing of Mashelkar Committee report has been perfect. In this court case, when the Indian companies are now effectively challenged on the issue that how they do not have legally the right to produce Gleevec and they should be made to stop production of Gleevec, the Mashelkar Committee report provides justification and opines on the legal validity of a Section 3(d) which had not been even referred to the committee. 

The Mashelkar Committee report has thus clearly chosen to go beyond its terms of reference in giving its opinion on the issue of Section 3(d). Although this Section 3(d) also deals with one of the many possible ways of ever greening, but the issue of legal validity of Section 3(d) was strictly speaking beyond its purview and the committee had no business to comment on this issue even tangentially. Going by the spirit of the deliberations that went on in the parliament on the amendments to the Indian Patent Act, 2002, the committee was in fact expected to suggest ways by which the Indian parliament would be able to further strengthen the Indian Patent Act, 2005 to prevent the large pharmaceutical companies from making use of the remaining possible ways of ever greening available to them in the patent legislation in India.

As things stand today, the report of Mashelkar Committee is an important weapon in the hands of Novaratis. It is now using its findings quite effectively in the Chennai court to get the judges to declare the whole section as legally unsound and Trade Related Intellectual Property Rights (TRIPS) Agreement incompatible. It is no coincidence that the Mashelkar Committee comes out with a report that is favourable for Novaratis and it becomes the basis for the court to pull the government before it on the issue of legal validity of Section 3(d). Read the tone of the report, it states, “Restricting patentability just to NCEs or NMEs could have both legal and scientific ramifications. There is a perception that even the current provisions in the Patents Act could be held to be TRIPS non-compliant. Strictly speaking, the opinion expressed by Mashelkar Committee is biased and mischievous.

MNCs’ INTERESTS CLAIMED AS NATIONAL INTEREST 

Coming to the recommendations, the Mashelkar Committee has tried passing off the interests of multinationals and a small set of Indian companies like Ranabaxy and Nicholos Piramal as the national interests of India. The Committee has concluded:

1. that it would not be TRIPS compliant to limit granting of patents for pharmaceutical substance to new chemical entities”, 

2. that “excluding micro-organisms per se from patent protection would be violative of the TRIPS Agreement”, 

3. that “limiting grant of patents to new chemical entities will not be conducive to competitive growth and incremental innovations are sequential developments that build on the original patented product –– and therefore, such incremental innovations ought to be encouraged by the Indian patent regime” and 

4. that “with an enabling provision for protection of intellectual property in bio-technological innovations and inventions provided through the provision of patentability of micro-organisms the Indian biotechnological research would be enabled to compete globally, attract collaborations, FDI, contract R&D etc. 

The conclusions reached by the Mashelkar Committee not only are biased and without cogent arguments but also are based on thin evidence. The conclusions reached are not even based on the clarifications provided in the Doha Declaration on TRIPS Agreement and Public Health which “affirms that the Agreement (TRIPS) can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all. The report ignores the fact of the patent law being territorial in nature and has to be in line with both, the stage of development of the industry and the socio-economic conditions of the nation. The Committee does not distinguish between discrimination and differentiation. To further substantiate the point of differentiation vis-à-vis discrimination, we only have to point out that even today by its Section 4, the Indian Patent Act, 2005 excludes patenting of inventions relating to atomic energy and that in Section 39 in the area of national security broadly if the invention is relevant for Defense purposes. Lastly, as far as the issue of attraction of FDI and contract R&D is concerned, it would be sufficient if we have a good contract law in place which provides for confidentiality requirements to be met properly. Since by meeting the requirements of confidentiality India has been able to attract already a lot of contract R&D and FDI the report of Mashelkar Committee is only pandering to the insatiable hunger of multinationals for profits.

REFER TO STANDING COMMITTEE 

Finally, it needs to be stated firmly by the government that we have had enough of Mashelkar on the patent law issues. We have to ensure that Dr Mashelkar and the other four committee members are not entrusted further the responsibility of any kind in relation to the subject of patent law. In fact, it would be prudent for the parliament to refer the matter to the standing committee of the ministry of commerce. The committee should organise a consultation on this important subject with all those who wish to give their views to the committee. Needless to say, the parliament would then be in better position to work out the mechanisms to strengthen the Indian patent regime on the above discussed patent law issues.