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Is Plagiarism the Only Problem with Mashelkar Report?

Plagiarism is unpardonable, particularly for the Mashelkar Committee, whose report deals with intellectual property. But that is not the only problem. With the report being cited as a credible and authoritative source in the Novartis case in the Chennai High Court, there is greater urgency to critically examine its findings.

Is Plagiarism the Only Problem with Mashelkar Report?

Plagiarism is unpardonable, particularly for the Mashelkar Committee, whose report deals with intellectual property. But that is not the only problem. With the report being cited as a credible and authoritative source in the Novartis case in the Chennai High Court, there is greater urgency to critically examine its findings.

DWIJEN RANGNEKAR

T
he withdrawal of the Mashelkar Committee’s report does not automatically put to rest the controversies it has raised. Attention has largely focused on plagiarism. Plagiarism is unpardonable, particularly for a report dealing with intellectual property. However, if for a mere moment we see the report with that inadvertently missing footnote reinstated, would the “problem” be solved? Possibly for Shamnad Basheer, the author of the report that was not cited. Yet, various detractors will hasten to add that the report was “influenced” by multinational pharma companies. And here, the Novartis connection looms large, as those scanning blog pages know very well. For that matter, Basheer’s report was commissioned and funded by a Swiss-based coalition of western pharmaceutical companies, INTERPAT. No doubt, Basheer provided his expertise in an independent and objective manner. And, it would be surprising if Mashelkar and colleagues would not avow to similar independence and objectivity.

The “problems” lie elsewhere and it belies our intelligence and the issues to focus exclusively on plagiarism and influence. With the Mashelkar Committee report being cited as a credible and authoritative source in the Novartis case in the Chennai High Court there is greater urgency to critically examine its findings. As the Committee’s conclusions, we now know, are intimately derived from Basheer, this analysis must necessarily include him as well. At the outset it is useful to distinguish the two documents. The latter is a substantial piece of legal research that explores case law, WTO panel deliberations, and legal commentary to come to its conclusions. And, it is easy to witness the progression of analysis and argument. In contrast, the Mashelkar Committee report was a consultative process and received written and oral submissions from a variety of quarters; however, all that we have at hand are its conclusions and not any legal analysis as to how they arrive at their conclusions. It couches its recommendations in hesitant tones. For instance, in paragraph 5.6 it says that the proposed exclusion is “likely” to contravene India’s obligations under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement and proceeds to acknowledge the “perception that even the current provisions in the Patents Act could be held to be TRIPS non-compliant” (paragraph 5.11). Unfortunately, we are neither told why this is “likely” nor whose “perceptions” were considered.

The issue addressed by both reports was whether “it would be TRIPS compliant to limit the grant of patents for pharmaceutical substance to new chemical entity or to new medical entity involving one or more inventive steps”. This question followed a proposal from Left parties during the third amendment to the Patent Act in March 2005, which the Congress rejected. Discussions here have implications to Section 3(d) of the Patent Act, which Novartis is challenging. This connection is clear from parliamentary debates and from the submissions of the counsel for Novartis where the Mashelkar Committee report finds notable citations.

Section 3(d) introduced new grounds for exclusions from patentability in the third amendment by raising the standards to exclude “the mere discovery of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.” In January 2006, the assistant controller of patents and designs (Chennai) upheld the decision not to grant a patent to Novartis for Glivec by citing Section 3(d) along with issues concerning lack of novelty and obviousness. In May 2006, Novartis filed affidavits claiming Section 3(d) is arbitrary, illogical and conflicts with obligations to TRIPS (particularly, Article 27). While Section 3(d) is unique to Indian statutes it parallels guidelines that are otherwise given to patent offices elsewhere. Thus, for example, the European Patent Office has guidelines on how to apply patent standards for particular technologies. Similarly, the US Patent and Trademark Office has specific guidelines for biotechnological inventions that spell out particular “utility” requirements. Thus, Section 3(d) is in good company, and should be seen with this genealogy as an effort to elaborate the “non obviousness” standard with respect to pharmaceutical inventions by requiring a demonstration of increased efficacy.

‘Non-Discrimination’ Principle Not Absolute

How did Basheer – and by obvious extension Mashelkar et al – arrive at their conclusion that limiting patents for pharmaceutical products to those inventions that meet particular standards is in conflict with TRIPS? At issue is their explanation of Article 27 (of TRIPS) which requires patents to be “available for any inventions, whether products or processes, in all fields of technology, provided they are new, involve an inventive step and are capable of industrial application [...] patent shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced”. Basheer’s explication of this Article is based on a reading of the WTO panel’s decision in the Canada-Generics case, where among other issues it had to elaborate on the meaning of nondiscrimination in Article 27.

Before unpacking the panel’s reading of Article 27, it should be appreciated that legal scholars and activists differ in how they understand its conclusions. Not surprisingly, the way one receives the panel report depends on whether one wants to interpret TRIPS provisions as singularly expansive for right-holders or whether one would prefer giving greater weight to public health and other principles. Though the panel exercises “interpretative custody” of

Economic and Political Weekly March 10, 2007

TRIPS provisions there is growing criticism of its conservatism. Some recognise that the political context of the Canada-Generics played a role; thus suggesting that if the panel had to decide on a similar provision post-Doha, it would conclude differently. The fact that legal interpretation is also hostage to context is neither surprising nor reassuring. It is this contingency to TRIPS interpretation that Basheer fails to grasp.

More significantly, his analysis does not explore the space left by the panel’s refusal to actually define the principle of nondiscrimination in Article 27. In a moment of rare reticence, rather than define “nondiscrimination”, the panel pointed out a number of fault lines. To begin, the obligation for non-discrimination is limited to three aspects: the field of technology, the place of invention and whether the products are imported or locally produced; thus other grounds for discrimination which are TRIPS-compliant are possible. Next it distinguished between de jure and de facto discrimination. While the former is an explicit form of discrimination the latter arises from “ostensibly identical treatment”. The panel agreed that assessing de facto discrimination is difficult. It cautions us that “preoccupation with the effects of a statute in one area does not necessarily mean that the provisions applicable to other areas are a sham, or of no actual or potential importance” (paragraph 7.106). This is useful in providing space for a provision that may be guided by a particular purpose but, as such, scripted in and made available to all fields of technology. Finally, the panel also stated “Article 27 does not prohibit bona fide exceptions to deal with problems that may exist only in certain product areas” (paragraph 7.92). The entire Doha process is testimony to this statement. For that matter, paragraphs 6 and 7 of the Doha declaration are directed at subset of a particular field of technology, viz, pharmaceutical products and WTO members have given legitimacy to the differential treatment of pharmaceutical products. Submissions to this panel from the US and Australia draw attention to the need for differential treatment to restore “parity of enjoyment” (paragraph 5.36) where the reference is to legislation directed at extending patent terms for pharmaceuticals. Not surprisingly, the panel refused to be drawn into commenting on this particular area.

This discussion of the panel’s deliberation should make clear that the principle of non-discrimination is not absolute and that there are grounds for differential treatment of particular fields of technologies and product areas. This is a particular reading of the panel’s report and others may disagree which only goes to confirm a deeper point: we are all making particular readings of a TRIPS provision in the absence of an authoritative interpretation that will only come with a dispute at WTO.

Returning to the Novartis case, as others including the counsel for the defendants have argued, the appropriate place for assessing TRIPS compliance is WTO’s dispute settlement process. The court would not want to get itself into an embarrassing situation of pronouncing on TRIPS to only be later overruled by a foreign body. Strategically, this requires Novartis to convince its host government, Switzerland, to launch a dispute at WTO. Hopefully, memories of previously aborted attempts to challenge patent law in the South will guide the Swiss government, if not Novartis. Finally, what about the Mashelkar Committee report? The withdrawal gives the government an opportunity to show its hand on issues concerning patents and medicines – and this time revealing how it arrives at its conclusions.

EPW

Email: d.rendnekar@warwick.ac.uk

Economic and Political Weekly March 10, 2007

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