Novartis And Mashelkar: Tripping Up On Patents

THE last few weeks has seen some major developments on the Indian Patents Act, as amended in 2005. One is the challenge by Novartis of Section 3(d) of the Act, which addresses what is not patentable on the grounds initially of not being TRIPS compatible, and now on the grounds of “discrimination”. The second is the Report of the Mashelkar Committee on two issues: (i) whether it is TRIPS compliant that only New Chemical Entities (NCEs) should be patentable and (ii) whether India is required under TRIPS to allow patenting of micro-organisms. The surprise is not that Mashelkar Committee has gone with an expanded understanding of TRIPS, but that he has lifted the operative part of his recommendations, lock stock and barrel, from one of the submissions! If this were a scientific paper, Mashelkar would have blotted his copybook permanently as a scientist. That he should have done this on a government committee opens the question of his integrity, not merely as a scientist but also as one of the leading administrators of science in the country.

Mashelkar’s fall from grace not withstanding, we must be clear on what Mashelkar has not said. According to Novartis, somehow Mashelkar’s report supports their claim that Section 3(d) of the Indian Patents Act is not TRIPS compliant. This is a lie. Mashelkar’s report examines only the issue of new chemical entities and not existing provisions of the Act. Even though we do not agree with his conclusion that giving patent protection to NCEs would violate TRIPS, nowhere in his report has he held that Section 3(d) is not TRIPS compliant. In fact, one of his arguments for not restricting patents only to NCEs is that for protection against frivolous patents and ever-greening, the existing sections provide enough protection. And obviously, one such protection is Section 3(d), which defines what is not patentable.


Following patent cases is obviously a boring exercise. No one in his right mind would pore over arcane matters on interpreting law were it not for its vital importance to the health of the people. High cost medicine under patents monopolies are wrecking the public health of systems of even advanced countries. Under WTO and TRIPS, they are now set to enter countries such as India, which had earlier not allowed product patents in medicines, food and chemicals. Having accepted that Intellectual Property could be discussed in GATTS in 1989, India finally succumbed to the US and the EU and accepted TRIPS in 1994. While we had a 10-year grace period before granting product patents, effectively we had thrown in the towel in 1994. The only issue that we could address was the degree and kind of monopoly we would have to concede.

This brings us to what is under contention in the Chennai High Court. Under pressure from the Left parties, the UPA government had accepted a number of changes to the amendments introduced in 2005. One crucial amendment was with regards to what would not constitute an inventive step in patents for chemicals. This is the Section 3(d), which Novartis has now challenged.

The three key parameters to any patent are 1) novelty—it must be new 2) there must be an inventive step—non-obvious to a skilled practitioner 3) it must have some utility. The problem with pharmaceutical sector is that drug companies have used minor variants of the same chemical compound to claim new patents. Unlike in mechanical devices, where such variations are easily dismissed, the patent offices have found it difficult to distinguish between genuine inventive steps and spurious ones in the chemical and pharmaceuticals.

Some of the ways that pharma companies have traditionally resorted to for continuing their monopoly is to claim new use of existing molecules, claim a mixture of two compounds to be new, changing dosage and so on. Section 3(d) therefore seeks to define what is not patentable and try and close these loopholes in law so that such spurious claims can be rejected.

The current Novartis case in Chennai High Court is based on the rejection by the Patent Office of Novartis’s application for a patent on Gleevec, anti cancer drug. The reason that the Indian patent office did not accept a patent for Gleevec is because its primary form was known before 1995, from when the TRIPS clock started ticking, and what Novartis sought to patent was only a minor variant of the same, thus failing the test of non-obviousness. The patent office has held that if the primary form of the drug could not be patented, its variant cannot be patented either, a simple consequence of Section 3(d).

This is also the reason that GlaxoSmithKline has withdrawn two applications for patents after pre-grant opposition from other parties. Glaxo has recently withdrawn its patent application on a mixture of fluticasone and salmeterol, an asthma preparation, after Cipla filed a pre-grant opposition. Earlier, Glaxo had withdrawn its patent claim on a mixture of zidovudine and lamivudine, an important AIDS medicine, after facing opposition from AIDS groups. The section of 3(d) in conjunction with pre-grant opposition, has indeed proved a powerful tool to prevent spurious patents. Incidentally, the big pharma lobby had originally got the government to do away with pre-grant opposition and it was only after the intervention of the Left parties that this section was restored.


The Novartis argument that TRIPS is meant to harmonise patent laws globally, and since Gleevec has received patents elsewhere and therefore it should be accepted for patent here also is simply not true. India has the sovereign right to define what is patentable.

TRIPS, while it insists on product patents, has left the boundaries of what would constitute a patent to the sovereign laws of the country. That is why some countries give software and life form patents and others do not. TRIPS has given no definition of novelty, inventive step and utility. Under Article 1.1 of the TRIPS Agreement, “Members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.” Therefore, it is valid to argue that India can limit patents only to NCEs and this is not incompatible with TRIPS.

There is no legal basis to claiming that boundaries of patent laws need to be defined by a set of generic criteria that stand outside or above the national laws. It is within the powers of a country to state that algorithms, life forms, etc, are not patentable even if they pass the test of non-obviousness, novelty and utility (usefulness criterion). So even if India adds an additional criterion over and above the above three, it is still within its rights to do so. As different areas have their own specificities, countries have the right to define what is patentable in each area based on the specific nature of the area.

This brings us to Mashelkar. Mashelkar Committee’s terms of reference were the following:
Whether it would be TRIPS compatible to limit the grant of patent for pharmaceutical substance to new chemical entity or to new medical entity involving one or more inventive steps
Whether it would be TRIPS compatible to exclude micro-organisms from patenting.

Mashelkar was an unfortunate choice for heading this committee as he has earlier taken positions on intellectual property rights in international forums that the government of India had to later withdraw. He stands for a particular view on Indian scientific research –– that CSIR and other laboratories should team up with multi nationals to do contract research for them. That this would mean using Indian taxpayers’ money to subsidise global MNC monopoly has not been of any concern to him. Nor that such global monopolies have resulted in astronomical drug prices which even the advanced countries are finding difficult to bear and condemning large sections of the global poor to remain without medicines. With such credentials, it is not surprising that Mashelkar has come to the conclusion that it is not TRIPS compatible to exclude NCEs from patenting.


While we may disagree with the Committee on this regard, the much bigger issue in this case is the manner in which Mashelkar Committee has gone about its report. After one and half year of supposed deliberations, in which it did not hold any public hearings, it has reproduced one of the submissions (Samnad Basheer, IP Institute) as its recommendations. Mashelkar may claim that the plagiarised part amount to only a few paragraphs, but the real issue is that this is the only operative part of the Report! Worse for the Committee, while reproducing the conclusions of Basheer’s submissions, it has not given any reason why it is not TRIPS compatible to exclude NCEs.

Basheer has himself stated his study was commissioned by Interpat, “a Swiss association of major European, Japanese and US research-based pharmaceutical companies’. This may or may not compromise Basheer; but picking up the conclusions of a study funded by big pharma and parading it as their recommendations certainly destroys whatever credibility the Mashelkar Committee may have had at the start.

Let us for a moment overlook that Mashelkar forgot to acknowledge his true source. It is an unfortunate habit not unknown to the scientific community in the country. The Committee was set up to examine whether it is TRIPS compatible or not to exclude NCEs from patenting. The minimum homework required for a committee was to examine the pros and cons of the issue and to provide argument why it has reached its conclusions. Mashelkar and company have provided none of the above and come out instead with what can only be termed as an oracular pronouncement.


The problems with Mashelkar Committee’s recommendations do not stop here. There is a whole section of what is India’s National Interest for patents and some highly contentious statements on incremental inventions and break through inventions, again borrowed heavily from Basheer’s submission. The Committee was not set up to examine what is in India’s National Interest; that exercise in this case was conducted by the parliament. Nor was it set up to discuss what should constitute invention in Indian Patent law. The only narrow issue the Committee was asked to examine is what is TRIPS compatible.

Predictably, Mashelkar opines that it is India’s National Interest to expand the criterion of patenting. This brings us to what is India’s National Interest. Is it that of MNCs and large Indian pharma companies? Is it that of India’s domestic capital engaged in the pharma sector? Or does it also include the Indian people and their need for cheap medicines?

Mashelkar of course nowhere refers to the peoples’ needs for cheap medicines and therefore the need for limiting patent monopoly. For him, national interest is synonymous with Indian big business, a weakness he shares with the current UPA government.

Even if we take his argument that easy patenting will also help Indian pharma companies, the only pharma company that is happy with his recommendations is Ranbaxy. All other major Indian drug companies have sharply criticised the Mashelkar Report. It is well known that MNCs have always stated their “philanthropic” desire to help domestic industry in the third world by strengthening the patent monopoly system. In India, the major section of the indigenous Indian industry – Indian Pharmaceutical Alliance – has publicly disagreed with Mashelkar’s definition of national interest. So Mashelkar’s national interest is Ranbaxy, which broke ranks with others in mid 90s to join the MNCs and of course the MNCs themselves!

The irony is that even Basheer, whose submission Mashelkar has so liberally borrowed, in his blog has expressed his discomfort with the way Mashelkar and company have dealt with the issue. He has conceded that opponents have a case that NCEs can be excluded from patenting under TRIPS, even if he does not agree with them.


Mashelkar is now trying to withdraw the Report, presumably so that he can do the cosmetic exercise of putting the paragraphs he has plagiarised in his own words. However, not only the Report but also the Committee is now completely de-legitimised by the way they have gone about their business. That after one and half years, they produce a report, which discusses a whole range of extraneous issues, provides their conclusions on the actual terms of reference through plagiarism and without any supporting argument is enough for the country to ask these gentlemen to go! No cosmetic exercise can now cure what has been a deeply flawed exercise. The only recourse is to appoint another committee, which will at least address the issues.