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Part I: Novartis feels the heat of the Indian Summer. What is the fate of similar applications filed by Indian Manufacturers?


In an article titled “India rejects Patent to Glivec’s Second Variant,” the Business Standard reported that the Swiss drug manufacturing multinational, Novartis AG, had been dealt with another blow by the Indian Patent Office. The Patent Office, in its March 30 ruling, accepted the pre-grant oppositions filed by Indian drug firms Sun Pharma, Okasa and others against Novartis’s five-year-old patent application over the alpha crystal form of Novartis’s blockbuster cancer medicine, Glivec.



This setback follows the steps of the erstwhile controversial Novartis decision wherein the Madras High Court rejected Novartis’s challenge to the constitutional validity of Section 3(d) of the Patent Act, 1970 as amended by the Patents (Amendment) Act, 2005. The High Court’s decision was one of the first instances of interpretation of Section 3(d) by the courts. Going back, the rejection of patent to alpha form of Glivec was on grounds similar to the grounds for rejection of the beta form by the Patent Office, i.e., the invention fell short of the standards laid out in Section 3(d). “If granted, it would have been a clear case of frivolous patenting. The different form of Glivec is in no way superior to the other form for which patent was not granted,” said an attorney involved in the pre-grant opposition. Interestingly, the rejection for patent over the alpha form comes when the apex complaint redressal forum, the Intellectual Property Appellate Board (IPAB), is about to give its verdict on Novartis’s appeal against the rejection of a patent to the beta crystal form of Glivec.



The Novartis litigation gave rise to a lot of negative publicity for the multinational and the main concern was access to Glivec at an affordable price. Presently, such access is ensured by the low-cost versions of Glivec is being sold by domestic companies in India. The patenting of the beta crystal form of Glivec was fervently opposed by NGOs and patient groups as it would lead to Novartis getting exclusive rights over the drug and drive out the cheaper Indian products. In fact, several groups had asked Novartis to drop the case against Indian patent law given the negative effect the challenge could have had on the access to medicines in developing countries.



SpicyIP has dealt extensively with the Novartis case and the Section 3(d) issue in several posts. Moreover, Shamnad and Prashant exhaustively analyze issues in an article titled, “The ‘Efficacy’ of Indian Patent Law: Ironing out the Creases in Section 3(d)”, available for download on SSRN http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1086254>.



More importantly, it is interesting to note that the Patent Office’s decision against the alpha variant comes when several Indian companies have also applied for patents over variants of imatinib mesylate. Some of these applications will be discussed in part II of this post. Unfortunately, the fate of the applications or any opposition proceedings filed against them is untraceable. The decisions in these applications become relevant because of the fact that there have been allegations in the past that the Indian Patent Office is more lenient to Indian pharmaceutical industry. Thus, the concern is whether the Patent Office will apply the same rigorous standards applied in the Novartis case to the Indian applicants, given the fact that if patents are granted to these variants the question of cheap access would be as relevant.



As far as Novartis is concerned, clearly the unfriendly Indian summer has caused a lot of heartburn to Novartis as it fails to reap monetary benefits for Glivec, its key blockbuster medicine. The official response came from Ranjit Shahani, vice-chairman and managing director, Novartis India and read as follows, “Novartis is disappointed that the patent for the alpha crystalline form of imatinib mesylate (chemical name of Glivec) has been rejected, even though the impact of the decision is low. We have 90 days to review the merits of the decision and to evaluate and decide our options.” In order to get out of the access to medicines debate, the company continues to lay claims on its philanthropy and says 99 per cent patients on Glivec in India get it for free and the others who pay for the drug are reimbursed. Further, according to Shahani, under the Glivec International Patient Assistance Program (GIPAP), Novartis has provided Glivec (beta form of imatinib mesylate) completely free of charge to more than 35,000 patients in 80 countries. “In India, around 11,000 patients currently receive Glivec absolutely free of charge through GIPAP. Since inception of GIPAP in India in late 2002, Novartis has distributed Glivec valued at more than Rs 2,900 crore free of charge to patients in need,” he said.



This claim to philanthropy is thwarted by groups like the Cancer Patients Aid Association (CPAA) which point out that the strings attached to the GIPAP make it an impossible option. For more on CPAA’s position read “CPAA responds to Novartis’ Open Letter”. In fact, the discounted price claim made by Novartis was also rubbished by the Indian Government during the Novartis litigation, if the statement of the Indian Ambassador in Belgium at the Exchange of views on Novartis case organised by the European Parliament in Brussels is any indication.



Part II of this post will deal with the specific applications made by the Indian companies, their possible outcomes and the role to be played by the Indian Patent Office.

2 comments.

  1. Avatarmnbvcxzaq1

    Totally agreeing with Shamnad’s earlier analysis [that in the earlier Novartis case regarding its beta crystalline form, the Madras High Court had arrived at the correct conclusion but through a faulty constitutionality analysis of Section 3(d)], it is a welcome sign of maturity (regarding product patenting) of the Indian Patent Office. I just hope it maintains consistency in its rulings! MNCs have so far been either exploiting (the extreme view) this Indian immaturity, or lackadaisical (the lenient view) in sticking to the strict standards of patent-filings, as they adopt in the mature jurisdictions. Depending on which view one subscribes to (which, in turn crucially depends on the ‘nationalist vs. universalist vs. rationalist’ ideological subscription of an individual), the interpretation of the role of pharmaceutical MNCs in this part of the world varies significantly. However, without going into these ideological issues at this stage, i would say “Caveat Pharma MNCs” now, irrespective of whether they had been ‘exploiting’ the Indian system’s immaturity so far, or they were not meticulously methodical in their Indian patent filings. Gone are those days now. Patent filings all across the world (at least in India) must adhere to the same standards of disclosure (of all sorts of relevant data).
    The fate of Novartis’ alpha crystalline form of Glivec is not an one-off example of its kind. If my understanding of the patent scenario in India is correct, then hundreds of more such patents (either ‘exploitative’ or poorly-drafted and ‘lax’ patents) are just waiting in the queue, possibly to meet the same fate. It is now imperative for the MNCs to either abandon (in case of ‘exploitative’ applications), or amend (in case of ‘lax’ applications) the patent applications that are under consideration. These Pharma Biggies must also have an introspection/change in their collective mind-set, especially regarding patent strategy towards India. Take note: India is well on the path to maturity (vis-a-vis product patenting), despite initial hiccups.

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  2. AvatarAaradhana

    I am happy to see a good use of the provisions of pre-grant oppositions in India. Do we really need s3(d) as it stands today in order to weed out frivolous filings / patents?

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