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
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
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
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.