Novartis challenges Indian IP law

A Swiss pharmaceutical company, Novartis, sought to have the January 2006 decision to reject its patent application for the cancer drug imatinib mesylate (Gleevec) reversed by the Chennai High Court in India. Gleevec is used in the treatment of Leukemia. Novartis sells Gleevec at $2500 per patient per month in India; generic versions cost $175 per month” (MSF). The Chennai Patent office rejected Novartis’ patent application on the grounds that the application was a new form of a known substance (Glivec).

Novartis challenged the Indian Intellectual Property (IP) law that prohibits the patenting of a minor variation in an old drug. “Novartis claims that Section 3(d) of the Indian Patents Act is not compliant with the WTO rules outlined in the agreement on Trade-Related Aspects of Intellectual Property (TRIPS). Section 3(d) formed a substantial part of the basis on which the Gleevec patent was originally denied” (ibid, & IPA s3(d)).

The decision to reject the patent in this case prima facie seems contrary to the established legal principle that a right-holder be granted “lengthy breathing-space to enable the invention to be developed and marketed without competition except from non-infringing substitutes” (Vaver, pg 113). Considering that cheaper generic versions of Gleevec are available, it appears that other companies are benefiting from the right-holder’s ingenuity.

However, it must be noted that in order to qualify for a patent, most countries require that the patent be novel, non-obvious, and useful. In Indian law, an enhancement in efficacy would also need to be proven (MSF). Since the drug is used to treat Leukemia, it is clearly useful. Nonetheless, Gleevec is a slight modification of an existing Leukemia drug and, thus, its patentability raises issues of novelty and ingenuity. It is also unlikely that Gleevec enhances efficacy, as there is no evidence that this drug is a substantial improvement over Gleevec.

Caselaw suggests that in order to prove Gleevec lacks of novelty, “one must…be able to look at a prior, single publication and find in it all the information which, for practical purposes, is needed to produce the claimed invention without the exercise any inventive skill” (Beloit para 29). One of the methods for determining whether this prior publication limits the novelty of the later invention is to reverse the order in time of the two patents . Accordingly, if Gleevec had been developed first, would the production of Glivec infringe? If the answer is yes, then Gleevec should not be considered a novel drug (Domtar, para 26). Both Gleevec and Glivec are used to treat Leukemia, so it may be argued that Glivec was used to “teach” the inventor how to produce Gleevec in order to treat a specific type of Leukemia, in which case Gleevec should not be considered novel. If Gleevec was a combination of two or more pre-existing drugs designed to create a different outcome, it is likely that the court would have considered it a novel drug, with enhanced efficacy. But since it is nothing more than a slight modification of an existing Leukemia drug, Glivec, it should not be considered novel, provided that there is no real ingenuity involved in this modification.

It is trite law that for an invention to be patentable it does not need to be complex (Vaver, pg 137). The question is “whether this mythical creature [the technician skilled in the art, but having no scintilla of inventiveness or imagination] … would, in light of the state of the art and of common general knowledge…have come directly and without difficulty to the solution taught by the patent” (Beloit, para 17). It seems that Gleevec would be an obvious treatment to Leukemia if Glivec, which also treated Leukemia, was similar in its composition and formation. This case is analogous to that of Hoechst, which challenged the patentability of anti-diabetic medicine (Hoechst). In Hoechst, the court determined that adding an inert carrier to the drug was not sufficient to warrant patentability of this later drug because simple dilution of medicine does not involve novelty or ingenuity (Ibid). Here, if this reformulation is akin to the simple dilution in Hoechst, it should be treated the same way and, thus, does not warrant patentability.

In addition to common technical requirements for patentability not being met, there are also public interest considerations that support the Court’s decision. The loss of affordable medicine would be a devastating result, particularly in developing countries like India, where Novartis operates. If Gleevec provides the only means of treating Leukemia in India, it should be excluded from patentability on the grounds that the soft law embodied in the Doha declaration requires that TRIPS be implemented in a manner that ensures access to medicines for all (MSF).

Medecins Sans Frontieres & Lawyers Collective, India “Novartis Challenges Indian Safeguards” (28 September 2006), online: People’s Health Movement <>, [MSF]

Indian Patents Act, 1970 s. 3(d), online: Office of the Controller General of Patents, Designs and Trademarks <>. Section 3 states: “the following are not inventions within the meaning of this act…(d) the mere discovery of any new property of 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”.

David Vaver, Intellectual Property Law: Copyright, Patents, Trademarks (Concord: Irwin Law, 1997) at 113.

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287, 7 C.I.P.R. 205, 8 C.P.R. (3d) 289 (Fed. C.A.) at para. 29

Domtar Ltd. v. MacMillan Bloedel Packaging Ltd. (1977), 33 C.P.R. (2d) 182 at para 26.

Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, [1964] S.C.R. 49 cited in Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504, 35 N.R. 390, 56 C.P.R. (2d) 146, 122 D.L.R. (3d) 203.

One Comment
  1. The Indian court’s decision to refuse Novartis’ patent application for Gleevec led the author to explore the compound’s merits for patentability and she ultimately agreed with the court that Gleevec lacked sufficient novelty to be patented. However, she failed to consider the rationale behind the court’s decision. The public interest consideration in this decision stems from India ’s policy not to permit evergreening of patents, which extends monopoly protection – in this case over drugs – by allowing protection for minor variants of the same drug. This practice has direct implications for the availability of affordable drugs to millions of people afflicted with Leukemia and other diseases because it keeps drug prices high and prevents generic drug manufacturers from producing and selling drugs at lower cost. In this case, Novartis could maintain a monopoly over Gleevec in India for up to 40 years at a cost of $2500/month to consumers. As the author indicates, generic versions of Gleevec cost $175/month. Besides the cost considerations, India has an immense economic interest in preventing evergreening because of its large generic drug manufacturing industry, which supplies affordable drugs worldwide for a variety of diseases, including HIV/AIDS. Had the court approved Novartis’ petition, the decision would have had immense and direct implications on the country’s economy in addition to impacting availability of affordable drugs. Overall, it appears that the court’s decision hinged on the consequences of allowing evergreening practices in India rather than on concerns over Gleevec’s lack of novelty over its predecessor Glivec.

Comments are closed.