Thursday, December 8, 2011

Rustling Section 3(d) in the Novartis (Glivec) case

A lot has been in the news about the Novartis case. This article briefly deals with the case in relation to Section 3(d), the contending section on which the case primarily pivots.

A Brief Background:

The Novartis patent application principally concentrates on formulating the beta-crystalline form of imatinib mesylate. It is to be noted that the renowned anti-cancer drug, Glivec /Gleevec was formulated from the beta-crystalline form of imatinib mesylate and the invention is already patented in nearly 40 countries.

So, why is Novartis facing difficulty in patenting the same invention in India? The short answer to that is Section 3(d) of the Indian Patent Act, 1970 which was inserted by way of an amendment in 2005 of the Act. The section reads-

“(d) the mere discovery of a new form 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.

Explanation.-For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy

The object of inserting Section 3(d) was to prevent the “ever-greening” of patents since there were cases wherein applicants tried patenting trivial modifications to current patented inventions to extend its monopoly regime. This section sought to prevent ever-greening by disallowing the patenting of a known substance unless it results in an ‘enhancement of the known efficacy of that substance’.

The case has appeared before the Madras High Court, the IPAB and now, before the Supreme Court, wherein the main point of objection is that the invention is a “mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance”.

After being rejected by the Indian Patent Office (Chennai) under Section 3(d), Novartis moved the Madras High Court in 2006 challenging the decision. It challenged the grounds on which the IPO rejected the application as well as Section 3(d) arguing that the Section contravenes TRIPS as well as Article 14 of the Indian Constitution (equality before the law).

The High Court, in 2007, decided to split the two challenges, deciding to continue to deal with the validity of the Indian law but referred the appeal challenging the grounds on which the Indian Patent Office (IPO) rejected the patent application to the Intellectual Property Appellate Board (IPAB).

Before the High Court:

On the matter of constitutional validity, Novartis stated that Section 3(d) violates Article 14 of the Constitution as the terms such as “enhancement of known efficacy” and “differ significantly in properties with regard to efficacy” are not accompanied by guidelines to define its scope, hence rendering the section vague and arbitrary, and as a result, conferring unfettered power to IPAB which violates the concept of equality enshrined in Article 14 of the Constitution.

The High Court, deciding on the validity of Section 3(d) held that Section 3(d) is constitutionally valid. It correctly noted

The argument that the amended section must be held to be bad in Law since for want of guidelines it gives scope to the Statutory Authority to exercise its power arbitrarily, has to be necessarily rejected since, we find that there are in-built materials in the amended section and the Explanation itself, which would control / guide the discretion to be exercised by the Statutory Authority. In other words, the Statutory Authority would be definitely guided by the materials to be placed before it for arriving at a decision.”
(Para 16)

However, the challenge of it being compliant with TRIPS was held not maintainable since the proper authority to settle this matter would be the WTO dispute settlement panel.

Additionally, as obiter dicta, the Court tried to define the scope of the term “efficacy” and took the aid of a medical dictionary to conclude that “efficacy” would mean “therapeutic efficacy”. This scope of “efficacy” was unclear as to whether bio-availabilty would count as therapeutic efficacy, since bio-availability might mean that a dosage of a certain medicine with side effects is reduced to a smaller dosage with no side-effects, thus making it therapeutically effective. The question was to whether bio-availabity would make the beta-crystalline form therapeutically efficacious was to be decided by the IPAB.

Before the IPAB:

In 2009, when the appeal challenging the grounds on which IPO rejected the application was heard before IPAB, IPAB held that though the claim covering the beta crystalline version of Imatinib Mesylate is both novel and inventive, it failed the test under section 3(d), which requires a demonstration of "significantly enhanced efficacy".

To this, Novartis showed that the beta-crystalline form of imatinib mesylate showed enhancement due to its 30% bio-availabity; however, this evidence was rejected by the IPAB which iterated that the evidence did not conclude the enhancement sought under Section 3(d). It stated that section 3(d) is a heightened inventive step standard and that the only kind of efficacy that would satisfy section 3(d) is therapeutic efficacy. It said that Novartis's beta-crystalline version may possess improved bioavailability, thermodynamic stability, improved flow properties and lower hygroscopicity, but this does not amount to an increase in "therapeutic efficacy". The IPAB did not provide detailed reasons as to why it thought the beta-crystalline form lacked efficacy.

Appeal to Supreme Court: Novartis, in 2009, appealed to the Supreme Court against this decision of IPAB. The case is still being heard before the Supreme Court, the next date of hearing being 28 February 2012.

The case is being closely watched as it is speculated that the Court would define the true scope of Section 3(d) amidst other matters.

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rahul March 5, 2012 at 3:12 PM  

Thanks for great information you write it very clean. I am very lucky to get this tips from you

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