India’s 3 D Message

It is a lawsuit that caught the attention of the world and generated enough commentary to have decimated a forest if all of it had been on paper. Not simply because India had denied a patent to a major innovator drug company—a patent that has been accepted in 40 other countries—but more because it focused on a specific section of the Indian patent law that has stuck in the craw of the global pharmaceutical industry. Finally, it has been made clear that India is not in the business of undoing the patent regime or rejecting patents on flimsy grounds but has a clear set of laws on what makes for patentability. In short, Section 3 (d) has been vindicated.

As the case filed by Swiss drug major Novartis against the denial of patent to its blockbuster blood cancer drug Glivec drew to a close at the Supreme Court on April 1, there was clarity on several issues in the verdict delivered by justices Aftab Alam and Ranjana Prakash Desai.

To start with, the 112-page ruling ( http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212) was not about the affordability of the drug. That was a point the judges did not look at even if patient groups and public health activists are celebrating. That is because the final rejection of the patent for imatinib mesylate in its beta crystalline form by the twojudge bench of the apex court means hugely cheaper generic versions of the life-saving drug will continue to be available.

The Novartis case was primarily a test of Section 3 of the Patent (Amendment) Act of 2005 which lays down what is not patentable and in particular Section 3 (d) that is aimed at preventing evergreening or the practice of extending the life of a patent through insignificant tweaks to the original claim.

Section 3 (d) says “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” is not patentable. As such, “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.”

Novartis had initially filed two writ petitions seeking a declaration that section 3(d) is unconstitutional because it not only violates Article 14 of the Constitution of India but is also not in compliance with the country’s obligation to WTO’s TRIPS (trade-related aspects of intellectual property rights) agreement.

That was thrown out by the Madras High Court. But it insisted that it was entitled to a patent for the beta crystalline form of the chemical compound imatinib mesylate which had been launched in 2003 and marketed as Gleevec or Glivec. Although imatinib itself was patented in 1993 in the US, Novartis had contended that it was “only the first step in the process to develop Glivec as a viable treatment for cancer”.

Subsequently, the mesylate salt of imatinib and then the beta crystal form of imatinib mesylate had been developed “to make it suitable for patients to take in a pill form that would deliver consistent, safe and effective levels of medicine”. This process was a breakthrough and more than an incremental improvement, according to the Swiss giant, which had said this process “cannot be interpreted as evergreening.”

The judges, however, begged to differ. They followed the sequence of the drug development and held that imatinib mesylate was the “known substance and is also the substance immediately preceding the patent product, that is, imatinib mesylate in beta crystalline form”. As such, they were “completely unable to see how imatinib mesylate can be said to be a new product, having come into being through an invention”.

This was exactly what the Patent Office and its appellate board had said earlier.

The other point on which the apex court brought some clarity was on efficacy. In its view, the term efficacy relates only to “therapeutic efficacy,” with the parameters for providing such proof to be weighed on “strict and narrow standards”. As such, that the physical-chemical properties of the drug, that is, “more beneficial flow properties, better thermodynamic stability and lower hygroscopicity, may be otherwise beneficial” but cannot even be taken into account since these properties have nothing to do with therapeutic efficacy.

The most important question that remains is whether the court has banned incremental innovation altogether. Not so, according to the two justices. Although the beta crystalline form of imatinib mesylate does not stand the test of Section 3(d), this does not mean that patents for all incremental inventions of chemical and pharmaceutical substances are out. It will be “a grave mistake” to read this judgment as such, it said emphatically. Is the drug industry happy?

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