Friday, April 06, 2007


Pursuant to an earlier post on this topic, the Madras (Chennai) High Court has transferred the Novartis matter to the Intellectual Property Appellate Board (IPAB). As I'd mentioned earlier, this is circuitous, as the matter is likely to find its way back to the High Court, by way of a writ petition against the order of the IPAB. For those of you interested in a succinct exposition of this case, read this article from IP-Watch, a news service that is gaining reputation as one of the most authoritative on matters of international intellectual property.

Fortunately though, the Madras High Court has not transferred the entire case to the IPAB, but only that bit that relates to the patentability of Imatinib Mesylate (the pharmaceutical salt form underlying the anticancer drug Gleevec). As those of you familiar with this case know, Novartis had appealed the Controller's decision that Imatinib Mesylate was not patentable, since:

1. It is not new (it is anticipated from a 1992 patent application covering the Imatinib base)
2. It is a salt form that does not demonstrate an "increased efficacy" over the earlier known Imatinib base and hence is unpatentable under section 3 (d). Novartis had also challenged the TRIPS compatibility and constitutionality of section 3(d). Since the Madras High Court completed hearing arguments on this aspect, the court decided to not transfer this aspect of the matter, but has reserved judgment. In any case, I'm not sure that the IPAB would have had jurisdictional competence to rule on this particular aspect of the matter.

Which way is the court/IPAB likely to go? Difficult to tell at this stage, but to the extent that one might reasonably predict outcomes, this is my take:

i) The Madras High Court is likely to avoid ruling on the TRIPS compatibility of section 3(d). Firstly, since India is a "dualist" nation, international treaties are not directly enforceable in India, but have to be separately legislated upon before they are enforceble. No doubt, the Vishaka case was an exception to this rule--but one will remember that the court was careful to qualify that international norms would be incorporated only if such norms did not conflict with domestic law. The Novartis challenge is quite different. Secton 3(d) is already part of domestic law. Novartis seeks to invalidate existing domestic law (section 3(d)) as not complying with an international legislation i.e. TRIPS. Secondly, the right forum to moot such a challenge is the WTO dispute resolution panel and not a domestic court. Thirdly, given the sensitivity of the Novartis case and the international uproar, the Madras High Court is more likely to duck the issue , on the ground that it lacks jurisdictional competence.

If the Madras High Court were to however rule on this aspect, the decision is likely to go against Novartis i.e. the likely holding will be that section 3(d) is compatible with TRIPS, as it is an "obviousness" standard that member states are free to define in a manner consistent with their national policy. Section 3(d) does not "discriminate" against the pharmaceutical sector but only makes a "justified" differentiation, given the specificity of salt forms in the pharmaceutical sector i.e. other technology sectors such as mechanicals, electronics etc do not face “different salt form” kind of issues. It bears noting that US patent law encompasses a heightened utility requirement in the context of gene patents—i.e. in order to be patentable, a gene sequence has to demonstrate “substantial”, "specific" and "credible" utility. This came out of a desire to put a stop on the multitude of frivolous gene patent applications that cited the obvious utility of being a “mere probe”. These steps that cater to the specificities of technology sectors are perfectly legitimate exercises of national discretion by member states. And India is no different.

For similar reasons, section 3(d) is not likely to be struck down as an “arbitrary” standard under Art 14 of the Constitution of India.

ii) The IPAB's ruling on "patentability" will depend on whether or not they are convinced that Imatininb Mesylate was in fact 30% more "bio-available" than the other forms and therefore more “efficacious” under section 3(d). If this is not factually correct, then the IPAB will uphold the decision of the Controller rejecting the patent. Unfortunately, the order of the Controller in this regard is not very illuminating. It appears that the Controller was not convinced, as a matter of fact, that this salt form was, in fact, 30% more bio-available.
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