NOVARTIS CASE TRANSFERRED TO THE IPAB


Pursuant to the last 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 Chennai 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. From the order, it appears that the Controller was not convinced, as a matter of fact, that this salt form was, in fact, 30% more bio-available.

Shamnad Basheer

Shamnad Basheer

Prof (Dr) Shamnad Basheer founded SpicyIP in 2005. He is currently the Honorary Research Chair of IP Law at Nirma University and a visiting professor of law at the National Law School (NLS), Bangalore. He is also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof Amartya Sen. Professional History: After graduating from the NLS, Bangalore Professor Basheer joinedAnand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Prof Basheer has published widely and his articles have won awards, including those instituted by ATRIP and the Stanford Technology Law Review. He is consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also serves on several government committees.

Leave a Reply

Your email address will not be published.