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What is novelty?

India’s record on protecting pharma patents is less dismal than it seems.

October 30, 2014 12:05:27 am
There is stricter application of what constitutes novelty, the latter a foundational edifice of the global patent regime. There is stricter application of what constitutes novelty, the latter a foundational edifice of the global patent regime.

By: Rajshree Chandra

The era of globalised markets is also an era of globalised sovereignties. Nation states must constantly sync their policies with global constituencies of policies and citizens. At times, domestic disharmony is the price nation states may be required and willing to pay. The case in point here is the proposed review of the intellectual property rights (IPR) policy, particularly those clauses that are related to pharmaceutical patent policy. The Department of Industrial Policy and Promotion has constituted a think tank on IPR whose primary mandate is to evolve a roadmap for the country’s IPR policy and to better India’s purportedly “dismal” record in protecting pharmaceutical patents.

It is important to understand why India’s record is seen as dismal. At the centre of the storm and a constant irritant for global pharma is a provision of the Indian Patents Act, Section 3(d), which doubles up as a health safeguard and perhaps even as “precautionary principle”. The main content of 3(d) is to do with an “efficacy clause”, which states that the new form of a known substance would only be entitled for a patent if it resulted in the enhancement of a known efficacy of that substance. In other words, drugs with minor improvements, or “evergreened” drugs, will not be eligible for patents unless they are proven to have “extra” efficacy. Section 3(d) has become the basis of patent offices rulings, court injunctions, and judgments in several cases. The latter includes rulings on Novartis’s Glivec (an anti-cancer drug), Boehringer Ingelheim’s nevirapine (an anti-HIV drug), Glaxo’s lapatinib (anti-cancer) and Allegan’s two HIV drug patents, making the prospect of super profits by pharma giants unpredictable, and India’s record “dismal”.

The efficacy clause of Section 3(d) is usually seen only as a health safeguard that restricts patents on drugs which lack the novelty criterion and therefore permits the play of generic drugs, cheaper and more accessible, in the market. While it is extremely important to keep this perspective, international law is not best leveraged in the “soft” terms of human rights claims. So it is imperative that we and more importantly, the think tank, understand 3(d) in terms that include public health concerns but are not limited to them.

An aspect of 3(d) that has been ignored and hence not leveraged is how it expands the interpretative framework of patentability. India has often been accused of not being TRIPS compliant. But it could also be argued otherwise, if we set aside for the moment the debate over whether we should strive for TRIPS compliance at all, overruling national concerns. Article 27 of the TRIPS agreement says that patents will be available for “novel” inventions, capable of industrial application. There is no further clarification on what constitutes novelty. The field of knowledge is an incremental and intergenerational one. So it is puzzling that “novelty” or “newness” is left undefined. Further, in some modern scientific sectors, especially the biochemical-pharmaceutical sector, it is difficult to determine a clear demarcation for the fulfilment of the novelty criterion. This has meant that member states can adopt their own understanding of what is novel, varying in stringency, depending on what suits their national and rational agendas.

For example, the eurozone and countries like the US and Australia often entertain “Swiss-type claims”, where the possibility and desirability of new medical uses for the same substance legitimises lower standards of patentability. Swiss-type claims are often used by pharmaceutical giants as a strategy to “evergreen” their blockbuster patented drugs. This strategy, popularly known as “life-cycle management” of a drug, entails making slight improvements on the basic invention through new drug delivery systems, new dosage forms etc, and claiming multiple patents on these minor improvements, thus extending the patent life of the drug.

India happens to fall on the other end of the novelty spectrum. There is stricter application of what constitutes novelty, the latter a foundational edifice of the global patent regime. So it could be argued that India actually exhibits greater compliance with the original idea of novelty. The amended section makes it clear that an improvement made to the known substance shall not merit protection unless the known substance exhibits higher efficacy.

The debate on what constitutes efficacy, invention and novelty is likely to get more intense, with more countries planning to incorporate 3(d)-type precautionary principles in their patent legislations. The Philippines and Argentina already have similar patent legislation. While access to essential medicines ought to be seen as a human rights issue, international law likes to keep the infective propensity of human rights talk firmly quarantined in separate forums. It is important that we not only assert the potential of progressive legislations like 3(d), but also leverage the sovereign space of co-equal rights, at least in interpreting the letter of international law.

The writer is a post doctoral fellow at Centre for Policy Research, Delhi

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