India’s Section 3(d) Conundrum02/09/2008 by Intellectual Property Watch 7 CommentsShare this Story:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Google+ (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)IP-Watch is a non-profit independent news service, and depends on subscriptions. To access all of our content, please subscribe now. You may also offer additional support with your subscription, or donate.The views expressed in this column are solely those of the authors and are not associated with Intellectual Property Watch. IP-Watch expressly disclaims and refuses any responsibility or liability for the content, style or form of any posts made to this forum, which remain solely the responsibility of their authors.Editor’s Note: This submission refers to the 2005 patent law in India, which amended India’s 1970 patent law and implemented the 1994 World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). India allowed proposed patent applications to be submitted in advance to a mailbox before the law’s passage.By Kamakhya SrivastavaThe third amendment to the Patent Act 1970 (hereinafter the Act) was a step ahead in India’s endeavour towards compliance of its patent regime with the TRIPS agreement. Product patents in drugs, chemicals and food opened doors for the examination of patent applications from “big pharma” on drugs which were till then lying in the notional mailbox.The product patent regime brought the inevitable, an upsurge in patent litigation. The Indian generic pharma industry known for its prowess in reverse engineering resulting in production of cheap generic version of pioneer drugs started feeling the heat resulting in large numbers of pre-grant and post-grant oppositions. The patient associations and non-governmental organisations contributing towards access to critical drugs have also joined the fray. Patent revocation proceedings arguing invalidity of the patent in addition to patent opposition are widely being used by the generic manufacturers. The generic drug manufacturers which were safely ensconced under the process patent regime have geared up for a fight and Section 3(d) of the Act seems to have become a potential tool in their hands.Section 3 of the Act enumerates inventions that are not patentable. An inquiry into grant of a patent starts with an examination of whether the invention is a patentable subject matter or not. Section 3(d) denies patent eligibility to new forms of known molecules unless they contribute to utility in terms of being efficacious over its prior form. The Explanation to section 3(d) makes the ground of patent eligibility more profound in the requirement of the derivatives of known substances being considered to be the same substance, unless they differ significantly in properties with regard to efficacy.Intellectual property laws are territorial in nature. The territorial specificities often raise controversies but Novartis’s effort to patent its myeloid leukemia cure, Gleevec [or Glivec], turned nasty with Novartis, on denial of the patent, arguing that the Indian patent regime is in violation of Article 14 of the Constitution of India and non-compliant with the parent treaty TRIPS agreement in a writ petition before Madras High Court.The third amendment to the Indian Patent Act in 2005 was mired in controversy right from its conception through its passage as an ordinance and finally as an Act of Parliament. Even after becoming the law of the land to appease the political parties in opposition a technical expert committee was set up to look into the righteousness of the amendments. The report of the technical committee again due to controversies was called back. Apart from the entire tumult, the impugned section poses itself as a riddle with respect to the ‘test’ it mandates for inventions not patentable to become a patentable subject matter.The part of the ‘Explanation’ appurtenant to clause (d) of section 3 – “considered to be the same substance, unless they (i.e., derivatives of known substances) differ significantly in properties with regard to efficacy”- reveals a test of patentability with ‘enhanced efficacy’ as the criteria. An efficacious derivative form over the known form becomes the subject matter to consider for the grant of a patent.The yardstick of ‘efficacy’ and manifestation of being efficacious formed the core of the controversy resulting after the denial of a patent for Gleevec and will continue adding to the domain as patent applications come up on the altar of examination from the mail box but deeper than that is the section 3(d) conundrum. The ‘test’ in its construction reveals a test of one of the patentability criteria viz. inventive step or non-obviousness. It is a point to ponder that tests of patentability, which is inherent in the three tests of patentability criteria viz. novelty, non-obviousness (inventive step) and industrial applicability (utility) come into picture once it is established that an invention conforms to patentable subject matter. But here we have a ‘test’ ingrained in the Explanation to section 3(d) which is very perceptibly a patent eligibility test.A derivative of a substance is not a ‘patentable subject matter’ unless it “differ[s] significantly in properties with regard to efficacy” which means that a derivative will become a subject matter if it shows “significant difference in properties with regard to efficacy” over the known substance from which it was obtained. It is very similar to the test of non-obviousness or inventive step, i.e. “technical advancement as compared to the existing knowledge.” The significant difference in properties with regard to efficacy shall always be in consonance with technical advancement as compared to the existing knowledge. The determination of patentable subject matter should not relate to a test but just a determination of inventions which fall within the scope of the chapter ‘Inventions not Patentable’ – section 3 of the Patent Act.The above scenario reflects a substantive patent law position where the concept of the test involved in a subsequent stage, i.e., test of non-obviousness, is ingrained in the determination of patentable subject matter thus making the two stages of determination of patentable subject matter and the patentability criteria of non-obviousness overlap. The movement from one stage to the next is not clearly demarcated but elements of the inventive step concept can be seen in the explanation to section 3(d).The part elucidating enhancement of the known efficacy in section 3(d) was supposedly put in to ward off ‘ever-greening’ of an existing patent, thus catering to the national interest. This intent is laudable but in that process it has led to a situation which gives ground to form the issue – whether a ‘test’ built in and an inalienable part of a subsequent stage can have its counterpart or equivalent in the preceding stage? Will this situation not be as the later stage being reflected in the previous stage and creating incoherency or more aptly a conundrum?Kamakhya Srivastava is an Associate with Lex Orbis, intellectual property practice, New Delhi. As a member of the Lex Orbis Group on Research, Publication & Programmes, he is involved in assignments and projects dealing with contemporary intellectual property policies and issues. Kamakhya has a Bachelor’s degree in science and law and a post-graduate in law with specialisation in Business Laws from National Law School of India University, Bangalore.Share this Story:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Google+ (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)Related"India’s Section 3(d) Conundrum" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.