India’s Section 3(d) Conundrum 02/09/2008 by Intellectual Property Watch 7 Comments Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (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) The views expressed in this article 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 Srivastava The 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:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (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.
Divya S says 03/09/2008 at 5:32 am I think Mr. Srivastava has written a brilliant piece!!! This is truly a fresh take on the nuances of S. 3 (d). Kudos to such an intellectual exercise!!! Reply
Atul Kaushik says 03/09/2008 at 9:18 am The idea being explored by Kamakhya in his write up is novel, and needs further examination by the IP community. It may be useful for ICTSD to get a more explicit exposition of the idea published for comments. For example, in the absence of details in his write-up, I am unable to make a distinction between the conundrum he points out as supposedly exceptional to Section 3 (d) of the Indian Patent Act and many counterfactuals where the subject matter gets affected at the rime of examination of an application on the criteria of patentability. Reply
Samuel Egerton says 08/09/2008 at 9:26 am Dear Sir, This article appears to have been written by a confused mind or at least a mind which is not trained in writing techno-legal pieces. The author himself does not appear to be sure what he is attempting to say. No where in the world, as stated by the author, “An inquiry into grant of a patent starts with an examination of whether the invention is a patentable subject matter or not”. The first thing to judge is whether an invention fulfills the three cardinal requirements of novelty, inventive step and industrial application. This is followed at much latter stage by the inquisitiveness whether the subject matter is one prohibited by a geographic or national legislation of a particular country or not. Please note that the above-stated first three criteria are universal in nature but specific prohibition to patenting a particular field of technology – say, method of treatment or software per se or plant or animal or even inventions contrary to public order or morality – is prerogative of a contracting member to TRIPS agreement. The TRIPS agreement itself has provided breathing space to member countries to determine within their auspices – what further criteria they deem fit to be imposed over and above the three criteria. For example, as far as the morality prohibition is concerned, it finds mention in EP, India and many other jurisdictions. However, what is moral to a society is case sensitive, i.e. what is moral to one country might not be moral to other. The contracting countries have, therefore, been provided with a space under TRIPS to legislate further requirements and/or prohibitions which suits there indigenous needs and necessities. Therefore, even though Section 3 (d) imposes further criteria for patentability, so does Sections 3 (k), 3 (e) etc. Agreed that the additional criteria are similar to inventive step but certainly it is per se reiteration of the criteria of inventive step and certainly not at a clearly demarcated separate stage. Additionally, as also pointed out by Mr. Kaushik, it is almost impossible to draw a distinction between the conundrum the author attempts to point out to without even bothering to elaborate upon such point in detail. I regret to say that the author has made a reasonable attempt to give a “fresh” take on this issue, but has failed blatantly in such attempt. Regards, Samuel Egerton Reply
Aita Kalia says 18/09/2008 at 6:59 pm Dear Mr. Samual, I am not so experienced in IP field but after reading your comment I couldn’t stop myself from writing that “An inquiry into grant of a patent DOES starts with an examination of whether the invention is a patentable subject matter or not”. Imagine a situation when a person approaches with his invention on an instrrument to commit suicide what would be the first thing in your mind? or suppose if someone wants to patent a process to clone humna beings what would be your reaction. I am sure at first instance you will say that these are totally prohibited in Patent law as they come under a list of non patenable invetion as stated in Section 3 of Indian Patents Act 1970.. Reply
Mark Taylor says 23/09/2008 at 12:39 pm Dear Kamakya, Just as well that you admit that you are not an expert in IP since it’s a very broad field (inclusive of Trademark, Copyright, Patent, Design, Plant Variety, Integrated Circuit and Trade Secret to name a few areas). Contrary to what you say, I have to agree with Mr. Egerton that an inquiry into “Grant of a patent” prima facie starts with the determination as to whether an invention is novel, inventive and possessed of industrial application or not. These are the three basic criteria to judge patentability and NOT patent eligibility of an invention. The desire to create something new, i.e. beyond what has been disclosed in prior art drives a scientist to invent something and not the concern whether his invention will be considered to fulfill or not fulfill the patent eligibility criteria of a particular jurisdiction. I hope you appreciate that whether an invention meets the “patent eligibility” criteria in a particular jurisdiction or not has nothing whatsoever to do with the actual process of the grant of a patent for such invention at least in other jurisdictions. If an invention does not strictly meet the patent eligibility criteria in a particular jurisdiction, one need not at all enquire into grant of a patent with respect to such subject matter. As also pointed out by Mr. Egerton, whether an invention past musters in respect of the specific prohibitions of the patent law of a particular country is a different ball game altogether. Please attempt to understand that as long as an invention fulfills the three fundamental requirements of patentability, which are universal, even though they might not be allowed a patent in a particular jurisdiction say, in India – on the basis of a local legislation – such invention is nevertheless eligible to be granted a patent in other jurisdictions which have different or divergent patent eligibility criteria. However, if an invention is considered per se not novel or inventive, it is almost impossible to secure grant of a patent on such invention anywhere in the world irrespective of the fact that such invention is patent eligible or not. Wishes, Mark Taylor Reply
Akash Mishra says 04/10/2008 at 6:40 pm Its a well written and having greate work ahead on patent law. Reply
Kamakhya Srivastava says 13/11/2008 at 9:45 am Dear all, Thanks for comments. Please accept my apologies for the delay in my response. The territorial nature of Intellectual Property Rights and the flexibility provided in TRIPs when utilized by a nation depending on its socio-economic condition, determines patentable subject matter. Indian Patent law under its section 3(d) does just that. The section bars inventions from being patent eligible which are mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance. The Explanation appurtenant to the section further qualifies “enhancement of the known efficacy”. It says that derivatives of known substances shall be considered to be same substance, unless they differ significantly in properties with regard to efficacy. Inventive step is defined as feature of an invention that involves technical advance as compared to the existing knowledge which makes the invention non-obvious to the notional skilled person. My observation is that the ‘enhanced efficacy’ requirement under section 3(d) and the inventive step definition are co-terminus. Both involve advancement over and above the existing prior art. In the pre-grant opposition of Nevirapine (pediatric suspension of Nevirapine Hemihydrate), the Asst. Controller denied observing inventive step in the absence of any disclosure of the advantage of smaller particle size (1-150 microns) in the composition. While looking at patent eligibility, the denial was due to non-placement on record of the data relating to therapeutic effect of the known substance and the claimed (i.e. derivative) substance. Both investigations i.e. determining patentable subject matter and inventive step harps on the advancement, the enhanced efficacy in the former while the cause leading to it in the latter. Reply