Saturday, July 25, 2009

Is Section 3(d) Separating Wheat from the Chaff?

Prior to the third amendment, the Indian patent law categorically barred patent protection not only to chemical and drug compounds and intermediates but also to pharmaceutical compositions, drug combinations, drug deliveries and any physical/chemical modification to chemical/drug compounds (such as polymorph, co-crystals, complexes, enantiomers and so on). However, ten-year transitional period provided by TRIPS agreement mandated India to allow patent protection to all fields of technology that included drug and chemical products. This mandate was met with strong resistance and protest from local pharmaceutical companies and public health NGOs, and one of the most heated issues was ever-greening. Acknowledging industry concerns about ever-greening and weighing flexibilities provided under TRIPS agreement, the Government of India diligently amended section 3(d) to separate wheat from the chaff. In other words, section 3(d) was amended to separate genuine inventions from frivolous inventions. In patent law, a frivolous invention is an invention which fails any of three criteria of patentability, that is, novelty, inventive step and utility. But if an invention satisfies all three criteria of patentability then it is not frivolous and is patentable until and unless categorically excluded under the law (such as section 4). Notably, the criteria of patentability are same in almost every country having patent law but the benchmark to judge those criteria may differ country to country (such as judicially evolved doctrine).

What differentiate patent law from other disciplines of law is that this is the only subject of law that specifically and particularly deals with advance science and latest technology. Obviously with the advancement of scientific research and technology, certain practices that may have well thought-out inventive almost a decade back has now become more or less a customary practice to a person skilled in the art. For example, almost 10-15 years back resolution of racemic mixture into isomers/enantiomers was novel and inventive practice considering the state of technology and scientific practice prevailing at that particular point of time but now it has become known and customary to an ordinary person skilled in the art. Similarly, concepts such as bilayer tablet or controlled release formulation using HPMC that may obviously thought inventive almost a decade (or two) back is now a common formulation practice. However, despite such practices becoming customary and obvious in state-of-the-art, patents are regularly been issued for inventions using /based on such practices. Unfortunately, the patent law is not able to keep in race with the changing technology and scientific practices and in many cases still scrutinizing inventions keeping in account decade old scientific practice. Such patents are now a major point of concern in healthcare industry, which not only hamper healthy competition but also create litigious market, and is often used as a part of business strategy positively referred as Product LifeCycle Management and negatively referred as Ever-greening.

History is witness that many countries in past, from time to time, amended their patent law to support their social and economic development and India is no exception to that. In 1970, following observations and recommendations made by Ayyenger Committee, the Government of India abolished patent protection to chemical, drug and food products which was a well-thought recommendation to support social and economic situation of India. The impact of that recommendation resulted into strong indigenous generic drug industry which not only supported widely-concern public health issue but also brought new business and employment opportunities for India. In 2005, India again carefully brought changes to its patent law not only in conformity to TRIPS agreement but also to support its socio-economic development. Inclusion of amended section 3 (d) is an example of such diligent approach to balance social and economic development and at the same time keeping patent law in pace with changing technology and scientific practices.

In our continuing post, we will particularly discuss section 3(d) in detail and will also try to rationalize the spirit and scope of section 3(d). However, we will be happy to welcome comments from our readers on this post and their opinion on section 3(d). Hope we can bring some value and clarity to section 3(d).


  1. Anonymous10:38 AM

    Thank you for starting this discussion.

    I wholly agree with the fact that under all circumstances ever greening of a patent should not be allowed. But frankly, section 3(d) is not the answer to that. It is sweeping in its reach. It does not separate wheat from the chaff, but grinds wheat along with the chaff.

    The problem in India is that laws like patent laws, despite being around for nearly 100 years now have not reached a level of maturity required to deal with complex science and technology issues. We do not have enough precedents in the practice of patent law to fall back on. I think (I hope I am wrong) problem lies in the fact that the law makers and the law practitioners have no idea about science, leave aside advancement in science.

    Any scientist worth his/her salt will know that the era of earth shaking inventions/discoveries has probably gone. The age of apple-falling-on-head leading to discovery of gravity has passed. Now the earth shaking discoveries/inventions will also be a result of long winding procedures consisting of incremental steps and probably not one sweeping experiment. One needs very high level of sophistication and precision to practice research in science. We can see that in the field of alternate energy. I am not undermining the ability of human race. But what I am coming to is that one already has a basis on which one is working, either to improvise or making it more accessible or cheaper or whatever else. This however does not make it less inventive. This also does not mean that these are the ONLY kind of inventions taking place. There are a lot of creative people in this world. In fact creativity is oozing out of every nook and corner!!

    Coming back to section 3(d). I think we need to divide it into, at least, two parts. One part should deal with inventions that are genuine and incremental in nature. All incremental inventions should not be rejected per se. By doing this we are killing the nascent environment of innovation in this country. The other part should deal with frivolous inventions.

    The implications of 3(d) are huge for the future of culture of innovation in Science & Technology, which is as it is way below the desired level. We have to move from being a service economy to knowledge economy. Hampering the growth of innovation with these kinds of laws will not help.

    Thank you,

    Anju Khanna

  2. Anonymous4:14 PM

    Get your basics right. An invention is one that has passed Novelty, Inventive Step, and usefulness test. Section 3 is for inventions that are not patentable in India, not frivolous inventions according to your definition.

  3. Dear Anju,

    Your initial lines and last lines are contradictory to each other..

    I believe section 3(d) is one of the most revolutinary section in patent laws and well drafted to consider incremental invention from frivolous one. Of course, legal practitioner needs to understand its nuances and they are ill equipped due to lack of technical foresight. unfortunately, from patent office oppostion cases to high profile cases in IPAB and HCs, everywhere hardcore lawyers represent who are not able to appreciate the case.

    Thanks Varun for a scintillating article..

    Ajay Sharma, Patent Agent

  4. Dr. Kulkarni6:01 PM

    Meticulous... great endeavour. We all need to understand section 3(d) with unbiased approach to know the essence.

    Thanking you !
    Dr. Kulkarni

  5. Dear Anju,

    To some extent I do agree with you that section 3(d) is not the answer to prevent ever-greening. In absence of proper precedents and examination guidelines, section 3(d) may unfortunately grind wheat along with the chaff. Even I do agree with you that there is enough room for learning for law makers and law practitioners about science and technology. Even I agree with you that improvising or making economically viable does not make contribution less inventive (in fact definition of ‘invention step’ in our patent law do accept that fact).

    My post is also intended to highlight the same issue that incremental issue should not be rejected per se under section 3(d), in fact, in my continuing post I will try to throw more light on this issue. However, at the same time we need to acknowledge that with time certain practices that may thought-out inventive in specific period of time may become more or less regular practice in industry and that thought should be well considered from time to time while scrutinizing patentable inventions. I agree with you that India can advance from service economy to knowledge economy if innovation culture is appropriately promoted in this country and patent law has big role to play in that.

    I sincerely appreciate your thoughts and valuable inputs made to the post. Hope to hear more from you.

    Thank you.

  6. Dear Ajay,

    I completely agree with you that the spirit and nuance of section 3(d) is often neglected by lawyers due to their lack of technical understanding. I appreciate your comments and hope to hear more from you.

    Thank you.

  7. Thank Dr. Kulkarni for your comments and appreciation. Hope our discussion may put some constructive light on section 3(d).

  8. Anonymous11:20 AM

    Hi PC,
    Below is an abstract of an article authored by Mr. Shanti Kumar et al. Seems relevant to the thread here. chanced upon it on SSRN

    Evergreening of Patents and Indian Patents Law

    Inventive activity necessitates dissemination of information across the spectrum of intellectual provenance, to ensure advancement in research and development. The disclosure requirement in case of patents fulfills this very purpose. Obtaining monopoly over an invention is subject to the disclosure requirement, whereafter the monopoly rights can be exercised for the term of the patent. However, there are attempts to unjustifiably stretch this monopoly by obtaining patents over insignificant or trivial modifications of the invention. This paper seeks to analyse the practice of evergreening in the context of Indian Patents Act and discusses the famous Novartis case, where the test of evergreening efficacy was laid down.


  9. Anonymous10:02 AM

    The Paper by Mr. Shanti Kumar and Nitin Shukla of Lex Orbis Intellectual property Practice and Tanushree Sangal (affiliation not provided) on the link below gives two ways to avert Evergreening -

    How to avert Evergreening:
    Evergreening can be averted by:

    (i)Not granting patents on the basis of trivial and insignificant changes in the original pharmaceutical patented product;

    (ii)Ensuring that generic manufactures can manufacture the patented pharmaceutical product soon after the term of patent expires, by making use of Bolar provision.

    The first way seems to be a very obvious methodology only depending on the wisdom of the patent examiners. The second way to avert evergreeniing is totally confusing as the same seems to be teaching the generic manufacturers to manufacture the patented pharma product after the expiry of the term of the patent BY USING THE BOLAR PROVISION (EXCEPTION) ?????

  10. This is very interesting. There is definitely a public interest in access to pharmaceuticals.