Once an Intermediate, Always an Intermediate

First Publication Date: 22nd December 2010
The other day, while I was having a heated discussion with 2 fellow bloggers about the patentability of repurposed drugs i.e. patenting of new use of a known drug, we hit a road block with regard to patent value of an intermediate. The question raised was “Will a newly found first use of an already known intermediate be patentable in India?”
I am rephrasing the question for the purpose of this discussion.

 “Will the exclusion criterion elaborated in Section 3 (d) of the Indian Patents Act exclude the patentability of the first known use of the intermediate?”

Whenever the exclusion pertaining to new use of a known substance has been discussed we have drawn an analogy to the second medical indication in Europe. In Europe, a second medical use of a known substance is patentable. For example, if one discovers that Aspirin which is a pain reliever can also be used in treatment of Cardio vascular diseases it is possible to get a patent for a purpose driven claim for the same aspirin pill for the newly found indication. The only road block in this case is that if Aspirin is under patent regime one may have to seek a license from the owner of that base patent.
On reading Section3 (d) we were certain that this second use of Aspirin will definitely not find place in the Indian Patent grant database as it is clearly non patentable subject matter. However, will the same analysis apply for intermediates whose first medical indication is not yet clear? To answer this question I invite you to take a closer look at the statute.
Section 3 (d) reads “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.”
As per this clause a mere discovery of a new use for a known substance is not considered patentable subject matter in India. Intermediates are known substances. We have nothing in the statute that talks about the first use or second use. However, the use of the intermediate was not known before and the patent act does not specifically define the word “New”. Hence the use of the intermediate can be safely referred to as “New Use”. Discovery is finding the inherent. The inherent property or use of a known substance can be referred to as a discovery (wonder why they use the adjective ‘mere’. I personally thought it tends to under rate discoveries.).
And then I realized the solution to my question was always there in the statute. Since the statute does not mention drug, pharmaceutical or medical even once in this clause, it was not appropriate of us to try to draw an analogy with the second medical indication related laws in Europe. There seems to be absolutely no link between the two. Strictly in the light of the wordings in Section 3 (d), new use of Intermediates will be considered a “mere” discovery and hence will not be considered patent worthy by the Indian Patent Office as it stands today.
However, is the statute in line with the rationale of the patent system? The last I checked the rationale was “to promote Science and technology for public good by giving limited exclusivity to the inventors for their invention.”  So the question I would ask here is, if I stumble upon an intermediate which may be a potential life saving drug, should I concentrate on the final product that gives me money on sale or should I invest in the research of the intermediate which will give me a prestigious publication in a reputed journal? (Do the journal guys pay well? I always knew I didn’t have a single academic bone in my body.)
Will look forward to your thoughts on this subject.
Image from: http://www.njfinechem.com/imglibs/images/46-1192673847600-big.jpg
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  • December 23, 2010 Posted
    Dr. Kalyan

    First use of an intermediate is patentable in India

    I disagree with Vinita’s conclusion with respect to patentability of an intermediate for which a first use is identified. If an intermediate to a final product does not have any use except in the creation of the final product, then it is not considered useful or industrially applicable under the Indian patent law and patent laws of other countries as well. Under such circumstances, the intermediate would be a compound that does not have any recognized use under the patent law. Now if a person identifies that the intermediate can be used for treating cancer, then it is its first use, which makes it patentable and cannot be excluded under section 3(d). If the claims are drafted to claim the compound in the light of its use for cancer, objections with respect to novelty and non-obviousness may also be overcome.

    It seems that Vinita is confused between use and property of a substance. Though a property of a compound may be linked to its use, they are two different parameters and must be treated separately for purposes of section 3(d). Thats why the section prohibits new use and new property discoveries separately. Assuming that a new property of a substance X is discovered and that property allows the usage of X for treatment of a disease Y, a claim directed to the use and not the property would be patentable. Of course, the assumption here is that X does not have any known use.

  • December 23, 2010 Posted
    Dr. Kalyan

    This comment has been removed by the author.

  • December 23, 2010 Posted
    Vinita Radhakrishnan

    Thanks Kalyan for your thoughts on the interpretation of the statute. But I beg to disagree with you on this. The clause clearly states that mere discovery of a new use of a known substance is not patentable. Since the substance is already known as an intermediate, any use stated of that intermediate will be considered as a discovery of a new use. And hence even though there has been no prior known use, I guess its just tough luck that the intermediate itself was known before.

    In any event, I would hope that the Patent office goes by your logic, since I personally feel such intermediates should be patentable. However, we will have to wait for a verdict from the office to get clarity on this issue.

  • December 23, 2010 Posted
    Dr. Kalyan

    Vinita, I think the emphasis here must be on new use and not on mere discovery. If the use itself is not a new use, the question of whether it si a mere discovery or a discovery does not arise.

  • December 23, 2010 Posted
    Vinita Radhakrishnan

    We all know that discoveries are not patentable under Indian Patent Law. So I really believe that the word ‘mere’ need not be delved upon. After all patent office does not have the authority to decide what is a discovery and what is a mere discovery. Well I believe equal emphasis needs to be given to the term” New Use” and to the term “known substance”. If the substance is known (which it is) discovery of a new use is not going to get you a patent. Also, if you give it a broader perspective. You cannot take away something that is already in public. So since the intermediate is public knowledge, you are trying to deprive the public from exploiting the intermediate to the fullest by getting a partial conditional right over the intermediate which may already be in public. May be that is what the patent act is looking to hinder.

  • December 23, 2010 Posted
    Supriya Ramacha

    I did a quick search to see if any patents have been granted for an intermediate. It turns out that there are patents with claims that claim an intermediate product synthesized through a novel process. For instance, a claim of 43679 reads:
    The intermediate products of the phthalocyanine synthesis obtained according to the process claimed in Claim l.
    In its description they also provide that the use of these intermediate products is to synthesize the phthalocyanine.
    Through this application it is more or less clear that the use of the intermediate to synthesize the final compound may be reckoned as the first use of the intermediate and any other use of the intermediate could be reckoned as a new use of the intermediate. Therefore I guess if we are emphasizing on the new use, intermediates with any other use other than the use for the synthesis of the final product may be considered as new use and may not be patentable.

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