Once an Intermediate, Always an Intermediate

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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.