Is Section 3 (d) of Patents Act good for innovation? - Yes

It is heartening to note that Section 3(d) has so far been largely implemented in India by the office of the Controller General of Patents, and has now been elegantly upheld by the Supreme Court.

The recent Supreme Court judgment deals with the genesis of 3(d) -- the intention and objective of enacting the amendment. Preventing “evergreening” through frivolous and mere physical modifications of already patented molecules in the public domain was the objective of the new 3(d).

At the same time, the amended 3(d), as stated by Justice Prabha Sridevan encourages innovation, gives an opportunity of obtaining protection for genuine innovation, which contributes enhancement in efficacy, even if through only a physical modification such as salts, esters or polymorphs.

While never-ending litigations are being fought on validity of Section 3(d) in India (in the case of Erlotinib, Sunitinib and others), it is heartening for patent researchers to take note that globally, including in PCT-ISA Search Reports and even in judgments in Europe and US, the need for improved efficacy is being sought while deciding on patentability.

The apex court has rightly observed: “We have held that the subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances.

It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Parent Act.”

As the Supreme Court has observed: “We have borne in mind the object which the amending Act wanted to achieve, namely, to prevent evergreening; to provide easy access to the citizens of the country to life saving drugs…”.

The Supreme Court has rightly referred to Prof Shamnad Basheer’s link of 3(d) to the Article 10(2)(b) of European Drug Regulatory Directive 2004 [from where the explanation to 3(d) was imported by Parliament.

Section 3(d) of the Patents Act, 1970 deals with the ‘invention not patentable’ in support of and complementary to Section 2(1)(j) and Section 2(1)(ja).

There are three dimensions to Section 3(d).

The first relates to ‘new form of a known substance which does not result in the enhancement of the known efficacy of that substance’.

The second relates to ‘mere discovery of any new property or new use for a known substance’.

The third relates to 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’.

The first and second dimensions have provided exceptions which make such known substances and process patentable, however, subject to conditions. Let us hope that Parliament further qualifies the second dimension to enable it to also protect genuinely new innovations.

The author is Founder and CEO, Gopakumar Nair Associates

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