Celebrations in Novartis case should be cautious, as the crux of the provision of Section 3(d) has not been clearly interpreted.
THERE is not much reason to celebrate the Novartis judgement since the Novartis judgement does not decide anything beyond the Glivec patent. Of course there is a lot of discussion about the politics of the WTO and country as a background to the conception of how to make drugs cheaply available to the people and the resultant balance which needed to be struck by the decision makers and the importance of generics in the world, the poor and India.
However it is urged that celebrations should be cautious since the crux of the provision of Section 3(d) has not been clearly interpreted.
Section 3(d) states: “Section 3. What are not inventions.– The following are not inventions within the meaning of this Act,– (d) 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.
Explanation — For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.”
The dispute was what does “unless they differ significantly in properties with regard to efficacy “ mean , and specifically what does efficacy mean and therefore what products would be protected under the provision and what would be outside it and therefore would not be allowed the benefit of patent under the Act.
The Court has held that efficacy under the provision meant “therapeutic efficacy” but refrains from answering the question very clearly as to what would constitute that and as a result makes it case specific.
It has been observed by the Court that efficacy means: “the ability to produce a desired or intended result”. Hence, the test of efficacy in the context of section 3(d) would be different, depending upon the result the product under consideration is desired or intended to produce. In other words, the test of efficacy would depend upon the function, utility or the purpose of the product under consideration. Therefore, in the case of a medicine that claims to cure a disease, the test of efficacy can only be “therapeutic efficacy”. The question then arises, what would be the parameter of therapeutic efficacy and what are the advantages and benefits that may be taken into account for determining the enhancement of therapeutic efficacy? With regard to the genesis of section 3(d), and more particularly the circumstances in which section 3(d) was amended to make it even more constrictive than before, we have no doubt that the ‘therapeutic efficacy’ of a medicine must be judged strictly and narrowly.
Our inference that the test of enhanced efficacy in case of chemical substances, especially medicine, should receive a narrow and strict interpretation is based not only on external factors but there are sufficient internal evidence that leads to the same view. It may be noted that the text added to section 3(d) by the 2005 amendment lays down the condition of “enhancement of the known efficacy”. Further, the explanation requires the derivative to “differ significantly in properties with regard to efficacy”. What is evident, therefore, is that not all advantageous or beneficial properties are relevant, but only such properties that directly relate to efficacy, which in case of medicine, as seen above, is its therapeutic efficacy. 187. In whatever way therapeutic efficacy may be interpreted, this much is absolutely clear: that the physico-chemical properties of beta crystalline form of Imatinib Mesylate, namely (i) more beneficial flow properties, (ii) better thermodynamic stability, and (iii) lower hygroscopicity, may be otherwise beneficial but these properties cannot even be taken into account for the purpose of the test of section 3(d) of the Act, since these properties have nothing to do with therapeutic efficacy.
That is clearly a judgment on facts and does not decide finally on the dispute as to the interpretation of Section 3 (d). The danger is the recording of the submission of Shri Shamnad Basheer’s argument, which is as follows:
185. Prof. Basheer, who appeared before this Court purely in academic interest as an intervenor-cum-amicus, agreed that not all advantageous properties of a new form (such as improved process ability or flow characteristics, storage potential, etc.) ought to qualify under section 3(d), but only those properties that have some bearing on efficacy. However, taking a less rigid position than Mr. Grover, Prof. Basheer argued that safety or significantly reduced toxicity should also be taken into consideration to judge enhanced therapeutic efficacy of a pharmaceutical product in terms of Section 3(d).
It is suggested that the Court may use the above mentioned line of argument which has been recorded to expand the protection to extend the tenure of patents in future.
The battle about Glivec is over, but it was about a drug which is way past its prime. The test would come in future. It is important that we are keenly aware and careful about further litigations regarding the said Section 3 (d) since the debate is far from settled.
(The Author is Advocate of Supreme Court and National Council Member of Swadeshi Jagran Manch)