The Indian Patents Law categorizes certain inventions as not inventions. Among these, the most discussed category is the Section 3(d), which prohibits patenting of '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'. The "new form" has been further explained to include salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance, and such new forms would be considered as the same known substance unless they differ significantly in properties with regard to efficacy.
The term efficacy or enhanced efficacy is not defined in the Act, but the Supreme Court of India has now provided guidance in deriving the meaning of the term 'enhanced efficacy', in Novartis Vs. Union of India & Ors (2013) Case No. 2706-2716. The Court clarified that the test of efficacy would depend upon the function, utility or the purpose of the product under consideration. Accordingly, for a medicine that claims to cure a disease, the test of efficacy is to be considered as "therapeutic efficacy". For a vaccine, the test of efficacy would be considered as "prophylactic efficacy".
The Court has distinguished here between the intended or desired use of the product as compared to the intended or desired use of the invention. When assessing the novelty and inventive step, the reference is made to invention. But while assessing the intended use, the reference is made to the intended use of the product and not the intended use of the invention. The implication of this difference is illustrated with the following example.
Consider a compound X which is known. A new form the compound X is developed, referred as NX. The compound X is for the treatment of disease Y. The compound X is to be administered only orally in solid dosage form, say tablets. However, the problem faced by the industry is that compound X is very hygroscopic and hence, the tablets are to be formulated in moisture-less conditions. Maintaining moisture-less conditions throughout the process of preparing and storing the active pharmaceutical ingredient (API), and then formulating into tablets until it is packaged in suitable container, adds substantially to the cost of manufacturing, leading to high price of the tablet containing the compound X, which is intended for treating disease Y. Assume that the price per tablet comes to US$ 4. To solve this problem of formulation industry, the new form NX was developed, which is sufficiently non-hygroscopic and hence, a tablet formulation containing the compound NX can be prepared under regular manufacturing conditions, which results in reduction of the price of the tablet containing the new form NX, and this is also intended for treating disease Y. The price per tablet in this case comes to only US$ 1. We assume here that the therapeutic efficacy of both the formulations is same or similar, i.e., the new form NX does not show enhanced therapeutic efficacy over the known form X.
If we apply the test as laid down by the Supreme Court, the new form NX fails under Section 3(d), as the intended use of the product NX is treatment of disease Y, but it does not have enhanced therapeutic efficacy.
If we consider the intended use of the invention, it has significant benefit, i.e., solving the problem of hygroscopicity. The intended use of the invention is to increase the manufacturing efficiency, and if the intended use of the invention is to be considered, enhanced efficacy can be shown in the manufacturing of tablet formulation. Hence, NX is not patentable under Section 3(d).
Further aspect of Section 3(d) is that, what is prohibited is the "mere discovery" of a new form. For discovery of a form, it would be assumed that such form already exists, but was not known, and now has been discovered. If it can be shown that the new form NX never existed, but has been manufactured synthetically, then would it still be falling foul of Section 3(d), in absence of enhanced therapeutic efficacy?
In the above-mentioned examination, the new form NX has failed the test of Section 3(d). I wonder if I can study more so that in the second attempt, the new form NX passes the test of Section 3(d).
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