Resolving the conflict between section 3(d) and section 3(e)

It is generally known and understood that every exception in the act should stand on its own footing. Two seemingly similar provisions in legal sense cannot lean back on one another to fortify the argument favouring the exception or otherwise. This seemingly sound argument suffers the close scrutiny of the Delhi High court in Best Agrolife Limited v Deputy Controller of Patents & Anr (WP(C)-IPD 11/2022 & CM 32/2022, 54/2022, 55/2022).[ 7 July 2022] where the Delhi High Court was drawn by the respondents (Controller and patentee ) to equate both the provisions and accept the reason given by the Controller under section 3(e ) for section 3(d ) as well. In this case, in order to justify the non-consideration of pregrant opposition under Section 3(d), respondent (Controller ) had vehemently canvassed that “the substance of Section 3(d) challenged is identical to the challenge under Section 3(e) and while Section 3(d) may not be specifically mentioned in the impugned order, relevant parameters for a Section 3(d) assessment are covered under the reasoning and conclusion rendered by Respondent No. 1 in para (iv) of the order under the heading 'Section 3(e) of The Patents Act, 1970”.

Before we dig further let us read fine prints of Section 3(d) and 3(e) of the Patents Act,

"3. What are not inventions.--The following are not inventions within the meaning of this Act,--

xxx xxx xxx

(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;

(e) a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance;"

Needless, to add that both Section 3(d) and 3(e) fall under Chapter II of the Act relating to what are not inventions within the meaning of the patents Act 1970. Whereas Section 3(d) inter alia provides that a mere discovery of a new form of a known substance which does not result in enhanced efficacy of that substance shall not be an invention. [Explanation to the Section provides that 'combinations' shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy]. Section 3(e) on the other hand provides that a substance obtained by a mere admixture resulting only in the aggregation of properties of the components thereof shall not be an invention. To be more precise legislature in its wisdom has enacted two different provisions and the tests for both are different. In the first case an assessment of 'enhanced efficacy' of the claimed composition in comparison to the efficacy of the known substance is required cross the bar imposed by this section. For the later case the assessment with a view to determine the so called synergistic effect of claimed composition with the individual properties of each component comprising the composition is to tested for clear the exception under the section.

Surprising added effect and patentability
When an examiner looks at a composition of known components, he look it with lens of section 3 (e) where a statutory bar is placed on such inventions that are “substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance”. But this restriction leaves enough room for patentability where such combination is not mere admixture. As practice if a combined action of two or more elements/integers producing an effect greater than the sum of the several effects taken separately, the invention is more likely to cross the section 3 (e) restriction. However, it remained a handy tool for Controller as well to refuse a combination product patents if the applicant fails to prove surprising added effect. In most of the patent jurisdictions the so-called synergism (added property of known integers) was not accepted as standard of patentability, yet it finds its useful application also in refusing the patents on combination patents. In light of this if we see section 3 (d), we will find that examiner looks for enhancement of known therapeutic efficacy of known substance or combination of known derivatives of known substance. But such combination of known substance /derivatives much result in properties that must differ significantly in properties with regards to efficacy. The term ‘aggregation of properties of the components’ in section 3(e) entails the presence of different components. In section 3 (d) components in the substance /derivatives combinations are considered as same substance hence the question of different components does not arise. Therefore, where the Controller argues that the relevant provision applicable for the patent application is section 3(e) and not section 3(d) in Best Agrolife case, it only point towards misinterpretation of the provisions of section 3(e) and use this provision to borrow support to allow patent for combination if synergism is proved. Delhi high court in Best Agrolife case categorically rejected the contention of both the respondents (Controller and Patentee) and went on to dig deeper into the exclusions under section 3(d) and section 3(e) and observed that

“Plain reading of the two provisions, indicates that Section 3(d) entails an assessment of 'enhanced efficacy' of the claimed composition in comparison to the efficacy of the known substance while the assessment under Section 3(e) is with a view to determine the synergistic effect of claimed composition with the individual properties of each component comprising the composition.”

To be more precise court observed that Legislature in its wisdom has enacted two different provisions and the tests for both are different. The court in this case ruled that

“once the Petitioner had raised opposition under Section 3(d) and 3(e) both, Respondent No. 1 was required to deal with the opposition, looking at the scheme of the Act and the intent of the legislature in enacting two separate provisions.”

This ruling clearly shows that there is no inherent conflict between section 3 (d) and section 3(e). This view also find support from the ruling of the Supreme Court in Novartis case wherein the court categorically stated that

“Section 3(d) is not ex majore cautela and sets up a second tier of qualifying standards in chemical substances/pharmaceutical products to encourage genuine inventions, at the same time keeping check on evergreening. Section 3(d) provides a safeguard to patentability of a new form of known substance if it does not pass the threshold of enhanced efficacy.”

Take aways

This facet of the Best Agrolife case becomes extremely significant and important for the Controller to look before ignoring the important aspects of provisions of section 3 (d). This aspect also gives credence to the view of the judgment of the Supreme Court in Novartis (supra), wherein the Supreme Court held that amendment to Section 3(d) cannot be underscored. Additionally, The Supreme Court in Novartis (supra) has observed that Section 3(d) is not ex majore cautela and sets up a second tier of qualifying standards in chemical substances/pharmaceutical products to encourage genuine inventions, at the same time keeping check on evergreening.” Section 3(d) provides a safeguard to patentability of a new form of known substance if it does not pass the threshold of enhanced efficacy. It is a caution for those inventors who believe that the easiest way to get over a section 3(d) objection is by invoking seemingly sound legal preposition that by arguing that the patent application does not attract section 3(d) in view of giving proof of synergistic combination under section 3(e) as it pertains to a combination of known substances. The courts in India may not buy such preposition and direct the Controller to deal with both provisions separately. Although in this case by shifting the focus to section 3(e), the patentee was able to shift the focus away from the applicability of section 3(d) and obtained a patent grant by overcoming the need to demonstrate enhanced therapeutic efficacy, but the court pierced through the smart approach and held that once the opponent had raised opposition under Section 3(d) and 3(e) Controller must deal with these grounds as separate provisions. Therefore, a smart strategy to draft a formulation/composition/combination claim to move the application away from the scrutiny of section 3(d) may not be very productive if it is tested in the courts. An expert opinion may help to meet this kind paradoxical situation in future. The Controller however, is duty bound to deal with the all the grounds of opposition separately. A word of caution from Controller General would be required to streamline the working of the patent office where provisions of section 3(d) and section 3(e) are used as grounds of opposition in view of the decision of Delhi high court in Best Agrolife.