On the CHC’s judgment clarifying the difference between the statutory filters under Sections 3(d) and 3(e), Srishti Gaur breaks down the Court’s findings and explains how this is not the first time that courts have faced confusion between the two provisions. Srishti is a third-year student at National Law University, Delhi. Her previous posts can be accessed here.
The 3(E)-3(D) Fumble: When Synergy Gets Lost in Application
By Srishti Gaur
Sections 3(d) and 3(e) of the Patents Act, 1970 (henceforth “Act”) are akin to statutory filters which aim to put a block on frivolous inventions from entering the patent system and ensure that genuine inventions get rewarded. But both of them have two different standards of inquiry to the goal – while Section 3(d) bars patenting new forms of substances unless they demonstrate enhancement of known efficacy, Section 3(e) can exclude admixtures unless they exhibit synergistic effect (the two tests will be explained further). However, in practice, these tests are repeatedly conflated since examiners and applicants often mistakenly apply the inquiry of one section to the other (see this, paras 42-46).
The Calcutta High Court (“CHC”) in Oramed Ltd. v Controller General of Patents and Designs and Another had the occasion to clear the air on this confusion between the applicability of Sections 3(d) and 3(e) of the Act. The Deputy Controller had rejected the patent application by invoking the test of therapeutic efficacy of Section 3(d) while applying Section 3(e). The Court rightly set aside the order and reaffirmed the distinction between the two provisions.
The blog post seeks to examine the judgement delivered by the CHC with particular emphasis on its interpretation of the differences between Sections 3(e) and 3(d) of the Act and focus on the missteps by the Patent Office on erroneously treating the two tests as interchangeable.
What is the Difference Between the Two?
Section 3 of the Act denies patent protection to an invention or discovery that falls within the different scenarios enumerated under the section. Section 3(e) of the Act is for a substance that is formed by merely mixing two substances, and the effect of the resulting substance is a mere aggregation of the two. In other words, if the resultant is merely a sum of its parts and does not exhibit any synergistic effect i.e. any improvement, it would not be considered an “invention” under the Act and will be unpatentable. Interestingly, the provision, unlike Section 3(d), 3(f), and 3(p) of the Act, does not require the ingredients to be known, only the effect matters (read more here).
An example for Section 3(e) can be found mentioned in the Guidelines for Examination of Patent Applications – the composition of paracetamol and ibuprofen helps in controlling pain and inflammation but they are not patentable. This is so both the drugs are known for those effects, and their combination does not result in any improvement and therefore, falls under Section 3(e) bar. All it requires to overcome the Section 3(e) test is that the composition should be more than an additive effect and have an enhancement over the individual features of the aggregation. This is done to prevent the practice of evergreening where inventors make minor changes to existing substances to extend their patent monopoly on one invention.
On the other hand, Section 3(d) of the Act excludes those form(s) of an already known substance which does not add to the existing efficacy of the substance from patent protection. Additionally, even the discovery of a new property or a new use of a known substance does not count as an invention. The difference between the original substance and its derivative should be substantial, as mentioned in the Explanation to the provision. The onus is to prove an increase in therapeutic efficacy and not merely an improved bioavailability since the latter reflects the absorption of the drug into the bloodstream and does not necessarily translate into better outcomes. The Madras High Court in Novozymes v Assistant Controller of Patents & Designs underscored that this Section incorporates a legal fiction that derivatives of a known substance are bound to be considered as the same substance until its therapeutic efficacy is proven.
What was the Case All About and How Did the Court Respond to it?
The present judgment was an appeal that arose under Section 117A of the Act against an earlier order, refusing the patent application, passed on 5 June 2020. The patent application was regarding an oral pharmaceutical composition aimed at providing an alternative route for the administration of insulin, which presently is administered dominantly through injection. To advance the presently available mechanism, the invention under consideration combined the use of two protease inhibitors – Aprotinin and Soy Bean Trypsin Inhibitor (SBTI). It sought to retain the beneficial properties of the composition, preventing breakdown of insulin, after its oral administration.
The appeal was invoked on two grounds: first, the appellant referred to a combination of prior arts, D1 to D4, in establishing a lack of inventive steps, despite which the Deputy Controller relied on only documents D1 and D4 without giving any notice or opportunity to the appellant. Second was related to the misinterpretation of Sec 3(e) of the Act for which the Deputy Controller applied the principles of Section 3(d) of the Act. The blog post will focus on the second ground.
The Court firstly, settled that the requirement of establishing therapeutic efficacy is for the purpose of Section 3(d) and not for Section 3(e). The hearing notice was under the latter but the Deputy Controller’s order relied on the application of Section 3(d). The CHC highlighted the error, noting that the Deputy Controller had imported Section 3(d) test into a Section 3(e) inquiry.
The 2019 Manual for Patent Office Practice and Procedure clearly states that for those inventions which are relying on a synergistic effect, the difference between the constituents and the resultant should be brought out in the description of the application itself at the time of filing the application. The difference between the constituents and the products needs to be explained through data analysis. While the Manual is not authoritative, Rule 13(7) of the Patent Rules, 2003 read with Section 10(4) of the Act, suggests that a complete specification must fully describe the particular invention. In case synergy is claimed, the applicant must demonstrate the same in their submission. In the case under discussion, the appellant had submitted such materials to the Deputy Controller, who overlooked them during the inspection (para 12).
The CHC clarified that for Section 3(e) to apply, admixture of two or more substances should result in an additive effect to the inherent properties of each of the substances. It held that the Deputy Controller erred in its findings as it failed to consider the description of the invention along with its specification and set aside the impugned order and directed it for fresh consideration.
Not the Only One!
The said confusion is a regular occurrence in the patent cases where one is confused for the other and the two tests are often merged into one. This primarily happens because in practice, these two provisions overlap but they should not be applied interchangeably.
In Best Agrolife v Deputy Controller of Patents, the appellant argued that the Controller ignored the enhanced efficacy test of Section 3(d) and only relied on the synergy test of Section 3(e). The Court ruled that both provisions lay down separate inquiries. For the former, enhanced efficacy is required, while for the latter, a synergistic effect is to be established over mere admixture. It further held that both tests may apply to the same composition but in different ways and cannot be a substitute for one another. One of the other reasons for the conflation, as noted in this article, is that Section 3(d) has a higher standard than Section 3(e). The higher threshold incentivizes companies to frame their inventions as compositions rather than as a derivative of a known substance to evade the requirement of therapeutic efficacy.
Misapplication of the two tests could be due to a multitude of reasons, but it vitiates the filter that the Indian patent regime attempts to create. The judgment thus acts as an apt reminder that both the provisions act in distinct spheres and cannot be collapsed into one another.