By Jigyasa Pareek

Considered evaluation of expert evidence and timely disposal of patent applications are two essential pillars of the Patents Act, 1970.

With regard to the first pillar, patent law, by its very nature, is rooted in scientific and technological complexity and that is precisely why the framework of the Patents Act and the accompanying Rules facilitates the inclusion of expert evidence in examining a patent application. As has also been pointed out by the Supreme Court of India, “where the science involved is highly specialized and perhaps even esoteric, the central role of an expert cannot be disputed”. An expert affidavit, while not determinative, is often indispensable in establishing how the invention would be understood by a person skilled in the art.

A representation for a pre-grant opposition, as mandated by Rule 55 of the Patents Rules, 2003, needs to include a statement of case and evidence, if any, and the applicant, if they so desire, has to file their statement and evidence, if any, in support of their application. Section 79 of the Patents Act specifies that in any proceeding under this Act before the Controller, evidence is to be given by affidavit in the absence of directions by the Controller to the contrary.

As for the second pillar, if delays in the prosecution process, whether due to administrative lapse or misuse of the pre-grant opposition mechanism, begin to eat into the life of a patent, the very object of the patent regime stands defeated.

Both these pillars were recently addressed by the Calcutta High Court in the case of ViiV Healthcare Company & Anr. vs Dy. Controller of Patents and Designs & Ors. [IPDPTA/1/ 2025, judgment dated May 14, 2025]. The appeal challenged the refusal of patent application number 3865/ KOLNP/ 2007, directed to two novel HIV integrase inhibitors: Dolutegravir and Cabotegravir.

The impugned refusal order is nothing short of a textbook example of a grave misinterpretation by the Patent Office of a judicial order, which resulted in the patent application pending for over 17 years being rejected without even considering the expert evidence placed on record in multiple oppositions.

The subject application had attracted six pre-grant oppositions between 2013 and 2020. Extensive proceedings were conducted. Six expert affidavits were filed by the Appellant, and in one opposition, cross-examination of the Appellant’s expert witness was conducted.

In 2019, Respondent No. 6 (fifth pre-grant opponent, Natco Pharma) filed a writ petition [W.P. 7470 of 2019] before the Calcutta High Court seeking cross-examination of the Appellant’s expert witnesses. The Court directed the Patent Office to consider this request. The request was ultimately rejected by the Patent Office. Aggrieved, Natco filed a second writ petition [WP 16643 of 2024], in which the Court passed a narrowly tailored order directing the Patent Office to consider the opposition of Natco without taking into account the six affidavits filed by the experts. This concession was clearly specific and limited only to Natco’s challenge and not to any other objections which were pending before the Controller.

Yet, when the Patent Office finally passed an order rejecting the application on 3 October 2024, it did so by reading the Court’s directive to mean that none of the expert evidence across any of the six oppositions should be considered. The expert affidavits were simply disregarded without any legal basis, and contrary to both the explicit direction and spirit of the Court’s order.

The Calcutta High Court took serious note of this error and observed that the Controller’s interpretation of the said Court’s direction was “ex facie perverse, distorted and inherently flawed”. The Court clarified that the Appellant had made no blanket concession regarding the exclusion of expert evidence in other five oppositions, and, the Controller was directed to not consider the expert evidence only in relation to the opposition filed by Natco. The Court remarked that the Controller “misinterpreted and misconstrued the order” which resulted in “a complete abdication of jurisdiction”.

The Court categorically held that reliance on expert evidence “is inbuilt and is a fundamental feature in most applications for patent”, and that the expert evidence was required to be considered in other five oppositions “regardless of the evidentiary value”, as the questions of novelty, inventive step and sufficiency of disclosure were involved.

The Court further recognised, with regret, that the application had faced “exceptional and extraordinary delay,” which had “emasculated the very object of the Act.”. The Court referred to various precedent (Procter & Gamble Co. vs Controller of Patents [2023 SCC OnLine Del 7832], R.C. Sharma vs Union of India [1976 (3) SCC 574], and BASF SE vs Joint Controller of Patents and Designs & Ors. [IPDPTA 5 OF 2024]) to reiterate that such delays are unacceptable, and that patent applications must be disposed of within a reasonable timeframe.

Accordingly, the Court allowed the appeal, set aside the impugned order, and issued specific directions to the Patent Office to consider all expert affidavits and evidence filed in opposition proceedings (except Natco’s).

While the Court’s intervention was both necessary and principled, it does not undo the irreversible damage caused by this prolonged and erroneous prosecution. No Court in India has, till date, restored a lost patent term, no matter how long the delay or how stark the institutional failure. The applicant alone bears the burden of such loss. Unless institutional actions evolve to match the Act’s object and intent of judicial pronouncements, applicants will continue to bear the brunt of systemic inefficiencies. But there is hope to be drawn from this judgment. When Courts express regret and call out abdication of jurisdiction, it sends a strong message and serves as a serious wake up call to the Patent Office.