The New Patent Playbook in Action: A Look at Rules 25(1) and 55(3) of the Patent (Amendment) Rules 2024 for Pre-Grant Oppositions

Recently, an interesting order was issued in Patent Application No. 202417006578 (pdf), by Vikas Verma, Assistant Controller of Patents & Designs, Patent Office (Chennai), in the context of a pre-grant opposition (PGO) against an application by Pharmazz Inc. What makes this decision particularly noteworthy is that it may be the first instance (at least as per the guess in a LinkedIn post by LCGN LLP here) where a new rule for PGO has been applied. Specifically, it concerns the requirement to establish a prima facie case (para 5 of the Order) before issuing a notice in a PGO. Apart from that, this order also warrants a deeper analysis for more substantive reasons: the prima facie analysis before acceptance of a PGO application, and the sustainability of the amendments diluting Section 8 requirement. Before delving into the factors that merit this decision more attention, a look at pre-grant opposition (PGO) hearings and the impact of the 2024 patent amendments on this provision.

Hear Ye, Hear Ye: PGO Hearings and Their Importance in the Indian Patent Regime

Under Section 25(1) of the Patents Act, 1970, any person can oppose a patent application after its publication but before its grant. Before the Patents (Amendment) Rules, 2024, PGO hearings under Rule 55 were limited to the representation itself, as clarified by the Delhi High Court in Novartis AG v. Natco Pharma Ltd. & Anr. (2024) by interpreting sub-rules (3), (4), and (5). The Court noted that the hearing process is triggered when the Controller, after considering the representation, believes the “representation raises questions worthy of consideration.”A similar observation was made in M/S Ucb Farchim Sa vs M/S Cipla Ltd. back in 2010. The Patents (Amendment) Rules, 2024 has now introduced additional qualifying criteria for the Controller to assess before admitting a PGO application.

Key Changes Introduced by the Patent Amendment Act, 2024: Revolutionary or Mere Paper Tigers?

On 15 March 2024, the Indian Patent Office introduced a set of procedural updates. The one that stands out for us in this context is the revision to PGO mechanisms under Section 25(1) of the Patents Act. Now, when a PGO is filed, the Controller must first assess whether the opponent has established a prima facie case. If a prima facie case is found, the process advances, with the patentee being formally notified to respond. However, if not, a notice of rejection is issued under Rule 55(3), and unless the opponent requests a hearing, the opposition is dismissed outright. While this effectively changes the opposition process by reducing the likelihood of drawn-out disputes over weak or unsubstantiated oppositions, it equally means that opponents face a heavier procedural burden. They will now need to present stronger initial evidence while also paying the newly introduced fees for PGO filings. Similar concerns were raised by Swaraj and Praharsh in their insights on the Patent (Amendment) Rules, 2024 (here).

The post highlights that despite concerns about the “cumbersome” opposition system, concrete data on its impact is scarce. Over the past three years, fewer than 200 post-grant oppositions have been filed annually against more than 60,000 granted patents, with at least 10% of these oppositions being substantial. This raises the question of whether the PGO process is truly a bottleneck or a scapegoat for deeper inefficiencies. Moreover, questions regarding the quantity and quality of patent examiners, as well as the training and resources available to them, also need to be considered, as procedural changes alone will not resolve the systemic problems in India’s patent system. 

The New Provisions in Action: Some Areas to Ponder Upon

The 7-page order was issued in Application No. 202417006578 which sought a patent for “lyophilized sovateltidebased injectable formulation and a process for preparation.” The PGO was raised based on four prior art documents. It was done citing lack of novelty, lack of inventive step, non-patentability under Sections 3(d) and 3(e), insufficient description of the invention or method, and non-disclosure under Section 8. These grounds were argued/ explained as follows:

Firstly, under Section 25(1)(b), the Opponent claimed that prior art disclosed injectable formulations of Sovateltide, rendering it non-novel. Secondly, under Section 25(1)(e), the injectable formulations were claimed to be obvious by the Opponent as they fall within standard pharmaceutical knowledge. Thirdly, under Sections 3(d) & 3(e), the opponent argued that the applicant failed to demonstrate enhanced therapeutic efficacy, and the claimed compositions were merely an admixture with no unexpected effect. Fourthly, under Section 25(1)(g), the claims were argued to be unclear and ambiguous. Lastly, under Section 25(1)(h), the opponent claimed non-disclosure of required information under Section 8. The Controller, in para 4, stated that while the opponent’s opinion is not conclusive, a prima facie case was accepted based on cited prior art.

This order is interesting for two key reasons. Let’s break them down one by one. 

Firstly, the IPO maintained a rigorous standard, even in what could have been seen as a “for show” hearing. The LinkedIn post mentions that the questions were “direct,” “tough,” and required “extensive preparation” of the case. It’s definitely reassuring that the IPO is upholding high standards, and this is a positive reflection of their commitment to their responsibilities. However, at the end of the day, it must also be noted that this is what is expected of them as essentially a part of their role. Moreover, on a separate note, the LinkedIn post also raised concern about the fact that the Controllers have the authority to treat a hearing as a ‘for show’ event. This is something that does raise concerns about the overall transparency and effectiveness of the process. However, the rules do explicitly provide that the authority must issue a speaking order under Rule 55(5) after conducting a hearing (image). This seems likely to act as a sufficient check on the nature of these hearings.

Secondly, the LinkedIn post highlights how this situation suggests that some of the new rules could be workable, but some changes are of genuine concern. As also highlighted by Swaraj and Praharsh (here), it is the revisions to Section 8 (Information and undertaking regarding foreign applications) requirements and the working statement obligations. The dilution of Section 8 requirements, in particular, has raised concerns. This is because IPO examiners can benefit from easily accessible information from major jurisdictions like the USPTO and EPO. These platforms provide details on patent status, prior art references, and applicants’ responses, all of which can aid in the examination process. It is sensible for the IPO to maintain some oversight over information sharing concerning parallel foreign patent applications while encouraging examiners to directly access freely available resources from other major patent offices whenever feasible. Interestingly, failure to provide the required information, or submitting false information under Section 8 (Form 3), can still be grounds for opposition. Guest bloggers Prathibha and Sreenath (here) had demonstrated concern about how diluted Section 8 requirements, when coupled with its continuing status as a ground for opposition, can severely stunt transparency in the Indian Patent system.

Evidently, as the Linkedin Post also astutely points out, the changes in the Rules 2024 are heavily tilted in favour of patentees, and it’s unfortunate that, despite the significant discussions on these provisions by both academicians and practitioners, there hasn’t been much serious effort put into challenging them. Moreover, it is also clear that these provisions, in action now, will likely fall short of addressing the procedural inefficiencies that continue to hinder the Indian patent process.