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India’s pre-grant opposition mechanism under Section 25(1) of the Patents Act, 1970 remains one of the most debated features of the country’s pharmaceutical patent regime. Introduced in its modern form after the 2005 TRIPS-compliant amendments, the provision permits “any person” to oppose a patent application after publication but before grant. While the framework was designed to prevent weak patents and evergreening, multinational pharmaceutical companies increasingly argue that the mechanism is susceptible to strategic abuse through repetitive and proxy oppositions, leading to prolonged uncertainty and delayed patent grants.
The debate has intensified following recent proceedings involving AbbVie’s pharmaceutical patent applications, particularly those relating to Upadacitinib (Rinvoq) and Venetoclax, which have reignited concerns regarding the balance between public-health safeguards and patent certainty.
Statutory framework
Section 25(1) allows pre-grant opposition on several grounds, including lack of novelty, inventive step, wrongful obtaining, insufficiency of disclosure, prior publication, and non-patentability under Section 3 of the Act, including Section 3(d).
Unlike post-grant opposition under Section 25(2), which is limited to a “person interested,” the pre-grant mechanism imposes no requirement of locus standi. This broad formulation was intentionally adopted to encourage public participation in patent examination, especially in sectors affecting public health and access to medicines.
The opposition process is governed by Rule 55 of the Patents Rules, 2003, under which the Controller considers the representation, hears the parties where necessary, and decides whether the patent should proceed to grant, be amended, or be refused.
Importance in pharma patent protection
India’s opposition system gained international prominence following the rejection of Novartis AG’s patent application concerning the beta crystalline form of Imatinib Mesylate. The decision became symbolic of India’s approach toward preventing “evergreening” and preserving access to affordable medicines.
Public-health groups and generic manufacturers argue that pre-grant oppositions serve as an essential filter against unjustified pharmaceutical monopolies. Courts have also acknowledged that oppositions may assist the Patent Office by bringing technical prior art and scientific evidence to the Controller’s attention, thereby improving patent quality.
However, innovator pharmaceutical companies contend that the mechanism is increasingly being used as a strategic commercial tool rather than solely in public interest.
AbbVie’s Venetoclax patent refusal and concerns over serial oppositions
The debate surrounding pharmaceutical patentability was further highlighted by the Indian Patent Office’s refusal of AbbVie Ireland Unlimited Company’s Patent Application No. 8004/DELNP/2011 relating to Venetoclax, a BCL-2 inhibitor used in cancer treatment.
On 31 December 2025, the Patent Office rejected the application after it faced seven pre-grant oppositions. The Controller concluded that the claimed invention lacked novelty and inventive step and was anticipated by the applicant’s own earlier patents. The application was viewed as an attempt at “evergreening” existing patent protection.
The Patent Office also held that the invention failed to satisfy Section 3(d) because the application did not establish enhanced therapeutic efficacy over known substances. In addition, the specification was found insufficient for failing to enable a skilled person to perform the invention without undue experimentation.
The decision reflects the rigorous standards applied by Indian authorities in pharmaceutical patent examination, particularly regarding inventive step, sufficiency of disclosure, and the anti-evergreening principles embodied in Section 3(d).
AbbVie’s Upadacitinib matter: The issue recently came into focus in proceedings before the Delhi High Court concerning AbbVie’s Indian patent application for Upadacitinib (Rinvoq API). The application reportedly faced a couple of pre-grant oppositions, leading to prolonged delays in prosecution.
In its order, the Delhi High Court directed the Patent Office to conclude all hearings and pass a consolidated order on the pending oppositions by 30 April 2026. The Court observed that the application had remained pending since 2012 and emphasized that such indefinite pendency could not continue endlessly.
The Court acknowledged the broader concern that repeated or cyclic pre-grant oppositions could derail the patent examination process and frustrate the legislative objective of timely patent adjudication. Importantly, while recognizing the statutory right of “any person” to file a pre-grant opposition, the Court also stressed the need to prevent procedural abuse causing endless delays.
The order is significant for the pharmaceutical industry because prolonged opposition proceedings not only delay patent certainty for innovator companies but also create uncertainty for generic manufacturers awaiting clarity regarding market entry.
Strategic use of pre-grant opposition
Multinational pharma companies argue that pre-grant oppositions are increasingly deployed strategically by generic competitors to delay patent grants and postpone enforcement rights. In many pharmaceutical matters, multiple oppositions are filed successively by different parties, significantly extending prosecution timelines.
Concerns have also emerged regarding “strawman” or “benami” oppositions, where individuals or entities allegedly file oppositions on behalf of undisclosed commercial interests. Such practices are criticized for creating procedural hurdles while concealing the identity of the real party in interest.
Indian courts have recently shown growing awareness of these concerns. In Novartis AG vs Natco Pharma Ltd, the Delhi High Court observed that repeated objections and hearings should not be permitted to “delay and derail” patent examination indefinitely. The Court clarified that patent examination proceedings and opposition proceedings are separate statutory processes and that opponents do not possess unrestricted rights to intervene at every stage of prosecution.
Similarly, in AIC246 AG & Co. KG, the Bombay High Court reiterated that examination proceedings under Chapter IV and opposition proceedings under Chapter V operate independently. The Court emphasized that applicant-centric examination hearings cannot be substituted or overridden by opposition proceedings.
Key judicial precedents
Several judicial decisions have shaped the interpretation of India’s opposition framework:
J. Mitra & Co Pvt Ltd vs Assistant Controller of Patents & Designs (Supreme Court): Clarified the distinction between pre-grant and post-grant opposition proceedings and the statutory remedies available under the Patents Act.
Dr. Snehlata C. Gupte vs Union of India (Delhi High Court): Emphasized adherence to the procedural requirements and timelines governing pre-grant opposition proceedings.
Mylan Laboratories Ltd vs Union of India (Delhi High Court): Reinforced the requirement for reasoned and speaking orders in matters involving pre-grant opposition.
Novartis AG vs Natco Pharma Ltd (Delhi High Court): Clarified that patent examination and pre-grant opposition are independent processes and limited the participatory role of pre-grant opponents to prevent undue delays.
Balancing public interest and patent certainty
The continuing debate surrounding pre-grant opposition reflects the broader tension between two competing objectives of India’s patent system: safeguarding public health through strict patent scrutiny and ensuring certainty and efficiency for genuine innovators.
Supporters of the current framework argue that India’s opposition system has been instrumental in preventing weak pharmaceutical patents and maintaining affordable access to medicines. Innovator companies, however, maintain that excessive delays and procedural uncertainty may discourage research-driven investment and undermine India’s attractiveness as a destination for pharmaceutical innovation.
Possible reforms suggested by stakeholders include stricter scrutiny of repetitive oppositions, disclosure of real parties in interest, imposition of costs for abusive conduct, and strict timelines for disposal of opposition proceedings.
Conclusion
A few critics opine that India’s pre-grant opposition framework remains a cornerstone of the country’s pharmaceutical patent regime, promoting patent quality and safeguarding public access to affordable medicines. However, recent disputes involving AbbVie’s Upadacitinib and Venetoclax patent applications have raised concerns about repetitive, strategic, and allegedly proxy oppositions that can significantly delay patent prosecution. Indian courts have increasingly sought to balance the right to public participation under Section 25(1) of the Patents Act with the need to prevent procedural abuse. The long-term effectiveness of the system will depend on preserving its public-interest function while ensuring timely and predictable patent prosecution.
(Author is IP Attorney, CLG, New Delhi)
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