What happens when patent oppositions are filed, heard, but never decided? Highlighting the specific instances of prolonged delays at the Patent Office, Prathibha Sivasubramanian explains how administrative inaction is undermining a critical safeguard in patent law and how such delays can quietly enable monopolies and impact access to essential medicines. Prathibha Sivasubramanian is a Senior Researcher working with TWN. She has over a decade of experience in access to medicines, patents, and intellectual property. She has worked extensively on patent oppositions and has been involved in patent challenges for key drugs, including the Gleevec-Novartis case. Views expressed here are those of the author alone.
Delay Enables Monopoly: How Inaction in the Opposition Proceedings at the Patent Office Undermines Access to Medicines
By Prathibha Sivasubramanian
What happens when an opposition to a patent application is filed, heard, and then… nothing happens?
Under the Indian patent framework, opposition proceedings serve as a critical safeguard to weed out unworthy and undeserving patents. Recently, more and more, the problem is not that poor-quality patents are being granted, but that oppositions are not decided at all. Delays in completing opposition proceedings and reaching a final conclusion often extend the prescribed statutory timelines. Still, opposition systems bear the brunt of the lag in patent grant, rather than administrative inaction.
In a recent letter (pdf) to the Department for Promotion of Industry and Internal Trade (DPIIT), Third World Network (TWN) highlights a troubling pattern: systemic delays and non-action in opposition proceedings at the Indian Patent Office, despite hearings having been concluded. Based on a review of proceedings in eleven oppositions filed by civil society organisations and patient groups, the letter reveals multiple instances of non-compliance with the Patents Act, 1970, and the Patents Rules, 2003.
The findings are hard to ignore.
- In about four pre-grant opposition matters, no orders have been issued despite the conclusion of hearings.
- In four cases, no notice of opposition has been issued, and no hearings have been scheduled, despite repeated requests
- Similarly, in post-grant opposition proceedings, Opposition Boards have not been constituted—despite this being a statutory requirement and despite the completion of pleadings by the parties.
What is striking here is not the low number of oppositions analysed, but their underlying subject matter — they concern critical life-saving drugs. These delays have serious health implications. Hence, the findings are not merely procedural lapses—they indicate to a systemic breakdown in the functioning of the opposition mechanism.
Setting the Legal Benchmark
To grasp the seriousness of these delays, it is imperative to briefly examine the relevant provisions of law. A review of the provisions of the Patents Act, 1970, and the Patents Rules, 2003, relating to oppositions reveals clear timelines for conducting and concluding pre-grant opposition proceedings; however, there are significant gaps in the timelines for post-grant proceedings.
In case of pre-grant oppositions, section 25(1) of the Patents Act, 2005, provides for filing a pre-grant opposition. Once the opposition is filed, the rules prescribe the procedure to be followed. According to Rule 55(3), after prima facie satisfaction, the Controller must forward the Opposition to the Applicant within one month of receiving it. The Applicant, within two months from the date of receiving notice of the Opposition, may file a reply and evidence, along with a copy to the Opponent.
Rule 55(5) states that once the pleadings are completed, the Controller may review the opposition, the applicant’s reply, and the evidence and submissions made by both parties. After hearing both sides, the Controller may either reject the opposition and grant the patent, with or without amendments to the complete specification and other documents, or refuse to grant the patent. The Controller must issue a reasoned order within one month of the completion of the opposition proceedings. It may be noted that the result of the opposition proceedings is either a grant or a rejection of the patent applicant. The law does not allow the opposition to be decided while the application is pending before the IPO. This reflects a clear legislative intent that such challenges—particularly those concerning pharmaceutical patents—be resolved expeditiously.
For post-grant oppositions, Section 25(4) read with Rule 56 requires the constitution of an Opposition Board to examine the matter and submit its recommendations before a final decision is taken. However, unlike pre-grant oppositions, the law does not prescribe clear timelines for crucial stages, such as a timeline to constitute the Opposition Board, scheduling hearings, or issuing orders.
This procedural lacuna has significant implications and far-reaching consequences. In reality, a lack of well-defined timelines will cause post-grant opposition proceedings to drag on indefinitely, with no meaningful progress or resolution. The result is that even potentially unworthy patents continue to enjoy de facto exclusivity, while challenges to their validity remain undecided.
These procedural steps are more than just formalities. They are important safeguards in the patent system that help make sure only deserving patents are granted or maintained. Even when timelines are not clearly set, there is always a duty to act within a reasonable time, especially in processes that affect public health and access to medicines.
If these safeguards are not properly followed, the patent system’s goal of balancing private rights with the public interest is seriously weakened.
What is Actually Happening?
The impact of these delays is even more starkly illustrated by specific cases. Take, for instance, Lumacaftor—a life-saving drug used in the treatment of cystic fibrosis. As noted in the letter, despite the conclusion of the hearings way back in April 2022, no order has been issued to date. This is not a minor procedural lapse, but a delay extending over years in a matter directly affecting access to essential treatment.
The letter says, “This delay constitutes a clear violation of Rule 55 (5) of the Patents Rules, which mandates that decisions in pregrant oppositions be issued ordinarily within one month from the conclusion of proceedings in pregrant opposition.”
Table 1: Oppositions in which hearings have been concluded but orders have not been issued.
| Sl.No. | Drug Name | Nature of Opposition | Application No. | Date of conclusion of hearing |
| 1. | Remdesivir | Post-grant | IN 201727012821 [IN332280] | 7/10/2024 |
| 2. | Molnupiravir | Pre-grant | IN201717025098 | November-December, 2024 |
| 3. | Lumacaftor | Pre-grant | 3158/KOLNP/2012 | 19/04/2022 |
| 4. | TBI-223 | Pre-grant | IN201817004931 | 17/02/2025 |
Similar concerns arise in other cases where the process has not even reached the hearing. In opposition proceedings relating to drugs such as Lenacapavir, AT527 (Bemnifosbuvir), and Glecaprevir/Pibrentasvir, no notice of opposition has been issued, and no hearings have been scheduled, even when the application is in the examination stage. In effect, there is a chilling effect on these oppositions at the threshold stage, with no progress or procedural movement.
Even in high-profile cases such as Remdesivir and Molnupiravir—drugs that gained global prominence during the COVID-19 pandemic—oppositions remain undecided despite hearings having been concluded. These examples collectively illustrate that the issue is not confined to a particular drug or procedure but reflects a broader and systemic pattern.
What emerges is not merely delay, but a pattern of administrative inaction at multiple stages of the opposition process. Requests for early hearings, issuance of notices, and post-hearing orders have reportedly gone unanswered.
Table 2: Oppositions – where early hearing/ issuance of notice requests have been filed
| Sl.No. | Drug Name | Application No. |
| 1. | Lenacapavir | IN202018020805 |
| 2. | Molnupiravir | IN202017019418 |
| 3. | Glecaprevir + Pibrentasvir | IN201817002543 |
Illustrating the delay in the conclusion of post-grant opposition, the letter says that, “…. post-grant opposition matters such as those concerning Cabotegravir, Baricitinib, and Ledipasvir in which Opposition Boards have not been constituted (Table 3). This is in clear conflict with Section 25(4) and Rule 56 of the Patents Act and Rules, which requires timely constitution of Opposition Boards in post-grant opposition proceedings. These provisions are not optional—they are binding statutory obligations designed to protect the public interest.:
Table 3: Post-Grant Oppositions – where requests to constitute opposition board to conduct hearing have been filed
| Sl.No. | Drug Name | Application No. |
| 1. | Baricitinib | 5348/DELNP/2014 |
| 2. | Remdesivir | 1328/CHENP/2013 |
This has far-reaching consequences. Opposition proceedings, which are intended to function as a timely check on patent validity, are instead rendered ineffective. The system continues to move—applications proceed, rights accrue—but the opposition itself remains suspended, without closure or clarity.
In effect, the question is no longer whether opposition proceedings delay patents, but whether delays in deciding oppositions are allowing patents to operate without scrutiny.
Why This Is Not Just Procedural — It’s Substantive
These delays are often framed as procedural inefficiencies. In reality, their consequences are far more substantive.
When an opposition remains undecided, the patent application remains pending. This uncertainty has a chilling effect on generic manufacturers. They are deterred from entering the market, and investment decisions are postponed. As the delay increases, the incentive for generic manufacturers to bring the drug to the market also diminishes. The result is a form of de facto exclusivity, even in the absence of a granted patent.
As the representation rightly points out, such delays have direct implications for access to medicines. The right to life under Article 21 has been interpreted to include the right to health and access to affordable treatment. Delays in deciding oppositions, therefore, do not merely defer legal outcomes—they delay access to life-saving medicines and impact public procurement and healthcare delivery.
Irony: 2024 Patent Rule Reforms vs Ground Reality
The situation is made more striking by recent reforms to the opposition framework in Patent Rules (Amendment), 2024. The amendments, which were justified on the ground that opposition proceedings were delaying patent grants.
The ground reality suggests otherwise. The issue is not that oppositions are delaying the system—it is that they are not being decided at all.
The problem, it appears, was never opposition. It was the administration.
The consequences of such inaction are far-reaching. The patent opposition, including those filed by patients and civil society organisations, which were often portrayed as a cause of delays in patent grants, was merely a convenient scapegoat. In practice, the actual problems lie with the IPO administration. It undermines the Patent Office’s credibility, weakens the effectiveness of the opposition mechanism, and creates an environment where strategic patenting and evergreening can flourish unchecked.
More importantly, it directly impacts access to medicines for critical conditions, including HIV, hepatitis, TB and COVID-19—areas where timely generic entry is essential for public health.
Conclusion
The concerns raised in the representation are not abstract—they point to clear implementation gaps. Addressing them does not require new reforms; it requires effective enforcement of existing law. At the same time, it is necessary to ensure that post-grant opposition proceedings are conducted within defined timelines so that they do not become redundant in practice.
This includes issuing orders in matters where hearings have already concluded, ensuring the timely constitution of Opposition Boards, fixing accountability for delays, and establishing mechanisms to monitor compliance with statutory timelines.
These are not ambitious reforms—they are basic administrative obligations. A patent system that cannot decide opposition risks becoming a system that silently enables monopolies. What is the value of an opposition right if it is never decided? In patent law, delay is not neutral—it determines who gets access to medicines, and who does not.