Understanding Pre-Grant Opposition in Patent Applications

Imagine a situation where a pharmaceutical company applies for a patent on a drug formulation that has, in fact, been publicly known for years – perhaps even documented in ancient texts or previously published research. Without any mechanism for the public to step in and flag this, that patent could sail through the system and grant the company a 20-year monopoly over something it never truly invented. This is precisely the problem that pre-grant opposition is designed to prevent. Under Section 25(1) of the Patents Act, 1970, Indian patent law gives any person the right to challenge a patent application before the patent is even granted – acting as a critical quality-check in the system.

What is pre-grant opposition? 🔗

Pre-grant opposition is a legal proceeding that allows any person to file a representation against the grant of a patent after the patent application has been published but before the patent is officially granted. Unlike post-grant opposition under Section 25(2) – which can only be initiated by a “person interested” – pre-grant opposition under Section 25(1) is open to any person, regardless of whether they have a direct stake in the matter. This makes India’s pre-grant opposition framework notably more inclusive than those found in most other jurisdictions, including Europe and the United States, where such an open-standing mechanism does not exist.

The underlying purpose is straightforward: rather than waiting for a flawed patent to be granted and then spending years fighting it in litigation or revocation proceedings, pre-grant opposition provides an early intervention point. If the opposition succeeds, the patent is refused at the gate itself. If it fails, the Controller proceeds with the grant.

The legal framework: Section 25(1) and its 2005 amendments 🔗

The current pre-grant opposition framework was substantially shaped by the Patents (Amendment) Act, 2005, which aligned India’s patent law with the requirements of the TRIPS Agreement. Before this amendment, only “persons interested” could oppose a patent before grant. The 2005 change widened this to “any person,” significantly democratising the process. The intent, as interpreted by courts, was not to create an individual right as such, but to enable members of the public to assist the Patent Office in making the correct decision.

The procedural rules for pre-grant opposition are primarily found under Rule 55 of the Patents Rules, 2003, as amended. A significant procedural update came through the Patent (Amendment) Rules, 2024, which introduced a prima facie screening requirement. Now, when a pre-grant opposition representation is filed, the Controller must first assess whether the opponent has established a prima facie case before formally notifying the patent applicant. If no prima facie case is found, the opposition can be dismissed outright under Rule 55(3), without the applicant being burdened by the proceedings at all. This was a significant shift – aimed at reducing drawn-out disputes over weak or unsubstantiated oppositions, though it also places a heavier initial burden on opponents.

When can a pre-grant opposition be filed? 🔗

The window for filing a pre-grant opposition opens as soon as the patent application is published and remains open until the patent is granted. Under Section 11A of the Patents Act, every patent application is ordinarily published 18 months from the date of filing or the priority date, whichever is earlier. The application can also be published earlier if the applicant makes a request for early publication.

Importantly, the representation is considered by the Controller only after a request for examination of the patent application has been filed. This is a crucial procedural condition – filing a pre-grant opposition before examination has been requested will not immediately trigger any action from the Controller. In practice, it is advisable to file the representation as early as possible after publication to ensure it receives consideration before the application proceeds to grant.

Grounds for pre-grant opposition under Section 25(1) 🔗

Section 25(1) lists eleven specific grounds – labelled (a) to (k) – on which a pre-grant opposition can be filed. No ground outside this list can be raised. These grounds are:

(a) Wrongful obtaining: The invention, or any part of it, was obtained from the opponent or any person from whom they derive title.

(b) Prior publication: The invention was anticipated by prior publication anywhere in the world before the priority date of the claim.

(c) Prior claiming: The invention is already claimed in a patent granted in India with an earlier priority date.

(d) Prior public knowledge or use in India: The invention was publicly known or publicly used in India before the priority date. An invention relating to a process is treated as publicly known if a product made by that process had already been imported into India before that date (except for reasonable trial or experiment).

(e) Obviousness / lack of inventive step: The invention is obvious and does not involve any inventive step when compared to what was publicly known before the priority date.

(f) Non-patentable subject matter: The claimed invention falls within the categories listed under Section 3 or Section 4 of the Patents Act – for instance, business methods, mathematical formulas, mere discoveries of natural phenomena, or inventions contrary to public order.

(g) Insufficiency of description: The complete specification does not sufficiently and clearly describe the invention or the method by which it is to be performed, so as to enable a person skilled in the art to work the invention.

(h) Failure to disclose or false disclosure under Section 8: The applicant has failed to disclose information regarding corresponding foreign patent applications as required under Section 8, or has furnished false information.

(i) Convention application not filed within time: In the case of a convention application, the application in India was not filed within 12 months of the first filing in a convention country.

(j) Non-disclosure or wrongful disclosure of biological material: The application involves biological material whose source or geographical origin has not been disclosed or has been disclosed incorrectly. This ground is particularly relevant in the context of India’s biodiversity and traditional knowledge.

(k) Anticipation by traditional knowledge: The invention is anticipated by knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere.

Procedure for filing a pre-grant opposition 🔗

Step 1: Filing the representation 🔗

The opponent must file a written representation at the same Patent Office branch where the original patent application was filed. The representation must clearly state the facts and the grounds of opposition being relied upon, drawn from the list under Section 25(1). It must be accompanied by supporting evidence – such as prior art documents, published research, or other material – that substantiates the claims made in the representation.

Step 2: Prima facie assessment by the Controller 🔗

Once the representation is received (and after examination has been requested), the Controller conducts a prima facie assessment. Under the 2024 amended rules, if the Controller finds that the opponent has not established a prima facie case, a notice of rejection is issued under Rule 55(3) and the opposition is dismissed – unless the opponent requests a hearing.

Step 3: Notice to the applicant 🔗

If the Controller finds merit in the representation (i.e., a prima facie case is established), the patent applicant is formally notified. The applicant is then given an opportunity to file their own statement and evidence in response, typically within three months of the notice. A copy of this statement is sent to the opponent.

Step 4: Hearing 🔗

If either party requests a hearing, the Controller may schedule one. Both sides get an opportunity to present their arguments. The Controller is expected to decide the pre-grant opposition concurrently with the patent application itself – either refusing the application, requiring amendments, or proceeding to grant. A reasoned order must be issued within one month as per Rule 55 of the Patents Rules, 2003.

What happens after the Controller’s decision? 🔗

The outcome of a pre-grant opposition can go one of two ways. Either the opposition succeeds and the patent application is refused, or the opposition is rejected and the patent proceeds to grant. The question of appeals, however, is legally complex.

Section 117A(1) of the Patents Act explicitly excludes Section 25(1) from the list of provisions against which an appeal lies before the High Court. This means there is no direct statutory right of appeal for an opponent whose pre-grant opposition has been rejected. However, if the patent application is refused (i.e., the opposition succeeds), the applicant can challenge that refusal as an order under Section 15 of the Act and appeal to the High Court. This position was clarified in the Yahoo Inc. v. IPAB case, where the Madras High Court held that a Controller’s refusal following a pre-grant opposition could be treated as an order under Section 15, making it appealable.

For opponents whose representation is rejected, the practical remedy – particularly if they qualify as a “person interested” – is to file a post-grant opposition under Section 25(2) or a revocation petition before the High Court under Section 64. The Supreme Court affirmed this position in J. Mitra & Company v. Assistant Controller of Patents & Designs [(2008) 10 SCC 368].

Landmark cases in pre-grant opposition 🔗

Novartis v. Cipla (2011) – the Section 3(d) question 🔗

Novartis filed a patent application in 2005 for dispersible tablets comprising Deferasirox at the Chennai Patent Office. Cipla filed a pre-grant opposition on grounds of obviousness (Section 25(1)(e)), non-patentable subject matter (Section 25(1)(f)), and failure to disclose under Section 8 (Section 25(1)(h)). The Controller allowed the representation, concluding that the claims were obvious in view of the prior art. Cipla won the case, establishing that even incremental pharmaceutical formulations must meet the inventive step threshold.

Hindustan Lever Ltd. v. Godrej Soaps (1996) 🔗

Two patent applications by Hindustan Lever relating to detergent bar formulations were opposed by Godrej Soaps on multiple grounds including prior publication, public use, obviousness, and insufficiency of description. After a hearing, the Controller ordered the applicant to amend the specifications. Once the amendments were made, the opposition was dismissed as the opponent could not establish their case to the Controller’s satisfaction. This case illustrates that a successful pre-grant opposition does not always mean outright refusal – it can lead to the patent being narrowed through amendment.

Yahoo Inc. v. IPAB – the appeal question 🔗

Yahoo filed a PCT application for a method related to search result ranking. Rediff.com filed a pre-grant opposition, and the Controller refused Yahoo’s application on grounds of lack of novelty and patentability. Yahoo’s appeal before the IPAB was initially rejected as not maintainable under Section 25(1), but the Madras High Court stepped in and interpreted the refusal as being under Section 15 – making it appealable. This case remains a key reference point on the procedural remedies available to applicants after a pre-grant opposition.

The “straw man” problem: misuse of pre-grant opposition 🔗

Because pre-grant opposition can be filed by “any person,” the system has occasionally been misused through what are called benami or straw man oppositions – where the actual interested party (say, a competitor) hides behind an unrelated individual to file the challenge, avoiding direct identification. In one notable case discussed before the IPAB (OA/2/2016/PT/MUM), a pre-grant opposition against a pharmaceutical patent was filed by a diamond merchant – clearly a proxy for another party. The Bombay High Court endorsed the IPAB’s condemnation of such filings, clarifying that the legislature’s intent was to help the Patent Office make correct decisions, not to create a vehicle for abuse.

The 2024 amendment’s prima facie requirement is partly a response to this problem – by filtering out weak or bad-faith filings early, it reduces the tactical use of pre-grant opposition as a delay mechanism.

Why pre-grant opposition matters 🔗

Pre-grant opposition is particularly significant in sectors like pharmaceuticals, biotechnology, and traditional knowledge, where the stakes of wrongly granted patents are high. A patent on a known molecule can block access to affordable medicines. A patent derived from traditional knowledge can erode community rights over indigenous resources. India’s relatively open pre-grant opposition mechanism – combined with strong exclusions under Section 3 – has made it one of the more robust systems globally for filtering out undeserving patent applications before they become enforceable rights.

At the same time, the system needs to be used in good faith. The 2024 procedural reforms signal a maturing of the framework – one that tries to balance openness with efficiency, and public interest with applicant rights.

What do you think? Given that pre-grant opposition is open to “any person” in India, does this openness strengthen the patent system’s integrity, or does the risk of misuse through benami filings outweigh the benefits? And with the 2024 amendments now requiring opponents to establish a prima facie case upfront, do you think this change makes the process fairer – or does it place too heavy a burden on legitimate public interest challengers?

References

1. https://ipindia.gov.in/writereaddata/portal/ev/sections/ps25.html
2. https://www.managingip.com/article/2a5bqtj8ume32iwlaqcps/court-curtails-straw-man-patent-oppositions-in-india
3. https://www.wto.org/english/tratop_e/trips_e/trips_e.htm
4. https://www.ipindia.gov.in/writereaddata/Portal/IPORule/1_83_1_Patent_Amendment_Rule_2024_Gazette_Copy.pdf
5. https://spicyip.com/2025/02/the-new-patent-playbook-in-action-a-look-at-rules-251-and-553-of-the-patent-amendment-rules-2024-for-pre-grant-oppositions.html
6. https://excelonip.com/pre-grant-opposition-in-india/
7. https://selvams.com/blog/pre-grant-patent-opposition-in-india/
8. https://www.lexology.com/library/detail.aspx?g=df6a81f0-4785-4bcb-ae0f-93415c790a33
9. https://ssrana.in/articles/patent-pre-grant-opposition/
10. https://www.lexology.com/library/detail.aspx?g=df6a81f0-4785-4bcb-ae0f-93415c700a33