In Zydus Healthcare Ltd. vs Assistant Controller of Patents and Designs & Anr. [W.P.(C)-IPD 23/2023], the Delhi High Court examined a writ petition filed under Article 226 of the Constitution challenging the grant of a patent after rejection of a pre-grant opposition under Section 25(1) of the Patents Act, 1970.

The writ petition was instituted by Zydus, challenging the grant of patent number 426553 in favour of Respondent no. 2 by the Mumbai Patent Office pursuant to patent application number 1009/MUMNP/2012, entitled “Compositions and Methods for Treating Centrally Mediated Nausea and Vomiting”.

Prior to issuance of the First Examination Report (“FER”), Respondent no. 2 (patentee) voluntarily filed an amendment (“first amendment”) under Section 57 by way of Form 13. Subsequent amendments were filed both in response to the FER (“second amendment”) and thereafter to comply with the objections raised in the hearing notice (third amendment).

A pre-grant opposition under Section 25(1) was filed by the Petitioner, inter alia, contending that the amendments impermissibly enlarged the scope of the claims and violated Section 59 of the Patents Act. A hearing on the pre-grant opposition was conducted after which the Controller reserved its order. Thereafter, the Controller issued a fresh hearing notice under Section 14 exclusively to the applicant. In response, Respondent no. 2 carried out a further amendment to the claims before the hearing. No notice or opportunity of hearing was afforded to the pre-grant opponent at this stage. The Controller ultimately rejected the pre-grant opposition and granted the patent.

The Petitioner’s challenge was founded on manifest jurisdictional error and violation of principles of natural justice. It was contended that:

• The Delhi High Court had jurisdiction to entertain the writ petition as the cause of action arose/ the patent had commercial impact within Delhi, invoking the doctrine of dynamic effect.
• The Controller failed to discharge the statutory duty under Sections 57 and 59 read with Rule 81(2) by not ‘determining’/passing an order allowing the amended set of claims.
• The Controller erred in granting a unilateral hearing to the applicant under Section 14 and permitting the third amendment without affording the Petitioner an opportunity to object.
• Although the impugned order recorded the Petitioner’s submissions regarding non-compliance with Section 59, it failed to return any finding on the issue.
• The issuance of the FER could not be construed as a “determination” under Rule 81(2), as the term connotes application of mind and an express conclusion, and not a mere examination opinion.
• The first amendment enlarged the scope of the independent Claim 1 and this impermissible enlargement percolated to the second amendment.
• The amendments altered the nature of the claims, converting method of treatment claims to pharmaceutical composition claims without compliance with Section 57(2), which mandates disclosure of full particulars and reasons for amendment.
• No alternative efficacious remedy existed, as rejection of a pre-grant opposition is not appealable under Section 117A, and the absence of any order under Section 57 foreclosed appellate recourse altogether.

Issues Framed by the Court

The Court identified four issues for determination:

1. Whether the Delhi High Court had territorial jurisdiction to entertain the writ petition?
2. Whether the petition was maintainable in view of alternative efficacious remedies?
3. Whether the Controller was required to pass a separate speaking order determining the amendments sought at the pre-FER stage or whether FER can be treated as a ‘determination’ under Sections 57(1) and 59 of the Act read with Rule 81(2) of the Rules?
4. Whether not granting the opportunity of hearing to the Petitioner pursuant to the third amendment constituted a violation of principles of natural justice?

Findings of the Court

1. Territorial Jurisdiction

The Court rejected the Petitioner’s reliance on the dynamic effect doctrine derived from Dr. Reddy’s Laboratories Ltd. & Anr. v. The Controller of Patents & Ors. [2022 SCC OnLine Del 3747]. It held that while dynamic effect may confer jurisdiction for revocation petitions under Section 64, it does not extend to writ petitions challenging orders of the Patent Office.

The Court characterised a writ petition under Article 226 to examine manifest jurisdictional error committed by the Controller as jurisdictionally analogous to an appeal under Section 117A, for which jurisdiction lies exclusively with the High Court within whose territorial limits the “appropriate office” is situated.

Since the subject application was prosecuted entirely before the Mumbai Patent Office, the Delhi High Court could not assume jurisdiction merely because the commercial impact of the patent might be felt within Delhi.

Accordingly, the Court rejected the Petitioner’s invocation of Article 226(2) based on cause of action or dynamic effect and held the writ petition to be not maintainable due to lack of territorial jurisdiction.

2. Alternative Efficacious Remedies

Placing reliance on Glochem Industries Ltd. vs Cadila Healthcare Ltd. & Ors. [2009 SCCOnLineBom1701], UCB Farchim SA vs Cipla Ltd. & Ors. [2010 SCC OnLine Del 523], and Rich Products vs The Controller of Patents & Anr. [2024 SCC OnLine Del 3144], the Court held that:

• Rejection of a pre-grant opposition can be challenged under Article 226 where the order suffers from manifest jurisdictional error, irrespective of the alternative remedy of filing a post-grant opposition under Section 25(2) or filing a revocation petition under Section 64.
• However, invoking writ jurisdiction is a discretionary remedy and the Court can decline to exercise the same where the petitioner is not able to establish manifest jurisdictional error.

3. Requirement of a Separate Determination Order under Sections 57 and 59 (Pre-FER Amendments/first amendment)

On the question whether the Controller was required to pass a separate speaking order determining the permissibility of amendments under Section 59 prior to issuance of the FER, the Court returned a clear finding in the negative. The Court held that:

• Voluntary amendments filed prior to issuance of the FER do not require a separate determination by passing an order prior to the issuance of the FER.
• The mention of amended claims in the FER indicates application of mind to the amended claims while issuing the FER.
• Neither the Patents Act nor the Patent Rules mandate a two-step procedure requiring a formal order approving pre-FER voluntary amendments.
• Examination is a continuous process and the Controller is entitled to consider amended and unamended claims in a consolidated manner in the FER.

The Court therefore rejected the contention that failure to pass a distinct order under Rule 81(2) amounted to a jurisdictional error, holding that the FER itself operates as the determination of pre-FER amendments.

Additionally, the Court noted that:

• The Petitioner had not raised this objection during the pre-grant proceedings.
• Having acquiesced to the examination proceeding on amended claims, the Petitioner could not belatedly challenge the absence of a separate determination order.

4. Review of Amendments and Section 59 Compliance in Writ Jurisdiction

On the substantive challenge that the amendments violated Section 59 by enlarging the scope of the claims or going beyond the complete specification, the Court declined to adjudicate.

Relying on Rich Products, the Court held that:

• Such issues require a review of the Controller’s decision on merits which is not permissible in the absence of manifest jurisdictional error.
• The Petitioner had already availed an alternative remedy by filing a counter-claim in the infringement suit instituted by Respondent no. 2, therefore, it would not be apposite to enter into disputed questions of merits under the writ jurisdiction.

Accordingly, the Court held that no interference was warranted on merits.

5. Alleged Violation of Principles of Natural Justice (Post-Reservation Hearing)

The Court rejected the Petitioner’s contention that the principle of natural justice was violated on the ground that, after concluding the pre-grant opposition hearing and reserving the order, the Controller issued a hearing notice to the applicant and proceeded to consider the third amendment without affording a hearing to the opponent.

The Court held that:

• Section 25(1) of the Act is exhaustive, as it permits opposition only on the grounds expressly enumerated therein and ends with the phrase “but on no other ground”. Since amendment of claims is not a ground under Section 25(1), the Petitioner could not raise such an objection at the pre-grant stage as well as in the writ petition, and the Controller committed no jurisdictional error in not considering said objection.
• The Controller followed due procedure by uploading the hearing notice for hearing II and the written submissions filed by Respondent no. 2 on the Patent Office website. The Petitioner therefore had the opportunity to seek liberty to file further submissions by way of a miscellaneous petition, which it chose not to avail.

Relying on Novartis AG v. Natco Pharma Ltd., 2024 [SCC OnLine Del 152] the Court noted that:

• Pre-grant opposition under Section 25 and examination under Sections 12-15 are distinct and independent procedures, and a pre-grant opponent has no right of hearing in the examination process. Since the third amendment was made pursuant to a hearing under Section 14, it formed part of examination.
• Under Section 57(3), only amendments considered substantive by the Controller are required to be advertised; non-substantive amendments need not be advertised. Further, Section 57(6) preserves the applicant’s right to amend documents to comply with directions or objections raised before grant.
• Rule 55 governs only the pre-grant opposition process. The obligation to grant a hearing under Rule 55(3)(ii) is confined to issues raised in the opposition, and does not extend to or regulate the examination process.
• The legislative intent behind Rule 55(5) is not to confer a participative right upon the opponent in the examination process. Therefore, the right of hearing of the opponent under Rule 55 of the Rules is confined to a consideration of issues raised in the pre-grant Opposition.

The Court thus found no violation of natural justice.

In view of the foregoing, the Court dismissed the writ petition.