Pre-Grant Opponents Cannot Seek Hearing In Patent Examination: Delhi High Court Rejects Zydus Plea Against Helsinn's Nausea Medication Patent
Safiya Malik
The High Court of Delhi Single Bench of Justice Tejas Karia has declined to set aside the Patent Office’s grant of a pharmaceutical patent covering an oral dosage form used to treat centrally mediated nausea and vomiting, dismissing a challenge by Zydus Healthcare Ltd. to Swiss drugmaker Helsinn Healthcare SA’s patent. In its December 24, 2025 judgment, the court found no jurisdictional infirmity or breach of natural justice in the grant process and upheld the patent grant order. The bench said that pre-grant opposition proceedings and the statutory examination of a patent application operate independently, and an opponent at the pre-grant stage has no entitlement to participate in, or seek a hearing during, the examination phase.
The petitioner filed a writ petition under Article 226 of the Constitution challenging an order dated 23.03.2023 passed by the Assistant Controller of Patents and Designs, which rejected the petitioner’s pre-grant opposition and granted a patent to Respondent No. 2 for an application titled “Compositions and Methods for Treating Centrally Mediated Nausea and Vomiting.”
Respondent No. 2 filed the patent application on 20.04.2012 with 51 claims. On 25.07.2013, Respondent No. 2 sought a voluntary amendment under Section 57 via Form 13, deleting claims 1–33 and restructuring the claim set to 14 claims. A First Examination Report was issued on 21.09.2017, and Respondent No. 2 replied on 19.03.2018 with further amendments reducing the claims to 11.
The petitioner filed a pre-grant opposition dated 06.09.2021, alleging that the amendments broadened the scope of the claims; another opponent filed a pre-grant representation on 22.06.2018 but did not prosecute it. A hearing on the pre-grant opposition was held on 20.05.2022, followed by the petitioner’s written submissions dated 04.07.2022. After the matter was reserved, the Controller issued a hearing notice dated 17.02.2023 under Section 14 to Respondent No. 2, held a further hearing on 03.03.2023, and Respondent No. 2 made another set of amendments; the petitioner was not given a hearing at this stage.
The petitioner contended that no separate determination was made on claim amendments under Sections 57 and 59 (read with Rule 81(2)), that the unilateral hearing and acceptance of further amendments violated natural justice, and that the complete specification did not disclose the claimed orally administered dosage form without the additional substance dexamethasone. Respondent No. 1 and Respondent No. 2 opposed maintainability on territorial jurisdiction and alternative remedies (including appeal/review/revocation routes), and Respondent No. 2 also relied on statutory provisions including Sections 3(d) and 3(e).
The Court stated that “in the case of appeals where challenges against orders of the Patent Office are raised the concept of cause of action cannot be pleaded to vest jurisdiction in other High Courts i.e. other than the one in the territorial jurisdiction of which the appropriate office is located.” It held that “As the Writ Petition under Article 226 of the Constitution to examine manifest jurisdictional error committed by the learned Controller is akin to an Appeal under the Act, the observation … as applicable to the appeals under the Act would be applicable to the Writ Petitions under Article 226 of the Constitution as well.” The Court then stated that “as the relevant Patent Office is not located within the jurisdiction of this Court, the present Petition is not maintainable due to lack of territorial jurisdiction, and this Court cannot entertain and decide the present Petition.”
On the exercise of writ jurisdiction where statutory remedies exist, the Court recorded that “this Court should not entertain the writ petition, not because it does not have the power or jurisdiction, but because the petitioner has an efficacious alternative statutory remedy to exhaust.” It stated that “the remedy under Article 226 of the Constitution of India is a discretionary remedy and the Court can decline to exercise the same if there is an efficacious, alternate and statutory remedy.”
On the relationship between the examination process and a pre-grant opposition, the Court stated: “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 two processes are separate from each other as the examination process demands a focused evaluation of the application while the opposition process is to address the concerns of external stakeholders.” In the same context, it recorded that “the opponent cannot be countenanced to have a right of hearing in the examination process…”
On amendments made prior to issuance of the First Examination Report, the Court stated that “the First Amendment was made prior to FER and, therefore, there was no requirement for separate ‘determination’ by Respondent No. 1 as regards the amendment by passing an order prior to issuance of the FER.” It recorded that “the Act and Rules do not contemplate the two-step procedure for issuance of a formal order in cases where the applicant has made amendments voluntarily prior to the issuance of FER.” It further stated that “there is no requirement under the Act or the Rules to pass a separate order determining the pre-FER amendment by way of separate order and FER itself is the determination of the pre-FER amendments.”
On the scope of interference in writ proceedings, the Court recorded that “we find no manifest or jurisdictional error warranting exercise of jurisdiction under Article 226 of the Constitution of India.” It stated that “it would not be apposite to undertake a merits review in a proceeding under Article 226 of the Constitution of India.”
The Court concluded: “If the relevant Patent Office is not located within the jurisdiction of the High Court, the Writ Petition under Article 226 of the Constitution is not maintainable due to lack of territorial jurisdiction. As the Patent Office is not located in Delhi, this Court cannot entertain and decide the present Petition.”
“Irrespective of the alternative remedy, an aggrieved party would have a recourse to invoke the extraordinary jurisdiction of this Court under Article 226 of the Constitution, and it is the discretion of the High Court to exercise the jurisdiction if it is found that there is manifest jurisdictional error committed by the learned Controller while deciding the pre-grant opposition.”
“There is no requirement under the Act or the Rules to pass a separate order determining the voluntary amendments sought prior to First Examination Report issued by the learned Controller and the same can be considered and determined in the First Examination Report itself.”
“A review on merits involving disputed questions of fact is not permissible while exercising the writ jurisdiction under Article 226 of the Constitution in absence of any jurisdictional error committed by the learned Controller.”
“As the pre-grant opposition and examination of patent are two separate proceedings, a pre-grant opponent cannot be countenanced to have a right of hearing in the examination process. There was no violation of principles of natural justice as there was no requirement to give opportunity of hearing for a second time, if any further amendments to claim are made after the hearing of pre-grant opposition is given such opposition is not contemplated under Section 25(1) of the Act.”
“In view of the above discussion, the present Writ Petition is dismissed.”
Advocates Representing the Parties
For the Petitioner: Mr. Dayan Krishnan, Senior Advocate with Mr. Adarsh Ramanujan, Ms. Bitika Sharma, Ms. Vrinda Pathak, Mr. P.S. Manjunathan, Ms. Sandhya Kukreti, Mr. Shreedhar and Mr. Parth Singh, Advocates.
For the Respondents: Mr. Vikrant N. Goyal, Mr. Prince Balyan, Mr. Kunal Dixit and Mr. Sachit Sharma, Advocates, Mr. Amit Sibal, Senior Advocate with Mr. Pravin Anand, Mr. Dhruv Anand, Ms. Udita Patro, Mr. Dhananjay Khanna, Ms. Nimrat Singh, Ms. Smriti Nair, Mr. Saksham Dhingra and Ms. Suditi Batra.
Case Title: Zydus Healthcare Ltd. v. Assistant Controller of Patents and Designs & Anr.
Neutral Citation: 2025: DHC:11932
Case Number: W.P.(C)-IPD 23/2023
Bench: Justice Tejas Karia
