Zydus Healthcare Ltd. Vs Assistant Controller of Patents

Zydus Healthcare Ltd, a pharmaceutical company, challenged the Controller's order granting Patent No. 426553 to Respondent No. 2 for an application filed in 2012 titled 'Compositions and Methods for Treating Centrally Mediated Nausea and Vomiting', which underwent three amendments to claims, reducing from 51 to a final set after voluntary changes and responses to FER and hearings.

Petitioner filed pre-grant opposition in 2021 alleging broadening of claims violating Sections 57 and 59, lack of hearing opportunity at second hearing violating natural justice, but Controller rejected opposition and granted patent after separate examination hearing to applicant only.

The court, relying on Novartis AG v. Union of India, held that pre-grant opposition and patent examination are distinct processes with no right for opponent to participate or be heard in examination phase, voluntary pre-FER amendments need no separate order and can be addressed in FER, no jurisdictional error or natural justice violation occurred as opposition hearing was provided and documents uploaded publicly, merits review impermissible in writ absent manifest error, and Delhi High Court lacks territorial jurisdiction since Patent Office is in Mumbai. Writ petition dismissed.

• Pre-grant opposition and patent examination are separate proceedings; opponent has no right to hearing or participation in the examination process: Para 60(e).
• Voluntary amendments to patent claims before issuance of First Examination Report require no separate determination order and may be considered in the FER: Para 60(c).
• High Court lacks territorial jurisdiction over writ petition challenging patent grant if relevant Patent Office is not located within its jurisdiction: Para 60(a).
• Review on merits involving disputed facts not permissible in writ jurisdiction under Article 226 absent jurisdictional error by Controller: Para 60(d).
• High Court may exercise extraordinary jurisdiction under Article 226 despite alternative remedies if manifest jurisdictional error found: Para 60(b).

Case Title: Zydus Healthcare Ltd. Vs Assistant Controller of Patents and Designs:24.12.2025:W.P.(C)-IPD 23/2023:2025:DHC:11932:Hon'ble Mr. Justice Tejas Karia

[Readers are advised not to treat this as substitute for legal advise as it may contain errors in perception, interpretation, and presentation]

[Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi]