In the case of Novartis Ag v. Natco Pharma Limited & Anr., a Division Bench of the Delhi High Court (in LPA 50/2023,) clarified that the process of substantive examination of a patent application and a pre-grant opposition proceeding are two separate and independent processes/proceedings, and that the opponent has no right to intervene in the substantive examination procedure.

Facts:

The Appellant, aggrieved by an inordinate delay in the determination of a post grant opposition (‘PGO’) proceeding, approached the Intellectual Property Appellate Board (‘IPAB’) for directions to the Indian Patent Office (‘IPO’) for the expeditious consideration of its application. The IPAB (which has since been abolished) directed the IPO to consider the oppositions seriatim and consider/dispose the same expeditiously. Thereafter, Natco filed an application seeking an opportunity to cross-examine the experts of the appellant whose affidavits were being relied upon in support of the patent application. The Controller,without considering the said request, proceeded to take up the PGO and commenced a hearing which ensued between 13th and 18th May 2021. This led to Natco approaching the Court by way of W.P. (C) 5558 of 2021.

Natco asserted that pre-grant opponents have the right to participate and be heard in the examination process after the IPO accepted their opposition, and that they ought to have been made a party to the process of amendments to the claims which proceeding happened between Novartis and the IPO.

Novartis argued that the Indian Patents Act, 1970 (as amended) (the ‘Act’) and/or Rules framed thereunder, do not envisage a hearing or participation of the opponent in the process of examination. It was submitted that while the representations of opposition may act as an aid to the examination process, the same does not detract from the independent duty and obligation cast upon the Controller to be satisfied that the application merits grant.

The learned Single Judge of the High Court disposed the matter on 27 May 2021, agreeing with Natco, held that pre-grant opponents have the right to be heard when it comes to amending the application, because the examination and pre-grant opposition processes merge once the IPO accepts the opposition.

Appeal to the Division Bench of the High Court:

An appeal was filed against the said decision, to the Division Bench of the High Court, which clarified the following issues:

• The right of hearing that is contemplated in Rule 55(5) of the Patent Rules, 2003 (as amended) (the ‘Rules’) is one which is concerned solely with the adjudication and disposal of the representation for opposition.

• An opponent cannot be countenanced to have a right of hearing in the examination process merely because the statute confers such an opportunity at the stage where the Controller is dealing with the representation. The pre-grant opposition representation merely aids the Controller in a holistic examination of the patent application.

• The principles of natural justice must be balanced with the applicant’s right to avoid inordinate delays, by inter alia considering cases and by conducting hearings in a seriatim manner.

• The rights of interested parties stand sufficiently under post-grant opposition.

• This view balances the interests of the applicants and the opponents, while maintaining the procedural autonomy of the Controller in conducting examination.