JUDGEMENT

YASHWANT VARMA, J. S. No. Particulars Paragraph Nos.

A. PREFACE 1-3 B. ESSENTIAL FACTS 4-10 C. THE STATUTORY PROVISIONS-PRE AND POST AMENDMENT 11 D. CONTENTIONS OF NOVARTIS 12-33 E. NATCO‘S SUBMISSIONS 34-42 F. STAND OF INDIAN PHARMACEUTICAL ALLIANCE 43-52 G. THE OPPOSITION BY DR. KANCHAN KOHLI 53-54 H. IMPACT OF AMENDED SECTION 57 55-57 I. THE EXAMINATION PROCESS 58-66 J. OPPOSITION PROCEEDINGS 67-69 K. AMENDMENT OF THE PATENT APPLICATION 70-75 L. FACETS OF PRE GRANT OPPOSITION 76-92 Page 3 of 141 M. THE HEARING UNDER RULE 55 93-96 N. THE NATURAL JUSTICE PRINCIPLES 97-100 O. THE RIGHTS OF AN OPPONENT-A GLOBAL PERSPECTIVE 101-113 P. THE IMPORT OF SECTION 57 114-117 Q. BALANCING OF INTERESTS 118-122 R. THE IMPUGNED JUDGMENT-A BRIEF CRITIQUE 123-127 S. CONCLUSIONS 128 T. OPERATIVE DIRECTIONS 129 A.

PREFACE

1. The present Letters Patent Appeal raises the important question of the extent of engagement of a pre-grant opponent under the Patents Act, 19701 in the course of proceedings initiated by the Controller requiring the applicant for a patent to amend or modify the application, the complete specifications thereof or any other related document.

2. NATCO Pharma Limited2, the original writ petitioner, had assailed the order of the Controller of Patents3 dated 14 December 2022 in terms of which certain amendments in Indian Patent Application No. IN4145184 filed by the appellant as directed were allowed on the ground that the said order came to be passed without 1 Act 2 NATCO 3 Controller 4 IN‘518 Page 4 of 141 NATCO being afforded an opportunity of hearing.

3. The submission essentially appears to have been that a pre-grant opponent would have the right to represent against both voluntary amendments as well as those that may be directed by the Controller.

According to NATCO, the consideration of the application alongside the representations of opposition are not liable to be viewed as operating in separate silos. The proceedings, according to NATCO, clearly merge and thus obligating the Controller to place all pre-grant opponents on notice of any amendments that may be directed by it. It is the aforenoted submissions and the view so canvassed which has been accepted by the learned Single Judge leading to the institution of the present appeal.

B.

ESSENTIAL FACTS

4. In order to examine the backdrop in which the matter came to be placed before the learned Single Judge, we deem it opposite to take note of the following important events as set out in the Written Note of Submissions tendered on behalf of the appellant: -

Page 5 of 141 (FER) dated 30.01.2015. 27.05.2016 The Appellant was granted Section 14 hearing on 27.05.2016 vide a Notice of Hearing dated 06.05.2016. However, before any order could be passed by the Controller on the examination and the hearing pursuant thereto, first PGO was filed by Indian Pharmaceutical Alliance (IPA) on 26.05.2016. 06.09.2016 The 2nd PGO was filed by Respondent No. 1 (NATCO).

“Date	Events
08.11.2006	The subject patent IN‘518, originated from PCT application no. PCT/US2006/043710 dated 08.11.2006, which was filed as Indian national phase application bearing no. 4412/DELNP/2007 on 08.06.2007 before the Controller of Patents (Respondent No. 2).
24.08.2007	The application was published inviting pre-grant oppositions. The application was examined under Sections 12 and 13 vide a First Examination Report

“Date	Events
08.11.2006	The subject patent IN‘518, originated from PCT application no. PCT/US2006/043710 dated 08.11.2006, which was filed as Indian national phase application bearing no. 4412/DELNP/2007 on 08.06.2007 before the Controller of Patents (Respondent No. 2).
24.08.2007	The application was published inviting pre-grant oppositions. The application was examined under Sections 12 and 13 vide a First Examination Report

23.08.2017 The 3rd PGO was filed by Kumar Sushobhan.

13.06.2019 The 4th PGO was filed by Dr. Reddy. 06.12.2019 1st Notice of hearing in re