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IN THE HIGH COURT OF DELHI AT NEW DELHI

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Judgment reserved on: 10 October 2023

Written Submissions filed on: 20 October 2023

Judgment pronounced on: 09 January 2024

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LPA 50/2023

NOVARTIS AG ..... Appellant

Through:

Mr. Hemant Singh, Ms. Mamta

Rani Jha, Mr. Siddhant Sharma,

Mr. Abhay Tandon and Ms.

Garima Mehta, Advs.

versus

NATCO PHARMA LIMITED & ANR. ..... Respondents

Through:

Mr.

J.

Sai

Deepak,

Mr.

Guruswamy

Nataraj,

Mr.

Shashikant Yadav and Mr. Rahul

Bhujbal, Advs. for R-1.

Mr.

Harish

Vaidyanathan

Shankar, CGSC along with Mr.

Srish Kumar Mishra, Mr. Sagar

Mehlawat,

Mr.

Alexander

Mathai Paikaday, Mr. M. Sriram

and Mr. Krishnan V., Advs. for

R-2.

Ms. Rajeshwari H., Mr. Tahir

A.J., Ms. Raj Latha Kotni and

Mr. Anirudh Ramanathan, Advs.

for Interveners- Dr. Charanjit

Kumar Sehgal and Dr. Kanchan

Kohli.

Mr. Rajiv Nayar, Sr. Adv. with

Ms. Bitika Sharma, Ms. Vrinda

Pathak, Mr. George Vithayathil

and Mr. Manjunathan, Advs. for

Digitally Signed

By:KAMLESH KUMAR

Signing Date:09.01.2024

19:08:38

Signature Not Verified

Intervener-

Indian

Pharmaceutical Alliance.

CORAM:

HON'BLE MR. JUSTICE YASHWANT VARMA

HON’BLE MR. JUSTICE DHARMESH SHARMA

J U D G M E N T

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

Digitally Signed

By:KAMLESH KUMAR

Signing Date:09.01.2024

19:08:38

Signature Not Verified

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. IN414518⁴filed 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

Digitally Signed

By:KAMLESH KUMAR

Signing Date:09.01.2024

19:08:38

Signature Not Verified

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