CS(COMM) 540/2016 and CS(COMM) 1119/2016 Page 1 of 86

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IN THE HIGH COURT OF DELHI AT NEW DELHI

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CS(COMM) 540/2016

F HOFFMANN-LA ROCHE LTD & OTHERS

..... Plaintiffs

Through:

Mr. Darpan Wadhwa, Senior

Advocate with Ms. Ruby Singh Ahuja,

Mr. Vishal Gehrana and Mr. Akshay

Agarwal, Advocates.

versus

DRUGS CONTROLLER GENERAL

OF INDIA & OTHERS

..... Defendants

Through:

Mr. Kirtiman Singh, Central

Government

Standing

Counsel

with

Ms. Vidhi Jain, Ms. Kunjala Bhadwal and

Mr. Madhav Bajaj, Advocates for DCGI.

Mr. Tejveer Singh Bhatia and Mr. Lakshay

Kaushik, Advocates for D-3.

+

CS(COMM) 1119/2016

ROCHE PRODUCTS (INDIA) PRIVATE

LIMITED AND OTHERS

..... Plaintiffs

Through:

Mr.

Sandeep

Sethi

and

Mr. Darpan Wadhwa, Senior Advocates with

Ms. Niti Dixit, Mr. Abhishek Tewari,

Ms. Samiksha Gadiyal, Ms. Ishita Mathur,

Mr. N. Mahabir, and Mr. Parth Dua,

Advocates.

versus

CADILA HEALTHCARE LIMITED

AND OTHERS

..... Defendants

Through:

Mr. Chander M. Lall, Senior

Advocate with Ms. Bitika Sharma, Mr. Kapil

Digitally Signed

By:KAMAL KUMAR

Signing Date:12.09.2023

20:29:25

Signature Not Verified

CS(COMM) 540/2016 and CS(COMM) 1119/2016 Page 2 of 86

Midha, Mr. Luv Virmani, Ms. Aadya

Chawla and Ms. Ananya Chug, Advocates

for D-1.

Mr. Kirtiman Singh, Central Government

Standing Counsel with Ms. Vidhi Jain,

Ms. Kunjala Bhadwal and Mr. Madhav

Bajaj, Advocates for DCGI.

CORAM:

HON'BLE MS. JUSTICE JYOTI SINGH

JUDGEMENT

JYOTI SINGH, J.

I.A. 2698/2017 (under Order VII Rule 11 CPC, by Defendant

No. 3) in CS(COMM) 540/2016 and

I.A. 4775/2021 (under Order VII Rule 11 CPC, by Defendant No. 1)

in CS(COMM) 1119/2016

1.

This judgment shall dispose of applications filed under Order

VII Rule 11 CPC, on behalf of Defendant No. 3/Hetero Drugs Limited

(hereinafter referred to as ‘Hetero’) in CS(COMM) 540/2016 and

Defendant No. 1/Cadila Healthcare Limited (hereinafter referred to as

‘Cadila’) in CS(COMM) 1119/2016, seeking rejection of the plaints in

the respective suits.

I.A. 4775/2021 (under Order VII Rule 11 CPC, by Defendant No. 1)

in CS(COMM) 1119/2016

2.

Present suit has been filed by the Plaintiffs inter alia seeking a

declaration that approval granted to Cadila’s drug for pre-clinical/

clinical trial protocols as well as manufacturing authorization granted

by Drugs Controller General of India (‘DCGI’) under the provisions of

Drugs and Cosmetics Act, 1940 (hereinafter referred to as the ‘Drugs

Act’) read with Drugs and Cosmetics Rules, 1945 (hereinafter referred

to as the ‘Drugs Rules’) and Guidelines on Similar Biologics:

Digitally Signed

By:KAMAL KUMAR

Signing Date:12.09.2023

20:29:25

Signature Not Verified

CS(COMM) 540/2016 and CS(COMM) 1119/2016 Page 3 of 86

Regulatory Requirements for Marketing Authorization in India,

2012 (hereinafter referred to as the ‘Biosimilar Guidelines’), for

manufacturing and marketing the biosimilar version of ‘Trastuzumab’,

be declared invalid as also for permanent injunction restraining Cadila

from selling, marketing and/or distributing its drug in the Indian

market as ‘Trastuzumab’ and from representing its drug as biosimilar

version of ‘Trastuzumab’ or of HERCEPTIN, HERCLON and

BICELTIS.

3.

Plaintiff No. 1 is an importer and marketer of ‘Trastuzumab’ in

India and Plaintiff No. 2 is a Switzerland based Company

manufacturing ‘Trastuzumab’ while Plaintiff No. 3 is a USA based

Corporation claiming to be the innovator of ‘Trastuzumab’. Defendant

No. 1 is a Company incorporated under the Companies Act, 1956 and

is engaged in manufacturing and marketing of various pharmaceuticals

products and is involved inter alia in Research and Development of

Biosimilars in India and