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* IN THE HIGH COURT OF DELHI AT NEW DELHI % Date of Decision: 11^th September, 2023 + 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 Signature Not Verified Digitally Signed CS(COMM) 540/2016 and CS(COMM) 1119/2016 Page 1 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:

Signature Not Verified Digitally Signed CS(COMM) 540/2016 and CS(COMM) 1119/2016 Page 2 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 in the overseas market and claims to be one of the leading pharmaceutical companies in India with domain expertise in the field of healthcare. Defendant No.1 forms part of the Zydus Cadila Group of Companies and provides comprehensive and complete healthcare solutions from formulations to active pharmaceutical ingredients and animal healthcare products to wellness products and is stated to be a fully integrated and global healthcare provider.

4. Defendant No. 2 is the Drugs Controller General o