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:

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 of India (DCGI), the Authority responsible for approval of ‘new drugs’, including biosimilar/biologic drugs in India and is empowered both to grant and revoke licenses inter alia for import, manufacture, distribution and sale of drugs in India. Defendant No. 3 is the Department of Biotechnology under the Ministry of Science and Technology which has drafted and introduced the Biosimilar Guidelines. It is also responsible for granting approvals during development of biologic drugs in India including approval for import of cell lines and for conducting, evaluating the pre-clinical trials, trial reports and recommending conduct of various phases of clinical trials.

5. This application under Order VII Rule 11 CPC has been filed by Cadila for rejection of the plaint. It is Cadila’s case that in 2015, after complying with all necessary requirements of the Drugs Act, Drugs Rules and Biosimilar Guidelines, Cadila received the manufacturing and marketing authorization/license from DCGI for launch of biosimilar version of ‘Trastuzumab’ on 28.10.2015. Apprehending that Plaintiffs might initiate action to thwart the launch and marketing of ‘Trastuzumab’, Cadila filed a suit before the High Court of Bombay bearing Suit No.1073/2015 on 30.11.2015, seeking declaration and injunction to restrain the Plaintiffs herein from interfering with or preventing Cadila from launching and marketing the biosimilar drug and to declare