JUDGMENT :

1. CS(COMM) No.1119/2016 has been instituted by the three plaintiffs, namely (a) Roche Products (India) Private Limited; (b) F. Hoffmann-La Roche, AG; and, (c) Genentech Inc., against (i) Cadila Healthcare Ltd. (Cadila); (ii) Drugs Controller General of India (DCGI); and, (iii) Department of Biotechnology (DoB), Ministry of Science & Technology, for

A. declaration:-

(i) that Cadila’s drug has not been tested as, and is not, a biosimilar product under applicable law;

(ii) that the approvals dated 30th March, 2012 and 18th September, 2012 by the Review Committee on Genetic Manipulation (RCGM) of the preclinical protocol and preclinical test results respectively of Cadila’s drug and Clinical Trials Registry – India (CTRI) registration bearing no.1 CTRI/2014/05/004605 and the DCGI’s approval dated 10th March, 2014 in relation to clinical trial protocol of Cadila’s drug are invalid and are not in accordance with applicable law;

(iii) that the manufacturing authorization dated 28th October, 2015 granted by the DCGI to Cadila for Cadila’s drug is invalid; and,

(iv) that the no objection dated 21st January, 2016 for Cadila’s drug, for the additional indications i.e. HER2+metastatic ga