MANMOHAN SINGH, J.

1. The plaintiffs filed the present suit for injunction seeking various prayers inter alia decree a decree of declaration that the defendant's drug has not been tested as a bio-similar product under applicable law, defendant No.3's CTR Registration Number CTR/2013/04/ 003549 is invalid and is not in accordance with applicable law. A decree of declaration that the approval granted by defendant No.1 on October 29, 2012 to defendant No.3's clinical trial protocol for the defendant's Drug is invalid and is not in accordance with applicable law and the manufacturing and marketing authorisation approved on 2nd June, 2015 by defendant No.1 to defendant No.3 for the defendant's drug for all of the Indications is invalid.

2. By this order I propose to decide the above mentioned two applications.

3. It is alleged in the plaint that the suit has been filed on account of the imminent threat and credible apprehension of the launch of defendant No.3's drug, TrastuRel ("TrastuRel"), a purported bio-similar version of the plaintiffs' biological drug Trastuzumab (the "plaintiffs' Trastuzumab") for the treatment of HER2+ metastatic breast cancer, HER2+ early breast cancer and HER2+ metastatic gastric cancer (collectively, "Indications"). The main contention in the suit is that the defendant No.3 for their product namely TrastuRel has not been adequately tested for HER2+ metastatic breast cancer in accordance with the applicable law in India, i.e. the Drugs and Cosmetics Act, 1940, as amended (the "Drugs Act"), the Drugs and Cosmetics Rules, 1945, as amended (the "Drugs Rules"), the Guidelines on Similar Biologies, 2012 (the "Bio-similar Guidelines") and other applicable law for the purpose of obtaining appropriate approvals, or tested at all for HER2+ early breast cancer and HER2+ metastatic gastric cancer (the "Additional Indications"). The averments and facts made in the injunction application and plaint are common, thus the plaint is being dealt with.

4. The injunction is sought by the plaintiffs restraining defendant No.3 from launching, introducing, selling, marketing and/or distributing the defendant's drug in the Indian market as 'Trastuzumab' or otherwise for any of the Indications, pursuant to the marketing authorisation to be granted by defendant No. 1, without appropriate tests having been conducted on the defendant's drug under the Drugs Act, the Drugs Rules and Bio-similar Guidelines and from representing the defendant's drug as 'Trastuzumab'.

5. Plaintiff No.1, Genentech Inc., a corporation incorporated in the State of Delaware, USA, with its principal office at 1DNA Way, South San Francisco, Cahfomia 94080, USA, is an affiliate of plaintiff No. 3. Plaintiff No.1 claims to be the innovator of the biological drug Trastuzumab. It is also the registered proprietor of the trademark HERCEPTIN® worldwide (including India). Plaintiff No.1 obtained registration of the mark HERCEPTIN® in India under Class 5 - Registration No. 358259 dated April 23, 2005 valid up to October 9, 2018. Plaintiff No. 1 was granted a secondary, formulation patent in relation to Trastuzumab from the Controller General of Patents, Designs and Trademarks of India, which was deemed to be effective from May 3, 1999 and which lapsed on May 3, 2013.

Plaintiff No.2, Roche Products (India) Private Limited, a company incorporated under the Companies Act, 1956, as amended (the "Companies Act"), with its registered office at 1503, 15th Floor, The Capital, Bandra Kurla Complex, Bandra (East), Mumbai - 400 051, is an affiliate of plaintiff No. 3, and is the importer and marketer of innovator molecule Trastuzumab in India. In India, the plaintiffs' Trastuzumab is sold under the brand names HERCEPTIN®, HERCLON™ and BICELTIS®. The plaintiffs' Trastuzum