MANMOHAN SINGH, J.

1. The plaintiffs filed the present suit for injunction against four defendants. By this order, I propose to dispose of the abovementioned pending applications.

2. The plaintiff No.1, Roche Products (India) Private Limited, a company incorporated under the Companies Act, 1956, as amended (the "Companies Act"), is an affiliate of plaintiff No.2, and is the importer and marketer of innovator molecule Trastuzumab in India. Trastuzumab is stated to be a biological drug used primarily for the treatment of HER 2 positive breast cancer. In India, Trastuzumab is sold under the brand names HERCEPTIN®, HERCLON™ and BICELTIS®. It is stated that Trastuzumab has become the accepted biological treatment for HER 2 positive breast cancer on a worldwide basis and enjoys a global reputation.

Plaintiff No.2, F. Hoffmann-La Roche AG, a joint stock company incorporated under the laws of Switzerland is an affiliate of plaintiffs No.1 and 3, and the manufacturer of innovator molecule Trastuzumab. Plaintiff No.3, Genentech Inc., a corporation incorporated in the State of Delaware, USA, is an affiliate of plaintiff No.2. Plaintiff No.3 is the innovator of the biological drug Trastuzumab and is the only entity worldwide entitled to claim the right to manufacture the biologic Trastuzumab. It is also the registered proprietor of the trademark HERCEPTIN® worldwide (including India). Plaintiff No.3 obtained registration of the trade mark HERCEPTIN® in India under Class 5 - Registration No. 358259 dated April 23, 2005 valid up to October 9, 2018.

Plaintiff No.3 was granted a secondary, formulation patent in relation to Trastuzumab from the Controller General of Patents, in India, which was effective from May 3, 1999 and it has been lapsed on May 3, 2013. All the three plaintiffs hereinafter collectively referred to as the "plaintiffs".

3. Defendant No.1, the Drug Controller General of India, Central Drugs Standard /Control Organization, Ministry of Health and Family Welfare, Government of India, is responsible for the approval of new drugs under the Drugs and Cosmetics Act, 1940, as amended (the "Drugs Act") and the rules framed thereunder, (hereinafter referred to either defendant No.1 or DCGI)

The defendant No.2, Biocon Limited, a company incorporated under the Companies Act, with its registered office at Bangalore, Kamataka - 561229, is a co-developer of a purported bio-similar version of Trastuzumab, along with defendant No.3, Mylan Inc., a corporation incorporated in the State of Pennsylvania, USA, with its principal office at Pennsylvania 15317, USA, who conducts business in India, through Mylan Pharmaceuticals Private Limited (defendant No.4 herein), Mylan Laboratories Limited and Mylan Laboratories India Private Limited. Defendant No.2 after filing of the suit markets its purported bio-similar Trastuzumab in India under the brand name CANMAb.

4. Defendant No.4, Mylan Pharmaceuticals Private Limited, a company incorporated under the Companies Act, with its registered office at Mumbai, is a subsidiary of defendant No.3 and pursuant to the co-development agreement between defendant No.2 and defendant No.3, has now launched a purported bio-similar version of Trastuzumab in India under the brand name HERTRAZ. Defendants No.1, 2, 3 and 4 are hereinafter (referred to as the “defendants”).

5. Originally the suit was filed on account of imminent threat of the introduction of purported bio-similar version of plaintiff No.3’s biological drug Trastuzumab, which is claimed to have been jointly developed by defendants No.2 and 3, under the brand names CANMAb (150 mg/440 mg) by defendant No.2 and HERTRAZ (150 mg/440 mg) by defendant No.1. CANMAb and HERTRAZ are together referred as the defendants’ drugs. It was the plaintiffs’ contention at that time that the defendants’ drugs are, inter alia, being misrepresented as “Trastuzumab”, “bio