Genentech Inc And Others vs Drugs Controller General Of India And ... on 25 April, 2016
66. The said Rule does not protect or enforce the right of the
innovator drugs. Even Mr.Sanjay Jain, learned ASG appearing on
behalf of the defendants No.1 and 2, has admitted that the procedure
CS (OS) No.3284/2015 Page 73 of 187
of granting approvals to manufacturers for biosimilar drugs does not
involve a lis between the manufacturer of the innovator drug and the
manufacturer of the biosimilar drug. Defendant No.1 does not
determine the rights of such parties at the time of granting approvals to
drug manufacturers. Therefore, the plaintiffs (i.e. the manufactures of
the innovator drug in the present case) are entitled to file a civil suit to
protect their rights in relation to the plaintiffs' Trastuzumab as
efficacious remedy under this Rule is not available. (See Ganga Ram
Hospital v. Municipal Corporation of Delhi (2001 (60) DRJ 549 at
paragraph 20).