office at Bangalore,
Kamataka - 561229, is a co-developer of a purported biosimilar version
of Trastuzumab, along with defendant No.3, Mylan Inc., a corporation ... Limited.
Defendant No.2 after filing of the suit markets its purported biosimilar
Trastuzumab in India under the brand name CANMAb.
4. Defendant
Reliance Life Sciences Pvt. Ltd. from
launching, marketing or selling ‘TrastuRel’, the biosimilar version of the
appellants drug ‘Trastuzumab’. In the suit, the approval granted ... sought to restraint respondent no.3 from representing
their product ‘TrastuRel’, as biosimilar to ‘Trastuzumab’
4. According to the appellants, the biosimilar product in India
that the defendant's
drug has not been tested as a biosimilar product under applicable law,
defendant No.3's CTR Registration Number ... defendant No.3's drug, TrastuRel ("TrastuRel"), a purported biosimilar
version of the plaintiffs' biological drug Trastuzumab (the "plaintiffs
manufacture, market and advertise their drug TrastuRel without calling the
same as biosimilar to the respondents/ plaintiffs drugs HERCEPTIN®,
HERCLON™ and BICELTIS®. The learned Single ... appellant from launching, selling, marketing and/or distributing the
appellant‟s biosimilar drug „TrastuRel‟, in the domestic market as
Trastuzumab, developed by the said respondents
Marketing Authorization in India,
2012 (hereinafter referred to as the 'Biosimilar Guidelines'), for
manufacturing and marketing the biosimilar version of 'Trastuzumab ... Indian
market as 'Trastuzumab' and from representing its drug as biosimilar
version of 'Trastuzumab' or of HERCEPTIN, HERCLON and
BICELTIS
stocks of the product "Sigrima" and/ or any similar biologic/
biosimilar of Pertuzumab, infringing the claims of IN 268632 and IN
4646464, from ... stocks of
the product "Sigrima" and/ or any similar biologic/ biosimilar of
Pertuzumab, infringing the claims
detailed that the defendant
was undertaking clinical trials for a similar biologic/ biosimilar of the
plaintiffs' Pertuzumab for its product under the nomenclature ... also scientific principles
that are foundational for the biologic and its biosimilar contender.
*** *** ***
25. Thus, in view of the aforenoted responses by Dr. Singhvi
violation of the Drugs Act , the Drugs Rules and the Biosimilar
Guidelines. Defendant No. 1 has failed to establish bio similarity
between the Defendant ... violation of the Drugs Act , the Drugs Rules and
the Biosimilar Guidelines and deserves to be restrained by this
Hon'ble Court
violation of the Drugs Act , the Drugs Rules and the Biosimilar
Guidelines. Defendant No. 1 has failed to establish bio similarity
between the Defendant ... violation of the Drugs Act , the Drugs Rules and
the Biosimilar Guidelines and deserves to be restrained by this
Hon'ble Court
detailed drug control research on
the ground that ZRC 3276 is a biosimilar of Nivolumab which was,
therefore, the "reference biologic ... patent, had the same amino acid
sequencing as in Nivolumab and (iii) biosimilars had necessarily to
have the same amino acid sequencing. Once, therefore
