Page 46 - A&A Patents&Design Rewind-2016

or in any way ascribing any bio-similarity with
that of the plaintiff’s products HERCEPTIN,
HERCLON, BICELTIS in any press releases,
public announcements, promotional or other in
printed form and from relying upon or referring
the Plaintiff’s names.
b) The Defendants may also manufacture and
market the drug by qualifying the INN name
Trastuzumab as Biocon’s Trastuzumab or
Mylan’s Trastuzumab wherever applicable to
describe the composition of molecule on the
product as well as in its insert and not in a
prominent manner. The said expression shall
be used at the bottom part of the carton and
should be in smaller sized letters than their
respective brand names. However, the INN
name cannot stand alone on the carton or
package and cannot be used as a brand name.
c) In view of the prima facie findings of misleading
use of innovator data by Biocon and Mylan in
the product insert without undertaking all the
required clinical trials, Biocon and Mylan were
also restrained from using the data relating
to manufacturing process, safety, efficacy and
tests conducted for the safety of the drugs till http://delhihighcourt.nic.in/dhcqrydisp_o.
the time the final decision on the issue of bio
similarity is issued.
d) If Biocon intends to claim biosimilarity they can
make an application in this regard to DCGI who
should then evaluate the case in accordance
46 | Patents & Design
with the Drugs and Cosmetics Act and Rules
and the Guidelines on Biosimilars and in light
of the Court’s order. In the alternative, Biocon
can await the final decision in this matter from
the High Court.
As per the Court, this interim measure is made
only in view of the peculiar facts of the present case
wherein the Defendant is already in possession of
approvals granted rightly or wrongly, validity of
which is questioned in this suit.
An appeal was subsequently filed against the order
of the Single Judge. The Division Bench issued notice
and stayed the order of the Single Judge.
The Division Bench of the Delhi High Court, has
now reversed the order of the Single Judge and has
permitted Biocon and Mylan to use Roche’s product
data for Trastuzumab.
The orders of the Single Judge and the Division
Bench can be accessed here:
http://lobis.nic.in/ddir/dhc/MAN/
judgement/26-04-2016/MAN25042016S3552014.
pdf
asp?pn=93307&yr=2016