G H M/S GENENTECH INC. & ORS. versus DRUGS CONTROLLER GENERAL OF INDIA & ORS.

Citation: [2019] 15 S.C.R. 318 · Decided: 17-12-2019 · Supreme Court of India · Bench: R. BANUMATHI, A.S. BOPANNA, HRISHIKESH ROY · Disposal: Appeal(s) allowed

Judgment (excerpt)

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SUPREME COURT REPORTS
[2019] 15 S.C.R.
M/S GENENTECH INC. & ORS.
v.
DRUGS CONTROLLER GENERAL OF INDIA & ORS.
(Civil Appeal No. 9491 of  2019)
DECEMBER 17, 2019
[R. BANUMATHI, A. S. BOPANNA
AND HRISHIKESH ROY, JJ.]
Drugs and Cosmetics Act, 1940 – A suit was filed by the
appellants before the High Court to restrain respondent No. 3 from
launching, marketing or selling ‘TrustuRel’ the biosimilar version
of the appellants drug ‘Trastuzumab’ – Prior to this suit, appellants’
had filed a similar suit against ‘B&M’ and High Court had allowed
‘B&M’ to market their drugs – However, respondent no. 3 in its
suit was restrained from launching and selling ‘TrustuRel’ and
injunction was ordered by the Single Judge of High Court on
25.04.2016 – According to the Single Judge of the High Court,
the approvals granted to ‘TrustuRel’ product were not on the basis
of the adherence of the guidelines 2012 and rules framed under
the Drug Act – However, respondent no. 3 was permitted to launch
and market ‘TrustuRel’ on the basis of the approval from the DCGI
and without projecting their product as a biosimilar to the
appellants’ product – The Division Bench of the High Court
granted interim stay of the Single Judge Order dated 25.04.2016
and allowed respondent no. 3 parity of operation with ‘B&M’ –
Earlier Supreme Court had in another Special Leave Petition had
directed the Division Bench of the High Court to simultaneously
take up the appeals and interim applications filed by both sides –
Held: As permitted by the interim order dated 25.04.2016, the
respondent no.3 had launched its biosimilar product and they were
in market with their drug for the last three and a half years – The
Division Bench of the High Court had only considered the appeal
and application filed by the respondent no.3 on merit without
entertaining appellants’ application – The Division Bench of the
High Court committed an error – Without analogous consideration
of the appellants’ applications, the Court should not have unsettled
the prevailing situation for last three and half years, without final
conclusion of the respondents’ suit – Therefore, the impugned order
   [2019] 15 S.C.R. 318
318
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passed by the Division Bench of the High Court set aside – The
interim direction given by the Single Judge on 25.04.2016 made
operational – Further, the High Court directed to dispose of the
pending suit expeditiously.
Allowing the appeal, the Court
HELD: 1. As permitted by the interim order dated
25.4.2016, the respondent no.3 launched their biosimilar product
‘TrastuRel’ and they have been in the market with their drug
for the last about three and a half years. They have also
participated in Government tenders and when certain doubts
were raised on whether the drug ‘TrastuRel’ is biosimilar with
‘Trastuzumab’, the High Court had intervened in favour of
respondent no.3, in separate proceeding. However, while the
interim order passed by the Single Judge of the High Court did
not stop the marketing of the drug ‘TrastuRel’, the Division
Bench of the High Court even while adverting to the concern
raised by the Single Judge on the issues, which are to be
determined when the suit is finally decided, allowed respondent
no.3 the parity of operation with ‘B&M’. The Division Bench
of the High Court felt that respondent no.3 is on similar footing
as ‘B&M’ and therefore parity in marketing of their respective
biosimilar product can be allowed. [Para 17] [329-D-F]
2. In their challenge to the impugned order, the appellants
have contended that in passing the impugned order, the Division
Bench of the High Court had failed to simultaneously consider
and dispose of the pending appeals and the interim applications
filed by the plaintiffs. This Court had earlier referred to the order
passed by this Court on 8.3.2019 in SLP (C) No.6203/2019 which
required the High Court to simultaneously take up the appeals
and the interim applications filed by both sides. Although some
of the contentions raised by the appellants counsel were taken
into consideration, those submissions were examined by the
Division Bench of the High Court only in the context of the
application filed by respondent no.3. On this aspect, the
respondent no.3 submitted that non mentioning of the FAO and
the IA of the appellants was an inadvertent omission. However
such submission, in the face of the specific observation made
by the Division Bench of the High Court in the impugned order,
cannot be acce

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