Holding

The Division Bench erred in not entertaining the appellants’ applications; the Single Judge’s interim order stands and the appeal is allowed.

Summary

Genentech Inc., Roche Products (India) and F. Hoffmann‑La Roche filed a suit in the Delhi High Court seeking to restrain Reliance Life Sciences from launching its biosimilar product ‘TrastuRel’, alleging improper use of data and passing off. The Single Judge of the High Court, on 25 April 2016, allowed Reliance to market the drug subject to conditions restricting claims of biosimilarity and specific labeling. The Division Bench later set aside that interim order and granted Reliance parity with other biosimilar manufacturers, but considered only Reliance’s application and not the appellants’ interim applications, contrary to a Supreme Court direction in SLP (C) No. 6203/2019 that both parties’ applications be heard analogously. The Supreme Court held that the Division Bench erred, reinstated the Single Judge’s interim order, set aside the impugned order, and directed the High Court to dispose of the pending suit expeditiously while allowing Reliance to continue participating in government tenders. The appeal was allowed.

Issues considered

The Division Bench’s compliance with the Supreme Court’s direction to consider both parties’ interim applications simultaneously.
Whether the interim order imposing labeling and biosimilarity restrictions should remain in force pending final determination of the suit.
Whether the expiry of the appellants’ patent on Trastuzumab affects the nature of the suit (extended passing off).
Whether the balance of convenience requires maintaining the status quo established by the Single Judge’s order.

Legislation cited

Drugs and Cosmetics Act, 1940
Drugs and Cosmetics Rules, 1945s. Rule 96

Subjects

biosimilardrug approvalinterim injunctionextended passing offpatent expirybalance of convenienceregulatory approvallabeling restrictionsDCGISupreme Court direction

Judgment

318 [2019]
SUPREME COURT 15 S.C.R. 318
REPORTS [2019] 15 S.C.R.

A M/S GENENTECH INC. & ORS.
v.
DRUGS CONTROLLER GENERAL OF INDIA & ORS.
(Civil Appeal No. 9491 of 2019)
B 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
C
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
D 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
E 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
F 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
G 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
H
318
M/S GENENTECH INC. & ORS. v. DRUGS CONTROLLER 319
GENERAL OF INDIA & ORS.

passed by the Division Bench of the High Court set aside – The A
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 B
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 C
‘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 D
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]
E
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 F
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
G
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 accepted. [Para 18] [329-G-H; 330-A-B] H
320 SUPREME COURT REPORTS [2019] 15 S.C.R.

A 3. When the impugned order of the Division Bench of the
High Court is read in the context of the express direction of
this Court, it is clearly discernible that the Division Bench of
the High Court had only considered the appeal and application
filed by respondent no.3 on merit; without entertaining the
appellants’ application. [Para 19] [330-B-C]
B
4. The appellants’ suit before the Delhi High Court is not
a trade mark action nor it is an attempt to enforce the appellants’
patent, which admittedly expired in 2013. The suit is an action
for extended passing off and to prevent the respondent from
using the appellants’ data and improper reference to its drug
C ‘Trastuzumab’. Therefore, the expiry of the appellants’ patent
right on the drug ‘Trastuzumab’ may not have any direct bearing
on the contention raised in the Reliance suit. [Para 24] [331-C-
D]
5. Reverting back to the impugned order, the Division
D Bench of the High Court had not only considered the contention
raised by the appellants but then rejected those, in the same
order. In such circumstances, directing the Division Bench to
now consider the appellant’s appeal and application would be
nothing but an empty formality, more particularly in the present
appeal when this Court taking note of the order passed by the
E Single Judge imposing conditions and the same being in
operation from 25.4.2016 has approved the same to be an
appropriate interlocutory order considering the nature of the suit
where all other issues are to be considered. [Para 26] [331-F-
G]
6. Because of the foregoing, and more particularly because
F
the Division Bench did not keep in view the order of this Court
dated 8.3.2019 to ensure analogous consideration of the interim
applications of both sides in terms of this Court’s earlier
direction and having regard to the fact that the position
prevailing since last three and a half years (pursuant to the Single
G Judge’s order dated 25.4.2016) have been upset without
considering the issue of balance of convenience, this Court is
persuaded to hold that the Division Bench was in error. Without
analogous consideration of the appellant’s applications, the Court
should not have unsettled the prevailing situation for the last
three and half years, without final conclusion of the respondent
H no.3’s suit. [Para 27] [331-H; 332-A-B]
M/S GENENTECH INC. & ORS. v. DRUGS CONTROLLER 321
GENERAL OF INDIA & ORS.

CIVIL APPELLATE JURISDICTION : Civil Appeal No. 9491 A
of 2019.
From the Judgment and Order dated 18.09.2019 of the High
Court of Delhi at New Delhi in C.M. Appl. No. 22510 of 2016 in
F.A.O. (OS) No. 181 of 2016.
B
Shyam Divan, Sajan Poovayya, Sr. Advs., Abhishek Tewari,
Ms. Niti Dixit, N. Mahabir, Aubert Sebastian, M/s. Muizz Drabu,
Ms. Sugandha Yadav, Aditya Garg, Pradeep Misra, Ms. Bitika Sharma,
Ms. Namrita Kochar, Luv Virmani, Pratibhanu, Kharola, Gaurav Sharma,
Gopal Jha, Mohd. Akhil, G.S. Makker, Advs. for the appearing parties.
C
The Judgment of the Court was delivered by
HRISHIKESH ROY, J.
1. Leave granted.
2. This appeal has been preferred against the interim order dated
D
18.09.2019 passed by the Division Bench of High Court of Delhi in
C.M. Application No. 22510/2016 in FAO (O.S) No.181/2016. Under
the impugned order, the Division Bench allowed the application filed
by respondent No.3-M/s Reliance Life Sciences Pvt. Ltd.1. The
CS(OS) No. 3284/20152 before the High Court of Delhi was filed by
appellant no.1-M/s Genentech Inc. together with appellant nos. 2 and E
3 namely Roche Products (India) Pvt. Ltd. and F. Hoffmann-La Roche,
AG3 respectively.
3. Plaintiff no.1- M/s Genentech Inc. claimed themselves to be
the innovators of the monoclonal antibody drug ‘Trastuzumab’ which
is manufactured by the plaintiff no.3- F. Hoffmann-La Roche and is F
being marketed in India by plaintiff no.2- Roche Products (India) Pvt.
Ltd. under the brand name HERCEPTIN, HERCLON and BICELTIS.
The drug ‘Trastuzumab’ is approved globally for treatment of cancer.
The suit before the Delhi High Court came to be filed seeking to inter
alia restrain respondent No.3-M/s Reliance Life Sciences Pvt. Ltd. G
from launching, marketing or selling ‘TrastuRel’, the biosimilar version
of the appellants drug ‘Trastuzumab’. In the suit, the approval granted
1
Defendant no.3 in O.S No.181/2016
2
Reliance Suit
3
Plaintiffs in O.S. No. 181/2016 H
322 SUPREME COURT REPORTS [2019] 15 S.C.R.

A by respondent no.1-Drugs Controller General of India4 to M/s. Reliance
Life Sciences Pvt. Ltd. for the manufacture and marketing ‘TrastuRel’,
was also challenged. The suit was filed at a stage when respondent
no.3 was yet to introduce their drug in the market. The appellants had
obtained patent for the drug ‘Trastuzumab’ but the same had lapsed
B on 3.5.2013 but they 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 to
be launched by respondent no.3, has not been tested as a biosimilar
drug in accordance with the law under the Drugs and Cosmetics Act,
C 19405 and other applicable norms and guidelines with the projection that
the respondent no.3 has not undertaken requisite chemical trials and
has not also generated adequate data to establish, inter alia, the safety,
efficacy and immunogenicity of the drug-‘TrastuRel’, manufactured by
respondent no.3.
D 5. Respondent no.3, however, contended that the appellants have
no enforceable right in the drug ‘Trastuzumab’ as the patent right with
respect to the drug, available with the appellants had lapsed in 2013.
Therefore, any other intending manufacturer could rely upon the
appellant’s data relating to Phase I and Phase II trials, as available in
public domain.
E
6. Prior to the Reliance suit filed against respondent no.3, the
appellants had filed the suit being CS (OS) No. 355/2014 against F.
Hoffmann-La Roche, AG, their associate Mylan Inc, seeking similar
restraint against purported biosimilar version of the appellants drug,
F “Trastuzumab”. Biocon and Mylan were however already in the
market by selling their products “Trastuzumab’ - ‘CANMab’ and
‘Trastuzumab’-‘HERTRAZ’ in the market.
7. The High Court of Delhi passed respective orders on
5.12.2014,14.2.2014 and 28.02.2014 in the Biocon’s suit and permitted
G Biocon and Mylan to market their drugs subject to the conditions that
they would not claim bio similarity with the appellants’ product
HERCEPTIN, HERCLON and BICELTIS. However, in the Reliance
suit, the learned Single Judge was of the prima facie view that the
4
DCGI
H 5
The Act
M/S GENENTECH INC. & ORS. v. DRUGS CONTROLLER 323
GENERAL OF INDIA & ORS. [HRISHIKESH ROY, J.]

approval by the DCGI for the biosimilar drug of respondent no.3, was A
far more egregious than in the case of the drug marketed by Biocon.
Accordingly, an interim order was passed on 2.11.2015 in the Reliance
suit whereby respondent no.3 was restrained from launching and selling
their product ‘TrastuRel’ in India, until the next date of hearing. In the
Biocon and the Reliance suits, the appellants had claimed that the
B
biosimilar version of the appellants ‘Trastuzumab’, were being launched
without the required test and studies under the applicable laws requiring
conducting of tests and obtaining of appropriate approval from the
regulatory authority including the DCGI. The appellants’ injunction
application was ordered by the learned Single Judge on 25.04.2016. The
Court recorded the prima facie finding that ‘TrastuRel was approved C
by the DCGI under applicable law. The learned Single Judge observed
that the approvals granted to ‘TrastuRel’ product are not on the basis
of the adherence of the Guidelines 2012 and rules framed under the
Drug Act. However, it was observed that the final finding in this respect
is yet to be arrived after the suit is heard and completion of the trial.
D
Accordingly, while permitting respondent no.3 to launch and market
‘TrastuRel’ on the basis of the approval from the DCGI, certain
conditions were imposed by the learned Judge to safeguard public health
and safety as also to protect the innovator of the biosimilar drug
‘Trastuzumab’. The relevant stipulations of the learned Single Judge
are noted as follows: E
“262. I am of the view that the approvals granted to TrastuRel
product are not on the basis of the adherence of the Guidelines
of 2012 and rules framed under the Drug Act. The final finding
in this respect is yet to be arrived after the present suit is heard
upon completion of the trial. Pending the final outcome of the F
suit, there is need to arrive at interim measure by working out
certain terms between the parties by passing the following
directions:-
(a) The defendant No.3 may launch to manufacture, market
and advertise their product under the name TrastuRel on G
the basis of the approvals already granted to defendant
No.3 without calling their product as “bio similar” and/ or
“bio similar to HERCEPTIN, HERCLON, BICELTIS” or
in any way ascribing any bio-similarity with that of the
plaintiffs products HERCEPTIN, HERCLON, BICELTIS H
324 SUPREME COURT REPORTS [2019] 15 S.C.R.

A in any press releases, public announcements, promotional
or other in printed form and from relying upon or referring
the plaintiffs’ names.
(b) The defendant No.3 may also manufacture and market the
drug by qualifying the INN name Trastuzumab but not to
B use the said name stand alone on the carton or package
insert as a brand name. The defendant No.3 can use the
INN name as Reliance Trastuzumab or TrastuRel
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
C
the bottom part of the carton and should be in small size
letters than the brand name TrastuRel.
(c) In view of prima facie findings that the use of the data by
the defendant No.3 in the product insert without undergoing
the entire process of the trials is misleading, the defendant
D No.3 is also restrained from using the data relating to
manufacturing process, safety, efficacy and tests conducted
for the safety of the drugs as complained of by the
plaintiffs till the time the final decision on the issue of the
bio similarity is made in the present suit.
E (d) In the event, the defendant No.3 intends to claim bio similar
as a description of its product or part of its promotional
campaign or otherwise in any other form, the defendant
No.3, if so advised, can re-apply the said license before
the relevant authorities including defendant No.1 and in
F which case, the defendant No.1, the authorities and
committees framed therein shall decide the said approval
application in accordance with the Rules and Guidelines
of 2012 and also the observations made by this court in
the present order. The defendant No.3 shall also be entitled
to use the data of the plaintiffs for the comparison
G purposes before the Regulatory Authority. In the alternative,
the defendant No.3 may await the outcome of the present
suit and can continue with the present arrangement as an
interim measure.
(e) This interim measure is made only in view of the peculiar
H facts in the present case only wherein the defendant No.3
M/S GENENTECH INC. & ORS. v. DRUGS CONTROLLER 325
GENERAL OF INDIA & ORS. [HRISHIKESH ROY, J.]

is already in possession of approvals granted rightly or A
wrongly validity of which is questioned in this suit. In future
application for approval(s) of biosimilar shall be decided
by the defendant No.1 and authorities and committees
while considering the guidelines of 2012 and also the
findings arrived at in the present order by this Court as
B
well as strictly as per the provisions of the Act and Rules.”
8. In a separate order, also dated 25.04.2016 in the Biocon suit,
the learned Single Judge imposed similar conditions as those on
respondent no.3.
9. Aggrieved by such restriction, Biocon and Mylan approached C
the Division Bench of the High Court. Likewise, the appellants filed
appeal FAO (OS) No. 227 of 2016. Respondent no.3 filed appeal
(FAO(OS) No. 181/2016) against the interim order dated 25.4.2016.
The Division Bench noted that Biocon and Mylan has been in the market
for almost two years and accordingly permitted them to continue to
D
market ‘CANMab’ and ‘HERTRAZ’ without complying with the
additional directions set forth in the order dated 28.06.2016.
10. In the appeals filed by respondent no.3 and in their challenge
to the Single Judge order of 25.04.2016, the Division Bench had not
granted any interim relief to respondent no.3 until the recent impugned
E
order (18.9.2019); The respondent no.3 accordingly filed SLP(C)
No.6203/2019 in this Court.
11. The earlier SLP(C) No.6203/2019 was disposed of by this
Court on 8.3.2019 with a request to the High Court of Delhi to
simultaneously take up the appeals preferred by the contesting parties F
at an early date and dispose of the same as expeditiously as possible
preferably within four months. In case, the appeals are not heard and
disposed of within the stipulated time frame, the High Court was
requested to take up the interlocutory application(s) filed by both
appellant and Respondent No. 3. The order passed by this Court on
8.3.2019 related to the FAO (OS) No.181/2016 and FAO (OS) No.227/ G
2016.
12. The Division Bench of the High Court thereafter considered
the FAO (OS) No.181/2016 and the C.M. Appln. No.22510/2016 filed
by respondent no.3 against the interim order passed by the learned Single
Judge on 25.04.2016 whereunder, respondent no.3 was permitted to H
326 SUPREME COURT REPORTS [2019] 15 S.C.R.

A launch and market their product ‘TrastuRel’ without projecting the same
as biosimilar to the appellants’ drugs HERCEPTIN, HERCLON and
BICELTIS. Under the impugned order dated 18.9.2019, the Division
Bench allowed the application of respondent no. 3 and granted interim
stay of the learned Single Judge order dated 25.04.2016 in terms of
the orders dated 28.4.2016 and as clarified vide order dated 3.3.2017,
B
in the FAO (OS) Nos.132/2016 and 133/2016, filed by Biocon and
Mylan. The Court justified the interim order by observing that the
regulatory authorities have granted their approval to the biosimilar drug
of respondent no.3 and prima facie the said approval cannot be
considered to be illegal. But it was not possible to determine at that
C stage, whether respondent no.3 has conducted the requisite trials as
are prescribed for a bio similar drug. The Division Bench held that in
the face of the expiry of the patent in favour of the plaintiff, their locus
standi to file the suit was considered to be relevant issue to be
determined and the possibility of the suit being filed with the objective
of stifling competition was taken into account and accordingly relief was
D
granted to respondent no.3 in marketing their product ‘TrastuRel’ on
the same terms, as was granted to Biocon and Mylan.
13.1 Assailing the impugned order of the Division Bench of the
High Court, Mr. Shyam Divan, learned Senior Counsel appearing on
behalf of the appellants contends that the Division Bench failed to
E
comply with the express directions contained in this Court’s order dated
8.3.2019 in the SLP(C) No. 6203 of 2019 whereby this Court had
expressly directed that the respective appeals and/or interim applications
filed by the appellants and respondent No. 3 be heard analogously and
disposed of. According to the appellants’ counsel, the Division Bench
F however considered only the application of respondent No. 3 on merit,
without simultaneously entertaining the appellants’ application.
13.2. On the claim for parity for the drug ‘TrastuRel’, with the
biosimilar drug produced and marketed by Biocon and Mylan, Mr. Divan
submits that the DCGI itself did not consider the drug of respondent
G no. 3 to be entitled to be treated at par with the product of Biocon and
Mylan. But this vital fact was ignored by the Division Bench in allowing
parity of operation to Reliance, with Biocon and Mylan.
13.3 The appellants then project that the Reliance has been
successful in participating in government tenders with their drug
H ‘TrastuRel’ and therefore, the conditions imposed by the learned Single
M/S GENENTECH INC. & ORS. v. DRUGS CONTROLLER 327
GENERAL OF INDIA & ORS. [HRISHIKESH ROY, J.]

Judge on 25.4.2016, should not have been interdicted without the final A
decision in the Reliance suit, pending before the Court instead the appeal
filed by appellant ought to have been considered, allowed and absolute
injunction should have been granted.
13.4 According to Mr. Divan the issue of International Non-
Proprietary Name (“INN”) goes to the very root of the dispute between B
the parties. He contends that Reliance is not entitled to use the INN,
since their drug has been approved without undergoing the required
testing, prescribed under the Act, the Rules and the 2012 Guidelines.
13.5 Referring to the consideration made by the learned Single
Judge in the Reliance Suit in disallowing parity to the drug ‘TrastuRel’ C
manufactured by the respondent No. 3, the appellants’ counsel submits
that the DCGI too had admitted that the Reliance did not conduct
Phase-I and II of the mandatory three phase sequential clinical trials
and that Reliance has misappropriated and reproduced the appellants’
data in their test dossiers and marketing material and therefore the
possibility of jeopardising public safety was considered by the learned D
Single Judge in stipulating certain conditions to allow marketing of the
drug ‘TrastuRel’, manufactured by Reliance. The learned Senior
Counsel emphasizes that the direction issued to Reliance to add qualifier
to the word ‘Trastuzumab’ was to avoid jeopardising the health and
safety of the patients and also to distinguish the Reliance’s drug from E
that of the innovator.
14.1 On the other hand, Mr. Sajan Poovayya, learned Senior
Counsel submits that the Division Bench while passing the impugned
order had considered elaborate arguments advanced by the counsel
representing the appellants and all their contentions were duly considered F
and therefore, there was adequate compliance with this Court’s order
dated 8.3.2019 in SLP(C) No. 6203 of 2019. According to the
respondent no. 3, the Division Bench was conscious of this Court’s order
and therefore, dealt with the submissions of the appellants as can be
seen from paragraphs 41 to 50 in the impugned order. The learned
Senior Counsel would therefore argue that the impugned order of the G
Division Bench cannot be said to be in violation of the direction issued
for analogous consideration of the appeals and interim applications, of
the rival parties.
14.2 The learned Senior Counsel submits that the appellants’
patent right on the product ‘Trastuzumab’ has lapsed in 2013 and H
328 SUPREME COURT REPORTS [2019] 15 S.C.R.

A therefore, in the Reliance’s suit, the conditions imposed by the learned
Single Judge on 25.4.2016 should not be allowed to continue to the
prejudice of respondent No. 3.
14.3 Mr. Poovayya submits that respondent No. 3 has faced
considerable difficulties in participating in tenders where the required
B product is described in its generic name ‘Trastuzumab’ and therefore,
despite being identically placed with other Indian manufacturers like
Biocon, Mylan, Zydus, the respondent No. 3 is unfairly restricted to
market their bio similar drug.
14.4 Respondent No. 3 next contends that the condition imposed
C by the learned Single Judge on the packaging/labelling on the drug
manufactured by the Reliance is contrary to Rule 96 of the Drugs and
Cosmetic Rules, 1945 and accordingly, he argues that the Division
Bench order which allows respondent No. 3 to manufacture and market
their bio similar product with the labelling direction given in the
Reliance’s suit, would not enable respondent No. 3 to conform to the
D
statutory rules.
14.5 Questioning the timing of the Reliance suit, Mr. Poovayya
submits that the suit was filed by the appellants just when Reliance was
ready to launch their product after obtaining all requisite approvals
including manufacturing and marketing authorisation granted by the
E
Subject Expert Committee (Oncology and Hematology) as also the
approval granted by the DCGI for manufacturing ‘Trastuzumab’, under
Form No. 46 and 46A of the Act. It was submitted that the package
insert, the carton package were duly approved by the Subject Expert
Committee, but on account of the interim order passed by the learned
F Single Judge on 25.4.2016, the respondent No. 3 had to revise their
packaging and package insert to the extent that the INN name
‘Trastuzumab’ was to be qualified with the company’s name.
15. The learned counsel appearing for Union of India makes no
specific submissions in the appeal but only submitted that DCGI has
G granted the approval to respondent No. 3.
16. Before we consider the rival contentions, at the outset it is
noted that the Reliance suit is now pending for final disposal in the High
Court. In the detailed interim order recorded on 25.04.2016, the
submissions of the learned ASG to the effect that the clinical trials of
H Phase I and Phase II for the drug manufactured by respondent no.3,
M/S GENENTECH INC. & ORS. v. DRUGS CONTROLLER 329
GENERAL OF INDIA & ORS. [HRISHIKESH ROY, J.]

are not registered with the DCGI but approvals were accorded on the A
basis of the justification given by respondent no.3 was noted by the
court. Whether the injunction suit filed by the appellants is an abuse of
the process of law and whether the approval was granted to the similar
drug manufactured by respondent no.3, without following 2012
Guidelines was also borne in mind. The possibility of the attempt by
B
the defendants to pass off their drug as biosimilar product
‘Trastuzumab’, marketed by the appellants was thought out. After
careful consideration of all those aspects including the projection from
the DCGI, the learned Single Judge felt that the process of obtaining
approval was flawed due to non-adherence to the statutory provisions
of the Act and the Rules as also of the 2012 Guidelines. Then reflection C
was made on the protective conditions which can be imposed for
allowing respondent no.3 to launch their product. Upon due assessment,
the interim order dated 25.04.2016 was then passed.
17. As permitted by the interim order dated 25.4.2016, the
respondent no.3 launched their bio similar product ‘TrastuRel’ and they D
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 learned Single Judge did not stop the marketing of E
the drug ‘TrastuRel’, the Division Bench even while adverting to the
concern raised by the learned 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 Biocon and Mylan. The Division Bench
felt that respondent no.3 is on similar footing as Biocon and Mylan and F
therefore parity in marketing of their respective biosimilar product can
be allowed.
18. In their challenge to the impugned order, the appellants have
contended that in passing the impugned order, the Division Bench had
failed to simultaneously consider and dispose of the pending appeals
G
and the interim applications filed by the plaintiffs. We 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 H
330 SUPREME COURT REPORTS [2019] 15 S.C.R.

A only in the context of the application filed by respondent no.3. On this
aspect, the learned senior counsel for 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 in paragraph 51 of
the impugned order, cannot be accepted by us.
B
19. When the impugned order of the Division Bench is read in
the context of the express direction of this Court, it is clearly discernible
that the Division Bench had only considered the appeal and application
filed by Reliance on merit that is FAO(OS) No. 227/2016 and C.M.
Appl. No. 22510/2016; without entertaining the appellants’ application.
C
In fact the Bench itself clarified the position in paragraph 51 of the
impugned order by stating the following:-
“……. …………. ……
51. We have heard learned counsels and considered their
D respective submissions. The submissions made on behalf of the
parties are being examined in the context of the appellant’s
application for stay of the impugned order.
…… ……. …… …….. …… ……. ……”
20. The fact that the Division Bench was singularly concerned
E with taking up the Reliance’s interim application is further established
from the separate order passed on 16.7.2019 in FAO (OS) No. 132,
133, 226, 227 and 268 of 2016 which directs the applications (including
the appeal and the application of the plaintiffs) to be listed on 11.2.2020.
By way of a separate order, of the same date i.e. 16.7.2019, the Division
F Bench reserved orders on Reliance’s application. Therefore, it is difficult
for us to accept as has been suggested by the learned Senior Counsel
for the respondent no.3 that the segregation of the application of one
party by the Division Bench, could be an inadvertent error.
21. In the above context, the Division Bench even without
G considering the appellants’ interim application through their observations
in paragraph 57, had clearly shut out any scope for the appellants’
application to be heard and in effect, ordered on the application.
22. In the interim order passed by the learned Single Judge on
25.4.2016, the conditions imposed on Reliance’s product by the DCGI
H were taken into account. The said interim order was operating without
M/S GENENTECH INC. & ORS. v. DRUGS CONTROLLER 331
GENERAL OF INDIA & ORS. [HRISHIKESH ROY, J.]

causing much hindrance and respondent No. 3 was successful in A
participation in government tenders and supplies, with their drug.
Therefore, the contrary submission made by the learned Senior Counsel
for respondent no.3 is found to be incorrect.
23. As regards the contention made by Mr. Poorvayya that the
condition imposed by the learned Single Judge on the packaging/labelling B
is contrary to the statutory prescriptions, it must be borne in mind that
the arrangement ordered by the learned Single Judge has been in
operation since 25.04.2016. Therefore without a final decision on the
suit on the basis of relevant evidence, the continuing arrangement in
our opinion should not have been disturbed, on this count.
C
24. The appellants’ suit before the Delhi High Court is not a trade
mark action nor it is an attempt to enforce the appellants’ patent, which
admittedly expired in 2013. The suit is an action for extended passing
off and to prevent the respondent from using the appellants’ data and
improper reference to its drug ‘Trastuzumab’. Therefore, the expiry of
the appellants’ patent right on the drug ‘Trastuzumab’ may not have D
any direct bearing on the contention raised in the Reliance suit.
25. As regards the submission on the timing of the suit and the
other contentions raised on the approval secured from the Subject
Expert Committee, these are matters which should appropriately be
dealt with when the suit is finally decided. Those need not be factored E
in at this stage, in support of the impugned interim order.
26. Reverting back to the impugned order, the Division Bench
had not only considered the contention raised by the appellants in
paragraphs 41 to 50 but then rejected those, in paragraphs 52 to 60 of
the same order. In such circumstances, directing the Division Bench F
to now consider the appellant’s appeal FAO No. 227/2016 and CM No.
26902 of 2016 would in our view be nothing but an empty formality,
more particularly in the present appeal when this Court taking note of
the order passed by the learned Single Judge imposing conditions and
the same being in operation from 25.4.2016 has approved the same to G
be an appropriate interlocutory order considering the nature of the suit
where all other issues are to be considered.
27. Because of the foregoing, and more particularly because the
Division Bench did not keep in view the order of this Court dated
8.3.2019 to ensure analogous consideration of the interim applications H
332 SUPREME COURT REPORTS [2019] 15 S.C.R.

A of both sides in terms of this Court’s earlier direction and having regard
to the fact that the position prevailing since last three and a half years
(pursuant to the learned Single Judge’s order dated 25.4.2016) have
been upset without considering the issue of balance of convenience,
we are persuaded to hold that the Division Bench was in error. Without
analogous consideration of the appellant’s applications, the Court should
B
not have unsettled the prevailing situation for the last three and half
years, without final conclusion of the Reliance suit.
28. In view of the aforesaid, the impugned order is set aside and
appeal is allowed. The interim direction given by the learned Single Judge
on 25.4.2016 is accordingly made operational. At the same time, as
C the Reliance’s suit is pending since 2016, the High Court is requested
to dispose of the CS (OS) No. 3284/2015 expeditiously and preferably
within 12 months of receipt of this order. In the meantime, to avoid
prejudice to respondent No. 3, whenever government procurement is
proposed for the drug by its generic name ‘Trastuzumab’, the Reliance
D should be allowed to participate with their biosimilar product, without
any impediment. It is made clear that the views expressed here is only
for the purpose of this appeal and should have no bearing in the
proceeding pending in the High Court.
29. With the above order, the appeal stands allowed without any
E order on cost.

Ankit Gyan Appeal allowed.

F

G

H