M/S Genentech Inc. vs Drugs Controller General Of India on 17 December, 2019


Supreme Court of India

M/S Genentech Inc. vs Drugs Controller General Of India on 17 December, 2019

Author: Hon’Ble Dr. Chandrachud

Bench: Hon’Ble Dr. Chandrachud, Hrishikesh Roy

                                                                              [REPORTABLE]

                                     IN THE SUPREME COURT OF INDIA
                                      CIVIL APPELLATE JURISDICTION

                                       CIVIL APPEAL NO. 9491 OF 2019
                                   (Arising out of SLP(C) No.24727 of 2019)


         M/s Genentech Inc. & Ors.                                      Appellant(s)


                                                   Versus


         Drug Controller General of India & Ors.                        Respondent(s)




                                               JUDGMENT

Hrishikesh Roy, J.

Leave granted.

2. This appeal has been preferred against the interim order dated

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.
Signature Not Verified

Digitally signed by
ASHOK RAJ 1 SINGH
Defendant no.3 in O.S No.181/2016
Date: 2019.12.17
18:04:09 IST

Page 1 of 21
Reason:

3284/20152 before the High Court of Delhi was filed by appellant no.1-

M/s Genentech Inc. together with appellant nos. 2 and 3 namely Roche

Products (India) Pvt. Ltd. and F. Hoffmann-La Roche, AG 3 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 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. from

launching, marketing or selling ‘TrastuRel’, the biosimilar version of the

appellants drug ‘Trastuzumab’. In the suit, the approval granted by

respondent no.1-Drugs Controller General of India 4 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 on

2
Reliance Suit
3
Plaintiffs in O.S. No. 181/2016
4
DCGI
Page 2 of 21
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, 1940 5

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.

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.

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

5
The Act
Page 3 of 21
restraint against purported biosimilar version of the appellants drug,

“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

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 approval

by the DCGI for the biosimilar drug of respondent no.3, was 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 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

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by the learned Single Judge on 25.04.2016. The Court recorded the

prima facie finding that ‘TrastuRel was approved 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. 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:

“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 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 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
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ascribing any bio-similarity with that of the plaintiffs
products HERCEPTIN, HERCLON, BICELTIS 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 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 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 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.

(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 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
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plaintiffs for the comparison 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 facts in the present case only wherein the
defendant No.3 is already in possession of
approvals granted rightly or 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 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 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 market ‘CANMab’

and ‘HERTRAZ’ without complying with the additional directions set forth

in the order dated 28.06.2016.

Page 7 of 21

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

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 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.227/2016.

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

launch and market their product ‘TrastuRel’ without projecting the same
Page 8 of 21
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, 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 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 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

Page 9 of 21
the appellants contends that the Division Bench failed to 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 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 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 ‘TrastuRel’ and

therefore, the conditions imposed by the learned Single Judge on

25.4.2016, should not have been interdicted without the final decision in

the Reliance suit, pending before the Court instead the appeal filed by

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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 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’

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 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

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the patients and also to distinguish the Reliance’s drug from 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 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 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 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.

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14.3 Mr. Poovayya submits that respondent No. 3 has faced

considerable difficulties in participating in tenders where the required

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 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

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 Subject

Expert Committee (Oncology and Hematology) as also the approval

granted by the DCGI for manufacturing ‘Trastuzumab’, under Form No.
Page 13 of 21
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 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

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 Phase I and Phase

II for the drug manufactured by respondent no.3, are not registered with

the DCGI but approvals were accorded on the 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

Page 14 of 21
mind. The possibility of the attempt by 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 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 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 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
Page 15 of 21
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 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

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

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.

Page 16 of 21

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. 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 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 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 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

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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 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

were taken into account. The said interim order was operating without

causing much hindrance and respondent No. 3 was successful in

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 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

Page 18 of 21
arrangement in our opinion should not have been disturbed, on this

count.

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 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 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 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
Page 19 of 21
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 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 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

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 the Reliance’s suit is pending since 2016, the High Court is requested
Page 20 of 21
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

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 order

on cost.

…………………………J.

[R.BANUMATHI]

…………………………J.

[A.S.BOPANNA]

…………………………J.

[HRISHIKESH ROY]
NEW DELHI
DECEMBER 17, 2019

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