XXVI All India Moot Court Competition at University Law College (ULC), Bangalore University, 2022

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Team Code: TC- 12

XXVI All India Moot Court Competition at University Law College (ULC),
Bangalore University, 2022

BEFORE
THE HON’BLE SUPREME COURT OF ARYAVARTHA
Original Writ Jurisdiction and Special Leave Petiton
(U/A 32 and 136 OF THE CONSTITUTION OF ARYAVARTHA)

IN THE MATTER OF

WRIT PETITION NO…………OF 2022

NYAYA NGO …………………………………...…………………………PETITIONER

V.

UNION OF ARYAVARTHA & RIO PHARMA & CO..........................................


RESPONDENT

WITH

SPECIAL LEAVE PETITION NO……. OF 2022

VIKRAM……………………..……………………………………………... APPELLANT

V.

RIO PHARMA & CO………………………………………………………...R ESPONDENT

MEMORIAL ON BEHALF OF RESPONDENT

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XXVI All India Moot Court Competition at University Law College (ULC),
Bangalore University, 2022

TABLE OF CONTENTS

TABLE OF CONTENTS .................................................................................................... 2


LIST OF ABBREVIATIONS .............................................................................................3
INDEX OF AUTHORITIES ................................................................................................4
BOOKS ................................................................................................................................4
STATUTES .........................................................................................................................4
WEBSITES .........................................................................................................................5
DICTIONARIES ..................................................................................................................5
CASE LAWS ......................................................................................................................6
STATEMENT OF JURISDICTION ....................................................................................7
SYNOPSIS OF FACTS ........................................................................................................8
STATEMENT OF ISSUES .................................................................................................10
SUMMARY OF ARGUMENTS .........................................................................................11
ARGUMENTS ADVANCED .............................................................................................12
1. Whether the Non-Disclosure Agreement is legally enforceable given the facts of the
case?.........................................................................................................................12
2. Whether, the instrumentality of State is bound to pay compensations for the victims
and take proactive actions?......................................................................................14
2.1 Report from unconfirmed sources is not valid………………………………...15
2.2 Rule 122 DAB of Drug and Cosmetic Act, 1940……………………………...16
3. Whether Vikram has a right to present a PIL against the State and others despite being
estopped by the non-disclosure agreement?............................................................19
A. Mr. Vikram does not possess the requisite locus standi in the instant
case…………………………………………………………………………...19
B. There exists ulterior motive behind filing the PIL…………………………..20
4. Whether the concerned Bar Councils are justified in holding Vikram for committing
acts amounting to misconduct and suspend him for life from practice…………..22
PRAYER ..............................................................................................................................26

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XXVI All India Moot Court Competition at University Law College (ULC),
Bangalore University, 2022

LIST OF ABBREVIATIONS

S.No ABBREVIATION FULL FORM

1.UOIUnion of India
2. Ors. Others

4.3. Hon’ble
Anr. Honourable
Another
6.5. SCC
SC Supreme
SupremeCourt
CourtCases
8.7. Sec.
Art. Section
Article
10.
9. u/s
u/a Under
Under Section
Article
12.
11. Ltd.
Pvt. Limited
Private

14.
13. AIR
NDPS All India
Narcotics Drugs and Reporter
Psychotropic Substances Act,
1985
16.
15. Edn.
IT Edition
Information Technology

17. Govt. Government

INDEX OF AUTHORITIES

STATUTES:

1. Constitution of India, 1950.

2. Narcotic Drugs and Psychotropic Substances Act, 1985

3. Drugs & Cosmetics Act, 1940

4. Indian Evidence Act, 1872

5. Indian Contract Act, 1872

6. Protection of Human Rights Act, 1993

INTERNATIONAL INSTRUMENTS:

1. Universal Declaration of Human Rights, 1947 (Adopted on December 10, 1948)

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XXVI All India Moot Court Competition at University Law College (ULC),
Bangalore University, 2022

BOOKS:

1. Arvind P. Datar, Datar on Constitution of India, Wadhwa & Company (2001).

2. Dr. J. N. Pandey, Constitutional Law of India, Central Law Agency (2005).

3. Durga Das Basu, Indian Constitutional Law, Kamal Law House Kolkata (2011).

4. H.K. Saharay, The Constitution of India: An Analytical Approach, Oxford Publishing


(2012).

5. M.P. Jain, Indian Constitutional Law, Lexis Nexis (2015).

6. Narendra Kumar, Constitutional Law of India, Allahabad Law Agency (2015)

7. P.N. Bakshi, ‘The Constitution of India’, Universal Law Publishing Co. (2015)

8. Dr. M.C.Mehanathan, Law on Control of Narcotic Drugs and Psychotropic Substances in


India, 3rd edition, 2015

9. Chandra Satish, “Indian Evidence Act, 1872”, Allahabad Law Agency, Faridabad, 2012.

10. R.P.Kataria, Law Relating to Narcotic Drugs and Psychotropic Substances in India, 3rd
edition 2010, reprint 2013 (with latest Case-law)

11. Sharma &Mago, Narcotic Drugs and Psychotropic Substances Laws, 3rd edition, 2016

12. N.K.Rastogi , An Exhaustive Commentary on The Narcotic Drugs & Psychotropic


Substances Act & Rules, 2002

WEBSITES:
1. www.eugdpr.org

2. www.lawctopus.com

3. www.legalserviceindia.com

4. www.meity.gov.in

5. www.scconline.com

6. www.manupatra.com

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XXVI All India Moot Court Competition at University Law College (ULC),
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7. www.shodhganga.inflibnet.ac.in

8. www.cis-india.org

9. www.lawfinderlive.com

DICTIONARIES:
1. Black, Henry Campbell: Black’s Law Dictionary ‟6th Edn. Centennial Ed. (1891-1991).

TABLE OF CASES

Ashok Kumar Pandey v. State of West Bengal (2004) 3 SCC 349 (India)…………………..21
Bandhua Mukti Morcha v. Union of India, (1984) 3 SCC 161 (India)………………………20
Burlington Home Shopping Pvt. Ltd. v. RajnishChibber, 1995 (35) DRJ 335 ……………..14
Calcutta Gas Co. Ltd. v. State of West Bengal, A.I.R. 1962 S.C. 1044 (India)……………..20
D.B. Singh v. Union of India, (2004) 3 SCC 363 (India) ………………………………….20
Dattaraj Nathuji Thaware v. State of Maharashtra, (2004) 3 SCC 349 (India) ……………..21
Federation of Bar Ass'n in Karnataka v. Union of India, (2000) 6 SCC 715 (India) ……….20
Harvey Tiling Company (Ply.) Limited v. Rodomac (Ply.) Limited, (1977) R.P.C. 399
(Supreme Court of South Africa). …………………………………………………………..14
Janata Dal v. H.S. Chowdhary, (1992) 4 SCC 305 (India) [hereinafter Janta Dal]…………20
Jayaraj v. Comm'r of Excise, (2000) 7 SCC 552 : A.I.R. 2000 S.C. 3266 (India)………….20

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XXVI All India Moot Court Competition at University Law College (ULC),
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Kalikumar Pal v. RajkumarPal 1931 (58) Cal 1379, Para 5)………………………………..25


Kazi Lhendup Dorji v. C.B.I., 1994 SCC (Cri) 873 (India)……………………………….. 20
Kushum Lata v. Union of India, (2006) 6 SCC 180 (India)……………………………….. .20
Lok Prahari v. State of Uttar Pradesh, (2016) 9 SCC 739 (India)…………………………..20
Mr. Diljeet Titus, Advocate v. Alfred A Adebare and Ors., 2006 (32) PTC 609 (Del.)….....13
Raj Veer Singh v State of U.P WRIT - A No. - 30084 of 2003………………………...…...15
Rajiv Ranjan Singh v. Union of India, (2006) 6 SCC 613 (India)…………………………...20
S.P. Gupta v. Union of India, (1982) 3 SCC 223 : A.I.R. 1982 S.C. 149 (India)…………....20
State of Uttaranchal v. Balwant Singh Chaufal, (2010) 3 SCC 402 : A.I.R. 2010 S.C.
2550..20 Vijay Kumar Gupta v. State of Himachal Pradesh, 2015 SCC OnLine HP
184 (India)…….20 State V. Lalit Mohan Nanda AIR 1961 Ori 1, 1961 CriLJ
124……………………………...24 Subhash Kumar v. State of
Bihar, (1991) 1 SCC 598 (India)………………………………..20
Union Carbide Corporation vs Union of India, 1990 AIR 273, 1989 SCC (2) 540………….19

STATEMENT OF JURISDICTION

With reference to the circumstances presented in the instant case, the Petitioner has invoked
the Public Interest Litigation and Special Leave Petition of the Hon’ble Supreme Court of

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XXVI All India Moot Court Competition at University Law College (ULC),
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Aryavartha under Article 321and Article 1362 respectively of the Constitution Aryavartha,
1950.

Hence, this memorandum sets forth the facts, contentions and arguments on which it is based.

STATEMENT OF FACTS

……………………………NON- DISCLOSURE AGREEMENT……………………..…

1
Right to Constitutional Remedies:
1. The right to move the Supreme Court by appropriate proceedings for the enforcement of the rights
conferred by this Part is guaranteed
2. The Supreme Court shall have power to issue directions or orders or writs, including writs in the nature
of habeas corpus, mandamus, prohibition, quo warranto and certiorari, whichever may be appropriate,
for the enforcement of any of the rights conferred by this Part
3. Without prejudice to the powers conferred on the Supreme Court by clause ( 1 ) and ( 2 ), Parliament
may by law empower any other court to exercise within the local limits of its jurisdiction all or any of
the powers exercisable by the Supreme Court under clause ( 2 )
4. The right guaranteed by this article shall not be suspended except as otherwise provided for by this
Constitution.
2
Special leave to appeal by the Supreme Court:
1. Notwithstanding anything in this Chapter, the Supreme Court may, in its discretion, grant special leave
to appeal from any judgment, decree, determination, sentence or order in any cause or matter passed or
made by any court or tribunal in the territory of Aryavartha
2. Nothing in clause (1) shall apply to any judgment, determination, and sentence or order passed or made
by any court or tribunal constituted by or under any law relating to the Armed Forces.

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XXVI All India Moot Court Competition at University Law College (ULC),
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Vikram, a promising student hailed from middle strata of Aryavartha Society secured a
scholarship to pursue Law at Sayadhri Law College. He excelled in his studies and worked as
a retainer with Rio Pharma & Co, a multi-national pharmaceutical company, being a
subsidiary of a Rio Country company duly registered in Aryavartha for nearly 5 years until
2005 after passing out from the Law College. That as a part of his employment contract,
Vikram was forced to sign a non-disclosure agreement applicable for life with other
stereotype clauses as in the case of any standard NDA template including other agreements.
That during his association with the said company, medical trials were conducted in relation
to a new wonder drug by name RioGen.

……………………………….MEDICAL TRIAL OF DRUG……………………………….

RioGen could be used for a variety of ailments including treatment of Covid 19, malaria,
dengue and other viral infections. That during the medical trial, it was noticed by the said
pharmacy giant, that despite combating the said viral infections, the wonder drug had various
side effects leading to impotency amongst men and frigidity in women. Further the use of the
said drug gave higher risk of women relating to various forms of carcinoma. The said wonder
drug also contained various combinations of addictives which were found in narcotics
substances in order to give scope for a “happy state/bliss feeling”. Out of thousands of
persons who were subjected to medical trial, more than half of them were privy to at least one
of the side effects. That the said drug proposed to make the patients addictive due to the
above reason, it also created various ramifications to heart, kidney and liver of patients after
consuming the said drug.

……………………………….STING OPERATION BY NGO……………………………

Nyaya, an NGO which was established for the purpose of protection of rights of the needy
and poor, conducted a sting operation with the help of one detective agent planted by the said
NGO. He procured various primary & secondary evidences including profiles of people who
took the RioGen on trial, medical history including subsequent medical complications pre
and post-trial and their current whereabouts etc. The evidence was handed over to Nyaya the
NGO, which tracked nearly 60% of persons who had undertaken the said medical trial and
from unconfirmed sources it was learnt that the rest 40% of persons who had taken the

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XXVI All India Moot Court Competition at University Law College (ULC),
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medical trial succumbed to death due to the side effects privy to the RioGen including kidney
failure, cirosis, cancer, depresssion, impotency, suicide tendencies, etc.

…………………… COMPLAINT LODGED AGAINST Mr. VIKRAM…………………

That the Chief Executive Officer of Rio Pharma & Co, one Stephen John lodged complaint
against Vikram alleging misconduct since Vikram was estopped from going beyond the Non-
Disclosure Agreement between himself and Rio Pharma & Co. The said complaint was filed
before State Bar Council of Sayadhri and notice was issued to Vikram, disciplinary
proceedings were held against him and he was found guilty of misconduct and was suspended
from practice for life solely relying on the Non-Disclosure Agreement. Finding the said
Disciplinary Proceedings being unfair, Vikram sought to file an appeal before the Bar
Council of Aryavartha; The Bar Council of Aryavartha confirmed the order passed by Bar
Council of Sayadhri.

…………………………..…..PETITION BY NYAYA………...…………………………….

In the meantime, Nyaya espoused the cause of the said persons and filed a PIL before the
Hon’ble Supreme Court under Article 32 of the Constitution of Aryavartha, seeking for
judicial intervention due to the failure of the State for not properly evaluating RioGen,
including competent authorities established under Drugs &Cosmetics Act 1940 as well as
under the provisions of Narcotics Drugs and Psychotropic Substances Act, 1985.

…………………………..PETITION BY MR. CAVIAR…………………………………..

Also, in a separate petition by Mr. Vikram, Supreme Court was dealing with the Special
Leave Petition against order passed by Bar Council of Sayadhri.

………………………….. CLUBBING OF PETITIONS………………………………….

All these petitions have been clubbed by the Supreme Court of Aryavartha for hearing.

ISSUES RAISED

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XXVI All India Moot Court Competition at University Law College (ULC),
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- ISSUE I -

Whether the Non-Disclosure Agreement is legally enforceable given the facts of the case?

- ISSUE II -

Whether, the instrumentality of the State is bound to pay compensations for the victims and
take proactive actions?

- ISSUE III -

Whether Vikram has a right to present a PIL against the State and others despite being
estopped by the non-disclosure agreement?

- ISSUE IV -

Whether the concerned Bar Councils are justified in holding Vikram for committing acts
amounting to misconduct and suspend him for life from practice?

SUMMARY OF ARGUMENTS

1. WHETHER THE NON-DISCLOSURE AGREEMENT IS LEGALLY


ENFORCEABLE GIVEN THE FACTS OF THE CASE?

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XXVI All India Moot Court Competition at University Law College (ULC),
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The respondents most humbly submit that the Non-Disclosure Agreement signed by
Mr. Vikram is completely valid as it fulfills all the essentials of a valid contract and is
legally enforceable under the provisions of Contract Act, 1872. Moreover breach has
been done by Vikram by disclosing of information. Thus, agreement is enforceable
given the facts of the case.
2. THAT THE STATE IS NOT BOUND TO PAY COMPENSATIONS FOR THE
VICTIMS.
It is most humbly submitted before this Hon’ble court that the State is not bound to
pay any compensation to the victims because the Company Rio Pharma had
permission from the State to produce the wonder drug RioGen and run human trials.
Further it is presumed if a person gives his Voluntary consent then no liability arises.
3. VIKRAM HAS NO RIGHT TO PRESENT A PIL AGAINST THE STATE AND
OTHERS AS BEING ESTOPPED BY THE NON-DISCLOSURE
AGREEMENT.
It is most humbly submitted before the Hon’ble Court that Nyaya and Vikram do not
have valid Locus Standi to file a PIL under Art. 32 of the Constitution. Further both
have approached the court with ulterior motive and Vikram is estopped by the Non-
Disclosure Agreement. Thus, Vikram has no right to present a PIL against the state
and others.
4. THAT THE CONCERNED BAR COUNCILS ARE JUSTIFIED IN HOLDING
VIKRAM FOR COMMITTING ACTS AMOUNTING TO MISCONDUCT
AND SUSPENDING HIM FOR LIFE FROM PRACTICE.
The respondent most humbly submits before this Hon’ble court that Mr. Vikram has
committed misconduct and concerned Bar Councils are justified in holding him liable
and suspending him for life from practice. Mr. Vikram had signed a non-disclosure
agreement for his lifetime with Rio Pharma& Co. to not disclose any confidential
information while signing his employment contract. Thus, appearing in media houses
and giving interviews in relation to issues privy to RioGen was beyond the NDA.

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XXVI All India Moot Court Competition at University Law College (ULC),
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ARGUMENTS ADVANCED

1. WHETHER THE NON-DISCLOSURE AGREEMENT IS LEGALLY


ENFORCEABLE GIVEN THE FACTS OF THE CASE

1. The respondents most humbly submit that the non-disclosure agreement signed by Mr.
Vikram is completely valid and is legally enforceable given the facts of the case.

2. NDA is a type of contract and the essentials of a valid contract were fulfilled. The
essentials of a valid contract are –
 Offer
 Acceptance ad idem
 Lawful object
 Lawful Consideration
 Free Consent
 Must not be expressly declared void

In the given case, Mr. Vikram signed the employment contract along with non-disclosure
agreement with Rio Pharma & Co. His signatures on the contract are a proof of his
acceptance (with meeting of minds). He worked with the respondent for 5 years. The object
was to avail his services in legal field and he was paid off accordingly. He signed this
contract with his free consent; there was no coercion, fraud or undue influence on him.
Further, the contract was legal and is not expressly declared void in any law provision.

3. TIME PERIOD OF NDA –

This particular NDA was a part of the employment contract. It was a non-mutual non-
disclosure agreement that is generally adopted in the relationship of employer and employee.
This type of agreement usually applies to new employees if they have access to sensitive
information about the company. In such cases, the employee is the only party signing the
agreement that is prevented from sharing confidential information. This NDA was signed for
a lifetime. Interestingly, Mr. Vikram then signed it and accepted that he will not disclose any

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XXVI All India Moot Court Competition at University Law College (ULC),
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confidential information but he did so and made a breach of the contract. NDAs can be made
for a lifetime if they contain any trade secret which is needed to be protected.

4. Trade secret as defined in the Black’s Law Dictionary means:

“A formula, process, device or other business information that is kept confidential to


maintain an advantage over competitors; information including a formula, pattern,
compilation, program, device, method, technique or process- that (1) derives independent
economic value, actual or potential, from not being generally known or readily ascertainable
by other who can obtain economic from its disclosure or use, and (2) is subject of reasonable
efforts, under the circumstances, to maintain its secrecy.” 3

5. Article 39.2 of the Agreement on Trade-Related Intellectual Property Rights which talks
about the IP protection of Trade Secret reads as follows:

“Natural and legal persons shall have the possibility of preventing information lawfully
within their control from being disclosed to, acquired by, or used by others without their
consent in a manner contrary to honest commercial practices so long as such information:

Is secret in the sense that it is not, as a body or in the precise configuration and assembly of
its components, generally known among or readily accessible to persons within the circles
that normally deal with the kind of information in question;

Has commercial value because it is secret; and

Has been subject to reasonable steps under the circumstances, by the person lawfully in
control of the information, to keep it secret.”

6. In the case of Mr. Diljeet Titus, Advocate v. Alfred A Adebare and Ors.3, the Hon’ble court
restrained the Defendant from misappropriating the information including the lists of clients
and other information forming the database of the firm.

7.In the given circumstances, the confidential information (including profiles of people who
took the RioGen on trial, medical history including subsequent medical complications pre
and post-trial and their current whereabouts, etc.)Was taken out from the possession of the

3
Mr. Diljeet Titus, Advocate v. Alfred A Adebare and Ors., 2006 (32) PTC 609 (Del.)

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XXVI All India Moot Court Competition at University Law College (ULC),
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Rio Pharma & Co. without their consent by a sting operation was illegal and they have no
right to access it without the permission of the Company.

8. Further, it has a lot of commercial value because if the said wonder drug RioGen is
released into the market it will earn a good market because of its features. RioGen is capable
of curing various infectious diseases like COVID-19, malaria, dengue, and other viral
infections.

9. There were reasonable steps taken to protect this trade secret and the non-disclosure
agreement is one of those reasonable cares that the company took to prevent every possible
step against them to harm its reputation and market.

10. In the case of Burlington Home Shopping Pvt. Ltd. v. RajnishChibber4, granted injunction
restraining the Defendants from using the compilations, database comprising the list of the
clients. The Court went on to hold that such database in fact amounted to copyright and
thereby deserved protection.

11. In the given facts, the non-disclosure agreement was a part of the employment contract
and no other clause was mentioned to make it void instead it contained all the stereotype
clauses that an agreement generally contains.

12. A Trade Secret, the Court observed that customer's lists and information concerning the
proposed contents of a mail-order catalogue, designs, drawings, manufacturing process 5,
architectural plans, business strategies, and business plans are some the examples of trade
secrets.

2. WHETHER THE INSTRUMENTALITY OF STATE IS BOUND TO PAY


COMPENSATIONS FOR THE VICTIMS AND TAKE PROACTIVE ACTIONS?

13. It is most humbly submitted before this Hon’ble court that the State is not bound to pay
any compensation to the victims because the Company Rio Pharma had permission from the
State to run human trials of new drug RioGen plus the humans who came for the trials did so
voluntarily and neither the company nor the State forced them to do so. It is presumed if a
4
Burlington Home Shopping Pvt. Ltd. v. RajnishChibber, 1995 (35) DRJ 335
5
Harvey Tiling Company (Ply.) Limited v. Rodomac (Ply.) Limited, (1977) R.P.C. 399 (Supreme Court of South
Africa).

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XXVI All India Moot Court Competition at University Law College (ULC),
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person gives his consent for a particular task knowing it all and the consequences, there is no
liability of the other.

2.1 Report from unconfirmed sources is not valid.

14. India neither has a particular law administering the lawfulness of sting operations nor a
judicial pronouncement laying down the guidelines for the regulation of sting operations.
Besides the Cable TV Regulation Act [ Cable Television Networks (Regulation) Act
(1995),which lays down the guidelines for the channels airing programmes, the Pre-natal
Diagnostic Techniques Act is the sole authority that talks about sting operations and
maintains the legitimacy of the same for the purpose of the Act. The Courts have decided
every matter so far on the actualities of the case.6

15. Allahabad High Court in the case of Raj Veer Singh v State of U.P 7 showcases the correct
method of handling sting operations as evidence. A news agency had conducted a sting
operation on the officials of the Forensic Laboratory, Agra, alleging that the right price could
buy a favourable report.

16. The alleged sting operation had an ambiguity with respect to the statement of the subject
where he used the words “two plus”, the news agency depicted this in a manner which made
it seem like the conversation pertained to asking for more than two lakhs as bribe money. But
the subject contended that the words used were in the context of certain tests conducted for
determining the level of sugar and albumin in the urine. The court observed that the issue of
authenticity of the recording was central to the case and needed to be considered before
reaching any substantive conclusion. They relied on a report from the Anti-Corruption Unit’s
forensic experts that unequivocally declared that the recording was edited and morphed, with
multiple scenes being omitted from even the supposedly unedited raw footage. Thus, the
court dismissed the allegations of bribery but still levied a minor punishment on the
laboratory officer for even entertaining people who had the intention of bribing him.

17. In the instant case the report was from unconfirmed sources 8 which came from Sting
Operation conducted by a Private Party which was appointed by the Appellant(Nyaya
NGO) is not authorised and the Hon’ble court cannot rely on that until and unless the report
6
Sting Operations : The Role of Media as a Vigilante, (2018) 4.2 IJLPP 61 at page 63
7
Raj Veer Singh v State of U.P WRIT - A No. - 30084 of 2003
8
Para No. 7 of Moot Proposition

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from authorized source come. So the instrumentality of state is not liable to pay the
compensation.

2.2 Rule 122 DAB of Drug and Cosmetic Act, 1940

18. Rule 122 DAB of Drug and Cosmetic Act, 1940 states that:

“122-DAB- Compensation in case of injury or death during clinical trial.-

(1) In case of an injury occurring to the subject during the clinical trial, free medical
management shall be given as long as required or till such time it is established that the
injury is not related to the clinical trial, whichever is earlier.

(2) In case, the injury occurring to the trial subject is related to the clinical trial, such subject
shall also be entitled for financial compensation as per order of the Licensing Authority
defined under clause (b) of Rule 21, and the financial compensation will be over and above
any expenses incurred on the medical management of the subject.

(2A) In case, there is no permanent injury, the quantum of compensation shall be


commensurate with the nature of the non-permanent injury and loss of wages of the subject.

(3) In the case of clinical trial related death of the subject, his / her nominee(s) would be
entitled for financial compensation, as per the order of the Licensing Authority defined under
clause (b) of Rule 21 and the financial compensation will be over and above any expenses
incurred on the medical management of such subject.

(4) The expenses on medical management and financial compensation in the case of clinical
trial injury or death of the trial subject shall be borne by the sponsor of the clinical trial.

(5) Any injury or death of the subject occurring in clinical trial due to following reasons shall
be considered as clinical trial related injury or death and the subject or his/her nominees(s),
as the case may be, are entitled for financial compensation for such injury or death:

(a) Adverse effect of investigational product(s);

(b) Violation of the approved protocol, scientific misconduct or negligence by the sponsor or
his representative or the investigator;

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XXVI All India Moot Court Competition at University Law College (ULC),
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(c) Failure of investigational product to provide intended therapeutic effect, where, the
standard care, though available, was not provided to the subject as per the clinical trial
protocol;

(d) Use of placebo in a placebo-controlled trial where, the standard care, though available,
was not provided to the subject as per the clinical trial protocol;

(e) Adverse effects due to concomitant medication excluding standard care, necessitated as
part of approved protocol;

(f) For injury to a child in-utero because of the participation of parent in clinical trial;

(g) Any clinical trial procedures involved in the study.

(6) The sponsor, whether a pharmaceutical company or an institution shall give an


undertaking along with the application for clinical trial permission to the Licensing Authority
defined in clause (b) of Rule 21, to provide compensation in the case of clinical trial related
injury or death for which subjects are entitled to compensation.

(7) In case, the sponsor fails to provide medical management for the injury to the subject
and / or financial compensation to the trial subject for clinical trial related injury or
financial compensation to the subject‘s nominee(s) in case of clinical trial related death of
the subject, the Licensing Authority may after giving an opportunity to show cause why such
an order should not be passed, by an order in writing, stating the reasons thereof, suspend or
cancel the clinical trial and/or restrict Sponsor including his representative(s) to conduct any
further clinical trials in the country or take any other action deemed fit under the rules.9

19. As per rule 122 DAB of Drugs and Cosmetics Rules 1945, this is the responsibility of the
sponsor as explicated mentioned in Rule 122DAB Sub-clause 4 of Drug and Cosmetic Act,
1940 to compensate financially in case of clinical trial-related injury/death as per the order of
DCGI based on the recommendation of Expert Committee and sub-clause 6 of Rule 122 DAB
explicated mention that Sponsor whether a pharmaceutical company or an institution shall
give the undertaking to provide compensation in the case of clinical trial-related injury or
death for which subjects are entitled to compensation.

9
Rule 122 DAB of Drug and Cosmetic Act, 1940.

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XXVI All India Moot Court Competition at University Law College (ULC),
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20. Indian law requires compensation to be paid by the sponsor if the injury or death is due
to the negligence of the sponsor, his representative, or the investigator.10

20. In the instant case as per Rule 122 DAB the pharmaceutical company that is Rio Pharma
& Company would be liable to pay compensation to all the victims of Medical Trail not the
instrumentality of State.

21. Pfizer offers reasonable compensation for time and effort to healthy volunteer subjects
and, depending upon study design, may also provide reasonable compensation to other study
subjects when health benefits from study participation are remote or non-existent. In addition,
reasonable compensation may be provided to parents, guardians, or caregivers of minor
children or incapacitated subjects.

22. Pfizer covers the cost for medical treatment for any injury or illness that occurs as a direct
result of taking part in a Pfizer-sponsored study at no cost to the research subject. Pfizer does
not use any exculpatory language in informed consent documents that will prohibit a research
subject from obtaining appropriate compensation for research injuries. Nominal gifts for
study participation are allowed as long as the item does not display Pfizer (or affiliate)
branding. For example, in studies involving minor children, a small, age-appropriate gift or
gift certificate may be provided to the child.11

23. Compensation/reimbursement must be:

 Based on consistent criteria (i.e., offered for all subjects in a country, at a site or to
subjects in the same treatment group at a site) as per the study budget.
 Consistent with the laws, regulations, and guidelines of the region in which the study
is conducted.
 Disclosed in the informed consent as per Informed Consent Document, including the
methods, amounts and schedule of any compensation provided.
 Reviewed and approved by an institutional review board/independent ethics
committee (IRB/IEC) before commencement of the study at the site; any change in
the methods, amounts, and/or schedule of compensation must be submitted as an

10
https://www.ncbi.nlm.nih.gov/
11
https://www.pfizer.com/science/clinical-trials/integrity-and-transparency/compensation-trial-participants

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informed consent amendment for review and approval by the IRB/IEC before the
change is implemented.
 In proportion to the amount of discomfort or inconvenience the subject will
experience during the study; when a study involves minor children or incapacitated
adults as subjects, compensation may be provided to the subject’s parent, guardian, or
caregiver for the inconvenience of study participation.12

24. In the case of Union Carbide Corporation vs Union Of India13 The Bhopal Gas Leak
tragedy that occurred at midnight on 2nd December, 1984, by the escape of deadly chemical
fumes from the appellant's pesticide-factory was a horrendous industrial mass disaster,
unparalleled in its magnitude and devastation and remains a ghastly monument to the de-
humanising influence of inherently dangerous technologies. The tragedy took an immediate
toll of 2,660 innocent human lives and left tens of thousands of innocent citizens of Bhopal
physically impaired or affected in various degrees. Court directed that there be an overall
settlement of the claims in the suit, for 470 million US dollars which will be paid by
Company Union Carbide Corporation.

25. In Instant case also it was Pharma Co. that was conducting the Medical Trail 14 and
Pharma Company should be made liable to pay compensation to victims of medical trail.

3. WHETHER VIKRAM HAS RIGHT TO PRESENT A PIL AGAINST THE STATE


AND OTHERS AS BEING ESTOPPED BY THE NON-DISCLOSURE
AGREEMENT?
26. It is most humbly submitted that PIL filed by Nyaya is not maintainable and Mr. Vikram
has no right to present a Public Interest Litigation before this honorable court. It is frivolous
and vexatious public interest litigation which is liable to be dismissed. The maintainability of
PIL is justified when petitioner has the locus standi and there is substantial question of law.
In the instant case, the Mr. Vikram lacks the locus standi to file the concerned petition [A];
there exists ulterior motive behind filing the PIL [B].

A. MR. VIKRAM DOES NOT POSSESS THE REQUISITE LOCUS STANDI IN THE
INSTANT CASE.

12
https://www.pfizer.com/science/clinical-trials/integrity-and-transparency/compensation-trial-participants
13
Union Carbide Corporation vs Union of India, 1990 AIR 273, 1989 SCC (2) 540
14
Para No.4 of Moot Proposition

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27. A petitioner, whose fundamental right has been violated or threatened to be violated has a
locus standi under Art. 3215. A person acting bona fide 16 and having sufficient interest17 in the
proceedings of the PIL will alone have locus standi 18 and can approach the court under Art.
32.19 Further, a PIL cannot be used for personal gains 20 or private profits or political motives
or any oblique consideration.21

In the case Mr. Vikram has no right to file a PIL because he is estopped by the Non-
Disclosure Agreement. Non Disclosure agreement bounds Mr. Vikram from revealing Trade
Secrets of the RioGen Drug.

B. There exists ulterior motive behind filing the PIL

28. It is most humbly submitted that the instant petition is one which has been filed with an
ulterior motive. It has been reiterated by the apex court of the country in numerous
judgements that court should exercise great care and circumspection while allowing petition
of PIL and it has to be carefully seen that behind the beautiful veil of public interest, an ugly
private malice, vested interest and/or publicity seeking is not lurking. It is to be used as an
effective weapon in the armory of law for delivering social justice to the citizens. The court
must not allow its process to be abused for oblique considerations.22

29. Public interest litigation has nowadays largely become 'publicity interest litigation',
'private interest litigation', or 'politics interest litigation' or the latest trend 'paise income
litigation’.23PIL should not be motivated by a political motive or should not be an instrument
of personal vendetta.24A writ petitioner who comes to court for relief in public interest must

15
Calcutta Gas Co. Ltd. v. State of West Bengal, A.I.R. 1962 S.C. 1044 (India); Federation of Bar Ass'n in
Karnataka v. Union of India, (2000) 6 SCC 715 (India); Lok Prahari v. State of Uttar Pradesh, (2016) 9 SCC
739 (India).
16
Bandhua Mukti Morcha v. Union of India, (1984) 3 SCC 161 (India); Subhash Kumar v. State of
Bihar, (1991) 1 SCC 598 (India).
17
Janata Dal v. H.S. Chowdhary, (1992) 4 SCC 305 (India) [hereinafter Janta Dal]; Kazi Lhendup
Dorji v. C.B.I., 1994 SCC (Cri) 873 (India).
18
Rajiv Ranjan Singh v. Union of India, (2006) 6 SCC 613 (India); Dattaraj Nathuji Thaware v. State of
Maharashtra, (2004) 3 SCC 349 (India).
19
D.B. Singh v. Union of India, (2004) 3 SCC 363 (India); Jayaraj v. Comm'r of Excise, (2000) 7 SCC 552 :
A.I.R. 2000 S.C. 3266 (India).
20
S.P. Gupta v. Union of India, (1982) 3 SCC 223: A.I.R. 1982 S.C. 149 (India); Kushum Lata v. Union of
India, (2006) 6 SCC 180 (India).
21
State of Uttaranchal v. Balwant Singh Chaufal, (2010) 3 SCC 402: A.I.R. 2010 S.C. 2550 (India); Vijay
Kumar Gupta v. State of Himachal Pradesh, 2015 SCC OnLine HP 184 (India).
22
Dattaraj Nathuji Thaware v. State of Maharashtra, AIR 2005 SC 540.
23
ibid
24
Sai Kripa Mangal Karyalaya & ors. v. Nagpur municipal corporation &ors., civil appeal no. 5577 of 20004

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come not only with clean hands like any other writ petitioner but also with a clean heart,
clean mind and clean objective.25

30. In the instant case, the PIL is clearly filed through Mr. Vikram in Private Interest, as both
the Nyaya NGO and Vikram were aware of the fact that Vikram was bound by the Non-
Disclosure Agreement for life and he cannot reveal the details that he came to know about the
RioGen drug during his role as retainer with the Company.

31. Further, Vikram also gave interview to various media houses in relation to issues privy to
RioGen and the interview was telecasted time and again in various platforms including social
media which shows that not only he disclosed the Trade Secrets but also tried to Defame the
Company’s Reputation to gain name for himself.

32. In Ashok Kumar Pandey v. State of West Bengal,26 Hon'ble the Apex Court has held that
a Public Interest Litigation cannot be entertained on the basis of speculative foundation and
premises so as to make a roving inquiry. For filing such petition, there must be enough
material providing basis before the Court to proceed further. The litigant also cannot claim to
have chance to establish his or her claim.

33. In the present case, Nyaya has filed case through Vikram on the basis of unconfirmed
sources. Thus, it is most humbly submitted that the present petition which is frivolous and
vexatious is liable to be dismissed with costs as had been laid down by apex court.

4. THAT THE CONCERNED BAR COUNCILS ARE JUSTIFIED IN HOLDING


VIKRAM FOR COMMITTING ACTS AMOUNTING TO MISCONDUCT AND
SUSPENDING HIM FOR LIFE FROM PRACTICE?

25
Ramjas Foundation v. UOI, 1992 AIR SCW3460.
26
Ashok Kumar Pandey v. State of West Bengal (2004) 3 SCC 349

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34. The respondent most humbly submits before this Hon’ble court that Mr. Vikram has
committed misconduct and concerned Bar Councils are justified in holding him liable and
suspending him for life from practice. It is so because Mr. Vikram had signed a non-
disclosure agreement for his lifetime with Rio Pharma & Co. to not disclose any confidential
information while signing his employment contract. Thus, appearing in media houses and
giving interviews in relation to issues privy to RioGen was beyond the NDA.

35. “A transgression of some established and definite rule of action, a forbidden act, a
dereliction from duty, unlawful behavior, willful in character, improper or wrong behavior,
its synonyms are misdemeanor, misdeed, misbehavior, delinquency, impropriety,
mismanagement, offence, but not negligence or carelessness.”27

36. In the case Noratanmal Chaurasia v. M.R. Murli28 the Supreme court has held that
misconduct has not been defined in the Advocates Act, 1966 but misconduct envisages
breach of discipline, although it would not be possible to lay down exhaustively as to what
would constitute misconduct and indiscipline which, however, is wide enough to include
wrongful omission or commission, whether done or omitted to be done intentionally or
unintentionally.

37. In the Instant case it was duty of Mr Vikram not to disclose any information, but in public
he disclose the secret information of company and he derelict this duty so the decision of bar
council of Aryavartha should be upheld.

38. According to entry no. 13 of Section II (Duty to the Client) of CHAPTER - II Standards
of Professional Conduct and Etiquette (Rules under Section 49 (1) (c) of the Act read with the
Proviso thereto) of BAR COUNCIL OF INDIA RULES. “It is the duty of an advocate
towards his client to not accept a brief or appear in a case in which he himself is a witness. If
he has a reason to believe that in due course of events he will be a witness, then he should not
continue to appear for the client. He should retire from the case without jeopardizing his
client’s interests.”29

27
Black's Law Dictionary, Sixth Edition at page 999
28
Noratanmal Chaurasia v. M.R. Murli Appeal (civil) 5476 of 1999

29
http://www.barcouncilofindia.org/about/professional-standards/rules-on-professional-standards/

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39. In case of State V. Lalit Mohan Nanda30 it was held that, “The penalty for breach of rules
of professional conduct is provided under Section 10(1) of the Indian Bar Councils Act, 1926
which provides that the High Court may reprimand, suspend or remove from practice any
Advocate of the High Court whom it finds guilty of professional or other misconduct. Section
12 lays down the procedure in enquiries providing that the High Court shall make rules to
prescribe the procedure to be followed by Tribunals and by District Courts respectively, in
the conduct of inquiries under Section 10, we are called upon to decide this case within the
ambit of the Indian Bar Councils Act and the rules made there under.

40. In instant case Mr Vikram is one of the evidence in the case and it was his duty to not
accept case in which he himself is a witness and he violates the rule of Bar Council. So this is
misconduct on the part of Vikram and decision of Bat Council of Aryavartha should be
upheld.

4.2 Violates the Section 126 of Indian Evidence Act.

41. Professional communications.—No barrister, attorney, pleader or Vakil shall at any time
be permitted, unless with his client’s express consent, to disclose any communication made to
him in the course and for the purpose of his employment as such barrister, pleader, attorney
or vakil, by or on behalf of his client, or to state the contents or condition of any document
with which he has become acquainted in the course and for the purpose of his professional
employment, or to disclose any advice given by him to his client in the course and for the
purpose of such employment.

42. In instant case Mr Vikram discloses the information related to company in open media
and under section 126 of Indian Evidence act, 1872, “No barrister, attorney, pleader or vakil
shall at any time be permitted, unless with his client’s express consent, to disclose any
communication made to him in the course and for the purpose of his employment” but Mr
Vikram discloses the information which is misconduct on part of Mr Vikram as an Advocate
so his suspension is valid.

43. This code of conduct is also applicable to the advocates or legal advisors which are found
in the Bar Council of India Rules Part VI, Chapter II, Section II, Rule 17 provides that
advocate shall not directly or indirectly commit a breach of obligation imposed under Section

30
State V. Lalit Mohan Nanda AIR 1961 Ori 1, 1961 CriLJ 124

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126 of the Indian Evidence Act, 1872, thus protecting the spirit of attorney client relationship
and breach of same would lead to the violation of the Bar Council Rules of India.

44. In case of State V. Lalit Mohan Nanda31 it was held that, “The penalty for breach of rules
of professional conduct is provided under Section 10(1) of the Indian Bar Councils Act, 1926
which provides that the High Court may reprimand, suspend or remove from practice any
Advocate of the High Court whom it finds guilty of professional or other misconduct. Section
12 lays down the procedure in enquiries providing that the High Court shall make rules to
prescribe the procedure to be followed by Tribunals and by District Courts respectively, in
the conduct of inquiries under Section 10, we are called upon to decide this case within the
ambit of the Indian Bar Councils Act and the rules made there under.

45. In instant case Mr Vikram has breached the Rule 17 that provides advocate shall not
directly or indirectly commit a breach of obligation imposed under Section 126 of the Indian
Evidence Act, 1872, so he should be held liable and decision of bar council of Aryavartha
should be upheld.

46. It also don’t come under the ambit of Exception 1 and 2 of section 126 of Indian
Evidence Act, 1872,

“(1) any such communication made in furtherance of any illegal purpose,

(2) any fact observed by any barrister, pleader, attorney or vakil, in the course of his
employment as such, showing that any crime or fraud has been committed since the
commencement of his employment.”32

47. In instant case all the works done by Rio Pharmacy & Co. are valid and medical trails are
being run with the permission of government and drug authority. So the information
disclosed by Vikram is legal one, hence the decision of Bar Council of Aryavartha should be
upheld.

48. In Memon Hajee Haroon Mohomed v. Abdul Karim 33case, it was provided that in order to
claim privilege under Section 126 of the Indian Evidence Act, 1872 a communication made
31
State V. Lalit Mohan Nanda AIR 1961 Ori 1, 1961 CriLJ 124
32
Section 126 of Indian Evidence Act18722
33
Kalikumar Pal v. RajkumarPal 1931 (58) Cal 1379, Para 5)

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by the party to their advocate must be confidential in nature. Also, no privilege will be given
to such communication which is made before the creation of attorney client relationship.

49. In the instant case Mr Vikram signed Non-disclosure Agreement and it was his duty not
to disclose anything related to company. But he in open media discloses information of
company which he was barred to do that, so the Decision of Bar Council of Aryavartha
should be upheld.

PRAYER

In the light of issues raised, arguments advanced and authorities cited, the Counsel for the
Respondents most humbly pray that the Hon’ble Supreme Court of Republic of
Aryavartha be pleased to adjudge, hold and declare:

1. That the Non- Disclosure Agreement is enforceable given the facts of the
case.
2. That the State and its Instrumentalities are not liable to pay compensation to

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victims.
3. That Vikram has no right to present a PIL against the State and Others as being
estopped by the non-disclosure agreement.
4. That Bar Councils are justified in holding Vikram for committing acts amounting to
misconduct and suspending him for life from practice.

AND/OR

Pass any order that this Hon’ble Court may deem fit in the interest of equity, justice and
good conscience.
And for this act of kindness, the counsel for the respondents shall duty bound forever pray.

ALL OF WHICH IS RESPECTFULLY SUBMITTED.

-Sd-
(Counsel on behalf of the Respondents)

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