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DR.

MUMTAZ AHMED KHAN


TH
7 NATIONAL MOOT COURT COMPETITION,2024

TEAM CODE:NMC - 707

DR. MUMTAZ AHMED KHAN


TH
7 NATIONAL MOOT COURT COMPETITION
2024

BEFORE

THE HON’BLE SUPREME COURT OF HIMVARSH

IN THE MATTERS OF:

MADAT & ORS PETITIONERS

V.

UNION OF HIMVARSH RESPONDENT

PETITIONS INVOKED UNDER ARTICLE 32 OF THE HIMVARSH CONSTITUTION,


1950 AND SECTION 104 OF THE HIMVARSH PATENT ACT, 1970 RESPECTIVELY.

UPON SUBMISSION TO THE HON’BLE JUDGES OF THE SUPREME COURT


OF HIMVARSH

MEMORANDUM ON BEHALF OF THE RESPONDENT

MEMORANDUM FOR RESPONDENT 1|Page


DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

TABLE OF CONTENTS

LIST OF ABBREVATIONS ………………………………………………………………. 4


INDEX OF AUTHORITIES ………………………………………………………………. 5
Cases Cited ………………………………………………….........……………………….… 5
Statutes, Acts and Rules ...…………………………….............……...……………….......... 7
Books and Commentaries ………………………………..........………………………………….....7
Legal Database ……………………………………...........…………………………………...8
Doctrines …………………………………………........……………………………………..8
STATEMENT OF JURISDICTION……………………...….………………….………...10
STATEMENT OF FACTS...................................................................................................11
ISSUE RAISED …………………………………………………………………………….12
SUMMARY OF ARGUMENTS …………………………………………………………..13
ARGUMENTS ADVANCED ……………………………………………………………...15

ISSUE 1: WHETHER THE INSTANT PETITIONS FILED BY THE PETITIONERS


ARE MAINTAINABLE UNDER THE EYES OF LAW?............................................15
1.1 The PIL filed by the Madat is not maintainable.........................................................15
1.1.1.The Madat (NGO) does not have the Locus standi to approach the Supreme Court.
1.1.2 The PIL petition is not maintainable..................................................................17
1.2 The Objection petition by Mrs.Summi Bannerjee is not maintainable............................19

ISSUE 2:WHETHER THE RIGHT TO PRIVACY OF THE BHIL TRIBALS ARE


VIOLATED BY THE GOVERNMENT OF HIMVARSH AND UMC OR
NOT?......................................................................................................................................20

MEMORANDUM FOR RESPONDENT 2|Page


DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

ISSUE 3:WHETHER THE RIGHT TO PRIVACY OF THE PREGNANT LADY ARE


VIOLATED BY THE GOVERNMENT OF HIMVARSH AND UMC OR
NOT?......................................................................................................................................23
3.1 Right to Health is paramount when compared to Right to privacy.................................23
3.2 Applicability of Doctrine of public necessity................................................................25

ISSUE 4: WHETHER THE CARPIL 10.5mg HAS PASSED THE “TEST OF


NOVELTY”. WHETHER THE COMMERCIALISATION OF CARPIL 10.5mg IS
UNFAIR AND THE GOVERNMENT SHOULD ENFORCE COMPULSORY
LICENCE OR NOT?....................................................................................................26
4.1 CARPIL is a genuine invention that deserves patent protection as per the Act................26
4.2 Approval of patent for CARPIL is to balance the right to investors..................................28

PRAYER ………………………………………...………………………………………… 29

MEMORANDUM FOR RESPONDENT 3|Page


DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

LIST OF ABBREVATIONS

S.No. ABBREVIATIONS EXPANSION


1 & And
2 ¶ Paragraph
3 AIR. All India Reporter
4 ANR. Another
5 Art. Article
6 UMC Universal Medical Company
7 Ors. Others
8 S. Section
9 SC Supreme Court
10 SCC Supreme Court Cases
11 UOI Union Of India
12 u/a Under article
13 u/s Under section
14 V. Versus
15 Govt. Government
16 CVD Cardiovascular disease
17 HPP Himvarsh Poltical Party
18 DCGH Drug Controller General of Himvarsh
19 HC High Court
20 HMA Himvarsh Medical Association
21 PIL Public Interest Litigations
22 NGO Non- Governmental Organization
23 Ltd. Limited
24 Hon’ble Honourable
25 Pp Page

MEMORANDUM FOR RESPONDENT 4|Page


DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

INDEX OF AUTHORITIES

CASES CITED

1. V.Annaraja vs. The Secretary to the UOI WP. NO. 3822 OF 2019
2. A.V. Venkateshwaran vs. R.S. Wadhwani 1961 AIR 1506, 1962 SCR(1) 753
3. Asstt. Collector of Central Excise Vs. Jainson Hosiery 1979 AIR 1889, 1980
SCR(1) 134
4. Secretary, Govt. of India Vs. Alka Shubhash Gadia 1990 SCR, SUPL. (3) 583
5. Avinash Chand Gupta Vs. State of UP writ No. 64118 of 2010
6. UOI Vs. Paul Manickam AIR 2003 SCRILJ 4561,
7. PN.Kumar v. Municipal Corp. of Delhi 1988 SCR (1) 732

8. Kanubai Brahmbhatt Vs. State of Gujarat AIR 1987 SC 1159

9. Confederation of All Nagaland State Services Employees’ Assn. Vs. State of


Nagalan1998 CRILJ 3451
10. Andhra Industrial works Vs. Chief controller of Imports and others, AIR 1974 SC
1539
11. S.P. Gupta vs. UOI & other 1982 AIR149
12. Subash Kumar vs. State of Bihar 1991 AIR 420
13. State of Uttaranchal Vs. Balwant Singh Chaufal & Ors AIR 2010 SC 2550
14. Ashok Kumar Pandey V. State of West Bengal AIR 2004 SC 280
15. District Registrar vs. S.K. Sharma AP. NO. 8228 of 2009
16. Dr. Asha Kumar vs. Union of India IA NO. 92465/2023
17. Dr. N. Kumar vs. Union of India
18. State of Punjab Vs. Mohinder Singh Chawla AIR 1997 SC 1225
19. Paschim Banga Khet Mazdoor Samity Vs. State of West Bengal1996 SCC (4) 37
20. State of Tamil Nadu vs. Dr. K. Balu AIRONLINE 2018 SC 420
21. Mr.X vs. Hospital Z AIR 1999 SC 495
22. State of Punjab vs. Mohinder singh chawla JT 1997 (1) SC 416
23. Vinod kumar v. Union of India (1996) 6 SCC 580
24. State of Gujarat vs. Mukul Sinha 1998 2GLR 1355
25. Union of India vs. Rajesh Kumar ABA NO. 2007/2022

MEMORANDUM FOR RESPONDENT 5|Page


DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

26. Union of India vs. Ravikumar 111(2004)DLT 126


27. Prajwala v. Union of India PIL NO. 138 of 2015
28. Malverer V. Spinke 1538 73 Er 79
29. Bishwanth Prasad Radhey Shyam V,Hindustan Metal Industries AP NO. 128/57
30. Lallubhai 1981 AIR 728
31. Cipla Ltd vs. UOI 2016 SC 763
32. Amgen Vs Chugai pharmaceutical 13 USPQ2d 1737

STATUTES, ACTS AND RULES

1. Constitution of India, 1950.


2. Indian Penal Code (IPC), 1860 (Sections 354, 403, 409, 420, 468)
3. Information Technology Act, 2000 (Rules 5)
4. Biomedical Waste Management Rules, 2016 (Rule 6)
5. Consumer Protection Act, 2019
6. Drugs and Cosmetics Act, 1940 and Rules, 1945
7. The Epidemic Diseases Act, 1897.

INTERNATIONAL LAW DATABASE

1. International law reports (ILR).


2. International legal material (ILM)
3. Oxford reports on international law (ORIL).

MEMORANDUM FOR RESPONDENT 6|Page


DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

INTERNATIONAL CONVENTIONS

1. Universal Declaration of Human Rights (UDHR).


 Article 3 (Right to life, liberty, and security of person),
 Article 7 (Right to privacy), and
 Article 8 (Right to an effective remedy)
2. International Covenant on Civil and Political Rights (ICCPR).
 Article 17 (Right to privacy),
 Article 6 (Right to life), and
 Article 2 (Right to an effective remedy).
3. Convention on the Rights of Persons with Disabilities (CRPD).
 Article 25 (Right to health),
 Article 31 (Right to privacy), and
 Article 32 (Right to an effective remedy)
4. Declaration on the Rights of Indigenous Peoples (UNDRIP).
 Article 4 (Right to self-determination),
 Article 23 (Right to health), and
 Article 24 (Right to privacy)
5. International Conference on Harmonization's (ICH) guidelines on Good Clinical
Practice (GCP).
6. World Health Organization's (WHO) Declaration of Helsinki.
7. UNESCO's Universal Declaration on Bioethics and Human Rights.
 Article 6 (Right to privacy),
 Article 7 (Right to informed consent), and
 Article 14 (Right to an effective remedy).

MEMORANDUM FOR RESPONDENT 7|Page


DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

BOOKS AND COMMENTARIES

1. P.M Bakshi,The constitution of India,15th Edition,2018.


2. Durga Das Basu, commentary on the constitution of India, 8th Edition,2007.
3. Mr. Sagar Kishore Savale, Indian parents Act,1970.
4. Pavan Duggal,Cyber Law,2nd Edition.
5. Vakul Sharma, Information Technology,5th Edition.
6. V.K.Ahuja, Intellectual Property Rights,2nd Edition.
7. AdarshRamanujan,Patents Law,2nd Edition.

LEGAL DATABASE

1. http://www.indiakanoon.com
2. http://www.legalserviceindia.com
3. http://www.lawoctopus.com
4. http://www.scconline.com
5. http://www.casemine.com
6. http://www.lawtimesjournal.com
7. http://www.blog.ipleaders.in
8. http://www.indialawjournal.com
9. http://www.academia.com

MEMORANDUM FOR RESPONDENT 8|Page


DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

DOCTRINES

S.NO. DOCTRINES AND PRINCIPLES


1. DOCTRINE OF PUBLIC INTEREST
2. DOCTRINE OF PRIOR INFORMED CONSENT
3. DOCTRINE OF PRIVACY
4. DOCTRINE OF PUBLIC NECESSITY
5. DOCTRINE OF LEGALITY
6. DOCTRINE OF CULTURAL INTEGRITY
7. DOCTRINE OF HUMAN RIGHTS
8. DOCTRINE OF PARENS PATRIAE

LEGAL PRINCIPLES

1. Necessitas publica major estquamprivata.


2. Salus populi suprema lex.
3. Necessitas excusatautextenuat delicta.
4. Necessity knows no law.

MEMORANDUM FOR RESPONDENT 9|Page


DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

STATEMENT OF JURISDICTION

It is most humbly submitted before this Hon’ble Supreme Court of Himvarsh on behalf of
Respondent has approached this Hon’ble Court in response to the petitions filed by the
petitioners under Article 32 of the Himvarsh constitution,1950 and Section 104 of the
Himvarsh Patent Act, 1970 respectively. The counsel on behalf of Respondent humbly
submits to dismiss these petitions, and the contention regarding the issues raised, will be
presented before the Hon’ble bench accordingly.

STATEMENT OF FACTS

MEMORANDUM FOR RESPONDENT 10 | P a g e


DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

Background of the case:


Laws of the Himvarsh are PariMateria with the laws of India. Himvarsh, a nation with a vast
population and growing economy, faces a significant public health challenge from
cardiovascular diseases (CVDs), which claim a substantial number of lives annually,
especially among younger populations. Research suggests a possible genetic association with
CVDs, and numerous studies linked to coronary heart disease, indicating a need for further
research to understand the causes and prevention of CVDs. In response to this crisis, the
Himvarsh Political Party has established dedicated research centres and invested 2000crs in
research to combat CVDs, aiming to find effective medicines and treatments to address this
pressing public health issue.
Crux of the case:
 In the year 2022, the government of Himvarsh collaborated with Universal Medical
Company (UMC) to research and develop a medicine for cardiovascular diseases
(CVDs) using DNA technology.
 A research team led by Dr. Sanjay Gupta conducted a community Screening program
for the Bhil tribe, who have a rare protective gene variant (PCSK9+) that makes them
less prone to CVDs.
 The research team conducted clinical trials on the three individuals, including a
pregnant lady, Mrs. Susmitha Anand, without her informed consent.The clinical trials
were successful, and the patients showed positive signs, but the pregnant woman’s
child was born with different physical features, leading to a controversy.
 In the year of 2022, UMC applied for and was granted a patent for the medicine,
CARPIL-10.5mg, which wasapproved for marketing by the Drug Controller General
of Himvarsh (DCGH).
 Social activist Mr. Trivedi Ahuja runs an NGO named MADAT, filed a writ petition
alleging unethical research practices, violation of privacy, and commercialisation of
CARPIL, demanding compulsory licensing.
 Research scholar Mrs. Summi Banerjee filed an objection petition against UMC,
challenging the grant of patent for CARPIL, claiming it is not an invention.The
Hon’ble Supreme Court of Himvarsh has decided to club all matters connected with
UMC for hearing.

ISSUE RAISED

MEMORANDUM FOR RESPONDENT 11 | P a g e


DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

ISSUE 1:WHETHER THE INSTANT PETITIONS FILED BY THE PETITIONERS


ARE MAINTAINABLE UNDER THE EYES OF LAW?

ISSUE 2:WHETHER THE RIGHT TO PRIVACY OF THE BHIL TRIBALS ARE


VIOLATED BY THE GOVERNMENT OF HIMVARSH AND UMC OR NOT?

ISSUE 3:WHETHER THE RIGHT TO PRIVACY OF THE PREGNANT LADY ARE


VIOLATED BY THE GOVERNMENT OF HIMVARSH AND UMC OR NOT?

ISSUE 4: WHETHER THE CARPIL 10.5mg HAS PASSED THE “TEST OF


NOVELTY”. WHETHER THE COMMERCIALISATION OF CARPIL 10.5mg IS
UNFAIR AND THE GOVERNMENT SHOULD ENFORCE COMPULSORY
LICENCE OR NOT?

SUMMARY OF ARGUMENTS

MEMORANDUM FOR RESPONDENT 12 | P a g e


DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

ISSUE 1: WHETHER THE INSTANT PETITIONS FILED BY THE PETITIONERS


ARE MAINTAINABLE UNDER THE EYES OF LAW?
The counsel on behalf of the Union of Himvarsh [i.e., hereinafter the respondent] humbly
submits the PIL petition filed under Article 32 of the Himvarsh constitution and objection
petition filed under section 104 of the Himvarsh Patent Act, 1970 are not maintainable since
there is no violation of fundamental right of the Bhil tribal’s and the pregnant lady
respectively. In the case of the UMCs research, the public health benefit was clear and
proportionate, as the research was aimed at developing a life-saving drug that addresses the
serious public health conern of CVDs. Therefore the Madat NGO’s PIL petition and Mrs.
Summi Banarjee’s objection petition lack merit. Through this, it is also clear that the
petitioners do not have the locus standi, thus humbly seeking the Hon’ble Supreme Court to
dismiss this petitions.

ISSUE 2: WHETHER THE RIGHT TO PRIVACY OF THE BHIL TRIBALS ARE


VIOLATED BY THE GOVERNMENT OF HIMVARSH AND UMC OR NOT?
The counsel on behalf of the Union of Himvarsh [i.e., hereinafter the respondent] humbly
submits that the right to privacy of the Bhil tribal community was not violated by the
government and UMC. The DNA samples were collected for a legitimate public health
purpose and that the benefits of the research outweigh any potential harm to the privacy
rights of the tribal community. It is highlighted through the maxims "Salus populi suprema
lex" which means that the health of the people is the supreme law that supports the
government's and UMC's measures in this case, as the protection of public health is a primary
duty and Necessitas non habet Legem” which ultimately mean that necessity has no law.
Hence the right to privacy of the Bhil tribals are violated by the government of Himvarsh and
UMC.

MEMORANDUM FOR RESPONDENT 13 | P a g e


DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

ISSUE 3: WHETHER THE RIGHT TO PRIVACY OF THE PREGNANT LADY ARE


VIOLATED BY THE GOVERNMENT OF HIMVARSH AND UMC OR NOT?
The counsel on behalf of the Union of Himvarsh [i.e., hereinafter the respondent] humbly
submits that there is no violation of right to privacy of the pregnant lady by the government
of Himvarsh and UMC. The government and the UMC have been involved in a joint effort to
develop a medicine for CVDs using DNA technology. This is a legitimate public health
purpose and it serves the interest of the society as a whole. Moreover the DNA samples
collected from the pregnant lady was necessary to conduct the research. Also the government
and UMC took all necessaries precautions to protect the confidentiality and security of the
genetic data collected, including encryption, access control, and date backups.

ISSUE 4: WHETHER THE CARPIL 10.5mg HAS PASSED THE “TEST OF


NOVELTY”. WHETHER THE COMMERCIALISATION OF CARPIL 10.5mg IS
UNFAIR AND THE GOVERNMENT SHOULD ENFORCE COMPULSORY
LICENCE OR NOT?
The counsel on behalf of the Union of Himvarsh [i.e., hereinafter the respondent] humbly
submits that categorically deny any allegations of unethical conduct or violation of privacy in
the development of CARPIL. Our research team led by Dr.Sanjay Gupta conducted a
community screening program and clinical trials for combating CVDs. It is important that the
collection of genetic data for scientific research is a standard practice all over the world, and
it is an essential part of developing new treatments for a variety of diseases. The CARPIL
10.5mg patent was granted by the Drug Controller General of Himvarsh (DCGH) based on
the positive result of the clinical trials which indicates that the drug is safe and effective in
the treatment of CVDs. Commercialization of CARPIL is fair and the patent application was
reviewed by a panel of experts, and it is found that the drug met all the requirements for
patentability. Hence the CARPIL 10.5mg has passed the test of novelty and the government
stand committed to making this life-saving drug accessible to the patient in Himvarsh at an
affordable price.

ARGUMENTS ADVANCED

MEMORANDUM FOR RESPONDENT 14 | P a g e


DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

ISSUE 1: WHETHER THE INSTANT PETITIONS FILED BY THE PETITIONERS


ARE MAINTAINABLE UNDER THE EYES OF LAW?

The counsel for the respondent most humbly submitted before this Hon’ble Supreme Court of
Himvarsh that the Public Interest Litigation filed by the NGO Madat and the objection
petition filed by the research scholar Mrs.Summi Banerjee are not maintainable. The
petitioners lack the essential ingredients to maintain the matter before the Hon’ble Supreme
Court of Himvarsh and High Court of Naya Dhillika respectively. Though the Hon’ble
Supreme Court of Himvarsh clubbed the matters connected with UMC, the issues regarding
the maintainability of the case must be highlighted before this court to prevent any
miscarriage of justice.

1.1. The Public Interest Litigation filed by the Madat is not maintainable.

The counsel on behalf of the Union of Himvarsh humbly submits that the petition filed under
Article 32 (PIL) of Himvarsh Constitution, 1950 by the Madat (NGO) is not maintainable
under the following grounds.

1.1.1. The Madat(NGO) does not have the Locus Standi to approach the Hon’ble
Supreme Court

It is humbly submitted that the Madat(NGO) does not have locus standi to file this PIL before
the Hon’ble Supreme Court. The locus standi of a petitioner for filing PIL is based on the
following:

 The bonafide aspects (must be obtained from CEC).


 Real and Genuine public interest.
 Sufficient interest in the proceedings.
 Violation of Fundamental Right of public at large.
 Not having any personal gain, political motive or oblique consideration.

It is therefore submitted that the Madat challenging the constitutionality of research and the
clinical trial which was conducted by the UMC which was exaggerated by the media is
proving that it is a kind of personal gain or private profit in terms of publicizing the

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DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

Organisation’s name as a famous organization, covering the aspects of the “publicity interest
litigation” as relied in the case V.Annaraja vs. The Secretary to the UOI1 .

It is further humbly submitted that it is clearly given that the couple filed a complaint before
Himvarsh Medical Association (HMA) regarding the issues related to informed consent was
not taken from Mrs. Sushmitha Anand for the purpose of clinical trial. Before the HMA
conclude, the Madat (NGO) concluded that the research and the clinical trial was conducted
by UMC was unethical which is only to popularize their Organisation. So that they directly
approached the Hon’ble Supreme Court and again raised the same issues related to the
unreliability and invalildity of clinical trial results.

In the light of the case A.V. Venkateshwaran vs. R.S. Wadhwani2, the court held that an
alternative remedy is a bar unless there was a complete lack of jurisdiction in the officier or
authority to take actions impugned.

It was held by this Hon’ble apex court in Asstt. Collector of Central Excise Vs. Jainson
Hosiery3 that where there is an alternative statutory remedy, the court should not interfere
unless the alternative remedy is too dilatory or cannot grant quick relief. Article 32 confers
“Extraordinary” jurisdiction, the same must be used wisely, and sparingly and shall be
brought into use under circumstances where there is no alternative efficacious remedy
available. The same as been upheld in a plethora of judgements rendered by this Hon’ble
court, they are Secretary, Govt. of India Vs. Alka Shubhash Gadia4, Avinash Chand Gupta
Vs. State of UP5 and UOI Vs. Paul Manickam.6

Therefore, the petitioner Madat is required to approach the High Court before approaching
the Supreme Court. Because of two main reasons: first, to reducing pendency of cases which
was held in the case PN.Kumar v. Municipal Corp. of Delhi7 and second, to inspire faith in

1
V.Annaraja vs. The Secretary to the UOI WP. NO. 3822 OF 2019
2
A.V. Venkateshwaran vs. R.S. Wadhwani 1961 AIR 1506, 1962 SCR(1) 753
3
Asstt. Collector of Central Excise Vs. Jainson Hosiery 1979 AIR 1889, 1980 SCR(1) 134
4
Secretary, Govt. of India Vs. Alka Shubhash Gadia 1990 SCR, SUPL. (3) 583
5
Avinash Chand Gupta Vs. State of UP writ No. 64118 of 2010
6
UOI Vs. Paul Manickam AIR 2003 SCRILJ 4561,
7
PN.Kumar v. Municipal Corp. of Delhi 1988 SCR (1) 732

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DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

the hierarchy of Courts and the institution as a whole which was held in the case Kanubai
Brahmbhatt Vs. State of Gujarat.8

The counsel for the respondent humbly & relevantly submits that Article 226 empower the
High Court to entertain a writ petition. It is pertinent to point out that Article 226 has a non-
obstante clause with respect to Article 32. It was held by the Hon’ble court in the case of
Confederation of All Nagaland State Services Employees’ Assn. Vs. State of Nagaland 9,
that the writ petitions should be agitated at the first instant before the High Court of
judicature exercise of its power under Article 226 of the Himvarsh constitution.

Therefore, the Madat (NGO) has approached the Supreme Court directly under Article 32
whereas the Madat should have moved to the High Court under Article 226, and they do not
have the locus standi to approach the Hon’ble Supreme Court of Himvarsh.

1.1.2. The PIL petition is not maintainable.

The counsel for the respondent most humbly submits that, the PIL is not maintainable under
Article 32 of the Himvarsh Constitution as there has not been violation of any fundamental
rights and the petitioner Madat is only meddling with the judicial process for their cheap
popularity.

It is further humbly submitted that the public interest litigation (PIL) to enforce fundamental
rights are protected by part III of the constitution, a PIL may be brought under Article 32 of
the constitution as it was mentioned in the case Andhra Industrial works Vs. Chief
controller of Imports and others, AIR 1974 SC 153910.

Since the State’s action was done to ensure the public health of the people, it cannot be said
to have been arbitrary in the current instance. As a result, there has been no breach of
fundamental rights which was held in the case S.P. Gupta vs. UOI & other11.

The counsel for the respondent most humbly & relevantly submits that the PIL petition filed
is completely frivolous as it lacks legal bases and authoritative evidence. The Hon’ble court

8
Kanubai Brahmbhatt Vs. State of Gujarat AIR 1987 SC 1159
9
Confederation of All Nagaland State Services Employees’ Assn. Vs. State of Nagalan1998 CRILJ 3451
10
Andhra Industrial works Vs. Chief controller of Imports and others, AIR 1974 SC 1539
11
S.P. Gupta vs. UOI & other 1982 AIR149

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DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

in the case of Subash Kumar vs. State of Bihar 12 discouraged the PIL filed by the petitioner
stating that PIL cannot be filed for private or personal welfare.

It is most humbly submitted before this Hon’ble court that this PIL is not maintainable as
there is conflicting interest that must be balanced by court relying on the case State of
Uttaranchal Vs. Balwant Singh Chaufal & Ors13, where “the court should ensure that there
is no personal gain, private motive or oblique motive behind filing the Public Interest
Litigation. The court should also ensure that the petitions filed by busybodies for extraneous
and ulterior motives must be discouraged by imposing exemplary costs are by adopting
similar novel methods to curb frivolous petitions and the petitions filed for extraneous
considerations”.

Similarly, In the light of the case Ashok Kumar Pandey V. State of West Bengal 14, it was
held that “the court must be careful to see that a body of persons or a member of the public
who approaches the court is acting bona fide and not for personal gain or private motive or
political motivation or other oblique consideration”. In the present case, the PIL is being filed
not for the interest of the public but rather to meet the personal needs of the Madat. There is
no establishment of public interest, and they are only concerned for their organisation.

Moreover, to publicize their organization name more and more, they don’t even concern
about the health Crisis happening in Himvarsh due to cardiovascular diseases (CVDs).
According to the facts of the instant case, the petitioner Madat’s allegations are the research
conducted on the tribals was conducted without informing them and the research team failed
to informed Mrs. Sushmitha Anand about clinical trials which is reported in the media. It is
cleared that the purpose of filing the PIL is only to popularize the NGO i.e. Madat and not for
the interest of the public. Therefore, in the present case the Madat has approached the
Hon’ble Supreme Court of Himvarsh with dirty hands and for their personal gains.

It is humbly submitted that in the light of above arguments presented, the power to grant
writs under Article 32 is a discretionary power vested in the hands of this Hon’ble Court.
Thus, the counsel humbly seeks this Hon’ble Court, must, therefore, exercise its discretion to
quash the instant petition on the grounds of non-maintainability.

1.2 The objection petition filed by Mrs.Summi Bannerjee is not maintainable.

12
Subash Kumar vs. State of Bihar 1991 AIR 420
13
State of Uttaranchal Vs. Balwant Singh Chaufal & Ors AIR 2010 SC 2550
14
Ashok Kumar Pandey V. State of West Bengal AIR 2004 SC 280

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DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

The counsel for the respondent humbly submits that the objection petition filed by the
research scholar Mrs.Summi Bannerjee before the Hon’ble High Court of Naya Dhilika is not
maintainable. The UMC, a multinational pharmaceutical company, developed CARPIL
10.5mg after investing significant resources in research and development. The drug has been
granted a valid patent, and the company has been manufacturing and selling it at a reasonable
price across the world.

It is humbly submitted that the petitioner contends that the patent application filed by UMC is
invalid as it fails to meet the criteria for patanability under section 3(d) of the Himvarsh
Patent Act 1970. As per section 3(d) of the act states that a patent will not be granted if the
invention is obvious or lacking in inventive step. However, the counsel for the respondent
would like to highlight that UMC has undertaken extensive research and development to
develop the drug CARPIL, and the invention is an original and non-obvious one.

Furthermore, Mrs. Summi Banerjee alleged that a potential breach of privacy and bodily
autonomy resulting from the collection genetic information from the Bhil tribals and the
research participants. The council for respondent would like to clarify that UMC collected the
genetic information for the purpose of research and development and the individuals
informed consent is not required in such cases. Additionally, UMC have taken necessary
steps to ensure the confidentiality and security of the genetic information.

Hence the petitioner failed to provide sufficient evidence to support their claims, and the
respondent has already provided the drug to patients in need. Moreover, alternative remedies
such as price control or subsidies are available and have not been exhausted. The respondent
believes that granting a compulsory license would unfairly infringe on their patent rights,
undermine the patent system, and discourage future innovation.

ISSUE 2: WHETHER THE RIGHT TO PRIVACY OF THE BHIL TRIBALS ARE


VIOLATED BY THE GOVERNMENT OF HIMVARSH AND UMC OR NOT?

The counsel on behalf of respondent has humbly submitted that the right to privacy of the
Bhil tribal’s does not violate by the government of Himvarsh and UMC.

According to the fact of the present case that “In accordance with the World Health
Organization, Himvarsh accounts for one-fifth of these deaths worldwide especially in

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DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

younger population. The results of Global Burden of Disease study state age-standardized
CVD death rate of 272 per 1, 00,000 population in Himvarsh which is much higher than that
of global average of 235”. It is evidently clear that the country is facing extreme health crisis
due to cardiovascular diseases (CVDs). So, to respond to this, the ruling Himvarsh Political
Party (HPP) has decided to collaborate with UMC to discover the medicine for CVD.

It is humbly submitted that the respondent would like to counter Mrs. Summi Banerjee's
contention that UMC and the government have violated the Bhil tribals' right to privacy by
collecting their genetic information without informed consent. The respondent’s contention is
that the government and UMC's measures in this case are necessary and proportionate to
achieving the public health goal of preventing the spread of diseases and promoting public
health. The government has a duty under Article 21 of the Indian Constitution and Section 41
of the Indian Medical Council Act, 1956, to safeguard the health of its citizens, which may
occasionally require the collection of genetic information without the individual's informed
consent.

The counsel for respondent has humbly submits that the action of government and UMC does
not violate any fundamental rights of the Bhil tribal’s and it is fall under the ambit of
reasonable restrictions and the Doctrine of Reasonable restriction was applied. Considering
the case, District Registrar vs. S.K. Sharma15 (2016) the court held that disclosure of
information for public health purposes is a reasonable restriction on privacy, with minimal
intrusion and maximum benefit.

Further, the public's interest in preventing the spread of diseases and promoting public health
may outweigh individual privacy concerns, as Section 4 of the Epidemic Disease Act, 1897,
provides that any person affected or suspected of being affected with a dangerous epidemic
disease shall obey all reasonable directions for their examination or treatment as given by an
authorized medical officer.

Also, in Dr. Asha Kumar vs. Union of India 16 (2018) the Hon’ble Supreme Court held that
disclosure of medical records for insurance purposes is a reasonable restriction on privacy.
No fundamental rights are absolute they are subjected to reasonable restrictions. With the
reference of the case, Dr. N. Kumar vs. Union of India17 (2018) the Hon’ble Supreme Court

15
District Registrar vs. S.K. Sharma AP. NO. 8228 of 2009
16
Dr. Asha Kumar vs. Union of India IA NO. 92465/2023
17
Dr. N. Kumar vs. Union of India

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DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

held that disclosure of medical records for research purposes is a reasonable restriction on
privacy.

It is submitted that the public health is a larger societal interest and if the CARPIL medicine
is proven to be effective in preventing heart attacks and strokes among patients with coronary
artery disease, then it serves the larger societal interest of saving lives and improving the
health of the public. Moreover, while informed consent may usually be required, it may not
always be feasible or practical to obtain it in emergency situations, as Section 40 of the
Indian Medical Council Act, 1956, provides that if it is not possible to obtain the consent of
the person concerned for administering a vaccine or test, it shall be administered after
informing the person concerned and with his or her permission.

Further, the doctrine of public interest is a principle recognized by the courts of Himvarsh,
which allows for the limitation of certain rights to serve a larger societal interest. The
doctrine of public interest has been applied in cases involving public health, environmental
protection, and other matters that affect the well-being of the public. Therefore, the courts
would have to balance the public interest in ensuring access to healthcare with the individual
right to privacy, which was allegedly violated during the discovery of the medicine and the
individual's interest in controlling access to his or her genetic data. It is noted that the maxim
“Necessitas non habet Legem” which ultimately mean that necessity has no law.

The respondents would also point out that the government has put in place measures to
maintain confidentiality and protect personal data, including the draft Data Protection Bill,
2019, which sets out rules for the management of personal data.

Hence the counsel for respondent would also highlight that the maxim "Salus populi
suprema lex" which means that the health of the people is the supreme law that supports the
government's and UMC's measures in this case, as the protection of public health is a primary
duty

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DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

ISSUE 3: WHETHER THE RIGHT TO PRIVACY OF THE PREGNANT LADY ARE


VIOLATED BY THE GOVERNMENT OF HIMVARSH AND UMC OR NOT?

The counsel on behalf of respondent has humbly submitted that the right to privacy of the
pregnant lady does not violate by the government of Himvarsh and UMC under the following
grounds:

3.1. RIGHT TO HEALTH IS PARAMOUNT WHEN COMPARED TO “RIGHT TO


PRIVACY”

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DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

It is most humbly submitted before this Hon’ble Supreme Court of Himvarsh that the right to
privacy is a fundamental right protected under the constitution of Himvarsh. But it is worth
mentioning that the said fundamental right is not absolute right and must be subject to
reasonable restrictions in the interest of the public order, morality, social welfare and health.

It is submitted that the government of Himvarsh and UMC’s actions were taken to protect the
public health interest, which is a legitimate state aim, as held in the case State of Punjab Vs.
Mohinder Singh Chawla18. In the present case, the government and UMC conducted clinical
trials to develop a vaccine, which is a public health measure aimed at preventing the spread
of diseases and the Doctrine of public interest was applied.

It is further submitted that the research and the clinical trials are conducted by UMC was not
unethical, as it was conducted in accordance with the principles of ethical research. The
clinical trials were conducted during a public health crisis, and obtaining informed consent
may not have been feasible or practical. In the case, Paschim Banga Khet Mazdoor Samity
Vs. State of West Bengal19 the Hon’ble Court held that in emergency situations like public
health crisis, informed consent may not be necessary. Also in the case, State of Tamil Nadu
vs. Dr. K. Balu20 the court held that disclosure of patient information for public health
purposes is a reasonable restriction on privacy, with minimal intrusion and maximum benefit.

In the present case, the clinical trials which were conducted by the UMC for the public health
and the data collected from the research team makes contribute to the development of
effective medical treatment that could be beneficial for the large number of people of the
Himvarsh.

It clearly mentioned in the fact sheet that the death rate of CVD in Himvarsh were more than
global average rates. So, it is essential to prioritizing the right to health over the right to
privacy. As per the act of the Epidemic Diseases Act of 1897, section 2A states that the
central government can take steps to prevent the spread of epidemic diseases throughout the
country.

At this point, it is to be noted that the case, Mr.X vs. Hospital Z21, the supreme court held that
the court balanced the right to privacy with the right to health, allowing for the disclosure of
medical information to protect public health. Moreover, in the case of State of Punjab vs.
18
State of Punjab Vs. Mohinder Singh Chawla AIR 1997 SC 1225
19
Paschim Banga Khet Mazdoor Samity Vs. State of West Bengal1996 SCC (4) 37
20
State of Tamil Nadu vs. Dr. K. Balu AIRONLINE 2018 SC 420
21
, Mr.X vs. Hospital Z AIR 1999 SC 495

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DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

Mohinder singhchawla22, the Court held that the right to health is more important than the
right to privacy in cases where the public health is at risk.

Similarly, In the case of Vinod kumar v. Union of India23, the Delhi High court clearly held
that the court prioritized the right to health over the right to privacy, allowing for the
disclosure of confidential information to prevent the spread of diseases. Further, submitted
that the world health organization (WHO) report (2019), National Human Rights
Commission(NHRC) Report (2018), International Commission of Jurists(ICJ) Report (2017),
UNAIDS Report (2019), National commission for protection of child rights (NCPCR) report
(2020), these reports from various commissions highlights the importance of prioritizing the
right to health over the right to privacy in certain circumstances, particularly when public
health is at risk.

In the instant case, the data collected was anonymized and used solely for public health
purposes and did not infringe on the privacy rights of the Bhil tribal’s and pregnant lady. The
collection of data was necessary for public health purposes and did not violate the right to
privacy, as recommended by the Justice A.P.Shah Committee Report (2018). The collection
of biometric data for welfare schemes is a reasonable restriction on privacy, with adequate
security measures as observed in the case State of Gujarat vs. Mukul Sinha24. In the case of
Union of India vs. Rajesh Kumar25 the Hon’ble Court upheld the validity of the Aadhaar
Act, stating that data collection for welfare schemes is a reasonable restriction on privacy,
with adequate security measures.

In the light of the case Union of India vs. Ravikumar26, the SC court held that the disclosure
of confidential information to prevent the spread of diseases, citing the doctrine of public
interest. Similarly, in the case Prajwala v. Union of India27, the SC held that the state's
interest in protecting public health and preventing the spread of diseases outweighs the
individual right to privacy.

3.2. Applicability of Doctrine of Public necessity

22
State of Punjab vs. Mohinder singh chawla JT 1997 (1) SC 416
23
Vinod kumar v. Union of India (1996) 6 SCC 580
24
State of Gujarat vs. Mukul Sinha 1998 2GLR 1355
25
Union of India vs. Rajesh Kumar ABA NO. 2007/2022
26
Union of India vs. Ravikumar 111(2004)DLT 126
27
Prajwala v. Union of India PIL NO. 138 of 2015

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DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

The counsel for respondent humbly and relevantly submits that the doctrine of public
necessity is derived from the maxim Salus populi suprema lex that is welfare of the people is
of paramount importance swhich is expressed in the case Rekharani Maitra & ors. V.
Additional District Magistrate & ors.

Also in the light of the case Malverer V. Spinke28, the Hon’ble court held that to achive the
public good, the property, liberty and life of an individual can be placed in jeopardy in the
case of existing, immediate and overwheling necessity.

Therefore, the government and UMC’s actions were taken in the public interest, and the right
to privacy cannot be invoked to prevent measures taken in the public interest. Moreover, the
Government of Himvarsh and UMC acted in good faith and without malice, and therefore
cannot be held liable for any alleged violation of privacy rights.

ISSUE 4: WHETHER THE CARPIL 10.5mg HAS PASSED THE “TEST OF


NOVELTY”. WHETHER THE COMMERCIALISATION OF CARPIL 10.5mg IS
UNFAIR AND THE GOVERNMENT SHOULD ENFORCE COMPULSORY
LICENCE OR NOT?

The counsel on behalf of the respondent has humbly submitted before this Hon’ble Court that
the approval of the patent for CARPIL 10.5mg by the Himvarsh Patent Office is legally
justified as it passed in the test of novelty. Hence, it meets the patentability criteria in view of

28
Malverer V. Spinke 1538 73 Er 79

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DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

the facts and the Himvarsh Patent Act, 1970. And the commercialization of CARPIL is also
fair and the government’s intention is to balance the rights between investors and the people.

4.1. CARPIL is a genuine invention that deserves patent protection as per the act.

It is humbly submitted that the CARPIL is a genuine invention that meets the requirements of
patentability under Himvarsh patents Act, 1970. As defined in section 2(20)(i), an
“invention” means a new product or process involving an inventive step and the capable of
industrial application. CARPIL satisfies this definition, as it is a novel product that involves
an inventive step and an industrial applicability (section 4)

In the light of the case Bishwanth Prasad Radhey Shyam V,Hindustan Metal Industries 29
this case established that the patentability of an invention depends on its novelty, inventive
step,and industrial applicability. The court held that mere modification of a known invention
is not patentable, but a significant improvement can be.

Relying on the facts of the present case it was clear that the CARPIL was an invention made
by the UMC and the patent right was given after the due verification from the Himvarsh
patent Office. So, it was transparent that the CARPIL has a unique chemical makeup that sets
it apart from existing compounds and there is no prior disclosure of pharmaceutical
application. The CARPIL exhibits surprising properties that aren’t inherent in its individuals’
components, demonstrating its novelty and isn’t junior minor modification of an existing
compound which offers substantial enhancements in efficacy and safety.

The CARPIL wasn’t publicly known or disclosed before the patent application was filed,
ensuring its novelty. As per the intellectual property appellate board (IPAB) decision 2018
the patentability of a pharmaceutical invention like CARPIL. The IPAB held that the
invention was novel, involved an inventive step, and had industrial applicability. In the case
of Lallubhai30 the court ruled that novelty is one of the most important criteria in determining
patent eligibility, as it is unknown and unused information that gives a competitive advantage
to the inventor.

29
Bishwanth Prasad Radhey Shyam V,Hindustan Metal Industries AP NO. 128/57
30
Lallubhai 1981 AIR 728

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DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

Relying on the case, Cipla Ltd vs. UOI31 the Hon’ble Supreme Court emphasized the
important of patent protection for encouraging innovation and technological advancement.
The court held that patent laws should balance the rights of inventors with need for public
access to new technologies. The patent for CARPIL was granted after a thorough evaluation
process, and the patent of is deemed it novel, non-obvious and industrially applicable. The
patent application fully disclosed the invention, and the respondent has complied with all
requirements and regulations. CARPIL is a significant improvement over existing drugs, and
its patenting will encourage innovation and investment in the pharmaceutical industry. The
respondent has conducted the extensive research and development, and the patent rewards
their hard work and investment.

As per the section 15 of the Himvarsh patent act, 1970 allows the patent office to grant a
patent if the invention is found to be new, involves an inventive step, and is capable of
industrial application. In re bergy, the Court ruled that a microorganism produced by genetic
engineering is patentable as a manufacturer or composition of matter.

The pharmaceutical industry is among the intellect driven industry. Pharmaceutical testing is
highly expensive and potentially unpredictable. The results of the research may take them
form of a new creative product or method which is useful. Pharmaceutical firms, in this
intensely defend their inventions from unauthorized commercial use by securing the right to a
patent on the patent product or process. In the light of a case Amgen Vs Chugai
pharmaceutical32 the federal circuit ruled that a recombinant DNA molecule is patentable as
a “composition of matter”.

4.2. Approval of patent for CARPIL is to balance the rights of investors and the people.

It is humbly submitted before the Supreme Court that the approval of patent for CARPIL by
the HPO is to balance the rights between the investors and the people. The commercialization
of CARPIL 10.5mg is a legitimate exercise of the UMC’s right to freedom of trade and
commerce. The respondent has taken all necessary safety and efficacy measures to ensure
public health is not compromised.

31
Cipla Ltd vs. UOI 2016 SC 763
32
Amgen Vs Chugai pharmaceutical 13 USPQ2d 1737

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DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

Further, the petitioners have not demonstrated any specific harm or injury caused by the
commercialization of CARPIL 10.5mg. The UMC has complied with all regulatory
requirements and obtained necessary approvals for the commercialization for CARPIL
10.5mg. And the privacy rights of the individuals are not violated as the drug is marketed and
sold in a manner that respects patient confidentiality.

PRAYER

IN THE LIGHT OF THE ISSUES RAISED, ARGUMENTS ADVANCED AND


AUTHORITIES CITIED, MAY THIS HON’BLE COURT BE PLEADED TO AJUDGE,
HOLD AND DECLARE THAT:

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DR. MUMTAZ AHMED KHAN
TH
7 NATIONAL MOOT COURT COMPETITION,2024

1. Dismiss the petitions.


2. In the alternative declare and adjudge.
 The collection of DNA samples by UMC and the government of Himvarsh
false under legal procedures and is not a violation of any rights.
 The commercialization of CARPIL 10.5mg is in compliance with all
relevant laws and regulations.
 UMC’s patent for CARPIL 10.5mg is valid and enforceable and there is
no abuse of power or misuse of any authority.

FOR THIS ACT OF KINDNESS, THE RESPONDENT SHALL HAS DUTY BOUND
EVER HUMBLY PRAY.

PLACE: HIMVARSH

DATE:

COUNSEL FOR THE RESPONDENT

MEMORANDUM FOR RESPONDENT 29 | P a g e

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