AACL 5th National Moot Court Competition, 2020

BEFORE THE HON’BLE SUPREME COURT OF INDIA

PROTOCARE PHARMA PRIVATE LIMITED (APPELLANT)

v.
MIXO CHEMICALS AND PHARMACEUTICALS LIMITED (RESPONDENT)

MR. ARJUN & ORS. (PETITIONERS)

v.
UNION OF INDENIA & ANR. (RESPONDENTS)

HEALTH INDENIA FOUNDATION (PETITIONER)

v.
UNION OF INDENIA (RESPONDENT)

MEMORIAL ON BEHALF OF RESPONDENT

TABLE OF CONTENTS
 AACL 5th National Moot Court Competition, 2020

List of abbreviations…………………………………………………………….....…..…3-4
Index of authorities………………………………………………………………….....…5-7
Statement of jurisdiction…………………………………………………………....….…..8
Statement of Facts………………………………………………………………….…….9-11
Issues presented…………………………………………………………...……………..…12
Summary of Arguments…………………………………………………….……………....13
Arguments Advanced ………………………………………………………..…………14-35
1.1. Absence of process Patent…………………………………...………...…...14
1.2. Disparate diseases…………………………………………………..…...….15
1.2.1. Difference in symptoms………………………………………….….
……...15
1.2.2. Difference in product specifications……………………….……………..17
1.2.2.1. Doctrine of pith and marrow……………………...….
…………..17
1.3. Assessment of Patent Office’s findings…………………………….………20
2.1. Adherence to prescribed Procedural Guidelines……………….……………22
2.1.1. Role of Government in public health………………………………...
……..23
2.1.2. Completion of bioequivalence and approval of DCGI…………….....….23
2.2. Consensual and informed participation in bioequivalence studies…………
24
2.2.1. Wash out period……………………………………………………………..…
25
2.2.2. Participation of subjects in similar studies………………………………..27
2.2.3. Absence of report by petitioners…………………………………………….27
3.1. Conscientiousness of approval of generic
drugs…………………………….29
3.1.1. Absence of arbitrariness……………………………………………….…...29
3.1.1.1. Tender Procedure…………...………………………………….. 30

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3.2. Tetromine is not proven to be ineffective……………………………....……31

3.2.1. Manufacturing and pricing……………………………………...……..…....31
3.2.2. Generic drugs as a boon……………………………………....……….…....33
3.3. Pursuance of Welfare State motive………………………………...………..33
3.3.1. Realisation of DPSP…………………………………………….…………...34
Prayer…………………………………………………………….………………………….36

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LIST OF ABBREVIATIONS

Abbreviation Expansion

& And

AIR All India Reporter

Anr. Another

Art. Article

BPPI Bureau of Pharma Public Sector

Undertakings of Indenia

CDSCO Central Drugs Standard Control

Organization

DARPG Department of Administrative Reforms and

Public Grievances

DCGI Drug Controller General of India

DCR Drugs and Cosmetic Rules

Dept. Department

Hon’ble Honorable

HC High Court

Govt. Government

GST Goods and Services Tax

ICCPR International Covenant on Civil and Political

Rights

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ICESCR International Covenant on Economic, Social

and Cultural Rights

IPAB Intellectual Property Appellate Board

NPPA National Pharmaceutical Pricing Authority

% Percent

r/w Read with

Sec. Section

SC Supreme Court

U.O.I Union of India

UDHR Universal Declaration of Human Rights

u/s Under section

v. Versus

INDEX OF AUTHORITIES

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CASES

1. Catnic Components Ltd. v. Hill & Smith Ltd. (1982) R.P.C. 1

2. Novartis AG v. Union of India [(2013) 6 SCC 1: (2013) 3 SCC (Civ) 227]
3. A.V. Janaki Amma And Ors. v. Union Of India and Ors. (2014) 5 SCC 377

STATUTES

1. Code of Civil Procedure, 1908

2. Drugs and Cosmetics Act, 1940
3. Drugs and Cosmetics Rules, 2019
4. Patents Act, 1970
5. The Constitution of India, 1950
6. The Indian Contract Act 1872

BOOKS

1. Banerjee, B.P., Writ Remedies: Remediable Rights Under Public Law (5th Ed., 2010)
2. Basu, DD, Introduction to the Constitution of India, (22nd Ed., Lexis Nexis, 2015)
3. Blackstone’s International Human Rights Documents (1st Ed.)
4. Das, J.K, Intellectual Property Rights
5. Fitzgerald, P.J., Salmond on Jurisprudence (12th Ed.)
6. Human Rights, III. The Relative Nature, (2014)
7. Intellectual Property Manual, (LexisNexis Legal to Business)
8. L. Wadhera on Patent, Trademarks, and Copyright Law.
9. Malik, Surendra, Supreme Court on Drugs, Medical Laws and Medical Negligence
10. Meenu Paul, Intellectual Property Law.
11. MP Jain, Indian Constitutional Law, (7th Ed., Lexis Nexis, 2016)

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12. Pearson, Intellectual Property (9th Ed.)

13. Pound, Roscoe, Jurisprudence.
14. Seervai, H.M., Constitutional Law of India (4th Ed., Silver Jubilee)
15. Shearer, Starke’s International Law (7th Ed.)
16. Singh, B.P., Human Rights in India.
17. The Code of Civil Procedure 1908 Bare Act with Amendments 2020 Edition by
Government of India.
18. The Indian Constitution: Cornerstone of A Nation (Classic Reissue by Austin
Granville)
19. James Ritter, A Textbook of Clinical Pharmacology and Therapeutics, 5Ed
20. Goodman and Gilman's The Pharmacological Basis of Therapeutics, 13th Edition
21. 1996 Britannica Medical & Health Annual
22. Susan M. Ford MN RN CNE, Roach's Introductory Clinical Pharmacology

MISCELLANEOUS

1. Aiyar P. Ramanathan, the Law Lexicon (3rd ed., 2012)

2. Black’s law Dictionary 10th ed., West group (2014)
3. Compact Oxford Dictionary

Law Reports

1. All India reporters

2. Halsbury’s Law of India

3. Manupatra

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4. Patent & Trade Marks Cases

5. Supreme court cases

6. Supreme court digest.

Online resources-

1. http://www.scconline.com
2. http://www.manupatrafast.com
3. http://www.westlawindia.com
4. http://www.jstor.org
5. http://janaushadhi.gov.in
6. https://cdsco.gov.in
7. .http://www.ipindia.nic.in
8. hthttps://www.ohchr.org/en/udhrtps://dhr.gov.in
9. https://www.inflibnet.ac.in
10. https://cdscoonline.gov.in/CDSCO/homepage

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STATEMENT OF JURISDICTION

1. The Hon’ble Supreme Court has exercised its power vested by Article 139A(1)1 of the
Constitution to transfer to itself the infringement suit pending in the High Court of
Shazanpur, filed by the Appellants i.e., ProtoCare Pharma Private Limited.

2. The Petitioners i.e., Mr. Arjun and ors. have approached the Hon’ble Supreme Court
under Article 322 of the Constitution by virtue of epistolary jurisdiction.

1 Where cases involving the same or substantially the same questions of law are pending before the Supreme
Court and one or more High Courts or before two or more High Courts and the Supreme Court is satisfied on its
own motion or an application made by the Attorney General of India or by a party to any such case that such
questions are substantial questions of general importance, the Supreme Court may withdraw the case or cases
pending before the High Court or the High Courts and dispose of all the cases itself: Provided that the Supreme
Court may after determining the said questions of law return any case so withdrawn together with a copy of its
judgment on such questions to the High Court from which the case has been withdrawn, and the High Court
shall on receipt thereof, proceed to dispose of the case in conformity with such judgment.

2 Remedies for enforcement of rights conferred by this Part

(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.

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3. The Petitioners i.e., Health Indenia Foundation have approached the Hon’ble Supreme
Court under Article 323 of the Constitution.

STATEMENT OF FACTS

1. Indenia, a country in South Asia, aims to establish a democratic socialist society with
emphasis on a well-planned, mixed economy. However, it has been popularly opined
that there is a high prevalence of crony capitalism in the country.
2. Production of generic drugs has been the norm, owing to the one-third population
living below poverty line, until 2005 when Indenia began to grant pharmaceutical
product patents.

I
3. ProtoCare Pharma Private Limited (hereinafter referred to as ProtoCare), a foreign
multinational pharmaceutical corporation with its unit in Shazanpur, has invented a
drug in its brand name Beta-X which is the only life-saving drug for a deadly disease
named Nenzimer, through the use of a tediously drawn-out process.
4. After compliance with the required regulatory mechanisms pertaining to
manufacturing, ProtoCare applied for the product patent of the drug before the Patent
Office of Indenia and was granted the same on 8th January, 2017 (No. 879269)
5. Meanwhile, another serious disease named Bronchus Trivoza emerged in a small
village called Raigaon in the state of Shazanpur. It originated from Maldenia, a
neighboring country. If proper treatment is not provided on time, it will lead to

3 Ibid

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blockage of respiratory tract and finally results in death. Death rate was estimated to
be around 525 within a short span.
6. Cure for Bronchus Trivoza was discovered by Mixo Chemicals and Pharmaceuticals
Limited (hereinafter referred to as Mixo) through a drug named Metrophill Codac.
The price of the drug being too high, it was unaffordable by a common man and the
death toll was increasing. The National Pharmaceuticals Pricing Authority
(hereinafter referred to as NPPA) issued a notification under the Drug Price Control
Order, 2013 by fixing the price of the drug as Rs. 680 (retail price exclusive of GST)
7. An application to obtain a synergistic patent over Metrophill Codac was rejected by
the Patent Office.
8. Mr. Savanth (former intern at ProtoCare), during his internship at Mixo, discovered
that Metrophill Codac was being prepared by using the process of Beta-X, the product
brand of ProtoCare. After confirmation of such use of process, ProtoCare filed an
infringement suit before the Patent Office of Indenia, which was rejected and the
same was upheld by the Intellectual Property Appellate Board (hereinafter referred to
as IPAB). Appeal has been filed against the order of IPAB to the High Court of
Shazanpur.

II
9. A generic drug named Metrocine for the treatment of Bronchus Trivoza was launched
by Forhealth Laboratories (hereinafter referred to as For Health) on 7th June, 2019.
Export license for the same was granted by the Drug Controller General of India
(hereinafter referred to as DCGI) to export the drug to Maldenia, which proved to be
highly effective.
10. Bureau of Pharma Public Sector Undertakings of Indenia (hereinafter referred to as
BPPI), an independent society functioning under the Dept. of Pharmaceuticals set up
by the GoI, was directed by the Ministry of Health and Family Welfare to take
appropriate action for enabling affordable access to the generic drug of the disease

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Bronchus Trivoza upon receiving grievances from the Dept. of Administrative

Reforms and Public Grievances (hereinafter referred to as DARPG)
11. BPPI invited E-tenders for manufacturing the same and received many bids, among
which Bestone Pharmaceutical Research and Manufacturers Limited (hereinafter
referred to as Bestone) got the tender. Bioequivalence studies were completed for the
generic drug named Tetromine and the same was approved by the DCGI on 28th
November, 2019. Prescription of Tetromine was mandated to doctors in government
hospitals and Sanjivini Aushadalaya (specialised outlets)
12. Mr. Arjun, aged 30, is a professional subject of studies and trials of bioequivalence.
On 4th
December 2019 he complained about certain disorders due to the bioequivalence
studies conducted by Bestone, which resulted in permanent loss of his eyesight. He
also contended
that few other subjects who participated in the bioequivalence study died. Mr. Arjun
and the legal representatives of the deceased claimed for compensation and the same
was denied by Bestone. Distressed, they wrote a letter to the Supreme Court praying
for appropriate remedy, which was converted into a writ petition under Article 32 of
the Indenian Constitution.

III
13. Dr. Suhas Mishra, a district surgeon, felt that Tetromine is less effective as compared
to brand drug Metrophill Codac as the condition of patients was deteriorating. After
conducting research and collecting reports, he discovered that Bestone had failed to
maintain therapeutic efficacy, safety and performance characteristics as its brand
counterpart. He approached Health Indenia Foundation (hereinafter referred to as
HIF), an NGO, which filed a PIL before the Supreme Court of Indenia alleging the
gross violation of Human Rights by the GoI.
14. The infringement petition was combined with the other two petitions by the Supreme
Court.

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ISSUES PRESENTED

ISSUE 1
WHETHER PATENT HAS BEEN INFRINGED.

ISSUE 2
WHETHER THERE IS VIOLATION OF FUNDAMENTAL RIGHTS OF ARJUN AND
OTHERS.

ISSUE 3
WHETHER THERE IS MASS VIOLATION OF HUMAN RIGHTS.

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SUMMARY OF ARGUMENTS

ISSUE 1
WHETHER PATENT HAS BEEN INFRINGED.

It is humbly submitted before the Hon’ble Court that there is absence of patent infringement
by virtue of absence of process patent held by the appellants. The same has been
substantiated with the support of doctrine of pith and marrow and product differentiation.

ISSUE 2
WHETHER THERE IS VIOLATION OF FUNDAMENTAL RIGHTS OF ARJUN
AND OTHERS.
It is humbly submitted before the Hon’ble Court that there is no violation of fundamental
rights of the petitioners. The respondents have acted with due care and caution while
administering bioequivalence studies, which the petitioners were a part of.

ISSUE 3
WHETHER THERE IS MASS VIOLATION OF HUMAN RIGHTS.
It is humbly submitted before the Hon’ble Court that there is no mass violation of human
rights. The respondent has adhered to the prescribed procedural norms and acted in
furtherance of welfare state objective and protection of human rights of the citizens.

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ARGUMENTS ADVANCED

ISSUE 1
Whether patent has been infringed

A patent is a monopoly right granted to a person who has invented a new and useful article or
an improvement of an existing article or a new process of making an article. Any person who
encroaches on the rights of a patentee commits an infringement of the rights of the patentee.
It is humbly submitted that the patent held by ProtoCare Pharma Private Limited
(hereinafter referred to as the “appellant”) has not been infringed by Mixo Chemicals and
Pharmaceuticals Limited (hereinafter referred to as “respondent”).

1.1. Absence of process patent

Indian Patents Act, 1970 (hereinafter referred to as the Act) has been amended in the year
2005 whereunder the concept of the product patent in relation to pharmaceuticals has been
introduced.
Patent can be granted for either products or process. Product patent confers the exclusive
right to manufacture the product on the inventor (patentee). Consequently, none apart from
the one who holds the patent in the product can manufacture the product irrespective of the
fact that the new manufacturer uses a process completely different from the patent holder 4
4 Intellectual Property Manual, (LexisNexis Legal to Business)

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Contrary to product patents, in the case of process patents the patentee gets a patent in the
process of manufacture of product and not the product itself.

It is alleged that the respondents have employed the same process used by the appellants in
manufacturing Beta-X, which has resulted in infringement of the patent held by the
appellants.
It is submitted that the alleged infringement is unfounded by virtue of the fact that the
appellant has obtained a product patent alone, and not a process patent. It follows that the
usage of the same process by the respondent does not pertain to the product patent held by the
appellant. In the absence of a patent process, the process may be adopted by any person5
Since the process adopted by the appellant is not patented, there can be no infringement of
the same.

1.2. Disparate diseases

It is submitted that the drugs manufactured by the two parties are designed to cure distinct
diseases. Beta-X is the only life-saving drug for a deadly disease termed Nenzimer, whereas
Metrophill Codac was invented to cure Bronchus Trivoza6. Contrast may be drawn and
depicted under two heads:

1.2.1. Difference in symptoms

The central subject while differentiating diseases is the symptoms exhibited by the afflicted
persons. Therefore, the recorded symptoms of both diseases must be examined in order to
analyze the variance. Due to the death of symptoms related to Nenzimer, it becomes
imperative to investigate the constituents used in Beta-X, which will disclose the symptoms
of the disease.

5 Factsheet ¶ 8.

6 Factsheet ¶ 4 and 7.

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The patent specification of Beta-X reads:

“A medication in the form of a capsule comprising a PDE inhibitor, which is to be
administered orally.”, PDE inhibitor being the crux constituent of the drug.
Phosphodiesterase inhibitors (PDE inhibitors) form a class of drugs that inhibit
Phosphodiesterase Enzymes (PDEs), which normally breaks a phosphodiester bond7. PDE
inhibitors are classified according to which enzyme(s) they act upon as non-specific, PDE5,
PDE4, and PDE3 inhibitors8.
Rules of interpretation mandate that Beta-X comprises a non-specific PDE inhibitor
considering the phraseology of its specification. Non-specific PDE inhibitors are employed
specifically for the treatment of COPD (Chronic Obstructive Pulmonary Disease), which is a
group of progressive lung diseases9. The major symptoms of COPD are:
1. Shortness of breath.
2. Wheezing.
3. Fatigue.
Au contraire, the major symptoms recorded for Bronchus Trivoza are:
1. Shortness of breath.
2. Blood vomiting.
3. Severe headache.
4. Fever.
It is conspicuous that the symptoms of Bronchus Trivoza are more acute and distinct when
placed in comparison with Nenzimer, which is relatively less drastic. Albeit shortness of
breath is a common symptom, blood vomiting, severe headache and fever are additional
symptoms highlighting the severity visible in Bronchus Trivoza, which are absent in
Nenzimer. The contention is supported by the facts of the case wherein it is provided that the
disease is contagious, spreading rapidly10, and if treatment is not provided on time, it leads to
7 James Ritter, A Textbook of Clinical Pharmacology and Therapeutics, 5Ed 327

8 Ibid.

9 Infra note 13.

10 Factsheet ¶ 6

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blockage of respiratory tract and finally results in death. Therefore, it is established that the
diseases are distinct, Bronchus Trivoza being relatively aggravated.

1.2.2. Difference in product specifications

In addition to the distinct diseases, it is submitted that there exists variation in the product
specifications of Beta-X and Metrophill Codac11.

1.2.2.1. Doctrine of pith and marrow

At the inception, the doctrine was applied by courts in the U.K. to implicate the crux of the
invention which is constituted by the essential integers of the invention. It evolved into the
rule of purposive construction from Catnic Components Ltd. v. Hill & Smith Ltd.12, where
the House of Lords laid down that the claims of the the patent had to be constructed through
the eyes of a notional addressee who is going to carry out the described invention. The
questions propounded in the case are:
1. What are the essential integers of the claim?
The specification of Beta-X reads:
“A medication in the form of a capsule comprising a PDE inhibitor, which is to be
administered orally.”. As already stated above (1.3.1.), PDE inhibitor is the crucial
component of the drug.

2. Infringing articles must be considered.

The specification of Metrophill Codac reads:

11 Factsheet ¶ 4 and 7

12 (1982) R.P.C. 183

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“A medication in the form of a capsule comprising a PDE inhibitor, which is to be

administered orally, from the PDE4 inhibitors group combined with a G2 adrenoceptor
agonist in free combination with tolerable salt of N-oxide.”
The core ingredients combined in Metrophill Codac are:
A. PDE4 inhibitor.
B. G2 adrenoceptor agonist.
C. N-oxide.
PDE4 inhibitor falls in the PDE inhibitors group, which is employed to treat severe COPD.
G-protein coupled receptor transduces extracellular signals across the cell membrane 13. At the
external side they receive a ligand (a photon in case of opsins), and at the cytosolic side they
activate a guanine nucleotide-binding (G) protein14. A ligand is a substance that forms a
complex with a biomolecule to serve a biological purpose.
Adrenoceptor agonist is a chemical that binds to a group of receptors on cell surfaces and
activates the receptor to produce a biological response15. It is a group of receptors on cell
surfaces that are activated by epinephrine or norepinephrine16. A receptor a nerve ending that
reacts to a change, such as heat or cold, in the body by sending a message to the central
nervous system. Epinephrine is used medicinally especially to stimulate the heart during
cardiac arrest and to treat life-threatening allergic reactions (also known as adrenaline).
Norepinephrine is used as a drug to raise blood pressure.

Heterocyclic N-oxides have emerged as valuable anticancer, antibacterial, antihypertensive,

antiparasitic, anti-HIV, anti-inflammatory, herbicidal, neuroprotective, and procognitive
agents. There are four principal modes of action that distinguish the heterocyclic N-oxide
motif with respect to each therapeutic area, from which nitric oxide mimics is the specific
13 Goodman and Gilman's The Pharmacological Basis of Therapeutics, 13th Edition 156.

14 Ibid

15 1996 Britannica Medical & Health Annual 232.

16 Ibid

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area that is applicable to the present drug17. The N–O moiety in a variety of heterocyclic N-
oxides can elicit nitric oxide-like effects, acting as a nitric oxide agonist. Nitric oxide diffuses
to underlying smooth muscle cells and causes them to relax18. This relaxation causes the walls
of blood vessels to dilate, or widen, which in turn increases blood flow through the vessels
and decreases blood pressure. Nitric oxide’s role in dilating blood vessels makes it an
important controller of blood pressure.

3. The article must take each and every one of the essential integers.
It is definite upon examination of the ingredients of both drugs that Metrophill Codac clearly
does not take each and every one of the essential integers of Beta-X. Alongside the
compositional distinction, it is submitted that the ligands in Beta-X and Metrophill Codac
operate through different pathways i.e., they exhibit distinct modes of functional mechanism.
It is discernible that the additional ingredients combined in Metrophill Codac viz., G2
adrenoceptor agonist and tolerable salt of N-oxide differentiate it from Beta-X. The
components read in conjunction with the symptoms reveals The existent disparity between
the drugs. Bronchus Trivoza, being relatively aggravated, demands supplementary ingredients
in view of proportionality of severity. The extra functional efficacy of Metrophill Codac is
absent in Beta-X, which encompasses the treatment of COPD alone.

1.3. Assessment of Patent Office’s findings

Utility criterion of patentability must be distinguished from efficacy as mentioned in section

3(d)19 of the Patents Act, 1970 . In order to attract section 3(d) of the Act, the subject product

17 Susan M. Ford MN RN CNE, Roach's Introductory Clinical Pharmacology 126

18 Ibid
19 the mere discovery of a new form of a known substance which does not result in the enhancement of the
known efficacy of that substance or the mere discovery of any new property or new use for a known substance
or of the mere use of a known process, machine or apparatus unless such known process results in a new
product or employs at least one new reactant.

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must be a new form of a known substance having known efficacy and “known” here connotes
proven and well-established20. The word efficacy in pharmacology is understood and
accepted to mean “therapeutic efficacy”. Efficacy, as defined in the Dorland’s Medical
Dictionary is “the ability of a drug to produce the desired therapeutic effect.”, where
“therapeutic” is healing of the disease (having a good effect on the body).
In the case of a medicine that claims to cure a disease, the test of efficacy can only be
therapeutic efficacy. This therapeutic efficacy of a medicine must be judged strictly and
narrowly. Under section 3(d) r/w the Explanation of the Act, not all advantageous or
beneficial properties of a new form are relevant, but only such properties that directly relate
to its efficacy.
On the other hand, the utility criterion of patentability implies that the invention must be
capable of industrial application i.e., it must perform some function of positive benefit to
society. It is not always necessary to establish the commercial success of the product/
process.

Mere non-fulfilment of patentability criteria does not amount to infringement. When read
with the distinction of products highlighted above (1.2.), it reveals that the enhanced
therapeutic efficacy under Sec. 3(d) is being fulfilled, whilst infringement of patent becomes
a detached subject altogether. Further, it would be erroneous to affirm the findings of the
Patent Office to be conclusive. Inclusion of provisions to challenge the decisions of the
Patent Office rests on the sole basis of providing room for rectification of inaccurate
judgement. Conjecture may not be made in respect of finality of the same.
Therefore, it is established that patentability and infringement are independent issues.

Explanation. -For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle
size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be
considered to be the same substance, unless they differ significantly in properties with regard to efficacy,
Patents Act, 1970.

20 Novartis AG v. Union of India [(2013) 6 SCC 1: (2013) 3 SCC (Civ) 227]

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ISSUE 2
Whether there is violation of fundamental rights of arjun and ors.

2.1. Adherence to prescribed Procedural Guidelines

In response to the outbreak of Bronchus Trivoza, the Government (hereinafter referred to as

respondent) took initiative and directed the BPPI to take necessary action21. The main motto
of BPPI is to manufacture quality generic medicines available at affordable prices for all.
Accordingly, it issued a notification inviting E-Tenders in view of manufacturing a generic
drug for curing the disease. It is evident that the respondent was receptive to the predicament
of the public and operated in the line of diluting the same while adhering to the Constitution.

The main objectives of BPPI are to22:

1. Ensure availability of quality drugs at reasonable prices as per the Pharma Policy.
2. Development of Pharma Infrastructure and Innovative Development in Pharma Sector
including through PPP.
3. Promote Pharma Brand India.
4. Encourage environmentally sustainable development of the Pharmaceutical Industry.
5. To establish NIPERs as nationally and internationally recognized brand in the field of
education and research of pharmaceutical sciences for the benefit of humankind.

21 Factsheet ¶ 11.

22 Annual report of BPPI, 2017-18

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2.1.1. Role of Government in public health

Indian Pharma Industry has been a global leader in Generic drugs. In order to acquire
leadership positions in drug discovery and development and to continue to excel in the
formulations, the Government recognized that the human resources/talent pool is very
critical. Also contributing to global health care, 20% of Global generics is supplied by Indian
pharmaceutical companies and 4 out of 10 generics in the USA are made in India23. Hence it
can be inferred that the government has taken utmost care of its public’s health and has time
and then taken necessary actions.

2.1.2. Completion of bioequivalence and approval of DCGI

Bioequivalence study is one of the main requirements for the generic drug approval
process. The Indian pharmaceutical industry at present is the global leader of growing
pharmaceutical manufacturing companies, providing wide range capabilities in the complex
field of technology and drug manufacturing. Generics have an important role to play in public
health as they are well known to the medical community and usually more affordable due to
competition. The legal requirement in India under the Drugs & Cosmetics Rules, 201924
(hereinafter referred to as DCR) for conducting bioequivalence studies has, so far, been
limited to only those generics that are approved by the DCGI within the first four years of the
innovator drug being approved in India because of its rigid procedure.
According to the law, bioequivalence tests are conducted for generic drugs to ensure and
guarantee that the bioequivalence is the same as the branded medicine. Bioequivalence
implies when two medicines are similar, they have a physiological action on the user.
It is submitted that the respondent has observed the prescribed guidelines:

23 Government of India. National Health Policy. Ministry of Health and Family Welfare, Government of India,
New Delhi: 2002

24 Chapter IV of Drugs & Cosmetics Rules, 2019

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1. Bioequivalence studies conducted by Bestone were monitored and successfully

concluded.
2. Due analysis and adherence to the stages prescribed for approval of drug.
3. NDA and ANDA followed the review process before the approval from the DCGI.
4. Procurement of DCGI’s approval.

Bioequivalence does not require the full clinical trial process that the name-brand version
must undergo. Instead, generic drugs only have to be bioequivalent, which means the
company applying for approval must perform the following steps25:
1. Test the generic drug against the brand-name drug on two small groups of test
subjects.
2. Demonstrate through statistical analysis that any difference in the drug’s
bioavailability in participants taking the brand name version versus participants taking
the generic version is not clinically significant.

It is submitted that there is clear fidelity to the rigid procedure of bioequivalence there has
been no mismanagement or negligence by the respondent.

2.2. Consensual and informed participation in bioequivalence studies

Before conducting bioequivalence studies, a procedure for informed consent must be

conformed with, which has been laid down by the Indian Council of Medical Research
(hereinafter referred to as ICMR). Informed consent protects the individual’s autonomy to
freely choose whether or not to participate in the research. The process involves three
components26 –

25 Bioequivalence and Bioavailability Studies in Human Volunteers by Vivek Paithankar, procedure under the
SUGAM Portal.

26 Section 5 Informed consent process, ICMR Ethical Guidelines 2017.

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A) Providing relevant information to potential participants,

B) Ensuring the information is comprehended by them, and
C) Assuring volunteer participation.

Informed consent explains medical terminology in simple terms and in a language that the
participant understands. Any foreseeable risks, discomfort or inconvenience to the
participant resulting from participation in the study is priorly informed to the subjects
and adequate time is given to read the consent form and seek clarification of her/his doubts
from the researchers/research team before deciding to enroll in the research. It is in the
discretion of the participants to take part in studies. Further, a separate Independent Ethical
Committee27 (IEC) monitors the informed consent procedure28.
It is humbly submitted before the Hon’ble court that the respondent with all the due
diligence has taken proper care during the studies.

2.2.1. Wash out period

In bioavailability studies utilizing crossover design, a sufficient length of washout period
between dosing periods is necessary to wear off the possible residual effect from the previous
dose that may be carried over to the next dosing period. It is generally required that at least
5.5 half-lives be considered to ensure there is a sufficient length of washout for immediate
release (IR) products. For controlled release (CR) products, on the other hand, it is indicated
that at least 8.5 half-lives should be considered to limit the chance of possible carry-over
residual effect.This should ensure an elimination of 99.9% of the administered dose and a
maximum carryover of less than 0.1% from first treatment.

27 Section 4, Ibid.

28 Supra note 24, Eyal, N. (2012). Informed Consent Retrieved August 15, 2012; from The Stanford
Encyclopedia of Philosophy; Human D, Fluss SS. The World Medical Association’s Declaration of Helsinki:
Historical and contemporary perspectives,

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It is submitted that the wash out period of Tetromine is one week. It becomes necessary to
examine the possible time frame of the bioequivalence studies to be compared with the phase
of adverse effects. Facts may be narrated herein29,
1. 2nd March, 2018 - Reduction of price of Metrophill Codac through a notification by
NPPA.
2. DARPG received representations to further reduce the price of the drug.
3. The grievance was forwarded to BPPI, whereafter E-Tenders were invited to produce
the generic version of Metrophill Codac.
4. 28th November, 2019 - Bestone obtained approval for Tetromine after completion of
bioequivalence studies.
5. 4th December, 2019 - Petitioners complained of adverse effects of the drug.

The time gap between the notification and the approval of Tetromine by the DCGI becomes
significant. Bioequivalence studies necessitate a certain amount of time, which is inclusive of
procedural adherence, creation and submission of reports, examination of reports by the
supervising authorities, etc. before obtaining approval from the DCGI.

Emphasis must be laid upon the duration between:

A) The completion of bioequivalence studies and approval of the drug for public usage.
B) Approval of the drug and surfacing of adverse effects.
It is submitted that there must be a considerable time span in between the completion of
studies and approval of the drug. Further, the petitioners complained about adverse effects
after a week post-approval. Restating the wash out period of Tetromine i.e., one week, it is
indisputable that the adverse effects experienced were caused by some factor independent of
the bioequivalence studies administered by Bestone.

2.2.2. Participation of subjects in similar studies

29 Factsheet ¶ 11, 12, 14.

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Multicentric research studies are carried out with the primary aim of providing a sound basis
for the subsequent generalization of its results. Usually they work on the same protocol but at
different investigational sites. All sites are required to obtain approval from their respective
IECs, which would consider the local needs and requirements of the populations being
researched and safeguard the dignity, rights, safety and well-being30.
It is submitted that no evidence exists to substantiate the role of Bestone in the arisal of
adverse effects experienced by the subjects. The petitioners were participants in similar
bioequivalence studies conducted by various other Clinical Research Organisations and were
paid incentives after completion of the same31. As already established under 2.2.1.,
probability of Tetromine being the source can be ruled out due to the expiry of wash out
period when the petitioners complained of the detrimental effects. Rationale follows that their
participation in similar studies becomes the cause of such impairment.

2.2.3. Absence of report by petitioners

In case of any serious adverse effects occurring during bioequivalence and generic
bioequivalence, it must be reported to the Ethics Committee32 . Any unexpected fatal or life-
threatening adverse reactions after due analysis shall be sent to the Central Licencing
Authority, chairperson of the Ethics Committee and the institute or the centre where the
bioavailability or bioequivalence study, as the case may be, has been conducted within
fourteen days of its occurrence33. The timeline for reporting such adverse effects differs on a

30 ICMR Ethical Guidelines, 2017.

31 Factsheet ¶ 14.

32 Rule 11(iv) where any serious adverse event occurs to a trial subject or to study subject during clinical trial
or bioavailability or bioequivalence study, the Ethics Committee shall analyse the relevant documents pertaining
to such event and forward its report to the Central Licencing Authority and comply with the provisions of
Chapter VI of DCR, 2019.

33 Rule 35 (ix) of DCR, 2019.

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drug-to-drug basis, which is informed to the subjects prior to taking their consent (known as
‘Informed Consent’34).
It is submitted that the petitioners failed to report any such effects to the authorities
within the prescribed time. Development in medical sciences has shed light on the issue of
progressive diseases. Aggravated conditions such as permanent impairment and death occur
over a span of time, which the petitioners failed to report.

ISSUE 3
WHETHER THERE IS MASS VIOLATION OF HUMAN RIGHTS.

It is humbly submitted before the Hon’ble Court that there is no mass violation of human
rights of the people of Indenia. The contention is reinforced broadly under three heads:

3.1. Conscientiousness of approval of generic drugs

It is submitted that the Government (hereinafter referred to as Respondent) has been

conscientious during approval of generic drugs.

3.1.1. Absence of arbitrariness

There exists no arbitrary action/decision of the respondent. The actions undertaken by the
respondent must be scrutinised in order to establish the absence of such arbitrariness. Going
by the chronology of facts,
1. Inception of the disease - Where the price of Metrophill Codac was too high and
unaffordable, the first action taken by the respondent was to reduce the price of the
34 Supra note 24.

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drug, which was the only life-saving drug for Bronchus Trivoza. The NPPA reduced
the price of the drug from Rs.1890 to Rs.680, by issuing a notification dated 2nd
March 2018 under Drug Price Control Order, 2013. It is submitted that the new price
is less than half of the foregoing price.
2. Further reduction in price - DARPG received several representations to further reduce
the price of the drug. As a second response, the Ministry of Health considered the
matter seriously and directed the BPPI to take appropriate actions. BPPI invited E-
Tenders to supply medicine to patients at a cheaper price. Tetromine was
manufactured after compliance with the prescribed procedure and successful
completion of bioequivalence studies.
In both instances, the action of the respondent was fair, prudent, just and reasonable.

3.1.1.1. Tender procedure 35--

It is submitted that the respondent has followed the procedure36 before selecting Tetromine.
The tender inviting authority of BPPI issued an advertisement in leading newspapers calling
for E-Tenders37 to present quotations for the manufacturing of generic drugs for Bronchus
Trivoza. As per the general procedure, BPPI selected the lowest bidders and after completion
of bioequivalence studies, the drug proved to be bioequivalent to its branded counterpart
Metrophill Codac. The DCGI has approved the generic medicine on 28th november 2019.

35 Tender procedure of BPPI.

36 E Tendering procedure-
1) Tenders process is determined
2)Request for tender is prepared
3)Tenders are invited
4)suppliers respond
5)Evaluation and selection
6)notification and debriefing
7)contract established and managed.

37 Supra note 33

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Therefore, it is established that there is no negligence or arbitrariness on part of the

respondent in selecting or approving Tetromine, as the respondent has exercised due care and
diligence before such approval.

3.2. Tetromine not proven to be ineffective

It is humbly submitted before the Hon’ble Court that the petitioner has considered merely the
relative efficacy of Tetromine in comparison with Metrophill Codac, and has disregarded the
capacity of public to afford life-saving medicine. It is discernible that Tetromine has not
proven to be ineffective, and the statement may be bolstered by the fact that Tetromine passed
the bioequivalence studies conducted by Bestone under the administration of the respondent.

3.2.1. Manufacturing and pricing

Generic drugs play an important role in health care and the availability of generic drugs
reduces the monopoly powers of the patent holder.
The Government of Indenia follows the practice of compulsory licensing in view to make
available the much needed generic drugs. By way of doing this, the respondent has attempted
to make medicine affordable to the general public, People with chronic health conditions are
particularly vulnerable because their illnesses or the treatments for their illnesses impede their
ability to work, with some patients losing employment altogether. Such individuals
frequently incur significant financial debt and deplete the assets they need to pay for
treatment, some to the extent that they must resort to bankruptcy.
Not only internally, but also it has a great influence in international markets. Presently, the
Indenian pharmaceutical sector has become a prominent provider of healthcare products. It
meets 95% of the country’s medical needs. The total Indian production constitutes about
1.3% of the world market in value terms and 8% in volume terms38. The Medical Council of
Indenia, in an amendment to the Code of Conduct for Doctors in October 2016, has

38 Health Administrator Vol : XIX Number 1: 16-19

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recommended that every physician should prescribe drugs with generic names legible and he
or she shall ensure that there is a rational prescription which promotes the use of generic
drugs39.

It is submitted that the respondent has imported the legal framework under which
doctors are mandated to prescribe generic medicines to patients.
Further, NPPI has reduced the price of the branded drug Metrophill Codac in furtherance of
public interest. The course of events may be narrated herein:
1. The initial price of the drug was Rs. 1890 per capsule to be consumed for 45 days40,
which results in a total cost of Rs. 85,050.
2. 2nd March, 2018 - the price of the drug was reduced to Rs. 680 per capsule41, which
results in a total cost of Rs. 30,600.
3. Tetromine was manufactured in bulk, priced at Rs. 31942. Parallel can be drawn to the
course of administration prescribed for Metrophill Codac on the grounds of
Tetromine being bioequivalent to the same. Therefore, the total cost from usage of
Tetromine amounts to Rs. 14,355.
Juxtaposing the healthcare costs involved in both drugs, the difference reduces to 42.64%,
Tetromine being the cheaper drug. The total reduction from the original price of Metrophill
Codac to the price of Tetromine boils down to 83.12%.

3.2.2. Generic drugs as a boon

A generic drug is identical or bio-equivalent to a brand name drug in dosage form, safety,
strength, route of administration, quality, performance characteristics and intended use.

39 The Hans India. 2017. [cited 2018 Apr 12]

40 Factsheet ¶ 7.

41 Supra note 36.

42 Factsheet ¶ 12.

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Although generic drugs are chemically identical to their branded counterparts, they are
typically sold at substantial discounts from the branded price ,Where indenia with its one-
third population living below the poverty line, contracting a disease comes with a huge cost is
strenuous,. At least 20-25 per cent of the patients deliberately look for branded medicines. So
they certainly will opt for the branded ones but for the remaining 75-80 per cent prescribing
generic medicine will be a boon43.

Government of Indenia , has undertaken many scheme to reduce disease burden and to make
medicines affordable to people . Government of Indenia introduced a scheme , Dina Raksha
arogya yojana (hereinafter referred as DRAY) with a motto, ‘Taking medicine to the mass,
DRAY Provides generic medicine with affordable cost to economically weaker section
through specialised outlets called sanjivini aushadalaya , Respondent has reduced health
care budget of every citizen of Indenia by providing quality medicine at affordable cost.

3.3. Pursuance of Welfare State motive

Indenia is described as a “sovereign socialist secular democratic republic” in the Preamble of

the Indian Constitution. Accordingly, the Constitution has extensive provisions to ensure
social and economic welfare of the people.

3.3.1. Realisation of DPSP

One of the salient features of the Indian constitution is the effort to establish a welfare state.
The Preamble and the Directive Principles of State Policy make it amply clear our goal is a
welfare 44and socialist state through democratic means.

43 Janodia M. Differences in price of medicines available from pharmaceutical companies and “Jan Aushadhi”
stores.

44 Article 38 - “The state shall strive to promote the welfare of the people by securing and protecting as
effectively as it may, a social order in which justice-social”.

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The Preamble promises to secure the Indian people Justice - social, economic and political.
The Directive Principles are non-justiciable, nonetheless they are regarded as fundamental in
the governance of the country.

Adhering to the goals set by the constitution-makers, the respondent has, in pursuance of
the welfare state motive enshrined in preamble as ‘socialist’, provided for effective and
affordable healthcare to the public. This provision has been laid down under Article 4745 of
the Constitution, which must be read in conjunction with Article 2146 imbibing the right to
health as per the interpretations of the Hon’ble Court.

It is submitted that the respondent has functioned in the direction of enhancement of these
rights insofar as the capacity of the state is concerned. Albeit the fragility of revenue
generated by the country, the respondent has successfully secured to its citizens affordable
medicine and due health care facilities. In A.V. Janaki Amma And Ors. v. Union Of India and
Ors47, the Hon'ble Court ruled, "If every violation of every fundamental right is brought under the
purview of constitutional tort and compensation awarded in public law remedy of writ jurisdiction, the
State and the Government would become bankrupt and the Government itself would be destroyed."

It is submitted that the respondent has operated in amplification of protection of basic human
rights of the citizens. Fortitude has been drawn from UDHR and other international
convention48 providing for the right to health, which has been implemented by the respondent
while adhering to Article 51(c) of the Constitution49.
45The State shall regard the raising of the level of nutrition and the standard of living of its people and the
improvement of public health as among its primary duties and, in particular, the State shall endeavour to bring
about prohibition of the consumption except for medicinal purposes of intoxicating drinks and of drug which are
injurious to health.

46No person shall be deprived of his life or personal liberty except according to procedure established by law.

47 SCC 2004(1) ALD 19.

48 Article 12 International covenant on economic social and cultural rights.

49 Article 51(1) Promotion of international peace and security The State shall endeavour to-
(c)foster respect for international law and treaty obligations in the dealings of organised peoples with one
another; and encourage settlement of international disputes by arbitration PART IVA FUNDAMENTAL

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Article 23 of UDHR50 provides for the right to life, liberty and the security of a person.
Further, Article 25 of the same document provides for the right to a standard of living
adequate for the health and well-being of himself and of his family, including food, clothing,
housing and medical care and necessary social services, and the right to security in the event
of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in
circumstances beyond his control. Article 6 of the International Covenant on Civil and
Political Rights provides, “Every human being has the inherent right to life. This right shall
be protected by law. No one shall be arbitrarily deprived of his life.”

DUTIES.

50Article 25(1)--
Everyone has the right to a standard of living adequate for the health and well-being of himself and of his
family, including food, clothing, housing and medical care and necessary social services, and the right to
security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in
circumstances beyond his control.

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PRAYER

WHEREFORE, in the light of issues raised, arguments advanced, and authorities cited, the
respondent prays before this Hon’ble Court that it be pleased to:

1. Declare the infringement suit to be unmaintainable.

2. Any other reliefs that this Court may grant in the interests of Justice.

The respondent(s) pray before this Hon’ble Court that it be pleased to:

1. Dismiss the Writ Petition filed against the respondent(s).

2. Dismiss the PIL filed against the respondent.
3. Any other reliefs that this Court may grant in the interests of Justice.

AND FOR SUCH ACT OF KINDNESS, THE PETITIONER AS IN DUTY

BOUND, SHALL EVER PRAY.

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Counsel(s) for the respondent(s).

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