Memorial - A

AACL 5th National Moot Court Competition, 2020
BEFORE THE HON’BLE SUPREME COURT OF INDENIA
Tr.(Civil) No.______/2018
PROTOCARE PHARMA PRIVATE LIMITED (APPELLANT)
v.
MIXO CHEMICALS AND PHARMACEUTICALS LIMITED (RESPONDENT)
W/P No._______/2019
MR. ARJUN & ORS. (PETITIONERS)
v.
UNION OF INDENIA & ANR. (RESPONDENTS)
PIL No.______/2020
HEALTH INDENIA FOUNDATION (PETITIONER)
v.
UNION OF INDENIA (RESPONDENT)
MEMORIAL ON BEHALF OF PETITIONER

TABLE OF CONTENTS
Particulars Page No.
Table of contents 02
List of abbreviations 03
Index of authorities 04 - 07
Statement of jurisdiction 08
Statement of facts 09 - 11
Issues presented 12
Summary of arguments 13
Arguments advanced 14 - 39
Prayer 40
-MEMORIAL ON BEHALF OF PETITIONER-
2
LIST OF ABBREVIATIONS
Abbreviation Expansion
& And
AIR All India Reporter
Anr. Another
Art. Article
CDSCO Central Drugs Standard Control Organization
DCR Drugs and Cosmetic Rules
Dept. Department
Hon’ble Honorable
Govt. Government
GST Goods and Services Tax
ICCPR International Covenant on Civil and Political Rights
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
U.O.I Union of India
UDHR Universal Declaration of Human Rights
u/s Under section
v. Versus
3
INDEX OF AUTHORITIES
CASES
1. A.D.M Jabalpur v. Sukla
2. Apparel Export Promotion Council Vs A.K Chopra, (1999) 1SCC 759/1
3. Asian Electronics Ltd. v. Havel’s India Ltd., [2010 (44) PTC 66(Del.)]
4. Bandhua Mukti v Union of India
5. CESC Ltd. vs. Subash Chandra Bose
6. Consumer Education and Research Centre v. Union
7. Consumer Education and Research Centre v. Union of India
8. Cotton Corp of India v. United Industrial Bank
9. Gideon v. Wainwright
10. Mani Subrat v. Haryana, A.I.R.1977 S.C.276.
11. Mu R v. Barker, (1762) 3 Burr 1265, 1267
12. Narendrajit Singh v. UOI
13. Novartis AG v. Union of India, [(2013) 6 SCC 1: (2013) 3 SCC (Civ) 227]
14. Paschim Banga Khet Mazdoor Samity & Ors. v. State of West Bengal, AIR 1996 4
SCC
15. Paschim Banga Khet Mazdoor Samity vs. State of West Bengal of India
16. People's Union for Civil Liberties v. UOI
4
17. Sabaf Spa v. MFI Centres Ltd. & Ors.
18. State of Punjab v. Mohinder Singh Chawal
19. State of Punjab v. Mohinder Singh Chawal
20. Union of India v. A.L. Rallia Ram
21. Union of India v. N.K. (P) Ltd
22. Vincent Panikulangara vs. Union of India. AIR 1987 SC 990: 995. p. 995
23. Vishaka v. State of Rajasthan
24. Winans v. Denmead , 56 U.S. (15 How.) 330
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
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. Goodman and Gilman's The Pharmacological Basis of Therapeutics, 13th Edition
7. Human Rights, III. The Relative Nature, (2014)
8. Intellectual Property Manual, (LexisNexis Legal to Business)
9. James Ritter, A Textbook of Clinical Pharmacology and Therapeutics, 5Ed
10. L. Wadhera on Patent, Trademarks, and Copyright Law.
5
11. Malik, Surendra, Supreme Court on Drugs, Medical Laws and Medical Negligence
12. Meenu Paul, Intellectual Property Law.
13. MP Jain, Indian Constitutional Law, (7th Ed., Lexis Nexis, 2016)
14. Pearson, Intellectual Property (9th Ed.)
15. Pound, Roscoe, Jurisprudence.
16. Seervai, H.M., Constitutional Law of India (4th Ed., Silver Jubilee)
17. Shearer, Starke’s International Law (7th Ed.)
18. Singh, B.P., Human Rights in India.
19. Susan M. Ford MN RN CNE, Roach's Introductory Clinical Pharmacology
20. The Code of Civil Procedure 1908 Bare Act with Amendments 2020 Edition by
Government of India.
21. The Indian Constitution: Cornerstone of A Nation (Classic Reissue by Austin
Granville)
MISCELLANEOUS
1. Black’s Law dictionary, 10th Ed., West Group (2014)
2. Compact Oxford Dictionary.
3. AIYAR P. RAMANTHAN, THE LAW LEXICON (3rd ed., 2012)
LAW REPORTS
1. All India reporters

2. Halsbury’s Law of India
3. Manupatra
4. Patent & Trade Marks Cases
5. Supreme court cases
6. Supreme court digest.
6
7. 1996 Britannica Medical & Health Annual
Online Resources-
1. http://www.scconline.com
2. http://www.manupatrafast.com
3. http://www.westlawindia.com/
4. http://www.jstor.org
7
STATEMENT OF JURISDICTION
1. The Hon’ble Supreme Court has exercised its power vested by Art. 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 Art. 322 of the Constitution by virtue of epistolary jurisdiction.
3. The Petitioner i.e., Health Indenia Foundation has approached the Hon’ble Supreme
Court under Art. 323 of the Constitution.
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
3
Ibid
8
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
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)
9
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 Forhealth) on 7th June, 2019.
Export license for the same was granted by the Drug Controller General of Indenia
(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
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
10
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 Art. 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 Govt. of India.
14. The infringement petition was combined with the other two petitions by the Supreme
Court.
11
ISSUES PRESENTED
ISSUE 1
WHETHER PATENT HAS BEEN INFRINGED
ISSUE 2
WHETHER THERE IS VIOLATION OF FUNDAMENTAL RIGHT OF ARJUN AND

ORS.
ISSUE 3
WHETHER THERE IS MASS VIOLATION OF HUMAN RIGHTS
12
SUMMARY OF ARGUMENTS
ISSUE 1
WHETHER PATENT HAS BEEN INFRINGED
It is humbly submitted before the Hon’ble Court that the product patent of the Appellant has
been infringed by the Respondent. The same has been substantiated through infringement
under the:
1. Doctrine of Equivalents, and
2. Patents Act.
ISSUE 2
WHETHER THERE IS VIOLATION OF FUNDAMENTAL RIGHT OF ARJUN AND
ORS.
It is humbly submitted that the fundamental right to life of the petitioners has been violated
by the respondents, which has been established chronologically in connection with the facts.
ISSUE 3
WHETHER THERE IS MASS VIOLATION OF HUMAN RIGHTS
It is humbly submitted that gross negligence and inaction of the State has resulted in mass
violation of human rights.
13
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 4. Any person who
encroaches on the rights of a patentee commits an infringement of the rights of the patentee 5.
ProtoCare (hereinafter referred to as appellants) has obtained a product patent dated 8th
January, 2017 (No. 879269). It is submitted that Mixo (hereinafter referred to as respondents)
has infringed the same.
1.1. Use of same process
It is humbly submitted that the process employed by the respondents to produce Metrophill
Codac is the same as the intricate process used by the appellants to produce their branded
drug Beta-X6. The fact is corroborated by the intern’s discovery and verification by the
appellants.
1.2. Infringement of product patent
It is averred before the Hon’ble Court that the product patent held by the appellants has been
infringed by the respondents. Infringement of patent is not expressly defined in the Patents
Act, 1970 (hereinafter referred to as ‘the Act’) and must be gathered from the scope of
4
Das, J.K, Intellectual Property Rights 324.
5
Ibid.
6
Factsheet ¶ 8.
14
monopoly rights conferred on the patentee7. Sec. 488 of the Act confers on the patentee, his
agents and licensees the exclusive right to make, use, exercise or distribute the invention in
Indenia. Any violation of the provisions of Sec. 48 constitutes infringement.
Assertion of such infringement may be tested and verified under three heads:
1.2.1. Open transitional phrase

While scrutinizing infringement of patents, it becomes imperative to interpret the patent
specification9. Patent specification is a document describing the technical details of the
invention culminating with one or more sets of claims defining the monopoly sought by the
patentee over the invention. A claim 10 is an ingredient of such specification which stakes out
that territory which the patentee considers his or her own, and any encroachment constitutes
an infringement.
Transitional phrase is a component of patent specification which determines the degree to
which a claim is considered11.
The specification of the product patent held by the appellants reads:
“A medication in the form of a capsule comprising a PDE inhibitor, which is to be
administered orally.”
Here, the word ‘comprising’ constitutes the transitional phrase, which falls under the group of
open (inclusive) transitional phrases. An open transitional phrase implies the presence of an
additional constituent or step not explicitly recited in the claim, which will not necessarily
avoid its literal infringement12.
7
Supra note 4 at 421.
8
Rights of patentees.—Subject to the other provisions contained in this Act and the conditions specified in s.
47, a patent granted under this Act shall confer upon the patentee— (a) where the subject matter of the patent is
a product, the exclusive right to prevent third parties, who do not have his consent, from the act of making,
using, offering for sale, selling or importing for those purposes that product in India; (b) where the subject
matter of the patent is a process, the exclusive right to prevent third parties, who do not have his consent, from
the act of using that process, and from the act of using, offering for sale, selling or importing for those purposes
the product obtained directly by that process in India.
9
Sec. 7(4), Patents Act, 1970.
10
Sec. 10(4)(c), Ibid.
11
Pearson, Intellectual Property (9th Ed.) 214.
12
15
On placing the above patent specification in juxtaposition with the product specification of
Metrophill Codac, the latter being:
“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.”,
it is discernible that certain ancillary components have been combined in Metrophill
Codac in an attempt to avoid literal infringement of patent. It is submitted that the
supplemental components of Metrophill Codac do not, in any manner, alter or improve the
core efficacy of the drug composition employed by the appellants to produce Beta-X. The
role of each ingredient of both drugs has been discussed in the subsequent arguments.
1.2.2. Doctrine of equivalents

One method of patent infringement is by equivalents, under which a product or process that
does not literally infringe upon the express terms of a patent claim may sometimes be found
to infringe if there is equivalence between the elements of the accused product or process and
the elements of the patented invention13.
The doctrine evolved from Winans v. Denmead14, where the U.S. Supreme Court ruled:
“The patentee, having described his invention, and shown its principles, and claimed it in that
form which most perfectly embodies it, is, in contemplation of law, deemed to claim every
form in which his invention may be copied, unless he manifests an intention to disclaim some
of those forms. The reason why such a patent covers only one geometrical form is not that the
patentee has described and claimed that form only; it is because that form only is capable of
embodying his invention; and, consequently, if the form is not copied, the invention is not
used…...It must be so near to a true circle as substantially to embody the patentee's mode of
operation, and thereby attain the same kind of result as was reached by his invention.”
According to the doctrine, a patent holder can claim patent infringement even if a device is
not an exact copy of his invention.
It is two-fold15:
13
Intellectual Property Manual, (Lexis Nexis Legal to Business) 356.
14
56 U.S. (15 How.) 330.
15
16
1. The patentee needs to show that the accused device performs substantially the same
function in substantially the same way to obtain the same result.
2. It allows a patentee to claim small or trivial alterations to a disclosed invention that
were not present in an original patent but still within the scope of the claims.
1.2.2.1. Same function in substantially the same way to obtain the same result
On examination of specifications of both products, it is evident that they share identical

words viz., “A medication in the form of a capsule comprising a PDE inhibitor, which is to be
administered orally”. Simulated differences arise in the latter half of the specification of
Metrophill Codac by virtue of inclusion of ancillary components viz., “from the PDE4
inhibitors group combined with a G2 adrenoceptor agonist in free combination with tolerable
salt of N-oxide”. In order to perceive the authentic congruency, it becomes crucial to delve
into the role of each ingredient used in the drugs.
Phosphodiesterase inhibitors (PDE inhibitors) form a class of drugs that inhibit
Phosphodiesterase Enzymes (PDEs), which normally breaks a phosphodiester bond 16. PDE
inhibitors are classified according to which enzyme(s) they act upon as non-specific, PDE5,
PDE4, and PDE3 inhibitors17.
Rules of interpretation mandate that Beta-X comprises a non-specific PDE inhibitor
considering the phraseology of its specification. Due to dearth of symptoms related to
Nenzimer, symptoms ought to be traced back to their roots. Non-specific PDE inhibitors are
employed specifically for the treatment of COPD (Chronic Obstructive Pulmonary Disease),
which is a group of progressive lung diseases18. The major symptoms of COPD are:
1. Shortness of breath.
2. Wheezing.
3. Fatigue.
Further, the intended effects of the inhibitor are:
1. Inhibition of proinflammatory mediators.
16
James Ritter, A Textbook of Clinical Pharmacology and Therapeutics, 5Ed 327.
17
Ibid.
18
Goodman and Gilman's The Pharmacological Basis of Therapeutics, 13th Edition 156.
17
2. Deceleration of fibrotic changes in the lung.

3. Relaxation of the bronchial musculature.
In the case of Metrophill Codac, PDE4 inhibitors have been utilised, which is used to treat
severe COPD carrying the same symptoms as COPD. Furthermore, the intended effects of the
inhibitor are:
1. Inhibition of proinflammatory mediators.
2. Deceleration of fibrotic changes in the lung.
3. Relaxation of the bronchial musculature.
Approaching the latter half of the product specification of Metrophill Codac which reads:
“a G2 adrenoceptor agonist in free combination with tolerable salt of N-oxide”,
the key components of which are:
1. G2 adrenoceptor agonist
2. N-Oxide
G-protein coupled receptor transduces extracellular signals across the cell membrane 19. 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) protein20. 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 response21.
Heterocyclic N-oxides have emerged as valuable anticancer, antibacterial,
antihypertensive, antiparasitic, anti-HIV, anti-inflammatory, herbicidal, neuroprotective, and
procognitive agents22. 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 area that is applicable to the present drug. The N–O moiety in a variety
of heterocyclic N-oxides can elicit nitric oxide-like effects, acting as a nitric oxide agonist.
19
Supra note 17.
20
Ibid.
21
1996 Britannica Medical & Health Annual 232.
22
Susan M. Ford MN RN CNE, Roach's Introductory Clinical Pharmacology 126
18
Nitric oxide diffuses to underlying smooth muscle cells and causes them to relax. This
relaxation causes the walls of blood vessels to dilate, or widen, which in turn increases blood
flow through the vessels and decreases blood pressure23.
It is submitted that the operation of these components do not fluctuate or transform the
essence of the drug when placed in contrast with Beta-X. When examined scrupulously, it is
axiomatic that G2 adrenoceptor agonist in free combination with N-oxide induces the same
reaction envisaged while using non-specific PDE inhibitor. Both ingredients work to cause
relaxation of bronchial musculature. Mere annexation of chemicals equivalent to, or rather an
elaboration of the core functionality, constitutes a small or trivial alteration to a disclosed
invention that were not present in an original patent but still within the scope of the claims.
Therefore, it is established that the product patent of the appellants has been infringed.
1.2.3. Infringement under Patents Act, 1970
As already stated above (1.2), any violation of Sec.48 of the Act is considered to be an
infringement of patent. The scope and meaning of the patent claims need to be asserted and
after that the properly construed claims are compared to the allegedly infringing device 24. The
test to establish such infringement is three-fold25:
1. The extent of monopoly right conferred by the patent, which is to be ascertained by
the construction of the specification.
A patent does not grant absolute monopoly. It is a fettered right and is subjected to certain
specific prescribed constraints26. While examining the construction of the patent
specification, it is conspicuous that the key elements of the drug are:
a) Capsule.
b) A PDE inhibitor.
c) Mode of administration (oral).
The central ingredient forming the crux of the invention is the PDE inhibitor. As already
established under 1.2.2.1., the kind of PDE inhibitor employed in Beta-X is non-specific i.e.,
23
Ibid.
24
Supra note 4.
25
Ibid.
26
Supra note 12.
19
it encompasses inhibitors of PDE3, -4 and -5. It is an indisputable fact that the scope of
monopoly rights conferred to the appellants extends to each class of PDE inhibitors. When
read in conjunction with the mode of administration, it is certain that the appellants possess
monopoly right over capsules from all classes of PDE inhibitors which are to be administered
orally.
2. Whether the alleged act amounts to making or using or exercising a product or

process patent.
The respondents have cumulatively made, used and exercised the product patent of the
appellants. Metrophill Codac has been manufactured using the same sophisticated process
adopted by the appellants. Usage of the product patent has been realised through the
duplication of the components of the patent along with a mere admixture of ancillary
components, which is obvious to a notional addressee to possess the same functional efficacy.
To satisfy the requirement of being “publicly known” as used in Sec. 64(1)(e) 27 and (f)28 of
the Act or to satisfy the requirement of being “known” in Sec. 3(d) it is not necessary that it
should be widely used to the knowledge of the consumer public. It is sufficient if it is known
to the persons who are engaged in the pursuit of knowledge of the patented product or
process as persons skilled in the art, either as men of science or as men of commerce or as
consumers29. Production and sale of Metrophill Codac amounts to exercise of the product
patent.
3. Whether what the alleged infringer is doing amounts to an infringement of the

monopoly conferred by the patent grant.
Reference ought to be made to s.48 of the Act which forms the basis for conferment of
monopoly rights of a patentee. The patentee enjoys the exclusive right to prevent third-parties
from making, using or exercising the product patent without the patentee’s consent. Any
27
That the invention so far as claimed in any claim of the complete specification is not new, having regard to
what was publicly known or publicly used in India before the priority date of the claim or to what was published
in India or elsewhere in any of the documents referred to in s. 13.
28
That the invention so far as claimed in any claim of the complete specification is obvious or does not involve
any inventive step, having regard to what was publicly known or publicly used in India or what was published in
India or elsewhere before the priority date of the claim.
29
Supra note 12.
20
person who encroaches on the rights of a patentee commits an infringement of the rights of
the patentee. As already established above, the act of the respondents clearly amounts to
making, using and exercising the product patent of the appellants. Transgression when read
with the doctrine of equivalents (1.2.2.) corroborates infringement of product patent by the
respondents.
1.3. Application for synergistic patent rejected
A mere aggregation of features must be distinguished from a combination invention. The

existence of a combination invention requires that the relationship between the features or
groups of features be one of functional reciprocity or that they show a combinative effect
beyond the sum of their individual effects30. Sec. 3(e)31 of the Act relates to a known
composition or mere admixture of known components which does not involve any synergistic
effects. Therefore claims are not allowed u/s 3(e) of the Act. The term “aggregation” has
been discussed in Sabaf Spa v. MFI Centres Ltd. & Ors.32,
“Where the claim is merely an 'aggregation or juxtaposition of features' and not a
true combination, it is enough to show that the individual features are obvious to prove that
the aggregation of features does not involve an inventive step. A set of technical features is
regarded as a combination of features if the functional interaction between the features
achieves a combined technical effect which is different from, e.g. greater than, the sum of the
technical effects of the individual features. In other words, the interactions of the individual
features must produce a synergistic effect. If no such synergistic effect exists, there is no
more than a mere aggregation of features.”
30
Supra note 4.
31
A substance obtained by a mere admixture resulting only in the aggregation of the properties of the
components thereof or a process for producing such substance is not considered as an invention unless the
functional interaction between the features of the components achieves a combined technical effect which is
greater than the sum of the technical effects of the individual features.
32
2005, RPC 10
21
Reference must be made to Sec. 3(d) 33 of the Act. In order to attract Sec. 3(d) of the Act, the
subject product must be a new form of a known substance having known efficacy and
“known” here connotes proven and well-established 34. 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. The section was inserted as an anti-evergreening law.
“Evergreening” is referred to the practice whereby pharmaceutical firms extend the patent life
of a drug by obtaining additional 20-year patents for minor reformulations or other iterations
of the drug, without necessarily increasing the therapeutic efficacy. A mere difference in
physical property is a well-known conventional variation of the same pure substance not
showing unobvious properties35. Therefore, the changes alleged by the respondents are in the
physical properties and not in the therapeutic efficacy. This clearly amounts to Evergreening
tendency which has been denied by Sec. 3(d).
All the substances which are produced by mixing components or a process of producing such
substances should satisfy the requirement of synergistic effect in order to be patentable. As
already established in issue 1.2., Metrophill Codac has been obtained by a mere admixture in
the absence of a functional interaction between the components achieving a combined
technical effect which is greater than the sum of the technical effects of the individual
features. It implicates the absence of novelty, utility and non-obviousness criteria of
patentability.
The same has been upheld by the Patent Office by way of rejection of the application
made for a synergistic patent.
33
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.
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.
34
Novartis AG v. Union of India [(2013) 6 SCC 1: (2013) 3 SCC (Civ) 227]
35
Asian Electronics Ltd. v. Havel’s India Ltd. [2010 (44) PTC 66(Del.)]
22
Patent law in Indenia should not develop in a manner where the scope of the patent is
determined not on the intrinsic worth of the invention but by the artful drafting of its claims
by skillful lawyers, and where patents are traded as a commodity not for production and
marketing of the patented products but to search for someone who may be sued for
infringement of the patent36.
Issue 2
Whether there is violation of fundamental right of Arjun and others
It is humbly submitted that the fundamental rights of Mr. Arjun and legal representatives of
the deceased (hereinafter referred to as petitioners) have been violated as a consequence of
36
(2013) 6 SCC 1: (2013) 3 SCC (Civ) 227
23
gross negligence and breach of duty by the Government and Bestone (hereinafter referred to
as respondents).
At the outset, it becomes fundamental to lay out the premise of the case. Locus standi
means the right to bring an action, to be heard in court, or to address the Court on a matter
before it. It is the ability of a party to demonstrate to the court sufficient connection to and
harm from the law or action challenged to support that party's participation in the case. Here,
the petitioners have been directly affected by the negligent action of the Govt., and the same
has been acknowledged by the Hon’ble Court by converting the petitioner’s letter into a writ
petition under Art. 32. Affirmation has been laid down in Narendrajit Singh v. UOI37 and
Cotton Corp of India v. United Industrial Bank38. Access to justice must not be hampered
even at the hands of the judiciary.
2.1. Negligence of state
Negligence of the state arises during two distinct circumstances in the chronology of facts:
2.1.1. Management of bioequivalence studies

Bioequivalence assessment is considered as a surrogate for clinical evaluation of the
therapeutic equivalence of drug products. Bioequivalence study has been defined under Sec.
2(f)39 of the Drugs and Cosmetics Rules, 201940 (hereinafter referred to as DCR).
37
The Supreme Court (Justice Mukherjee) stated that any person complaining of infraction of any Fundamental
right guaranteed by the Constitution may move the Supreme Court. But the rights that could be invoked under
Art. 32 must ordinarily be the rights of the petitioner himself who complains of infraction of such rights and
approaches the court for relief.
38
(1983) 4 SCC 625: AIR 1983 SC 1272; the Supreme court stated that anyone having a right, that is, legally
protected interest, complains of its infringement and seeks remedy/ relief through court must have an
unhindered, uninterrupted access to law courts. The expression ‘court’ must be understood in its widest
amplitude comprehending every forum where relief can be obtained in accordance with law.
39
A study to establish the absence of a statistically significant difference in the rate and extent of absorption of
an active ingredient from a pharmaceutical formulation in comparison to the reference formulation having the
same active ingredient when administered in the same molar dose under similar conditions
40
Notification dated 19/04/2019 [G.S.R.227(E)]
24
It is conducted to establish that two medicines, normally the original patented drug and a
generic version, have the same biological equivalence i.e., they work the same way, to the
same extent and for the same purpose41. It implies the absence of difference in bioavailability
of the two drugs i.e., the rate and extent at which the drug reaches the blood circulation must
be the same. Rate and extent means the amount of drug being absorbed from the site of
administration into site of action after disintegration in an acidic medium and entering the
bloodstream42.
Certain guidelines have been laid down under DCR with respect to appropriate standards to
be met while conducting bioequivalence studies. Rule 31(2) 43 prescribes that bioequivalence
studies shall not be conducted in the absence of permission granted by the Central Licensing
Authority and approval by the Ethics Committee44.
Further, in order to conduct bioequivalence studies on human subjects, an application
needs to be filed to obtain permission by the Central Licensing Authority 45. Since the reports
of bioequivalence studies for the manufacturing of Tetromine was approved by the DCGI,
presumption must be drawn that compliance to the above rules has been adhered to. It follows
that certain professional subjects of the studies have experienced adverse effects by virtue of
participation in the same. A clear nexus arises between the negligence on the part of Ethics
Committee during discharge of its functions and the ensuing impairment experienced by the
subjects, who were a part of the studies. Rule 7(6) of DCR mandates adherence of the Ethics
Committee to the rules of DCR and Good Clinical Practices Guidelines to safeguard the
rights, safety and well-being of the of the trial subjects.
Good Clinical Practices46 (hereinafter referred to as GCP) evolved from the Helsinki
Declaration with its principles based on the same origin.
41
Supra note 21.
42
Ibid.
43
No person or institution or organisation shall conduct bioavailability or bioequivalence study of a new drug or
investigational new drug in human subjects except in accordance with the permission granted by the Central
Licencing Authority and without the protocol thereof having been approved by the Ethics Committee
constituted in accordance with the provisions of Rule 7.
44
Rule 7 and 8, Drugs and Cosmetics Rules, 2019.
45
Rule 33, Drugs and Cosmetics Rules, 2019.
46
1. The rights, safety, and well-being of the trial subjects are the most important considerations and should
prevail over interests of science and society.
25
Further, the procedure for compensating human participants who suffer adverse effects
from the research has been embodied under DCR 47. Subjects may be paid for the
inconvenience and adverse effects after administering the drug. Presumption must be drawn
from the facts that the company has followed the required procedure 48 while obtaining
consent from the subjects49. It follows that the proviso for compensation is within the scope
of the informed consent process undergone by the petitioners. Therefore, they would be
entitled to compensation in case of any adverse effects of the drug by the sponsorer, 50 which
they failed to comply with.
By application of Art.51(c) 51 of the Constitution, reference can be made to international

declarations to support the contention. Reaffirmation was laid down by the Hon’ble Supreme
Court in Apparel Export Promotion Council v. A.K.Chopra 52. The same was upheld by the
Hon’ble Court in People's Union for Civil Liberties v. UOI53.
2. It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of
the human subject.
3. Prior to the beginning of the study the investigator(s) should obtain the Ethics Committee’s
approval for the written informed consent form and all information being provided to the Subjects
and/or their legal representatives or guardians as well as an impartial witness.
4. Every medical research project involving human subjects should be preceded by careful assessment
of predictable risks and burdens in comparison with foreseeable benefits to the subject or to others.
47
Chapter IV of Drugs and Cosmetics Rules, 2019
48
Rule 1 of Fourth Schedule and Rule 2, Ibid.
49
Rule 2, Ibid.
50
Rule 3 of Third Schedule of Drugs and Cosmetics Rules, 2019.
51
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.
52
(1999) 1SCC 759; the court is under obligation to give due regard to international convention and norms for
constructing domestic laws, more so, when there is no inconsistency between them and there is a void in
domestic law. The court also observed that in cases involving violation of human rights, the courts must for ever
remain alive to the international norms and domestic law occupying the field /1
53
(1997) 1 SCC 301
26
2.1.2. Additional guidance for organizations performing in vivo bioequivalence studies

prescribed under WHO
The World Health Organisation (hereinafter referred to as WHO) has furnished elaborate
guidelines in the same area. Art. 11 of GCP embodies safety management and reporting
during bioequivalence studies, which states,
“All bioequivalence studies must be managed for safety. Although all parties who oversee
or conduct clinical research have a role/responsibility for the safety of the study subjects, the
clinical investigator has primary responsibility for alerting the sponsor and the IEC/IRB to
adverse events, particularly serious/life-threatening unanticipated events, observed during the
course of the research.”
It is submitted that the respondents have failed to comply with the rules and guidelines
formulated to safeguard the health and interests of the subjects. Under s.12 of Annex 9 54, it is
said that monitoring is an essential part of medical research.
2.2.2. Approval by DCGI

On 28th November, 2019, Tetromine was approved by the DCGI after completion of
bioequivalence studies, which has been established to be implemented negligently by the
respondents. Clinical Research is regulated by the DCGI. The office of DCGI runs under
54
WHO Technical Report Series No. 937, 2006;
12.1. The main responsibility of the monitor for a bioequivalence trial is to ensure that the study is conducted in
accordance with the protocol, GCP, GLP and applicable ethical and regulatory requirements. This includes
provision of guidance on correct procedures for completion of CRFs and verification of the accuracy of data
obtained.
12.3. The frequency of monitoring visits should be agreed to between the contract resource organization
(hereinafter referred as CRO) and the sponsor. However, pre- and post-study visits as well as a monitoring visit
during the conduct of the trial are usually performed. The monitor should prepare a written report after each site
visit.
12.4. The CRO should have a written set of SOPs concerning the visit procedures, extent of source data
verification, drug accountability and adherence to the protocol.
12.5. Separate Standard Operating Procedures (hereinafter referred as SOPs) along with checklists for the
monitor for the initiation visit, routine monitoring visits and a closing visit are recommended.
27
Central Drugs Standard Control Organization (hereinafter referred to as CDSCO). It bears the
main responsibility of regulating research related to medicines.
The clinical studies reports and related information for the process of approval of new
drugs in Indenia with emphasis on clinical trials should follow the Schedule Y, the DCR
given by the CDSCO. By adopting the CTD (Common Technical Document) format the
CDSCO hopes to improve approval times for the importation, manufacture, and marketing of
new drugs. The format has been adopted from the ICH guidelines, which provides for an
agreement to assemble all the Quality, Safety and Efficacy information in a common format.
The objective of adopting this guideline is a more economical use of human, animal and
material resources, as well as the elimination of unnecessary delays in the availability of new
medicines, whilst maintaining safeguards on quality, safety, and efficacy and regulatory
obligations to protect public health.
It is contended that the authority has not complied with the prescribed procedure. It
was negligent and compromised the quality of the drug for price. It is submitted that the State
should be held contractually liable for the act of DCGI. Thus, subject to the formalities
prescribed by Art.29955 the contractual liability of the Central or State Govt. is the same as
that of any individual under the ordinary law of contract. Further this contract can be brought
under Art.29856 which expressly provides that the executive power of the Union to make
contracts of any purpose, public interest is the paramount consideration.
55
(1) All contracts made in the exercise of executive power of the union or a State Shall be expressed to be
made by the President or by the Governor of the State as the case may be, and all such contracts and all
assurances of property made in the exercise of that power shall be executed on behalf of the President or the
Governor by such person and in such manner as he may direct or authorize.
(2) Neither the President nor the Governor shall be personally liable in respect of any contract or assurance
made or executed for the purpose of any enactment relating to Govt. of India hereto before in force , nor shall
any such contract or assurance on behalf of any of them be personally liable in respect thereof".
56
Power to carry on trade, etc The executive power of the Union and of each State shall extend to the carrying
on of any trade or business and to the acquisition, holding and disposal of property and the making of contracts
for any purpose: Provided that
(a) the said executive power of the Union shall, in so far as such trade or business or such purpose is not one
with respect to which Parliament may make laws, be subject in each State to legislation by the State; and
(b) the said executive power of each State shall, in so far as such trade or business or such purpose is not one
with respect to which the State Legislature may make laws, be subject to legislation by Parliament
28
In Union of India v. A.L. Rallia Ram57, tenders were invited by the Chief Director of
Purchases, Govt. of India. R’s tender was accepted. The letter of acceptance was signed by
the Director. The question before the Supreme Court was whether the provisions of Sec.
175(3) of the Govt. of India Act, 1935 (which were in pari materia with Art. 299(1) of the
Constitution of India) were complied with. The Court held that the Act did not expressly
provide for execution of a formal contract. In absence of any specific direction by the
Governor-General, prescribing the manner or mode of entering into contracts, a valid contract
may result from the correspondence between the parties.
The Supreme Court in another case Union of India v. N.K. (P) Ltd58upheld the same principle.
2.3. Violation of right to health
“Healthcare is not a privilege. It is a right. It is a right as fundamental as civil rights. It is

a right as fundamental as giving every child a chance to get a public education.” penned Rod
Blagojevich.
The object of the fundamental right under Art. 21 is to prevent encroachment upon personal
liberty and deprivation of life except according to procedure established by law. With the
upsurge of judicial interpretations and judicial activism, the scope of Art. 21 is immense and
carries far-reaching influence. Various facets of Art. 21 have emerged, which encompasses
the right to health as a fundamental right. In Consumer Education and Research Centre v.
Union of India59, the court had expressly opined that right to health was also an integral factor
to lead a meaningful life and for the right to life under Part III, and the court also stated that
health includes the access to medical care for the highest attainment of living standards.
57
AIR 1963 SC 1685.
58
(1973) 3 SCC 388; It is now settled by this Court that through the words ‘expressed’ and ‘executed’ in Art.
299(l) might suggest that it should be by a deed or by a formal written contract, a binding contract by tender and
acceptance can also come into existence if the acceptance is by a person duly authorised on this behalf by the
President of India.
59
1995 AIR 922, 1995 SCC (3) 42.
29
It is submitted that the respondents failed to protect the rights of the petitioners while
conducting the studies. The mode of implementation of studies ought to have been as
follows:
1. Exercise of due care post-studies.
2. Adequate research plan.
3. Adequate provisions for monitoring the data collected
4. Ensuring the safety of the subjects.
Art. 21 imposes an obligation on the State to safeguard the right to life of every person 60.
The Govt. is under an obligation to protect the health of the people because there is a close
nexus between health and the quality of life of a person. The principle has been enunciated in
the cases of State of Punjab v. Mohinder Singh Chawal 61. In CESC Ltd. vs. Subash Chandra
Bose62 the Supreme Court relied on international instruments and concluded that right to
health is a fundamental right.
Further, international covenants have set certain guidelines regarding the adequate standard
of living to be provided by the State. Art. 25(1) 63 of Universal Declaration of Human Rights
embodies the same principles. The right to health, like all human rights, imposes three types
or levels of obligations64 on States parties.
60
Paschim Banga Khet Mazdoor Samity vs. State of West Bengal
61
(1997)2 SCC 83; it was decided that right to health was an integral part of right to life and the Govt. has a
constitutional obligation to provide health facilities.
62
AIR 1992 SC 573,585
63
Everyone has the right to a standard of living adequate for the health and well- being of himself and his
family, including clothing, food, housing and medical care (hospitals, clinics, doctors and medical services
should be easily available and accessible to all whenever and wherever they need in a good condition and it
should be guaranteed to every citizen) 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.
64
1. The obligations to respect protect and fulfill. In turn, the obligation to fulfill contains obligations to
facilitate, provide and promote.
2. The obligation to respect requires States to refrain from interfering directly or indirectly with the
enjoyment of the right to health.
3. The obligation to protect requires States to take measures that prevent third parties from interfering with
Art. 12 guarantees.
30
Notwithstanding the voluntary consent of the petitioners to participate in the studies, duty
rests on the State to set up regulations and assuring minimum ethical standards in protecting
the subjects. Adequate safety measures to safeguard the health of the subjects are also critical
to the society's research goal. It carries prospective ramifications upon the crowd psychology
in the field of research and trials. It is submitted that the State is accountable for non-exercise
of due care in approval of drugs for public use.
2.4. Application of writ of Mandamus
A letter of grievance was written by the petitioners to the Hon’ble Supreme Court which was
suo moto converted into a writ petition by the Supreme Court. The cognizance of SC and
applicability of writ of Mandamus are discussed under the following sub-heads:
2.4.1. Writ of Mandamus

The word "Mandamus" means "the order". The writ of Mandamus is thus an order by a
superior court commanding a person or a public authority (including the Govt. and public
corporation) to do or forbear to do something in the nature of public duty or in certain cases
of a statutory duty65. Primary purpose of a writ of mandamus is to protect an established right
and to enforce a corresponding imperative duty imposed (or created) by law.
Tests to laid down writ of mandamus as laid down by the Supreme Court66,
1. There must be public or private duty.
It is submitted that public duty was cast on the respondents to safeguard public health and
safety, which was reliant upon the standard of care exercised while manufacturing and
approving Tetromine. As already established (2.1.), the duty was negligently performed by
the respondents.
4. Finally, the obligation to fulfill requires States to adopt appropriate legislative, administrative,
budgetary, judicial, promotional and other measures towards the full realization of the right to health.
65
Basu, DD, Human Rights and Constitutional Law (2nd Ed., 2003) 354
66
Ibid.
31
2. There must be a specific demand and refusal.

The specific demand of the petitioners is of compensation with regard to the injury suffered
by them while participating in the bioequivalence studies, and there has been specific refusal
of the same by the respondents.
3. There must be a clear right to enforce the duty.
To maintain a petition for mandamus, the petitioner must show that he has a right to compel
the Govt. to act in a particular manner. The existence of such a right is the sine qua non for
the issuance of the writ67. Clear right arises when the respondents have violated the
fundamental rights of the petitioners, which has been established under 2.3.
Therefore, it is established that the petitioners are entitled to the issuance of writ of
mandamus to claim for compensation from the respondents.
Issue 3
Whether there is mass violation of human rights
It is humbly submitted before the Hon’ble court that mass violation of human rights of the
people of Indenia has precipitated as a consequence of negligence and arbitrariness of the
Govt. (hereinafter referred to as respondent).
The contention is bolstered by three arguments:
3.1. Infraction of International human right laws
67
Mani Subrat v. Haryana, A.I.R.1977 S.C.276.
32
The power of Parliament is reinforced by Art. 253 68 to make law in accordance with
International treaties and conventions. The Indenian parliament has the sovereign power to
legislate on subjects in Lists 1 and 2 of seventh schedule of the Constitution for
implementation of any treaty, agreement or convention at any International Conference,
where Supreme Court sought help of International convention for the purpose of construction
of domestic laws in the case of Vishaka v. State of Rajasthan.69 The respondent has acted in
acute contravention of the following major international laws pertaining to human rights:
3.1.1. Universal Declaration of Human Rights (UDHR)
Human rights are world-recognized standards and are an integral part and prerequisite for
normal existence. Universal Declaration of Human Rights (hereinafter referred to as UDHR)
sets out the fundamental Human Rights to be universally protected. The General Assembly
proclaims the UDHR as a common standard of achievement for all peoples and all nations, to
the end that every individual and every organ of society shall strive to promote respect for
these rights and freedoms and by progressive measures, to secure their universal and effective
recognition and observance.
Further, it provides that everyone has the right to life, liberty and the security of a person 70
and that everyone has the right to a standard of living adequate for the health and well-being
of himself and of his family 71. It is submitted that the actions of the respondent are in breach
of internationally recognized rights.
3.1.2. International Covenant on Civil and Political Rights
Considering the obligation of States under the Charter of the United Nations to promote
universal respect for and observance of Human Rights and freedoms, the individual is under a
68
Legislation for giving effect to International agreements - Notwithstanding anything in the foregoing
provisions of this Chapter, Parliament has power to make any law for the whole or any part of the territory of
India for implementing any treaty, agreement or convention with any other country or countries or any decision
made at any International Conference, association or other body.
69
AIR 1997 SCC 3011
70
Art. 3, Universal Declaration of Human Rights
71
Art. 25, Ibid.
33
responsibility to strive for the promotion and observance of the rights recognized in the
present Covenant. In the context of right to life, which encompasses the right to health, the
Covenant lays down, “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.”72
3.1.3. International Covenant on Economic and Cultural Rights
States parties to the International Covenant on Economic and Cultural Rights (hereinafter
referred as ICECR) recognize the right of everyone to “the enjoyment of the highest
attainable standard of physical and mental health.”73
The term “health” is understood not just as a right to be healthy, but as a right to control
one's own health and body, and be free from interference such as torture or medical
experimentation. States must protect this right by ensuring that everyone within their
jurisdiction has access to the underlying determinants of health, which is available to
everyone without discrimination, and economically accessible to all.
Improving environmental and workplace health, preventing, controlling and treating

epidemic diseases, and creating conditions to ensure equal and timely access to medical
services for all74 are also to be mere obligations of State Parties. It can be implied that the
Govt. of Indenia being a signatory to UDHR and international conventions has a clear
obligation to protect human rights of its subjects. Not only has the respondent contributed in
the deterioration of the health of the public through mandating Tetromine, but also failed to
bring under control the prevalent circumstances of chronic epidemic on the rise. Fact is note-
worthy that Bronchus Trivoza emerged sometime during late 2017/ early 2018, while the
respondent has manufactured and sold Tetromine in 2020, which is in clear infringement of
Art. 12 of ICECR (mandates timely access to medical services). At the dawn of the epidemic,
the death rate was estimated to be 525 during a short span. The catastrophe that has followed
in the span of 2 years is incomprehensible.
3.2. Negligence of State
72
Art. 6, International Covenant on Civil and Political Rights
73
Art. 12, International Covenant on Economic, Social and Cultural Rights.
74
Art. 12.2, supra note 73.
34
Two distinct circumstances may be highlighted with regard to negligence of the respondent,
which culminated into mass violation of human rights:
3.2.1. Approval of Tetromine
The Ministry of Health classified the disease as serious and directed BPPI to take appropriate
action, as a result of which E-Tender was invited. Considering the cost of medicine as the
primary element, the respondent has compromised with the quality of medicine, and generic
drug approving authorities have failed to substantiate the reports submitted by Bestone
(already established under Issue 2). Tetromine proved to be ineffective as per the studies
conducted by Dr. Suhas Mishra, a district surgeon with 20 years of experience, and the
subjects who were part of bioequivalence studies suffered injury and death. It is submitted
that Tetromine is not only ineffective, but also fatal.
3.2.2. Issuance of notification

Issuance of notification dated 11th January, 2020 mandating doctors in Govt. hospitals to
prescribe only Tetromine to treat Bronchus Trivoza amounts to gross negligence, where the
Govt. has exhibited extreme disregard to the health and safety of the public. It is submitted
that the Govt. along with the public were conscious apropos the ineffectiveness of Tetromine,
which has been perceived to the extent where articles (“Generic drugs: lifesaver or
business?”) were published in newspapers expressing the same. Further, the petitioners
complained of adverse effects on 4th December 2020, whereafter the notification has been
issued. This highlights the Govt.’s colossal disregard to public health and safety. Considering
the gravity of the circumstances, enhanced care ought to have been exercised by the Govt.
Tetromine has fallen short of clinical efficacy, as a consequence of which the subjects of
bioequivalence studies suffered injury. As per the report submitted by Dr Suhas Mishra, the
bioequivalence studies conducted by Bestone had actually failed to maintain the same
therapeutic efficacy, safety, and performance and when he prescribed the same, the health of
the patients further deteriorated. It is therefore established that Tetromine failed both on the
experimental and practical bedrock as a repercussion of the respondent’s negligence.
35
3.3. Violation of Art. 21
In the Constitution of Indenia, the right to health has not been directly incorporated as a
fundamental right. It has evolved through judicial interpretations and must be read in
conjunction with DPSP to bring out its real essence. The Govt. has a constitutional
obligation to provide health facilities. In Bandhua Mukti v Union of India75, the Court held
that although the Directive Principles of State Policy hold persuasive value, yet they should
be duly implemented by the state; and it was in this case also that the Court had interpreted
the dignity and health within the ambit of life and liberty under Art. 21 of the Constitution.
Right to life under Art.21 of the Constitution has been liberally interpreted to mean
something more than merely human existence and includes the right to live with dignity and
decency. The recognition of dignity and fundamental right to life led to recognizing the
importance of health. Right to health is not just considered as Human Right, the Hon’ble
Court in numerous cases, opined that right to health is an integral part of Art. 21. Several
instances are A.D.M Jabalpur v. Sukla76, Consumer Education and Research Centre v. Union
of India,77 where the Court had expressly opined that right to health was also an integral
factor to lead a meaningful life and for the right to life under Part III. And the Court also
stated that health includes the access to medical care for the highest attainment of living
standards. The same was upheld in Paschim Banga78case. Moreover, Art.21 imposes an
obligation on the state, the State is required to protect and safeguard the rights of every
individual79.
75
AIR 1984 SC 812.
76
AIR 1976 SC 1207; The Supreme Court of Indenia held that the UDHR and the two International Covenants
on Human rights were not a part of the Municipal law in Indenia, despite Indenia being a signatory to them.
The Parliament has the power and indeed the duty to study the law and analyze the implications not only on
domestic law but also on economic policy, domestic interest above all the welfare of the people.
77
AIR 1995 922 SCC(3) 4
78
AIR 1996 4 SCC 37; The scope of Art. 21 was further widened, wherein the Court held that it is the
responsibility of the Govt. to provide adequate medical aid to every person and to work in the welfare of the
general public.
79
Ibid.
36
3.3.1. Provisions of DCR
Scrutiny of the compensational provisions provided in DCR is required. They are embodied
under Chapter VI of the Rules. Rule 39(1) reads:
“Where any death of a trial subject occurs during a clinical trial or bioavailability or
bioequivalence study, the legal heir of the trial subject shall be provided financial
compensation by the sponsor or its representative.”
Correspondingly, Rule 39(2) reads:
“Where permanent disability or any other injury occurs to a trial subject during a
clinical trial or bioavailability or bioequivalence study, the trial subject shall be provided
financial compensation by the sponsor or its representative.”
It is submitted that the word “during” has been incorporated into every provision legislated
with regard to adverse effects arising while administering bioequivalence studies and clinical
trials. “Adverse event” has been defined under Rule 2(d) as, “any untoward medical
occurrence (including a symptom or disease or an abnormal laboratory finding) during
treatment with an investigational drug or a pharmaceutical product in a patient or a trial
subject that does not necessarily have a relationship with the treatment being given.”
Identical provisions have been legislated (Rule 41 80, embodying consideration of injury or
death or permanent disability to be related to clinical trial or bioavailability and
bioequivalence study) which have limited outlook.
The legislation is deficient insofar as the scope and impact of such studies are concerned.
Justification prevails upon the medico-scientific facet of drug administration in the human
body. The duration of impact made by the drug along with its residual period fluctuates and
80
Any injury or death or permanent disability of a trial subject occurring during clinical trial or bioavailability
or bioequivalence study due to any of the following reasons shall be considered as clinical trial or bioavailability
or bioequivalence study related injury or death or permanent disability, namely:-
(a) adverse effect of the investigational product;
(b) violation of the approved protocol, scientific misconduct or negligence by the sponsor or his representative
or the investigator leading to serious adverse event;
(c) failure of investigational product to provide intended therapeutic effect where, the required standard care or
rescue medication, though available, was not provided to the subject as per clinical trial protocol;
(d) not providing the required standard care, though available to the subject as per clinical trial protocol in the
placebo controlled trial;
(e) adverse effects due to concomitant medication excluding standard care, necessitated as part of the approved
protocol;
(f) adverse effect on a child in-utero because of the participation of the parent in the clinical trial;
(g) any clinical trial procedures involved in the study leading to serious adverse events.
37
cannot be straitjacketed. Most drugs persist in the human body in the form of metabolites
even after wash-out, which carries significance while determining the cause of adverse
effects81. Therefore, restricting the provisions to solely encompass the duration of the study
and not providing consideration to the aftermath constitutes violation of right to health under
Art. 21. It highlights the legislative inadequacy and incompetence of the State to provide
satisfactory protection to the rights of its citizens.
3.3.2. Govt.’s Failure in Public Health Services and Mass violation of Human Rights
Indenia being the world’s 2nd most populated country having 17.7% of the world’s
population, has 20% of disease burden. Globally, it can be inferred that the State is unable to
provide proper medical care to its people. The private sector dominates healthcare in Indenia
, but inadequate legislation and failure to enforce regulations are contributing to poor
quality medical services, says a World Bank publication. Eighty percent of spending on
health in Indenia is from personal funds, but existing laws do not ensure that private medical
services maintain even minimum standards, says the report. It says there are no laws
regulating the geographical distribution of healthcare providers and the types of technology
to be made available, and it suggests that the influx of technology may have led to
unreasonable use of equipment. Yet, despite such problems most people still choose the
private sector, because of accessibility and shorter waiting times for diagnosis and treatment.
As per the survey conducted in 2014 by the National Sample Survey Office (NSSO) on
healthcare shows the staggering number of 82% in urban and 86% of the rural population
not covered under any scheme of health expenditure support82.
It must be reiterated that the respondent has exhibited sheer apathy for over a span of two
years. Bronchus Trivoza is a perilous disease which killed as many as 72 inhabitants at the
inception, the estimated death rate being 525 persons within a short span. The respondent
failed to take adequate and effective measures to curb the rapidly spreading disease. Inability
of the respondent to take necessary precautions, provide adequate supply of medicines to
people, and its negligent act of prolonged approving procedure for generic drugs increased
81
Goodman and Gilman's, The Pharmacological Basis of Therapeutics, 13th Edition 256.
82
India - Private Health Services for the Poor (May 2005) HNP Discussion Paper, World Bank Publication.
38
the death tolls up to thousands within very less interval of time. Therefore, it is established
that the respondent has violated the right to life and health of the citizens of Indenia.
PRAYER
WHEREFORE, in the light of issues raised, arguments advanced, and authorities cited, the
appellant prays before this Hon’ble Court that it be pleased to:
1. Direct the seizure, forfeiture or destruction of Metrophill Codac.

2. Grant damages insofar as this Hon’ble Court may deem fit.
3. Any other reliefs that this Court may grant in the interests of Justice.
The petitioner(s) pray before this Hon’ble Court that it be pleased to:
39
1. Direct the concerned authorities to grant damages insofar as this Hon’ble Court may
deem fit.
2. Cancel the license to manufacture Tetromine held by Bestone.
3. Direct the concerned authorities to withdraw Tetromine from public access.
4. 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.
Counsel(s) for the petitioner/appellant.
40

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AACL 5th National Moot Court Competition, 2020

BEFORE THE HON’BLE SUPREME COURT OF INDENIA

MEMORIAL ON BEHALF OF PETITIONER

Particulars Page No.

-MEMORIAL ON BEHALF OF PETITIONER-

AIR All India Reporter

CDSCO Central Drugs Standard Control Organization

DCR Drugs and Cosmetic Rules

GST Goods and Services Tax

ICCPR International Covenant on Civil and Political Rights

ICESCR International Covenant on Economic, Social and Cultural Rights

IPAB Intellectual Property Appellate Board

NPPA National Pharmaceutical Pricing Authority

r/w Read with

U.O.I Union of India

UDHR Universal Declaration of Human Rights

u/s Under section

-MEMORIAL ON BEHALF OF PETITIONER-

1. A.D.M Jabalpur v. Sukla

2. Apparel Export Promotion Council Vs A.K Chopra, (1999) 1SCC 759/1

4. Bandhua Mukti v Union of India

5. CESC Ltd. vs. Subash Chandra Bose

6. Consumer Education and Research Centre v. Union

7. Consumer Education and Research Centre v. Union of India

8. Cotton Corp of India v. United Industrial Bank

10. Mani Subrat v. Haryana, A.I.R.1977 S.C.276.

11. Mu R v. Barker, (1762) 3 Burr 1265, 1267

12. Narendrajit Singh v. UOI

16. People's Union for Civil Liberties v. UOI

-MEMORIAL ON BEHALF OF PETITIONER-

17. Sabaf Spa v. MFI Centres Ltd. & Ors.

18. State of Punjab v. Mohinder Singh Chawal

19. State of Punjab v. Mohinder Singh Chawal

20. Union of India v. A.L. Rallia Ram

21. Union of India v. N.K. (P) Ltd

23. Vishaka v. State of Rajasthan

24. Winans v. Denmead , 56 U.S. (15 How.) 330

1. Code of Civil Procedure, 1908

-MEMORIAL ON BEHALF OF PETITIONER-

1. Black’s Law dictionary, 10th Ed., West Group (2014)

2. Compact Oxford Dictionary.

3. AIYAR P. RAMANTHAN, THE LAW LEXICON (3rd ed., 2012)

1. All India reporters

-MEMORIAL ON BEHALF OF PETITIONER-

7. 1996 Britannica Medical & Health Annual

-MEMORIAL ON BEHALF OF PETITIONER-

-MEMORIAL ON BEHALF OF PETITIONER-

-MEMORIAL ON BEHALF OF PETITIONER-

7. An application to obtain a synergistic patent over Metrophill Codac was rejected by

-MEMORIAL ON BEHALF OF PETITIONER-

-MEMORIAL ON BEHALF OF PETITIONER-

WHETHER PATENT HAS BEEN INFRINGED

WHETHER THERE IS VIOLATION OF FUNDAMENTAL RIGHT OF ARJUN AND

WHETHER THERE IS MASS VIOLATION OF HUMAN RIGHTS

-MEMORIAL ON BEHALF OF PETITIONER-

-MEMORIAL ON BEHALF OF PETITIONER-

1.1. Use of same process

1.2. Infringement of product patent

-MEMORIAL ON BEHALF OF PETITIONER-

1.2.1. Open transitional phrase

-MEMORIAL ON BEHALF OF PETITIONER-

1.2.2. Doctrine of equivalents

-MEMORIAL ON BEHALF OF PETITIONER-