Original Writ Jurisdiction Public Interest Litigation: Team Code: Nmc104

AACL NATIONAL LEVEL MOOT COURT COMPETITION 2016
TEAM CODE : NMC104
IN THE HON’BLE SUPREME COURT OF YOUNGISTAN
ORIGINAL WRIT JURISDICTION

PUBLIC INTEREST LITIGATION
Writ Petition (Civil) No. _____
(Filed under Article 32 of the Constitution of Youngistan)
ICE Athreya Pharmaceuticals Pvt.Ltd and Union of Youngistan and others

…(Petitioners)
Versus
Kani Tribes and others

…(Respondents)
UPON SUBMISSION TO THE HON‟BLE CHIEF JUSTICE AND HIS

COMPANION JUSTICES OF THE SUPREME COURT OF
YOUNGISTAN
MEMORANDUM ON BEHALF OF THE PETITIONER
1
Written submission on behalf of the petitioner
Table of Contents
List of Abbreviations ................................................................................................................. 3
Index of Authorities ................................................................................................................... 4
Statement of Jurisdiction............................................................................................................ 6
Statement of Facts ...................................................................................................................... 7
Questions Presented ................................................................................................................. 11
Summary of Pleadings ............................................................................................................. 12
Pleadings ......................................................................................................................................
1)Whether the order passed by the IPAB for Compulsory License is Justifiable
1.1 the Compulsory License is not justifiable.

1.2 Voluntary Licence
1.3 Lee Pharma Vs AstraZeneca
2) Whether the PIL is maintainable
2.1 the PIL is not maintainable under sec 38 and 47
2.2 company has not committed biopiracy
2.3 Universal Declaration of Human Rights
3) Whether the order of NBA is reasonable
3.1 The order of NBA is not reasonable on the grounds that it is against
principles of natural justice.
3.2 Rule against bias
4) Whether the revocation of patent is valid
4.1 the revocation of patent is invalid on the grounds that there is an

improvement in efficacy of the known substance under Sec 3 (d)
4.2 Exceptions on the Ground of Pubic Health
4.3 Patents for improvement
Prayer …………………………………………………………………………….25
2
List of Abbreviations:
AIR All India Report
Art. Article
ICCPR International convention of Civil and Political Rights,1966
PIL Public interest litigation
SC Supreme Court
SCC Supreme Court Cases
Sec. Section
Bom Bombay
CLA Compulsory Licence Application
u/a Under Article
u/s Under Section
UDHR United Nations Declaration on Human Rights
TRIPS Trade Related Intellectual Property Rights
NBA National Biodiversity Act
3
INDEX OF AUTHORITIES
CASES:
1. Bayer Corporation v Natco pharma limited ,2014 SCC online bom 963
2. Consumer Education and Research Centre v Union of India ,1995 SCC (3)42
3. State Of Punjab v Ram Lubhaya Bhagga,1998 AIR 1703
4. KesavananthaBharati v State Of Kerala,1973 (4) SCC 225
5. Jolly George Varghese v Bank Of Cochin,1980 AIR 470
6. Chairman,Railway Board and others v MrsChandrima Das,2000 (2) SCC 465
7. AK Kraipak v Union Of India, AIR 1970 SC 150
8. Novartis AG v Union of India and others (2013) 6 SCC 1
BOOKS
1. Elizabeth Varkey,Law Of Patents,SecondEdition,Eastern Book Company

2. SuvarnaPandey,PatentAttorney,Biopiracy Related To Traditional Knowledge And
Patenting Issues
3. Feroz Ali Khader,The law Of Patents-With a Special Focus On Pharmaceuticals in
India,Student edition 2009,Lexis Nexis
4. Kalyan C Kankanala,Arun K Narasani,VinitaRadhakrishnan,Indian Patent Law And
Practice,First Edition in 2010,Oxford University Press
5. P Narayanan,PatentLaw,FourthEdition,Easterb Law House
6. Matthew Fisher,Fundamentals Of Patent Law,Interpretation And Scope Of
Protection,First Indian Reprint 2010,Mohan Law House
7. Philip W Grubb and Peter R Thomsen,Patents For
Chemicals,Pharmaceuticals,andBiotechnology,FifthEdition,Oxford University Press
8. Dr J J R Upadhyay,EnvironmentalLaw,SecondEdition,Central Law Agency
9. P Leelakrishnan,Environmantal Law Case Book,SecondEdition,Lexis Nexis
10. V.N.Shukla,Constitution Of India,TwelfthEdition,Eastern Book Company
4
LEGAL DATABASE
1. Manupatra
2. Lexis nexis
3. SCC online
4. Hein onine
5. Legal Trac
6. West Law
LEGISLATIONS
1. The Constitution Of India,1950

2. Environment Protection Act 1986
3. Forest Conservation Act,1980
4. Indian Forest Act,1972
5. Schedule Tribe and Other Forest Dwellers Act 2006
6. Panchayats(Extention to The Schedule Areas)Act 1996
7. Indian Patent Act 1970
8. Biological Diversity Act 2002
9. German Patents Act, 1936
10. Drugs and Cosmetics Act, 1940
CONVENTIONS
1. TRIPS Agreement-Trade Related aspects of Intellectual Property

Right
2. The Indigeneous And Tribal Population Convention,1957
3. The Rio Submit 1952
4. United Nations Declaration of Human Rights,1948
5. International Convention Of Civil And Political Rights,1966
6. International Covenants On Economis ,Social and Cultural
Rights,1966
7. Unites Nations Declaration Of Indigeneous People,2007
8. Doha Declaration,2015
5
STATEMENTOFJURISDICTION
The Hon’ble Supreme Court of Youngistan has the jurisdiction in this matter under
Art 32 of the Constitution of Youngistan which reads as follows:
“32. Remedies for enforcement of rights conferred by this Part-
(1) The right to move to 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. “
6
STATEMENT OF FACTS :
1. Kani is a triabal community inhabiting the Kannimalai tropical rain forests of Western
Ghats of Youngistan. Kannamalai is one of the Biological Diversity
Hotspot of Youngistan. KaniTriabal community being an indigenous people possess
immense knowledge of their environment, based on centuries of living close to nature.
2. 95% of Medical Products being used are derived from plants .Arogyapaacha being
one among them.Arogyapaacha (TrichopusZeylanicus) is a herbal medicinal plant
found only in Kannimalai tropical rain forest and used by KaniTribals in their
traditional medicines as a immune enhancer.
3. ICE Pharma Pvt. Ltd., Registered in the year 1995 and located in Normand uses time-
tested Ayurvedic therapies blended with contemporary sciences. One of the
employees of the ICE PharrnaPvt, Ltd., during his trip to Western Ghats of
Youngistan got to know the significance of this medicinal plant. When this was
informed to ICE Pharma Pvt, Ltd., ( hereinafter known as the parent company ) it
decided to establish a subsidiary company by name ICE Athreya Pharmaceuticals Pvt,
Ltd ., ( hereinafter known as the subsidiary company ) in Youngistan in the year 2000.
The subsidiary company approached the Government seeking permission to conduct
research at Kannaimalai. Subsequently, the Government had granted permission to
conduct research only at Kannimalai with a condition that such research will not be
used for commercial purpose. The company established a research center at Western
Ghats .
4. The Knowledge regarding the Arogyapaacha was divulged by Kani Tribal members
to the scientist of Subsidiary company and with further laboratory research they found
the only cure for Systemic Lupus Erythematosus and developed the drug “Cuzalin”.
Consequently, the company got the drug patented in Normand in the year 2005.
Subsequently the Parent company through its subsidiary company applied for patent
protection in the year 2008 in Youngistan and the same had been granted by the
patent office.
5. Systemic Lupus Erythematosus is the most common form of the disease. It may affect
virtually any organ or the structure of the body, especially the skin, kidneys, joints,
hearts, gatrointestional tract, brain and, serous membranes. While systemic Lupus
can affect any area of the body,most people experience symptoms in only a few
7
organs. No two people will have identical symptoms .the course of the disease is also
variable and is marked by periods when the disease is active and by other periods
when symptoms are not evident. Subsidiary company is the only company
manufacturing drug for is dreaded disease.
6. TRIO Pharma Pvt,Ltd,. Company ( hereinafter known as company 1) is a registered
company located in Sourashtra, which is a state in Youngistan and founded in the year
2000. It is engaged in the manufacturing of pharmaceuticals. Susbsidiary company
and company 1 have signed a lease agreement for manufacturinf of the drug “Cuzalin
“. A clause of the lease agreement reads as such – “Wherein the subsidiary company
shall grant lease of patent for the manufacturing of the drug “Cuzalin “ to company 1
.On the condition that the company 1 can manufacture and distribute the drug only
within the state of Sourashtra “. Company 1 has monopoly over the drug within the
state.
7. Other companies like Stepford Pharma Pvt.Ltd., Avalon Pharma Pvt.Ltd., and FLO
pharma Pvt.Ltd., (FLO pharma Pvt.Ltd hereinafter known as the company 2) are
engaged in manufacturing of pharmaceuticals and all these companies are efficient
enough in manufacturing same quality of medicine.
8. Company 2 has a negotiationwith company 1 which manufactures pharmaceuticals.
The terms and conditions put forth by the company are as follows :-
1) Exclusive Distribution Agreement.
2) Resale Price Maintenance.
3) Royalties.
4) Licensing Fee.
Due to the above reasons the negotiation failed between them. Consequently the
company 2 has approached the controller of patents for the purpose of granting
compulsory license for manufacturing the drug “ Cuzalin’ in other parts of Sourashtra
where there is a shortage of drug supply. The controller of patents after listening to
the parties had granted compulsory license to company 2 .
9. Aggrieved by the order of the controller of pantents the company 1 had approached
the Intellectual Property Appellate Board ( hereinafter known as the IPAB) of
Youngistan . The IPAB had upheld the order of the controller of patents. Derived by
the order of the IPAB the aggrieved party has approached the Supreme court of
Youngistan via writ petition.
8
10. Mr. Kumar a resident of Western Ghats a public spirited citizen filed a Public Interest
Litigation before the Supreme court contending that the subsidiary company has
created Biopiracy by accessing the traditional knowledge belonging to the Kani tribe
without the prior permission of the National Biodiversity Authority ( hereinafter
known as NBA),he also contended that the government has not taken the welfare of
the people of Kani tribes into consideration as it granted the subsidiary company
permission to conduct research at Kannimalai without taking appropriate measures
which would afftevt the livelihood of the tribal people and ultimately it would result
in the exploitation of the traditional knowledge of Kani Tribe .
11. The Kani Tribes had approached the NBA seeking the equitable benefit sharaing from
the subsidiary company. The NBA had referred the matter to the National Biological
committee to inquire into the matter , which after conducting its inquiry had submitted
its report to NBA. Subsequently the NBA had ordered the subsidiary company to
share the benefits arising from the commercialization of the Traditional Knowledge. It
had determined the quantum of equitable benefit sharing at the rate of 50% of the total
turn over of the company which is 50 million USD per annum. The subsidiary
company has filed a petition before the Hon’ble Supreme court of Youngistan by
stating that the quantum fixed by the NBA is unreasonable and there is no Biopiracy
committed by them.
12. Stepford Pharma Pvt.Ltd. being a major player in the pharmaceuticals has filed for
revocation of patent under the patent act before the IPAB , contending that the patent
granted was based on traditional knowledge which falls under non-patentable subject
- matter. The IPAB after hearing the parties to the dispute has passed the order of
revocation of the patent of the drug “Cuzalin”. Aggrieved by the order oof the IPAB
the subsidiary company has approached the Hon’ble Supreme court of Youngistan via
writ petition for setting aside the order of IPAB and restoring the patent of the drug.
The Supreme court of Youngistan after hearing all the matters has decided to combine all the
matter for the final disposal on the 13th march 2016.
9
PARTIES TO THE CASE :
ICE Athreya Pharmaceuticals Pvt.Ltd. – Petitioner 1
Union of Youngistan and others –Petitioner 2
Trio Pharma Pvt.Ltd – Petitioner 3
Kani Tribes – Respondent 1
Mr.Kumar –Respondent 2
FLO Pharma Pvt. Ltd – Respondent 3
Stepford Pharma Pvt. Ltd – Respondent 4
10
STATEMENT OF ISSUES
ISSUE 1 :
Whether the order passed by the IPAB for Compulsory License is Justifiable?
ISSUE2 :
Whether the PIL is maintainable?
ISSUE 3 :
Whether the order of NBA is reasonable?
ISSUE 4 :
Whether the revocation of patent is valid?
11
SUMMARY OF PLEADINGS :
ISSUE 1:
Whether the order passed by IPAB is for Complusort License is justifiable?
It is humbly submitted before the Hon’ble Court that the Compulsory License is not
justifiable as the applicant has not made credible attempts to obtain voluntary license and was
unable to satisfy the conditions proves that he is not efficient enough to produce the drug.
Also, applicant has failed to provide the evidences and did not satisfy any of the grounds
under sec 84 (1) of the Act.
ISSUE 2:
It is humbly submitted before the Hon’ble Court that the PIL is not maintainable as it is the
obligation of the State to ensure improvement of the public health under sec 38 and 47 of the
Constitution. As well as, there was no biopiracy created as the drug was developed for the
dreaded disease and with the intention to benefit sharing.
ISSUE 3:
It is humbly submitted before the SC that the order of NBA is not reasonable as it violates the
principles of natural justice and the quantum fixed by the NBA is unreasonable.
ISSUE 4:
Whether the revocation of Patent is Valid?
It is humbly submitted before the Hon’ble Court that the revocation of patent is invalid on the
grounds that there is an improvement in efficacy of the known substance under Sec 3 (d) and
hence, the requirements are satisfied as before it was used only as an immune enhancer but
now for the cure of the disease.
12
ARGUMENTS ON BEHALF OF THE PETITIONER:
ISSUE 1:
Whether the order passed by the IPAB for compulsory license is justifiable?
1) A compulsory license is an authorization given by an authority allowed by law to
grant a license, without or against a consent of the title holder for the exploitation of a
subject matter protected by a patent.
Compulsory license are license that are granted by a government to use patents or other types
of intellectual property. Government issue compulsory license to broaden access to
technologies and information in order to achieve a number of public purposes1.
Sec 84 clause (1) of the Act2 states as follows:

“84.Compulsory licences.
(1) At any time after the expiration of three years from the date of the grant of the
patent,any person interested may make an application to the Controller for grant of
Compulsory licence on patent on any of the following grounds, namely:-
(a) That the reasonable requirements of the public with respect to the patented inventions
have not been satisfied, or
(b) That the patented invention is not available to the public at a reasonable affordable
price, or
(c) That the patented invention is not worked in the territory of India.”
In accordance with the scheme if the Act, the controller, while considering an application
under Section 84 of the Act is also required to take into account the factors mentioned in Sun-
section (6) of section 84 of the Act. The said provision is as follows:
_________________________
1
ElizabethVerkey, Law of Patents, Second Edition, Eastern Book Company.
2
Indian Patents Act, 1970
13
“84.Complusory licences-
(6) In considering the application filed under this section, the Controller shall take into
account,-
(i) the nature of the invention, the time which has elapsed since the sealing of the patent and
the measures already taken by the patentee or any licensee to make full use of the invention;
(ii) the ability of the applicant to work the invention to the public advantage;
(iii) the capacity of the applicant to undertake the risk in providing capital and working the
invention, if the application were granted;
(iv) as to whether the applicant has made efforts to obtain a licence from the patentee on
reasonable terms and conditions and such efforts have not been successful within a
reasonable period as the Controller may deem fit.
Provided that this clause shall not be applicable in case of national emergency or other
circumstances of extreme urgency or in case of public non-commercial use or on
establishment of a ground of anti- competitive practices adopted by the patentee, but shall not
be required to take into account matters subsequent to the making of the application.
Explanation- For the purpose of clause (iv), “reasonable period” shall be construed as a
period not ordinarily exceeding a period of six months”
2) Voluntary licence3
A patentee while responding to a request for a voluntary license to put forward queries to the
applicant in relation to the applicant’s ability to manufacture the patented drug to the
advantage of the public, the capital capacity of the applicant to undertake the process of
manufacturing of the patented drug etc. In case the voluntary licensing applicant responds to
the queries it would be clear that the voluntary license applicant is a serious applicant and
based on the response a call could be taken by the patentee,
__________________________
3
Bayer vs Natco 2014 SCC Online Bom 963
14
whether further negotiations can be carried put on terms and conditions to grant a voluntary
license from the patentee.
In case the voluntary license applicant fails to respond it proves that the applicant has not
made any credible attempt to obtain the voluntary license.
In this case the Respondent 3 has applied for voluntary licence but were not able to fulfil the
conditions put forth by the Petitioner 3. Hence, it shows that the Respondent did not intend to
get the voluntary license and no credible attempt to fulfil the conditions were made and it
should be considered as only a mere application to show that they wanted licence.
3) Lee Pharma Vs AstraZeneca4
(i)According to Sec 24(1) of the Germans Patents Act:
“If the applicant or pantentee refuses to permit the exploitation of the invention by another
person offering to pay reasonable compensation and to furnish security therefore,that person
shall be given authority to exploit the invention if permission is indispensable in the public
interest”.
The German Patents Act provision relates to the requirement of “public interest “.A court will
only grant a compulsory licence if a plaintiff can prove that the working of the defendant’s
patent is in the public interest.The Federal Patents court had granted the defendant’s a
compulsory licence.The Patents Court came to the conclusion that direct public interest
exsists in the continued availability to the general public of the marketed drug,polyferon.
The Federal Supreme Court reversed the decision .It declared that the term “public interest”
is an undefined legal concept that requires clarification by the courts. The Federal Supreme
Court reversing the decision of the Federal Patents Court reasoned that whether a public
interest demanding the grant of a compulsory licence to the particular licence exsists,depends
on the facts of each case and must be determined by weighing the patentee’s interest in
protection against the public interest in exploitation.
_________________________
4
C.L.A. 1 of 2015
15
Thus, The Federal Supreme Court held that “Public interest” cannot be characterised in some
generally applicable manner and when an alternative is available Compulsory License cannot
be granted. In the case in India ,
(ii)The Indian Patent Office has rejected the application of Hyderabad-based drug maker Lee
Pharma for a compulsory licence to make a copy of AstraZeneca's anti-diabetes drug
saxagliptin, which is branded Onglyza. Under the Indian Patent Act, a compulsory licence
allows an entity other than the patent owner to reproduce the patented product or process,
without the patent holder's consent.
(i) Here in the above mentioned case the application for the compulsory licence was
rejected on the ground that the applicant has failed to provide the evidences and
did not satisfy any of the grounds under sec 84 (1) of the Act. Similarly, in this
case the Respondent 3 has not given any evidences to show that sec 84 (1) was not
satisfied to claim the compulsory licence.
(ii) And also here SITAGLIPTIN AND VILDAGLIPTIN are also listed along with
the SAXAGLIPTIN in the list of essential medicines to treat Type-II DM. Hence,
the Controller of Patent, Patents Office held that compulsory license wasn’t
necessary as it was not only the cure available.
Similarly, in this case Stephford Pharma Pvt.Ltd and Avalon Pharma Pvt.Ltd were also
efficient enough in manufacturing the same quality of medicine, there isn’t a need for
granting of compulsory license.
16
ISSUE 2 :
1) Sec 38 and Sec 47 of the Constitution5 :
(i) Right to health is not included directly in as a fundamental right in the Indian Constitution
.The Constitution maker imposed this duty on state to ensure social and economic justice.
Part four of Indian constitution which is DPSP imposed duty on States. If we only see those
provisions then we find that some provisions of them has directly or indirectly related with
public health. The Constitution of India not provides for the right to health as a fundamental
right. The Constitution directs the state to take measures to improve the condition of health
care of the people. Thus the preamble to the Constitution of India, inter alia, seeks to secure
for all its citizens justice-social and economic. It provides a framework for the achievement
of the objectives laid down in the preamble. The preamble has been amplified and elaborated
in the Directive Principles of State policy.
*Sec38 of the Indian constitution under Directive Principles of State Policy, which
ensures the State to secure a social order for the promotion of welfare of the people
[(1)] 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, economic
and political, shall inform all the institutions of the national life.
*sec47 of the Indian constitution states that ‘The 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 drugs which are injurious to health.
Hence, it is the obligation of the State to ensure improvement of the public health.
In this case ‘Systemic Lupus Erythematosus’ is a dreaded disease and there was a
necessity for a drug and hence, the State allowed for the research purpose.
5
Constitution of Youngistan ,Pari Materia to Constitution of India (Herein after referred as Constitution)
17
In Consumer Education and Research Center v. UOI6, the Court has held that the right to
health was an integral factor of a meaningful right to life. The court also held that the right to
health and medical care is a fundamental right under Article 21. The Supreme Court, while
examining the issue of the constitutional right to health care under arts 21, 41 and 47 of the
Constitution of India in State of Punjab v Ram LubhayaBagga7, observed that the right of one
person correlates to a duty upon another, individual, employer, government or authority.
Hence, the right of a citizen to live under Art 21 casts an obligation on the state. This
obligation is further reinforced under art 47; it is for the state to secure health to its citizens as
its primary duty.
2) Certain persons not to undertake Biodiversity related activities without permission of

NBA8
(1) No person referred to in sub-section (2) shall, without previous approval of the National
BiodiversityAuthority, obtain any biological resource occurring in India or knowledge
associated thereto for research or for commercial utilization or for bio-survey and bio-
utilization
(2) The persons who shall be required to take the approval of the National Biodiversity
Authority under sub-section (1) are the following, namely:
(a) a person who is not a citizen of India;
(b) a citizen of India, who is a non-resident as defined in clause (30) of section 2 of the
Income-tax Act, 1961;
(c) a body corporate, association or organization-
(i) not incorporated or registered in India; or
___________________________
6
1995 SCC (3) 42
7
1998 AIR 1703
8
The Biological Diversity Act, 2002.
18
(ii) incorporated or registered in India under any law for the time being in forcewhich has
any non-Indian participation in its share capital or the management.
As contended by the Respondent that the company has not got the prior permission by the
NBA as mentioned above the sec 3 of The Biological Diversity Act, 2002 clearly mentions
the person who need to take approval from the National Biodiveristy Authority. Hence, the
company has not committed biopiracy by accessing the traditional knowledge.
3) Biopiracy
Biopiracy is a situation where indigenous knowledge of nature, originating with indigenous

people, is used by others for profit, without permission from and with little or no
compensation or recognition to the indigenous people themselves 9 and Here as the company
also accepted to pay monetary compensation as given under sec 21(2)(f) but only contended
that the quantum fixed is unreasonable, it shows that it was not for any profit purpose and
hence, the company had not committed biopiracy. \
4) Universal Declaration of Human Rights :
The article 25 of “Universal Declaration Of Human Rights” states that “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”.
India was a signatory to the Universal Declaration of Human Rights. A number of

fundamental rights guaranteed ta the individuals in Part Ill of the lndian Constitution are
similar to the provisions of the Universal Declaration of Human Rights.
___________________________
9
Suvarna Pandey, Patent Attorney, Biopiracy related to Traditional knowledge & Patenting Issues
19
In KeshavanandaBharathi v. State of Kerala10 , the Supreme Court observed, "The Universal

Declaration of Human Rights may not be a legally binding instrument but it shows how India
understood the nature of human rights at the time the Constitution was adopted." In the case
of Jolly George Varghese v. Bank of Cochin11, the point involved was whether a right
incorporated in the Covenant on Civil and Political Rights, which is not recognised in tie
lndian Constitution, shall be available to the individuals in lndia. Justice Krishna lyer
reiterated dualism and asserted that the positive commitment of the State Parties ignites
legislative action at home but does not automatically make the Covenant an enforceable part
of the 'Corpus Juris' in lndia. Thus, although the Supreme Court has stated that the Universal
Declaration cannot create a binding set of rules and that even international treaties may at
best inform judicial institutions and inspire legislative action. Constitutional interpretation in
lndia has been strongly influenced by the Declaration. In the judgement given in the
Chairman, Railway Board and others v. Mrs. Chandrima Das12, the Supreme Court observed
that the Declaration has the international recognition as the Moral Code of Conduct having
been adopted by the General Assembly of the United Nations. The applicability of the
Universal Declaration of Human Rights and principles thereof may have to be read, if need
be, into the domestic jurisprudence. In a number of cases the Declaration has been referred to
in the decisions of the Supreme Court and State High Courts.
Here, The applicability of Universal Declaration of Human Rights and principles may have to
be read, as it plays an important aspect in the judging the case. In this case as contended by
the Respondent 4 that the government did not take welfare of the people into consideration is
false as it had an obligation to look into ‘public welfare’ aspect and the drug to treat the
dreaded disease was essential.
___________________________
10
1973 (4) SCC 225
11
1980 AIR 470
12
2000(2) SCC 465
20
ISSUE 3:
1) The order of NBA is not reasonable on the grounds that it is against principles of
natural justice.
India there is no statute laying down the minimum procedure which administrative
agencies must follow while exercising decision-making powers. This minimum fair
procedure refers to the principles of natural justice Natural justice is a concept of common
law and represents higher procedural principles developed by the courts, which every
judicial, quasi-judicial and administrative agency must follow while taking any decision
adversely affecting the rights of a private individual.
Natural justice implies fairness, equity and equality.
In a welfare state like India, the role and jurisdiction of administrative agencies is
increasing at a rapid pace. The concept of Rule of Law would lose its validity if the
instrumentalities of the State are not charged with the duty of discharging these functions
in a fair and just manner. In India, the principles of natural justice are firmly grounded in
Article 14 & 21 of the Constitution. With the introduction of concept of substantive and
procedural due process in Article 21, all that fairness which is included in the principles
of natural justice can be read into Art. 21. The violation of principles of natural justice
results in arbitrariness; therefore, violation of natural justice is a violation of Equality
clause of Art. 14.
RULE AGAINST BIAS (NEMO JUDEX CAUSA SUA)
Bias means an operative prejudice, whether conscious or unconscious in relation to a

party or issue. The rule against bias flows from following two principles: -
a) No one should be a judge in his own cause
b) Justice should not only be done but manifestly and undoubtedly be seen to be
21
In, A.K.Kraipak Vs. UOI 13, Audi alteram partem - Hear the other party or the rule of
fair hearing or the rule that no one should be condemned unheard.
The concept of natural justice is to prevent miscarriage of justice and it entails –
(i) No one shall be a judge of his own cause.
(ii) No decision shall be given against a party without affording him a reasonable hearing.
(iii) The quasi-judicial enquiries should be held in good faith and not arbitrarily or
unreasonably.
Therefore, in this case there is the violation of Priniciples of Natural Justice in a way that,
the Respondent was not given an opportunity to be heard and the quantum fixed by the
NBA is unreasonable as the company had already spent huge amounts on the research.
Hence, it would be a loss for the company and the company had not done biopiracy but
only produced the medicine for the dreaded disease in good faith.
ISSUE 4:
Whether the revocation of patent is valid?
Sec 3(d) comprises three parts and one explanation.For the sake of clarity,the parts of sec
3(d) are detailed separately.The sec states that the following are not inventions within the
meaning of the Patents Act:
(1)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
(2)the mere discovery
(a)of any new property or new use for a known substance;or
(b)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.
________________________
13
AIR 1970 SC 150
22
Exceptions on the Ground of Pubic Health
Sec 3(d) may also be viewed as an exception under the ambit of art 27.2.Art 27.2 of the
TRIPS Agreement provides for exception to patentability made on grounds of health.The said
provision gives enough room for member countries to crave out exceptions on the grounds of
public health.Such measure may also extend to pharmaceuticals as patents for
pharmaceuticals can have a direct impact on human health.The Doho Declaration promote
access to medicines for all. A Declaration on public health furtherreiterates that the provision
of the TRIPS agreement must be interpreted and implemented in a manner supportive of
WTO members right to protect public health and to promote access to medicine for all.
Patents For Improvement
Whether a particular inventions will qualify for an improvement will depend on facts and
circumstances of each case having regard to the technical advancement over the earlier
invention. Similarly,’enhancement of the known efficacy’should also be determined having
regard to known efficacy and the significant difference made through the enhancement.A
new product or a process could also mean a new improvement over an exsisting product or
process.In plain terms,’enhancement of the known efficacy’means an improvement on what
is already known.It is a well established principle in patent law that improvement are
patentable.An improvement or modification of an earlier patent may qualify for a patent as a
patent of addition.The first part of sec 3(d) will be relevant in determining novelty of a
knowsubstance.It has an in-built guideline as it refers to two comparative concepts
is,’knownefficacy’and ‘enhanced efficacy’for determining patentability of new forms of
known substance.The first part states that the’enhanced efficacy’ has to be determined vis-à-
vis the ‘known efficacy’.
Supreme Court in the case Novartis AG VS Union of India and othersinterpreted the
meaning of “efficacy” in Section 3(d).
_________________________
14
(2013) 6 SCC 1
23
It said that the new form of a drug must demonstrate an improvement in its therapeutic effect
or curative property as compared to the old form in order to secure a patent.
Here, in this case Arogyapaacha was used only as an immune enhancer by the tribal people
but only after the research it was found that it could cure the disease Systemic
LopusErithemotosus. Hence, it is significantly an “improved efficacy” , and therefore, the
patent cannot be revoked.
Therefore, The patenting of traditional knowledge is beneficial to the wider society as it

allows the knowledge into the public domain, rather than keeping it a secret for only a few
people to benefit. Ayla Hussain of L’Oreal says, “We take ideas that are thousands of years
old and use modern technology to maximise their efficiency” .Therefore, if nothing else, the
public disclosure aspect of patents is substantial enough for the system to be deemed
necessary, “… disclosure is necessary if people are to learn from and build on the ideas of
others”.14 If there were no patent system, knowledge otherwise remains undisclosed and
therefore unusable, benefiting no one.
____________________________
15
Moore, ‘Intellectual Property – Moral, Legal and International Dilemmas’ – page 30
24
PRAYER
In the light of the issues raised, arguments advanced and authorities cited, may this Hon’ble
Court be pleased to:
1. Cancel the order passed by the Controller of Patents in providing Compulsory License
And to hold IPAB’s orders to be unjustifiable.
2. Pronounce the judgement as that of the PIL is not maintainable.
3. State that the quantum fixed by the NBA to be unreasonable and that no biopiracy has
been committed.
4. Order that the revocation of patent is invalid.
AND/OR
Pass any other order that it deems fit in the interest of Justice, Equity and Good Conscience.
And for this, the Petitioner as in duty bound, shall humbly pray.
COUNSELS FOR THE PETITIONER
25

Original Writ Jurisdiction Public Interest Litigation: Team Code: Nmc104

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AACL NATIONAL LEVEL MOOT COURT COMPETITION 2016

TEAM CODE : NMC104

IN THE HON’BLE SUPREME COURT OF YOUNGISTAN

ORIGINAL WRIT JURISDICTION

Writ Petition (Civil) No. _____

(Filed under Article 32 of the Constitution of Youngistan)

ICE Athreya Pharmaceuticals Pvt.Ltd and Union of Youngistan and others

Kani Tribes and others

UPON SUBMISSION TO THE HON‟BLE CHIEF JUSTICE AND HIS

MEMORANDUM ON BEHALF OF THE PETITIONER

1.1 the Compulsory License is not justifiable.

2) Whether the PIL is maintainable

2.1 the PIL is not maintainable under sec 38 and 47

2.2 company has not committed biopiracy

2.3 Universal Declaration of Human Rights

3) Whether the order of NBA is reasonable

4) Whether the revocation of patent is valid

4.1 the revocation of patent is invalid on the grounds that there is an

4.2 Exceptions on the Ground of Pubic Health

4.3 Patents for improvement

AIR All India Report

ICCPR International convention of Civil and Political Rights,1966

PIL Public interest litigation

SCC Supreme Court Cases

CLA Compulsory Licence Application

u/a Under Article

u/s Under Section

UDHR United Nations Declaration on Human Rights

TRIPS Trade Related Intellectual Property Rights

NBA National Biodiversity Act

1. Elizabeth Varkey,Law Of Patents,SecondEdition,Eastern Book Company

1. The Constitution Of India,1950

1. TRIPS Agreement-Trade Related aspects of Intellectual Property

PARTIES TO THE CASE :

ICE Athreya Pharmaceuticals Pvt.Ltd. – Petitioner 1

Union of Youngistan and others –Petitioner 2

Trio Pharma Pvt.Ltd – Petitioner 3

Kani Tribes – Respondent 1

FLO Pharma Pvt. Ltd – Respondent 3

Stepford Pharma Pvt. Ltd – Respondent 4

Whether the order of NBA is reasonable?

Whether the revocation of patent is valid?

Whether the order of NBA is reasonable?

ARGUMENTS ON BEHALF OF THE PETITIONER:

Sec 84 clause (1) of the Act2 states as follows:

3) Lee Pharma Vs AstraZeneca4

(i)According to Sec 24(1) of the Germans Patents Act:

Whether the PIL is maintainable?

1) Sec 38 and Sec 47 of the Constitution5 :

2) Certain persons not to undertake Biodiversity related activities without permission of

(a) a person who is not a citizen of India;

(c) a body corporate, association or organization-

(i) not incorporated or registered in India; or

Biopiracy is a situation where indigenous knowledge of nature, originating with indigenous

4) Universal Declaration of Human Rights :

India was a signatory to the Universal Declaration of Human Rights. A number of

In KeshavanandaBharathi v. State of Kerala10 , the Supreme Court observed, "The Universal

Natural justice implies fairness, equity and equality.

RULE AGAINST BIAS (NEMO JUDEX CAUSA SUA)

Bias means an operative prejudice, whether conscious or unconscious in relation to a

a) No one should be a judge in his own cause

The concept of natural justice is to prevent miscarriage of justice and it entails –

(i) No one shall be a judge of his own cause.