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AACL NATIONAL LEVEL MOOT COURT COMPETITION 2016

TEAM CODE: NMC115

BEFORE THE HONBLE SUPREME COURT OF YOUNGISTAN


WRIT PETITION NOs. ___________ OF 2016
UNDER ARTICLE 32 OF THE CONSTITUTION OF YOUNGISTAN
IN THE MATTER OF:
TRIO PHARMA PVT. LTD.....................................PETITIONER
v.
FLO PHARMA PVT. LTD...............................RESPONDENT
AND
MR. KUMAR....................................PETITIONER
v.
UNION OF YOUNGISTAN AND OTHERS..........RESPONDENT
AND
ICE-ATHREYA PHARMACEUTICALS PVT. LTD.

......PETITIONER

v.
KANI TRIBES.....................................RESPONDENT
AND
ICE-ATHREYA PHARMACEUTICALS PVT. LTD........PETITIONER
v.
STEPFORD PHARMA PVT. LTD.........................RESPONDENT

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TABLE OF CONTENTS

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


INDEX OF AUTHORITIES ................................................................................................... 4
STATEMENT OF JURISDICTION ...................................................................................... 6
STATEMENT OF FACTS ...................................................................................................... 7
ISSUES ...................................................................................................................................... 9
SUMMARY OF ARGUMENTS ........................................................................................... 10
ARGUMENTS ADVANCED ................................................................................................ 12
I. THAT THE ORDER PASSED BY THE IPAB FOR COMPULSORY LICENCE
IS JUSTIFIABLE. .............................................................................................................. 12
A. That The Reasonable Requirements Of The Public Have Not Been Met .......... 12
B. That Efforts Were Made To Obtain Voluntary License From Trio. ................. 13
C. That Flo Is Competent To Work The Invention To Public Advantage ............. 14
II. THAT THE PUBLIC INTEREST LITIGATION IS NOT MAINTAINABLE. .. 15
A. That the Petitioner does not have locus standi ..................................................... 16
B. That No Fundamental Rights Of The Tribes Were Infringed Upon. ................. 17
III.

THAT THE ORDER OF NBA IS REASONABLE. ............................................ 18

A. That The Petition Should Not Be Maintainable ................................................... 18


B. That Traditional Knowledge Was Used And Biopiracy Committed By IceAthreya Pharmaceuticals Pvt. Ltd. ............................................................................... 20
C. That The NBA Order Is Reasonable ..................................................................... 24
IV.

THAT THE REVOCATION OF PATENT IS VALID. ...................................... 25

A. That There Exists Ground For Revocation Of The Patent Under The Patents
Act 25
B. That Stepford Pharma Pvt. Ltd. Is A Person Interested ..................................... 27
C. That The Patent Falls Under Non-Patentable Subject Matter ........................... 28
D. That The Invention Is Based On Traditional Knowledge ................................... 29
PRAYER ................................................................................................................................. 31

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LIST OF ABBREVIATIONS

PIL

Public Interest
Litigation

Art.

Article

IPAB

Intellectual
Property
Appellate
Board

NBA

National
Biodiversity
Authority

v.

Versus

&

And

R&D

Research

and

Development
EPO

European
Patent Office

Honble

Honourable

Ltd.

Limited

Pvt.

Private

RPC

Reports

of

Patent
TRIPS

Trade Related
Aspects

of

Intellectual
Property Rights
US

United

States

of America

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INDEX OF AUTHORITIES
CASES
Associated Provincial Picture Houses Ltd v Wednesbury Corporation, (1947) EWCA Civ 1
.............................................................................................................................................. 19
BALCO Employees Union (Regd.) v. Union of India, (2002) 2 SCC 333.............................. 15
Baldev Singh Gandhi v. State of Punjab, (2002) 3 SCC 667. ................................................. 15
Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries, AIR 1982 SC 1444........ 23
Dattaraj Nathuji Thaware v. State of Maharashtra, (2005) 1 SCC 590. ................................ 14
Dhanpat Seth and Ors. v. Nil Kamal Plastic Crates Ltd., AIR 2008 HP 23. .......................... 24
Enviro Spray System Inc. Patent, 1986 RPC 147 Pg 156 ........................................................ 12
Globe Industries Corporations Patent, (1977) RPC 563. ...................................................... 22
Gopal Das Mohta v. Union of India, AIR 1955 SC 1. ............................................................ 15
Hindi Hitrakshak Samiti v. Union of India, (1990) 2 SCC 352............................................... 15
Kalle & co.s AG Patent 1996 FSR 112 p. 115. ...................................................................... 12
North Eastern Marine Engineering Company v. Leeds Forge Company, (1906) 2 Ch 498, p
500. ....................................................................................................................................... 21
S.K Sinha v. Patna University, AIR 1965 Pat 253................................................................... 16
S.P Gupta v. President of India, AIR 1982 SC 149 ................................................................ 14
S.P. Anand, Indore v. H.D. Deve Gowda. ............................................................................... 14
State of Orissa v. Radheyshyam Meher, 1995 AIR 855. ......................................................... 20
Triggs Application, (1945) RPC 18. ....................................................................................... 22
Youth for Unity and Voluntary Action v. State of Maharashtra, AIR 1991 Bom 60. ............. 13
BOOKS
Biodiversity Act, 2002. ............................................................................................................ 16
Blacks Law Dictionary ........................................................................................................... 10
D D Basu, Shorter Constitution of India 548 (14th ed. 2011). ................................................ 13
Patent Law P. Narayanan ..................................................................................................... 21
THE LAW OF PATENTS WITH A SPECIAL FOCUS ON PHARMACEUTICALS IN INDIA
.............................................................................................................................................. 10
STATUTES
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Indian Constitution................................................................................................................... 16
Indian Patents Act,1970. .......................................................................................................... 10
Notification of Access and Benefit Sharing Guidelines. ......................................................... 20
MISCELLANEOUS
http://www.wipo.int/tk/en/tk/................................................................................................... 23
Pharmaceutical Biopiracy and Protection of Traditional Knowledge, International Journal of
Research and development in Pharmacy and Life Sciences. ............................................... 17
www.biopiraterie.org. .............................................................................................................. 19
www.cbd.int/abs/ ..................................................................................................................... 17
TREATISES
TRIPS Agreement .................................................................................................................... 11

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STATEMENT OF JURISDICTION
The Petitioner has approached this Honble Court under Article 32 of the Constitution.
32. Remedies for enforcement of rights conferred by this Part(1) The right to move the Supreme Court by appropriate proceedings for the enforcement of
the rights conferred by this Part is guaranteed

(2) The Supreme Court shall have power to issue directions or orders or writs, including
writs in the nature of habeas corpus, mandamus, prohibition, quo warranto and certiorari,
whichever may be appropriate, for the enforcement of any of the rights conferred by this Part

(3) Without prejudice to the powers conferred on the Supreme Court by clause ( 1 ) and ( 2 ),
Parliament may by law empower any other court to exercise within the local limits of its
jurisdiction all or any of the powers exercisable by the Supreme Court under clause ( 2 )

(4) The right guaranteed by this article shall not be suspended except as otherwise provided
for by this Constitution

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STATEMENT OF FACTS
I.

Kani is an indigenous tribal community living in the Kannimalai tropical


rainforests of the Western Ghats of Youngistan. The region is a Biodiversity
Hotspot. The community has in depth knowledge of their environment, as they
have stayed close to the environment for centuries.

II.

Arogyapaacha (Trichopus Zeylanicus) is an herbal medicinal plant used by the


Kani Tribe as an immune enhancer in their traditional medicines. The plant is only
found in the Kannimalai rain forest.

III.

ICE Pharma Pvt. Ltd. a company located in Normand and registered in 1995, set
up a subsidiary company in Youngistan, ICE Athreya Pharmaceuticals Pvt. Ltd.
(hereinafter known as Company 1), in the year 2000. The subsidiary company
approached the Government for permission to conduct research at Kannimalai.
The Government granted the subsidiary company permission for non commercial
research.

IV.

After acquiring the knowledge of Arogyapaacha from the Kani Tribes, the
Subsidiary Company conducted further laboratory research and developed the
only drug for Systemic Lupus Erythematosus, Cuzalin. The drug was patented
in Normand in 2005 and patent protection was grated in 2008 by the Patent Office
in Youngistan. Systemic Lupus Erythematosus is a disease which may affect any
part of the body. The symptoms differ from person to person and the course of the
disease is marked by periods when the disease is active and other periods where
symptoms are not visible.

V.

The Subsidiary Company signed a lease agreement with TRIO Pharma Pvt. Ltd
(hereinafter known as Company 1), which is a drug manufacturing company, for
the manufacturing of Cuzalin. Company 1 would have lease of patent for
manufacturing Cuzalin, provided it manufactured and distributed the drug only
in Sourashtra, a state in Youngistan. Company 1 would have monopoly over the
drug in the state. There are various other companies such as Stepford Pharma Pvt.
Ltd, Avalon Pharma Pvt. Ltd. and FLO Pharma Pvt. Ltd. (hereinafter known as
Company 2), which are in the pharmaceutical industry and have the efficiency of
producing the same quality of medicines.

VI.

Company 1 and Company 2 began negotiations, where Company one laid the
following

conditions-

Exclusive

Distribution

Agreement,

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Resale

Price

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Maintenance, Royalties and Licensing Fee. The negotiations failed. Subsequently,


Company 2 got a Compulsory License, for manufacturing Cuzalin, from the
Controller of Patents. There is a shortage of supply of the drug in some parts of
Sourashtra. Company 1 approached the Intellectual Property Appellate Board
(hereinafter known as IPAB), challenging the order of the Controller. The IPAB
upheld the order of the Controller. Thus, aggrieved by this, Company 1 has filed a
Writ Petition in the Honble Supreme Court of Youngistan.
VII.

Mr. Kumar, a public spirited citizen, has filed a Public Interest Litigation before
the Honble Supreme Court of Youngistan. His contention that the Subsidiary
Company accessed biological resources without taking prior permission of the
National Biodiversity Authority (hereinafter known as NBA). This amounted to
biopiracy, and the Government had not kept the interests of the Kani Tribe while
granting permission for non commercial research. This would lead to exploitation
of Traditional Knowledge of the Tribe and also affect their livelihood.

VIII.

The Kani Tribes approached the NBA for equitable benefit sharing with the
Subsidiary Company. The NBA asked the National Biological Committee for a
report, pursuant to which the quantum of benefit sharing was fixed at 50% of the
total turnover of the Company, which is 50 million USD per annum. Finding the
quantum unreasonable the Subsidiary Company approached the Honble Supreme
Court of Youngistan via Writ Petition.

IX.

In the meanwhile, Stepford Pharma Pvt. Ltd. filed for revocation of the patent
granted to Cuzalin before the IPAB. Stepford argued that the patent was based
on Traditional Knowledge, which was non-patentable subject matter. The IPAB
passed an order revoking the patent. Aggrieved by this, the Subsidiary Company
has approached the Honble Supreme Court of Youngistan via Writ Petition, for
setting aside the order of the IPAB and restoring the patent.

X.

The Honble Supreme Court of Youngistan, after hearing all matters, has decided
to hold a combined hearing for final disposal of all matters on 13th March, 2016.

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ISSUES
I.

WHETHER THE ORDER PASSED BY THE IPAB FOR COMPULSORY


LICENSE IS JUSTIFIABLE?

II.

WHETHER THE PIL IS MAINTAINABLE?

III.

WHETHER THE ORDER OF NBA IS REASONABLE?

IV.

WHETHER THE REVOCATION OF PATENT IS VALID?

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SUMMARY OF ARGUMENTS
I.

THAT THE ORDER PASSED BY THE IPAB FOR COMPULSORY


LICENCE IS JUSTIFIABLE.

Compulsory License is a statutorily created licence that allows certain people to pay
royalty and use an invention without the patentees permission. In order to grant a
compulsory license the Controller needs to take into consideration conditions such as
whether the applicant has made efforts of obtaining a voluntary license from the patent
holders and whether the applicant is efficient enough to work the patent in Youngistan.
FLO Pharma fulfilled both conditions as it made necessary efforts to obtain a voluntary
license from TRIO Pharma and is efficient enough to manufacture the same quality of
medicine and work the patent in Youngistan. Section 84(1) of the Patents Act, 1970
provides that if reasonable requirements of the public with respect to the patented
invention have not been satisfied then it is a valid ground for the grant of a compulsory
license. Here the shortage of Cuzalin in some parts of Sourashtra amounts to nonsatisfaction of reasonable requirements of the public of Sourashtra with respect to the
patented invention. Hence, the order passed by the IPAB for compulsory licenses is
justifiable.
II.

THAT THE PUBLIC INTEREST LITIGATION IS NOT MAINTAINABLE.

A Public Interest Litigation under Art.32 of the Constitution is maintainable only if there
is a violation of any fundamental right. A PIL filed by a public spirited individual is
entertained only if the affected persons are unable to represent themselves in Court. The
relief demanded by the Petitioner must not differ from the relief demanded by the affected
persons. The Kani Tribes have approached the National Biodiversity Authority seeking
equitable benefit sharing with the Subsidiary Company. This is contrary to the demand of
Mr. Kumar. The Petitioner has also not been able to show the inability of the Tribes to
approach the Court. No fundamental right of the Tribes has been violated. The
Government order granting research permission to the Subsidiary Company is in
accordance with law. There is no evidence to show that the livelihood of the Tribes is
affected because of the Subsidiary Company utilizing the Arogyapaacha plant.
III.

THAT THE ORDER OF NBA IS REASONABLE.

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Without the use of traditional knowledge given by the Kani Tribes development of
Cuzalin would not have been possible. It is after this very traditional knowledge that the
research centre was set up in the first place. Biopiracy is committed when there is
commercialization of traditional knowledge and no benefit of it is provided to the
community or traditional knowledge holders. ICE-Athreya has used precious traditional
knowledge of the Kani Tribes and provided know benefit of it to the community
members, committing biopiracy. The order given by the NBA is not reasonable as it is the
right of the Kani Tribes to receive benefit for the commercial use of their knowledge. The
quantum decided by the NBA is based on the guidelines provided by the Access to
Biological Resources and Associated Knowledge and Benefits Sharing Regulations, 2014
and not arbitrary. It is given keeping in mind the interests of the Kani Tribes,
conservation of the rights of the indigenous people and is therefore not unreasonable.
IV.

THAT THE REVOCATION OF PATENT IS VALID.

A patent is a limited monopoly granted by the State onto the inventor to reap the benefits
and profits that can be derived from the patent. However, since the ultimate aim of every
patent is the benefit of the public, the Patents Act, 1970 also provides for revocation of a
patent on various grounds. The patented drug Cuzalin is based on the knowledge and
components that are only found in Kannimalai and used have been used by the local Kani
tribes for generations. The subject matter that the patent falls under is non-patentable
under the Act by virtue of it being based on the traditional knowledge of the local
indigenous community for generations. There is no novelty of the drug and without
information about the medicinal plant by the locals the drug would not even have come
into existence. Continuance of the patent will not only endanger knowledge traditionally
available only in Kannimalai, but will also leave the local Kani community devoid of
their fair and equitable distribution of profits that the Company derives from their
knowledge and resources.

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ARGUMENTS ADVANCED

I.

THAT THE ORDER PASSED BY THE IPAB FOR COMPULSORY LICENCE IS


JUSTIFIABLE.
Compulsory License is a statutorily created licence that allows certain people to pay royalty
and use an invention without the patentees permission.1The grant of a patent confers limited
monopoly on the patentee to the exclusion of others. Though the law permits this, it also
takes into account the fact that the monopoly granted through a patent may be abused hence,
provides for certain restrictions to its enjoyment. The grant of compulsory license is one such
restriction imposed on the absolute exploitation of a patent.2 Chapter XVI of the Patents Act,
1970 governs compulsory licensing. A plain reading of section 84(1) stands as follows:
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
license on patent on any of the following grounds, namely:(a) that the reasonable requirements of the public with respect to the patented invention
have not been satisfied, or
(b) that the patented invention is not available to the public at a reasonably affordable
price, or
(c) that the patented invention is not worked in the territory of India.3
A. That The Reasonable Requirements Of The Public Have Not Been Met
The predominant purpose of granting a compulsory licence is to ensure the supply of the
patented invention in the Indian market.4
We know that, there is a shortage of Cuzalins supply in some parts of Sourashtra,5leaving
the public in that area devoid of the only cure of a dreaded disease i.e., Systemic Lupus
Erythematosus. This satisfies the requirement for granting of compulsory license on ground
of reasonable requirements of the public not being met with.

Blacks Law Dictionary


THE LAW OF PATENTS WITH A SPECIAL FOCUS ON PHARMACEUTICALS IN INDIA.

2
3

Sec. 84(1), Indian Patents Act,1970.


Sec. 90(1)(vii) Indian Patents Act, 1970.
5
Moot Problem, Para 8.
4

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The reasonable requirements of the public will not be deemed to have been satisfied if the
refusal of the patentee to grant a license results in a demand for the patented article not being
met to an adequate extent or on reasonable terms.6
Here, the refusal of the patentee to grant a licence would perpetuate the shortage of the said
drug in some parts of Sourashtra hence resulting in the demand for the patented article not
being met adequately, making the grant of the compulsory license by the IPAB justifiable in
order to enable availability of the said drug in shortage areas.
B. That Efforts Were Made To Obtain Voluntary License From Trio.
Article 31 of the TRIPS agreement sates thatOther Use without Authorization of the Right Holder
Where the law of a Member allows for other uses of the subject matter of a patent without
the authorization of the right holder, including use by the government or third parties
authorized by the government, the following provisions shall be respected:
(a) authorization of such use shall be considered on its individual merits;
(b) such use may only be permitted if, prior to such use, the proposed user has made efforts to
obtain authorization from the right holder on reasonable commercial terms and conditions
and that such efforts have not been successful within a reasonable period of time.7

In pursuance of the TRIPS agreement, the following regulation was set up under the Patents
Act, 1970 In considering the application field under this8 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;

Section 84(7)(ii) Indian Patents Act, 1970.

Article 31, TRIPS Agreement.

Sec. 84(6) Indian Patents Act, 1970

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(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 purposes of clause (iv), "reasonable period" shall be construed as a
period not ordinarily exceeding a period of six months.]

In the present case, FLO had a negotiation with TRIO in order to obtain a voluntary license,
but the negotiation failed between them and therefore FLO filed an application for the grant
of a compulsory licence to them.
The condition precedent to entertain an application of compulsory licence by the controller
requires an effort on the part of the applicant to obtain a voluntary license. In the case at hand
we see that negotiations had taken place between the two parties and the conditions put forth
by TRIO were unreasonable and anti-competitive in nature and hence it can be inferred that
adequate efforts had been taken by FLO, thus fulfilling the requirement as prescribed under
the Patents Act, 1970.
C. That FLO Is Competent To Work The Invention To Public Advantage
The predominant purpose of granting a compulsory licence is to ensure the supply of the
patented invention in the Indian market. 9
The ability of the interested person to work the invention to the public advantage and the
capacity to take the risk in providing capital and working the invention shall also be
relevant10
If on evidence it is shown that the applicant could properly exploit the invention, the
compulsory license should be granted.11

Ibid, n.4.
Enviro Spray System Inc. Patent, 1986 RPC 147 Pg 156.
11
Kalle & co.s AG Patent 1996 FSR 112 p. 115.
10

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FLO is also engaged in manufacturing of pharmaceuticals and is efficient enough in


manufacturing the same quality of medicine12as TRIO.
Therefore, FLO satisfies another condition precedent for consideration of granting of
compulsory license by proving its competency to work the invention to public advantage
while TRIO fails to do so.
Hence, in the interest of the aggrieved sections of the public, the grant of compulsory license
to FLO is justified.
II.

THAT THE PUBLIC INTEREST LITIGATION IS NOT MAINTAINABLE.

The sole object of Art.32 is the enforcement of fundamental rights guaranteed by the
Constitution. 13
A plain reading of Article 32 stands as follows:
32. 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

A matter of public or general interest does not mean that which is gratifying curiosity or a
love for information or amusement, but in which a class of the community have a pecuniary

12

Moot Problem, Para 7.

13

D D Basu, Shorter Constitution of India 548 (14th ed. 2011).

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interest or some interest by which their legal rights or liabilities are affected. A PIL has to be
started as such, it is a proceeding under Art. 32 and it is entertained to protect the right of
persons or class of persons who are not in a position to move court. 14
A. That the Petitioner does not have locus standi.
There must be real and genuine public interest involved in the litigation and concrete or
credible basis for maintaining a cause before court and not merely an adventure of a knight
errant borne out of wishful thinking.15It is now established that a writ petition may be moved
not only by an aggrieved individual but also by a public spirited individual or a journalist or a
social action group, for the enforcement of the constitutional or legal rights of some other
person, provided such other person is unable to approach the Court for redress owing to(a) such person being in custody; or
(b) such person belongs to a class or group of persons who are in a disadvantaged
position on account of poverty, disability or other social or economical impediment,
and are unable to enforce their rights. 16
It is contended that the Kani Tribe does not fall under any of the above categories. The
Petitioner has failed to show that the Tribes are economically insufficient or socially impeded
to approach the Court. The fact that the Tribes approached the NBA17shows that they are well
aware of their legal rights. Also, the remedy sought by the Petitioner and the affected party
are different. In S.P Gupta v. President of India,18 the Supreme Court observed, Before we
part with this general discussion in regard to locus standi, there is one point we would like to
emphasise and it is that cases may arise where there is undoubtedly public injury by the act
or omission of the State or a public authority but such act or omission also causes a specific
legal injury to an individual or to a specific class or group of individuals. In such cases, a
member of the public having sufficient interest can certainly maintain an action challenging
the legality of such act or omission, but if the person or specific class or group of persons
who are primarily injured as a result of such act or omission, do not wish to claim any relief
and accept such act or omission willingly and without protest, the member of the public who
complains of a secondary public injury cannot maintain the action, for the effect of
14

Youth for Unity and Voluntary Action v. State of Maharashtra, AIR 1991 Bom 60.

15

D D Basu, Shorter Constitution of India 572(14th ed. 2011).


D D Basu, Shorter Constitution of India 568(14th ed. 2011).
17
Moot Problem, Para 11.
18
S.P Gupta v. President of India, AIR 1982 SC 149.
16

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entertaining the action at the instance of such member of the public would be to foist a relief
on the person or specific class or group of persons primarily injured, which they do not
want. Though the Tribes have not given up any relief, the nature of relief demanded by them
is different from the Petitioners demands. Public interest litigation is a weapon which has to
be used with great care and circumspection and the judiciary has to be extremely careful to
see that behind the veil of public interest, an ugly private malice, vested interest and/or
publicity seeking is not lurking.19No one has a right to the waiver of the locus standi rule and
the court should permit it when is satisfied that the carriage of proceedings is in the
competent hands of a person who is genuinely concerned in public interest and is not moved
by other extraneous considerations.20 The courts have held time and again that PIL is an
instrument to render justice to that class of people who are unable to represent themselves or
approach courts. The locus standi in such matters is only for bona fide petitioners who have
sufficient interest in the litigation. The courts have warned against unscrupulous litigants and
meddlesome busybodies who waste the time of courts. The Petitioner has not been able to
show sufficient interest in the welfare of the affected party.
B. That No Fundamental Rights Of The Tribes Were Infringed Upon.
Mr. Kumar, the Petitioner has contended that ICE- Athreya Pharmaceuticals Pvt. Ltd., the
Subsidiary Company has accessed Traditional Knowledge without the permission of the
NBA and the Governments decision of granting the Subsidiary Company permission for non
commercial research has affected the livelihood of the Kani Tribes. 21
A bare reading of Section 48 of the National Biodiversity Act is as follows:
48. (1) Without prejudice to the foregoing provisions of this Act, the National Biodiversity
Authority shall, in the discharge of its functions and duties under this Act, be bound by such
directions on questions of policy as the Central Government may give in writing to it from
time to time.

Provided that the National Biodiversity Authority shall, as far as practicable, be given
opportunity to express its views before any direction is given under this sub-section.

19

Dattaraj Nathuji Thaware v. State of Maharashtra, (2005) 1 SCC 590.


S.P. Anand, Indore v. H.D. Deve Gowda.
21
Moot Problem, Para 10.
20

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(2) The decision of the Central Government whether a question is one of policy or not shall
be final.
From the above it is clear that the Act gives the Central Government the final word in making
any decision with regards to the policy or any other aspect relating to the Act. Thus, the
Government was well within its authority to grant permission for non commercial research to
the Subsidiary Company. The Court will not interfere with a policy decision of the
government unless that amounts to a direct and casual violation of a fundamental right
guaranteed by Part III of the Constitution. 22
The Kani Tribes used the Arogyapaacha plant in their traditional medicines as an immune
enhancer.23It is farfetched to imply that the Tribes used the plant as a means of livelihood.
The right of using this plant is not limited to the Tribes. The Company uses the plant in the
manufacture of Cuzalin, a drug for Systemic Lupus Erythematosus. The use of the plant is
for different purposes; hence no fundamental right of the Tribes is violated. The sole object of
Art. 32 is the enforcement of the fundamental rights guaranteed by the Constitution.24The
infringement of fundamental rights cannot be founded on remote or speculative ground.25In
BALCO Employees Union (Regd.) v. Union of India,26 the Supreme Court observed, It will
be seen that whenever the Court has interfered and given directions while entertaining PIL it
has mainly been where there has been an element of violation of Article 21 or of human
rights or where the litigation has been initiated for the benefit of the poor and the
underprivileged who are unable to come to Court due to some disadvantage. Thus, a grave
violation of Art. 21 has to be shown in order to maintain a PIL under Art. 32. Hence, for the
above reasons the PIL is not maintainable.

III.

THAT THE ORDER OF NBA IS REASONABLE.

A. That The Petition Should Not Be Maintainable


Efficacious remedy implies a form of relief that can be obtained at a different forum from the
current forum. It is generally required to exhaust any other form of efficacious remedy before
filing a writ petition because the inherent powers of the Supreme Court to issues prerogative
22

Hindi Hitrakshak Samiti v. Union of India, (1990) 2 SCC 352.


Moot Problem, Para 2.
24
Gopal Das Mohta v. Union of India, AIR 1955 SC 1.
25
Baldev Singh Gandhi v. State of Punjab, (2002) 3 SCC 667.
26
BALCO Employees Union (Regd.) v. Union of India, (2002) 2 SCC 333.
23

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writs or order in terms of Article 32 of the Constitution is discretionary and the Supreme
Court bars any person from invoking the extraordinary jurisdiction of the Supreme Court in
the instances where he has a remedy available elsewhere.
The spirit of the Constitution of India reflects on its positive approach towards the
enforcement of fundamental rights. Article 13 of the Constitution makes all laws made by the
State, which are in violation of the Part III of the Constitution, void. Article 32(1) and 226
empower the Supreme Court and High Court respectively to enforce these Rights. Article 32
(3) also empowers the Supreme Court to delegate the power to enforce the fundamental rights
to other Courts.
Courts can exercise this power by using the tools that have been given to them by Art 32(2)
and 226. Art 32 (2) grants the Supreme Court the 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 (III) Part27.
Article 226 provides a parallel right to the High Courts. However, a major difference between
the power endowed by Article 32 and Article 226 is that while Article 32 can be invoked only
in case of a breach of Fundamental Rights, Article 226 can be invoked for any other purpose
also.
In the case of S.K Sinha v. Patna University28the petition under Art.32 was denied on the
ground that there existed an equal and efficacious remedy under the University Act.
Under the Biodiversity Act, 2002 section 52 states that
Any person, aggrieved by any determination of benefit sharing or order of the National
Biodiversity Authority or a State Biodiversity Board under this Act, may file an appeal to the
High Court within thirty days from the date of communication to him, of the determination or
order of the National Biodiversity Authority or the State Biodiversity Board, as the case may
be

27

Article 32, Indian Constitution.


S.K Sinha v. Patna University, AIR 1965 Pat 253.

28

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Provided that the High Court may, if it is satisfied that the appellant was prevented by
sufficient cause from filing the appeal-within the said period, allow it to be filed within a
further period not exceeding sixty days29
From a plain reading of the section, it can be seen that the petitioner should have first
appealed to the High Court. The petitioner failed to exhaust all alternate remedies available to
him before applying to this court.
It is respectfully submitted that in the present case, the respondents had an efficacious remedy
available under the Biodiversity Act. In the presence of the plausible remedies that the
petitioners could invoke, the right to invoke writ jurisdiction of the Supreme Court has not
arisen unless there is violation of any fundamental right which is not the case here, as there is
no prima facie violation of any fundamental right. The order was in line with the parameters
and the guidelines provided by the Biodiversity Act and given keeping in mind the interests
of the Kani Tribe Community.
Hence, due to the availability of an efficacious remedy the petition shall not be maintainable.

B. That Traditional Knowledge Was Used And Biopiracy Committed By IceAthreya Pharmaceuticals Pvt. Ltd.
The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of
Benefits Arising from their Utilization to the Convention on Biological Diversity is an
international agreement which aims at sharing the benefits arising from the utilization of
genetic resources in a fair and equitable way. It entered into force on 12 October 2014, 90
days after the date of deposit of the fiftieth instrument of ratification.30It is a landmark treaty
that was devised keeping in mind the increasing loss of biodiversity on Earth. The Nagoya
Protocol specifies the means by which the CBD can be applied. The Nagoya Protocol,
especially the Access and benefit sharing clause, calls for systems to be put in place.
According to the protocol, organizations will have to pay a significant amount of their
revenue and royalties to indigenous communities and host countries for the drug they develop
from genetic resources.

29
30

Sec. 52 Biodiversity Act, 2002.


www.cbd.int/abs/

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The revised patent system will also add to the cost of drug development. Due to the rules and
regulations laid down by the Nagoya Protocol, organizations would have to execute joint
patents with the communities from whom they source resources.31
In pursuance of the Nagoya Protocol on access to genetic resources and the fair and equitable
sharing of benefits arising from their utilization to the Convention on Biological Diversity the
Biodiversity Act provides for provisions for equitable sharing of benefits.
Section 6(2) of the Biodiversity Act states that
The National Biodiversity Authority may, while granting the approval under this section,
impose benefit sharing fee or royalty or both or impose conditions including the sharing of
financial benefits arising out of the commercial utilization of such rights.32
Section 21 of the Biodiversity Act states that
Determination of equitable benefit sharing by National Biodiversity Authority
21.

(1) The National Biodiversity Authority shall while granting approvals under section 19

or section 20 ensure that the terms and conditions subject to which approval is granted
secures equitable sharing of benefits arising out of the use of accessed biological resources,
their by-products, innovations and practices associated with their use and applications and
knowledge relating thereto in accordance with mutually agreed terms and conditions
between the person applying for such approval, local bodies concerned and the benefit
claimers.
(2) The National Biodiversity Authority shall, subject to any regulations made in this behalf,
determine the benefit sharing which shall be given effect in all or any of the following
manner, namely:
(a) grant of joint ownership of intellectual property rights to the National Biodiversity
Authority, or where benefit claimers are identified, to such benefit claimers;
(b) transfer of technology;

31

Pharmaceutical Biopiracy and Protection of Traditional Knowledge, International Journal of Research and
development in Pharmacy and Life Sciences.
32
Sec. 6(2) Biodiversity Act, 2002.

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(c) location of production, research and development units in such areas which will facilitate
better living standards to the benefit claimers;
(d) association of Indian scientists, benefit claimers and the local people with research and
development in biological resources and bio-survey and bio-utilization;

(e) setting up of venture capital fund for aiding the cause of benefit claimers;

(f) payment of monetary compensation and non-monetary benefits to the benefit claimers as
the National Biodiversity Authority may deem fit.

(3)

Where any amount of money is ordered by way of benefit sharing, the National

Biodiversity Authority may direct the amount to be deposited in the National Biodiversity
Fund:
Provided that where biological resource or knowledge was a result of access from specific
individual or group of individuals or organizations, the National Biodiversity Authority may
direct that the amount shall be paid directly to such individual or group of individuals or
organizations in accordance with the terms of any agreement and in such manner as it deems
fit.
(4) For the purposes of this section, the National Biodiversity Authority shall, in consultation
with the Central Government, by regulations, frame guidelines33
Now, we can see that NBA has the authority to ensure securing of equitable sharing of
benefits arising out of accessed biological resources, their by-products, innovations and
practices associated with their use and applications and knowledge relating thereto.
In the case at hand, 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 Cuzalin34.
33

Sec. 21 Biodiversity Act, 2002.


Moot Problem, Para 4.

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The benefits have arisen by the commercialization of the drug Cuzalin which is based on
the traditional knowledge provided by the Kani Tribes and the production of this drug has
only been possible due to access to biological resources of the Kannimalai Tropical Forest.
Hence, it is proven that traditional Knowledge was used in the development of Cuzalin.
Further, Biopiracy can be defined as, the misappropriation and commercialization of genetic
resources and traditional knowledge of rural and indigenous people. Pharmaceutical
biopiracy is a term used generally to describe the legal practice by pharmaceutical companies
exploiting the indigenous peoples traditional knowledge of medicine.
It involves making profit from freely available natural products (plants, seeds, leaves etc.) by
copying techniques used daily for generations by local peoples in order to feed and take care
of themselves. Bio pirates do not give any profit or proper benefit to local communities and
traditional Knowledge holders.35
From the above definition we see that in order to commit biopiracy it is essential that
1) Misappropriation and commercialization of traditional knowledge takes place
2) Copying of techniques used daily for generations by local peoples
3) In order to feed and take care of themselves
4) Do not give proper benefits to local communities and traditional knowledge
holders.
In the case at hand, there has been misappropriation and commercialisation of traditional
knowledge as the research was only supposed to be undertaken for non-commercial purposes
by the petitioners. They have copied techniques used daily for generations by local peoples in
order to feed and take care of themselves as the Kani Tribes relied on Arogyapaacha for
enhancing their immunity and taking care of themselves. They have also after having
commercialised the traditional knowledge not provided any benefits to local communities and
holders of traditional knowledge.
Therefore, Biopiracy has been committed and Kani Tribes have every right to be entitled to
equitable share in the benefits arising from the proceeds of Cuzalin.

35

www.biopiraterie.org.

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C. That The NBA Order Is Reasonable


In order to test reasonability we take the help of the Wednesbury Principles of reasonableness
which have been used to test reasonability in a number of cases.
In the case of Associated Provincial Picture Houses Ltd v Wednesbury Corporation it was
held that
The court is entitled to investigate the action of the local authority with a view to seeing
whether they have taken into account matters which they ought not to take into account, or,
conversely, have refused to take into account or neglected to take into account matters which
they ought to take into account. Once that question is answered in favour of the local
authority, it may be still possible to say that, although the local authority have kept within the
four corners of the matters which they ought to consider, they have nevertheless come to a
conclusion so unreasonable that no reasonable authority could ever have come to it.36
The essentials for reasonability therefore are
1) Whether matters which were not to be taken into account are taken into account
2) Whether things that were to be taken into account are not taken into account
3) Whether conclusion is so unreasonable that no other reasonable authority would
have come to it
According to Guidelines on Access to Biological Resources and Associated Knowledge and
Benefits Sharing Regulations, 2014 - Determination of benefit sharing shall be based on
considerations such as commercial utilization of the biological resource, stages of research
and development, potential market for the outcome of research, amount of investment already
made for research and development, nature of technology applied, time-lines and milestones
from initiation of research to development of the product and risks involved in
commercialization of the product.37
The above mentioned things were to be taken into account. The NBA arbitrarily has not
decided the quantum of benefit sharing. Taking into account the above parameters and the
fact that Cuzalin is the only cure for a dreaded disease and its demand will only increase in
turn increasing the turn over and also the extent of commercial utilization of Arogyapaacha it

36

Associated Provincial Picture Houses Ltd v Wednesbury Corporation, (1947) EWCA Civ 1.
Section 14, Notification of Access and Benefit Sharing Guidelines.

37

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is justified to give 50% of the petitioners turnover to the Kani Tribes as without their
knowledge the development of the drug would not have been possible.
There are no reasonably foreseeable matters that should not have been taken into account and
were still taken into account.
And the order is definitely not so unreasonable that no other authority would have come to it.
In the case of State of Orissa v. Radheyshyam Meher38it was held that
Government order issued in public interest overrides individual interest and the question of
public interest must be considered not from the point of view of the interest of the person on
whom the restriction is imposed, even if the restriction operates in him harshly
Therefore, even though the restriction of benefit sharing with the Kani tribes operates harshly
on the petitioner the order cannot be held unreasonable as it is issued keeping in mind the
interest of the Kani Tribes.
It is therefore humbly submitted that the NBA order is not unreasonable for the above
mentioned reasons.
IV.

THAT THE REVOCATION OF PATENT IS VALID.

A. That There Exists Ground For Revocation Of The Patent Under The Patents Act
Although the patentee has the exclusive right of making, using or selling the invention, the
validity of the patent is not guaranteed by the Government. A patent is a kind of a monopoly
granted to the true and first inventor as a reward for the creation of something new and useful
which might ultimately benefit the public. The public should therefore be given the
opportunity to challenge the validity of the grant if the patent does not fulfil any of the
conditions laid down under the Act for the grant of such monopoly 39
TRIPS Agreement allows member countries from enforcing grounds under which patentable
and non-patentable subject matters can be defined. The Agreement says that members may
exclude from patentability inventions, the prevention within their territory of the commercial
exploitation of which is necessary to protect order public or morality, including to protect
human, animal or plant life or health or to avoid serious prejudice to the environment,

38

State of Orissa v. Radheyshyam Meher, 1995 AIR 855.


Patent Law P. Narayanan, p. 437 (4th ed., 2006).

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provided that such exclusion is not made merely because the exploitation is prohibited by
their law 40
Revocation is a process by which a patent may be put to an end before the expiry of the
ordinary term of the patent. Upon revocation, all the rights and privileges offered by the
patent will cease to have any effect41. An order of revocation has the effect of rendering the
patent void ab initio42. A proceeding for revocation can be initiated only on specific ground in
specific circumstances. In addition, a proceeding for revocation can be instituted by certain
persons before the authorities specified in the Patents Act.43
A petition for revocation before the Appellate Board can be filed under Section 64 of the
Patents Act. The Section has defined who can file a petition for revocation, the procedures to
be followed for filing and adjudicating of such petitions and the authorities before which such
petitions can be filed. The grounds for revocation under this Section are exhaustive because
the language stating the words on any of the following grounds implies that only the
grounds enumerated are available for revocation44. The grounds under which a petition for
revocation can be filed have been given under sub-section (1) of Section 64:
Section 64 (1): Subject to the provisions contained in this Act, a patent, whether granted
before or after the commencement of this Act, may, 149 [be revoked on a petition of any person
interested or of the Central Government by the Appellate Board or on a counter-claim in a
suit for infringement of the patent by the High Court] on any of the following grounds that is
to say(k) that the subject of any claim of the complete specification is not patentable under this Act;
(q) that the invention so far as claimed in any claim of the complete specification was
anticipated having regard to the knowledge, oral or otherwise, available within any local or
indigenous community in India or elsewhere.]

Under the case at hand, ICE-Athreya Pharmaceuticals Pvt. Ltd. has violated two clauses of
the Section 64 (1), namely Clause (k) (non-patentable subject matter) and Clause (q)
(invention based on traditional knowledge). By violating Section 64(1) under Clause (k), the
40

Article 27 (2), TRIPS Agreement.


The Law of Patents With a Special Focus on Pharmaceuticals in India, p. 433, (1st ed., 2007).
42
North Eastern Marine Engineering Company v. Leeds Forge Company, (1906) 2 Ch 498, p 500.
43
Sec. 64, Indian Patents Act, 1970.
44
The Law of Patents With a Special Focus on Pharmaceuticals in India, p. 455, (1st ed., 2007).
41

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company has also violated Section 3 (p) of the Act (an invention which is based on traditional
knowledge shall not be considered to be an invention under the Patents Act).
B. That Stepford Pharma Pvt. Ltd. Is A Person Interested
Section 64 of the Act deals with provisions relating to revocation of patents. A patent can be
revoked:
1. On a petition of any person interested; or
2. On a petition of the Central Government by the Appellate Board; or
3. On a counter-claim in a suit for infringement of the patent by the High Court.
Stepford Pharma Pvt. Ltd. has filed the petition for revocation as any person interested, as
defined under the Act. A person interested includes a person engaged in, or in promoting,
research in the same field as to which the invention relates45
Any person who is interested in manufacturing or carrying on the manufacture of an article
which is the subject matter of a patent will be regarded as having an interest in the
manufacture of that article. An existing manufacturer whose livelihood may be threatened by
a patent could bring an action of opposition to ensure that the proposed monopoly is
confined within proper limits and rests upon and adequate description in the specification 46.
To come within the ambit of a person interested, it would be sufficient for a person to show
that he has a genuine trading interest which may be prejudiced.47
Stepford Pharma Pvt. Ltd. is engaged in manufacturing of pharmaceuticals and in efficient
enough in manufacturing the same quality of medicine as ICE-Athreya Pharmaceuticals Pvt.
Ltd48. Being a major company in the same pharmaceutical industry, Stepford Pharma Pvt.
Ltd. is clearly a person interested within the meaning of a person interested given under the
Act.
Thus, Stepford Pharma Pvt. Ltd. qualifies as a person interested and, accordingly, has the
locus of filing a petition of revocation.

45

Section 2 (1) (t), Indian Patents Act, 1970.


Triggs Application, (1945) RPC 18.
47
Globe Industries Corporations Patent, (1977) RPC 563.
48
Moot Problem, Para 7.
46

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C. That The Patent Falls Under Non-Patentable Subject Matter


Section 64 (1) specifies the various grounds under which the patent can be revoked. The
grounds violated by ICE-Athreya Pharmaceuticals Pvt. Ltd. are mentioned under clauses (k)
and (q), specified below.
A patent may be revoked on the ground that the subject of any claim of the complete
specification is not patentable under this Act49.
Non-patentability of an invention as a ground for revocation has been defined under Section
3. An invention has to be understood based on how the three of its subjective constituents,
i.e., novelty, inventive step and industrial application are understood.50
The three prerequisites of an invention, i.e., novelty, inventive step and industrial application
contained in Section 2 (1) (j) should be satisfied for an invention to be patentable under the
Patents Act. What is not patentable under the Patents Act shall also not be an invention
within the meaning of the Patents Act51. Inventions not patentable under the Patents Act are
defined in Section 3, which is a broad ground which, along with Section 64(1), may be used
to revoke a patent on the ground that it is not in conformity with the provisions of the Patents
Act. The scheme of the Act also reinforces the view that the exceptions have to read first
before determining whether the invention defined in Section 2 (1) (j) is made.52
In the case at hand, the patent violates Clause (p) of Section 3, which reads as:
Section 3: The following are not inventions within the meaning of the Act(p) an invention which, in effect, is traditional knowledge or which is an aggregation or
duplication of known properties of traditionally known component or components.
Traditional knowledge (TK) is defined as knowledge, know-how, skills and practices that are
developed, sustained and passed on from generation to generation within a community, often
forming part of its cultural or spiritual identity 53
Arogyapaacha (Trichopus Zeylanicus), the herbal medicinal plant used to develop the drug
that was patented as Cuzalin, is found only in the Kannimalai tropical rainforest and used by
49

Section 64 (1) (k), Indian Patents Act, 1970.


Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries, AIR 1982 SC 1444.
51
The Law of Patents With a Special Focus on Pharmaceuticals in India, p. 553 (1st ed., 2007).
52
The Law of Patents With a Special Focus on Pharmaceuticals in India, p. 35 (1st ed., 2007).
53
http://www.wipo.int/tk/en/tk/
50

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Kani Tribes in their traditional medicines. The patented drug was also developed by ICEAthreya Pharmaceuticals Pvt. Ltd. after the knowledge regarding Arogyapaacha was divulged
by Kani Tribal members to the scientist of the Company54. The plant and the knowledge
surrounding it have been passed on from generation to generation within the community.
Without the knowledge of the existence of the plant, its medicinal properties and its usages,
the Company would not have been able to come up with the medicine. Since the local tribal
communities were the only people in the world who knew about the plant and have been
using it for medicinal purposes for generations, the Company making the patented drug
clearly infringes upon the traditional knowledge of the community. Since the patent is based
on traditional knowledge, the patented drug is not even an invention as an invention is
defined under Section 3.
Therefore, on violation of Section 64 (1) (k) read with Section 3 (p), not only does the
patentable drug come under non-patentable subject matter by virtue of Clause (k) of Section
64 (1), but it also disqualified as an invention vide Section 3 (p). These reasons clearly justify
the revocation of the patent.
D. That The Invention Is Based On Traditional Knowledge
Section 64 (1) has specified the grounds under which a patent can be revoked. Violation of
any ground under this Section can qualify for revocation of any patent based on them. Clause
(q) of Section 64 (1) reads as:
Section 64 (1): Subject to the provisions contained in this Act, a patent, whether granted
before or after the commencement of this Act, may, 149 [be revoked on a petition of any person
interested or of the Central Government by the Appellate Board or on a counter-claim in a
suit for infringement of the patent by the High Court] on any of the following grounds that is
to say(q) that the invention so far as claimed in any claim of the complete specification was
anticipated having regard to the knowledge, oral or otherwise, available within any local or
indigenous community in India or elsewhere.]
Any invention that is based on traditional knowledge cannot be even called an invention.
Traditional knowledge is knowledge that is passed on from generation to generation within
an indigenous community. An invention based on traditional knowledge lacks the required
54

Moot Problem, Para 2 & 4.

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ingredient of novelty by virtue of it already being in existence for generations. A device


developed as a result of traditional knowledge and aggregation/duplication of known
products cannot be said to be an invention55.

The patented drug has been based on Arogyapaacha, a medicinal herb that is only found in
the rainforests of Kannimalai. Only the local Kani Tribes have the knowledge of the
medicinal and therapeutic properties of the drug. The fact that the Company obtaining
information for producing the drug from the Kani tribes and their knowledge of the herb,
clearly shows that the patented drug is based on traditional knowledge that is available within
an indigenous community. Therefore, the patent qualifies for revocation on the ground as
mentioned under Section 64 (1) (q).

55

Dhanpat Seth and Ors. v. Nil Kamal Plastic Crates Ltd., AIR 2008 HP 23.

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PRAYER

Wherefore, in the light of facts stated, issues raised, arguments advanced and authorities
cited; it is most humbly and respectfully prayed before The Honble Court:
1. To uphold the order of the IPAB granting Compulsory License.
2. To dismiss the PIL with exemplary costs.
3. To uphold the order of the NBA with regards to equitable benefit sharing.
4. To uphold the order of the IPAB revoking the patent for the drug Cuzalin.
And pass any other order or grant any other relief in favour of the Respondents, which this
Honble Court may deem fit to meet the ends of justice, equity and good conscience.

For This Act of Kindness, the Respondents Shall Duty Bound Forever Pray.

Date: ___ of March, 2016


Place:
Sd/Counsel(s) for the Respondents

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