Compulsory Licensing of Pharmaceuticals under TRIPS: What ...
Compulsory Licensing Under Indian Law- Agitha
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Transcript of Compulsory Licensing Under Indian Law- Agitha
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Indian copyright lawprovisions
n Section 31 (1) (a) General provision validity to be tested with the three-step test
n Section 31 (1) (b) based on Berne 11bis (2)
n Section 31 A
n Section 32 Based on Berne Appendix Article
IIn Section 32 A - Based on Berne Appendix
Article IIIn Section 32 B - Based on Berne Appendix
Article IV
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International mandate
nArticle 9 (2) of the Berne Convention (B.C.)
nArticle 11bis (2) of the (B.C.)nArticle 13 of the TRIPS Agreement
n TRIPS also incorporate articles 1-21 of the
B.C and the appendix thereto. (includingthe Berne acquis and not simply theindividual provisions as stated by the WTO
panel in WT/DS 160)
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Article 9 (2) of the BerneConvention
n Laid down the three-step at Stockholm
Conference 1967n Before that national legislators enjoyed
discretionary power to lay downlimitations
n 9 (2) brought in restrictions on thisdiscretionary power by introducing threestep test
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Three-step test B.C.- Art. 9 (2)
n A limitation/compulsory license with respect to the
exclusive right of reproduction is valid only if it is
limited ton Certain special cases
n Provided that such reproduction does not conflict witthe normal exploitation of the work of the author and
n does not unreasonably prejudice the legitimateinterests of the author
n A flexible interpretation of this provision can make
the C.L. under this provision more useful
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Interpretation of Three-StepTest
n Certain special cases
n policy objectives of national legislator has to be taken
into account WTO panel decision is not acceptablen No conflict with normal exploitation
n Not all exploitation, but normal exploitation there is aconflict only when there is a substantial market
impairment . Markets that are neither developed, norlicensed to develop, will then fall beyond the scope of this
n Do not unreasonably prejudice with the legitimateexploitation
n Kingpin balancing public and individual interests
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Compulsory license - permissibilityunder three-step test
n India opposed introduction of three-step test -demanded compulsory general license similar to
Article 11bis (2) B.C for the educational and culturaldevelopment of newly independent colonies like Indi
n Compulsory general licensing granting of C.L ofalready published works on two simple conditions: 1)
refusal to grant license by author/owner, 2) paymentof compensation fixed by competent authorityn India feared that three-step test may restrict
compulsory licensing scope
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Compulsory license - permissibilityunder three-step test
n Indias demand was rejected, but open-ended three-step test was accepted as a compromise formula
n No explicit reference to compulsory licensen But it was accepted among the members that
compulsory licensing is permissible under the thirdstep
n preparatory documents and the commentatorsconcurred that the harm may be renderedreasonable if the author is compensated including bymeans of compulsory license
n Thus compulsory license formed part of Berne acquisof three-step provision
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Vienna Convention on the Lawof Teaties
n As per Article 31 (1) of the Vienna Convention on theLaw of Treaties (VCLT), a treaty has to be interpreted in
accordance with the ordinary meaning to be given to thterms of the treaty in their context ....n Article 31.2 of the VCLT explains that context for the
purpose of the interpretation of a treaty shall comprise,.....(a) any agreement relating to the treaty which was madbetween all the parties in connection with the conclusioof the treaty
n Records of the Main Committee I reports of Stockholm
Revision Conference reveals the presence of such an
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TRIPS Article 13 andcompulsory license
n While incorporating Article 1-21 B.C and
Appendix the Berne Acquis and not just theindividual provisions was incorporated(WTO panel decision)
n Thus compulsory licensing available underarticle 9 (2) got recognized under article 13of the TRIPS also
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Berne Appendix
n Special provision for developing countries
n Available with respect to translation and reproduction
rightsn Irrational and troublesome procedures
n Total failure in reality
n Now developing countries need to go beyond BerneAppendix
n it is paradoxical that now compulsory licensingpermissible under the third criterion of the three-step
test is more attractive than the special provision for
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Berne Appendix and Three-step test
n Appendix
n Applicable to right of
reproduction andtranslation
n Troublesome procedure
n Conditions like withholding
etc. are not applicable-simple condition- paymentof compensation
n Three-step
n Under TRIPS
coverage is extendedn No troublesome
procedures
n Has to satisfy first
two tests
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Section 31 (1)(a)
n General provision
n Does not fall within the scope of the Berne appendix(validity has to be tested against the three-step test)
n But its application is limited to Indian works
n The only ground for issuing compulsory license
under it is withholding the work from the publicn It is paradoxical in view of the Indian position in
international negotiations demanding a provisionassuring availability of foreign works at affordable
rate for developing countries
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Section 31 (1)(a)
n Needs to be extended to foreign worksand to cases of non-availability at
affordable/reasonable pricen Such expansion does not violate three-
step test
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Article 13 TRIPS and 31 (1)(a)
n Present situation of withholding from public
n Is a special case as when the work is sowithheld no justification for copyright
protection
n No exploitation at all no conflict with second
criterion
n There is payment of remuneration fixed by
Copyright Board no violation of third criterion
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Article 13 TRIPS and 31 (1)(a)
n If extended to foreign works
n Same logic applies as copyright protection is not territorial
in naturen If extended to cases of non-availability of works at
affordable/reasonable price
n Still falls within certain special case as non-availability at
affordable price means no access
n No conflict with normal exploitation as the consumersavailable under compulsory lisensing may not be available
otherwise
n Payment of compensation no conflict with third step
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Sections 32, 32 A, 32 B
n Based on Berne Appendix
n applicable only to right of reproduction and
right of translation
n Irrational and troublesome proceduralrequirements
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Sections 32, 32A and 32 B
n Conditions
n Waiting periodn Grace period out dated works
n Strict stipulations with respect to recording
refusal by the copyright ownern Risk of termination of license on the
authors/owners entering into market
himself.
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Sections 32, 32 A, 32 B
n these provisions are not being utilizedby any one and not expected to be
utilized also in view of the stringent/irrational conditions attached to them
n To be made useful need to be amended
n This requires amendment of BerneAppendix
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Criticism of 1983 Amendment
n Knowing fully well the scope of compulsorylicense under article 9 (2), Berne, and the
irrationality and non-utility of Berne Appendix,India opted for taking benefit from Berne
Appendix rather than amending 31 (1) (a) tosuit its demand raised in international
negotiations from 1960 onwardsn i.e. To make available works of developing
countries at affordable price
n India failed to practice what it preached in the
international fora.
A ti l 11bi (2) d ti l 13
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Article 11bis (2) and article 13TRIPS
n As rightly said by the WTO panel, and acceptedby Ricketson there is a conflict between the two
n The second step requirement goes against thepurpose of Article 11 bis (2)
n Unlike article 9 (2), article 11bis (2) confers morediscretion on national legislation to impose
conditions on broadcasting rights (only conditionsare protection of moral rights of the author and
payment of equitable remuneration)
S ti 31 (1) (b) d ti l
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Section 31 (1) (b) and article13 TRIPS
n Therefore Article 11bis (2) is not subjected to Article 13TRIPS
n If Article 11bis (2) is made subject to article 13 TRIPS,11bis (2) can never serve its purpose
n It is as good as TRIPS excluding Article 11bis (2)
n The mere inclusion of 11bis (2) while incorporatingarticle 1-21 B.C, leads to the conclusion that 13 doesnot cover 11bis (2)
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Section 31 (1) (b)
n Is withholding from the public a condition, orin other words, can a C.L. be issued when
the work is available to the public?n Whether such C.L. could be issued to more
than one person in view of section 31 (2)
which states that when there are morecomplainants license has to be granted tothe one who best serves the interests of the
public?
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Section 31 (1) (b)
n Based on 11bis (2) of the Berne convention
n Applicable to broadcasting right
n Conditions prior publication, refusal to allowcommunication to the public by broadcast on terms the
complainant considers reasonable, payment ofremuneration as fixed by Copyright Board
n
Reason behind such a provision regulating industrialpractices by restricting the monopolistic power of collective
societies to control industry (though ultimate aim is benefitof general public)
n
Multiple licenses to promote competition is intended
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Section 31 (1) (b)
n Different from 31 (1) (a) as withholding ornot is not the concern of the provision
n Promoting competition and avoidance ofmonopolization is the real concern
n Indian courts failed to recognize its real
purpose of restricting monopoly and theneed to regulate industrial practices
Recent Supreme Court
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Recent Supreme Courtdecision
n The court failed to take note of the absence of arequirement of withholding from the public in Section 31
(1) (b) and held that if voluntary licenses are given to some
broadcasters, doors will be closed for others to approachCopyright Board
n However, taking into account the ground realities (the
number of broadcasters in India), it held that fixing
unreasonable terms amounted to refusal of permissionn it also held that Section 31 (1) (b) does not create an
entitlement in favour of an individual broadcaster. But it leftsection 31 (2) uninterpreted and thus failed pay attention to
the earlier Bombay High Court Judgment.
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Conclusion
n India needs to take maximum use of the compulsorylicensing provision allowable under three-step test rather
than relying more on the Berne Appendix
n Thus section 31 (1) (a) needs to be amended bringingforeign works and situations of non-availability of works ataffordable price within its scope
n Section 31 (1) (b) also should be extended to foreign works
as the only stipulation under Berne is that the conditionsapply only in the countries where they have beenprescribed
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Conclusion
n Negotiations for amending Berne Appendix tobe strengthened
n The need of the day is not to scrapcompulsory licensing provision but to
strengthen it
n Thus violation of copyright could be
prevented to a greater extent