Implementing the TRIPS Agreement: Policy Options Open to India

Author(s): Jayashree Watal

Source: Economic and Political Weekly , Sep. 27 - Oct. 3, 1997, Vol. 32, No. 39 (Sep. 27 -
Oct. 3, 1997), pp. 2461-2468
Published by: Economic and Political Weekly

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 SPECIAL ARTICLES

Implementing the TRIPS Agreement

Policy Options Open to India
Jayashree Watal

This paper sets out India 's obligations under the TRIPS Agreenment and shows that the options before the country
are tIot as stark as they seem. It is possible for India to coniply with the provisions of the TRIPS Agreement while
retaininig a balance between puiblic initerest and the private interest of the hlolders of intellectual property rights.
The immediate task before the govertnment of India is to mcake the acceptance of product patent applications
in pharmaceuticals atid agricultural chemicals legal and transparent and then begin the more comprehensive
legislative exercises. Given the time constraint int complying with a majority of the TRIPS provisions within two
years or so, it would seem prudent nIot to lose an)' more time and to beginz the process of weighing all the available
options immediately.

THE Agreement on Trade Related aspects with the provisions of the TRIPS Agreement To comply with certain TRIPS provisions
of Intellectual Property Rights (TRIPS) of the while retaining a balance between public on trademarks, geographical indications and
Worldc Trade Organisation (WTO) is an interest and the private interest of holders of protection of undisclosed information,'0 the
integral part of the WTO Agreement which intellectual property rights.' As long as this existing laws will need marginal amendments.
was concluded amongst 1 17 countries, includ- is so, leaving the WTO may be too high a For instance, although Indian jurisprudence
ing India, in April 1994 at Marrakesh. The price for the country to pay. protects a distinctive sign or combination of
WTO Agreement was the culmination of the The philosophy underlying India's already signs as a trademark, including service marks,
longest and most comprehensive 'round' of extensiveexistinglegislation and jurisprudence the Trade and Merchandise Marks Act, 1958
multilateral trade negotiations held under the on intellectual property matters in India, needs amendment to allow their registration.
aegis of GATT, known popularlv as the covering copyright, trademarks, patents and Similarly trade secrets are protected through
Uruguay Round. Unlike other rounds, forthe industrial design, is that the protection of contract law and common law but third party
first time in the history of trade negotiations, intellectual property rights is desirable for theinvolvement may need statutory backing."
the results of the Uruguay Round were to be encouragement of beneficial creative and The case of Article 39.3 of TRIPS on
accepted or rejected as a single undertaking innovative activity within the country.2 India protection of test data needs close study as
or as a package deal without any a la carte is also a member of several international it could lead to marketing monopolies in new
picking and choosing of agreements or pro- conventions on intellectual property rights, pharmaceutical and agricultural chemicals by
visions. Also forthe first time all the agreementsnotably the Berne Convention for the originator companies. Protection needs to be
ensuing from the Uruguiay Round were equallyprotection of Literary and Artistic WIrks. limited in time to five years, at best, even
applicable to developing countries. Any special 1971. However, TRIPS extends intellectual though no time limit is specified in the text.
concessions given to these countries were property protection to certain new areas not In the case of geographical indications, the
mainly in terms of longertransitional periods, covered by current international law and lays additional protection forwine and spirits would
i e, delays in the date of implementation of down, for the first time, fairly detailed norms need legislative changes either to the Trade
certain provisions. This is generally the case and standards for the protection and and Merchandise Marks Act, 1958orthrough
in the TRIPS Agreement where the provisions enforcement of intellectual property law in a separate legislation. TRIPS gives an
of the agreement apply equally to all countries general. The focus of this paper is on the opportunity to aggressively protect Indian
with longerdelays allowed forleast developed principal areas of legislativechange, including geographical indications such as 'Darjeeling
countries than for developing countries. provisions that enable the maintenance of the tea' and 'Basmatirice' abroadandtheIndian
The TRIPS Agreement has raised a furore required balance.3 case would beb stronger if these were first
in India and some vociferous opponents of effectively protected at home.'2
the TRIPS Agreement have gone -s far as OVERVIEW OF TRIPS AGREEMENT The changes required to be made to Indian
suggesting that India gi ve up its mevibership law as described above have not been
of the WTO. While this is an option which The TRIPS Agreement lays down norms particularly controversial in India. This is w
exists in theory, given the growing importanceand standards for seven types of intellectual amendments have already been substantially
of international trade to India, the 'act that property, viz, copyright and related rights,4 carried out in the areaof copyright and related
theWTO is and will remain the most important trademarks,5 geographical indications,6 rights in 1994 itself to the Copyright Act,
institution to make and enforce rules of industrial design, patents,7 undisclosed 1957, bringing it in line with TRIPS.'3 It is
international trade and the difficulties faced information' and layout designs of integrated a matter of speculation whether, were it not
by important non-members like China and circuits. The manner of legal compliance is for the controversy on amendments relating
Russia in gaining entr y into the WTO, India left to each individual WTO member.9 India, to the patent law, the remaining changes
could not consider leaving the WTO without through her laws and jurisprudence, is already required for the other intellectual property
adequate and serious cause. On the other substantially in.compliance with the TRIPS rights would have gone through parliament
hand, if India is to remain in the WTO, standards on copyright and related rights, or not.
compliance with the TRIPS Agreement has trademarks, geographical indications, It is in the area of patents that the greatest
to be real, credible and defensible before anyindustrial design, undisclosed information and exist between the current patent
deviations
future dispute settlement panel of the WTO.even with some of the provisions on patents. law, viz, Patents Act, 1970, andthe provisions
This paper sets out India's obligations underCompletely new legislation is required only of the TRIPS Agreement. Even in this field
the TRIPS Agreement and shows that the in the area of layout designs for integrated there are already areas of compliance. The
options before the country are not as starkcircuits where this is the case for many, rest of the paper is devoted to the subject of
including OECD countries.
as they seem. It is possible for India to comply patents.

Economic and Political Weekly September 27, 1997 2461

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 AREAS OF COMPLIANCE becomes necessary to use it. It may be recalled regard it may be advisable to follow the
that the government of India exercised its existing international convention on the
There is no basic change required in the powers recently when it revoked the subject, UPOV, although this is not strictly
criteria for) patentability laid down in the 'Agracetus' patent on genetically engineered necessary.' The other point to be noted in
Indian law. Under the TRIPS Agreemenit to cotton. this context is that Article 27.3(b) is to be
qualify forpatent protection, inventions should There are also many aspects of Article 31 reviewed by the WTO TRIPS Council by
be new, involve an inventive step or be non- of TRIPS on the use without the authorisation 1999. Therefore it may be preferable to
obvious to a person skilled in the art and be ofthe right holderwhich allow forconsiderable legislate on this subject before this review,
useful or capable of industrial application. flexibilityin drawingup asubstantially similar even though there is time up to January 1,
The criteria of 'new and useful' is laid down regime of compulsory licensing and 2000, in order to take advantage of the freedom
in Section 2 (j) of the Patents Act, 1970 in now available and credibly defend our position
government use as currently given in Chapters
defining invention and the criteria of non- XVI and XVII of the Patents Act 1970. This in the TRIPS Council.
obviousness or inventive step is laid down in will be dealt with in some detail below. The termi of protectiona of patents in all
Section 25(e) which deals with grounds for fields of technology must be 20 years from
CHANGES REQUIRED
opposition to the grant of patents. It is up to the date of filing32 (Article 33 of TRIPS), thus
each country to interpret these criteria and The most fundamental change required to closing the option of different terms of patent
no specific guidelines have been laid down be made to Indian patent law is onpatenitable protection for food and drug or medicine as
in TRIPS.'4 There is clearly atrade-off betweensuibject matter. Article 27 of TRIPS makes exists in the current patent law.33 The longer
patent 'length', which has now been fixed in mandatory the availability of patents for any term would even be applicable to all existing
TRIPS, and 'breadth' in terms of the scope invention, irrespective whether this relates to patents valid as on January 1, 2000.34
of patent protection.'-5 Narrow patent claims a process or a product, in all fields of There are two major differences between
engender competition through follow-on technology, with only some limited exceptions. the riglits of patentees defined in Section 48
inventions that 'invent around' the patent. In complying with TRIPS many of the of the Patents Act, 1970 and those that have
The Japanese system encouraged the narrow exclusions to patenting now permitted under to be followed under Article 28 of TRIPS.
interpretation of patent claims for this very the 1970 law will have to go. India allows The Indian law gives product patentees the
reason. The option of following this system only process patents in inventions relating to right to prevent third parties from making,
of patent practice and procedure requires food, pharmaceuticals, agricultural chemicals using, selling or distributing the product and
immediate study. and chemicals.2" No patents. either for gave the process patentees the exclusive right
The conzditionis imposed onz patent products or processes, are allowed in the field only of using or exercising the patented
applicanits aredefined inArticle 29ofTRIPS. of atomic energy.2' The filing for product process. Under TRIPS the product patentee
India complies with Article 29.1 through patents must be allowed in these areas pursuant can also prevent third parties from offering
Section 10 of the Patents Act 1970. Section to TRIPS - for pharmaceuticals and for sale or importing the patented product35
10 (4) (b) requires the patentee to disclose agricultural chemicals this must be allowed and secondly. all the rights of product patent
the 'best method of performing the invention' from January 1 1995,22 and for food, holders are extended to process patentees for
which is permissible under Article 29.1 of chemicals, atomic energy (other than those the product obtained directly fromthe patented
TRIPS. Strict disclosure requirements are the inventions excluded on grounds of national process. It can be argued that the right of
very foundation of the patent system and security)23 and for micro-organisms from importationisimplicitintherightsenumerated
ensure that society receives precise knowledgeJanuary 1, 200S. However, it is important in Section 48 as it would be difficult to
about the invention in exchange for the grant to note that process patents, including for imagine what an importer would do with
of patent rights. India can also retain Sectionmicro-biological processes, with extension of patented products if he could not sell or
of its law under which the Patent office canrights over the products directly obtaineddistribute them.36
demand information concerning the from these processes, with a patent term of The more significant change is in the rights
applicant's corresponding foreign applications 20 years and with reversal of burden of proof of process patentees. The extension of rights
and grants. in case of infringement, must be available over the product, even where the product is
There is also no substantive change required from January 1, 2000 for all fields of not in itself patentable, in conjunction with
to the provisions on revocation of patents technology. the reversal of the burden of proof, given in
given in Sections 64, 65 and even 66 as the Someexisting excliusionisfrot?npatenitability Article 34 of TRIPS, would considerably
only requirement under TRIPS Article 32 is on grounds of morality, public health,25 strengthen the rights of the process patentee.
that an opportunity for judicial review be methods of treatment of humans and animals26 Article 34 of TRIPS states that judicial
available. There are no restrictions on the and biotechnological inventions covering authorities shall have the authority to order
grounds for revocation of patents. 'F Therefore, plants and animals and biological processes the defendant to prove that the process he
it can be argued that as revocation on grounds used to obtain an identical product is different
for thei r producti on27 can remai n on the statute
of public interest is not expressly prohibited even when inventions meet the patentability from the patented process. This is a reversal
underTRIPS or under the Paris Convention ,'I criteria. Other exclusions that would not be of the burdeni of proof as it is normally up
India can thus retain the grounds of revocation compatible with the application of the criteria to the petitioner to adduce evidence about the
in public interest (Section 66).x India will, of patentability,2' orthe definitionofinvention, infringement of his patent right. WTO
however, have to follow Article SA of the would have to be amended i n order to complymembers have a choice of two circumstances
Paris Convention in cases of revocation on with TRIPS . Since the term ' invention' is not under which any identical product produced
grounds of failure to work or other abuse of defined under TRIPS there is considerable without the authorisation of the patent owner
patent rights. In such a case the initial remedy flexibility availablein theframingofanationalshall, in the absence of proof to the contrary,
is grant of compulsory licence three years legislation. This is particularly relevant in the be deemed to have infringed the patented
from the date of grant of the patent and onlyarea of biotechnological inventions in order process: (a) if the product obtained by the
if this does not work can proceedings for the to exclude 'discoveries'.'9 patented process is new;37 or (b) if there is
revocation of a patent be instituted two years While plants can be excluded from a substantial likelihood that the identical
from the grant of the first compulsory licence. patenting, TRIPS Article 27.3(b) requires product was made by the patented process
Thus Section 64(4) will have to be deleted WTO members to provide an 'effective sui and the patent owner has been unable through
in its present form. However, Section 89 is genleris'3{ system for the pr)otectionI of nlew reasonable efforts to determine the process
comDpatible with Article 5A of the Paris f)lant varieties. Since the word 'effective' has actually used.
Convention.'9 Therefore, India still retains not been defined, considerable freedom In the second case itis clear that the petitioner
the most powerful remedy of revocation in remains in the framing of appropriate still has to adduce evidence that there is a
public interest in the extreme case where it legislation on plant breeders' rights. In this 'substantial likelihood"~that his patented

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process was used and that he made 'reasonable iaw gives unfettered rights to patent owners be sufficient to maintain competition in the
efforts' to actually fioid out the actual process without also incorporating remedies for the market and keep prices reasonable as well as
used. It is the nationaljudicial authorities who abuse of patent rights or for use of patents ensure the local working of the patent.
would have to determine these terms and it in public interest or for other similar reasons. Compatibility with the 11 clauses of Article
isonl, au7terconsidering the likelihood aspects Such use might be dealt with by some countries31 of this and other broad grounds is set out
cliat there is a reversal of the burden of proof under their competition laws and by others in some detail below in order to clarify that
that the defendant prove he has not used the under their patent laws or, as is the most the list is not unnecessarily restrictive. The
infringing process and the final judgment common case, under both. Patent rights are first clause, Article 3 1 (a) is that 'authorisation
would be passed on the infringement case also limited by governments who wish to use of such use shall be considered on individual
afterhearing both sides. However, the second patents for their own purposes. merits'. The merits in such a case would be
case applies even when the product is not The final text of Article 31 ofTRIPS which to decide before actual use whether the
new. deals withthis subject laysdown 11o restrictionts applicant is qualified52 and whether the terms
On the other hand, members who opt for onz the grounds43 on which members could of royalty finally settled are reasonable.
the first option would be rigidly required to permit the use of patents by third parties or Similarly, the individual merits ofacompulsory
deem infringement in all cases where the governments without the authorisation of the licence based on any ground, say, public
product is new to the market and where the patent owner. Al so, the conzditionts are really interest, would bedefined by the ground itself.
alleged infringer is unable or unwilling to on thle actuial uise of the patent and not on The secotnd clause, Article 31 (b), that the
disclose the actual process used. Paragraph thegrantofcompulsory licences." However, proposed user should have made efforts to
in the first paragraph of Article 27.1 it is
3 of Article 34 does allay some fears as, under obtain the authorisation from the right holder
both options, the legitimate interests of the clearly stated that patents shall be made on reasonable commercial terms and
defendants in protecting their manufacturing available and patent rights shall be enjoyed conditions over a reasonable period of time,
orbusiness secrets shall be taken into account irrespective of the place of invention, field would also be met in this case. This condition
in the adducing proof to the contrary. The of technology or whether the products are is similar to that laid down in Section 88(1)
Patents Act, 1970 has no such provision and imported or locally produced. The last two to (4) of the Patents Act 1970 even under
in this case the preferred option would, sub-clauses were intended to ensure that the automatic licences of right system. This
perhaps, be to follow the second case.: compulsory licences could not be granted for is only a normal commercial practice to
The rights of patent owners are not absoluteparticular sectors. such as pharmaceuticals, approach the patent owner or his licensee and
as there are limited exceptions allowed in or on the sole ground of local manufacture.45 make efforts to obtain a voluntary licence.
almost all patent laws for private non- Thus, licences of right for pharmaceuticals The requirement to meet this clause is diluted
commercial use.39 These exceptions include or food or compulsory licences forthe working when there is a national emergency and when
the use of the patented invenltion for the of the patent on grounds that the right holderthe government or a third party on behalf of
following purposes: was meeting the domestic demand solely or the government wants to use the patent for
* Research, experimental or teaching predominantly by importing the patented public non-commercial use. More importantly
purposes, invention are no longer permissible. Article 31 (k), the eleventh claiuse, exempts
* For private non-commercial purposes, Many believe that Article 27 with the WTO members from this condition in cases
* Preparation of medicinal mixtures numerous conditions attached to Article 31 where a compulsory licence is granted, after
individually according to a prescription, ensured that compulsory licences can rarely judicial or administrative process, to remedy
* Development activities relating to the be used in a post-TRIPS regime.46 However, an anti-competitive practice. In such cases the
obtainingof marketing approvals forgeneric it can be argued that the fact that there are condition limitingexports is also removed and
drugs, or no grounds to limit the grant of compulsory the remuneration can be limited by the need
* Protection of prior users' rights.4" licences make the conditions fairly loose and to correct the practice. India can use this
These wel l-recognised exceptions have been this article can be used to bring about a provision to set up an independent administ-
incorporated in Article 30 of TRIPS under balance between the rights of patentees and rative body to effectively determine and control
broad wording which allows for limited the interests of the public.47 Only the anti-competitive practices by patentees ortheir
exceptions so long as these do not imagination and creativity of legal expertslicensees,
in without of course. discriminating
'unreasonably conflict with the normal developing countries limit the proper use between of fields of technology, place of
exploitation of the patent and do not this article to bring in this balance." invention or local and imported products.
unreasonably prejudice the legitimate interests What would be the single most effective The third clause, Article 31 (c) is that the
of the patent owner, taking into account the for compulsory licensing which is
ground scope and duration of such luse shall be limited
both compatible with TRIPS and ensures thatto the purpose for which it was authorised'.
legitimate interests of third parties'. It would
be necessary to follow the existing laws of patented products are available at reasonable This is not as draconian as it appears if it is
developed countries and incorporate such prices? China, in its latest 1992 patent law borne in mind that in certain cases where the
exceptions in Chapter XVIII dealing with has one ground49 for compulsory licences, ground for such authorisation is broad, such
infringement. Some TRIPS commentators viz, where any entity that is qualified to exploit as non-grant of voluntary licences on
claimthatthisexception can be used to shortenthe patent fails to obtain the patentee's reasonable terms orpublic interest, the scope
the term of pharmaceutical product patents authorisation under 'reasonable terms" within will cover the complete use of the patent and
or other drastic remedies.4' However, it is a "reasonable period of time". The applicant the duration may well be for the entire length
very doubtful if this would be compatible with for a compulsory licence must furnish proof of the patent term. The same argument holds
TRIPS. Others include parallel importation of inability to conclude a voluntary licence for the seventh clauise (g) that such authori-
and compulsory licensing under this article on such terms. Such licences are to be sought sation is liable to be terminated if the circum-
to be doubly sure that these are exceptions only after 3 years from the date of grant ofstances that led to it cease to exist and if they
to patent rights.42 However, this seems the patent and are decided on individual are unlikely to recur.53 Even if a request is
unnecessary as Articles 6, 28 and 31 of merits.51 This would be very similar to the made for such termination, it is perfectly
TRIPS appear to be clear and adequate for automatic licence of right system incorporatedTRIPS-compatible to adequately protect the
these purposes. in Section 87 and 88 of the Patents Act 1970,legitimateinterestsofthecompulsory licensees,
Oneofthe most interestingquestions raised as every qualified applicant is automatically who may have made a considerable invcstment
in theTRIPS negotiations was the state setting entitled to use the patent. The only difference
or preparation for using the invention by this
limits to the absolute rights of the patent is that it would not be limited to any fieldtime.
owner through compulsory licences or other of technology and there can not be restricti onsThefoulrth clau(se, Article 3 1(d) is that such
use of patenlts withoult the authorisationl ofon royalty,?i a point dealt with later. This one
use shall be non-exclusive. This means that
the right holder. Generally speaking, no patent TRIPS-compatible ground would appear to the government cannot grant compulsory

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licences to the exclusion of even the patent patent law. It is interesting that it is only the the Drug Price Control Order, are currently
owner. Section 93(3) of the Patents Act 1970 legal validitv of any decision relating to the compatible with the TRIPS Agreement and
allows forthe possibility of granting exclusive authorisation that is subject to such review would be yet another remedy available to
compulsory licences, depriving the patentee and not the grounds for such authorisation. government to keep the prices of patented
of all his rights and revoking all licences issued That too such a review need not be by a articles reasonable.
by him. This was meant to protect the judicial authority but by an independent In order to encourage domestic innovation
compulsory licensee from the patentee placing distinct highler author-ity. This power could several developing and developed countries
obstacles in his business. But it would be clear well be vested with an independent have a system of utility models or 'petty
to anyone that exclusive licences would not administrative authority, thus ensuring patents'.
speedy
Such patents are generally available
be able to prevent this and the objective of administration of justice and fair play. for small, innovative improvements although
correcting the abusive use of patent monopoly There is a separate provision on dependent the duration of protection is typically shorter.
can be achieved through non-exclusive patents56 given in Article 31(1), the last clause. The TRIPS Agreement leaves members free
licences.54 Section 96 of the Patents Act 1970 deals and to introduce such legislation as there are no
That the compulsory licence is non- lays down that in order to be eligible for the specific rules on this subject. India should
assignableexcept with thatpartoftheenterprise grant of such compulsory licences, the second consider this option seriously as this is
or goodwill that enjoys such use is thefifth invention had to make 'a substantial considered to be the first step towards the
clause, (e). This is a standard commercial contribution to the establishment or effective use of the patent system fordomestic
licensing condition as it is only fair that the development of commercial or industrial innovation.
compulsory licence does not become a tradable activities in India'. The TRIPS text narrowly Thus, it is clear from the above analysis
commodity to be sold at a profit. restricts the use of such licences to cases that even in the case of patents, there are
The sixthz clause, (f), that such use shall wherethe second patent involved 'an important already areas of compliance and there is
be predominantly for the supply of the technical advance of considerable economic considerable scope for retaining a balance
domestic market would appear to have a significance'. However, this can be interpreted between public interest and pri vate intellectual
limited impact. With the coming into force as beingofconsiderableeconomic significance property rights i n any future regime of patents,
of the TRIPS Agreement, patent owners of to India. Overall, considering that the objective while complying tully with the TRIPS
significant products would have covered of the patent law is encouragement of Agreement. There is a strong case for
almost all markets and therefore, exp*rtsinnovation by and not industrial development empowering an indlependent administrative
acompulsory licjnsee would be allowed only ner se, for which there are other instruments, authority with appellate powers on matters
where parallel importation is allowed. It is the TRIPS text should not be unacceptable. relating to use withiout the authorisation of
difficult to believe that the encouragementThe of clause that any compulsory licences for the right holder.
such limited exports would be the sole purpose dependent patents would necessarily entail
TIMING OF IMPLEMENTATION
of any government in granting compulsory cross li censing, where the second patent would
licences.5 In any case this condition does not have to allow the first patent owner a licence The provisions of the TRIPS Agreement
apply if the compulsory licence was granted too, is already incorporated in Section 96(2)(i) are to be implemented in phases by developed,
to remedy an adjudicated anti-competitive of the Patents Act 1970. developing, least dcveloped countries and
practice. It should be noted that there would be a economies in transition. Further, there is some
Even before TRIPS, there was no patent considerable gain over the current situation differential phasing in for provisions relating
law in the world where compulsory licences for patentees even if India were to use to certain fields of technology which were
were granted without reasonable remuneration compulsory licensing, as they would obtain earlier exempt from product patents.
to the right holder, although in many cases, reasonable royalties,tfrom domestic users for Developed country members got a general
therewereceilinglimitson theroyaltypayable. the use of their inv6ntions. Domestic users, period of one-year, i e, up to January 1, 1996
The eighth claiuse (h) speaks of 'adequate on the other hand, would still have access to to bring theirdomestic legislations in line with
remuneration taking into account the important patented products and processes, theTRIPS Agreement.57 Developingcountry
circumstances of each case and the economic even if at a price. As noted above there can members are entitled to delay implementation
value of the authorisation' . The interpretationbe a number of grounds for compulsory of the Agreement for a further period of four
of these terms has to be left to national licences or governmenit use of patents, some years, i e. up to January i, 2000.11 However,
authorities, and significantly not necessarilyof whichi are described in Correa (1994). In all members would have to implement the
to courts of law. All decisions on remuneration spiteoft;his, forthe sakeof clarity, coherence provisions on national treatment and most-
will bg subject to an independent review and legal certainty, both for the right holder favoured-nation treatment by January 1,
within the country, according to the tenth as well as the potential licensee, it is better 1 996.59
clause, (j). Each country could interpret what to make the grounds for grant of compulsory Article 65.4 of TRIPS furtherprovides that
is adequate, taking into account the licences simple and clear. thus achieving the developing countries, which do not extend
circumstances, as, for instance, in the case policy objectives, without cluttering the text product, patent protection to certain areas of
of life saving drugs. It would be necessary with innumerable, duplicative grounds. technology as on January 1, 1995 may avail
to ensure that the compulsory licensee does In addition to compulsory licences and of an additional period of five years in order
not rake in abnormal profits by charging other use without the authorisation of the rightto apply the provisions of this Agreement.
excessively high prices, while paying low holder, WTO members are also allowed This means that for those countries which do
remuneration to the right holder. For through Article 40 of TRIPS, to adopt not provide product patent protection for, for
instance, if the patented product was a legislative measures to control anti-competitiveexample, food, chemicals and pharmaceuticals
medicine that was subject to price control licensing practices engaged in by intellectual as on January 1, 1995 would be obliged to
then the economic value of the compulsory property right holders such as exclusive do so only by January 1, 2005.
licence may be quite low. As noted earlier, grantbaick conditions. Section 140 of the As we have seen, this additional period
this condition of adequate remuneration does Patents Act, 1970 already makes it illegal to relates to only applications for product patents
not apply to compulsory licences granted to insert certain restrictive clauses in patent for food, chemicals, pharmaceuticals,
remedy an adjudicated anti-competitive licences. This would be the right opportunity agricultural chemicals, micro organisms and
practice as this can be left to the competent to develop this further and integrate it into atomic energy relating to Sections 4 and 5
authorities to determine. a well structured competition law, in the light of the existing Patents Act, 1970. All other
That the decision to authorise such use of the jurisprudence in this country and amendments to the Patents Act 1970 such
should be subject to review by a higher elsewhere. as other exceptions to patentability, non-
It must be pointed out that existing
authority is the n int/i claulse, (i) and is accepted discrimination, rights of patent holders, use
universally, including in the current Indian administrative price control regimes, such as without authorisation, reversal of burden of

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proof and the term of patent will all have to there may well be cases where such approvals 32 or 40.68 In addition, the definition of 'drug
be put into place by January 1, 2000. Thus, would take a much shorter period. The or medicine' given in the current Patents Act
india has oiil) aniother two vears or so to proposal as incorporated in Article 70.8 and 1970, a broad definition whose original
amend its existing intellectual property 70.9 was to give effective protection for purpose was to maximise exclusions, was
laws, such as on patents, trademarks, and pharmaceutical and agricultural chemical adopted in the Bill. This may enable many
trade secrets or introduce new intellectual products right from the date of entry into intermediate chemical and biotechnological
property laws such as on layout-designs force of the TRIPS Agreement, viz, January product inventions to get covered.6
for integrated circuits or geographical indi- 1, 1995 itself.6" As long as there are no The US and the European Union have
cations, in compliance with her TRIPS applications for the grant of EMRs before taken India to the WTO dispute settlement
obligations. January 1, 2000, the effect of amending the mechanism for violation of Article 70.8 and
Moreover, notwithstanding the 10-year Patents Act, 1970 to incorporate product 70.9 of TRIPS. The WTO panel has ruled
transition period under Article 65.4. Article that Indiahas failed to establish a mechanism
patents for pharmaceuticals and agricultural
70.8 brings in an obligation fornew inventions chemicals with effect from January 1. 1995 in respect of obligations for product patents
made in the field of pharmaceuticals and would have been exactly identical to following relating to pharmaceuticals and agricultural
agricultural chemical products. It obliges all the five-year EMR route. This is because, chemicals. The conclusion of the Panel as
those countries that do not provide product realistically speaking, given the four conditions
given in para8. 1 ofits report isreproducedbelow:
patents as on January 1, 1995 in accordance to be fulfilled, very few cases will come up India has not complied with its obligations
with Article 27 for these sectors, to provide for grant of EMNRs before even 2005 but the under Article 70.8(a) and in the alternative,
a means for the acceptance of applications provision of a five-year EMR term ensures paragraphs I and 2 of Article 63 of the TRIPS
for product patents by January 1, 1995. Whenthat those few cases are effectively protected. Agreement. because it has failed to establish
the provisions of the TRIPS Agreement in Further, the principal right of a product a mechanism that adequately preserves novelty
respect of these sectors are made applicable patentee is the exclusive right to sell the and priority in respect of applications for
to the country, such applications must be patented product. The other patent rights of product patents in respect of pharmaceutical
examined according to the criteria laid down making or using the product would be and agricultural chemical inventions during
in the Agreement and product patent protection important in the case of intermediate products the transitional period to which it is entitled
provided from the date of grant of the patent or components but not in the case of final under Article 65 of the Agreement and to
for the remainder of the 20-year patent term, pharmaceutical or agricultural chemical publish and notify adequately information
counted from the date of filing of the products. about such mechanism; and that India has not
application. in the meantime, according to It should be noted that the TRIPS EMR complied with its obligations under ArticlI
Article 70.9, during the transition period, has no legal precedent anywhere in the world. 70.9 of the TRIPS Agreement, because it has
exclusive marketing rights (EMRs) are to be Almost all developing countries to whom failed to establish a system for the grant of
granted for a period offive years from theArticle 70.8 applied. such as Turkey. Brazil, exclusive marketing rights.
date of obtaininlg marketing a)pproval in thatArgentina and other Latin American and The only immediate obligation that India
counti' or uintil a produci patent is granitedsoutheast Asian countries, have opted instead accepted before the WTO Panel was to
or rejected, .vhichlever period is shorter, to introduce product patents by amending accept product patent applications in
provided that the following conditions are their patent laws. The EMR route causes pharmaceuticals and agricultural chemicals
fulfilled by such a-patent applicant subsequent many legal complexities necessitating the from January 1. 1995. India argued that
to January 1, 1995; interpretation of many grey areas such as the applications for product patents in
(a) A patent application has been filed in separate processing of product and process pharmaceuticals and agricultural chemicals
India; claims forthe same invention, allowing Indian could be accepted under Section 6 of the
(b) A patent granted forthe product in another inventors EMRson the basis of process patents Patents Act 1970, which allows the acceptance
WTO member country; only without violation of nationai treatment of applications for a patent for anv invention.
(c) Marketing approval obtained in such other clause, grant of EMRs forpatent applications It is only upon examination later that it is
WTO member country; and on which patents could be rejected later, determined whetherthe invention is patentable
(d) Marketing approval obtained in India. compulsory licensing, revocation, etc. There or not under Section 5. Further, afterthe lapse
are also questions of now to modify existing
Thus, there are two distinctly different routes of the Ordinance in March 1995,
available to countries that do not provide provisions of patent lawto suittheirapplication administrative instructions had been issued
product patents for pharmnaceuticals andto EMRs. Moreover, even if, for argument's patent offices to continue to receive patent
agricultural chemicals: sake, none of this was valid, EMRs are at applications and to store them separately for
* amend the law to introduLce such product least equivalent to patents and delaying processing when such products became
patents, or legislation on product patents, for another patentable under Indian law. However, no
* wait up to January 1, 2005 to amend the five years after allowing the filing of patent evidence could be produced to this effect
law and ensure the grant of EMRs based applications, would neither benefit Indian before the WTO Panel except for a reply
on patents and marketing approvals grantedindustry nor consumers.64 made in August 1996 to a Lok Sabha question
in other WTO member countries. Government of India, however, upon the that 893 patent applications had been recei-
It is well known that the industrial sectors advice of I I patent experts,65 felt it necessary ved in the field of 'drug or medicine' up to
most sensitive to patent protection are to legislate for this purpose but failed to pass July 15, 1996 and would be taken up for
pharmaceuticals and specialised chemicals.") the Patents Amendment Bill, 1995 to provide examination after January 1, 2005 as per the
However, unlike other patented products, for a 'mailbox'66 to accept product patent WTO Agreement. While the WTO Panel has
new pharmaceuticals and agricultural applications and toexamine and grant EMRs. clarified that it is up to India to decide how
chemicals have to undergo extensive In testing
trying to follow the EMR route and yet to implement its obligations, there should be
on animals and humans before being given maintain a balance between public interest legal security that the novelty and priority
marketing approvals. It has been estimated and private rights, the drafters of the proposed rights of patent applicants under Article 70.8
that in the US the average time taken by the legislation inco'rporated many measures such are preserved until the patent law is amended
US Federal Drug Administration (FDA) was as compulsory licensing, pre-examination of to grant such patents. More importantly, the
about 10 years from the date of filing the patent applications against Sections 3 and 4, Panel has ruled that Indiais obliged to establish
patent applications, thus cutting down the special route forlndian applicants. etc.67 Givena system for the grant of EMRs 'at any time
effective patent life of patentable products.6' the wording of theTRIPS text in Articles 70. 8 after the entry into force of the WTO
This period has been halved after I 99262 and and 70.9, there may be stronger grounds to1 Agreement' . The US had claimed that at least
the FDA is moving towards *further question these measures than those that can one applicant had obtained patents and
be taken for patents under Articles 30, 31,
streamlining oft!he system. 'Thus, in the future, marketing approval s el sewhere and was ready

Economic and Political Weekly September 27, 1997 2465

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to file for marketing approval in India. (1) exclude the provision of product patents In order to use the flexibility available in the
However, some steps would have had to be for food, pharmaceuticals. agricultural TRIPS Agreement it may be better to opt for
taken to comply with Article 70.8, if only to chemicals, otherchemicals, micro-organisms a comprehensive one-time amendment to the
widely publicise the current legal provisions and atomic energy for which the patent law patent law, while fully safeguarding national
in orderto accept all valid patent applications could be amended by January 1, 2005 while interest. The immediate task before'the Indian'
for product inventions in these sectors from providing forEMRs for pharmaceuticals and government is to make the acceptance of
January 1, 1995. agricultural chemicals; or product patent applications in pharmaceuticals
India has decided to appeal against this (2) be in full compliance of TRIPS for all and agricultural chemicals legal and transparent
ruling."' This appeal can only be limited to sectors in a one-time amendment to the patent
and then begin the more comprehensive
issues of law covered in the panel report and law. legislative exercises. Given thetime constraint
legal interpretations developed by the panel. In making a choice between these two in complying with a majority of the TRIPS
Indeed, there is no dispute on the facts but options it must be borne in mind that: provisions within two years or so, it would
the legal interpretation made by the Panel, * Although there are sectors such as food. seem prudent to not lose any more time and
the first to adjudicate a dispute under the chemicals, micro-organisms and atomic begin the process of weighing all the options
TRIPS Agreement, has serious ramifications energy (other than inventions relating to open to India immediately.
for the future and need to be struck down. national security) forwhich product patents
In para 7.18 the Panel states 'In our view good need to be introduced only by January 1, Notes
faith interpretation (of theTRIPS Agreement) 2005, in all these cases strong process [The views expressed in this paper are personal,
requires the protection of legitimate patents from January 1, 2000 would give based on publicly available material and do not
expectations derived from the protection of effective protection to the ensuing products. in any way implicate the government of India or
intellectual property rights provided forin the Moreover, some of the most sensitive areas any other organisation or institution with which
Agreement'. If India loses the appeal, she will for Indian industry are pharmaceuticals the author is associated.]
I See Reichman (1995) who acknowledges the
have to either comply with the WTO ruling and agricultural chemicals and product
achievements of developing country
or face any trade sanctions that the petitioning patent applications for these are already to
negotiators 'who have built numerous
parties may seek from the WTO Dispute be accepted from January 1, 1995. safeguards and escape hatches into the TRIPS
Settlement Body. * If many chemical and biotechnological in- Agreement'.
Some of the TRIPS-legal options open to ventions can claimto beclassified as pharma- 2 See Anand (1991).
India in respect of Article 70.8 and 70.9 of ceuticals and agricultural chemicals,74 the 3 This paper does not comment on the fears
expressed by commentators on the
TRIPS are: number of inventions being excluded for
implications of the TRIPS Agreement on
* Do nothing till the WTO dispute is settled a further period of five years may not be
pharmaceutical prices and consumers' welfare,
and there is a cleardirection from the WTO a significant factor so as to require prices of seeds and plant varieties, biodiversity,
after which the options can be weighed; duplicating the legislative process to amend patenting of life fonns, etc. However, the
thismaybepoliticallyconvenientbutwould the patent law again by January 1, 2005. author has done some work on the first issue.
entail only further loss of time and may * There is no practical difference between See Watal (1996) in which the major findings
possibly close some options. The panel are that pharmaceutical prices of patented
following the EMR route or the patent
products (currently 10 per cent of the total
report, which is already available with the route for pharmaceutical and agricultural
pharmaceutical market) would rise by about
government, should guide this decision; chemicals except that legally the EMR 50 per cent while welfare losses are likely
* Reintroduce the Patents Amendment Bill route is more complex, less amenable to to be in the range of $33 million per annum
as it was drafted;7' this has the advantage incorporating a balance in terms of public (i e, 3 per cent of total pharmaceutical sales).
of administrative ease but would create interests than the patents route75 and would 4 The term 'related rights' covers rights of
legal uncertainty as explained above; involve duplication in legislative effort, performers, producers of sound recordings
and broadcasting organisations.
* lntroducearevised Bill settingout 'mailbox' without any practical gain.
5 Includes service marks.
as well as EMR provisions as laid down * In examining and grantingproduct patents, 6 Includes appellations of origin.
in TRIPS, without any embellishments that the patent office has an opportunity to 7 The section on patents includes a provision
are TRIPS-inconsistent; here there is the examine the criteria of patentability for plant variety protection. However,
dangerofblindly followingpatents granted independently of any decision taken in interestingly Article 1.2 of TRIPS which
elsewhere and of not maintaining the otherjurisdictions unlike in the EMR case defines 'intellectual property' as referring to
all categories of intellectual property that are
required balancebetween public and private where the decision of the patent offices of
the subject of Sections I through 7 can be
interest; other WTO members will have to be
interpreted to exclude plant variety protection
* Introduce a revised Bill only setting out accepted till the patent application is as the subject of section 5 is patents.
India's immediate obligation of 'mailbox'; examined arid accepted or rejected.76 8 This term includes trade secrets and test data
and specifically preserving the right of * Full compliance with TRIPS by bringing 9 Article 1.1 of TRIPS: '...members shall be
priority and novelty of the patent applicants forward the date of full compliance by five free to determine the appropriate method of
implementing the provisions of this Agreemcnt
while clarifying to the WTO members that years could, perhaps, be used to extract
within their own legal system and practice'.
India is examining the options between other much desired concessions from
10 Also amendments to 'Convention Country'
EMRs and patents; this has the advantage important WTO members, and lastly clauses in existing intellectual property laws
of simplicity but would only postpone the * Full compliance with TRIPS would be a are required to comply with the TRIPS clauises
choice between EMRs and patents for only further step in liberalisation and in legal on national treatment and most-favoured-
a little while longer, necessitating legislative transparency, important for attracting nation treatment.
action again; or alternatively, take foreign investment, thus enhancing India's I I This appears to be the case even in Europe,
particularlv in Germany. See Rudolf Krasser's
administrative action and issue a public credibility in multilateral economic fora.
'The Protection of Trade Secrets in the TRIPs
notification from the patent office of the This paper has attempted to set out the Agreement' in Beier and Schricker (eds)
acceptance of the relevant product patent options open to India in implementingTRlPS, (1996), pp 216-25.
applications and the preservation of the particularly the provisions relating to patents.12 According to Article 24.9 of TRIPS there is
rights of novelty and priority.72 India has only two years or so to legislate on no obligation on the part of any WTO member
In addition to adhering to Article 70.8 and most of the provisions of TRIPS, whatever to protect geographical indications which are
not protected or cease to be protected in their
70.9 of TRIPS, it would be necessary to option is taken. India already has a long
country of origin.
simultaneously begin serious work on a legislative history and jurisprudence in the
1 3 At the time ofthe Uruguay Round negotiations,
comprehensive amendment of the Patents protection of intellectual property and even the Indian Copyright Act, 1957, as amended
Act 197073 to be put into place by January in the controversial area of patents, thereuare from time to time, offered one of the highest
I, 2000, by either choosing to already points of convergence with TRIPS. levels of protection in the world. Some of

2466 Economic and Political Weekly September 27, 1997

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 the significant amendments made in pharmaceuticals or agricultural chemicals, implications of instituting a regime of parallel
1994 included, itnter alia, the inclusion in i e, if they are intended for such final or imports under the Indian Patent Law needs
Section 14 (meaning of copyright) of rental intermediate use or are involved in the to be studied carefully as this could at best
rights ftor computer programmes. manufacturing process, filing for product have a marginal impact in enabling India to
cinematographic films and sound recordings patents can take place from January 1, 1995. reduce prices through imports from cheaper
and the addition of Chapter Vill on the Rights Since applications filed under Article 70.8 countries, while inducing worldwide patent
of Broadcasting Organisations and of are not required to be examined there is a real owners or their licensees to maintain high
Performers. possibility that very few product inventions prices in all markets.
14 SeeJoseph Strauss, 'Implications ofthe TRIPS relating to chemicals or micro-organisms 36 Indeed, Section 95(2) of the Patents Act 1970
Agreement in the Field of Patent Law' in would really have to wait until January 1. which sets out the terms and conditions of
Beier and Shricker (eds) (1996), pp 160-215. 2005. compulsory licences makes it clear that
15 Or even 'depth' or 'height'. There is vast 25Section 3(b) of Patents Act, 1970 allows the importation of the 'patented article or
theoretical work available on this subject of exclusion of 'an invention the primary or substance made by a patented process' is not
which Klemperer (1990) is but one example. intended use of which would be contrary to allowed to such licensees as it could constitute
16 This is the interpretation of Correa ( 1994) but law or moralisy or injurious to public health'. infringement of the patentee's rights.
Strauss, in Beier and Schricker (eds) ( 1996) TRIPS Article 27.2 allows the exclusion of 37 It is most likely that 'tXew' Is used here in
interprets grounds for revocation to be strictly inventions whose commercial exploitation the sense of being .ew to the market and not
limited to the Paris Article 5 A. must be prevented to protect 'ordr-e JubliC 'new' as in Article 27.1 of TRIPS.
17 Article 2.1 of TRIPS requires WTO members or morality, including to protect human, 38 Joseph Strauss in Beier and Schricker (eds)
to comply with Articles 1 through 12, and animal or plant life and health or to avoid ( 1996) advocates that countries adoptinrt this
Article 19 of the 1967 Stockholm Act of the serious prejudice to the environment, provided provision for the first time choose 'Ae first
Paris Convention for the Protection of that such exclusion is not made merely because option as it is confined strictly to n w products.
Industrial Property. India is one of the few the exploitation is prohibited by law'. There However, since there is no discretion left to
developing countries that are not yet a member are nuanced differences but the spirit behind the judge in the first option, the second case
of this Convention. the concept is similar in both cases and seems preferable.
1 8 This is the interpretation given in Bodenhausen adopting the TRIPS text 'should not create 39 As distinct from government authorised use,
(1968) in his commentary on the Paris any substantive problem. which is dealt with in Article 31 of TRIPS.
Convention and also in a recent (December 26 Section 3(i) of the Patents Act is broader than 40 The term 'prior user' denotes a third party
5, 1995) decision of the German Federal Article 27.3(a) of TRIPS in that the former who had already started to use, or had
Supreme Court cited in footnote 188 on p includes treatment of plants and includes undertaken serious preparatory acts to use,
204 of Beier and Schricker (eds) ( 1996). This treatment to increase the economic value of the invention before the application for patent
may be a controversial interpretation in that plants and animals and that of their products. was filed or was published.
it is likely to be opposed in the WTO. However, Also, Section 3(h) excludes a method of 41 See Weismann (1996).
given the clear wording of the TRIPS text and agriculture or horticulture, which is certainly 42 See Correa (1994).
given the interpretation of Article 5A by not part of TRIPS Article 27.3(a). 43 An exception has been made for semi-
Bodenhausen, India would be on fairly strong 27 There is no such specific exclusion for conductor technology which can be subjected
grounds. biotechnological inventions in the Patents to cvmpulsory licences only on two grounds:
19 One of the difficulties faced by the author in Act, 1970 but Section 2(j) limits the term public non-commercial use and as a remedy
comparing the Patents Act 1970 to the TRIPS 'invention' to art, process, method or manner for adjudicated anti-competitive practices.
Agreement was that the same subject matter of manufacture; machine, apparatus or other Article 17.2 of TRIPS also subject these
has been dealt with repetitively and in some article; and substance produced by licences to the 11 conditions set out in
cases differently in different sections of the manufacture,'thus implicitly excluding plants, Article 3 1.
patent law. The TRIPS Agreement provides animals or biological processes for their 44 This distinction has not been,pnderstood by
India with the opportunity to rewrite the manufacture. some commlentators [see Correa 1994] who
patent law in a clear and coherent manner, 28 Those not compatible with the criteria of have presumed that Article 31 lists conditions
without unnecessary repetition. patentability would include 3(d) and (g) as for the grant of compulsory licences.
20 Section 5(a) excludes substances relating to these could be new, non-obvious and involve 45 There has, however, been another inter-
food, 'medicine or drug', i e, pharmaceuticals an inventive step. Those that could be pretation of this proviso, viz, that it only
and agricultural chemicals and Section 5(b) compatible are probably section 3(a) and 3(c) prohibits discrimination in compulsory
excludes substances produced by chemical as these inventions would not be useful or licensing between imported or locally
processes and makes clear that only claims industrially applicable, 3(e) and (f) as these produced products and that if compulsory
for methods or processes of manufacture are inventions would be obvious and would not licences are granted on both categories of
patentable. involve any inventive step. But this would products there is no contradiction with
21 Section 4 of Patents Act 1970. have to be further studied by legal experts Article 27.1. See Correa (1994) and South
22 Article 65.4 allows developing countries to as it could be argued that Section 3 defines Centre (1995). This proposition may not be
delay the extension of product patents to 'invention' and not 'patentability'. meaningful if the ground for grant is itself
areas not so covered by the date of application29 See Correa (1994) and Strauss in Beier and local working. In any case even compulsory
of TRIPS by a period of ten years. However, Schficker (eds) (1996). working of patents is usually qualified by
Article 70.8 of TRIPS, overrules the 30 Meaning 'one of its kind'. justifications for non-working on legal,
transitional provisions of Article 65.4 and 31 Passions run high on this subject in India commercial or technical grounds and it would
obliges the acceptance of the filing of product on account of the 'neem' controversy be extremely difficult to force patentees to
patent applications in pharmaceuticals and blurring the fact that UPOV 1978 gives con- work their patents. Even the Patents Act 1970
agricultural chemicals from January 1, 1995. siderable freedom to its members and has such provisions in Section 91.
With 70.8 this transition period for India would gain international credibility as 46 These views have been advocated by the US
pharmaceuticals and agricultural chemicals is well as safeguard national interest were she Pharmaceutical and Research Association in
cut back to zero as not even a day's transition to join UPOV 1978. their 'Industry Profile, 1997' and find
has been allowed for them. In addition, 32 This term was adopted in the TRIPS reflection in Robert Sherwood (1995) and
under Article 70.9 exclusive mnarketing rightsnegotiations 'even while several developingPrimo Braga (1996).
for a period of five years or up to the grantcountries including the US, Japan, Australia 47 See South Centre (1995), Reichman (1995)
or rejection of a patent have to be made and New Zealand had different patent terms and Weismann ( 1996) who also reflect similar
available, on demand, if certain conditions in their own national legislations. views.
are met. These issues are dealt with later in 33 Section 5 3( 1 ) of the Patents Act, 1 970 provides48 TRIPS itself gives guidance as Article 7 of
this paper. an effective patent term of seven years from TRIPS lays down the objectives of the
23 This exception is allowed in general under the date of the patent for process patents agreement and states that the protection of
Article 73 of TRIPS as a Member is allowed relating to food, drug or medicine and 14 intellectual property should contribute '..to
to take any action it considers necessary for years for all other patents. the transfer and dissemination of technology..
the protection of its essential security interests 34 This follows from Article 70 on the Protection in a manner conducive to social and economic
in relation. initer alia, to fissionable and of Existing Subject Matter. welfare, and to the balance of rights and
derived materials. 35 The exclusive right of importation is limited obligations'. More importantly Article 8
24 This follows from Article 65.4. It must be by the country's regime on parallel imports, permits members 'to adopt measures necessary
noted that where the chemicall substances or which is left to each Member to decide as to protect public health and nutrition and to
micro-organisms can be classified as per Article 6 (see footnote 6 of TRIPS). The promote the public interest in sectors of vital

Economic and Political Weekly September 27, 1997 2467

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 importance to their socio-economic and China 'pipeline protection' foi productpatents Agreemnenit ont Trade-Related Aspects of
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January 1. 1996 as for all other metnbers of75 Refer to the analysis in this paper of the Competition: Law and Econtiomics Review,
the WTO. flexibility available in the TRIPS Agree- Vol 20, No 2, December.
60 See studies done by Taylor and Silberston ment in terms of compulsory licensing, Weismann, Robert (1996): 'A Long, Strange
(1973), Mansfield (1986) and Levin et al government use and revocation, in addition TRIPS: The Pharmaceutical Industry Drive to
(1987) who have shown that patents are much to independent examination of the criteria of Harmonise Global Intellectual Proreity Ru!es,
more important for pharnmaceutical and patentability. and thc Remaining WTO L.egal Alternatives
specialised chem'n!. th..n for other industrial
7 1t is entirely another matter wn'ither the Indian Available to Third World Countries,
products. patent offices have the capacity to take Unive rsity of Pennsylvania Journal of
61 See Table 4.2 on Mean and Median Effective adv:ntage of this opportunity but if we are Intern(ationial Economic Law, Winter.
Patent Life on p 84 of the document of the to be world players in patenting we will have World Trade organisation (1995): The Results
Office of Technology Assessment: Pharina- to build up this expertise. of the Uruguiay Round of Multilateral Trade
ceutical R and D: Costs, Risks and Rewaids, Negotiations: The legal Texts: Annex IC:
1993, which places the mean for a sample References Agreemenit on Trade-rel(ated aspects of
of 113 drugs at 10.6. intellectual Property Rights.
62 Claim of Pharmaceutical Research and Anand, Pravin (1991): 'India: Assessing TRIPS -: Overview (f the TRIPS Agreement, available
Manufacturers' Association in an - Developed vs Developing Countries', IP at the WTO web site.
advertisement that appeared in Washington As:':, January 10. - (l1997)t WT/DS 50/R 'India - Patent Protection
Post on 8-9-1997. Beier, Friedrich-Karl and Schricker, Gerhard (eds) forPharmaceutical and Agricultural Chemical
63 The US had demanded and obtained fiom (1996): Fromn GATT to JTRlPs - The Products: Report of the Pane', September 5.

2468 Economic and Political Weekly September 27, 1997

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