CHAPTER SEVEN

INDIAN PATENT LAW AND ITS COMPATIBILITY TO

TRIPs UNDER WTO

The Patents Act 1970, along with the Patents Rules 1972, came
into force on 20th April 1972, replacing the Indian Patents and Designs Act
1911. The first major transition in the Indian patents act 1970 which came
into force on 20th April 19721. The Patents Act was largely based on the
recommendations of the Ayyangar Committee Report headed by Justice
N. Rajagopala Ayyangar2. One of the recommendations was the allowance
of only process patents with regard to inventions relating to drugs,
medicines, food and chemicals. Later, India became Signatory to many
international arrangements with an objective of strengthening its patent
law and coming in league with the modem world. One of the significant
steps towards achieving this objective was becoming the member of the
Trade Related Intellectual Property Rights (TRIPs) system .
It is one of the controversial areas to amend the Patents Act to make it
conform to these international agreements4.

tushikand Hasija, Patent Pharmaceuticals: The Indian Scenario-.M.D.U.law journal. vol.9,2004,p.281

1957, the Government of India appointed Justice N. Rajagopala Ayyangar Committee to examine the
stion of revision of the Patent Law and advise government accordingly
though the India was contracting parties of GATT
jraham B.Paul.The Emersins Patents andIPRs Resime Implications for Indian Industry,Globalization
India,p.87

195
 As TRIPs became a part of the WTO regime the member countries
became bound to provide intellectual property protection as per TRIPs
provision and were forced to amend their laws in tune with TRIPs.The
TRIPs agreement have motivated the members countries to formulate
more or less uniform IPR laws 5. WTO's dispute settlement mechanism6
made sure that those countries which failed to amend their laws forced to
do so. For example, on a complaint by the US, the WTO appellate body
held that India's patent law violated
. (i) Article 70.8(a) of TRIPs7, and
(ii) Article 70.9 of TRIPs8
As a result, India was forced to amend the patent law in 1999 with effect
from 1995. The binding nature of the TRIPs Agreement is likely to have
immense impact once all the member countries become bound to
implement an across-the-board product patent regime. Before the
Agreement came into force many developing countries, including India,
allowed patents only for pharmaceutical processes and not for
pharmaceutical products9. Some countries like Brazil, Thailand and Korea
simply did not include medicines within the patent laws. Due to a weak
patent regime generic versions of patented medicines could be produced
locally and therefore, the local prices of a formulation were much lower
compared to that in the developed world. However, a product patent
results in a complete monopoly in favour of a patentee and he becomes
free to manipulate the market price of the product. Arguably, patent rights
for pharmaceutical products result in higher prices making the drugs

5 Ray Alok, Intellectual Property Rizhts in WTO Resime, The law ofIPRs-Editor,S.S. Singh, Deep and
Deep,p.61
6 See Rao M.B. WTO Dispute Settlement lexis Nexis Buuterworths Publications.
7 by failing to provide a means for the filing of patent applications for pharmaceuticals and agricultural
chemical products
8 for not providing exclusive marketing rights (EMRs) to pharmaceutical and agricultural products.
9 See Indian Patent Act, 1970

196
 inaccessible for the poor. There, thus, seems to be an apparent conflict
between the TRIPs regime and human rights values10.

Under the World Trade Organisation obligations, each member-State is

required to provide for a minimum level of protection of IPR embodied in
the Agreement on Trade-Related Aspects of Intellectual Property Rights
(TRIPs). The recent changes in IPR laws reflect India's compliance with
the obligation under the TRIPs Agreement. The TRIPs Agreement signed
in 1994 has provided ten years’ time from 1-1-1995 to the countries who
became its signatories for providing product patent protection to
inventions which were not protected through product patents at the time of
entering into the agreement vide Article 65(4) of the TRIPs Agreement.
Since India became a member of WTO on 1-1-1995 in order to satisfy this
requirement our Parliament amended the Patents Act so as to make it in
conformity with the TRIPs Agreement. In order to comply with the
obligations under the TRIPs agreement, as a WTO founding member,
India in recent past undertook several structural amendments were
introduced in the national patent law*11. Our legislatures are called upon to
amend our laws in conformity with the international treaties.

For example, The Copyright Act, 195712 has been amended to include
computer program as literary work as required by Article 10 of the
TRIPs13 Agreement.

The Trade and Merchandise Marks Act, 195814 has been replaced with the
Trade Marks Act, 1999 which includes protection of well-known marks,
certification marks and collective marks. It now provides for registration

10 Gupta Amit and Patel,Aditi, A Human Right approach to TRIPsA20041 7 SCC (J) 61
11 Kaushik, H.Hasiia .Patent Pharmaceuticals: The Indian Sce»ar/o.MDULJ.2004.p.281
12 It came into force on 21.01.1958
13 TRIPs is known as Magna Carta of the IPRs
14 Repealed by TM Act, 1999

197
 of trade mark for services as well. This is in compliance with Article 16 of
the TRIPs Agreement.

Other recent legislations include the Geographical Indications of Goods

(Registration and Protection) Act, 1999, The Designs Act15, 2000 and
The Protection of Plant Varieties and Farmers' Rights Act, 2001.

The Agreement on Trade-Related Aspects of Intellectual Property Rights

(TRIPs Agreement) imposes several obligations on the Government of
India in the area of patent protection. It calls for substantial changes in the
Indian Patent Act, 1970 to satisfy these obligations.
The Agreement helps India to introduce the changes at three different
stages. To satisfy the first set of obligations, the Patent (Amendment) Act,
1999 was enacted after India lost the dispute with USA in WTO16. The
Patent (Amendment) Act, 2002 was intended to satisfy the second set of
obligations. This included changes in patentable inventions, grant of new
rights, extension of the term of protection, provision for reversal of burden
of proof in case of process patent infringement and conditions for
compulsory licenses17. The Patent (Amendment) Act, 2005 make the
Indian patent Act fully compatible18.
The preceding fifteen years have seen many new IPR enactments. With
globalization, liberalization and privatization, the ambit of IPR has grown
multifold and its importance has amplified, having a profound impact on
commercial interests19.
The TRIPs agreement made drastic changes in the international patent
regime. It prescribed a universal minimum protection for patent including
the scope of patentability, rights of the patentee, duration of protection,

15 It was enacted with an objective to consolidate and amend the law relating to protection of Design
6 Under the WTO Dispute Resolution Meehan ism,India has lost its case related to Implementation of
TRIPs provisions.
17 Gopalakrishnan N.S.The Patents (Second Amendment) Bill. 1999 - An Analysis. (2001)1SCC (Jour) 14
8 Venkatarammu Preeti .Protection of inventions: A bird eve ofPatent Laws in JW/a.Intellectual Property
^aws-Sreenivasulu N.S.,Regal Publications
19 Lahoti R.C.,Justice .Role ofJudiciary in IPR development and adjudication , (2004) 8 SCC (J) 1

198
 compulsory licensing, burden of proof and set-up an enforcement
mechanism. The developing countries were given a transitional period to
switch over to the new regime. However, this transitional benefit was
neutralized by the obligation on the developing countries to provide
exclusive marketing rights for agrochemicals and pharmaceuticals. Thus,
the developed countries had to change their intellectual property laws,
especially patent law, to make it in compliance with the TRIPS
Agreement. Therefore, the crucial question is how the developing
countries can make their laws TRIPS compatible and at the same time
safeguard their core developmental objectives.

B. The Main provisions of TRIPs

Articles 3, 4, 5 and 70 of the TRIPs are of peculiar importance and
deals within the national treatment20, Most, favoured nation21 and
multilateral agreement on acquisition of IPRs .

1. Patent without discrimination, subject to the normal

tests of novelty, inventiveness and industrial
applicability — The TRIPs Agreement required Member
countries to make patents available for any inventions
whether products or processes, in all fields of technology
without discrimination, subject to the normal tests of
novelty, inventiveness and industrial applicability23. There

0 Article 3 of the TRIPs agreement provides for the same treatment as nationals of countries of the
nion.,for the nationals of countries outside the union who are domiciled or have real and effective
onnection in the territory of one of the countries.
1 Article 4 of the TRIPs agreement providesthe protection of intellectual property,any
dvantage,favour,privilege or immunity granted by a member to the nationals of any country shall be
scorded immediately and unconditionally to the nationals of all other members..
2 Article 5 of the TRIPs agreement deals with the obligationunder Article 3 and 4 do not apply to
rocedures provided in multilateral agreemnts concluded under the auspices of the WIPO relating to the
iquisition or maintenance of IPRs.
Article 27.1 .these are three litmus test for granting patent

199
 are three permissible exceptions to the basic rule on patent
ability.
2. Inventions contrary to order public or morality — For
inventions contrary to order public or morality; this
explicitly includes inventions dangerous to human, animal
or plant life or health or seriously prejudicial to the
environment. The use of this exception is subject to the
condition that the commercial exploitation of the invention
must also be prevented and this prevention must be
necessary for the protection of ordre public or morality24
3. Exceptions — Members may exclude from patent ability
diagnostic, therapeutic and surgical methods for the
nr

treatment of humans or animals

4. Plants and Animals-- Members may exclude plants and
animals other than microorganisms and essentially
biological processes for the production of plants or animals
other than non-biological and microbiological processes.
Moreover, the whole provision is subject to review four
years after entry into force of the Agreement .Members
may provide limited exceptions to the exclusive rights
conferred by a patent, provided that such exceptions do not
unreasonably conflict with a normal exploitation of the
patent and do not unreasonably prejudice the legitimate
interests of the patent owner, taking account of the
legitimate interests of third parties

24 Article 27.2.
25 Article 27.3(a).
26 Article 27.3(B)
27 Article 30

200
 5. Patent Period — The term of protection available shall not
end before the expiration of a period of 20 years counted
from the filing date28
6. clear and complete Disclosure — Members shall require
that an applicant for a patent shall disclose the invention in
a manner sufficiently clear and complete for the invention
to be carried out by a person skilled in the art and may
require the applicant to indicate the best mode for carrying
out the invention known to the inventor at the filing date or,
where priority is claimed, at the priority date of the
application29 .If the subject-matter of a patent is a process
for obtaining a. product, the judicial authorities shall have
the authority to order the
defendant to prove that the process to obtain an identical
product is different from the patented process, where
certain conditions indicating a likelihood that the protected
process was used are met30
7. Compulsory licensing and government use --
Compulsory licensing and government use without the
authorization of the right holder are allowed, but are made
subject to conditions aimed at protecting the legitimate
interests of the right holder. The conditions are mainly
contained in Article 31.

C. Difference between TRIPs,Provisions and Indian Laws

The main provisions of TRIPs in so far as they are different from the
existing form of protection under the Patents Act (1970) were:

8 Article 33
’ Article 29.1

! Article 34 of TRIPs Agreement

201
 1. Patent terms— A minimum patent terms of 20 years from the date of
filing,13'Product
42 * 6 patent for pharmaceutical and agricultural
•yy

chemical -products .
2. Working of patent —Importation to be accepted as "working of
patent"33 Compulsory licensing to be confined to special circumstance
such as emergency or abuse of patent rights. (Article 31 of TRIPS
Agreement.).
3. Burden of proof—Reversal of the burden of proof in legal actions over
process patents -this will oblige the defendant to prove that his
process is non- infringing34.
4. Micro organisms to be patented
5. Effective protection for plant varieties Effective protection for plant
varieties either by patents or by an effective sui generis system .

D. Obligation of India under TRIPs

(a) To recognize in principle all kinds of inventions - India has under

obligation to recognize in principle all kinds of inventions in the area of
pharmaceutical and agricultural chemical products in accordance with Article 27
of the Agreement,

(b) To provide a mechanism for filing applications- India has to set up new
mechanism as prescribed by the TRIPs agreement by which applications can be
filed for new inventions as understood in Article 27 in these areas from 1-1-1995,

1 Article 33 of TRIPs Agreement.

2 Article 27of TRIPs Agreement
3 Article 28 of TRIPs Agreement.
4 Article 34 of TRIPs Agreement
’ Aricle 27(2) of TRIPs agreemnt
6 Article27 b of TRIPs Agreement

202
(c) To apply the test of patentability - according to the TRIPs agreement India
has to apply the test of patentability as laid down in the Agreement, irrespective
of the law of the country on the date of filing, at the time when patent is granted
or rejected,

(d) To provide patent protection for a period of 20 years- Before 1995 there is
different patent protection in India which is 14 years. But under TRIPs agreement
it is uniform patent protection to every member country. So India should provide
patent protection for a period of 20 years from the date of filing once the parties
decide to grant patent,

(e) Grant exclusive marketing rights for five years in the case of product patent
applications in these areas, grant exclusive marketing rights for five years or until
patent is granted or rejected whichever period is shorter. Granting of exclusive
marketing rights is subjected to three conditions:

(i) Product patent granted by another member country, —Product patent

for the invention has been granted by another member country,
(ii) Market approval - Market approval is obtained in such other member
country and
(iii) Market approval from the country/member granting exclusive marketing
right is granted.

E. The Year 1995

On account of signing of the TRIPs Agreement from 1-1-1995, the Indian Patents
Office has started receiving applications for pharmaceutical substances as per
Article 70 of GATT. These applications are commonly called “Black Box
applications” and have been taken up for consideration only after 31-12-2004 for
grant of patent.

203
 This provision has been included to protect new inventions made after 1-1-1995
satisfying the requirements of Article 27 of the TRIPs Agreement. It is also
intended to exclude this benefit to inventions made before 1-1-1995. That is the
reason why the provisions clearly stated that the inventions must take place after
1-1-1995 and insisted for a patent grant from another member. If one were to
examine the Indian Patents Act, 1970, Section 5 of the Act expressly prohibits
product patents protection for inventions relating to medicines or drugs and
substances prepared or produced by chemical processes, This in fact excludes
product patent for some items of pharmaceutical products and agricultural
chemical products as envisaged in the TRIPs Agreement.

According to Article 27, patent shall be granted to inventions in all fields of

technology both for product and process. This is obligatory if the invention is
new, involves an inventive step and is capable of industrial application. It also
mandates that the patent rights must be made available irrespective of the place of
invention or field of technology, and whether the products are imported or locally
produced.
India signed the Uruguay round Agreement in 1995 as founding member.
This led to a number of amendments in the Indian Legislations and formulation
of economic Policies to implement the WTO agreement

Through India had a transition period of 5 years (w.e.f. 1-1-1995) under

Art 65 to apply the provisions of the agreement and an additional period of 5
years for extending product patent protection to areas of technology no protected
so far, certain obligations were required to be fulfilled w.e.f. 199538

To satisfy the first set of obligations, the Patent (Amendment) Act, 1999 was
enacted after India lost the dispute with USA in WTO. The Patent (Second
Amendment) Bill, 1999 was intended to satisfy the second set of obligations.
This included changes in patentable inventions, grant of new rights, extension of

Mittal J,K WTO and India .. New Era Publication, (p.7)

I Vikas T>v..Law and Practice ofIntellectual Property, Bharat Publication at p. 1

204
 the term of protection, provision for reversal of burden of proof in case of
process patent infringement and conditions for compulsory licences. India has
amended in 2005 to introduce protection for pharmaceutical products,
agricultural chemical products, inventions relating to atomic energy and plant
varieties. Apart from the provisions for satisfying TRIPs obligations some other
provisions are also included in the Bill to modernise the Indian Patent Act to suit
the requirements of the technological changes 39.

In order to comply with the obligations under the TRIPs agreement ,as a
WTO founding member, India in recent past undertook several structural
amendments were introduced in the national patent law.40

E. Amendments of Indian Intellectual Property Legislations:

To meet the above requirements India has initiated the process for the
comprehensive amendment of its IP legislations. India has complied with its
obligations under TRIPs through a series of amendments of its existing laws and
enacting new legislations. They are;

The Trade Marks Act, 199941

The copy right (Amendment) Act, 199942

The Designs Act, 199943,

The Protection of Plant Varieties and Farmer’s Right Act, 200144

The Semi-conductor and Integrated Circuits Layout Designs Act 1999.

39 Gopalakrishnan N S.The Patents (Second Amendment) Bill. 1999 - An Analysis (2001)1SCC (Jour)14
40kaushik,and Hasiia.Patent Pharmaceuticals: the Indian scewflr/o.M.D.U.law journal. vol.9,2004,p.281
41 Supra note 14
42
Supra note 12
43 Supra note 16
44 Same was notified in 2003

205
 The Geographical Indications of Goods (Registration and Protection) Act, 1999

The Patents (Amendment) Act, 1999

The Patents (Amendment) Act, 2002

The Patents (Amendment) Act, 2005

After conclusion of the Uruguay Round at Marrakesh (Morocco) which adopted

WTO - TRIPs Agreement, the next step was to be the issue of implementation
in most of the developing countries India after authenticating the final Act on
15th April 1994, promulgated an ordinance on 31st December 1994 amending the
Patents Act, 1970 and acceding to WTO. This ordinance was the first step to
comply with immediate obligations under Article 70.845 and Article 70.946.

• INDIAN PATENT (AMENDMENT) ACT, 1999

The Patents (Amendment) Act, 1999 specified four pre-conditions to be met by

an EMR applicant: (a) The applicant must hold a valid patent on pharmaceutical
product granted after January 1, 1995 in any of the WTO member countries
(countries who are also WTO members); (b) The applicant, should have
marketing rights in the member countries; (c) A product patent application
should already have been made in India, and (d) Marketing approval of the same
product should have been granted in India. The first three conditions were as per
the stipulation of TRIPs agreement. The fourth clause was incorporated to meet
the Indian drug regulatory approval. The EMRs were to be given for a period of
5 years as per TRIPs requirement. The other important change made was the
removal of restriction on residents to apply for patents outside India. In the
Patent Act (1970) it was obligatory for residents (section 39) to seek prior
permission before applying for patents outside India.

icceptance of applications for product patents for Pharmaceutical and agricultural chemical products
m 1.1.1995 by providing a “mailbox”
-rant of Exclusive Marketing Rights (EMRs) to these products for five years

206
 As mentioned earlier the 1999 (Amendment) Act to the Patent Law deals with
the minimal amendments, which were necessary to be done and from which
there was no escape, after India lost the case against USA & EC in WTO
Dispute Settlement Body47.

The Patents (amendment) Act 1999 introduced two main changes to the Act.
Firstly, it introduced a new sub-section to section 5 prohibiting product patents on
medicines and drugs. The new clause left the prohibition untouched but permitted
the filing of a patent claim. Secondly patent applications for food or health related
products had to be dealt with according to a new Chapter IVA which set out the,
specific conditions under which this was to take place and provided for the grant
of exclusive marketing rights as called for under TRIPs Agreement.48

While the adoption of the 1999 amendments proved to be a lengthy process, it

constituted a tiny part of the overall changes that had to be put in place of TRIPs
compliance. Since India had to comply with the most of its other TRIPs
obligations by 1 January 2000, this led to the introduction of another proposed set
of amendments in December 1999. These amendments were referred to a
Parliamentary Committee that studied the proposed changes for the better part of
the next two years. Apart from the amendments made in March, 1999, the Patents
Act, 1970 has not undergone any change till 2002. During this period of time,
however, there has been considerable technological innovation and development
of knowledge and the concept of IP as a resource for knowledge- based
industries has become well recognised the world over. Development . of
technological capability in India, coupled with the need for integrating the IP
system with international practices and intellectual property regimes require that
the Patents Act, 1970 be modified into a modern, harmonised and user-friendly
Act to adequately protect national and public interests, while simultaneously
meeting India’s international obligations under the TRIPs Agreement.

47 See Rao M.B.and Guru Manjula WTO Dispute Settlement and developing Countries.Lexis Nexis,Legal
tto Business,2004
48,Patents (Amendment) Act 1999, Gazette of India,26 March, 1999.

207
 Eventually, the amendments proposed by the government in 1999 were adopted
without major changes in 2002.

© The Highlights of the Patents (Amendment) Act, 199949 are:

The Patent (Second Amendment) Bill, 1999 was intended to satisfy the second set
of obligations. This included changes in patentable inventions, grant of new
rights, extension of the term of protection, provision for reversal of burden of
proof in case of process patent infringement and conditions for compulsory
licences. India has time up to 2005 to introduce protection for micro-organism,
pharmaceutical products, agricultural chemical products, inventions relating to
atomic energy and plant varieties. Apart from the provisions for satisfying TRIPs
obligations some other provisions are also included in the Bill to modernise the
Indian Patent Act to suit the requirements of the technological changes50

A) Product Claims allowed for medicine/drug & agrochemicals except for those
ordinarily used as intermediates in the preparation/manufacture of such
substances, under certain conditions, such as:

i) Patent Applications made under the above provision shall be consigned/kept in

a "Black Box" and shall not be examined till 31-st December 2004. However, in
the interim period Exclusive Marketing Rights (EMR) for a period of 5 years may
be given on applying specifically for EMR, subject to fulfilling certain conditions.

ii) Term of EMR for a period of 5 years from the date of approval or till the date
of grant of patent or till the date of rejection of application for the grant of patent,
whichever is earlier.

iii) Exclusion of substances based on system of Indian Medicine.

K,aushik.and.Hasiia Patent pharmaceuticals: the Indian scenario-.M.D.U.law journal.

9,2004,p.281,VISWANATHAN, AJndia:Patent (Amendment) Actl999 .International Business
/yer, VOL.27,no.9,1999,385-432,see also Naraynan,P. Indian Patent Law,Eastern Book Company.
Gopala Krishnan N.S .The Patents (SecondAmendment) Bill, 1999-An Analysis (2001)1 SCC(Jour) 14

208
 iv) Compulsory License: after 2 years from date of approval of EMR.

v) Importation deemed to be working of Patent.

B) Residents allowed to apply for Patents outside India without first filing for
Patent in India, as was the case in the Indian Patents Act 1970, Section 39 has
been omitted in the Amended Act 1999.

® The Patents (Amendment) Act, 2002

India amended its Patents Act again in 2002 to meet with the second set of
obligations (Term of Patent etc.), which had to be effected from 1-1-2000. The
Patents (Amendment) Act, 2002 closely follows TRIPs and in the process does
away with provisions of the 1970 Act that constituted India’s own response to the
challenge of providing exclusive commercial rights in a field concerned with the
fulfilment of basic health needs51. India amended its Patents Act again in 2002 to
meet with the second set of obligations (Term of Patent etc.), which had to be
effected from 1-1-2000. This amendment, which provides for 20 years term for
O

the patent, Reversal of burden of proof etc. came into force on 20th May, 2003.
The Third Amendment of the Patents Act 1970, by way of the Patents
(Amendment) Ordinance 2004 came into force on 1st January, 2005 incorporating
the provisions for granting product patent in all fields of Technology including
chemicals, food, drugs & agrochemicals and this Ordinance is replaced by the
Patents (Amendment) Act 2005 which is in force now having effect from 1-1-
2005 .

Some of the salient features of the Patents (Amendment) Act 200252 amendments
are as follows:

51 Cullet Philipp^Amended Patents Act and Access to Medicines after Do/?a-EPW-vol.37.June 15-June

21,2002
52 Kaushik,and Hasiia Patent Pharmaceuticals: the Indian ScenarioM.D.V.law journal. vol.9,2004,p.281

209
 Patent rights and terms of patents: Under section 48 of the amended act, the
patent owners will have the exclusive right to Prevent others who do not have
their consent, not only from making, using or selling the invented product or
process in India, but also importing from other countries. Under the original 1970
Act, importing was not mentioned as an exclusive right. This is however subject
to the provision in Section 107A (b), inserted in the amended act, which permits
parallel imports. Under this section, “importation of patented products by any
person from a person who is duly authorised by the patentee to sell or distribute
the product”, will not be considered to an infringement of the patent right. Thus if
a patented product is offered for sale in another country at a lower price by the
patent holder or with the patent holder’s consent, the patent holder here cannot
legally stop its imports by others.

The term of the patent granted will be 20 years from the date of filing of the
application for the patent53. Under the 1970 act, the term for pharmaceuticals, was
five years from the date of sealing or seven years from the date of the patent,
whichever is shorter. (For other products the term was 14 years).

Section 47 of the original Patents Act of 1970 contains a research exemption for
patented inventions54. This section, which can be interpreted as applicable for
both academic and commercial research, has been left unmodified by all
subsequent amendments to the patent regime.

But three major changes introduced in the Amendments of 2002 affect the
patenting of research tools for biomedical and biotechnological inventions in
India. These are as follows:

• The Patent Act has extended the scope of patentable inventions to a method or
process of testing during the process of manufacture, including those in
biochemical, biotechnological and microbiological areas.

section 53(1)
>ee section 47(3)

210
 Agreement. Further the amendments seek to provide as extensive as a scope for
section 5, which restricts patentability to process, patents by specifying that the
chemical processes referred to include biochemical, biotechnological and
microbiological processes.

A special mention may be made of the question of the protection of the plant
varieties. The revised section 3(j) specifically rejects the patentability of seeds and
plant varieties. However article 27(3) (b) requires protection of plant varieties.
One of the few areas where government can choose the protection system they
want through the sui- generis option. In this case, the government decided to use
this option and chose to draft a separate Act for this purpose. The Plant Variety
Protection Act, which introduces Plant Breeder’s Right and farmer’s rights.

The amendments also seek to provide answers to some of the new issues facing
the patent system. The amendments provide at least a partial answer to biopiracy
concerns by requiring the disclosure of the sources and geographical origin of the
biological material used in chemical inventions. This is supplemented by a
provision, which makes the failure to disclose the source and geographical origin
of the biological material used a ground for opposing the grant of patents. This act
also indirectly addresses questions related to the traditional knowledge protection
by denying the patentability of traditional knowledge. Thus the act now allows the
generic producers to get ready for marketing their products immediately after the
patents expire, thereby reducing the time lag between patent expiration and
availability of generics58.

The system of compulsory licensing was strengthened. Interestingly, section 83

specifically mention that the patents granted should not hamper the protection of
the public health and should not prohibit the Central Government from taking
measures to protect the public health. The patents should be granted to make the

58 Chaudhury Sudip, ‘TRIPS Agreement and amendments of the Patents Act in India. 37/32, Economic
and Political Weekly (10 August 2002)p.3354.The first such provision was introduced in the United States
in a revision of Federal Food, Drug and cosmetic act, PL98-417(1984)at section 202

212
 0 Section 3 of the Patent Act that deals with inventions that are not patentable was
amended in 2002 to include any process for the diagnostic or therapeutic
treatment of human beings or for a similar treatment of animals or plants55

As a result of these provisions, biomedical research tools are patentable under

Indian patent law. Medical, diagnostic and therapeutic kits/ tools are not
patentable only when they are for the treatment of human beings or animals or
plants.

The Patents (Amendment) Act, 2002 closely follows TRIPs and in the process
does away with provisions of the 1970 Act that constituted India’s own response
to the challenge of providing exclusive commercial rights in a field concerned
with the fulfilment of basic health needs56.

The amendments adopted in 2O0257 have removed most of the elements that gave
the Patents Act 1970. The most important impact of this change was the balance
between the interests of the patent holders and the society’s interests. Some of the
changes include the increase of the term of protection to a uniform 20-year term,
thereby increasing significantly the average duration of protection and removing
the discrimination put in the place in the case of process patents in the field of
health and nutrition where the term was only for 7 years.

In the midst of changes which significantly reinforce the position of patent

holders, the amendments also seek in some respect to limit the rights of the patent
holders. The specific flexibility offered by the TRIPs Agreement has been used
in several cases. The environmental and health exceptions were authorized by
Article 27(2) of the TRIPs Agreement are drafted into the section 3(b).Similarly a
new section 3(j) used all exceptions allowed under Article 27(3) of TRIPs

55 Section 3(i)).
56 Philippe Cullet Amended Patents Act and Access to Medicines after Doha ,EPW June 15 - June 21,
2002
57 This Act makes the Indian patent law not only TRIPs compliant but also incorporates safeguards for the
protection of public interest, national security, bio-diversity, traditional knowledge, etc. The opportunity
has also been utilised to harmonise the patent granting procedures with international practices and to make
the system user friendly.

211
 benefits of the patented inventions available at a reasonably affordable price to the
public.

The 2002 amendments was followed by a set of amendments which are required
to put India in compliance with its obligations to introduce the product patents in
health and food sector. A Bill 2003 was introduced at the end of 2003.The Bill
was not passed by the parliament the government promulgated a temporary
ordinance after the end of the parliamentary session which had the effect of
putting the country in compliance with its TRIPs obligations.

The Patents (Amendment) Act, 2002 was passed by Parliament in May, 2002 and
notified in June, 2003. The Act has been made effective from May, 2003 and has
brought about lot of changes.

Modification of term invention59:

The Sec. 2 (l)(j) of Patent (Amendment) Act 2002, defines the term “invention”
as "a new product or process involving an inventive step and capable of industrial
* O

application" Where ’’Inventive step” means a feature that makes the invention not
obvious to person skilled in the art.

Earlier “invention” means any new and useful -

(i) Art, process, method or manner of manufacture;

(ii) Machine, apparatus or other article;

(iii) Substance produced by manufacture;

and includes any new and useful improvement of any of them, and an alleged
invention.

Examination of application60

59 See section 2(1 )j

213
 India has opted for a deferred examination system. This means the Controller will
not initiate examination of the application. Examination of an application will
now be taken up only upon request by applicant or in the Form 19 with fees of
Rs.1000 for individual applicant or Rs. 3000 for legal entity other than an
individual, at the appropriate office of the Patent office (Rule. 24).

The request is to be made within forty-eight months from the application filing
date. Where an application was filed prior to May 20, 2003 (i.e. before the
commencement of the Patent (Amendment) Act 2002), a request for examination
is required to be made within a period of twelve months from May 20, 2003 or
forty-eight months from the filing date, whichever is later. Upon failure to request
examination, the application shall be treated as withdrawn by the applicant. The
applicant or agents can also withdraw the application at any time (before the grant
of the patent) after filing the application.

Ptiblication/Notification of the Application61:

After the expiry of 18 months from the date of filing or the date of priority
whichever is earlier, the Controller will notify the contents of the applications
falling within the provision in the Gazette of India Part-Ill Sec.2 (Rule 25).

Term of Patent62:

The term of patent has been enlarged to twenty years for existing patents and
patents granted on pending applications. This term is calculated from the date of
filing of the application. Earlier the term of patent for method or process of
manufacture of substance (e.g. food, medicines, drugs etc.) was five years from
the date of the sealing of the patent, or seven years from the date of patent
whichever period is shorter and in respect of any other invention, fourteen years
from the date of the patent.

i Sec. 11(b)
Sec. 11 (a)
: Sec.53

214
 Burden off proof63:

The burden of proof in a proceeding for process patent infringement has been
reversed and imposed on Defendant.

Prohibition to apply abroad 64:

No person shall file an application or patent for an invention without applying in

India or without the written permission of the Central Govt. If the applicant is not
interested to secure a patent in India or the invention is not patentable according
to the Indian law, he has to mandatory file an application for the said invention
and has to wait for the expiry of six weeks after filing the application and then
only file the corresponding application abroad for the same invention.

Date of Patent65:

The date of every patent will be the date of filing the application for patent.
According to The Patent Act 1970, the date of patent was the date of filing of
complete specification. The date of patent is very important to determine the term
of parent.

Rights of patentee66:

The rights can be consider as negative because the rights of patentee, in the case
of product patent, prevent third parties without the consent of the patentee, from
making, using, offering for sale, selling or importing into India and the rights in
the case of process patent, prevent third parties without the consent of the
patentee, from the act of using that process and offering, for sale or selling in India
or importing for those purposes the product obtain directly by that process,
provided that the product obtained is not patentable under the Act.

63 Sec. 104 A
64 Sec. 39
65 Sec. 45
66 Sec. 48

215
 The Powers of the Branch Office :

The branch offices of the Patent office have been vested with more powers. Under
Sec. 68 the actions such as making a request of sealing of patents, registration of
assignment 68etc has to be made in the appropriate Branch offices of the Patent
office and not at the Head Office as the case earlier.

Appellate Board69:

Appeal Board appointed under the Trade and Merchandise Marks Act 1999 shall
be the Appeal Board for purposes of Patents Act. This Appellate Board hears and
decides appeals from the decision of the controller. The Head Quarter of the
Appeal Board is to be in Chennai.

It is clear that the definition of term invention in Patent Act, 2002 has enlarged the
scope of protection. The controller has also been vested with the power to
consider the question of obviousness of the invention disclosed while conducting
the examination of application for considering the grant of a patent for the
invention. In this context it should be noted that in the Patent Act, 1970 the
Controller has no direct power to consider the question of obviousness. The
power is only for the opponents while opposing the draft of patents under Sec. 25
of the Patent Act, 1970. The effect of this amendment is that it may not be
possible to get a patent for trivial modifications.

Time for placing the application in order for acceptance70:

The time frame for putting an application in order for acceptance subsequent to its
first examination has been shortened to 12 months (non-extendible) from the date
of First Examination Report (FER). The first reply to the first examination report
is required to be made within 4 months of the date of its issuance.

Rule 4
Sec. 68
Sec. 2 (l)(a)
Sec. 21

216
 Unity of Invention71 :

The concept of 'unity of invention' has been broadened to include a group of

inventions linked so as to form a single inventive concept. The claims in a
specification should relate to a single invention or a group of invention linked so
as to form a single inventive concept. Now, by this amendment it may be possible
to claim more than one process in a single application if these processes fall under
one group and are closely linked.

Electronic Communication72:

The documents can also be filed by electronic transmission duly authenticated. In

that event the document should be clear, properly addressed and mailed and its
original has to be submitted within fifteen days from the date of receipt of
communication. The drawings can also be filed electronically.

7”?
Statement and Undertaking :

For filing the Statement and Undertaking on Form 3 a provision has been
provided to seek extension beyond three months.

Declaration of inventor-ship74

The declaration of inventor ship on Form 5 should be filed along with the
complete specification. An extension of one month beyond this period can be
secured by filing a request on Form 4 with the fees Rs. 250/- pm if the applicant is
an individual or Rs. 1000/- pm if the applicant is a legal entity.

Abstract75:

71 Sec. 10(5)
72 Rule 6
73 Rule 12(4)
74 Rule 13 (6)
75 Rule 13 (a) to (d)

217
 While filing the application accompanied with a complete specification, an
abstract of the invention maximum 150 words have to be filed.

Application76:

An application for patent corresponding to International application (PCT

application) has to be filed on Form 1 A.

Licenses of right77:

The Provisions relating to "licenses of right" deleted.

Restoration of lapsed patent78 :

The time for filing the request for restoration of the lapsed patent has been
extended from one year to eighteen months.

The 2002 Amendment to the Indian Patents Act had provided for Patenting of
microorganisms and microbiological processes - thus opening the door for patent
« o

protection to biotechnological inventions both in the agricultural sector

(genetically modified seeds, etc) and in the case of pharmaceuticals produced
through biotechnology. This provision which follows the TRIPs provisions of the
same kind, was one of the most controversial in the TRIPs agreement. As a result,
at the time of signing of the agreement it had been agreed upon that this clause
would be reviewed within 4 years. The clause is under review in the TRIPs
council, but because no consensus has been arrived at, it continues to be a part of
the TRIPs agreement. While this clause has not been deleted from the Indian Act,.
the Govt, has given a commitment that the matter would be referred to a
committee, and if felt necessary by the committee, the Act would be modified at a
later stage.

Rule 20(1)
Sec. 86 to 88
Sec. 60

218
 Similarly, the Government has given a commitment that the issue of further
defining what a pharmaceutical substance is to restrict the scope of patenting
frivolous claims would be referred to a committee and further amendments can be
considered based on the committee's findings.
Indian Patents Act, 1970, amendment 2002, has excluded from patentability under
Section 3(j), plants and animals as a whole or any part thereof other than
microorganisms but including seeds, varieties and species and essentially
biological processes for production or propagation of plants and animals and

Section 3(i) 'any process for medical, surgical, curative, prophylactic (diagnostic,
therapeutic), or other treatment of human beings, or any process for a similar
treatment of animals to render them free of disease or to increase their economic
value or that of their products79, The making of human body parts is not viewed as
invention since they exist in nature, but modified or isolated body parts are
viewed as multicellular organisms and treated as such for patentability if they
meet the statutory requirements80.

• Patent (Amendment) Act 2005

The Third Amendment of the Patents Act 1970, by way of the Patents
(Amendment) Ordinance 2004 came into force on 1st January, 2005 incorporating
the provisions for granting product patent in all fields of Technology including
chemicals, food, drugs & agrochemicals and this Ordinance is replaced by the
Patents (Amendment) Act 2005 which is in force now having effect from 1-1-

r9This is in pursuance to the TRIPs Agreement Article 27.3 (a) and (b). Further TRIPS Article 27.2
nentions that States may exclude from patentability inventions, whose commercial exploitation within their
erritory needs to be prevented to protect ordre public or morality including to protect human, animal or
)lant life or health or to avoid serious prejudice to the environment'
!0 K. V. Swaminathan, Patenting in Biotechnology. In Proc. Roving Seminar on 1PR in Biotechnology. CIMAP, Lucknow, 2002

219
 2005. Changes have been made in Patent Act 1970 by the patent (Amendment)
Act, 2005 to meet the requirements of the TRIPs and PCT81.

India was required to introduce product patent protection in these sectors from
1.1.2005 in accordance with the obligation under the TRIPs Agreement of the
WTO. The Patents (Amendment) Act, 2005 introduces product patent regime for
food, chemicals and pharmaceuticals.

To fulfill this requirement, Government of India had issued an Ordinance in 2004.

The Ordinance was to be approved by the Parliament. While introducing the
Patents (Amendment) Bill 2005 in the Parliament, Government introduced certain
O')

changes from the provisions in the Ordinance .

Features of the Patents (Amendment) Act, 2005

The main important changes which have been made in Patent Act 1970 are

The Patent (Amendments) Act of 2005 has also extended the grounds on which a
patent can be opposed in the pre-grant period. These are now contained in Section
25 of the 2005 Act. The earlier Ordinance had come under criticism on this point,
since it reduced the grounds for pre-grant opposition of patents to only two (from
the nine grounds listed in the original Act of 1970). The 2005 Act has now
retained the nine grounds listed in the original Act of 1970 (with some
modifications) and also added two more grounds of pre-grant opposition: on the
lack of disclosure or no disclosure of source of geographical origin of biological
material and another on the presence of indigenous knowledge, oral or written, of
O'!

local and indigenous communities in India m the invention .

1 Hands on Guide to Patents Act with patent /?tt/&s-Taxmann’s.p.I-5

2 The patent (Third) Amendment Act also provide for deletion of provisions relating to exclusive
larketing right, which would become redundant, and steamlines the system by having both pre-grant and
ost grant opposition to patents in pursuance of the TRIPs agreement negotiated during the Uruguay
tound.
1 See section 25(j) and (k)

220
 a) Extension of product patent protection to all fields of technology84; The
Third Amendment Act, 2005 has introduce product patent protection in all
fields of technology as envisaged in Article 27.1

b) Deletion of the provisions relating to Exclusive Marketing Rights

(EMRs) (which would now become redundant), and introduction of a
transitional provision for safeguarding EMRs already granted;

c) Introduction of a provision for enabling grant of compulsory licence for

export of medicines to countries which have insufficient or no
manufacturing capacity, to meet emergent public health situations85

d) Modification in the provisions relating to opposition procedures with a

view to streamlining the system by having both Pre-grant and Post-grant
opposition in the Patent Office;

e) Addition of a new proviso in respect of mailbox applications so that

patent rights in respect of the mailbox shall be available only from the date
of grant of patent, and not retrospectively from the date of publication.

f) Strengthening the provisions relating to national security to guard

against patenting abroad of dual use technologies;

g) Rationalisation of provisions relating to time-lines with a view to

introducing flexibility and reducing the processing time for patent
applications, and simplifying and rationalising procedures.

84 i.e., drugs, foods and chemicals

85 In accordance with the Doha declaration on TRIPs and Public health

221
 The Act has the effect of invalidating Section 5 of the Indian Patent Act,
which granted only process patents for food, medicines and other drug substances.
As a result, reverse engineering possibilities available to the pharmaceutical
industry will only be limited to those drugs that are off-patent. The Act also
introduces Section 92(A) on compulsory licensing, in keeping with 30 August
2003 Decision of the WTO. Section 92 (A) of the Act deals with compulsory
licensing of pharmaceuticals for export purposes. This is meant to facilitate the
Indian industry to continue supplying cheaper generic versions of patented drugs
to those LDCs that do not have adequate domestic manufacturing capabilities.

The Patent (Amendments) Act of 2005 was preceded by an earlier 2004

Patent (Amendments) Ordinance that was different in several aspects from the
Amendments Act of 2005 that has now been enacted. For example, the 2004
Ordinance provided for exclusive marketing rights (hereafter, EMRs) that were to
be effective under the same terms under which they were granted, and also laid
out the power of the government to sell or distribute the article for which the
EMR was granted and to direct that the EMR-based product be sold at a regulated
price86.

Expansion of the Scope of Patentability:

Some of the key issues relating to the scope of patentability are given
below.
Inventive Step: The Bill .provides the following definition of what is required of
a patent application to meet the inventive step criteria:”a feature of an invention
that involves technical advance as compared to the existing knowledge or having
economic significance or both that makes the invention not obvious to a person
skilled in the art”.

The above provision arguably broadens the existing provision to the benefit of
patent holders and is ambiguous to the extent that it allows for two criteria for
meeting an inventive step. As it stands, to meet an inventive step criteria the

action 24(d),the patent amendment act 2005 now omitted section 24

222
patentee will either have to show that the invention includes a “technical advance”
or has economic significance, or both.
The provision should have required the applicant to comply with both
requirements for an inventive step, namely “existing knowledge and having
economic significance” and delete the term “or both”. Otherwise, the requirement
of technical advance is compromised and diluted by the fact that a patent could be
simply granted on economic significance alone. Economic significance alone,
cannot determine the inventive step of a patentable invention.

Pharmaceutical substance:
The amendment currently describes “Pharmaceutical substance” as “any new
entity involving one or more inventive steps”.
As it stands, the provision is too broad as it allows all types of
pharmaceutical substances. The term “chemical” ought to have been inserted so as
to read “any new chemical entity”.
Inventions not patentable:
Section 3(d) has been amended to read:

’’the mere discovery of a new form of a known substance which does not result in
the enhancement of the known efficacy of that substance or the mere discovery of
any new property or new use for a known substance or the mere use of a known
process, machine or apparatus unless such known process results in a new product
or employs at least employs one new reactant”.

The use of the phrase “which does not result in the enhancement of the known
efficacy” is ambiguous, too broad and potentially allows for new forms of
existing substances to become patented. For example, “result in enhancement of
efficacy” could be a minor amendment to an existing invention to in order
to get around the provision as it stands.
In addition, the new Act retains the word “mere” which potentially causes
ambiguities within the provision.

223
Also, the explanation supporting the above provision provides:

The phrase “unless they differ significantly in properties with regard to

efficacy” is not necessary and offers an entry point in favour of the
patentee, thus leading to excessive litigation. For example, certain
properties are never known or are clear at the time of application in the
claim so one would not know how they differ, thus leaving any recourse to
opposition.

The definition of pharmaceutical substance is not linked to the provisions

relation to the exclusion for patents and, therefore, stands alone.
Furthermore, the inventive step requirement has been severely diluted. As a result,
section 3(d) allows “evergreening”.

Immunity to on going generic production:

The Act permits generic manufacturers to continue producing generic versionof

new drugs which are in the mailbox. However, this only applies where thegeneric
producer has made a significant investment provided they were producing and
marketing the generic version prior to 1 January 2005. However, the generic
companies are required to pay the patent holder a reasonable royalty.

The question of “significant investment” poses a threat of potential

infringement suits as the generic producer would have to clearly show that
it has made what would be considered a significant investment in producing and
marketing the generic drugs. With respect to the reasonable royalty itcreates the
problem of excessive demands from the patent holder and litigation.

The reasonable royalty rate should have been fixed at a particular

percentage,the norm being 4%.For example in that in South Africa, Glaxo Smith
Kline demanded a royalty of 25 % before the courts intervened.

224
 Pre-grant Opposition:

The amendment has restored the ability for any member of the public to
oppose patent applications before its grant. The grounds for bringing an
opposition remain as before and provide recourse to challenging frivolous
and legally invalid patents.
However, the effectiveness of the opposition process depends upon the accessto
information on the mailbox applications. The Patent Office in 2005 has issued a
notification in its official journal that inventions either filed or claiming priority
on 30 July 2003 have been deemed to have been
published. However, there no actual physical publications available. This
lack of publication takes away the possibility of accessing information
relating to the patent application and the ability to oppose the same.

Publication:
The Act amends Section 11A of the Patents Act which prescribes the
initialpublication requirement. After the publication the applicant shall have the
rights as if patent for the invention had been granted on the date of publication of
the application. However, no infringement proceeding is
permissible until the grant of patent. This means that one can get the
privilege of patent from the date of publication i.e. even before filing the
request for the examination of application. Lastly the Bill refers to the
publication of an application, but fails make the publication of the
complete specification available to the public. This will greatly hamper
opposition proceedings

Compulsory Licences :

The effective and efficient issuance of compulsory licences is imperative

to curb the abuse of patent rights by the patentee. The amendment has only made

87 Hands on Guide to Patents Act with patent /?w/es-Taxmann’s,p.I-21

225
cosmetic changes to quicken the process of dealing with an application for a
compulsory licence in section 84(6) to the extent that where 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,
the Controller can now interpret “reasonable period” to mean a period not
ordinarily exceeding 6 months.
However, the amendment does not remove the existing requirement that only
after three years after the grant of a patent, (unless there is a national emergency,
which has never been used) can a person make an application to the Controller for
the grant of a compulsory licence. Therefore, in total the request for a compulsory
licence does not have to be considered for at least 3 years and 6 months from the
date of the grant of the patent.
Furthermore, one also has to take into the account that the Bill fails to
provide a timeline within which the Controller must deal with compulsory licence
application once made. Therefore, this could lead to a further delay before any
licence can be issued as it is well known that MNC pharmaceuticals often refuse
to deal with requests for compulsory licenses or demand high royalties.
With respect to exporting drugs to a country which makes a request for a
generic drug, the amendment no longer requires the importing .country to
issue a compulsory licence. However, one question that arises is whether the
procedure for the grant of the compulsory licence for the domestic market will
also be the same for compulsory
licenses for export. It is quite possible to argue the procedure both ways,
therefore, potentially delaying urgent new drugs that a developing or least
developing country may require.

The Act further fails to provide the safeguard available within Article 44
of TRIPs, which effectively allows Member States to limit remedies to
remuneration that would be available to the patent holder where third
parties are authorised by the Government, without the authorization of the right
holder, to use the patented good rather than issue an injunction.

226
 Patent law has been formulated with an objective to promote and protect the
inventions and methods. The object of granting a patent is to encourage and
develop science, technology and industry.

The third amendment to the 1970 Patent Act goes much further than
required to fulfils India’s WTO obligations and does not have provisions that are
necessary to strike a balance between the rights and obligations of the patent
holder88.

Patentable inventions

The TRIPs Agreement for the first time not only laid down uniform international
norms for an invention to be patentable but also spelt out the exceptions based on
which patents could be denied. Article 27(1) has not defined the term "invention"
but only lays down the norms/test to find out what constitutes an invention
whether it is a product or process. For an invention to be patentable as per TRIPs,
the invention shall be "new", having "inventive step" and "capable of industrial
application". It is important to note that these terms are not defined in TRIPs. It
appears that the Bill introduced a new definition for invention to satisfy Article.
The Bill also defined "inventive step and "capable of industrial application. It is
felt that these amendments are not required at this stage as the present Act and the
case-law produced under them serve the purpose proposed to be achieved by the
amendments. Inventions not patentable:
In line with Article 27 (2 and 3) of the TRIPs agreement, the following have been
excluded from patentability inventions:
(i) harmful for environment, human, animal or plant life etc;
(ii) diagnostic, therapeutic and surgical methods for the treatment of humans
or humans and animals and

88 Biswajit Dhar , C Niranjan Rao ,Third Amendment to 1970 Patent Act -- EPW VOL 39 No. 52 Dec 25 -
Dec 31,2004

227
 (iii) plants and animals other than microorganisms but including “seeds, varieties
and species and essentially biological processes for production or propagation of
plants and animals”.
One type of invention which has not been specifically mentioned in the TRIPs
agreement, but which has been excluded in the amended act is the country’s
traditional knowledge89.In fact grant of patent can be opposed on the ground that
the invention relates to “knowledge, oral or otherwise, available within any local
or indigenous community in India or elsewhere”90.
The Patent Act, 1970 followed a unique approach in identifying the inventions
capable of patent protection in India. It defined the term "invention and
expressly excluded certain inventions as not inventions for the purpose of the
Act. Even though inventions relating to atomic energy91 are treated as inventions
we excluded some of them from patent protection. In case of medicine or drugs
and chemical products there is no product patent but only process patent
protection. This was done to take care of the public interest particularly of food
security and health care.

An analysis of the existing definition of invention further makes it clear that it

includes both product and process inventions and incorporates the test of
patentability i.e. "novelty" and "utility". It is true that the terms "new" and
"useful" are not defined in the Act. But the terms "novelty" and "utility" have
■ been interpreted by the Supreme Court in Bishwanath Prasad Radhey Shyam v.
Hindustan Metal Industries92 to take care of the situation. The Act also mandates
that the patent examiner should examine the patent application for anticipation
by prior publication before grant of patent. Similarly an application can be
opposed on the grounds of anticipation by prior publication, prior use, lack of
utility, obviousness and lack of inventive step. These grounds have direct
relation to the terms "new", "inventive step" and "capable of industrial
application" mentioned in TRIPs. We have not experienced any difficulty in the

i9 Section 3(p)
’° Section 25(l)(k)
11 Section 4
’2 AIR 1983 SCI 444

228
 existing definition; nor are our provisions in conflict with Article 27 of TRIPs.
So there is no need to introduce a new definition for invention.

In fact the new definition may create difficulties for interpreting other terms. For
example, the term "product" is not defined. It is doubtful whether this will
include products of manufacture and other things as well. It is the application of
inventive faculty or the extent of human intervention that is traditionally treated
as inventive step in India. In Section 25(1 )(e) obvious and inventive step are
treated as two separate grounds to be established in case of opposition. As such
the present definition of "inventive step" runs counter to our present
understanding. The term "obvious" has not yet been subjected to any judicial
interpretation in India. The US courts in a number of cases interpreted the term
and it is different from inventive step, as we understand in India. The TRIPs
Agreement Note 5 however helps us to treat the terms "inventive step" and
"capable of industrial application" synonymous with the terms "non-obvious"
and "useful" respectively. In this situation it may be better for us to maintain the
status quo.

As per the TRIPs Agreement there is no obligation to grant patent protection for
the following inventions: (i) an invention the commercial exploitation of which
is prohibited on the ground of public order and morality (ii) an invention relating
to diagnostic, therapeutic and surgical methods for the treatment of humans or
animals, and (iii) invention of plants, animals, plant varieties and biological
processes93.

The revised clause seems to be against the letter and spirit of Article 27(2)of the
TRIPs Agreement. As per Article 27(2) an exemption is possible only in cases
where there is an express prohibition by law the commercial exploitation of the
products of the inventions on the grounds of public order and morality. This
may include protection of life, health and environment. It is also made clear that

93 The amendments introduced in Section 3 of the present Act are intended to make our exemptions in tune
with TRIPs.

229
such prohibition of commercial exploitation is not merely of the domestic law.
This means that the prohibition must be in areas where majority of member
States are also prohibiting commercial exploitation and denying protection. This
presupposes the existence of a domestic law similar to that of laws in other
countries prohibiting the commercial exploitation of the products based on new
invention. Only then it will be possible to deny patent protection to that
invention on the grounds of public order and morality. This is to ensure that in
case there is no prohibition of the commercial exploitation of an invention in a
country, the patent to an invention cannot be denied on the ground of public
order and morality.

As per the new clause (b) it is not mandatory that in all cases the commercial
exploitation must be prohibited by law. Even if there is no law prohibiting the
commercial exploitation of the product of the invention, under this clause patent
can be denied to the invention on the ground of morality or on the ground that
the invention causes serious prejudice to human, animal or plant life or health or
to the environment. Thus in a case where a patent to a new invention is denied
on the above ground in India, the product based on that invention can be
commercially exploited in India by any person if there is no law prohibiting the
commercial exploitation of that product. This is what Article 27(2) wanted to
prevent. Therefore the clause may be worded as follows:

(b) “an invention the commercial exploitation of which is prohibited by law on

the ground of public order or morality or causes serious prejudice to human,
animal or plant life or health or to the environment."

To expressly exclude naturally occurring things from patenting, the existing

Section 3(c) is amended to include "discovery of any living thing or non-living
substance occurring in nature". Sub-clause (g) of Section 3 is deleted and sub­
clause (i) dealing with inventions relating to method of treatment revised by way
of including "diagnostic and therapeutic". Inventions relating to method of

230
 treatment of plants are now patentable94.The amended Section 3(i) of the present
Act in addition to this also excludes from patent protection inventions relating to
the method of treatment of animals "to increase the economic value or that of
their products". This means new methods of hybridization to increase the
economic value of the animals or their products are not patentable. It is doubtful
whether this is permissible under Article 27(3)(a) since the expression
"treatment" seems confined to treatment for disease.

It included six more new clauses , to exclude life form , computer program,
works protected under copyright, method of mental acts or playing games and
integrated circuits , from patent protection in India. The new sub-clause (j) in
Section 3 dealing with exemption of patent protection on inventions relating to
life forms excluded micro-organisms. This means that there can be immediate
patent protection for micro-organisms. It is true that as per Article 27(3) India is
required to grant patent protection for new micro-organisms. But as per Article
65(4)31 of the TRIPs Agreement

It is common knowledge that the items like literary, dramatic, musical works
will not fall within the scope of patent law. They are protected under the
Copyright Act. If sub-sections (1) and (n) are included by way of abundant
caution keeping in mind the new definition of "invention" there is no
justification in excluding "sound recording" from this provision, which finds
protection under the Copyright Act. It is necessary to include "sound recording"
since this can also be treated as a product.

Rights of patent owner95

The TRIPs Agreement has spelt out various rights available to the owner of
product and process patent separately. This includes the new right of
importation of patented products. Section 48 of the Patent Act is amended

94 As per Article 27(3)(a) of the TRIPs Agreement only diagnostic, therapeutic and surgical methods of
treatment of humans or animals can be excluded from patent protection.
95 Section 48

231
 prospectively to satisfy this requirement. Thus the new rights are available to the
owners of the patents granted only after the commencement of the Patent
(Second Amendment) Act, 1999. The terminology used in the section is the
same as that of the TRIPs Agreement. It is clear from the TRIPs Agreement that
the right of importation will not affect the exhaustion of rights. Making use of
this provision a new provision is introduced to facilitate parallel import of
patented products. According to new Section 107-A importation of patented
products by any person from a person who is duly authorised by the patentee to
sell or distribute the product shall not be considered as an infringement of patent
rights. This is a welcome step and will surely help to reduce the adverse impact
of the right of importation.

Term of protection96

The term of protection in India as per the existing law is fourteen years counted
from the date of patent. But in case of process patent for food, medicine or drug,
the period is five years from the date of sealing of the patent, or seven years
from the. date of patent, whichever period is shorter. This existence of the patent
is subjected to periodic renewal of the patent by payment of fee. The TRIPs
Agreement mandates a uniform term of twenty years from the date of filing of
the patent application irrespective of whether the invention is a product or
process. The Bill introduces this uniform term of patent. To make it clear that
there shall not be any protection for the invention after the expiration of the term
of patent a new sub-section is also introduced. It is true that we have no option
but to change the law. But the extension of period of patent protection is going
to be disadvantageous to Indian industry and economic growth considering the
fact that the majority of the patents taken in India are by foreigners that too in
sectors where we have the potential to grow.

Use without authorisation

few term is Uniform throughout the world i.e. 20 years

232
 The Patent Act, 1970 envisages grant of compulsory licences97 and statutory
licences98 for not working the patent in India to satisfy the reasonable
requirements of the public. These provisions were introduced in the Act
considering the fact that majority of the commercially viable patents taken in
India were owned by foreigners and were not actually worked in India by
manufacturing the product by the owners or by giving licences to the Indian
manufacturer. It was also felt that the existence of unrestricted patent monopoly
was a hindrance to the industrial growth of our nation. The TRIPs Agreement
introduced many restrictions regarding the use of patent by an individual or by
the Government without authorisation of the patent owner. These restrictions
conflict with the existing provisions of the Patent Act. Many changes are
introduced in the Bill to make the Act in tune with the TRIPs provisions.

One of the important restrictions in TRIPs is that compulsory licence shall be

granted only on the basis of individual merits and that too after the unsuccessful
efforts by the proposed user to get a voluntary licence from the owner on
reasonable commercial terms and conditions. This is to ensure that there must be
efforts to get a voluntary licence by the proposed user before restoring to
compulsory licences and also to make sure that there are no provisions for the
grant of statutory licences. There is an exception to these requirements in case of
national emergency, circumstances of extreme urgency and public non­
commercial use. As per the existing provisions of the Act this is not required.
There are also instances where after the expiry of three years of grant of patent
the invention can be used by anyone without the permission of the owner by
satisfying the conditions laid down in the Act99. A consequential amendment is
also introduced in Section 89 dealing with revocation of patent on the ground of
non-working even after the grant of compulsory licence. Thus the provision

97 The compulsory licence is granted at the request of an interested person.

58The statutory licence include the general power of the Central Government to notify any patent as a patent
endorsed with the licence of right and an express provision treating all patents relating to drugs or
medicine as patents deemed to have been endorsed with licence of right.
39 Statutory licence

233
 dealing with statutory licence is taken away from the Act100. But it is interesting
to note that non-working of patented invention in. India has been expressly
provided as a ground for compulsory licence in Section 84.

There are many circumstances under which the reasonable requirements of the
public by working the patents in India will be deemed to have been not satisfied
for the purpose of the grant of compulsory licences. They are spelt out in
Section 90 of the Act. These grounds take care of not only the industrial growth
of India but also availability of the products to the consumer at reasonable price.
If these grounds are not satisfied it is possible to grant a compulsory licence.
One of the conditions included in Section 90 as a ground for satisfying
reasonable requirements of the public is the obligation to actually manufacture
the patented product either by the owner or by his licensee. Since Article
27(1)101 mandates grant of patent and patent rights irrespective of whether the
patented products are imported or locally produced and Article 28102 expressly
recognises importation of the patented products as a right of the patent owner, it
is not obligatory on the part of the patent owner to actually manufacture the
patented product in the country to satisfy the reasonable requirement of the
public. It is possible for the owner to import the patented product and sell it at a
reasonable price and satisfy the requirement of the public. Thus the grounds
"failure to manufacture the products in India" and "satisfying the reasonable
requirements by importing the products" are omitted from Section 90.' But it is
pertinent to note that Section 90(e) dealing with importation affecting the
working of patents in India is retained with modification . It appears that this
provision will conflict with the importation right of the patent owner and his
right to enjoy his patent rights even without locally producing the patented
product recognised under TRIPs, Just like clause (id) we have to omit clause (e)
also.

To introduce the TRIPs conditions a new sub-clause is introduced in the existing Section 85 and
ctions 86, 87 and 88 dealing with licences of right (statutory licence)
Article 2
Article 28

234
 A new ground is introduced in Section 90 to prevent imposition of
unreasonable conditions while granting voluntary licence. Now it is possible to
grant a compulsory licence if the patentee insists on including an exclusive
grant-back clause or a clause preventing the challenges to the validity of patent
or a coercive package licensing as conditions for grant of licence. This is a
welcome move. To satisfy other conditions in Article 31 an amendment is
introduced in Section 95 dealing with the conditions for grant of compulsory
licence. A new Section 95-A dealing with termination of the compulsory licence
is also introduced since there is no such provision at present in the Act103. The
provision dealing with the power of the Government to use the patent is also
amended.

The history of administration of compulsory licensing provisions in the

Act shows that these provisions were used only on very limited occasions104.
But in the context of liberalisation and globalisation the compulsory licensing
provisions may be of better use for Indian industrial growth. Even today 85 per
cent of the patents taken in India are owned by foreigners105. Many of them are
not worked in India by actual manufacture of the products. At least in some
sectors Indian industries are- capable of manufacturing these new products if
permission is granted. It is needless to mention that it is the actual manufacture
of the patented products in India by our industries that will enable us to get the
maximum return for the grant of patent monopoly. But the strict conditions
particularly prior negotiations, non-exclusive and non-assignable nature of
licence, use of the licence predominantly for supply of the products in the Indian
market, provision for termination of the licence when the circumstances for the
grant of compulsory licence are unlikely to occur etc., will make the fate of the
provision the same as that of its predecessor. These conditions will force the
Indian manufacturers to go for voluntary licensing with strict conditions or for

103 This allows the patentee or others interested in the patent to approach the Controller for the termination
of the compulsory licence since the circumstances under which the licence was granted are not in existence
and are unlikely to occur
104 This may be due to the nature of the industrial and economic policies followed in India
105 See Grover Anand. A Patent Follv.From lawyers Collective January 2005 p.6

235
 equity participation or for joint venture rather than manufacture the product
based on compulsory licences. This will make the Indian industry and economic
growth largely dependent and controlled by foreign patent-holders who are
undoubtedly large corporations.

e REVIEW

The Patent Act 1970 (Amendment 2005) has thus finally come to exist against the
above background. The main point of conflict was the deletion of Section (5) of
the earlier Act106 .In the present Act the product patents are now being allowed in
these cases also. The restriction to process patenting in these vital sectors was in
keeping with the interests of the country where a large population remains below
poverty line and the development of processes alternative to the patented ones
was an incentive to Indian scientists in the country to invent. This provision
served to nurture the development of an indigenous pharmaceutical industry and
by the 1990s Indian drug companies had become the fourth largest in the world
when ranked by volume of drugs produced. Now with the product itself being
patentable, an invention of any alternative process may not yield the desired
effect.
The second bone of contention relates to the period of grant of Patents
which is now uniform for all products for 20 years. This will seriously affect the
availability of new life saving drugs at affordable costs for many more years than
otherwise provided for under the earlier Act and this view is shared by several
academics, economists and industry men in India and in other developing
countries.
The third point is in the definition of "patentable inventions" wherein new use of a-
product was not an invention earlier. This has been amended to describe "mere
new use" as being non-patentable invention u/s 3(d) of the new Act. This
amendment, as aptly described, shall lead to "ever greening of Patents".

which provided only for process patenting in food, medicine and drugs for period of 5 years from the
:e of sealing of the Patent or 7 years from the date of Patent whichever be shorter.

236
 The selection of the above issues is done because of the need to focus on the
provisions of patent and other related issues. The states which are party to these
arrangements are obliged to legislate their IP laws in a manner which makes it
compatible with the agreement per se. However, even with this mandatory
nature of the agreement, it has left adequate space for the individual states to
sufficiently manoeuvre their interest at the national level. Adoption of the
regime of intellectual property protection in conformity with the proposals of the
TRIPs Agreement has been at the centre of an ongoing debate in India for
several years now.With the enactment of Patent Amendment Act 2005,the
amending process of IPA,1970 to bring it in line with the TRIPs final
agreement has been completed107.

The third amendment to the 1970 Patent Act goes much further than required to
fulfil India’s WTO obligations and does not have provisions that are necessary
to strike a balance between the rights and obligations of the patent holder.108.

While the recent changes in India patent laws are a dramatic shift in intellectual
property policy in India, it is a first step. Promulgation of rules to implement the
new law remains outstanding, and certain provisions of the Act are controversial
in that it is not clear that they are in compliance with TRIPs. Thus, the rules, as
well as the law itself, are still subject to revision.

The three amendments to the Indian Patents Act were made alongside intense
debates which emphasised that with the rights of the patent holders strengthened
under TRIPs, there is an urgent need to balance this situation with more effective
instruments so as to ensure that the public interest issues, as for example, access
to medicines at affordable prices are also addressed. The global community took a
major step towards bringing about a balance through the 2001 Doha Declaration
on TRIPs Agreement and Public Health. While the third amendment of the Indian

107 Venkatarammu PreetLProtection of inventions:A bird eve ofPatent Laws in facfcr.Intellectual Property
Laws-Sreenivasulu N.S.,Regal Publications,p.31
108 Dhar Biswajit and Rao C Niranjan, Third Amendment to 1970 Patent Act, EPW,VOL 39 No. 52 25 -
Dec 31,2004

237
 Patents Act takes steps to address some of the more difficult issues in TRIPs,
there remains a need to revisit the key provisions of the Patents Act keeping in
view the imperatives of access to medicines109.
With effect from 3-1-2005 India has recognized the product patents of all
signatories to GATT. The important changes are110:
o grant of patents for pharmaceutical, chemicals and food substances per se
which are at present unpatentable vide Sections 3 and 5 of the Patents Act;
® enlargement of the term of a patent from 14 years to 20 years from the date of
filing;
• recognition of micro-organism as a patentable subject-matter;
® reversal of burden of proof in cases of infringement of a process for
producing a novel compound where it prima facie appears that no other
process could have been used.
With the enactment of third patent amendment act, India have a fully TRIPs
compliant system and scene has been set in India for an interesting era in the
national patent system. Now it is said that the compliance of TRIPS by India will
disturb the well drafted Indian Patents Act by diluting the obligations of the patent
holder to the country where it is commercialized at the same time, enlarging the
legal right of the patent holder. Future will tell ,but we have to take maximum
benefit out of the new patent regime.

The Patent provisions of TRIPs would of course place India in an unfavourable

situation when compared to the past. However an impartial judgement would
perhaps justify the patent provisions of TRIPs11'.
India been a developing country and a signatory member to TRIPs agreement
got the benefit of transitional period of 10 years to make its IP laws, particularly
patent law, TRIPs compliant. This transitional period was from 1.1.1995 to
1.1.2005. In line to be TRIPs compliant Government of India made three

> Dhar Biswajit and Rao C Niranjan, Reflections on a TRIPS-Compliant Law. EPW ,VOL 40 No. 15
-il 09-April 15,2005
i Katju Markandey,Justice, Intellectual Property Rishts And The Challenges Faced By The
irmaceutical Industry (2004) 4 SCC (Jour) 46
Mvneni.S.R..-JFor/d' Trade Organisation ,Asia Law House, p.70

238
 important amendments to the .Patents Act, 1970. The first amendment (1999)
introduced the provisions regarding Exclusive Marketing Rights (EMR) for
pharmaceutical and agro-chemicals products, famously known as “Mail-box”
provision. The second amendment (2002) made some critical amendments
including term of patent (20 years from’ the date of filing, earlier it was 14 years
for non-pharmaceutical patents and 7 years from pharmaceutical patents),
broadening the scope of non-patentable inventions and provisions regarding
PCT. The third and last amendment (2005) deleted EMR provisions and
reintroduced the product patent in the field of pharmaceuticals, chemical, agro­
chemicals and food. However, third amendment also further broadens the scope
of non-patentability, particularly related to pharmaceuticals to prevent the ever
greening of patents.

Section 5 of the Indian Patents Act, which deals inter alia with patentability of
inventions where only methods or processes of manufacture relating to
medicines, drugs stands amended. Sub-clause (2) has now been inserted which
provides that a claim for patent of an invention for a substance itself intended
for use, or capable of being used, as medicine or drug may be made. The manner
how such claim is to be dealt with is provided in the newly inserted Chapter
IVA.

The Indian Patents Act sets forth the requirements for patents, specifically
detailing patent rights and terms, and describes that subject matter which cannot
be patented. Although the Act was not always TRIPs compliant, the Dispute

Settlement Body of the World Trade Organization declared in May 1999 that India is
now in full compliance with its “international obligations” to the WTO, including
TRIPS.With India signing the WTO agreement in 1995, which included a TRIPs
component, it committed itself to make its IPR regime TRIPs—compliant112.

112 Kaushik, H.hasiia Patent Pharmaceuticals the Indian Scewa/mM.D.U.law journal. vol.9,2004,p.281

239
 At last we can say that India ratifies the agreement establishing the WTO.
This agreement inter alia prescribes the minimum standards to be adopted by the
member countries in respect of Intellectual Property. The TRIPs Agreement has
provided the most comprehensive global framework for patenting which its
member countries have to implement through national legislations. The
amendment of the Patents Act, 1970 was only the first step to comply with
immediate obligations under Article 70.8 (acceptance of applications for product
patents for pharmaceutical and agricultural chemical products from 1.1.1995 by
providing a "mailbox") and Article 70.9 (grant of exclusive marketing rights to
these products for five years) after India lost the case against the United States
and the European community before Dispute Settlement Body of the WTO. By
introduction of the product patent and patent term of 20 years, India has
complied with the TRIPs Agreement in toto.

Despite the detrimental effect that the TRIPs agreement is going to have the right
to health if the citizens, India has to large extent already implemented its
obligations by amendments to the patents Act 1970 introduced in 1999,2002and
2005. These amendments effectively provide protection for both product and
process patents, extend the period of protection from 7 to 20 years, set up the mail
box facility for product patent applications and provide for the granting of EMRs
in the interim period between 1-1-95 to 1-1-2001. Provisions for compulsory
licenses have also been incorporated with all the required safeguards. Thus the
only amendment that was required to be made by the government to comply with
TRIPs was one which dealt with the processing of product patent applications113,
which has been fulfilled in 2005 amendment.
The recent amendment to the Patent Act, 1970 brings India into lull compliance
with its obligations under the Trade-related Aspects of Intellectual Property
Rights agreement, in particular allowing for product patents in the area of
pharmaceuticals and agri-chemicals. This amendment, the third to the 1970 Act,

3 Grover, Nikku,/4 Patent folly. Lawyers collective, Jan 2005, p.4

240
 was characterised by a relatively muted rhetoric and a remarkable level of
shared consensus amongst campaigners and critics114.

The 2005 Amendment Act makes the Indian Patent Law not only ' TRIPs
compliance but also incorporates safeguards for protection of public interest,
national security, bio-diversity, traditional knowledge etc. The opportunity has
also been utilized to harmonize the patent procedures with international
practices, and to make the system user friendly.

114 Rangnekar Dwijen, No Pills for Poor People? EPW : VOL 41 No. 05 Feb 04 - Feb 10,2006

241