CHAPTER-2

REGIME OF PATENT IN INDIA AND ITS GLOBAL SCENARIO

2.1 INTRODUCTION
It has been recognized by industry, academia, and policy makers alike that
innovation is pivotal to value creation, competitive advantage, and sustainable
economic growth. As knowledge economy became the basis for globalization,
innovation opportunities have been incessantly emerging around the world for
value-added products, processes, and services to meet the ever-growing needs,
wants, challenges, and opportunities of the world 1.Innovation has been a vital
component of the American success story. In fact, the Joint Economic Committee of
the U.S. Congress estimates that as much as 50% of all economic growth in the US
over the past half-century can be attributed to productivity gains resulting from
innovation2

Patents is the representation of innovation and so one of the most powerful

Intellectual property rights. The purpose of the law of patents is to protect inventive
ideas by giving the inventor exclusive rights over the invention for a period of time.
The procedure for granting patent, the requirements placed on the patentee and
the extent of exclusive rights vary between countries according to the national laws
and international agreements. The protection provided by patents is more useful in
some industries than in others. For example, chemical and pharmaceutical firms
are large users of the patent system partly because innovations within these
industries tend to be relatively cheap to imitate. Companies within these industries
see patent registration as an important part of maintaining competitive advantage.

In all areas of intellectual property there is trade-off between the creator’s right to
commercially exploit his or her novel idea and the community’s right to benefit
from those creations. Intellectual property rights are regarded as personal property
and can be bought, sold and licensed like other forms of property. In the light of
importance of innovation link with development of society this paper is discussing
on the Indian patent law and its scenario in the global context.

An invention relating to a product or a process, involving inventive step and

capable of industrial application can be patented in India. However, it must not fall
into the category of inventions that are non-patentable as provided under Section 3
and 4 of the (Indian) Patents Act, 1970. In India, a patent application can be filed,
either alone or jointly, by true and first inventor or his assignee.

The chronology of Indian Patent Act is as follows:

1
Kung Chung Liu and Uday S. Racerla (eds.), Innovation, Economic Development, and
Intellectual Property in India and China 272 (Springer, Singapore, 2019)
2
Khanna, Aman Raj; Singh, Hemant Krishan. 2015. India’s IPR Regime: Reconciling
Affordable Access with Patent Protection.
 A) 1856 - The Act of 1856 on protection of inventions based on the British
Patent Law of 1852. Certain exclusive privileges granted to inventors of
new manufactured for a period of 14 years.
B) 1859 – The Act modified as act xv Patent monopolies called exclusive
privileges (making, selling and using inventions in India and authorizing
others to do so for 14 years from the date of filling specifications)
C) 1872- The patterns & Designs Protection Act
D) 1883- The protection of Inventions Act
E) 1888- Consolidation as the Inventions & Designs Act
F) 1911- The Indian Patents & Designs Act vii) 1970 - The Patents Act, 1970
G) 1999- On march 26,1999 Patents( Amendment) Act, (1999) came into force
from01-01-1995
H) 2002- The Patents (Amendments ) Act 2002 came into force from 20th
May 2003.
I) 2005 - The Patents (Amendment ) Act 2005 effective from 1st January
2005

In India Patent Act was introduced in the year 1856 which remained in force for
over 50 years, which was subsequently modified and amended and was called The
Indian Patents and Designs Act, 1911 3. After Independence a comprehensive bill on
patent rights was enacted in the year 1970 and was called “The Patents Act, 1970”.

Later, India became signatory to many international arrangements with an

objective of strengthening its patent law and coming in league with the modern
world. One of the significant steps towards achieving this objective was becoming
the member of the Trade Related Intellectual Property Rights (TRIPS) system.

Significantly, India also became signatory of the Paris Convention and the Patent
Cooperation Treaty on 7th December 1998 4 and thereafter signed the Budapest
Treaty on 17th December 2001.

2.2 CONCEPT OF PATENT

The creative work of the human mind is protected through several measures and
the main motivation for the same is that such protection is a definite measure of
encouragement for the creative activity. Several forms of protection of the creative
activity have come about including those which are of particular interest in the
industrial development. Patents being one of them. Generally speaking, patent is a
monopoly grant and it enables the inventor to control the output and within the
limits set by demand, the price of the patented products. Underlying economic and
commercial justification for the patent system is that it acts as a stimulus to
investment in the Industrial innovation. Innovative technology leads to the
3
Department for Promotion of Industry and Internal Trade | MoCI | GoI | Ministry
of Commerce and Industry | GOI"

4
The PCT now has 153 Contracting States". WIPO. Retrieved 17 October 2019.
maintenance of and increase in nations stock of valuable, tradable and industrial
assets.

The grant of first patent can be traced as far back as 500 B.C. 5 It was the city
dominated by gaurmands, and perhaps the first, to grant what we now-a-days call
patent right to promote culinary art. For it conferred exclusive rights of sale to any
confectioner who first invented a delicious dish. As the practice was extended to
other Greek cities and to other crafts and commodities, it acquired a name
‘monopoly’, a Greek Portmanteau word from mono (alone) and polein (sale).

Evidences of grant to private individuals by kings and rulers of exclusive property

rights to inventors dates back to the 14th Century, but their purpose varied
throughout the history. History shows that in 15th Century in Venice there had
been systematic use of monopoly privileges for inventors for the encouragement of
invention. Utility and novelty of the invention were the important considerations for
granting a patent privilege. The inventors were also required to put their invention
in commercial use within a specified period. In 16th Century the German princes
awarded inventors of new arts and machines and also took into consideration the
utility and novelty of inventions. Early laws in American colonies served primarily
to encourage foreign manufacturers to establish new industries in the colonies by
providing them protected domestic markets.

By the late 15th Century, the English monarchy increasingly started using
monopoly privilege to reward court favourites, to secure loyalty and to secure
control over the industry but these privileges were not used to encourage
inventions. In 1623, the English Parliament adopted a Statute of monopolies which
recognised the inventors patent as a justifiable monopoly to be distinguished from
other monopoly privileges. The Statute outlawed the awarding of monopoly
privileges except for first and true inventor of a new manufacture.

In England during the 16th and 17th Century, the inventor’s patent of monopoly
had become of great national importance. From the mid-seventeenth Century
through the mid-nineteenth Century, the laws recognising the patent monopoly
spread throughout Europe and North America, but these privileges were not
granted without the opposition.

The origin of the Indian Patent System could be traced to the Act of 1856 granting
exclusive privileges to inventors. The patent regime at the time of Independence
was governed by the Patents and Designs Act, 1911, which had provisions both for
product and process patents. It was, however, generally felt that the patent law had
done little good to the people of the country. The way the Act was designed
benefited foreigners far more than Indians. It did not help at all in the promotion of
scientific research and industrialization in the country, and it curbed the
innovativeness and inventiveness of Indians.

5
History of Patents: Everything You Need to Know;https:upcounsel.com
Shortly after Independence, therefore, in 1949, a committee was constituted under
the chairmanship of Justice (Dr.) Bakshi Tek Chand, 6 a retired judge of the Lahore
High Court, to undertake a comprehensive review of the working of the 1911 Act.
The Committee submitted its interim report on August 4, 1949 and the final report
in1950 making recommendations for prevention of misuse or abuse of patent rights
in India. It also observed that the Patent Act should contain a clear indication that
food and medicine and surgical and curative devices were to be made available to
the public at the cheapest price commensurate with giving reasonable
compensation to the patentee. Based on the committee’s recommendations, the
1911 Act was amended in 1950 (by Act XXXII of 1950) in relation to working of
inventions, including compulsory licensing and revocation of patents. In 1952, a
further amendment was made (by Act LXX of 1952) to provide for compulsory
license in respect of food and medicines, insecticide, germicide or fungicide, and a
process for producing substance or any invention relating to surgical or curative
devices. The committee’s recommendation prompted the Government to introduce a
bill (Bill no. 59 of 1953) in Parliament, but the bill was not pressed and it was
allowed to lapse.

In 1957, another committee came to be appointed under the chairmanship of

Justice N. Rajagopala Ayyangar to take a fresh look at the law of patent and to
completely revamp and recast it to best sub-serve the contemporary needs of the
country. Justice Ayyangar’s report specially discussed (a) patents for chemical
inventions; and (b) patents for inventions relating to food and medicine. Justice
Ayyangar submitted a comprehensive Report on Patent Law Revision in September
1959 and the new law of patent, namely, the Patents Act, 1970, came to be enacted
mainly based on the recommendations of the report, and came into force on April
20, 1972 replacing the Patents and Designs Act, 1911. However, the 1911 Act
continued to be applicable to designs.

2.3 THE PATENTS ACT, 1970

The Patents Act, 1970 remained in force for about 24 years without any change till
December 1994. Being a landmark in the industrial development of India, the basic
philosophy of the Act is that patents are granted to encourage inventions and to
secure that these inventions are worked on a commercial scale without undue
delay; and patents are granted not merely to enable patentee to enjoy a monopoly
for the importation of the patented article into the country. The said philosophy is
being implemented through compulsory licensing, registration of only process
patents for food, medicine or drug, pesticides and substances produced by
chemical processes which, apart from chemical substances normally understood,
also include items such as alloys, optical glass, semi-conductors, inter metallic
compounds etc. It may, however, be noted that products vital for our economy such
as agriculture & horticulture products, atomic energy inventions and all living
things are not patentable. Thus, the Patents Act 1970 was expected to provide a
6
Guidelinesfor Examination of Patent Applicationsin the Field of Pharmaceuticals; available at
https://ipindia.gov.in/writereaddata/Portal/IPOGuidelinesManuals/1_37_1_3-guidelines-for-examination-of-
patent-applications-pharmaceutical.pdf
reasonable balance between adequate and effective protection of patents on the one
hand and the technology development, public interest and specific needs of the
country on the other hand.

Uruguay round of GATT negotiations paved the way for WTO. Therefore, India was
put under the contractual obligation to amend its Patents Act in compliance with
the provisions of TRIPS. India had to meet the first set of requirements on 1-1-
1995. Accordingly an Ordinance effecting certain changes in the Act was issued on
31st December 1994, which ceased to operate after six months. Subsequently,
another Ordinance was issued in 1999. This Ordinance was subsequently replaced
by the Patents (Amendment) Act, 1999 that was brought into force retrospectively
from 1st January, 1995. The amended Act provided for filing of applications for
product patents in the areas of drugs, pharmaceuticals and agro chemicals though
such patents were not allowed. However, such applications were to be examined
only after 31-12-2004. Meanwhile, the applicants could be allowed Exclusive
Marketing Rights (EMR) to sell or distribute these products in India, subject to
fulfilment of certain conditions.

India amended its Patents Act again in 2002 through the Patents (Amendment) Act,
2002 increasing the term of patent to 20 years for all technology, Reversal of
burden of proof, compulsory licences etc. This Act came into force on 20th May
2003 with the introduction of the new Patent Rules, 2003 by replacing the earlier
Patents Rules, 1972.

The third amendment to the Patents Act 1970 was introduced through the Patents
(Amendment) Ordinance, 2004 w.e.f. 1st January, 2005 incorporating provisions
for granting product patent in all fields of Technology including chemicals, food,
drugs & agrochemicals. This Ordinance was later replaced by the Patents
(Amendment) Act 2005 on 4th April, 2005 which is in force now having effect from
1-1-2005.

2.3.1 Product and process patent

Section 5 of the Patent Act 1970 had provided for grant of only process patents in
certain categories of inventions. It may be pointed out here that under the Patent
Act, 1970, in all other areas product and process patents could be issued and have
been issued. The Paris Convention has left this issue to be dealt with in the States
legislation in a manner of its own choice.

The TRIPs Agreement under Article 27.1 7 stipulates that patents shall be available
for any inventions, whether products or processes in all fields of technology except
for the exclusion stipulated under Article 27.2 and 27.3.

7
World Trade Organization, "Part II — Standards concerning the availability, scope and use of Intellectual
Property Rights; Sections 5 and 6", Agreement on Trade-Related Aspects of Intellectual Property Rights
Pursuant to the TRIPs agreement, the Patent Act, 1970 was amended in 2002 8.
Section 5 of the Patents Act, 1970 (as it stood after the 2002 amendments) provided
that, in the case of inventions being claimed relating to food, medicine, drugs or
chemical substances, only patents relating to the methods or processes of
manufacture of such substances could be obtained.

An explanation appended to the Section 5 provided that “chemical process”

includes biochemical, biotechnological and microbiological processes.
Subsequently, Section 5 of the Patents Act, 1970 was deleted by the Patents
(Amendment) Act, 2005 that came into force on 01.01.2005, thereby paving the
way for product patents.

This deliberate strategy of denying product patent protection to pharmaceutical

inventions is traceable to the Ayyangar Committee Report, a report that formed the
very basis of the Patents Act, 1970. The Committee found that foreigners held
between eighty and ninety percent of Indian patents and that more than ninety
percent of these patents were not even worked in India. The Committee concluded
that the system was being exploited by multinationals to achieve monopolistic
control over the market, especially in relation to vital industries such as food,
chemicals and pharmaceuticals.

The Patents Act has been amended keeping in view the development of
technological capability in India, coupled with the need for integrating the
intellectual property system with international practices and intellectual property
regimes. The amendments have also been aimed at making the Act a modern,
harmonised and user-friendly legislation to adequately protect national and public
interests while simultaneously meeting India’s international obligations

2.3.2 Duration of patents

Section 53 provides that the term of every patent granted after the commencement
of the Patents (Amendment) Act, 2002 and the term of every patent which has not
expired and has not ceased to have effect, on the date of such commencement,
shall be twenty years from the date of filing of application for the patent.

Explanation to Section 53(1) clarifies that the term of patent in case of

international applications filed under the PCT designating India, shall be twenty
years from the international filing date accorded under the Patent Cooperation
Treaty.9

A patent shall cease to have effect on the expiration of the period prescribed for the
payment of any renewal fee, if that fee is not paid within the prescribed period or
within such extended period as may be prescribed. Further on cessation of the

8
The Patents (Amendment) Act, 2002, No. 38, Acts of Parliament, 2002 (India), available at
http://www.ipindia.nic.in/ipr/patent/patentg.pdf

9
World Trade Organization, "Part II — Standards concerning the availability, scope and use of Intellectual
Property Rights; Sections 5 and 6", Agreement on Trade-Related Aspects of Intellectual Property Rights
patent right due to non-payment of renewal fee or on expiry of the term of patent,
the subject matter covered by the said patent shall not be entitled to any
protection.

2.3.3 Patentable subject matter

A patent is granted for an invention which may be related to any process or

product. An invention is different from a discovery. Discovery is something that
already existed but had not been found. Not all inventions are patentable. An
invention must fulfil certain requirements known as conditions of patentability. The
word invention under the Patents Act 1970 means a new product or process
involving an inventive step and capable of industrial application. (Section 2(1)(j)).

The patent must be in respect of an invention and not a discovery. The

fundamental principle of Patent Law is that a patent is granted only for an
invention which must be new and useful. That is to say, it must have novelty and
utility. It is essential for the validity of a patent that it must be the inventor’s own
discovery as opposed to mere verification of what was already known before the
date of the patent… It is important to bear in mind that in order to be patentable
an improvement on something known before or a combination of different matters
already known, should be something more than a mere workshop improvement;
and must independently satisfy the test of invention or an “inventive step”. To be
patentable the improvement or the combination must produce a new result, or a
new article or a better or cheaper article than before.

Therefore, the conditions of patentability are Novelty, Inventive step (non-

obviousness) and Industrial applicability (utility)

2.3.3.1 Novelty

A novel invention is one, which has not been disclosed, in the prior art where prior
art means everything that has been published, presented or otherwise disclosed to
the public on the date of patent. Therefore, an invention shall be considered to be
new, if it does not form part of the prior art. 10 Although the term prior art has not
been defined under the Indian Patents Act, it shall be determined by the provisions
of Section 13 read with the provisions of Sections 29 to 34

a) An invention shall not be considered to be novel if it has been anticipated

by publication before the date of the filing of the application in any of the
specification filed in pursuance of application for patent in India on or
after the 1st day of January 1912.
b) An invention shall not be considered to be novel if it has been anticipated
by publication made before the date of filing of the application in any of the
documents in any country.
c) An invention shall not be considered to be novel if it has been claimed in
any claim of any other complete specification filed in India which is filed
before the application but published after said application.
10
The expression 'background art' ... must have the same meaning as the more familiar expression 'prior art'"
in EPO Board of appeal decision T 11/82 of 15 April 1983
 d) An invention shall not be considered to be novel if it has been anticipated
having regard to the knowledge, oral or otherwise, available within any
local or indigenous community in India or elsewhere.

2.3.3.2 Inventive Step (Non-obviousness)

Inventive step is a feature of an invention that involves technical advance as

compared to existing knowledge or having economic significance or both, making
the invention non obvious to a person skilled in art. Here definition of inventive
step has been enlarged to include economic significance of the invention apart from
already existing criteria for determining inventive step. 11

An invention shall not be considered as involving an inventive step, if, having

regard to the state of the art, it is obvious to a person skilled in the art. The term
"obvious" means that which does not go beyond the normal progress of technology
but merely follows plainly or logically from the prior art, i.e. something which does
not involve the exercise of any skill or ability beyond that to be expected of the
person skilled in the Art.

2.3.3.3 Industrial Applicability

An invention is capable of industrial application if it satisfies three conditions,

cumulatively which are can be made, can be used in at least one field of activity
and can be reproduced with the same characteristics as many times as necessary.

2.3.4 Non Patentable subject matter

An invention may satisfy the condition of novelty, inventiveness and usefulness but
it may not qualify for a patent. The following are not inventions within the meaning
of Section 3 of the Patents Act, 1970:

a) an invention which is frivolous or which claims anything obviously contrary

to well established natural laws;
b) an invention the primary or intended use or commercial exploitation of
which could be contrary to public order or morality or which causes serious
prejudice to human, animal or plant life or health or to the environment;
c) the mere discovery of a scientific principle or the formulation of an abstract
theory or discovery of any living thing or non-living substances occurring in
nature;
d) 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 property or mere new use for a known substance or of
the mere use of a known process, machine or apparatus unless such known
process results in a new product or employs at least one new reactant;
Explanation to clause (d) clarifies that salts, esters, polymorphs, metabolites,
11
Barton, John H. (2003). "Non-Obviousness". IDEA. 43 (3): 475–506. "Non-obviousness," or, as known in
Europe, "inventive step" is one of four traditional (and widely accepted) requirements for the grant of a
patent.
 pure form, particle size, isomers, mixtures of isomers, complexes,
combinations and other derivatives of known substance shall be considered
to be the same substance, unless they differ significantly in properties with
regard to efficacy
e) a substance obtained by a mere admixture resulting only in the aggregation
of the properties of the components thereof or a process for producing such
substance
f) the mere arrangement or re-arrangement or duplication of known devices
each functioning independently of one another in a known way;
g) a computer programme per se other than its technical application to
industry or a combination with hardware;
h) a method of agriculture or horticulture;
i) any process for the medicinal, 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 products;
j) plants and animals in whole or any part thereof other than micro-organisms
but including seeds, varieties and species and essentially biological
processes for production or propagation of plants and animals;
k) a literary, dramatic, musical or artistic work or any other aesthetic creation
whatsoever including cinematographic works and television productions;

Section 20 of the Atomic Energy Act, 1962 contains special provision relating to
inventions. Under Section 20 (1) of the Atomic Energy Act, 1962 “no patents
shall be granted for inventions which in the opinion of the Central Government
are useful for or relate to the production, control, use or disposal of atomic
energy or the prospecting, mining, extraction, production, physical and
chemical treatment, fabrication, enrichment, canning or use of any prescribed
substance or radioactive substance or the ensuring of safety in atomic energy
operations”.

2.4 PATENT AMENDMENTS POST 1995

TRIPS accelerated the transformation of India's patent laws in a multi phased
manner that corresponded to three amendments to the Patents Act, 1970. Initially
a mailbox facility was established, which allowed applicants to file pharmaceutical
product patent applications. Applicants were to be given exclusive marketing rights
("EMRs"), subject to certain conditions, to market the product for a period up to five
years from the date of grant. 12 The second amendment to the 1970 law was made in
2002.13 This amendment brought it into conformity with TRIPS on many issues, as
it provided for a twenty year patent term," reversal of the burden of proof for
process patent infringement, and modifications to compulsory licensing
requirements. By virtue of the third amendment in 2005, 14 the 1970 law offered

12
The Patents (Amendment) Act, 1999, No. 17 sec. 24(B)(1)(a)-(b), Acts of Parliament, 1999 (India), available at
http://ipindia.nic.in/ipr/patent/patact-99.PDF.
13
The Patents (Amendment) Act, 2002, No. 38, Acts of Parliament, 2002 (India), available at
http://www.ipindia.nic.in/ipr/patent/patentg.pdf
patent protection to pharmaceutical products, and in the process became
substantially compliant with TRIPS 15.

2.5 PATENTS AMENDMENT ACT 1999

Even though India was given exemptions from implementing
pharmaceutical/agrochemical product patents until 2005, it was mandated to set
up a mailbox facility for such product patent applications filed during the TRIPS
transition period and to assign each application a filing date. Another obligation
under TRIPS was the provision dealing with the grant of EMRs for mailbox
applications that met specified conditions during the transition period. India
initially tried to implement the mailbox facility and grant EMRs by way of a
presidential order.16 For various reasons the Indian parliament failed to pass the
law dealing with mailbox facility and EMRs. This prompted the United States to
utilize the WTO's dispute resolution mechanism to address India's failure to enact
the mailbox and EMR regime into a law. 17 The WTO's Appellate Body held in
December 1997 that India's failure to make timely amendments to its patent laws
had resulted in its non-fulfillment of obligations covered by Article 70.8(a) of the
TRIPS Agreement, which mandated that India establish "a means" that adequately
preserved novelty and priority of pharmaceutical product patent applications.
Finally, in March 1999, the amendment was passed by the Indian parliament; India
formally implemented the mailbox procedure for pharmaceutical product patent
applications and gave it retroactive application from January 1, 1995. 18

Mailbox applications were deposited in a "black box," and they were not taken out
for examination until March 2005. During India's ten-year TRIPS transition period,
8926 mailbox applications were filed in the four branches of the Indian Patent
Office. The framework for filing mailbox applications, in order to comply with the
TRIPS transition requirements, ended for India on December 31, 2004. This means
that the provisions dealing with mailbox applications/ EMRs became obsolete in
2005 and they have been repealed by way of the 2005 amendment.19

Few applicants who filed mailbox applications during the TRIPS transition period
took the additional step of seeking EMRs for their inventions. The grant of an EMR

14
The Patents (Amendment) Act, 2005, No. 15, Acts of Parliament, 2005 (India), available at
http://ipindia.nic.inlipr/patent/patent-2005.pdf.
15
D.K. Nauriyal, TRIPS-Compliant New Patents Act and Indian Pharmaceutical Sector: Directions in Strategy
andR & D, INDIANJ. ECON. & Bus. 189 (2006)
16
The Patents (Amendment) Ordinance, 1994, No. 13, Acts of Parliament, 1994 (India), available at
http://www.wipo.int/clea/docs-new/pdf/en/in/inOOlen.pdf. Presidential authority for the promulgation of an
ordinance is derived from Article 123(l) of the Indian Constitution. INDIA CONST. art. 123(1). Ordinances are
promulgated as a stop-gap measure to deal with urgent situations when the Indian Parliament is not in session
and the President of India is satisfied that circumstances exist which render it necessary for him/her to take
urgent action.
17
Ruth L. Okediji, Public Welfare and the Role of the WTO: Reconsidering the TRIPS Agreement, 17 EMORY
INT'LL. REV. 819, 890-93 (2003).
18
Mukherjee, supra note 52:The Patents (Amendment) Act, 1999, No. 17 sec. 24(B)(I)(a)-(b), Acts of
Parliament, 1999 (India), available at http://ipindia.nic.inlipr/patent/patact_99.PDF.
19
Mukherjee, supra note 52, at 7 (Patents Amendment 2005 which states that Chapter IVA of the 1970 Law
shall be omitted).
would have conferred the exclusive right to sell or distribute the invention in India
for a period of five years from the date of the grant until either a patent was
granted, or the application was finally rejected, whichever was earlier. 20 An EMR
was granted only for those inventions claimed in mailbox applications that further
satisfied the following requirements:

a) an examination by the Indian Patent Office had established that the

invention did not fall within any of the categories of subject matter
considered as non-patentable inventions like business methods, frivolous
inventions, mere admixture, or within the scope of the prohibition on
patenting inventions relating to atomic energy; 21
b) the mailbox/EMR applicant had filed a patent application for the same
invention, claiming the "identical article or substance" in a "convention
country" on or after January 1, 1995;22
c) the mailbox/EMR applicant had been granted a patent by the convention
country on or after the date it filed its mailbox application in India.
d) the convention country had issued "approval to sell or distribute the article
or substance" in the convention country, "on the basis of appropriate tests
conducted" in the convention country on or after January 1, 1995.
e) an authority on behalf of the Indian government had given approval to sell or
distribute the article in India.

The 2002 amendment brought into force other changes aimed at bringing India's
patents law in tune with the TRIPS Agreement, including new definitions of
invention and inventive step23, and new exclusions from patentable subject matter
like business methods, algorithms, and traditional knowledge. The amendment also
reversed the burden of proof provision involving cases of process patent
infringement and streamlined the compulsory licensing framework. The 2002
amendment also paved the way for patentability of microorganisms. 24

The 2002 amendment provides three grounds for seeking a compulsory patent
license. First, the law provides the broadest grounds for seeking a compulsory
patent license in the case of non-working of patented inventions. Such a license
can be sought only three years after the sealing of the concerned patent. Second,
there is another provision for grant of compulsory licenses on notification of the
Indian government in circumstances of national emergency or extreme urgency like
the breakout of epidemics. Third, there is a provision for compulsory licenses in the
case of certain patents that are essential to the efficient working of other patented

20
Mukherjee, supra note 52; The Patents (Amendment) Act, 1999, No. 17 sec. 24(B)(1), Acts of Parliament,
1999 (India), available at http://ipindia.nic.in/ipr/patent/patact_99.PDF; The Patents (Amendment) Act, 2002,
No. 38 sec. 4(k), Acts of Parliament, 2002 (India), available at http://www.ipindia.nic.in/ ipr/patent/patentg.pdf
21
The Patents (Amendment) Act, 2002, No. 38 sec. 24A(2), Acts of Parliament, 2002 (India) (nonpatentable
inventions are covered under Section 3 and inventions relating to atomic energy are covered in Section 4
22
The Patents (Amendment) Act, 2002, No. 38 sec. 24A(2), Acts of Parliament, 2002 (India) (nonpatentable
inventions are covered under Section 3 and inventions relating to atomic energy are covered in Section 4
23
The Patents (Amendment) Act, 2002, No. 38 sec. 3, Acts of Parliament, 2002 (India), available at
http://www.ipindia.nic.in/ipr/patent/patentg.pdf (amending section 2(1), (j) and adding sections 2(1), (ja)).
24
sec. 4 (adding section 3(j) dealing with plant varieties. India drafted a new law called Protection of Plant
Varieties and Farmer's Rights 2001 to give effective protection to plant varieties.).
inventions. The 2002 amendment abolished the concept of Licenses of Right 25.
Under this concept, process patents pertaining to medicines and food "were
automatically deemed to be endorsed with the words 'licenses of right,"' which
would make them available for compulsory licensing by all applicants three years
after the patent grant.

2.6 THE PATENTS (AMENDMENT) ACT, 2005

The last step in India's implementation of the changes required to make its patent
law TRIPS compliant happened by way of the 2005 amendment. Through this
amendment, Indian law, for the first time since 1970, allowed patent protection to
substances capable of being used as pharmaceuticals, food, and agro-chemicals. 26

The 2005 amendments contain many controversial features that have caused many
disputes. They include elaborate provisions concerning what is and is not
considered patentable subject matter,27 a new definition of the "inventive step"
criterion of patentability, 28 procedures governing both pre- and post-grant
opposition and a more liberal framework for compulsory licensing.

2.7 FLEXIBILITIES BUILT INTO THE INDIAN PATENT LAW

India's current patent law is armed with several flexibilities that the TRIPS
Agreement provides to its member states.

2.7.1 Section 3(d) of the Patents Act

This is a newly introduced provision in the patent law, and has led to some famous
patent disputes between multinational and Indian companies. 29 Section 3(d) states
that 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 of the mere use of a
known process, machine or apparatus cannot be considered as an invention.

It further clarifies that "salts, esters, ethers, polymorphs, metabolites, pure form,
particle size, isomers, mixtures of isomers, complexes, combinations and other

25
The Patents (Amendment) Act, 1999, No. 17 sec. 87, Acts of Parliament, 1999 (India), available at
http://ipindia.nic.in/ipr/patent/patact 99.PDF; see The Patents (Amendment) Act, 2002, No. 38, Acts of
Parliament, 2002 (India), available at http://www.ipindia.nic.in/ipr/patent/patentg.pdf (abolishing section 87
of the Patents (Amendment) Act of 1999); see also M. B. RAo & MANJULA GURU, PATENT LAW IN INDIA 251
(2010).
26
The Patents (Amendment) Act, 2005, No. 15 sec. 3, Acts of Parliament, 2005 (India), available at
http://ipindia.nic.in/ipr/patent/patent_2005.pdf (deleting section 5 of the 1970 Law which prohibited product
patents on the said substances).
27
These changes inserted by substituting Section 3(d) of the 1970 Law with a new definition. The Patents
(Amendment) Act, 2005, No. 15 sec. 2, Acts of Parliament, 2005 (India), available at http://ipindia.
nic.in/ipr/patent/patent 2005.pdf
28
These changes inserted by substituting section 2 (ja) of the 1970 Law with a new definition.
29
Raheel Rashad Daureeawo, The Controversy of Section 3(D) of The Indian Patent Act, LEGAL SERVICE INDIA
(Nov. 22, 2009), http://www.legalserviceindia.com/article/1400-Controversy-of-Section-3(D)- of-The-Indian-
Patent-Act.html.
derivatives of known substance shall be considered to be the same substance,
unless they differ significantly in properties with regard to efficacy. 30

This amendment's objective is to prevent the grant of frivolous patents on

substances that are only trivial modifications of existing inventions. Within the
pharmaceutical industry, it is very common for companies to try to extend patent
protection by obtaining separate patents on multiple attributes of a single product.
31
Even though Section 3(d) might have been the first provision targeting trivial
modifications of pharmaceutical inventions to be codified anywhere in the world,
many countries like the United States have devised ways to deal with such patents.
U.S. courts rely upon the doctrine of inherent anticipation to deal with such
patents, and this was demonstrated by the U.S. Court of Appeals for the Federal
Circuit ("CAFC"), which invalidated a patent on the metabolite of the antihistamine
drug Loratadine because the metabolite "necessarily and inevitably" formed from
ingestion of Loratadine under normal conditions.32

Scholars point out that Section 3(d) is a "bold legislative move" that has the
potential to curb the illegitimate "evergreening" of patents and may compel other
countries to imitate India's example in attempting to curb such practices. 33

2.7.2 Application of Section 3(d)-Novartis Case

In May 2006, Novartis petitioned before the Madras High Court, contending that
the Patent Controller erroneously rejected its patent application for the drug beta
crystalline form of imantinib mesylate under Section 3(d) of the Patents Act. 34
Novartis also argued that the provision violated Article 14 35 of the Constitution of
India because the wide breadth of discretion given to the patent controller could
lead to discriminatory results.36 The case was split up between the Madras High
Court and the Intellectual Property Appellate Board. The challenges on TRIPS
compliance and the constitutionality of Section 3(d) were heard by the Madras High
Court, which issued a judgment against Novartis. The issue dealing with
patentability was heard by the IPAB, which also ruled against Novartis.

The High Court had to examine three issues. The first was whether Indian courts
had jurisdiction to review Section 3(d)'s consistency with Article 27 of TRIPS, and to
grant declaratory relief if the section was not consistent with TRIPS. The second

30
The Patents (Amendment) Act, 2005, No. 15 sec. 2, Acts of Parliament, 2005 (India), available at
http://ipindia.nic.inlipr/patent/patent-2005.pdf.
31
Carlos M. Correa, Public Health and Patent Legislation in Developing Countries, 3 TUL. J. TECH. & INTELL.
PROP. 1, 30 (2001).
32
Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373 (Fed. Cir. 2003)
33
Rajarshi Sen & Adarsh Ramanujan, Pruning the Evergreen Tree or Tripping up Over TRIPS?- Section 3(d) of
the Indian Patents Act, 1970, 41 INT'L REV. INTELL. PROP. & COMPETITION L. 170, 186 (2010)
34
Novartis AG v. Union of India, 2007 A.I.R. 24759 (Madras H.C.) para. 1 (2007); The Patents (Amendment) Act,
2005, No. 15 sec. 3(d), Acts of Parliament, 2005 (India), available at http://ipindia.nic.in/
ipr/patent/patent_2005.pdf (excluding derivatives of known substances from being issued to a patent).
35
Article 14 of the Indian Constitution deals with equality before law; it states that the State shall not deny to
any person equality before the law or the equal protection of the laws within the territory of India. INDIA
CONST. art 14
36
Novartis AG, 2007 A.I.R. at para. 6
issue involved examining whether Section 3(d) was consistent with Article 27 of
TRIPS. The third issue was whether Section 3(d) violated Article 14 of the
Constitution of India because it was vague, arbitrary, and conferred uncontrolled
discretion to the Patent Controller.

The Court held that it did not have jurisdiction to adjudicate a case dealing with
the compliance of a domestic Indian law with an international treaty. Thus, it did
not grant any declaratory relief to Novartis. Since the Court decided that it did not
have jurisdiction to adjudicate whether a domestic law violated an international
treaty, it declined to deal with the issue of whether Section 3(d) was compliant with
TRIPS. On the third issue, the Court held that Section 3(d) did not violate Article 14
of the Indian Constitution, was not vague or arbitrary, and did not confer
uncontrolled discretion to the Patent Controller. The Court concurred with the
contention of the Indian Government that it had a constitutional duty to provide
good health care to its citizens by giving them easy access to life-saving drugs. The
Court also agreed that in doing so there should be suitable legislative measures put
in place to prevent ever greening of patents, which could have disastrous
consequences with respect to availability of affordable medicines.

2.7.3 . Inventive Step

Indian patent law now defines inventive step as "a feature of an invention that
involves technical advance as compared to the existing knowledge or having
economic significance or both and that makes the invention not obvious to a
person skilled in the art.37 Thus, Indian law has tried to add new criteria like
"technical advance" and "economic significance" onto the standard non obviousness
requirement. Scholars opine that the new broadened definition of inventive step will
give "the Patent Office and courts an explicit mandate to consider a claimed
invention's economic significance.

2.8.4 Pre-Grant and Post-Grant Opposition Before the Patent Controller

Indian law provides two administrative opportunities to challenge the grant of a

patent before the patent offices: pre-grant and post-grant opposition. 38 India is one
of the few systems to provide pre-grant as well as post-grant opposition
proceedings.39 Interestingly, most advanced countries do not follow pre-grant
opposition proceedings.

India's pre-grant procedure allows any person to file a pre-grant opposition with the
relevant patent office. Any person" has been interpreted to cover potential generic
competitors as well as social action groups representing interests of patients
suffering from various diseases like cancer and AIDS. The grounds upon which a
pre-grant opposition can be made are also very broad. The grounds for opposition

37
The Patents (Amendment) Act, 2005, No. 15 sec. 2, Acts of Parliament, 2005 (India), available at
http://ipindia.nic.in/ipr/patent/patent_2005.pdf (which updates Section 2(ja)).
38
The Patents (Amendment) Act, 2005, sec. 23 (which changed Section 25(1) and 25(2))
39
Christopher Arup & Jagjit Plahe, Pharmaceutical Patent Networks: Assessing the Influence of India's
Paragraph 3(d) Internationally, INTELL. PROP. Q. 1, 32 (2010).
mainly consist of lack of novelty, lack of inventive step, insufficiency of description,
and non-patentability of the invention under the existing law.

2.7.5 Compulsory Licensing Provisions

India's law has very expansive compulsory licensing provisions. Compulsory

licensing may be invoked three years from the patent grant upon satisfying the
following conditions:

a) the reasonable requirements of the public with respect to the patented

invention have not been satisfied;
b) the patented invention is not available to the public at a reasonable price;
c) The patented invention is not worked in the territory of India. 40

Additionally, the Indian government may grant a compulsory license in

circumstances involving national health emergencies. 41 The law also provides
mechanisms to manufacture and export patented medicines to other countries
without local manufacturing capacity.

2.7.6 Experimental Use Exemptions

According to Indian law, any person may make or use the patented invention,
whether it is a product or a process-or even an article or product made by a
process-for the purpose merely of experimentation or research including the
imparting of instructions to pupils.

Scholars note that this provision seems more liberal than corresponding provisions
in most other countries, and that it is wide enough to even support activities such
as inventing around the patented invention or the making of improvements thereto.

Along with this general experimental use exception, Indian law also exempts
experimental trials conducted on patented drugs from the purview of patent
infringement. This provision is much wider than the corresponding U.S. law, as it
allows the making, constructing, using or selling of a patented invention for the
purpose of generating regulatory data to comply with both domestic (Indian) drug
regulatory law, and any corresponding foreign law, while U.S. law exempts only
activities connected with a regulatory submission within the United States.

2.7.7 Parallel Imports

India's new Patents Act implements the principle of international "exhaustion of

patent rights.42 The expression "exhaustion of patent rights" means that right
holders who sell their invention lose the right to control the resale of the invention.
In other words, once a patented product has been sold with the patentee's approval
outside India, the subsequent importation of that same patented item into India
40
The Patents Act, No. 39 of 1970, INDIA CODE (1995) sec. 84(l)-(6), available at http://indiacode.nic.in. The
Patents Act also includes a list of instances where the reasonable requirements of the public shall be deemed
to be unsatisfied.
41
The Patents (Amendment) Act, 2005 sec. 55
42
Enrico Bonadio, Parallel Imports in a Global Market: Should a Generalised International Exhaustion Be the
Next Step?, 33 EUR. INTELL. PROP. REV. 153, 153 (2011).
will not amount to infringement of the Indian patent. The law provides that
"importation of patented products by any person from a person who is duly
authorised under the law to produce and sell or distribute the product, shall not be
considered as an infringement of patent rights.43

While most developed countries' patent regimes do not have provisions

incorporating international exhaustion of patent rights, the developing and least
developed countries have included them in their patent laws with the aim of
ensuring their citizens' access to lower-cost medicines. The TRIPS Agreement is
also silent about international exhaustion, as Article 6 of the Agreement states that
"nothing in this Agreement shall be used to address the issue of the exhaustion of
intellectual property rights.

The present Indian position in respect of patent law is governed by the provisions of
the Patents Act, 1970 as amended by the Patents (Amendment) Act, 2005
(hereinafter referred to as the Act) and Patents (Amendment) Rules, 2019
(hereinafter referred to as the Rules) Department of Industrial Policy and Promotion
(DIPP) has amended Patent Rules 2003 with effect from 17th September 2019
called as the Patent (Amendment) Rules, 2019.

The Head Patent Office is located at Kolkata and its branch offices are located at
Delhi, Mumbai and Chennai. Patent system in India is administered by the
Controller General of Patents, Designs, Trademarks and Geographical Indications.
Each office has its own territorial jurisdiction for receiving patent applications and
is empowered to deal with all sections of Patent Act.

The jurisdiction for filing the patent application depends upon:

a) Indian applicant(s): determined according to place of residence, place of

business of the applicant or where the invention actually originated.

b) Foreign applicant(s): determined by the address for service in India

2.8 PARIS CONVENTION FOR THE PROTECTION OF

INDUSTRIAL PROPERTY
The Paris Union, established by the Convention, has an Assembly and an Executive
Committee. Every State member of the Union which has adhered to at least the
administrative and final provisions of the Stockholm Act (1967) is a member of the
Assembly. The members of the Executive Committee are elected from among the
members of the Union, except for Switzerland, which is a member ex officio.

The Paris Convention, concluded in 1883, was revised at Brussels in 1900, at

Washington in 1911, at The Hague in 1925, at London in 1934, at Lisbon in 1958
and at Stockholm in 1967, and it was amended in 1979.
43
The Patents (Amendment) Act, 2002, sec. 44 (which updates §107A(b)); The Patents (Amendment) Act, 2005,
No. 15 sec. 58, Acts of Parliament, 2005 (India), available at http://ipindia.nic.in/ipr/patent/patent .2005.pdf
(which updates Section 107A(b))
The Convention applies to industrial property in the widest sense, including
patents, marks, industrial designs, utility models, trade names, geographical
indications and the repression of unfair competition. The substantive provisions of
the Convention may be divided into three main categories namely national
treatment, right of priority, common rules

2.8.1 National treatment

Under the provisions on national treatment, the Convention provides that, as

regards the protection of industrial property, each Contracting State must grant
the same protection to nationals of other Contracting States that it grants to its
own nationals. Nationals of non-Contracting States are also entitled to national
treatment under the Convention if they are domiciled or have a real and effective
industrial or commercial establishment in a Contracting State .

2.8.2 Right of priority

The Convention provides for the right of priority in the case of patents marks and
industrial designs. This right means that, on the basis of a regular first application
filed in one of the Contracting States, the applicant may, within a certain period of
time (12 months for patents and utility models; 6 months for industrial designs
and marks), apply for protection in any of the other Contracting States. These
subsequent applications will be regarded as if they had been filed on the same day
as the first application. In other words, they will have priority (hence the expression
"right of priority") over applications filed by others during the said period of time for
the same invention, utility model, mark or industrial design. Moreover, these
subsequent applications, being based on the first application, will not be affected
by any event that takes place in the interval, such as the publication of an
invention or the sale of articles bearing a mark or incorporating an industrial
design. One of the great practical advantages of this provision is that applicants
seeking protection in several countries are not required to present all of their
applications at the same time but have 6 or 12 months to decide in which countries
they wish to seek protection, and to organize with due care the steps necessary for
securing protection.

2.8.3 Common rule

Patents granted in different Contracting States for the same invention

are independent of each other: the granting of a patent in one Contracting State
does not oblige other Contracting States to grant a patent; a patent cannot be
refused, annulled or terminated in any Contracting State on the ground that it has
been refused or annulled or has terminated in any other Contracting State.

2.9 PATENT COOPERATION TREATY (PCT)

The Patent Cooperation Treaty (PCT) is an international patent law treaty, concluded
in 1970 consisting of with more than 150 Contracting States. The PCT created a
Union of the contracting parties. The Union has an Assembly. Every signatory State
to the PCT is a member of the Assembly. The PCT makes it possible to seek patent
protection for an invention simultaneously in a large number of countries by filing
a single “international” patent application instead of filing several separate national
or regional patent applications.

A patent application filed under the PCT is called an international application,

or PCT application. A single filing of a PCT application is made with a Receiving
Office (RO) in one language. It then results in a search performed by an
International Searching Authority (ISA), accompanied by a written opinion
regarding the patentability of the invention, which is the subject of the application.
It is optionally followed by a preliminary examination, performed by an
International Preliminary Examining Authority (IPEA). 44

A PCT application, which establishes a filing date in all contracting states, must be
followed up with the step of entering into national or regional phases to proceed
towards grant of one or more patents. The PCT procedure essentially leads to a
standard national or regional patent application, which may be granted or rejected
according to applicable law, in each jurisdiction in which a patent is desired. 45

END NOTES
India has always acknowledged the importance of a strong patent system for the
development of industry and commerce, which is evident for the amendments done
to bring India at par with the modern world. With the promulgation of the product
patent regime in India, most of the countries are now looking for business
opportunities. There has been a considerable rise in the patent filing. Innovators
and inventors from all fields of technology are keen on protecting their intellectual
property.

The Indian Patent Office and courts face significant challenges in interpreting and
applying the new Patent Act's provisions. While India's patent system emerges as a
unique model, there will be greater demands from stakeholders to make the system
more transparent. In the past two years, some significant measures have been
taken to increase transparency and it is expected that more steps will follow. In the
short-term, opponents of stronger patent protection may be able to take advantage
of ambiguities in the interpretation of various provisions of the patent law. But this
can have serious long-term consequences, as a lack of confidence in the patent
system could adversely impact indigenous innovation to a large extent and foreign
direct investment to a small extent.

44
Patent Cooperation Treaty (PCT). wipo.int. WIPO.
45
Oxonica Energy Ltd v Neuftec Ltd (2008) EWHC 2127 (Pat), item 45.