A PROJECT ON:

CRITICAL ANALYSIS OF PATENT

ACT IN INDIA
(Studied under Intellectual Property
Rights-I)

MATS LAW SCHOOL

MATS UNIVERSITY, RAIPUR (CHHATTISGARH)

Session- 2016

Submitted To:
Ms. Ruqaiyyah Naaz
Stuti Baradia
(Assistant Professor of Law)
B.B.A LL.B
MATS LAW School
Sem VII (4th year)
MU13BBALLB29

Submitted By:

Date of Submission: _________________

A critical evaluation of the Patent (Amendment) Act, 2005

A country without good patent laws is just a crab and can't travel any way but sideways and
backwards.1
I. Introduction
The Patent (Amendment) Act 2005 (hereinafter referred to as the 2005 Amendment) was
passed by the Parliament in its budget session of 2005 to amend The Patent Act, 1970
hereinafter referred to as The Act) and meet its obligation under TRIPS Agreement of WTO.
The Act was effective from 1st January 2005. Although the Act makes wide ranging changes
to India's patent regime, the most controversial provision is the one introducing product
patents in the area of pharmaceuticals.
The objective of present work is to find out the necessary implications of 2005 Amendment
on the product patent system in India and Indian economy.
II. Meaning of Patent
In simple words, Patent is a document which is generally issued by government conferring a
monopoly right on an inventor to exploit his invention for a limited period. The person to
whom patent is granted in called as Patentee. It gives the patentee an exclusive right to use,
manufacture and sell the invention for a limited period of time. The grant of such a patent to
the inventor of any invention is only for a fixed or limited period of time and thus after the
expiry of such period, the patented invention passes on to the public domain.
Patents are one of the oldest forms of intellectual property protection and, as with all forms of
protection for intellectual property; the aim of a patent system is to encourage economic and
technological development by rewarding intellectual creativity. The purpose of a patent is to
1 Mark Twain, A Connecticut Yankee in King Arthur's Court (1889)

provide protection for technological advances i.e. inventions. It provides an award for the
disclosure of the creation of something new as well as for the further development, or
refinement, of existing technologies. In short, through patents, progress in changing
technologies finds incentive to improve.2
Abraham Lincoln describes the importance of Patent as Before then [the adoption of the
United States Constitution], any man might instantly use what another had invented; so that
the inventor had no special advantage from his own invention. The patent system changed
this; secured to the inventor, for a limited time, the exclusive use of his invention; and
thereby added the fuel of interest to the fire of genius, in the discovery and production of new
and useful things.3
III. Some Major Changes Introduced by the 2005 Amendment
The 2005 Amendment amended many provisions of the Act; these amendments were
absolutely necessary for India to meet its obligation under TRIPS Agreement. Some of
important amendments are discussed below 1. Extension of product patent protection to all fields of technology
The most prominent and controversial change of the 2005 Amendment has been the deletion
of section 5 of the Act, thereby paving the way for product patents in the area of
pharmaceutical and other chemical inventions. Section 5 of the Act (as it stood after the 2002
amendments) had 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 obtained4. Before this Amendment in the Act,
Product Patent was not granted on the inventions related to drugs, foods and chemicals and
only process patents were granted on these inventions. It means if a company invented a
2 Electronic Business and Patents available
on http://www.internationalprivatelaw.com/files/003BP202.pdf (Last visited on 25th Dec
2010)
3 Abraham Lincoln, Second lecture on discoveries and inventions, February 11, 1859

4 See Shamnad Basheer INDIAS TRYST WITH TRIPS: THE PATENTS (AMENDMENT) ACT,
2005 THE INDIAN JOURNAL OF LAW AND TECHNOLOGY Volume 1, 2005
2

medicine to cure a disease using a certain process. That company cant claim a patent on that
medicine while the company can claim a patent on the process which it has used to
manufacture that medicine. In the other words that company cant stop other competitors
from manufacturing the end product but can stop others from producing the end product
using their patented process or method. This resulted in a situation in which reverse
engineering mechanism was highly used to develop the same medicine and drugs with
slightly or substantially different process. This copycat business helped a few pharmacy
companies, to grow into global players and made medications cheaper. The pharmacy MNCs
were forced to watch Indian companies eat into their market share as Indian companies
developed same medicine at much lower cost because of relatively lower investment in R&D.
The Process Patent regime left no scope for absolute monopoly in the market; this resulted in
increased competition in market and consequently leads to further drop in medicine prices.
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, 19705. 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. Medicines were arguably
unaffordable to the general public and the drug price index was rising rapidly. The Committee
therefore recommended that certain inventions such as pharmaceutical inventions, food and
other chemical inventions be granted only process patent protection.6 Indias well-developed
generic industry today is testimony to the farsightedness of this report.
Few cases reported by media and newspapers, given below, provide glimpses of how
Indian companies have taken legal measures to refute claims of multinational drug
majors for extension of their patents.

5 N.R. Ayyangar, Report On The Revision Of The Patents Law (1959) [Hereinafter
Ayyangar Report].
6Martin J. Adelman & Sonia Baldia, Prospects and Limits of the Patent Provision in the
TRIPS Agreement: The Case of India, 29 VAND. J. TRANSNATL L. 507, 518 (1996).

a. A case that attracted a lot of attention in India is that of the Swiss drug company
Novartis. Novartis had challenged Section 3(d) of the Indian Patents Act claiming
immunity for their drug Gleevic, a major drug for leukemia on the pleas that the new
Gleevic was a major improvement over a older version whose patent was over. This
was disputed by Indian companies such as Natco Pharmaceuticals. The plea of
Novartis was rejected consequently enabling manufacture by Indian generic
companies. Cost estimates of the new generic drug place it at one tenth the price of
Gleevic.
b. In a similar case the Delhi Court rejected the petition of Bayer Healthcare, a German
drug major from preventing the Drug Controller General of India giving marketing
approval to Indian company Cipla for the generic version of the cancer drug Nexavar.
The ruling however had a caveat namely, that if the Indian drug company is found
guilty of patent infringement damages will have to be compensated by payment to
Bayers.
c. Cipla in another case won the right to manufacture and market the generic version of
the anti-cancer drug Tarceva originally patented by the Swiss pharma company
Hoffman La Roche both in Delhi Court7 and the Supreme Court.8
d. Recently, Aurobindo Pharma an Indian drug pharma received USFDA approval for
Risperidone Oral Solution a drug used in the treatment of mental and emotional
problems. Indian companies are becoming increasingly active in the US market. In the
first quarter of 2009 Indian companies had achieved 50 ANDA approvals.9
2. No Swiss Claims and Expansion of Exclusion under Section 3(d)

7 F. Hoffmann-La Roche Limited and Another v Cipla Limited 148(2008)DLT598

8 Reported in Financial Express., 5th September,2009 and Economic Times.,19th August, 2009. The
price difference for example, in the case of Cipla v/s Roche, Roche sells Tarceva for Rs.4500 per
tablet while Ciplas generic is sold at Rs.1500 per tablet.
9 See report on The Indian Pharmaceutical Industry 2009., Espicom Business
Intelligence, May 2009

A Swiss Claim is a claim for patent wherein the use of a substance or composition that has
already been used for a medical purpose is intended or specified to be used for a new medical
purpose. Section 3(d) as amended by the 2005 Amendment clarifies that mere discovery of a
new form of a known substance, which does not result in the enhancement of the known
efficacy of that substance is not an invention and therefore not patentable. For the purposes of
this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers,
mixtures of isomers, complexes, combinations and other derivatives of known substances are
to be considered to be the same substances, unless they differ significantly in properties with
regard to efficacy.
In order to fully understand the amended Section 3(d), one need to first address the issue of
what exactly the term efficacy means. The term has not been defined in the Act, but in
Novartis AG v. Union of India10, the High Court of Madras , while answering the question,
whether section 3(d), as amended by the Third Amendment, is violative of the fundamental
rights guaranteed under Article 14 of the Indian Constitution, interpreted the phrase
efficacy as the ability of a drug to produce the desired therapeutic effect i.e. how effective
the new discovery made would be in healing a disease/having a good effect on the body,
for which an applicant in order to pass the test of efficacy" needs to show that the discovery
of a new form of a known substance has resulted in the enhancement of the known efficacy of
that substance and if the discovery is nothing other than the derivative of a known substance,
then, it must be shown that the properties in the derivatives differ significantly with regard to
efficacy. Further, the Honble High Court stated that such enhanced efficacy could be shown
by giving necessary comparative details based on the relevant scientific data demonstrating
the enhancement in the known efficacy of the original substance and that the derivative so
derived will not be the same substance, since the properties of the derivatives differ
significantly with regard to efficacy.
In this case a Swiss drug company Novartis had challenged Section 3(d) of the Indian Patents
Act claiming immunity for their drug Gleevic , a major drug for leukemia on the pleas that
the new Gleevic was a major improvement over a older version whose patent was over. This
was disputed by Indian companies such as Natco Pharmaceuticals. The plea of Novartis was
rejected consequently enabling manufacture by Indian generic companies. Cost estimates of
the new generic drug place it at one tenth the price of Gleevic.
10 (2007) 4 MLJ 1153.
5

The Hon'ble High Court also noted that though section 3(d) is not only limited to drugs and
pharmacological substances, it is clear that certain portions of the section and the attached
explanation is only referable to pharmacological substances.
3.Software Patentability
Section 3(k) of the Patents Act, 1970 excluded a computer programme per se from the
scope of patentability. This exclusion met with conflicting interpretations at the patent office,
with some examiners granting patents to software combined with hardware or software with a
demonstrable technical application of some sort. The 2004 Ordinance therefore qualified this
exclusion by stating that software with a technical application to industry or when
combined with hardware would be patentable. Owing to vigorous opposition from the free
software movement11, this provision was removed from the 2005 Act. The earlier position
under the Patents Act, 1970 that a computer programme per se is not patentable now prevails.
4. Deletion of the provisions relating to Exclusive Marketing Rights (EMRs)
Section 21 of 2005 Amendment deleted the Chapter IVA of the Act. The 1999 Amendment
inserted this chapter in the Act to provide that applications claiming pharmaceutical
inventions would be accepted and put away in a mailbox, to be examined in 2005. These
applications are commonly referred to as mailbox applications. This amendment was in
pursuance of a TRIPS obligation aimed at preserving the novelty of pharmaceutical
inventions in those developing and least developed country (LDC) members that did not
grant product patents for pharmaceutical inventions in 1995 12. By virtue of this mailbox
11 See Free Software Foundation, Representation Made by the Free Software Foundation
of India to the Government of India to Immediately Withdraw the Patents (Amendment)
Ordinance, 2004, at http://fsf.org.in/representation/representation.html (last visited Oct.
18, 2005).

12 Agreement on Trade-Related Aspects of Intellectual Property Rights, Including Trade in Counterfeit Goods,
Dec. 15, 1993, 33 I.L.M. 81 [hereinafter TRIPS Agreement]. In the WTO dispute filed by the United States
against India for a failure to comply with this provision, the WTO appellate body held that India was obliged to
provide a sound legal mechanism for an interim mailbox arrangement. See WTO Appellate Body, India: Patent
Protection for Pharmaceutical and Agricultural Chemical Products, WT/DS50/AB/R (Dec. 19, 1997)The Patents
(Amendment) Act, 1999 was introduced as a response to this ruling, and was in fact given retrospective effect
from 1995, the date on which India was supposed to have instituted the mailbox facility under TRIPS.

facility, applications would be judged for novelty on the basis of the filing date and not
with reference to 2005, the year in which product patents were first incorporated into the
patent regime.
To obtain an EMR, the following conditions must be fulfilled:
a) The product must be patentable, that is, it must be an invention as per Section 2 of the
Patents Act 1970, and must not fall under the non-patentable products listed in
Sections 3 and 4, such as products derived from traditional knowledge or atomic
energy-related products.
b) The invention must have been made in India or in a WTO Convention country. If
made in a convention country, the invention must have been:
i.

Filed on or after January 1, 1995, and

ii.

Before getting a patent in India, the applicant must have obtained such a patent
in the Convention country.

c) If the invention has been made in India,

i.

The application for patent for the method or process of production of such a
substance should have been filed on or after January 1, 1995, and

ii.

The patent must have been granted on or after the date of filing of such
EMR.13

5. Compulsory Licensing Regime

Section 84 of The Act provides for the grounds on and procedures by which, a compulsory
license will be granted. The 1999 Amendment adds an entire chapter to the Patents Act on the
working of patents, compulsory licenses, and revocation of licenses. After this amendment,
the grounds on which a compulsory license will be granted are:
a. Reasonable requirements of the public with respect to the patented invention have not
been satisfied; or,
13 www.thehindubusinessline.com/2003/10/04/04hdline.htm
7

b. The patented invention is not available to the public at a reasonably affordable price;
or,
c. The patented invention is not worked (i.e. not used or performed) in the territory of
India.
In respect to the 2005 Amendment following amendments have been made in respect of
compulsory licencening regime a) Automatic Compulsory Licences for Mailbox Applications
The 2005 Amendemt provides that in the case of those mailbox applications that result in the
grant of a patent, an automatic compulsory licence would issue to those generic companies
that made a significant investment and were producing and marketing a drug covered by
the mailbox application prior to 2005.14 Such licence is subject to a payment of a reasonable
royalty. However, no specific yardstick is provided to determine reasonableness and this
term is likely to lead to disputes in coming years.15
b) Compulsory Licences for Exports
In order to incorporate what is commonly referred to as the Paragraph 6 Decision 16, the
Ordinance introduced section 92A, which provides for compulsory licences to enable exports
of pharmaceutical products to those countries with no manufacturing capacity of their own.
Unfortunately, this suffered from a handicap - the provision required that the exporter obtain
a compulsory licence from the importing country as well. In the process, the provision failed
14 Patents Act, 1970, s.11A, proviso, amended by Patents (Amendment) Act, 2005.

15 It is pertinent to note that during the Parliamentary debates, a number of members suggested that a specific
royalty rate or a ceiling on the royalty rate be fixed (see specifically comments by Mrs. Maneka Gandhi and Mr.
Suresh Kurup). However, at the time of voting, the clause was adopted with the words reasonable royalty and
no
specific
percentage
was
fixed.
See
Lok
Sabha
Debate,
Mar.
22,
2005,
athttp://164.100.24.230/Webdata/datalshom001/dailydeb/22032005.htm.

16 Patents Act, 1970, s.87, omitted by Patents (Amendment) Act, 2002. Since the 1970
regime provided only process patents in the case of pharmaceutical inventions, it was
not too surprising that this compulsory licensing provision was hardly ever invoked by
generic manufacturers.

to cater to those situations where there was no patent in such importing country and no
requirement for obtaining a compulsory licence there. The 2005 Amenment therefore seeks to
rectify this by adding that an exporter can resort to section 92A where the importing country
has by notification or otherwise allowed importation of the patented pharmaceutical
products from India.
c) Procedural Changes
The general compulsory licensing procedure under Chapter XVI states that in most cases, a
compulsory licensing application can be entertained only if negotiations towards a voluntary
licence have not borne fruit within a reasonable time period. In order to prevent patentees
from dragging on voluntary negotiations to the detriment of applicants, the Act caps a
reasonable period of negotiations at six months.17

6. Other Amendments
There are many changes brought by the 2005 Amendment in the provisions of the
Act, that can be summarized as follows
a) The 2005 Amendment amend the definition of New Invention,Inventive Step and
insert a new entry of Pharmaceutical Substances in the definition clause.
b) Provision of 'acceptance of specification' and its advertisement have been deleted.
c) 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.
d) Application for patent will be published in Official Journal. At that time opposition
can be made on limited grounds but hearing is not mandatory.
e) After grant of patent, opposition can be made within 12 months.

17 See Supra note 4

9

f) Suit for infringement of patent cannot commence before date of publication of

publication of the application.
g) Penalties enhanced substantially.
h) Strengthening the provisions relating to national security to guard against patenting
abroad of dual use technologies.
i) Rationalization of provisions relating to time-lines with a view to introducing
flexibility and reducing the processing time for patent applications, and simplifying
and rationalizing procedures.
IV. Implications of 2005 Amendment on Indian Economy
Some possible implications of product patent regime in the field of food, medicine, drugs or
chemical substances can summarised as below
1. Price rise and access to medicine It is feared that the 2005 Amendment would spur a steep rise in drug prices and an adverse
impact on access to important and life saving drugs. From a completely objective point of
view two categories of drugs will be affectedfirst, medicines that will be invented after
January 1, 2005. If a medicine is patentable, the patent holder will be granted a 20-year
monopoly from the date of filing as a result of the new rules. Without a compulsory license,
generic versions will not be permitted on the market for the life of the patent. In other
developing countries that have begun protecting patents on medicines in accordance with
WTO rules, the vast majority of medicines patent filers in developing countries are
multinational drug companies based in industrialized countries.
The second category of medicines that will be affected by the 2005 Amendment are those that
have been patent protected outside of India since January 1, 1995. According to WTO rules
(TRIPS Art. 70.8), India was required to establish a mailbox where patent applications
could be filed between 1995 and 2005. After January 1, 2005, the mailbox will be opened,
and requests for patents considered by the Indian Patent Office.18
18 See Health Global Access Project Fact Sheet: Changes to India's Patents Act and Access to Affordable
Generic
Medicines
after
January
1,
2005,
available
athttp://www.healthgap.org/press_releases/04/121404_HGAP_FS_INDIA_patent.pdf (Last visited 20 Jan 2011)

10

In a nutshell, there is no doubt that, after 2005 Amendment, the prices of above mentioned
drug will rise but the question which really needs to be answered is to what extent this price
rise will eventually affect the access and affordability of life saving or very essential drugs to
most of the Indian population. In statement issued by Shri Kamal Nath, Union Minister of
Commerce & Industry, on 04 Apr 2005 said that 97% drugs in the market, and 100% of all
essential drugs are not covered by patents19. On the other hand fear of substantial price rise,
in life saving drugs patented after 2005 can be addressed to a certain extent by safeguards
built in the 2005 Amendment and other related laws for the time being in force, such as
a. Compulsory licensing,
b. Parallel import of products,
c. Acquisition of patent rights by the government,
d. Revocation of patents in the public interest
e. Provisions to deal with emergency situations
f. Patentability threshold,
g. Opposition mechanism, and
h. Price control regime like Essential Commodities Act, 1955, etc
Now the real issue is whether these provisions would in fact be interpreted and implemented
in a manner conducive to public health needs of Indian society at large and would largely
depends upon the efforts of the government towards the same. The Indian Policy makers have
to keep in mind, the ground realities of India while implementing these provisions. Ground
realities of India is substantially different from developed nations, under pressure of whom

19 Press Release ENOUGH SAFEGUARDS IN PATENTS ACT TO PREVENT PRICE RISE

DOMESTIC PHARMA INDUSTRY INTERESTS FULLY PROTECTED: KAMAL NATH DIPP-UNCTAD
SEMINAR ON PRODUCT PATENTS HELD at
http://commerce.nic.in/pressrelease/pressrelease_detail.asp?id=1610 (Last visited 20 Jan
2011)

11

we have adopted product patent regime in pharmaceuticals. In India there is no sound

healthcare insurance system and per capita income is also relatively very low.
According to Health GAP (Global Access Project), a US-based NGO that advocates the cause
of AIDS patients, human rights and fair trade, the 2005 Act fails to utilise fully the public
health safeguards available to WTO member states under TRIPS, which were reaffirmed by
the Doha Declaration on the TRIPS Agreement and Public Health. 20 Going by this history,
one is prone to be a little skeptical of the role of price control in India. For e.g. when India
passed its Patent Act in 1970, it also instituted a Drug Price Control Order (DPCO) under the
Essential Commodities Act of 1955 to control the price of drugs and ensure access to the
general public. Under this order, prices of bulk drugs and their formulations were fixed by the
government as per a specified formula that allowed a 100% margin on ex factory cost. Price
changes of the remaining drugs were also to be monitored. However, over a period of time, as
a result of sustained lobbying by the Indian pharmaceutical industry, the number of drugs
listed in the DPCO fell from 347 in 1979 to 76 in 1995. 21 A new pharmaceutical policy in
2002 that sought to relax controls even further was challenged on the ground that, under the
policy, certain life saving drugs had the potential of being excluded from the DPCO. The
challenge made its way to the Supreme Court and is yet to be resolved.22
In August 2005 there were indications that, the government is considering strengthening the
price control regime to increase competition and ensure affordable medicines to the general

20 Health Global Access Project, The Impact of India's Amended Patents Act to Access to Affordable
HIV Treatment, at http://www.healthgap.org/press_releases/05/020105_hgap_fs_india_ipr.pdf (Last
visited 20 Jan 2011)
21 Siddarth Narrain, A Life Saving Order, FRONTLINE, Jul. 17-30, 2004,http://
www.frontlineonnet.com/fl2115/stories/20040730004110300.htm (Last visited 15 Jan
2011).

22 Union of India v. K.S. Gopinath, S.L.P.(C) No. 3668 of 2003. This is an appeal from a
lower court ruling that had stayed the operation of the new policy. Although the Supreme
Court granted leave in the matter, it is still to render any decision or pass any orders. The
net result is that the stay on the policy granted by the lower courts continues to be
operational. See SC Concern Over Non-Inclusion of Essential Drugs, HINDU, Aug. 2, 2003,
http://www.hinduonnet.com/thehindu/2003/08/02/stories/2003080204201300.htm(Last
visited14 Jan, 2011).

12

public. To this end, a new Drug Pricing (Regulation & Management) Act was being
considered23, but still after almost six years it is yet to be implemented.
2. Cultivating Innovation Culture in India
In the fear substantial price rise people are ignoring one of the biggest advantages of the 2005
Amendment. The Indian Pharmaceutical Industry today consist of about 8174 bulk drug
manufacturing units and 2389 formulations units spread across the country. Pharmaceutical
Companies Operating in India is a pool representing about 250 large Pharmaceuticals
manufacturers and suppliers and about 8000 Small Scale Pharmaceutical & Drug Units
including 5 Central Public Sector Units. The 2005 Amendment by giving an extra incentive
to new and innovative drugs will also cultivate an innovation culture in Indian pharma
industries. It needs to be noted however that basic reverse engineering skills (organic
chemistry skills) are different from the skills required to arrive at new drugs (medicinal
chemistry skills).24 Besides, the costs of researching upon and introducing a new drug into the
market are colossal.25 It therefore remains to be seen whether incentives through a patent
regime will achieve the desired results and whether Indian companies will be able to compete
with global multinational companies on this turf. A commentator rightly notes that till
recently, the emphasis has been mainly on building a system of production and not on a
system of innovation.26

23 K.G. Narendranath, DPCO May be Retained in New Drug Pricing Act, FIN. EXPRESS,
Aug, 1, 2005,http://www.financialexpress.com/fe_full_story.php?content_id=98022 (Last
visited 15 Dec. 2010).

24 See S. Subramaniam, Pharmaceutical R&D in India: Addressing the Emerging Model of

Drug Innovation, Address at Chatham House Conference, London, UK (Feb. 1, 2005),
available at http://www.chathamhouse.org.uk/pdf/conferences/proceedings/subr0105.ppt
(Last visited 29 Dec. 2010).

25 The current average capitalised cost of developing a new drug is estimated to be US$
870 million. See generally J.A. DiMasi et al., The Price of Innovation: New Estimates of
Drug Development Costs, 22 J. HEALTH ECON. 151 (2003). This estimate has been
criticised as not representing what companies actually spend to discover and develop
new molecular entities. It includes the expense of using money for drug research rather
than other investments (known as the opportunity cost of capital). Public Citizen,
Critique of the DiMasi/Tufts Methodology and Other Key Prescription Drug R&D Issues, at
http://www.citizen.org/congress/reform/drug_industry/articles.cfm?ID=6532 (last visited
12 Dec. 2010).

13

V. Conclusion
In all possibility, it can be said that Indian Pharma Industry will not end up where it started in
pre 1970 era but it is safe to assume that Indian drug companies might become dependent on
MNCs for technology to produce new drugs. According to reputed magazine it is likely that
the existing drugs say about 10 per cent of the marketed drugs are likely to become expensive
due to amendments made in new Patents Act.27 It must be noted that the remaining 90
percent of drugs will be unaffected by this amendment.
The safeguards provided under the Act and other laws, if implemented in a manner conducive
to Indian consumers can prove a boon for them. The Indian consumers in that case can enjoy
the benefits of both innovative as well as affordable drugs. To conclude it can be clearly said
that, this amendment will definitely have a varied implication on Indian economy. On one
side it may compromise with the interest of certain Indian companies and consumers but on
the other side it will act as decisive step in internationalization of Indian Patent System and
cultivating an innovation culture in Indian Pharmaceutical Industry.

26 Padmashree Gehl Sampath, Economic Aspects Of Access To Medicines After 2005:

Product Patent Protection And Emerging Firm Strategies In The Indian Pharmaceutical
Industry 30, available at
http://www.who.int/intellectualproperty/studies/PadmashreeGehlSampath Final.pdf (Last
visited 10 dec. 2010).

27 www.pharmabiz.com/article/SectionWiseArchiveNews.asp?id=46
14