Changing IP Regime – How to Balance Interests |

TABLE OF CONTENTS

1. Introduction………………………………………………………… 1

2. Intellectual Property Rights And Protection ………………………. 1

3. TRIPS – Backdrop and Genesis………………………………….... 3

4. TRIPS – Provisions and Implications……………………………….5

5. Features of the Indian Patents Act, 1970…………………………... 6

6. Fears of the Indian Pharmaceutical Industry………………………. 7

7. Pro – Indian Features of TRIPS……………………………………..8

8. An Insight Into The Novartis Case…………………………………10

9. Prospects for Indian Pharmaceutical Industry Post – TRIPS………13

9.1 Patents in Indian Context…………..…………………….…13
9.2 Healthcare in India…………………...……………………..14
9.3 Prices of Drugs………………………...……………………14
9.4 R & D………………………………………………………..14

10. Conclusion…………………………………………………………15

11. Bibliography……………………………………………………….16
 Changing IP Regime – How to Balance Interests |

INTRODUCTION
For a student of law and economics, a project report on the Changing IP Regime with
respect to the Indian pharmaceutical industry has a lot of importance. This industry in
particular raises quite a few interesting questions of economic aspects. The research and
development of any medicine involves a lot of costs and hence interests of many
companies are vested in protecting the innovation. Moreover, the pharmaceutical industry
is a highly regulated sector as far as safety and efficacy are concerned. Apart from that,
even the price, promotion and expenditure are heavily regulated. In addition to that,
major drugs developed by multinational companies are of global importance and hence,
international economy is affected to a great extent by this particular sector. Hence,
socially optimal allocation is completely different than an economically optimal
allocation and free rider tendencies by nations are encouraged.

Hence, the challenge is to suggest a way by which a balance can be struck between the
socially optimal allocation and the economically optimal allocation. However, to suggest
a way to strike such a balance, it is important to understand the backdrop of the battle of
Intellectual Property Rights, TRIPS and the Indian Patents (Amendment) Act, 2005(with
special reference to the Indian pharmaceutical industry).

INTELLECTUAL PROPERTY RIGHTS & PROTECTION

Ideas and knowledge are an increasingly important part of knowledge and trade. Most of
the value of new medicines and other high technology products lies in the amount of
invention, innovation, research, design and testing involved. Just the way one has
ownership rights on physical property and land, one needs to have ownership rights over
knowledge and ideas as well. Intellectual property (IP) rights are the rights awarded by
society to individuals or organizations principally over creative works: inventions,
literary and artistic works, and symbols, names, images, and designs used in commerce.
They give the creator the right to prevent others from making unauthorized use of their
property for a limited period. Knowledge, however, can be said to have the characteristic
of a no-rival public good, the more people use it – the more benefit the society gets. But
then, if it would have so simple we wouldn’t have had the world fighting over it, the
 Changing IP Regime – How to Balance Interests |

TRIPS and eventually this project report. A question that becomes pertinent is that why
do we need to protect knowledge from passing freely from one person to another and
what is the need for Intellectual Property Rights or IPRs.

The need for IPR can be supplemented by the fact that once an idea is known to someone,
it is very easy to replicate it and sell it to others without incurring the R&D costs that the
original innovator had done while developing the innovation. Moreover, knowledge has
become completely commercial. It is used to develop medicines (as far as the
pharmaceutical sector is concerned) and these medicines are eventually used by the
developers to make money and if they are not protected, those spending millions in
acquiring this knowledge in the first place won’t have any incentive to do so. The
argument that goes against providing protection to intellectual property especially in the
pharmaceutical sector is that it leads to an increase in the price of certain important life
saving drugs and because of non-availability of such drugs, thousands of people would
die without proper treatment. This debate between the rich and the poor, the privileged
and the forsaken, the haves and the don’t haves seems to have been in the society since
antiquity and shall continue forever. There are basically two reasons for this struggle
between the developing and the developed nations: -
1. The exigency of the situation of public health crisis that the developing
nations in general and Africa in particular are facing in catastrophic
proportions.
2. The conduct of USA and the other developed nations was considered a
threat to the very purpose of the WTO – to promote economic growth
and peaceful trade relations following the 2nd World War.1

TRIPS – BACKDROP AND GENESIS

With the incipient of the new information based trade and investment, there had been a
great change in the technological structure of world economy. The root cause for the
lobbying by developed nations and multinational companies can be summed up in one
line – the developed nations were spending huge amounts of money on R&D and the

1
Abbot (2002), p 311
 Changing IP Regime – How to Balance Interests |

developing nations like India were duplicating it due to a loose IPR regime. Let’s
consider India as a perfect example of a developing nation getting full advantage of the
pre-TRIPS era.

Before the creation of the World Trade Organization in 1995, individual countries were
free to have their own patents laws. India was one of the developing countries which took
advantage of this freedom and replaced the British Patents and Designs Act, 1911 by the
Patents Act, 1970 in 1972. The Indian Patent Act was created in 1970 and on the one
hand was implemented to encourage innovation by protecting proprietary research and
development.

This philosophy, however, was at odds with India’s desire (dare it be said necessity) to
encourage and allow access to foreign technologies (e.g., pharmaceuticals) to Indian
society that otherwise might be unavailable to its people due to cost and pricing structures
under a proprietary intellectual property protection system.

Thus, to bridge this gap, patents were only issued for methods of producing products
(also referred to as compositions of matter), but not for the products themselves (i.e.,
pharmaceuticals). This allowed one to commercialize a drug that was a proprietary
product of another as long as ones own method of producing that product was used.

Furthermore, the patent term of an Indian patent for chemicals, food, and drugs was
seven years; far short of the WTO mandated 20-year term from application filing date.
Finally, imported products were not themselves protected, only the means of producing
that product.

Hence, it was all gains for India. The impact of the Indian Patent’s Act, 1970 was
magnanimous. At the time when we got independence, there was no pharmaceutical
industry to speak of and the government had the option of both importing medicines from
outside and subsidizing them or to provide incentives for the growth of a pharmaceutical
industry in the country. The latter option was chosen and as a result the ‘Indian Patent
 Changing IP Regime – How to Balance Interests |

and Design Act of 1911’ was replaced with the ‘Indian Patent Act, 1970’ and as a result
product patents2 became history. As the western European countries did not consider
India as a major rival in the pharmaceutical sector, this was not at all opposed in the first
place.3 Now that the Indian pharmaceutical companies had the option of manufacturing
drugs by taking advantage of a loose process patent4 regime, they started manufacturing
expensive antibiotics at cheap prices and as a result, even the consumers shifted loyalty
from the branded expensive medicines to cheap Indian brands. Even the multinationals
benefited from this as Indian firms entered into production contracts with them,
permitting them to enjoy low cost production.

Another major concern that was troubling the western nations was that why should
people in countries like America die in absence of cheap drugs while people in countries
like India can have the same medicine for throw away prices. Moreover, the
multinationals couldn’t take this copying of their innovations easily. For example, in
October 2005, CIPLA, an Indian pharmaceutical firm announced the launch of a generic
version of Roche’s (Switzerland) anti-influenza drug Tamiflu, for curing Avian Flu. The
result of this announcement was a complete stir-up in global markets as CIPLA promised
to launch the drug at half the price it’s being sold in USA and UK. The company Chief,
Dr. Yusuf Hameid cited humanitarian grounds for the development and promised to
honour the patent in countries where it is applicable.5

In the backdrop of these events, at the Eighth Round of the Multilateral Trade
Negotiations under GATT, held in 1986 at Uruguay, the demand for the inclusion of

2
Product Patents are patents granted for the product itself such that no one else can manufacture it even by
a different method.
3
Ramani and Maria (2005) p 676
4
Process Patents are patents where patent is granted only on the process by which a particular innovation
has been created.
5
Reported by Businessline, article available at
http://www.thehindubusinessline.com/2005/10/15/stories/2005101502720200.htm, last visited on 25th
December, 2005
 Changing IP Regime – How to Balance Interests |

TRIPS was made which was resisted by the developing countries. However, they were
ultimately persuaded to let it be included after negotiations by USA offering a
commitment to pursue reductions in agricultural export subsidies, textile quotas and to
alleviate restrictions on the import of tropical products.6

Finally, in 1994, at after the conclusion of the Eighth Round of the Multilateral Trade
Negotiations under GATT, the WTO agreements were signed by the 128 members of the
then GATT.7 As of 11th December, 2005 the WTO has 149 members, with Saudi Arabia
being the latest member joining on 11th Dec 2005.8

TRIPS – PROVISIONS AND IMPLICATIONS

According to the WTO, the TRIPS agreement has 5 major concerns that are needed to be
addressed9: -
1. How basic principles of the trading system and other international intellectual
property should be applied?
2. How to give adequate protection to intellectual property rights?
3. How countries should enforce those rights adequately in their territories?
4. How to settle disputes on intellectual property between members of the WTO?
5. Special transitional arrangements between the periods when the new system is
being introduced.

In order to achieve these goals, a few measures were suggested by the WTO in the TRIPS
Agreement which all the signatory members had to comply with and in order to do that
the Indian government brought about three amendments to the Indian Patents Act, 1970.

6
Abbot (2002) p 314
7
India signed the GATT on 8th July, 1948, list available at
http://www.wto.org/english/thewto_e/gattmem_e.htm, last visited on 25th December, 2005
8
Complete list of members and date of joining available at
http://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm, last visited on 25th December 2005
9
As enlisted by WTO, available at http://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm7_e.htm, last
visited on 25th December, 2005
 Changing IP Regime – How to Balance Interests |

A look at the new provisions brought about by the Indian Patents (Amendment) Act,
2005 would give a clear view on what the TRIPS wanted the nations to do.

FEATURES OF THE INDIAN PATENT ACT, 1970

a) Extension of product patent protection to all fields of technology (i.e., drugs,

foods and chemicals);
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 situations (in accordance with the Doha Declaration
on TRIPS and Public Health);
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.

Moreover, the 2nd amendment10 in the Patents Act had made a provision under Section
107A (b) providing for '
parallel import'
. However, this required that the foreign exporter
was duly authorised by the patentee to sell and distribute the product. In the Act of 2005,

10
Indian Patent(Amendment) Act, 2002
 Changing IP Regime – How to Balance Interests |

this has been amended to say that the foreign exporter need only be '
duly authorised
under the law’.

FEARS OF THE INDIAN PHARMACEUTICAL INDUSTRY

What will be the implications of the new Act? Over a period of time Indian drug
companies will lose the opportunity to develop processes for patent protected drugs in the
country. Indian drug companies might become dependant on MNCs for technology to
produce new drugs. It was feared most that, technological dependence on MNCs will
lead to establish their dominance over the Indian drug market. MNCs once again may
start charging exorbitant prices for drugs in the Indian market. In product patent regime
the drugs showing fastest growth would have been priced way beyond the capacity of the
average consumer. Hence, in a nutshell, the fears of the Indian Pharmaceutical Industry
can be summarized as follows: -
1. In the TRIPS era, multinational pharmaceutical industries of developed countries
will exploit the '
right to trade'of TRIPS agreement.
2. It is opined that TRIPS violates the human rights. Indian sovereignty and the
public health policy should not be compromised at huge costs to the Indian public.
It is expected that drugs could become expensive and beyond the reach of
common man.
3. TRIPS would strike at the industry'
s ability to engage in a sustainable
development in self reliant way.
4. TRIPS will hinder the preservation and become a threat to innovation and
practices of indigenous medicines, especially alternative medicines like Ayurveda
and Unani.
5. A number of medium and small pharmaceutical companies may force to close
down; this will lead to loss of job for thousands of employees.
6. Companies which do not have enough R&D competence and orientation and want
to be in the race and survive may be forced to go in for mergers, joint ventures
etc., or have to increase their R&D spending and allocations.
 Changing IP Regime – How to Balance Interests |

7. Overall growth rate of the industry may slow down considerably or may be even
remain stagnant for some time.

PRO – INDIAN FEATURES OF TRIPS

Again, a look at the Indian Patents (Amendment) Act, 2005 and the earlier amendments
clearly indicate the following features of the Act which are ameliorating Indian
pharmaceutical industry’s fears and apprehensions: -

1) Indigenous manufacturers are allowed to manufacture patented products even after a

patent is granted, in respect of mailbox applications, on payment of a reasonable royalty
to the patent holder, if they had been producing and marketing the concerned product
since prior to 1/1/2005. This provides a level playing field for domestic players who have
already made substantial investments and have been manufacturing the products for
which applications for patents have been received in the mailbox. This provision ensures
the smooth transition from pre patent era to post patent era. There can be a marginal rise
in the existing drugs as the licence to the marketed products will be nominal in most of
the cases. There can be negotiations with the patent holder on price and technology
transfer.

(2) The system provides for both pre-grant and post-grant opposition avenues, and
reduces the timeframe for grant of patents in a cost-effective manner, while taking care of
public interest. In fact, pre-grant opposition to patents has been strengthened and all the
11 grounds for pre-grant opposition to patents have been specifically listed in the Act, in
the same way as before the Ordinance of December 2004.This provision is aimed at
establishing a mechanism by which system of patent protection and provide avenues for
the patent holders to challenge violation of their intellectual property rights by unfair
means.

(3) In order to prevent "ever greening" of patents for pharmaceutical substances,

 Changing IP Regime – How to Balance Interests |

provisions listing out exceptions to patentability (or what cannot be patented) have been
suitably amended so as to remove all ambiguity as to the scope of patentability. This is
very important in Indian context as it is very rich in traditional knowledge and heritage.
The clear-cut instructions regarding what can not be patented would help public at large
in a long run. The healing techniques of well established in ethnic system of medicines
such as Ayurveda, Siddha and Unani system and formulations there in can not be
patented.

(4) Conditions for obtaining compulsory licence have been clarified in order to facilitate
export of patented pharmaceutical products by Indian companies to countries that do not
have adequate production capacities such as least developed countries. The compulsory
licensing is an instrument that the TRIPS allows by which governments can allow
domestic manufacturers to manufacture patented products within 3 years of their
introduction. The provision of this would be an opportunity for indigenous manufacturers
to export the medicines to third world countries which can not manufacture their own
drugs. There are many countries in Africa, Asia and South America which are in need of
cheap drugs due to poor economic development in this area. It will be a boon for basic
and formulation manufacturers as the market to this segment will definitely promotes
opportunities. India being rich in cost effective and intellectually competitive manpower
and other resources would definitely emerge as world leader as far as export of drug is
concerned.

(5) '
Reasonable period'for negotiations between the patent holder and companies seeking
compulsory licence has been fixed at six months. This provision of the Act would ensure
positive dialogues and negations to happen between indigenous manufacturers to arrive at
deals leading to win situations. In due course of time a better understanding of the
situations and conditions in the needy poor nations would resolve the conflicts as the
patent holders would also appreciate the efforts of the indigenous manufacturers efforts to
sell drugs at a cheaper price. The patent holder will not be interested to sell the drugs to
the poor nations as he would find practically obstacles and considerations are not cost
effective for him.
 Changing IP Regime – How to Balance Interests |

(6) Exemption of research and development from the ambit of patents, including
experimental and educational purposes. The basic research and education are the pillars
of applied research. The education and research methodologies are the tolls for
developing science and technology. Barring this area from the patent, government wants
to ensure availability of trained manpower for sustained growth.

AN INSIGHT INTO THE NOVARTIS CASE11

Talking about the landmark cases related to infringement of Intellectual Property Rights,
the Novartis AG and Anr v Mehar Pharma and Anr12 deserves special mention. Before
discussing the nuances of this case, lets have a look at the factual matrix of this case and
the cause of action which led to this case.

The plaintiff, Novatis AG had developed an anti-cancer drug composed of the “B-
Crystalline form of Imatinib Mesyiate salt” for which they had obtained the Exclusive
Marketing Rights from the Indian Patent Office granted under Chapter IV-A of the
patents Act, 1970. The defendants, Meher Pharma, were manufacturing for sale, sell,
marketing and exporting their anti cancer drug composed of the “B-crystalline form of
imatinib Mesyiate salt” under the brand name “VEENAT”.

Novartis contended the following points in the appeal: -

it had obtained patent protection for the drug in question in 31 countries of the
world;

the examination of an EMR application is distinguishable from that of a patent

application in that no question of prior art examination is mandated for the EMR
process

the substance in question was neither known nor invented till Novartis invented
the same;

11
MANU/MH/1058/2004
12
Ibid
 Changing IP Regime – How to Balance Interests |

the generic manufacturer before the High Court came into the market only in
January 2003, thus giving lie to its claim that the substance had been known since
1993;

it had spent decades of research and millions of dollars in research in inventing

and developing the drug in question;

that it has been running a free program in 70 nations including India called
‘Glivec International Patients Assistance Program’ (GIPAP) and thus fulfilling
the interest of the public.

On the contrary, the defendant contended the following points: -

the nature of the monopoly right claimed by Novartis was different in nature,
scope and legal effect from other forms of intellectual property such as trademark
and copyright. Whereas registration of trademark and copyright in one country
has a persuasive value in another, patent and design rights are statutory creatures,
territorial in nature and dependant only on specific registration in each country;

the EMR provisions have been enacted in utter disregard of the constitutional
restrictions, giving rise to a draconian creature, uncontrolled by any constitutional
restraints. In other words, the procedure for grant of an EMR is not subject to any
pre-decisional or post-decisional hearing or any other form of redressal and thus
violative of the constitutional guarantees;

the subject matter of the EMR was already disclosed in a pre-TRIPS Canadian
patent of April 1, 1993 and, it became part of the public domain in India for lack
of any corresponding patent protection in India;

that none of the conditions for grant of EMR was satisfied by Novartis;

that the subject matter of the EMR was an anti-cancer life saving drug and
Novartis was not manufacturing the same in India but merely exporting it to India
for distribution through its subsidiary. With 30,000 afflicted patients in India and
a demand for over 3,000,000 capsules per month, Novartis alone would not be in
 Changing IP Regime – How to Balance Interests |

a position to meet these challenges for lack of effective distribution network and
infrastructure;

the defendant is the largest supplier of the anti-cancer drug in the market and any
adverse order of injunction would completely stifle all avenues of supply of this
life saving drug and leave the patient at the mercy of erratic and costly supply by
Novartis as against USD 20 per capsule of Novartis the defendant’s per capsule
price worked out to USD 2 only).

the settled law in relation to a patent (which is obviously on a higher level than an
EMR) lays down that the court will not grant an interlocutory injunction where a
patent is of recent date. It is an admitted position that Novartis’ EMR was granted
only in November 2003 and thus of recent date.

any grant of interim injunction against the defendant would not only dismantle
the defendant’s manufacturing and marketing network but also create scarcity of
the life saving drug and thus prove disastrous for patients.

After getting into acquaintance with the facts of the case and the identifying the
issues, the High Court of Mumbai declined to provide relief to Novartis and
observed that: -

The grant of EMR in favor of Novartis raises serious questions as to its validity.

It appeared that the 1993 application submitted by Novartis in Canada prima facie
shows that Novartis had disclosed the subject matter of the EMR and it has been
part of the public domain in India

The EMR in question was admittedly of recent origin and even if Novartis
ultimately succeeded, the loss or injury that may be caused to it was capable of
being compensated in terms of money.
 Changing IP Regime – How to Balance Interests |

The balance of convenience lay in favor if defendant because the drug in question
was an anti-cancer drug and Novartis does not manufacture the drug in India.

The aspect of the difference of prices of the respective drugs could not be ignored
at the stage of question of interim relief.

The order of injunction granted by the high court of Chennai was not based on a
correct application of the settled law in the matter of grant of temporary
injunction in relation of a patent of recent origin.

PROSPECTS FOR INDIAN PHARMACEUTICAL INDUSTRY POST-TRIPS

Patents in the Indian Context

So far Indian companies were acclaimed for their "reverse engineering" skills that
provided the cost effective and quality drugs to millions of people worldwide and
compete fiercely with the multinational companies. This may no longer continue, as now
Indian companies have to abide by new patents act. Although most of drugs available on
Indian market are off patent drugs, drugs developed to combat severe diseases like AIDS
and Cancer may cost dearer as most of these drugs are patented by MNCs. Further the
money invested for R&D by Indian companies was minimal compared to their
counterparts in developed countries. But since last couple of years Indian companies
started investing heavily in R&D and the percentage of amount spend for this activity has
shot up. Thus Indian companies also started gearing for the product patent regime.
Further Indian government has mooted the process to make amendments in various laws
to make it compliant with TRIPS and at the same time making essential drugs available at
affordable prices. The task of government is Herculean as they have to adopt two
pronged strategy to comply with TRIPS and safeguarding public interest.
 Changing IP Regime – How to Balance Interests |

Healthcare In India
It is known that people in India have to pay from pocket to buy medicines.
Millions in country cannot purchase drugs and only 30 % of population has access to
modern medicine. Unlike other countries where medical and healthcare insurance is
provided for the citizens, India lacks this provision. Presently roughly around 5% of
population is covered by medical and healthcare insurance, which is minuscule compared
to other countries. Government needs to take proactive step and bring the citizens under
the healthcare insurance and benefit schemes.

Prices of Drugs
Though the prices of drugs in India are the lowest, it is equally important to note
that the per capita income in India is also among the lowest. The expenditure on
healthcare in India is among the lowest US$ 3 per annum compared to US$ 412 in Japan,
US$ 222 in Germany, US$ 191 in the USA, US$ 124 in Canada and US$ 7 in China.
After the passage of the amended act the Union Minister of Commerce and Industry, Shri
Kamal Nath had said in his speech that13

“The prices of drugs will not shoot up due to patents, because of the strong safeguards, checks
and balances. There are comprehensive provisions in the amended act to deal with the issues
concerning the price and availability of medicines. These include provision for compulsory
licensing to ensure availability of products at reasonable prices; parallel importing of drugs;
acquisitions of product rights by the government; revocation of patents; and provisions to deal
with emergency situation. It must also be noted that 97 % of drugs in the market and 100 % of
essential drugs are not covered by patents.”

But for the drugs for HIV and Cancer, it is feared that the prices of these drugs will go
up. Experts opine that the entire group of AIDS drugs that used to be produced by the
Indian companies will be unavailable or become costly due to new patent regime.

R&D
Although Research and Development had not been cup of tea for Indian
pharmaceutical companies, Indian companies have to plan for research and development
to compete and succeed at global level. Companies can go for Novel Drug Delivery
Systems (NDDS), New Drug Discovery and Research (NDDR). Indian companies have

13
Full text of the speech available on http://www.loksabha.nic.in , last visited on 26th December, 2005
 Changing IP Regime – How to Balance Interests |

started working in this area and the R&D spend by some big Indian companies have
increased tremendously in last couple of years. This is a good sign of Indian companies'
vision to compete in post patent era.

CONCLUSION

Although there are many facets and many issues involved with the implementation of
Intellectual Property Rights, it is important for pharmaceutical companies to provide
quality products for better healthcare of people and equally responsible is the government
to ensure that needy people are not deprived of basic rights of healthcare due to
exorbitant prices of drugs due to patent protection. There is also a need to create
awareness among general public regarding the issues of IPR and its impact on society.
This will make pharmaceutical industry more competent and the government will be
more vigilant to curtail misuse of patents.

When issues of patent policy are considered by the courts, the Parliament, and the
Executive branch, one can be sure that the opinions of patent lawyers and patent holders
will be heard. While their arguments will often be couched in terms of the public interest,
at bottom their interest is in their own profits and livelihoods, not in designing a patent
system that fosters the overall rate of innovation. Yet the long-term well-being of
everyone depends on a robust innovation system, and patents play a crucial role in that
system.

Because it has been left to the special interests, patent policy seems arcane and obscure.
And there are certainly many details of patent law that are mind-numbingly complex. But
at its heart, the patent system is about three things. It is about technology--the endlessly
curious and fascinating process by which new ideas for machines or drugs or computer
programs are conceived and developed. It is about people--inventors who create and
develop new ways of doing things; business people and lawyers who make decisions
about investing in innovation, suing each other, and defending such suits; and
government employees who must evaluate the competing claims of different parties and
 Changing IP Regime – How to Balance Interests |

make decisions. And it is about how the rules and procedures established by Congress
and the courts affect how the people interact with the underlying process of technological
progress. That interaction ultimately affects us all, and so should concern us all.

BIBLIOGRAPHY
Abbot, Frederick M. (2002), The TRIPS-legality of measures taken to address public
health crises: Responding to USTR-State-industry positions that undermine the
WTO published in The Political Economy of International Trade Law: Essays in
Honour of Robert E. Hudec, Cambridge University Press, Cambridge.

Carvalho, Nuno Pires de (2002), The TRIPS Regime of Patent Rights, Kluwer Law
International, Hague

Gervais, Daniel (1998), The TRIPS Agreement: Drafting History And Analysis, 1st ed.,
Sweet And Maxwell, London

Narayana P (2001), Intellectual Property Law, 3rd ed., Eastern Law House, Kolkata

Ramani, Shyama V and Augustin Maria (2005), TRIPS: Its Possible Impact on Biotech
Segment of the Indian Pharmaceutical Indusry, Economic And Political Weekly,
Vol. XL, No. VII. pp 657 to 683

Rashid, Taufiq (2005), Bird flu: India safe so far but fears spark pharma war, 15th
October, The Indian Express, New Delhi, p1

Worthy, John (1994), Intellectual Property Protection After GATT, EIPR, Vol 5, p 195