Guide
Guide
Guide
TO HEALTH
A DISSERTATION
Submitted by
JAHNAVI ANAND
21222205
Dr. VIKALP
in
School of Law
May 2022
Approval of Dissertation
Health by JAHNAVI ANAND, 21222205 is approved for the award of the degree of LLM
Examiners:
1. ___________________ ___________________
2. ___________________ ___________________
3. ___________________ ___________________
Supervisor:
___________________ ___________________
Chairman:
___________________ ___________________
2
DECLARATION
I Jahnavi Anand hereby declare that the dissertation, titled pharmaceutical patenting
in India: Problem of Public Access to Health is a record of original research work
undertaken by me for the award of the degree of Master of law in Corporate and
Commercial Law. I have completed this study under the supervision of Dr. Vikalp,
Associate Professor, School of Law, CHRIST (Deemed to be university), Delhi NCR.
I also declare that this dissertation has not been submitted for the award of any degree,
diploma, associateship, fellowship or other title. I hereby confirm the originality of
the work and that there is no plagiarism in any part of the dissertation.
Date:
3
CERTIFICATE
This is to certify that the dissertation submitted by Jahnavi Anand, 21222205 titled
‘Pharmaceutical Patenting in India: Access to Public Health’ is a record of research
work done by her during the academic year 2021-2022 under my supervision in partial
fulfilment for the award of Master of laws in Corporate and Commercial Law.
This dissertation has not been submitted for the award of any degree, diploma,
associateship, fellowship or other title. It has not been sent for any publication or
presentation purpose. I hereby confirm the originality of the work and that there is no
plagiarism in any part of the dissertation
Place: Bengaluru
Date:
School of Law
4
Acknowledgement
I record my thanks to esteemed Director and Dean, Fr. Dr. Viju P D for inculcating
the concept of preparing this dissertation and allowing me to present my view point in
liberal manner.
5
Table of Contents
1 INTRODUCTION 12
1.1 STATEMENT OF PROBLEM 13
1.2 RESEARCH QUESTIONS 13
1.3 OBJECTIVES 13
1.4 RESEARCH METHODOLOGY 14
2 LITERATURE REVIEW 15
3 HISTORICAL ASPECT OF DRUG PATENTING 28
3.1 HISTORY OF PATENT 28
3.1.1 HISTORY OF PATENT ACT,1970 29
3.2 JUSTICE BAKSHI TEK CHAND COMMITTEE 31
3.3 JUSTICE RAJAGOPALA AYYANGAR COMMITTEE 32
3.4 POSITION BEFORE 1970 34
3.4.1 POSITION AFTER 1970 36
4 THE VARIOUS TREATIES AND CONVENTIONS GOVERNING THE LAW OF
PATENTS ARE 41
4.1 PARIS CONVENTION (1883) 41
4.1.1 PATENTS. 42
4.2 GATT-GENERAL AGREEMENT ON TRADES AND TARIFFS 45
4.2.1 THE IMPACT OF THE INDIAN PATENT REGIME ON THE PHARMACEUTICAL
INDUSTRY 46
4.2.2 PRICE OF A DRUG 47
4.2.3 REASONS FOR PRICE INCREASES FOLLOWING GATT-2005 48
4.2.4 49
4.2.4 PHARMA TECHNOLOGY HAS A MAJOR IMPACT 49
4.2.5 R&D HAS A DIFFICULT IMPACT (OF INDIAN PHARMA COMPANIES) 50
4.2.6 THE MORE FORWARD-THINKING AND GLOBALLY CONSCIOUS AMONG
THEM HAVE DEVISED A TWO-PRONGED STRATEGY: - 50
4.2.7 THERE ARE SEVERAL AREAS OF RESEARCH THAT COULD BE DONE ON
TRIPS. THE FOLLOWING ARE A FEW OF THEM: 51
4.3 THE PATENT COOPERATION TREATY (PCT) 52
4.4 TRIPS NORMS 54
4.5 BUDAPEST TREATY 55
4.6 WIPO 56
4.7 WTO-WORLD TRADE ORGANIZATION 59
5 IMPACT OF TRIPS ON GENERIC MEDICINE 66
5.1 TRIPS AGREEMENT AND ITS MANDATE 68
6
5.1.1 TRIPS AND PUBLIC HEALTH 69
5.1.2 TRIPS COMPLIANT WITH INDIA 71
5.1.3 APPLICATION FOR COMPULSORY LICENSE AND REVOCATION OF PATENT
APPLICATION BEING WITHDRAWN AFTER ACQUISITION BY ANOTHER COMPANY
73
5.2 CASE ANALYSIS 74
5.2.1 NATCO WITHDREW OPPOSITION TO GILEAD’S DRUGS 74
5.2.2 RANBAXY WITHDRAWS PATENT CHALLENGE OF PFIZER’S
BLOCKBUSTER MEDICINE LIPITOR FILED IN MORE THAN EIGHT COUNTRIES 76
5.3 GENERIC MEDICINE – WHAT IS IT? 78
5.3.1 Differences in Branded and Generic Medicines: - 79
5.3.2 GENERIC MEDICINES IN INDIA 81
6 EFFECT OF ANTI- EVERGREENING – AN AID TO THE HEALTHCARE SYSTEM OF
INDIA 82
6.1 INTRODUCTION: - 82
6.1.1 1970-1995: Development of a Generic Drug Industry 82
6.1.2 TRANSITION PERIOD [1995 to 2005] 83
6.2 TRIPS REQUIREMENTS AND FLEXIBILITIES 84
6.2.1 COMPULSORY LICENSING AND BAYER V. NATCO 85
6.2.2 THE BAYER V. NATCO DECISION 86
6.2.3 “REASONABLY AFFORDABLE” 86
6.2.4 “WORKING” 87
6.2.5 RAMIFICATIONS OF THE IPAB INTERPRETATION 87
6.3 ANTI-EVERGREENING AND NOVARTIS AG V. UOI 89
6.3.1 THE NOVARTIS AG V. UOI DECISION 91
6.3.2 “KNOWN COMPOUND” 92
6.3.3 “ENHANCEMENT OF KNOWN EFFICACY” 93
6.3.4 RAMIFICATIONS OF THE SUPREME COURT OF INDIA’S INTERPRETATION
93
7 CONCLUSION 97
7.1 SUGGESTIONS OR RECOMMENDATIONS 100
8 BIBLIOGRAPHY 103
7
ABSTRACT
Intellectual Property Rights have played an important role in the growth of the
economies of the developing and developed countries around the world, imbued,
providing large and small sector with a variety of tools to help small sectors drive
their success, and whilst benefiting consumers and society through a continuous
stream of innovative, competitive products and services. Lion’s share of creative and
innovative products and services primarily are based on Patents, Copyrights,
Trademarks, Industrial Design etc.
The first chapter of the dissertation deals with the introduction to the
dissertation and the second chapter covers the various literature review which the
researcher has gone through to form an idea of the topic of dissertation. In the third
chapter, Historical aspect of drug patenting, the researcher has elaborated on the
history and evolution of patents and the first patent act passed in India. The various
committees were formed to look into the issue of patent reform and make
recommendations to the government. In the fourth chapter the researcher has
examined the various treaties and conventions governing the law of patents. The
researcher has also given special reference to the various international organizations
like WTO and WIPO and how the WTO has provided with the patent protection for
any innovation and invention in drug without any discrimination. In the fifth chapter
the researcher has discussed about the impact of TRIPS on Generic Drug Production
and how has the India complied with the TRIPS norms due to its status as a
developing country. Despite the patent debate, there are laws in place to ensure that
access to medicines is preserved while remaining technically compliant with the
TRIPS Agreement. The sixth chapter mentions about the effect of anti-evergreening
– an aid to health care system of India and mentions about the production of generic
drugs in India. The development of generic drug industry and its transition period has
been mentioned with how the TRIPS have provided certain requirements and
flexibilities for the production of generic drugs. And the last chapter Conclusions and
Suggestions is based upon the study of the research, summarizing the various aspects
of drug patenting. The chapter also provided valuable suggestions and
8
recommendations which can be implemented to aid the public health care system and
the access to drugs can be made more affordable.
9
LIST OF ABBREVIATIONS
BIRPI- Berne Convention and the Paris Convention combined and formed an
international organization called the United International Bureaux for the Protection of
Intellectual Property (" BIRPI ").
EU-European Union
NPPA-Non-Performing Assets
10
MNC- Multi National Corporations
11
TABLE OF CASES
Novartis Ag vs Union of India & Ors on 1 April, 2013
Natco Pharma Limited vs Bayer Healthcare Llc on 11 July, 2019
Hoffmann-La Roche Ltd. &Anr. v. Cipla L
AT&T Knowledge Ventures LP, re 2009 EWHC 343 (Pat).
Bilski v. Kappos, 130 SC 3218 (2010).
Dimminaco AG v. Controller of Patents and Designs, (2002) I.P.L.R. 255 (Cal).
Edwards v. Picard (1909) 2 KB 903 at 905 CA.
Electric Storage Battery v. Shimadzu 307 U.S. 5 (1939).
Farbewerke Hoechst AG v. Unichem Laboratories AIR 1969 Bom 255.
Gandhimati Appliances Ltd. v. LG Varadaraju 2003 3 MLJ 85 (DB).
Gibbons v. Ogden 22 U.S. 1 (1824).
Green Peace Ltd v. Plant Genetic Systems N.V. T. 0356/93-334 dated 21 Feb. 1995.
Hoechst v. Unichem 1969 RPC 55.
Hotchkiss v. Greenwood 52 U.S. 248 (1850).
Indian Vacuum Brake Co. Ltd. v. E.S. Luard AIR 1926 Cal 152.
Imperial Chemical Industries Ltd. v. Controller General of Patents, Designs and Trade
Marks, A.I.R. 1978 Cal. 77.
Jazz Photo Corp v International Trade Commission, 264F.3d 1094 (Fed. Cir. 2001)
Lord Russel in EMI Ltd v. Lissen Ltd. (1938 56 RPC 23 57 (HL). xvii Marker/Beattie
T 603/89 1992 OJ EPO 230
Pennock v. Dialogue 27 U.S.I (1880).
Prometheus Laboratories v. Mayo Collaborative Services, 2010 WL 5175124 (Fed.
Cir. Dec. 17, 2010).
Raj Prakash v. Mangat Ram Choudhury AIR 1978 Del 1. Research Corp.
Technologies Inc. v. Microsoft Corp, 2010 WL 4971008 (Fed. Cir. Dec. 8, 2010).
Roche Products Inc. v. Bolar Pharmaceuticals Co. Inc. Inc 221 USPQ 937 (Fed Cir
1984).
Smithkline and French Laboratories Ltd. v. Evans Medical Ltd., (1989) FSR 561.
Sri Gajalakshmi Ginning Factory Ltd. v. CIT (1952) 22 ITR 502 (Mad).
State of Punjab and others v. Ram Lubhaya Bagga and others (1998) 4 SCC 117.
12
Suffolk Mfg. Co. v. Hayden 70 U.S. 315.
Thomson Brandt v. Controller of Patents AIR 1989 Del 249.
United Indigo Chemical Co Ltd. v. Robinson, (1932) 49 RPC 178.
13
14
CHAPTER-I
1 INTRODUCTION
Intellectual Property Rights have played an important role in the growth of the
economies of the developing and developed countries around the world, imbued,
providing large and small sector with a variety of tools to help small sectors with a
variety of tools to help small sectors with a variety of tools to help drive their success,
and whilst benefiting consumers and society through a continuous stream of
innovative, competitive products and services. Lion’s share of creative and innovative
products and services primarily are based on Patents, Copyrights, Trademarks,
Industrial Design etc.
15
weaker section of the society. The TRIPS agreement made it mandatory for the
countries to do drug patenting, but initially India was hesitant to do so, and it only
applied it when the USA made a complaint about India not following the TRIPS
agreement. The general purpose of drug patenting is to safeguard the interest of the
drug companies. These drug companies invest hefty amounts for the purpose of
research and development of a particular drug, before actually bringing it out on the
market level. The process of research and development may be as long as 10-15 years,
which costs a huge amount of investment to be made.
The general problem which has evolved out of drug patenting is that it causes
suffering to common people in the country. As patenting of these essential drugs
increases their market costs which supplements the drug companies in making profit,
but the common people are not able to afford it due to its higher prices. The TRIPS
agreement has been implemented in India which badly affected the production of
generic drug. As the TRIPS specifically mentions about “evergreening”. But when
India made its own patent law it added an anti-clause which is in opposition to the
TRIPS agreement referred to as “anti -evergreening.” The present law built on TRIPs
is believed to ignore certain legitimate interests of the developing countries and may
create certain problems for them including India. Although some flexibilities have
been provided by the TRIPs agreement but they are good on paper and are difficult to
apply.
Whether the TRIPS agreement has impacted the production and distribution of
drug production in India?
1.3 OBJECTIVES
▪ Research and analyze the impact of drug patenting on the Indian health care
system.
The research methodology which has been applied here is the “Qualitative and
Descriptive Legal Research”.
The data collected from secondary resources were properly analyzed and interpreted
to draw the conclusion.
17
CHAPTER II
2 LITERATURE REVIEW
2.1 ARTICLES
Nilesh Zacharias and Sandeep, [Farias Patents and Indian pharmaceutical]
industry, [2002]
In this article the authors Nilesh Zacharias and Sandeep Farias have mentioned
about how the pharma industry in India is growing and has developed over the
decades. The authors talk about the Indian pharma industry is expanding all over the
globe, due to its favorable government and liberalization policy. Various efforts have
been made to strengthen the intellectual property protection in the country. One of
them being the protection of drug patenting, which is being done by the big privately
or government owned pharma companies. Huge investments are being done by the
research and development team of the pharma company. And so, strong patent policy
needs to be framed to protect the erosion of Indian pharma company from the global
market.
The thing which has been not mentioned by the author in this literature is how
the drug companies use the process of evergreening to increase profits. And how the
drug companies just by making a little, changes in their chemical formulations intend
to patent the drug so, there prices are high and they could earn huge chunk of money.
18
William Greene in this article talks about how the Indian pharma company came into
existence after the implications of WTO, TRIPS agreement came into India. The
Indian Patent (Amendment) Act,2005 came into existence after this. But before the
Indian Drug Company could actually acquire the foreign market, it has to sell the
generic drug to cover up the revenues invested in manufacturing the drug.
But the shortfall or the impact these drug companies are facing due to the
selling of generic drugs is that they have to face the price compression and stiff
market competition to establish themselves in the market.
Pradeep S. Mehta in this article mentions about the impact of TRIPS agreement on
the Indian pharmaceutical sector and how it is affecting the developing nations like
India. He mentions about the introduction of product patenting and its impact on the
country in such a way that the drug companies, for the purpose of expanding their
market share have started investing more in the research and development.
The investment in the R&D is essential for the growth and development of a
drug company, but what Is missed out by these companies is that they have been
focusing more on “process innovation” rather than focusing on “product innovation”.
Which is the whole and sole motive of drug patenting.
Although the TRIPS agreement did somehow affect the Indian drug companies
but also some flexibilities have been provided by the TRIPS agreement, so that the
drug companies can set up their market. Various provisions have also been included in
the Indian Patent Act like compulsory licensing, or restriction on grant of a patent for
new use of a known substance etc.
19
This can be regarded as the major difference between the pre -TRIPS era and
the post-TRIPS era.
Neena Bedi and P M S Bedi in their article mentions about the Post-TRIPS Scenario
in India. The pharmaceutical industry's future depends on research and development.
A consistent investment in R&D should be contributed for the significant
improvement in life expectancy and health around the world.
And according to current research, since TRIPS has been formed in 1995, there
has been an increase in the number of patent applications filed in India. The fact that
pharmaceutical corporations have recognized the importance or the outcome of the
research and development, and the legal protection in terms of output SME’s R&D
intensity, on the other hand, is high. The pharmaceutical industry is far too little in
comparison, due to a lack of resources in comparison to huge corporations. Upgrading
the technology assistance and resources growth of their internal research and
development would facilitate the result. There is a pressing need for the survival of
SMEs to build a collaborative culture with governmental and private funding research
organizations.
21
Jagashetty R Bharatesh, [A critical study on Law pertaining to Drugs and their
Patenting, the problems involved in its Application in India in the context of World
Legal Regime], Ph. D Thesis, Bangalore University,2004
Dhar B.& Anuradha R.V., Economic & Political Weekly, March 26, 2005.
Dhar B. &Anuradha R.V. in their paper titled ‘Substantive Patent Law Treaty (SPLT) What
does this signify for India?' The Tenth Session of the Standing Committee on the Law of
Patents, WIPO, in 2004 discussed some of the provisions of a proposed substantive patent
law treaty. In this regard, a major question is whether the implementation of the SPLT, which
meshes perfectly patent rules, is a step toward adopting a TRIPS-plus system in terms of
member countries' duties. It concludes that current TRIPS flexibilities may be significantly
reduced if patent harmonization under the WIPO patent agenda develops toward higher and
tighter criteria.
Moore K.A. in his Article titled ‘Worthless Patents’ indicates the value of patents and
the value of patents that aren't worth anything. When it comes to patents, there are at
least two types of value: valuable inventions and valuable patents. A pioneering patent
is one of the highest societal values and is typically referred to as a patent on a basic
invention in a new subject. These patents may or may not bring in a lot of money for
their creators. A patent with high private value is one that benefits the owner
22
regardless of the benefit to society. Many analysts have claimed that patent quality has
deteriorated significantly in recent years, according to the author. Is there a
considerable number of useless patents issued by the US Patent and Trademark Office
(PTO)? Why do firms pursue useless patents, given the enormous cost of patent
preparation and prosecution?
Preparation and prosecution fees range from as little as AS5000 for a simple
invention to hundreds of millions of dollars for more sophisticated discoveries. The
PTO fees are a little part of the overall costs.
The fees to the PTO do not stop once a patent is issued. During the life of a
patent, the patentee is obligated to pay maintenance costs at three periods. The
patentee must pay the maintenance costs three and a half years, seven and a half years,
and eleven and a half years after issuance, otherwise the patent will expire at 4, 8, and
12 years, respectively. Instead of paying $910 in maintenance costs, the patentee
decides to let the patent expire because he previously paid $5000 to $30000 for
preparation and prosecution. The author's empirical study is based on a population of
96713 patents issued in the United States in 1971, with 53.71 percent of patentees
allowing their rights to expire due to nonpayment of maintenance fees. Even more
intriguing is the fact that patents that expire due to nonpayment of maintenance fees
have a number of distinguishing traits.
Wanli (Lily) Tang in his Note ‘Revitalizing the Patent System to Incentivize
Pharmaceutical Innovation: The Potential of Claims with Means-Plus-Function
Clauses’ As a potential remedy for this problem, calls for a wider use of means-plus-
function provisions in pharmaceutical patents. Although Congress approved means-
plus-function claims in the 1952 Patent Act, they have received little attention in the
pharmaceutical industry. This Note contends that for pharmaceutical patents, this
claiming method is not only appropriate, but also highly effective.
23
Even with limited use of the doctrine of equivalents, means-plus-function
claims would offer drug-product patents substantial scope, providing the protection
needed for inventive enterprises to overcome numerous attacks by generic producers.
Finally, this Note considers difficulties that may arise when using means-plus-
function claims in pharmaceutical patents and suggests potential remedies.
Henry G. Grabowski and John M. Vernon in their paper “Substitution Laws and
Innovation in the Pharmaceutical Industry “Examine why intellectual property
protection is important in the creation of innovative pharmaceutical goods. Patents
play a larger role in seizing the advantages of invention in pharmaceuticals than in
other high-tech businesses, according to previous survey studies of R&D leaders.
Based on an investigation of the economic characteristics of R&D expenses and
returns in the pharmaceutical and biotechnology industries, this paper considers why
this occurs. The third section looks at current policy changes and challenges in this
industry, such as patent lifetime and generic competition.
A.M.Y Kapczynski, in his article has presented a case study of the Indian
pharmaceutical industry in light of the TRIPS agreement's product patent regime The
author commends the country's progress in the generic medication market. He admires
the Indian Patent Act's overall design, particularly the clauses dealing to efficacy,
traditional knowledge, and disclosure of the geographical origin of biological material
in patent applications. He instructs Indian patent examiners not to adopt U.S. and
European Union judgements on PCT applications at face value.
24
Vermont S. in his article titled ‘Independent Invention as a Defense to Patent
Infringement’ contends that independent invention should be a defense if it is made
before the independent inventor has actual or constructive notice that someone else
has already made it. Despite limiting the incentives to invent below the essential
minimum, the defense lowers unnecessary duplication of work and improves
distribution of discoveries. According to Bye's theorem, the fact that an innovation has
a high probability of being produced by multiple people is proof that a substantially
reduced predicted reward will drive at least one inventor to make the idea without
inefficient delay.
2.2 BOOKS
Grubb P.W. and Thomsen P.R., [Patents for Chemicals, Pharmaceuticals &
Biotechnology’-Fundamentals of global law, practice and strategy] Fifth Edition
2017
Grubb P.W. and Thomsen P.R. in their book provide with a complete description
Successful patent practice and portfolio management are based on approaches and
industry know-how. All patent agents and experts working in the field of patent law
will benefit from this. This book will appeal to scientists, researchers, and managers
without a legal background due to its clear and accessible presentation and sensible
approach.
P.K. Mittal and O.P. Chadha, [Supreme Court on Trade Marks, Copyrights,
Patents and Designs (1950 to 2005’)], 2006
P.K. Mittal and O.P. Chadha in the book Supreme Court on Trade Marks,
Copyrights, Patents and Designs (1950 to 2005’) has dealt with practically all of the
Supreme Court of India's decisions on Trade Mark Copy Right, Patents, Designs,
Domain Names, and other similar IP Rights from 1950 to 2005, which have been duly
annotated in full length.
Bansal. I and Purohit, [H Intellectual Property Rights: The Emerging Issues For
Industry], (2004)
25
Bansal. I and Purohit. H in their book n’ emphasizes the need of effective IPR
management in knowledge-based businesses.
Khader F.A. The interesting intersection between science and law is represented by
this sculpture. It is the study of how a patent specification is comprehended and
interpreted. A patent specification, as a techno-legal document, encompasses the
problems of both science and law in that it aims to preserve an invention's rights while
also explaining the scientific progress it makes. What is true in science is also true in
law: disagreements over the meaning of words are a perpetual source of conflict.
This book describes Indian patent law and the problems that inventors, patent
holders, licensees, patent brokers, patent examiners, lawyers, and courts encounter
while dealing with patents. Because the chapters are created and arranged around the
requirements of the Patents Act 1970 and the Patents Rules 2003, it keeps familiarity
with them. It includes a detailed study of Indian and foreign rulings as well as a
comprehensive commentary on all facets of the law.
This book examines the law in light of post-TRIPS modifications and argues
that patent law should be interpreted in light of the TRIPS Agreement's flexibility.
The Patents (Amendment) Act 2005 and the Patents (Amendment) Rules 2006 are
among the key developments in patent law. It also takes into account recent case law,
such as the Novartis-Gleevec Exclusive Marketing Rights and Novartis-Gleevec
Patent Application instances. This book focuses on pharmaceutical patents because
the law contains a number of clauses that pharmaceutical companies may use more
frequently companies. Selection patents, novelty of use, Swiss version of claims,
patentability of pharmaceutical and biotechnological inventions, restricted marketing
rights, pre-grant opposition, compulsory licencing, export of pharmaceutical products,
Bolar exemptions, parallel importation, and other provisions of the Patents Act 1970
are also discussed.
26
Hiroya Kawaguchi, [The Essentials of Japanese Patents Law Cases and
Practice],2007
Hiroya Kawaguchi in his book mentions about a systematic and condensed analysis
of theoretical concerns and details of practical utility, such as patent inspection,
recommendations, and so on, as well as an assessment of the facts of major case laws
This book is aimed for legal professionals who work in the subject of Intellectual
Property Law, particularly in the field of Patens Law.
2.3 EDITORIALS
Danga A. Director General OPPI, The Economic Times December 21, 2004
Danga A. Particular people believe that the increase in the price of medicines is a
hoax spread by some parts of the industry. He also noted that over 95% of the
pharmaceuticals on the World Health Organization's (WHO) list of essential drugs are
now out of patent and therefore will continue to be available at present costs, and that
there are many therapeutic counterparts for the remaining drugs. The National
Pharmaceutical Pricing Authority (NPPA) will also continue to keep an eye on prices.
As a result, pharmaceuticals account for just around 15% of total health-care
spending. Diagnostic tests, hospitalization, and doctor's consultation fees account for
the majority of spending (85%). As a result, India's fixation with drug pricing is
unjustified.
27
In addition, the author discussed pre-grant vs. post-grant opposition. Currently,
any member of the public has the opportunity to file objections following the patent
controller's assessment for patentability. The majority of the industrialized world, on
the other hand, only recognises post-grant opposition. This is due to the fact that pre-
grant opposition frequently results in frivolous objections that cause the patent process
to be delayed. As a result, he argued, India should go with the post-grant opposition.
Narayan S. in the editorial column titled ‘Drug IPR: Where India must not ‘trip
Indian business, media, and interested industry have been engaged in a debate about
intellectual property protection that spans between extremes of cold rationality and
wild emotion, according to where India must not 'trip'. India has established enormous
pharmaceutical manufacturing capacity. India's government now aspires to become a
key player in the development of novel pharmaceutical goods, including through its
own research and development efforts and clinical trials. Lack of clarity in the
intellectual property regime, as well as in medication pricing, would stifle innovation,
new drug discovery, and new R&D investments. Bringing India's patent processes into
compliance with the TRIPS agreement is in India's best interests.
Bhasin A. in his editorial stresses the view on the top ‘Networking Technologies:
Driving Pharma Industry Growth’ Many multinational corporations have set up shop
in India in order to sell medications and perform clinical trials and research. As a
result, pharmaceutical research, manufacturing, and outsourcing have gotten a boost in
the country, giving the impression that there are plenty of chances in the
pharmaceutical industry. The CII study also predicts that by exporting domestically
made generic products and marketing itself as an offshoring destination for clinical
and pre-clinical research and other support services, India could become a global
pharma hub. Consumer healthcare spending increased from 4% of GDP in 1995 to 7%
of GDP in 2007. By 2017, the figure is predicted to reach 15% of GDP.
28
There was a fierce pricing war among companies in the earlier years of the
Indian pharmaceutical industry, as they focused on reverse engineering complicated
chemicals at cheaper costs and manufacturing ‘me-too' drugs with similar medicinal
capabilities. Now, Indian pharmaceutical companies are focusing their R&D efforts on
new treatment regimens and compounds. This emphasizes the importance of having
safe and reliable networks for huge data flows. Drug research and testing are not a
priority for many Indian SMEs in the pharmaceutical industry.
They still require technology to increase quality assurance and control, as well as to
comply with regulatory standards for operations and testing, as well as to improve
batch monitoring and expiry date tracking. Credit and logistics control must also be
optimized, as well as product promotion, discounting, and purchase-sales-inventory
analysis.
After reviewing the various articles, books and news articles by different
author’s it can be mentioned how the Indian pharmaceutical industry is
revolutionizing itself and moving towards drug patenting. And how it has applied the
WTO & TRIPS agreement for the protection of its pharmaceutical sectors. With the
application of TRIPS norms and the enforcement of the Indian Patent Act, 1970 how
the Indian companies have moved towards drug patenting leading it has helped to
increase the process of novelty and innovation in the pharmaceutical companies.
Leading towards the tremendous growth of the Indian pharmaceutical sector in the
international market. Due to which the country has seen a tremendous shift in its
world trade. It has also helped in the economic growth of the countries and has helped
in the creation of jobs, which has resulted into job creation opportunities.
The developing country like India where on one hand has benefited from the
drug patenting but on the other hand the weaker or poorer section of the Indian society
has been affected due to the non- availability of some specific medicines which are so
high in prices that a middle- class person or the lower -class person belonging to the
Indian society cannot afford it easily.
This has been the same case in a developed country like America. The pharma
companies have made an impactful use of the drug patenting, which in turn has
29
resulted in the growth of pharmaceutical countries and has helped in the growth of the
American economy. Many organizations or institutions have been set up in America
which aids the common people in funding resources when they lack funds to avail a
proper medical benefit.
But now the question shifts to how many people are able to avail it.
For pharmaceutical patenting, drug companies invest hefty amounts for the
purpose of innovation, as only those drugs can be patented which are: -
• Novel
• Non-obvious &
• Useful.
But sometimes drug companies use the method of Evergreening, in which the drug
companies make a minor change in the formulation of a drug or a medicine, to
increase the patent life of the medicine without actually increasing the drug efficacy.
This has been regarded as the abuse of drug patenting and is one of the major flaws
which the patent law suffers, when it comes to drug patenting, be it INDIA or U.S.A.
One of the landmark judgments in this area is the NOVARTIS case, where the
drug company Novartis Ag, which is a Swiss multinational pharmaceutical company
tried to increase its drug patent life for another 20 years by bringing in a small
chemical change in the drug which they had patented in 1993. On which the honorable
supreme court rejected the plea stating that according to section (3)d of the Patent Act
“A mere discovery of a new property of known substance is not considered
patentable”.
30
CHAPTER – III
Vitruvius, a judge in Alexandria at the time, tried and exposed several poets
who had stolen the work of others in their area hundreds of years later. Although there
were no intellectual property rules in place at the time, Roman jurists considered
various sorts of ownership for intellectual works from then on.
The first patent for a technological discovery was granted to Ser Franciscus
Petri of Rhodes by the Great Council of Venice in 1416. Filippo Brunelleschi was
later given an act to preserve his IPR for an industrial invention in 1421. He was
granted a three-year monopoly for the construction of a marble-transporting barge
with hoisting gear. During the following two centuries, apparently, such preferred
awards to designers reached out from Italy to other European nations. In 1474, the
31
Venetian Senate introduced the first patent legislation, the Venetian Statute, which
provided protection for novel and inventive technologies in exchange for disclosure to
the Venetian Republic.
In several cases, such as, in England during Queen Elizabeth I's reign
(1558–1603), governments provided incentives for the importation and formation of
new businesses. The Privy Council and hence the precedent-based regulation courts
started to investigate licenses all the more intently, as general assessment expanded,
that the English ruler was abusing its position to issue such privileges. The Statute of
Monopolies was finally passed by Parliament in 1623. Albeit the regulations banned
most imperial syndications, it protected the capacity to concede "letters patent" for as
long as 14 years for creative assembling disclosures. The US Constitution enabled
Congress to lay out a National Patent System altogether "to advance the advancement
of science and valuable expressions, by getting for restricted times to writers and
designers the selective right to their particular works and revelations". The first Patent
Act was passed in 1790 by Congress. The following year, France implemented a
patent system. Many countries had patent laws by the end of the nineteenth century,
and there are now over a hundred different patent jurisdictions.
In 1623, the English Parliament enacted the Monopoly Statute. "The mother of
modern patent law in all common law countries," according to Luigi Palombi. Prior to
1623, England had its own monopolies. In 1449, for example, Henry VI allowed a
Flemish man letters patent to make stained glass in England. Sir Edward Coke was the
one who wrote the majority of the documents. The 1623 statute was primarily written
by Sir Edward Coke to prohibit abusive monopolies, especially those obtained
through the King's letters patent. The Statute of Anne, a copyright legislation, was
passed in 1710.
Congress was given the power to protect inventors' rights in 1787 by the United
States Constitution1 .Patent protection has been in place in the United States since
1790, with standards greatly enhanced in the 1950s. The patent law has undergone
numerous revisions since then.
32
3.1.1 HISTORY OF PATENT ACT,1970
Act VI of 1856 was the first patent act passed in India. The goal of this law was to
encourage the development of innovative and beneficial products as well as to
persuade innovators to reveal their innovations' secrets. Because it was passed without
the authority of the British Crown, the Act was abolished by Act IX of 1857. Act XV
of 1859 was enacted in 1859 to provide new legislation for giving "exclusive
privileges." This bill made a few changes to the previous bill, such as granting
exclusive privileges to valuable discoveries alone and extending the priority period
from six to twelve months. Importers were not included in the definition of an
inventor under this law. The 1852 United Kingdom Act served as a model for this
legislation.
To offer protection for designs, the Act of 1859 was consolidated in 1872. Under Act
XIII of 1872, the act was renamed "The Patterns and Designs Protection Act." The
Act of 1872 was revised again in 1883 (XVI of 1883) to provide a provision to
safeguard the uniqueness of inventions that had been disclosed in the Indian
Exhibition prior to filing an application for protection. After the date of the
inauguration of the Exhibition, a six-month grace period was established for filing
such petitions.
All of the earlier Acts were repealed by the Indian Patents and Designs Act,
1911 (Act II of 1911). For the first time, the Controller of Patents was in charge of
patent administration under this Act. In 1920, the Act was revised to allow for
reciprocal agreements with the United Kingdom and other countries in order to secure
primacy. Further revisions were enacted in 1930 to include, among other things, rules
33
dealing with the grant of secret patents, patents of addition, government use of
inventions, the Controller's authority to revise patent registers, and the extension of
the patent period from 14 to 16 years. An adjustment was adopted in 1945 that
allowed for the filing of a tentative specification and the submission of a complete
specification within nine months.
To see if any specific restrictions on patents in the areas of food and medical
should be imposed;
To make recommendations for improving the patent system's and patent
literature's visibility, particularly with respect to patents obtained by Indian
innovators;
To explore the requirement for and possibility of laying out a National Patents
Trust;
Analyze if patent specialists ought to be managed.
To look at the Patent Office's activities and public administrations and make
proper proposals for development; and
34
to cover any progressions the Committee accepts are expected to make the
Indian Patent System more helpful for public interest by cultivating creation,
financial turn of events, and utilization of innovations.
The interim report was produced by the committee on the 4th of August, 1949, with
recommendations for preventing the exploitation or abuse of patent rights in India, as
well as proposed revisions to sections 22, 23, and 23A of the Patents & Designs Act,
1911. The Acts of 1919 and 1949 in the United Kingdom were used as inspiration.
The 1911 Act was changed in 1950 concerning working of innovations and
constrained permit/denial, in light of the Committee's proposition. Different
arrangements related with the public authority supporting the patent on an application
with the expression "authorized of right" so the Controller approved issue licenses.
Licenses connecting with food and meds, bug spray, disinfectant, or fungicide, and a
strategy for creating substance, as well as any improvement connecting with careful or
restorative gadgets, were allowed mandatory licenses in 1952.Once the Central
Government published a notification, the compulsory license was also accessible. A
bill was proposed in Parliament in response to the Committee's recommendations. On
notification from the Central Government, the compulsory license was made
accessible. In 1953, a bill was proposed in Parliament based on the recommendations
of the Committee (Bill No.59 of 1953). However, the bill was lapsed as the
government did not urge for its consideration.
35
portion delves into the terms and conditions of the lapsed laws from 1953. The first
portion consists of addressing the flaws in the patent system and provide solutions as
well as legal advice. Despite its flaws, the Patent System was recommended for
retention by the committee. The Patents Bill, 1965, was introduced as a result of this
report's recommendations for significant changes in the law.
A law was proposed in the Lok Sabha on September 21, 1965, but it did not
pass. A revised bill was introduced in 1967, which was sent to a Joint Parliamentary
Committee, and the Patents Act of 1970 was approved based on the Committee's final
recommendation. In terms of patent law, this Act repealed and replaced the 1911 Act.
The 1911 Act, on the other hand, was still in effect for designs. The Patent Rules,
1972, published on April 20, 1972, implemented the majority of the provisions of the
1970 Act.
Until December 1994, this Act stayed in effect for over 24 years without
alteration. On December 31, 1994, an ordinance amending the Act was adopted,
although it only lasted six months before it expired. In 1999, a new ordinance was
enacted as a result of the previous one. The Patents (Amendment) Act, 1999, which
went into effect on January 1, 1995, replaced this ordinance. Although such patents
were not allowed, the modified Act allowed for the filing of product patent
applications in the areas of medications, pharmaceuticals, and agrochemicals. Such
applications, then again, were uniquely to be considered after December 31, 2004. In
the interim, the candidates might be given Exclusive Marketing Rights to sell or
disperse specific items in India assuming that specific circumstances are met.
The Patents (Revision) Act of 2002 corrected the Patents Act of 1970 for the
subsequent time (Act 38 0f 2002). This Act became successful on May 20, 2003, with
the section of the new Patent Rules, 2003, which supplanted the more seasoned Patent
Rules, 1972.
The Patents (Revision) Ordinance, 2004, was the third correction to the Patents
Act 1970, and went into force on January 1, 2005.The Patents (Amendment) Act 2005
(Act 15 Of 2005), which took effect on January 1, 2005, eventually repealed this
Ordinance on April 4, 2005.
36
3.4 POSITION BEFORE 1970
However, patent laws may be traced all the way back to the mid-nineteenth century,
when the British government extended patent protection to India in one or more
forms, as India was still under British rule at the time. The Patents and Design Act of
1911 is considered to be the first patent protection legislation in India. This Act
remained in force till the Act of 1970, even after India gained independence in 1947.
If there was a time to celebrate after independence, there were also concerns in the
form of problems that the country faced in order to foster India in practically all
sectors of the economy. All industries were behind the times, with agriculture and
pharmaceuticals being the most concerning. The Indian government was well aware
that the patent laws in place previous to independence were not serving the country's
interests, as evidenced by the appointment of two separate committees led by retired
judges to examine the workings of the patent laws and make recommendations for
their abolition. The government was eager and motivated to enact legislation that
would best serve the country's interests in every way. There were debates in
parliament about these difficulties, and it took nearly 25 years for country-made patent
laws to be enacted in 1970.
According to the Act of 1970, no one other than the patent holder was permitted to
develop a patented drug, even if it was done in a completely different way. For a
longer period of time, the patent holder had monopolistic power to manufacture the
medicine. Essentially, the patent holder had complete control over the drug's
availability and pricing.
37
foreign innovators and overseas R&D while providing no economic rewards. There
was a deadweight loss in the local economy.
38
In 1970, India lacked the indigenous talent, skills, finance, and infrastructure
required to create highly profitable research-based domestic firms capable of
competing effectively with foreign competitors. The country's recognition of the
patent regime as a useful tool of national economic strategy was only inevitable. The
desire for a system that did not obstruct the development of home industrial and
technological skills was strong.
39
alloys, optical glass, semi-conductors, intermetallic compounds, and other items not
normally considered chemical substances. It is important to note, however, that
products critical to our economy, such as agriculture and horticulture products, atomic
energy ideas, and all having things, are not patentable. Thus, the Patents Act of 1970
was supposed to strike an acceptable balance between adequate and effective patent
protection on the one hand, and technology progress, public interest, and the country's
special demands on the other. The pharmaceutical and medicinal sector has grown
quickly and efficiently under the Patents Act of 1970. The expansion of this industry
has resulted in a greater availability of medicines at low prices. This sector is
particularly important in our country, where big populations are affected by a variety
of ailments and the healthcare system remains woefully inadequate. Without a doubt,
the absence of patents on items in the food and pharmaceutical industries has aided
India's extraordinary growth in the generic pharmaceutical industry. Drugs protected
in other countries might be examined and made without paying a royalty under the
former patent system. This provision aided the growth of an indigenous drug industry,
and by the 1990s, Indian pharmaceutical companies had risen to fourth place in the
world by volume of medications produced. The fundamental concern that the social
and economic costs of implementing pharmaceutical patents will likely outweigh the
benefits in most developing nations encourages a cautious approach to intellectual
property protection in the pharmaceutical industry. This patent law aided India's
transformation from one of the world's highest drug prices to one of the lowest.
Capital investment in the Indian pharmaceutical sector increased from Rs. 225 crores
to Rs. 2,500 crores over a 25-year period, while investment in research and
development (R&D) increased from Rs. 10.50 crores to Rs. 2,500 crores. India's
patent protection was thought to be inadequate, and this had a negative impact on
international pharmaceutical and chemical companies. The US pharmaceutical
business is estimated to lose $450 million each year owing to piracy, but Indian
officials have a different perspective. For any innovation planned or potential and be
used as a nutrition, medicine, or drug, or for substances generated or created by
chemical processes, product patents were prohibited under Indian patent law. As a
result, many drugs developed by foreign firms are widely replicated. In others, patents
40
for some other products were issued for period of 14 years from the date of filing. As
a signatory to the Uruguay Round of the GATT, remembering its principles for Trade
Related Intellectual Property Rights (TRIPS), and as an individual from the World
Trade Organization (WTO), India was expected to carry out a thorough arrangement
of item licenses by 2005.Even in mature and developed countries, the exploitation and
abuse of the patent system by foreigners who did not use the patents economically in
the country of grant but only as a way of ensuring a monopoly of importation had not
gone unnoticed. As a result, it was only natural for India to develop its policy and
legislation along similar lines in order to oppose this trend of foreign patentees. With
the passage of time, Indian pharmaceutical businesses grew at a rapid rate, and their
market share in the availability of medications increased to almost 85%. In terms of
drug pricing, thanks to the competitive climate and the new patent system, drug prices
have dropped to the lowest levels in the world. In addition, the sector has built
sufficient excess capacity to accommodate export requests from both developed and
emerging countries. From 183 in 1970 to 957 in 1986, the number of overseas
collaborations has increased dramatically.
The indigenous industry's reverse engineering skills were one of the key causes
for the pharmaceutical industry's development. With the advancement of new drugs at
a global level and their patenting elsewhere, local industries were able to manufacture
a substitute by any other procedure in a matter of years. As a result of this reverse
engineering, not only was local supply and demand met at a relatively low cost, but
also export to a number of emerging and least developed countries. Even now, India is
the primary source of numerous life-saving pharmaceuticals for the majority of the
world's nations. The patent statute's system of granting forced licences is fairly
widespread. According to the Indian Act, after three years from the date of grant, all
patents in the fields of food, drugs, medicines, and chemicals are deemed to be
instantly endorsed with the words licences of right, and any individual who wants in
the field is allowed to a licence under such patent as a factual matter, subject only to
payment of royalties with a highest ceiling of 4%.The complaint based solely on these
clauses does not appear to be valid, as many other countries used the same provisions
in their own legislation. In their early stages of development, developed countries
41
likewise relied on lesser patent protection. The provisions regarding compulsory
licencing and licence of right were even drafted in the model law for developing
countries by the BIRPI, a predecessor of WIPO.' Meanwhile, the provisions regarding
keeping food, medicines, and chemical products out of the purview of product
patentability have been a huge success in the development of indigenous industry in
these sectors. The patent statute's system of granting forced licences is fairly
widespread. Whereas the rules exempting food, medicines, and chemicals from
product patentability have been a huge success in the growth of the indigenous
industries in these fields. When India adopted these features into patent laws, we were
also on the cusp of the chemical industry's development, and the nations that are today
the most industrialized had changed to the merchandise patent regime in this sector
fairly late in the 1970s and 1980s, including Canada in 1988. The patent regime in this
area came late in the 1970s and 1980s, with a country like Canada adopting it in 1988.
The patent law, which was enacted at the national level, has prevented the
patent system from being abused. Patent laws do not create monopolies; yet,
numerous steps to prevent or limit monopolistic exploitation were unavoidable in the
public interest. As a result, features such as compulsory licensing, patent expirations,
revocation on certain grounds, and encouraging development within the grant country
rather than depending on imports were integrated in the national interest. The duration
for which patent rights were given differed from country to country, and national
governments determined the duration based on their own needs. Since the patent
system is so important to a country's industrialization and technological achievements,
there is no need to hold back if the provisions are for the development of the local
indigenous industry to strengthen it and bring it up to worldwide standards.
As a result, it may be studied by looking at how the patent system has evolved
throughout time. In comparison to the Indian Patents and Designs Act of 1911, the
Patents Act of 1970 has far-reaching implications.
42
CHAPTER- IV
43
● TRIPS - 1995
Various Organizations which regulate the patent protection and various countries are
signatories to it-
● WIPO
● WTO
(1) The Convention's public treatment prerequisites required each Contracting State to
give similar degree of security to nationals of other Contracting States as it does to its
own nationals with regards to modern property assurance. In the event that they are
domiciled or have a genuine and successful modern or business presence in a
Contracting State, nationals of non-Contracting States are additionally qualified for
public treatment under the Convention.
(2) Licenses, brand names, and modern plans all have a right of need under the
Convention. This right permitted a candidate to look for security in any of the other
Contracting States in light of a customary first application submitted in one of the
Contracting States. Following which the applications were treated as though they were
44
documented around the same time as the first. All in all, they would have priority
(hence the expression "right of need") over applications documented by others for a
similar creation, utility model, or patent during a similar time span. One of the huge
advantages of this arrangement was that, the candidates looking for insurance in
different nations were not expected to present each of their applications
simultaneously, yet rather have 6 to a year to conclude which nations they need to
look for security in, and to painstakingly design the means important to acquire
assurance.
(3) The Convention lays out a bunch of general standards that all Contracting States
should stick to. Coming up next are the main ones:
4.1.1 PATENTS.
• Licenses allowed in various Contracting States for a similar innovation are
autonomous of each other.
• A patent allowed in one Contracting State doesn't commit other Contracting States to
concede a patent; a patent can't be rejected, repealed, or ended in one Contracting
State since it has been declined, invalidated, or ended in another Contracting State.
• A patent may not be denied or nullified on the premise that the offer of the protected
item, or an item gotten through the licensed cycle, is dependent upon limitations or
constraints forced by homegrown regulation.
• Each Contracting State that establishes regulation and permits obligatory licenses to
be conceded, to forestall manhandles emerging from the selective freedoms given by a
patent, may do it just under indicated conditions. A mandatory permit (a permit
allowed by a public power of the State concerned instead of the patentee) in view of
inability to work or inadequate working of the protected innovation. It could be
allowed solely after three years from the award of the patent or four years from the
documenting date of the patent application, and it should be declined assuming the
patentee gives genuine motivations to their inaction.
45
• Moreover, even in conditions where giving a mandatory permit could not have
possibly been sufficient to stay away from the maltreatment, loss of a patent may not
be taken into consideration. In the last situation, methods for patent relinquishment
might be brought, however solely after a two-year time span has elapsed since the
principal obligatory permit was conceded.
The Convention of Paris for the Protection of Industrial Properties are the very
first major international treaty designed to help people from one nation obtain
protection in other countries for one ‘s intellectual creations in the form of industrial
property rights, such as inventions (patents), trademarks, and industrial designs, was
signed in 1883, marking the first step towards making patent laws have international
application. The main motivation for the creation of this Convention was that each
country's patent rules only applied inside its borders, whereas the patent right holder
wished to explore his innovation outside the borders of the country that granted the
patent. The Paris Convention came into force in 1884, with 14 signatories who
established an International Bureau to oversee its implementation. The Paris
Convention for the Protection of Industrial Property (hereinafter referred to as the
Paris Convention) was signed in Paris, France, on March 20, 1883, and was revised.
The wording of the Paris Convention was changed seven times between 1883 and
1967, when it was last rewritten in Stockholm. Nonetheless, the Convention's basic
intent of only allowing the articulation of other patent regimes has been maintained.
The purpose of this Convention was to assist citizens of its member countries in
obtaining international protection for their right to control and be compensated for the
use of their creative works2. The signing of these two key treaties might be seen as the
beginning of the internalization of intellectual property standards. The Berne
Convention, like the Paris Convention, established an International Bureau to handle
administrative matters. These two minor bureaux merged in 1893 to establish the
United Worldwide Bureaux for the Protection of Intellectual Property, an international
institution (best known by its French acronym BIRPI). This modest institution, based
2
http: www.wipo.int/treaties/en/convention/trtdoc-wo029.html last visited on 3-3-2008.
46
in Berne, Switzerland, with a staff of seven, was the forerunner of the World
Intellectual Property Organization of today - a vibrant entity with 184 member states3.
3
http: www.wipo/int/members/en/index.jsp last visited on 3-3-2008.
4
http: www.wipo.int/treaties/en/convention/trtdoc-wo029.html last visited on 3-3-200
5
http.www.wipo.int/treaties/en/agreement/index.html last visited on 3-3-2008.
6 http.www.wipo.int/treaties/en/agreement/trtdocs-wo030.html last visited on 3-3-2008. '"*
47
WIPO is only responsible for intellectual property, whereas the WTO is responsible
for both intellectual property and trade in commodities and services. WIPO has never
considered intellectual property to be a remnant of international trade, but the WTO
has linked intellectual property to trade issues. The World Intellectual Property
Organization's (WIPO) low degree of protection of intellectual property rights caused
unhappiness among industrialized countries, and the dire situation made the United
States concerned and antagonistic. As a result, the United States transferred its
international intellectual property efforts to the Uruguay Round negotiations. Later,
efforts led by the United States resulted in TRIPs, a detailed proposed agreement.7
Outside of the EU, no two countries have identical IPR protection. Even among
developed countries, there are significant disparities in IPR systems8. Even in 1968,
four nations (Dermiark, Finland, Norway, and Sweden) approved new patent laws,
while Germany revised its existing patent laws, all of which were nearly comparable
and represented near-complete harmonization.9
The GATT accords address aspects of international trade in products and services,
as well as technological innovation protection and enforcement. The following are the
key aspects of GATT: -
7
Surender Bhandari, (2001) World Trade Organization (WTO) and Developing Countries. Deep and Deep Pub.
New Delhi p.26.
8
Keith E Maskus, (2000) Intellectual Property Rights in The Global Economy. Institute of International
Economics Washington: pp3
9
J. W Baxter. (1968) World Patent Law and Practice. Sweet and Maxwell London. pp207
10
Keith EMaskus (2000) supra notes 15 ppl6
48
property rights (TRIPS) (GATS). The TRIPS arrangement's general objective is to
protect and implement protected innovation freedoms to cultivate specialized
development and innovation move and dispersal for the common advantage of makers
and clients of mechanical information. It determines the arrangements and extent of
patentability for drugs and agrochemicals. Licenses will be accessible and patent
privileges will be appreciated regardless of the site of creation, the area of innovation,
or whether things are imported or privately delivered, as per the TRIPS understanding.
Exclusive Marketing Rights (EMR) will be granted to the patentee if certain
conditions are met, allowing them to safeguard their innovations or product patents by
preventing others from creating, selling, or distributing them, even if they are made
using a different procedure.
Because patentability covers both items and processes, the terms of the patent
would be applied for twenty years for product patents and twenty years for process
patents, especially in the chemical industry where pharmaceuticals and pesticides are
concerned. Patents will be available in the case of pharmaceuticals or treatments for
their usage forms, dosage forms, and combinations. New processes and dosage forms,
among other things, would be patented, and monopoly protection in some form or
another would be granted for a period of 10 to 15 years, covering around 70% to 80%
of the pharmaceutical industry's revenue.
Due to the abundance of small firms and severe generic rivalry, there may not
be much of an influence on the pricing of existing formulations in India. However, in
the post-GATT future, where the creator has the right to patent its invention for 20
years, enjoy monopoly, and set its own price, there will be an increase in price
competition. It's usually found in life-saving medications.
The projected globalization of patents would have the greatest influence on the
pricing of medications, which would increase by many times, making it extremely
impossible for India's poor to pay them after the GATT agreement. Some top
economists and industrialists argue that if India's price-regulating authorities are
strong (DPCO, NPPA), as well as the compulsory licensing system, there may not be
much of an effect on the steep rise in prices. However, as India moves toward
globalization and compares to other countries that have adopted WTO implications, it
is at least expected at this stage that drug prices will rise.
50
It's also possible that there won't be a significant increase in drug prices at first,
thanks to certain clever marketing methods used by multinational corporations to keep
India's poor people calm, interested, and not despondent. Then, over time, they would
gradually raise drug prices one by one because they can’t keep their temptation down
for a long time.
b) Only 20% of all patents are related to pharmaceuticals, with the balance relating to
chemicals, electronics, electrical, mechanical, and other fields.
c) In medicine and pharmaceuticals, patents are more often associated with some
variation of earlier medications (process patents).
d) Following the adoption of product patents and the signing of the WTO, GATT, and
Paris Conventions, India will benefit from the 'Right of Priority,' which will give India
automatic priority in the queue for patent rights in all member countries. This will
contribute to increased trade among WTO members as well as a better industrial
climate, increased information flow, improved and expanded protection of Indian
investors abroad, encouragement of scientific research and technological
development, and membership in the Patent Cooperation Treaty (PCT) and other
treaties, all of which will contribute to the country's overall growth.
51
The availability of new pharmaceuticals from local enterprises' indigenous sources
would be completely out of the question. Import dependency would increase.
The majority of new pharmaceuticals approved in the previous five years are
still protected by patents, and their formulations are made in India from imported bulk
drugs. The origins of such imports are usually not the original manufacturers, and as a
result of GATT, they are likely to dry up. The development of alternative technologies
or a technical collaboration arrangement will determine their continued availability.
The present industry, particularly in the middle and small-scale sectors, will
face substantial degrowth over the next decade or two as they will be unable to take on
new items due to the new patent regime. New patents will be filed even for existing
products or methods, making it impossible for businesses to market their current
products.
The Indian indigenous sector has more potential for technological collaboration
with enterprises that are not represented in India.
Aside from that, Indian firms will get access to contract manufacturing, contract
research, and co-marketing options. Furthermore, the Indian government's R&D
programs will undoubtedly stimulate new medication development in India. After the
GATT Agreement, India's future strategies will face a rise in drug prices.
Now that the GATT has become a reality and will enter into force within the
agreed-upon timeframe, Indian businesses are imagining the best ways to deal with
the situation.
53
Building and sponsoring enough capacity, infrastructure, and resources for
indigenous drug research and development.
Adopt a drug policy that is holistic and needs-based.
Adopt a rational competition policy in the pharmaceutical industry, which will
result in lower drug prices.
Both the government's policy of granting automatic approval for joint ventures
involving up to 51 percent foreign investment (which applies to the pharmaceutical
industry) and the new incentives being considered for total R&D should go a long way
toward encouraging indigenous companies to adopt the future strategy.
54
economic climate, this has become a trend. A study of such a company's
strategy as a metric of revenue growth can be conducted.
It is thought that mergers and acquisitions aid in growing a company's market
share. A study could be conducted to determine the rise in market share.
Many software businesses have created a variety of software that decreases costs in
new product development and supply chain management, from manufacturing to
retail. This is a topic that can be thoroughly researched.
Medicines deal directly with people's lives. There is concern that in the post-
GATT period, low-income and general people will find it difficult to afford drugs due
to price increases. It is also possible to research the involvement of the government
and pharmaceutical corporations in corporate ethics and corporate governance.
Alternatively, Indian pharmaceutical companies, with public support, should oppose
GATT implementation in the nation.
55
On June 1, 1978, it started operational with 18 contracting States. The Treaty
aims to make the filing and processing of patent applications easier all around the
world. In fact, it is part of WIPO's continuous international effort to simplify and
streamline the patent application process. It is frequently referred to as the most
significant step forward in international collaboration in this subject since the Paris
Convention was adopted.
The PCT states that any Contracting State may file an application for the
protection of an invention containing a request, a description, claims, drawings if
necessary, and an abstract in any prescribed language, along with prescribed fees.12
The PCT does not issue patents. It simplifies the process of getting national
patents in a number of nations. It is divided into two parts: an international and a
national phase. The international phase entails a centralized filing and search
procedure (PCT Chapter I) as well as an optional international primary examination
(PCT Chapter II). The ultimate patent awarding procedure before national or regional
industrial property authorities is dealt with in the national phase. The filing of a single
worldwide application has the same impact as if the applicant filed separate national
or regional applications in each of the countries listed in his international application.
Only when filing patent applications in many countries does the PCT become
significant. There were 139 contracting states parties to the PCT as of April 2008. 14
India became a member of the PCT on December 7, 1998. In the PCT Contracting
States that you select in your application, your international patent application has the
12
see Art. 3 of Patent Cooperation Treaty 1970 Amended in 1979, 1984 and 2001 (as in force from April 1,
2002) hereinafter called PCT
13
Art. 33 of PCT
14
http://en.wikipedia.org/wiki/Patent_Cooperation_Treaty
56
same effect as a national patent application. It's crucial to note that filing a PCT
application is only a way to gain more time to file national phase applications. A PCT
application does not automatically result in a patent; it is the national phase
application that may lead to a patent.
At the outset of the plaintiff's case, the defendant will be entitled to timely
written notice including sufficient details, including the foundation for the plaintiff's
claims. The legal counsel of the parties to the judicial proceedings shall be allowed to
represent them. The member countries must give judicial authorities the authority to
15
Art. 63(2) Agreement on Trade Related Aspects of Intellectual Property Rights. Hereinafter called TRIPs
(1994)
57
order prompt and effective provisional measures, especially where any delay is likely
to result in irreparable loss or harm to the right holder, or where evidence is likely to
be destroyed, or to prevent an infringement of I.P.R. from occurring16. If a member
country implements a criminal procedure for willful violation of intellectual property
rights on a commercial scale, the punishments available include imprisonment and/or
monetary fines adequate to establish a deterrent.17
16 Art. 50
17
Art. 61
18
http://en.wikipedia.org/wiki/Budapest_Treaty last visited on 5-3-2008. "
19
http://www.wipo.int/'treaties/en/registratioa/budapest lrtdocs_wo002.html
58
patent candidate, or an individual who applies for a patent, isn't expected to store
natural material in everything countries where a patent is looked for, as per the
Budapest Treaty. The candidate simply has to store organic material at one supported
establishment, and that store will be acknowledged by all nations that have consented
to the arrangement.
Until September 2008, there were 70 member countries, and India has been a
signatory to the Budapest Treaty since December 17, 2001. The "International
Depository Authority (IDA)" is the name given to the designated collection centers.
Any microorganism deposited with an international depositary authority must be
stored for at least five years after the most recent request for a sample of the deposited
microorganism was received by the said authority and, in any case, for at least 30
years after the date of the deposit, with all the care necessary to keep it viable and
uncontaminated. An IDA is required to keep deposited microorganisms for at least 30
years after they were first deposited21. In order to apply for a patent, an applicant must
deposit the micro- organisms not later than the date of patent application.
4.6 WIPO
The passage of the TRIPs agreement in the context of the WTO, which incorporates a
substantial portion of the Paris Agreement to advance patent law. WIPO has launched
a number of new measures since the TRIPs agreement was adopted. It initially
resulted in the successful conclusion of negotiations for a convention aimed at
harmonizing procedural criteria in patent applications, which was enacted in 2000.22
Since then, WIPO has begun on a considerably more ambitious initiative that has the
potential to be at least as far-reaching in the evolution of patent law around the world
as the TRIPs agreement. Patents have become much more expensive in different
nations, and these costs may be reduced if some of the fundamental principles
underlying patent award, such as the definitions of previous art, novelty, inventive
step, and industrial applicability, were harmonized.23
20
Art. 5 of Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes
of Patent Procedure 1977 hereinafter called Budapest Treaty
21
Rule 9.1 Regulations under The Budapest Treaty
22 Patent Law Treaty, Geneva, 1 June 2000, WIPO DOC PT/DC/47
59
The World Intellectual Property Organization (WIPO) in Geneva has been
negotiating a Substantive Patent Law Treaty for three years. This Substantive Patent
Law Treaty (SPLT) would eliminate most of the remaining national flexibility in
patent systems, paving the way for a future world patent given directly by the World
Intellectual Property Organization (WIPO). This is an alluring prospect for
multinational firms and big countries such as the United States and the European
Union (EU), which regard patents as the principal tool for controlling a global
economy. A global patent system, on the other hand, is bad news for developing
nations and their citizens, who would lose even the minimal freedoms provided under
the WTO TRIPs agreement. Transnational firms and patent system planners have long
wished for a fully global patent system, with a single control office issuing patents
valid in any country on the planet. It was thought to be an unachievable ambition
before the World Trade Organizations and TRIPs agreement, because comprehensive
harmonization did not appear to be politically feasible. WIPO has tried and failed
before, most notably in the 1990s. This is why industry persuaded governments to
refer patent disputes to the World Trade Organization (WTO), a technical body with
no political influence or expertise.24
TRIPs set the conditions for the world patent to be resurrected. TRIPs were
soon recognized by WIPO as a stepping stone to higher levels of harmonization.
WIPO has been working on three main parts of a strategy to construct a world patent
23 7 WIPO Suggestions for the Further Development of International Patent Law, Standing Committee on Law of
Patents, Fourth Session, Geneva, November 2000, WIPO Doc ScP/4/2.
24 http://www.listbox.wipo.int/wilma/scpefonun/2003/msg90017/wip-splt-2003-en-pdf.
60
system with WIPO at the lead since TRIPs came into effect in 1995. The World
Intellectual Property Organization (WIPO) is very forthright about this.25
The substantive patent law treaty is at the heart of the patent agenda from a
political standpoint. It discusses the substance of patents, including what can and
cannot be patented, under what circumstances, and to what effect. For WIPO, the
SPLT is the most difficult component of the puzzle. Patent laws have always been
limited to national territory, and individual governments are hesitant to give up their
right to determine patentability requirements. Despite the fact that a number of
treaties, dating back to the Paris Convention of 1883, have established a system of
mutual recognition between national patent systems, there has been little substantive
harmonization at the global level.
The SPLT is designed to take things a step further. The harmonization floor
(minimum standards) is defined by TRIPs, however SPLT will raise the floor and add
a ceiling. The floor will be set far higher than TRIPs'. Additionally, there will be a
maximum standard, which will prohibit the use of any new patentability criterion.
While countries can impose any new requirements to award a patent now unless the
matter is explicitly regulated by TRIPs, they will only be able to do so in the future if
the SPLT expressly allows it.26
25 ibid
26 ibid
61
sectors, particularly increased access to developed country markets for agricultural
and textile exports. The SPLT is being negotiated in a unique situation. There are no
external chips, and there is no way to exchange apples for pears. Any agreement must
be reached within the parameters of the patent system.
In a formal sense, joining the SPLT will be voluntary. In contrast to the WTO's
package agreement premise, countries can approve WIPO treaties on a case-by-case
basis. In actuality, however, all WIPO members would be under a lot of pressure to
join. Unlike some of the more specialized WIPO treaties, the SPLT will be so
important to the future of the patent system, and indeed, global power structures, that
opting out will be difficult.27
27 ibid
28
WTO was established with the aims to achieve the transparency in international trade relations by changing
trade policies and rules.
29
(GATT Article 1, GATS Article II and TRIPs Article 4), the principle of not discriminating between one’s
trading partners. If the member country provides any advantage favour, privilege or immunity with regard to the
protection of intellectual property to the nationals of a particular country that country will provide the same
facility immediately and unconditionally to the national of all other members.
30
Obligation under Article III of the GATT 1994 which requires that imports be treated no less favorably than
domestically produced goods once they have passed custom
62
employment, and income growth. It also has the authority to sanction members who
break the rules31.
The World Trade Organization's goal is to ensure that global trade begins
smoothly, freely, and predictably. The World Trade Organization (WTO) strives to
provide economic peace and stability to the world through a multilateral system based
on consenting member nations that have ratified the WTO's regulations in their own
countries. WTO rules become part of a country's internal legal system in this way.
The aforementioned three goals were also contained in the GATT; however, the WTO
also has some additional goals.
31
Mathew Kurian. WTO agreement and Aeroculture-a third world perspectives. Mainstream, Dec 22- 28,2006,
p.91
32
3oel Arun and Mhd Noor, WTO in the New Millennium.y.3 ’preamble of the WTO
63
To ensure that planetary resources are used to their full potential.
Acceptance of the concept of sustainable development and environmental
protection.
All forms of protectionism are condemned.
Through a series of multilateral trade discussions, trade obstacles will be
removed and discriminatory treatment in international trade will be eliminated.
Overseeing the implementation of multilateral trade rules and enforcing legally
binding duties in order to provide a fair, predictable, and open rule-based
trading system.
Creating a system for resolving trade disputes.
Integrates the world trading system with developing and least developed
economies.
The World Trade Organization (WTO) was established to achieve these goals.
The World Trade Agency (WTO) is the world's only intergovernmental organization
tasked with enforcing global trade regulations. New issues are introduced to the
GATT's ministerial conferences on a regular basis. An open, rule-based trade system
based on non-discrimination principles was essential for global peace and prosperity,
and the World Trade Organization (WTO) has met that need.
The World Trade Organization (WTO) has 153 members as of August 2009.
When countries join the WTO33, they agree to abide by the specific agreements that
are appended to the WTO Agreement34. They cannot opt out of some agreements
while being a party to others. The World Trade Organization (WTO) is divided into
three sections: goods, services, and intellectual property rights. To begin, all trade in
goods (agricultural, industrial, and other) will be governed by GATT reformulations.
33
At present, 153 members are there
34
’Here are approximately 29 legal text documents under the agreement which are related to World Trade;
anisation which deals with agriculture, clothes, textiles, services, intellectual property, exchange, ironmen,
labour, education, health etc.
64
They cannot opt out of some agreements while being a party to others. The
World Trade Organization (WTO) is divided into three sections: goods, services, and
intellectual property rights.
Third, the WTO’s (TRIPS) establishes the criteria and conditions for
international intellectual property movement.35
On April 15, 1994, 125 countries agreed to form the World Trade Organization
at a conference in Marrakesh that ended the arduous Uruguay Round of GATT
negotiations after more than seven years of hard bargaining36. The World Trade
Organization (WTO) was established as a result of seven years of discussions at the
Uruguay Round, and its member countries are obligated to implement the agreement's
principles and provisions. One of the most significant differences between the WTO
and the GATT is that all countries wishing to join and benefit from the WTO's market
assessment must accept all of the WTO's major agreements, including the TRIPs
agreement, which deals with trade-related intellectual property37.
35
Ray Alok, Intellectual property rights law in WTO regime-The perspectives and challenges for elopim
countries. The law of intellectual property rights. (Deep and Deep pbn). P.52.
36
Myneni, S.R., -World Trade Organization, p.8, Asia Law House
37
Manohar, Sujata J., Inaugural address of seminar on "WTO, patent law and national economic interest' hi Bar
Review, vol. XXI-1999
65
Este, with an ambitious agenda of 15 sectors to negotiate, including trade in services38,
and concluded on April 15, 1994, in Marrakesh, Morocco, with the adoption of the
WTO agreement.
The Uruguay Final Act was signed on April 15, 1994, but it went into effect on
January 1, 1995, as part of a package of 28 agreements that included TRIPs. It also
brought the failed attempt to build an international trade organization in 1948 back to
life in an upgraded form. Developing countries had not actively participated in global
trade negotiations prior to the Uruguay Round (UR) (MTNS). On the one hand, the
most favored nation (MFN) provision of the General Agreement on Tariffs and Trade
(GATT), now a core component of the World Trade Organization (WTO), granted to
all GATT members offered developing countries a free ride. Prior to the Uruguay
Round, the GATT only applied to goods, and intellectual property rights were largely
ignored.
As a result of the Uruguay round of the GATT (1986-963), the World Trade
Organization (WTO) was born. In April 1994, the members of the GATT reached an
agreement in Morocco for the establishment of a new body known as the World Trade
Organization (WTO).
38
GATT Ministerial Declaration on the Uruguay Round. 25th September 1986. GATT Press Release 1396.
39
Wadehra.B.L.. /
66
GATT rounds were a series of trade discussions that began at the end of WWII with
the goal of lowering tariffs and facilitating worldwide commerce on products.
The reasoning for GATT was based on the Most Favored Nation (MFN)
clause40, which grants special trading rights to a country when it is assigned to it by
another. As a result, GATT sought to assist all nations in achieving MFN like status so
that no single country would have a trade advantage over others.
In 1995, the World Trade Organization (WTO) took over as the world's global
trading body, and the present set of regulations derives from the Uruguay Round of
GATT negotiations, which took place between 1986 and 1994.
GATT trading rules (particularly those negotiated during the Uruguay Round)
remained the dominant rule book for multilateral goods trade between 1947 and 1994.
Specific sectors, such as agriculture, as well as concerns associated with them, have
been addressed. The Uruguay Round also established the framework for regulating
services trade. The General Agreement on Trade in Services (GATS) is a multilateral
trade regulation for services. The GATS is an integral aspect of the World Trade
Organization and is ipso facto binding on all WTO20 members.
Despite the fact that the GATT was successful in promoting and ensuring
liberalization, it was not without flaws.
Much of the world's trade has flaws and issue areas, such as.
It has international stature similar to that of the IMF and the IBRD, although it is not a
United Nations organization. It codifies member countries' rights and obligations in
international commerce, and it's backed up by specific dispute-resolution procedures41.
40
Most Favored Nation is based on Principle of equality.
67
The World Trade Organization (WTO) is one of the most important
international organizations in the world today. It contains a set of rules that influence
the government's power to impose trade restrictions, and it has aided in the gradual
expansion of international trade since 1950protests. It is a unique organization in that
it provides a framework for member states to enact enforceable rules, as well as a
unique dispute settlement system and a range of transparency mechanisms.
CHAPTER -V
41
Dispute settlement system under WTO-Lawz.iune.2005
42
Earlier services were not included in GATT
43
Which includes Transfer of technology also.
68
Abstract: The acquisition of generic drug manufacturing companies has an impact on
a variety of aspects of a company's operations, including spending on research and
development, the introduction of new drugs to the market, the production of drugs
included in the NLEM, drug availability, and generic drug prices. Various case studies
in the previous chapter shed light on these implications following the purchase of
generic medicine manufacturing companies. This chapter discusses the relationship
between generic medicine manufacturing company acquisitions and compulsory
licensing.
Nations continued to accept the call for free trade agreements after World War I ended
(FTA). The GATT was the starting point for discussions (General Agreement on
Tariffs and Trade). The Uruguay Round, the most recent of six GATT rounds, resulted
in the formation of the TRIPs Agreement in 1994. TRIPs were primarily prompted by
industrialized countries' concerns about worldwide piracy and infringement of
intellectual property rights. TRIPs recognize the need to "promote fair and effective
mechanisms of enforcement" intellectual property rights and calls for "expedited
international avoidance and dispute resolution processes in regard to intellectual
property rights in person." The TRIPs Agreement's provisions were harmonized to
allow all signatories to apply local law in order to implement the TRIPs Agreement's
patent protection at the bare minimum. The TRIPs agreement also establishes
requirements for patentable subject matter44.
69
accorded benefit, favour, right, or exemption as provided by a member of the
Agreement instantly and without question. It also emphasizes the essential rights that
residents of each of the Agreement's states will be granted. The major components of
TRIPs law have been amended and transitional criteria for the life of the patent have
been implemented, which now range from 17 years from the date of approval to 20
years from the date of registration. The TRIPs document also safeguards
underdeveloped countries by requiring a protracted implementation period.
Furthermore, many countries justify and implement the TRIPs Agreement since
it highlights challenges on the WTO agenda. It's a "Global Carrier," according to
Christopher Arup, an arrangement that reaches societal difficulties beyond national
borders that aren't typically associated with a trade problem. TRIPs regulatory and
reform imply that the WTO agenda for trade liberalization goes beyond deregulation
of national legalities that have been recognized as roadblocks to liberalization. An
examination of the regulations for this intellectual document demonstrates that it has a
considerable and far-reaching impact on national laws. Patents are obviously
significant in the pharmaceutical industry. Chemical products are vulnerable to patent
protection in developing nations, and medicine patents have been denied on public
health grounds.
The TRIPs Agreement is a step toward ensuring that intellectual property rights
are protected internationally46.The TRIPs Agreement has a long-term impact on the
shifting values in developing countries' intellectual property legislation.
45
Weinman Hu, International Patent Rights Harmonization: A case study of China Francis Group Publication,
1st edn., 2017, P.5 -34.
46
Pfizer Products Inc v. BL Com (2002) 25 PTC 262 (Del).
70
as a standard-setting agreement because it raised the bar in terms of patentability,
rights, disclosure requirements, patentability exclusions, authorized uses, and patent
length47.
The TRIPs Agreement's impact on the Patents Act of 1970 has been thoroughly
documented.48 Through a series of revisions, the TRIPs Agreement's patent provisions
have been completely included into the Patents Act 1970, culminating in the Patents
(Amendment) Act 2005. Some of these provisions have already been challenged in
court. Since its commencement in 1995, India has been a signatory to the TRIPs
Agreement. All signatories to the TRIPs Agreement are bound by it. However, the
EPO's Board of Appeal has ruled that because the EPO was not a signatory to the
TRIPs Agreement, it is not bound by it. The Board of Appeal, on the other hand,
noted that the TRIPs were intended to establish common standards and that they were
an indicator of modern trends49.
47
TRIPS Agreement, arts 27 to 34
48 Jayashree Watal, Intellectual Property Rights in the WTO and Developing Countries, OUP, 2001; Sudip
Chaudhuri, The WTO and India’s Pharmaceuticals Industry, Patent Protection, TRIPS, and Developing
Countries, 2005.
49
T1173/97 IBM/Computer programs (2000) EPOR 219, pp 224-5 (Technical Bd App). 3 WTO Ministerial
Conference, Fourth Session, Doha, 9-14 November 2001, Declaration on the TRIPS Agreement and Public
Health, WT/MIN (01)/Dec/2. See appendix 6
50
Preamble of the Trade-Related aspects of Intellectual Property Rights (TRIPs) Agreement, 1994
71
are covered by the TRIPs agreement, and the patent term has been set at 20 years for
all pharmaceutical products.51
51
Article 33 determines the term of protection which shall not end before the expiration of a period of twenty
years counted from the filing date.
52 Ibid, Article 31 (f) and 31(h).
53
The Ministerial Conference meets once every two years and is the highest-level decision-making body of the
World Trade Organization. World Trade Organization, Understanding the ID: The Organization, Whose WTO
Is It Anyway? http://www.wto.org/english/thewto-e/whatis-e/tife/orgle.htm#ministerial. The Ministerial
Conference can make formal decisions on matters under any of the WTO agreements.
54
World Trade Organization, Declaration on the TIR/PS Agreement and Public Health of 14 November 2001,
WT/MIN (01)/DEC/2,41 I.L.M. 755 (2002) (hereinafter Doha Declaration), available at:
http://www.wto.org/engish/thewtoe/minist-e/min0l_e /minded trips-e.htm.
55
TRIPS Agreement, supra note 8, at art. 51 (specifying that Members shall adopt suspension procedures of
counterfeit trademarks and copyrights (emphasis added)); see also Frederick M. Abbott, Worst Fears Realized.
The Dutch Confiscation of Medicines Bound from India to Brail, BRIDGiS, international Centre for Trade and
Sustainable Development, Feb. - Mar. 2009, 13, available at: http://ictsd.org/downloads/bridges/bridges13-1
.pdf.
72
Members specified in the Doha Declaration that the TRIPS Agreement should not be
read or implemented in such a way that it prevents Members from preserving public
health and encouraging access to medicines.
The Doha Declaration clarified the TRIPs agreement's execution, but it also
acknowledged that certain developing countries lack the resources required to
manufacture medication, even if they are permitted to do so.56 This acknowledgment
was significant because it opened the door to a waiver of Article 31(f), which
mandates that products produced under compulsory licence be limited to the local
market's primary supply.57 If parties otherwise comply with prescribed registration and
packaging standards, this waiver allows compulsory licencing for export to nations
with insufficient production capacity. However, because the procedures are laborious,
this method has been of little utility58. In addition, the ruling includes a waiver
exempting the importing Member from the duty to pay adequate payment under
TRIPs Article 31(h).59 Under this waiver, the exporting Member, not the importing
Member, is responsible for compensating the importing Member for manufacturing
products that are subject to compulsory licensing.60
The waivers were created to improve developing countries' capacity to get important
medicines for public health needs. The WTO Member States commenced discussions
for the first official modification to the TRIPs Agreement itself, which would
completely incorporate the 2003 Waivers, after accepting the 2003 Waivers. The first
Protocol modifying the TRIPS Agreement was adopted on December 6, 2005,
56
This provision prohibited a nation from manufacturing a product for the purpose of exporting to a third-party
country in need. While the issue was left unresolved, the Doha Declaration did at least recognize the difficulties
that developing countries would face when incapable of manufacturing their own drugs, Doha Declaration
57
General Council, World Trade Organization, Implementation of Paragraph 6 of the Doha Declaration on the
TRIPS Agreement and Public Health, WT/L/540 (Aug. 30, 2003) (hereinafter Paragraph 6 Implementation
Decisionl, available at: http://www.wto.org/english/tratop-e/ trips-e/implem-para6_e.htm.
58 Médecins Sans Frontières (2006), Neither Expeditious, nor a Solution: The WTO 30 August Decision is
73
although it has yet to be ratified by the required two-thirds of WTO members.61The
ratification date was extended twice, first to December 31, 2009, and again to
December 31, 2011, depending on the Ministerial Conference's decision.62 If passed,
the TRIPs Agreement would explicitly empower developing nations to use these
flexibilities to expand their access to vital medicines in express textual terms.
Despite the patent debate, there are laws in place to ensure that access to
medicines is preserved while remaining technically compliant with the TRIPS
61
General Council, World Trade Organization, Amendment of the TRIPS Agreement, WT/L/641 (Dec. 6, 2005),
available at http://www.wto.org/english/tratop-e/trips-e/wtl641 e.htm
62
General Council, World Trade Organization, Amendment of the 7IRIPS Agreement- Second Extension of the
Period for the Acceptance by Members of the Protocol Amending the I RIPS Agreement, WT/L/785 (Dec. 18,
2009), available at http://www.wto.org/english/tratope/tripse/wt-l-785_e.pdf
63
TRIPS Agreement, supra note 8, at art6.5 (4) (allowing a developing country Member that did not provide
patent protection for pharmaceutical products at the time of the general date of application of the TRIPS
Agreement, on January 1, 1995, a total of 10 years, until January 1, 2005, to implement such protection in
national legislation).
64
Frederick M. Abbott, Sei. Zre of Generic Pharmaceuticals in Transit Based on Allegations of Patent
Infringement. A Threat to International Trade, Development and Public Welfare, 1 W.I.P.O.J. 43, 49 (2009).
65
Govt. Plugs Gap in Patents Bill, Bus. STANDARD (India), Mar. 22, 2005 available at: http://www.business-
standard.com/india/news/govt-plugs-gaps-in-patentsbi1l/ 203059/).
66
Id.
74
Agreement.67 Fears and concerns about decreased access to medicines for the poor
continue to be expressed in relation to India's compliant laws, but the Patents Act's
interpretation since its passage in early 2005 has shown that India has preserved
critical safeguards for those with the least access to essential medicines. As a result,
despite technical conformity with the TRIPs Agreement and increased protection of
patent rights, the execution and interpretation of India's legislation have served to
preserve the Doha Declaration's fundamental aim of public health protection.
67
In creating legislation for patent protection, countries such as India must face the challenge of satisfying not
only the minimum standards of the TRIPS Agreements and the public health needs of developing and least-
developed countries, but also the interests and benefits of its own country. Jessica L. Greenbaum, TRIPS and
Public Health: Solutions for Ensuring Global Access to Essential Medication in the Wake of the Paragraph 6
Waiver, 25 J. Conte. Mp, Health L & Policy 142,157 (2008)
75
WITHDRAWN AFTER ACQUISITION BY ANOTHER
COMPANY
Many times, generic medication corporations have sought compulsory licensing or
patent revocation for noncommercial usage or to make their products unavailable to
inhabitants of the country. These applications are either withdrawn or denied. When
they are rejected, it is either because to a lack of proof or because they have been
proven false. When they are removed, however, it is usually as a result of a settlement
with the patent owner corporation. The following are some of the types of acquisitions
that have a direct impact on obligatory License applications.
Cipla filed a petition with DIPP on October 21, 2014, asking for the revocation
of five patents granted to Novartis for the respiratory medicine 'Indacaterol' (brand
name: Onbrez), as well as the launch of a cheaper generic version. This claim was
brought under the Patents Act's section 66 (public interest revocation) and section
92(3) (ii) (compulsory licence in case of extraordinary urgency). Novartis had
exercised its patent in a manner adverse to the public interest and harmful to the state,
according to Cipla, by:
“Not making available to the public, adequate quantities of the drug at reasonable
prices for the patients in India for a disease [Chronic Obstructive Pulmonary
Disease] which is prevalent in epidemic proportions”.
It noted that Novartis was not manufacturing the medicine in India and was just
importing a minimal quantity, which only met 0.03 percent of the drug's demand in
the country. It further stated that it offered the medicine for Rs. 300 per month, as
compared to Rs. 2,000 per month as charged by Novartis. Finally, it was revealed on
June 13 in response to an RTI that Cipla had withdrawn its representation for
revocation of Novartis' Onbrez patents, and that the case had been closed. Soon after
Novartis' application for patent revocation was withdrawn, the two businesses
announced that they had partnered to promote Novartis' medications in India. 68
68 Bill Ackman
76
5.2.1 NATCO WITHDREW OPPOSITION TO GILEAD’S DRUGS
On January 6, 2014, Natco Pharma, a generic medication manufacturer based in
Hyderabad, filed a pre-grant opposition to Nucleoside Phosphoramidate Prodrugs (an
invention that claims to generate unique chemical compounds that can be utilized to
treat Hepatitis C). On October 20, 2009, Gilead filed a patent application for the
medication Sovaldi. Natco withdrew its opposition from the Indian Patent Office on
September 12, 2015. "Due to some operational reasons," the reason for the withdrawal
was given.
The Indian Patent Office confirms this. On the 2nd of March, 2015, Natco and
Gilead announced that they had agreed into a licencing deal. 69
In the United States, Gilead sold the medication for $1,000 each pill.
According to the terms of the Natco agreement. In exchange for the rights to Sovaldi,
Gilead received a 7% royalty.70 37 The medicine was being sold for an MRP of Rs
19,900 for a bottle of 28 pills by companies that have agreements with Gilead.
However, because the medicine was supplied at a substantial discount, the actual
selling price was roughly Rs 10,000.
69 NATCO Announces Licensing Agreement with Gilead Sciences, Natco News and Announcements,
https://www.natcopharma.co.in/about/news/
70 Girish Malhotra, Comparison of Drugs Prices: US vs. India; Their Manufacturing Costs and Opportunities to
Improve Affordability, AMERICAN PHARMACEUTICAL REVIEW, (Feb 16, 2018), (15 April, 2018)
https://www.americanpharmaceuticalreview.com/Featured-Articles/347177-Comparison-of-Drugs-Prices-US-
vsIndia-Their-Manufacturing-Costs-and-Opportunities-to-Improve-Affordability/
77
Pharmaceutical Association and Natco estimated that the generic versions of
sofosbuvir would cost $900-$1000 for a full 3-month therapy, but could be
significantly cheaper for community procurements in India's northeast. The medicine
was thought to be able to be made and sold for roughly $200-$300 with the correct
economies of scale. They believed that this pricing had to be reached in order for it to
truly be accessible and cheap to everyone. As of September 10, 2015, the market price
for a bottle of 28 sofosbuvir pills in India ranged from $161 by Emcure
Pharmaceuticals Ltd to $258 by Natco and Zydus Hepatize, according to a price list
compiled by the Asia Pacific Network of People Living with HIV (APN+).
According to a patent expert, the enormous license deals between Gilead and
the Indian generic competitors are significant in the realm of patent litigation in India.
The move demonstrated that, while patient groups and generic drug companies had
previously fought for the same aim of affordable pharmaceutical availability, their
ultimate interests were divergent.
This also indicated that the larger generic players were broadening their
geographic focus. According to Swaraj Paul Barooah,71, one expects that smaller
enterprises will now take on the burden of contesting patents and working to make
pharmaceuticals more accessible. A stipulation in the agreement between the generic
medicine producer and the originator for anti-diversion measures40 was another
problem that the generic drug manufacturer had to deal with. Consider how this might
affect a patient's right to privacy, particularly in diseases like Hepatitis C and HIV. 72
71
Editor-in-chief of intellectual property blog Spicy IP and visiting faculty at Nalsar University of Law,
Hyderabad
72
Where the generic drug manufacturer has to provide the patient information to the originator
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market for an additional 20 months, generating an estimated $20 billion (Rs 85,800
crore) for the US drugmaker.73
Pfizer Inc. stated that it had reached a deal with India's Ranbaxy Laboratories
Ltd. and certain of its affiliates to resolve practically all of their patent disputes
regarding Lipitor, the world's most-prescribed cholesterol-lowering drug. Ranbaxy
was granted a license to market generic versions of Lipitor and Caduet in the United
States under the terms of the deal.74
The deal gave Pfizer and Ranbaxy stockholders, as well as patients, significant
assurance that a generic version of Lipitor would be available in the United States.
Ranbaxy was also granted a license to market generic versions of Lipitor in seven
additional countries, including Canada, Belgium, the Netherlands, Germany, Sweden,
Italy, and Australia. Pfizer and Ranbaxy have also reached an agreement in Malaysia,
Brunei, Peru, and Vietnam for Lipitor. According to the agreement, the cases between
Pfizer and Ranbaxy over Lipitor and Caduet were dismissed in the listed countries,
and Ranbaxy no longer contests the validity of Pfizer's patents in the specified
countries, including the United States.
73
Bhuma Shrivastava, Susan Decker & Shannon Petty, Ranbaxy and Pfizer settle Lipitor lawsuit, Business Wire,
(Jun 19, 2008), https://www.pfizer.com/news/press-
release/pressrelease/detail/pfizer_and_ranbaxy_settle_lipitor_patent_litigation_w
74
Pfizer and Ranbaxy Settle Lipitor Patent Litigation Worldwide Ranbaxy to Receive License in U.S. Press
Release Pfizer & Ranbaxy, (November 30, 2011), (15 March, 2018) http://press.pfizer.com/press-release/pfizer-
and-ranbaxy-settle-lipitor-patent-litigation-worldwide,
79
"Innovators would face substantial hurdles without patents and a strong
protection of intellectual property rights, which might stifle the creation of novel
treatments," Mr. Read warned. Ranbaxy received rights to all of the patents it needed
to develop the generic medicine, allowing it to manufacture and launch a generic
version of Lipitor before the crystalline and amorphous patents expired.
The settlement complies with all applicable regulations and excludes any of the
current activities recognized as being of concern by the US Federal Trade
Commission, such as "reverse payments." Since 2003, Pfizer has been fighting
Ranbaxy's Lipitor patent challenges all around the world. The agreement only applies
to Ranbaxy and its affiliates, and it excludes legal issues.
The settlement complies with all applicable regulations and excludes any of the
current activities recognized as being of concern by the US Federal Trade
Commission, such as "reverse payments." Since 2003, Pfizer has been fighting
Ranbaxy's Lipitor patent challenges all around the world. The agreement only applies
to Ranbaxy and its affiliates, and it excludes legal issues challenges to the Lipitor
patents involving other generic manufacturers. However, Ranbaxy was the first
generic challenger to the listed Lipitor patents and, as such, holds the rights to 180
days of marketing exclusivity in the United States.
As stated in the National Health Policy 2017, the government is dedicated to making
healthcare cheap. The cost of healthcare in India has pushed an estimated 94 million
people into poverty. Medicines account for around two-thirds of all spending. Generic
drugs are just as effective as their brand-name counterparts. The governments and the
Medical Council of India's initiative to make it necessary for doctors to write generic
prescriptions has sparked numerous worries about generic drug availability and
quality. The case in favor of generic medicine is supported by experience in the
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United States and Canada. India is the primary source of generic medications for the
United States. Pharmaceutical corporations should not be bribed to advertise their
branded drugs, as is the case in the United States. The government could make generic
pharmaceuticals more accessible, improve quality control, and educate clinicians
about the advantages of taking generic drugs.
The Indian government is committed to providing residents with inexpensive,
high-quality healthcare. Its new move to promote access to cheap drugs by requiring
doctors to write only generic prescriptions is generating a lot of buzz in India. While
all parties agree that it is a good idea, there are a number of issues that need to be
solved. The quality of generic drugs, as well as their availability, are key problems.
The scientific aspects of this endeavor, as well as the implementation issues, are
presented here.
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fertilizers. Generic drugs can be prescribed in two ways: generic-generic (with only
the generic name) or generic-brand (with the manufacturer's name in bracket). Generic
drugs are not inferior; they are the same as brand-name medicines, but they are
available at a later stage in the market cycle. A generic medicine is one that is
manufactured and sold by a firm other than the one that originated it. It may differ in
color, packaging, and inactive chemicals, but the active ingredient is the same. Table 1
shows the differences between branded and generic drugs.
Medicines account for around two-thirds of total spending, making them a key source
of poverty in India. Generic drugs are much less expensive than branded medicines,
costing about one-fourth to one-tenth of the price (Rao, 2017). As a result, their
widespread use will significantly lower health-care spending by both individuals and
governments. Generic drugs are 80–85 percent less expensive than brand-name
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medicines, according to the US Food and Drug Administration (FDA) (US Food and
Drug Administration, 2016). There is no system in place to keep supply-chain margins
under check. As a result, in addition to prescribing generic medications, the
government regulates the prices of vital medicines by releasing a list of drugs that are
subject to price limits.
“Generic medicines are important options that allow greater access to health care for
all Americans. They are copies of brand-name medicines and are the same as those
brand name medicines in dosage form, safety, strength, route of administration,
quality, performance characteristics and intended use. Health care professionals and
consumers can be assured that FDA approved generic medicine products have met the
same rigid standards as the innovator medicine. All generic medicines approved by
FDA have the same high quality, strength, purity and stability as brand-name
medicines. And, the generic manufacturing, packaging, and testing sites must pass the
same quality standards as those of brand-name medicines.”75
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right to health. The promotion of generic drugs builds on a wealth of experience from
states across the country, particularly Rajasthan and Tamil Nadu, which were early
adopters of generic medicines in the public health system. These states have improved
procurement through e-tendering to increase transparency, quality control, and
electronic monitoring of medicine stockpiles, reducing stock-outs and lowering drug
costs significantly.
CHAPTER – VI
6.1 INTRODUCTION: -
During the last quarter of the 20th hundred years, India was named the "Drug store of
the Developing World," as a basic wellspring of minimal expense, life-saving
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medications for the world's most unfortunate individuals. At the point when India
joined the World Trade Organization in 1995, it became subject to the Agreement on
Trade Related Aspects of Intellectual Property ("TRIPS"), which required it, in
addition to other things, to restore drug item licenses by a specific date. The Patents
Act Amendments of 2005 in India did definitively that, however they likewise
incorporated an assortment of "Excursions adaptabilities" expected to lessen the
mischief to admittance to drugs. (1) An obligatory authorizing arrangement expressed
that public interest prerequisites could really compel brand-name drug organizations
to consent to permit their protected medications; and (2) an enemy of evergreening
arrangement set the stakes for what drug organizations needed to show in any case to
acquire a medication patent. The Amendments accentuated the points of these
arrangements: the necessary permitting proviso was intended to protect general
wellbeing, while the counter evergreening area was intended to dispose of
unnecessary endeavors to keep feeble licenses alive.
The Intellectual Property Appellate Board in Bayer v. Natco and the SC of
India in Novartis AG v. UoI looked to support the basic reasoning of these two key
TRIPS adaptabilities in the two most significant choices. Notwithstanding, Bayer and
Novartis at last interpreted with the two adaptabilities in different ways which
compromised with the standards they should reinforce.
India's most memorable patent regulation was ordered during the pioneer time frame
and was designed after British patent regulations. The early Indian patent approach,
similar to the British framework, gave vigorous assurances that pulled in worldwide
firms to the Indian market. By 1970, unfamiliar drugs controlled around 70% of the
home market and were charging a portion of the world's most noteworthy medication
costs. Wages, then again, had not stayed aware of cost increments. Because of rising
general wellbeing concerns, the Indian government sanctioned the Patents Act of
1970, which revoked all medication item licenses in a single singular motion. Area 5
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of the Act precluded drug companies from gaining item licenses on their medications,
leaving them with simply process licenses, which are frequently simple to plan
around.
Regardless of whether a drug organization procures a cycle patent for a medication's
assembling technique, other drug organizations could figure out the medication and
produce it utilizing a strategy not framed in the process patent. Also, the Act
decreased the quantity of years that interaction licenses award security from fourteen
to seven, which is significantly less time than is for the most part expected for drug
examination, testing, and advancement. Drug organizations seldom looked for process
licenses since they gave so restricted insurance.
Throughout the following thirty years, the quantity of medication licenses
granted diminished to basically zero, permitting native drugs to grow their innovative
capacities. India made one of the world's most hearty nonexclusive drug public Indian
business people consumed a huge lump of the neighborhood piece of the pie recently
held by worldwide firms in a moderately brief timeframe.
Despite the fact that the TRIPS arrangements obviously preferred well-to-do
nations that trade data, nations, for example, India had no choice except for to take the
understanding's terms to join the WTO. Agricultural nations, then again, were
permitted chance to bring themselves into TRIPS consistence, with the most un-
created nations settling the score more.
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6.2 TRIPS REQUIREMENTS AND FLEXIBILITIES
TRIPS lays out various clear rules. Licenses should be given for creations in "all parts
of innovation," with a couple of exemptions, and should be legitimate for somewhere
around twenty years. A few extra guidelines, then again, are ambiguously
characterized, and states have had critical space in deciphering the TRIPS
prerequisites' particular limits. India took on item licenses for drugs in the 2005
Amendments in the Patents Act ("2005 Amendments") simply by nullifying sec 5 of
Patents Act. A portion of the responses were undeniable — necessary permitting, for
instance, had previously gotten a ton of consideration as a basic instrument for
expanding access — yet others utilized patent freedom limitations. They additionally
forced limitations on an assortment of expectations that patent-holding organizations
might attempt to force on authorizing from now on.
Notwithstanding, the counter evergreening provision segment 3(d), which bars from
patentable topic any new type of a realized compound that doesn't have a "viability"
over and past that of the known substance (depicted more meticulously underneath),
has drawn in much more global consideration. India's admittance to drug interests
would doubtlessly be progressed by required authorizing and hostile to evergreening
measures, following two conclusive court triumphs for the Indian generics industry in
2013 — one maintaining the first obligatory permit allowed in Quite a while and the
other justifying the principal significant enemy of evergreening challenge to an
unfamiliar drug's item patent.
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6.2.1 COMPULSORY LICENSING AND BAYER V. NATCO
Section 84 of the Patents Act
As unfortunate nations joined the WTO in the last part of the 1990s, numerous
pundits considered necessary permitting as the essential means for guaranteeing that
TRIPS rules didn't substantially restrict admittance to drugs. Following worries that
the TRIPS confirmations were not express to the point of giving sufficient security to
countries in the worldwide south, the ("Doha Declaration") attempted to explain any
false impressions connecting with TRIPS' mandatory permitting instrument.
The 2005 Amendments framed three conditions under which necessary licenses
ought to be given, as per TRIPS and the Doha Declaration. In any case, there is a
crisis arrangement in area 92, which permits the public authority to sidestep the
Controller of Patents' watchfulness and request mandatory authorizing in "conditions
of public crisis, outrageous desperation, or public non-business use. "As per TRIPS,
patentees will be paid "sensibly" in all conditions.
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general society for the medication were not met; and (3) Nexavar was not being
worked in India.
The Nexavar question in India started when Bayer sent off a claim against
Indian drugmaker Natco, saying that Natco was making a conventional rendition of
Nexavar in break
On March 9, 2012, the Controller conceded Natco the first ever required permit
in Quite a while, and Bayer was granted an eminence of 6% of Natco's incomes.
Bayer documented an allure. The IPAB kept up with the Controller's honor of the
required permit on March 4, 2013, yet expanded the eminence to 7%. In its decision,
the IPAB said on different occasions that the main worry of the necessary permit
system — and the way to deciphering segment 84 — is whether the "public interest"
has been served.
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By taking on this translation to current realities, the IPAB concluded that the
Controller of Patents found that the 280,000 rupees each month was charged for
Nexavar and was "separated from everyone else important" in concluding that the
medication was not genuinely reasonable under segment 84. (1).
6.2.4 “WORKING”
At long last, the IPAB thought about whether the compulsory permit could be given in
light of the fact that the drug was "not [being] worked in that frame of mind of India"
as characterized by area 84(1). (c). Bayer kept up with that bringing in could meet the
functioning standards and that "working" didn't need neighborhood fabricating in
India. In reality, that's what Bayer expressed "working" may include bringing in
certain cases, like this one, when "the amount [of the drug] expected in India doesn't
monetarily legitimize the structure of an assembling production line in India.
"That's what Bayer said "working" didn't require the neighborhood produce as
it was dismissed by the IPAB, albeit the IPAB left open what "working" required.
Without a doubt, the IPAB discovered that the expression "worked," as characterized
by area 84(1)(c), "should be settled." dependent upon the situation, with "'working' [in
some situations] meaning completely nearby production and 'working' in [other] cases
essentially importation."
The "in all actuality reasonable" referenced in segment 84(1)(b) basically does
all of crafted by the obligatory permitting system, as the other two guidelines have
either been deciphered away or delivered so indistinct that they have no pragmatic
impact because of Bayer. As indicated by the IPAB, giving the item out for nothing to
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people who can't bear the cost of it doesn't fulfill the "need will of the general
population" arrangement in segment 84(1)(a), on the grounds that such projects don't
bring down the medication's market cost. A drug company might have to bring down
the cost of a medication for everybody to show that "sensible public necessities" have
been met. In the interim, the IPAB has total caution to decide if "working" requests
nearby buying of the medication on a specific situation premise, in this way the
"working" prerequisite of area 84(1)(c) conveys no weight, essentially ex bet. The
"working" condition is in all probability too hazy to even consider giving helpful data
from a restorative point of view. At last, whether or not the necessary authorizing
system's public premium objective is achieved, the IPAB's point of view focuses on a
solitary variable — market cost — as the foundation of the mandatory permitting
system.
On one hand, the IPAB's understandings aren't really unfavorable to get to. The
determined spotlight on cost has a characteristic instinctive allure, since it would
persuade brand-name drug organizations to sidestep mandatory permit necessities to
stay with their market cost low. Drug organizations are, all things considered, in the
best situation to analyze the expenses of a forthcoming mandatory permitting to the
expenses of offering a less expensive cost. Then again, financial real factors make this
judgment troublesome. An elite spotlight on cost may not be the most socially helpful
methodology since it confines the quantity of potential outcomes accessible to mark
name meds with regards to making the medication accessible. The motivation to make
programs like Bayer's patient help program, as well as the impetus to develop nearby
creation offices in India, which would normally increment neighborhood access, has
dissipated. The IPAB declined to investigate this other option, in spite of the
Controller's solid sign that such strategies would do the trick to keep away from
constrained authorizing. Under the IPAB's understanding of the compulsory
permitting plan, cost separation, a methodology through which endeavors charge
different costs to various gatherings relying upon their singular capacities to bear the
cost of the products, may in any case have been conceivable.
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The IPAB's view puts India more presented to WTO debates, as well as
conceivably undermining the entire motivation behind the mandatory permitting
arrangement. As recently expressed, the IPAB by and large saw segment 84(1) as an
"adaptable" condition that might require neighborhood fabricate contingent upon the
conditions. This view goes against the TRIPS Agreement's standards. "Licenses will
be accessible and patent freedoms appreciated without segregation as to... whether
items are imported or privately created," says article 27.1 of TRIPS. This standard of
non-segregation as far as assembling area would seem to preclude convincing drug
organizations to produce locally to stay away from constrained permitting.
The IPAB kept up with its understanding, guaranteeing that Bayer's patent on
Nexavar had been "gave" with "no separation in light of absence of neighborhood
fabricate." The IPAB's guard verifiably expressed that the non-segregation rule simply
applied to the actual patent, not the mandatory permit. However long the shortfall of
neighborhood produce didn't keep the patent from being conceded in any case or
result in the creation being denied later, the obligatory permit could be allowed. In any
case, this contention disregards TRIPS article 27.1, that's what which determines
"patent freedoms [must] be appreciated" — not just "licenses will be conceded" —
paying little heed to where an item is made. While constrained licenses affect when or
not licenses are granted, they can really invalidate a patent holder's satisfaction in
patent freedoms if, for instance, the party that gives the mandatory permit acquires the
patent holder's whole portion of the overall industry.
In its 2005 Amendments, India forced various patentable topic limitations that had "no
equal elsewhere on the planet." Section 3(d) denies licenses on "new types of existing
substances" — like new salt, ester, polymorphism, or isomeric types of perceived
compounds — if "their characteristics change essentially as to viability"
Area 3(d) has the most extensive repercussions in the domain of drugs, while
not being straightforwardly tended to at the drug business. As indicated by gauges,
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patent applications for changes of existing drugs made up more than 3/4 of the 9,000
patent applications under assessment by the Indian Patent Office in 2007. Moreover,
records of tense contentions in the Indian Parliament over area 3(d) recommend that
the proviso was expected to forbid a particular practice in the drug business:
evergreening.
In any case, debate ejected very quickly after the death of area 3(d) with
respect to what precisely evergreening involved. The differentiation between
"evergreening," which is broadly recognized as useless and shameful of patent
assurance, and "gradual development," whose patentability has been addressed by
scholastics, is basic — though vague. Despite the fact that gradual development and
evergreening give off an impression of being basically the same on paper, steady
advancement is typically perceived as a pivotal venturing stone in the production of a
cutting-edge treatment, yet evergreening isn't. It's very likely evergreening in the event
that a drug simply changes the tablet tone or latent elements of a medication and cases
a patent on the change. It's a more powerful medication when a change expands its
bioavailability, which is portrayed as "how much a medication or other substance is
consumed or arrives at an objective spot in the body." It's a more troublesome issue
when a change works on a medication's bioavailability, which is characterized as
"how much a medication or other substance is retained or arrives at an objective spot
in the body." Improved bioavailability should address another difficulty, yet it can
prompt critical upgrades in medicine conveyance and permit more patients to profit
from the treatment's belongings. The inquiry then emerges whether this sort of steady
improvement is patent-commendable.
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the Gleevec development met the two rules, albeit the patent was nullified under area
3 of the Patent Act (d). Novartis has recorded an allure with the Supreme Court of
India.
The court-maintained Novartis' patent dismissal under area 3(d), observing that
while the substance Novartis looked to patent, imatinib mesylate beta glasslike, was
another type of the known compound imatinib free base, Novartis didn't give adequate
proof of a remedial viability improvement in imatinib mesylate beta translucent over
imatinib free base. Thus, the court resolved two central points of contention made by
segment 3(d): first, what comprises a "known substance" against which the guaranteed
structure is assessed, and second, what "further developed viability" comparable to the
realized synthetic is expected to defeat a part 3(d) challenge.
The court, then again, stayed quiet on this issue. Notwithstanding suggesting
that imatinib mesylate non-translucent may be the reasonable "known substance"
under a segment 3(d) examination, the court avoided articulating it unequivocally. All
things considered, the court went directly to a correlation of the efficacies of imatinib
mesylate beta glasslike and imatinib free base, asserting that the examination was the
underpinning of Novartis' case "as made forward in the subject application and the
going with records the supporting oaths."
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The court then, at that point, tended to the principal wellspring of discussion for the
situation: exactly how high of a bar is set by "improvement of known adequacy" in
segment 3? Obviously tolerating Novartis' place that the "known compound" mark of
examination was imatinib free base, the court then tended to the principal wellspring
of discussion for the situation: exactly how high of a bar is set by "upgrade of known
adequacy" in segment 3? (d). Imatinib mesylate beta translucent, as indicated by the
court, didn't meet that necessity. The court needed to limit the generally expansive
term "viability" to confirm that the beta translucent type of imatinib needed
satisfactory "adequacy" over a perceived compound. It did it through a two-venture
process.
As indicated by the court, the main certified question was whether further
developed bioavailability, or the extent of a medication that can be assimilated or
taken up by the body, could be thought of "remedial viability." Novartis, then again,
neglected to exhibit the bio availabilities of imatinib mesylate beta translucent and
imatinib free base by means of "established...research proof," whether or not higher
bioavailability might comprise "restorative adequacy."
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an enemy of evergreening understanding of the arrangement, and may have even
harmed its point. The court contrasted imatinib mesylate beta translucent with an early
and distant adaptation of imatinib free base that had extensive evergreening potential,
utilizing its segment 3(d) approach. Furthermore, in responding to that inquiry, the
court arrived at the questionable resolution that Novartis' Gleevec patent was intended
to keep alive a material that had never been utilized as a treatment and would never
be. Shockingly, such a perusing of area 3(d) could affect admittance to meds in the
immature world by beating Indian medication advancement for dismissed illnesses
down. Albeit the court's explanations behind dismissing Novartis' patent were
convincing from an admittance to drugs angle, it left the "known synthetic" issue
irritating. The court conjectured that imatinib mesylate beta translucent was the
appropriate "known particle" in dicta on the grounds that it was "two phases away"
from imatinib free base. The court, nonetheless, didn't seek after that examination and
couldn't make sense of how it arrived at the resolution that imatinib free base was
"two phases eliminated." At least two vital elective principles for deciding "stages
eliminated" were considered by the court. In any case, the quantity of "stages
eliminated" might be entirely relying upon the medication's turn of events. Taking on
such a model would put the obligation to prove any claims on drug organizations to
show how much exertion was placed into moving starting with one phase then onto
the next. On the other hand, the quantity of "stages killed" could be a more
mechanical test that requests that assessing bodies take a gander at an atom's actual
construction and ask the number of synthetic units should be altered to get from
compound A to intensify B. In Hoffmann-La Roche v. Cipla, in which Indian
conventional organization Cipla tested the legitimacy of the patent, the last strategy
was supported by the New Delhi High Court of Hoffmann-La Roche's patent on its
pancreatic disease drug "Tarceva". The prior standard, then again, is more predictable
with a deliberate understanding of segment 3. (d). Assuming courts decipher "known
compound" fully intent on distinguishing licenses in which an organization rapidly
and inexpensively recognized a minor change basically to keep its past patent
evergreen, then, at that point, how the different mixtures were created ought to issue
more than the number of mechanical advances were engaged with that interaction.
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The court's befuddling choice on what establishes a "known compound" is especially
tricky considering two contemplations. In the first place, the court couldn't conclude
whether area 3(d) required patentable topic or patentability (proposing a more all-out
way to deal with every similar to case) (recommending a more individualized survey
of each case). Subsequently, patent workplaces and lower courts will be left in
obscurity with regards to assessing future discussions over the appropriate "known
compound" place of correlation. Second, since drug research is regularly founded on
comparative before compounds, what characterizes a "known synthetic" is an
especially important subject in the drug area. It's hard to visualize a part 3(d)
challenge to a medication patent that doesn't start a great deal of conversation in
regards to the right "known particle" to contrast the subject creation's viability with.
All the more significantly, the court's perusing of "known compound" goes against the
point of area 3(distasted), which is to forestall patent evergreening. By neglecting to
characterize an implementable norm for laying out the "known compound" and
afterward looking at the viability of imatinib mesylate beta glasslike only to imatinib
free base, the court gave the deep-seated impression that imatinib free base was the
applicable "known compound." The arrangement's enemy of evergreening design is
sabotaged by this translation of segment 3(d). Regardless of the way that "free base
structure [i]imatinib has very little or no dissolvability" and is "thusly not equipped for
being controlled as a drug to people," the court utilized imatinib free base as the
"known compound" in a segment 3(d) examination. Also, the court's treatment of
"helpful viability" is upsetting.
Despite the fact that Novartis' incredibly high obstacle under segment 3(d) may
seem, by all accounts, to be a transient triumph for admittance to medication
endeavors, it could affect Indian innovative work in the domain of infections intended
for the worldwide south.
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CHAPTER-VII
7 CONCLUSION
Access to essential drugs or medications is vital for preventing and treating diseases
worldwide. According to the World Health Organization, one-third of the world's
population currently lacks access to essential drugs, reaching nearly 50% in some
regions of Africa and Asia. The causes for lack of access to various medicines are
multifaceted. Still, in reality, the focus should be on drug costs primarily influenced
by international trade regulations and patent restrictions.
The fundamental concern for a sustainable health care law is how intellectual
property restrictions have contributed to the challenges of global access to vital drugs.
The current problem is that the TRIPS agreement requires every country to have
patent regulations similar to those in the United States and Europe. Some proponents
of intellectual property claim that expanding the patentability of medications for
developing-country disorders will encourage medical research and therapeutic
development for diseases that are primarily seen in impoverished nations and have
historically been overlooked. However, this is not the case.
Ordinary people are terrified of the product patent regime because it denies
them access to essential drugs. Patent holders can demand extravagant prices for their
products since they enjoy a twenty-year monopoly. "Patents should offer inventors
incentives and awards for their labor," the public believes, "but patents should not
restrict the ordinary man's access to protected goods." The goal of patents is to benefit
society by encouraging and funding further research and development. Granting
patents must be made to boost market incentives. Market extremism in product patents
and exclusive monopolies, particularly over needs, cannot be justified at the expense
of society's health and wellbeing. The government is responsible for ensuring that the
average person has affordable access to patented essentials.
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Pharmaceutical companies use price discrimination between markets as a
critical revenue-generating strategy. When they have a monopoly on a single drug,
they charge the price that maximizes their total earnings. As long as they own the
patents, the legal protection provided in each market allows them to negotiate the
price and seek a return on their investment. On the other hand, parallel imports run the
danger of undercutting a company's price discrimination strategy.
Pharmaceutical companies are adamantly opposed, stating that revenue will dry
up without patent protection, diminishing the incentive to create new drugs. WHO
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pays for AIDS research in the first place, though? The truth is that taxpayers have
borne the bulk of the financial load, not stockholders. AIDS drug research has
received hundreds of millions of dollars in government cash from publicly-funded
research councils. Without a doubt, the Pharmaceutical Research and Manufacturers
of America, an industry campaigning bunch, assesses that the private area reserves
just around 43% of medication advancement. The topic of loosening patent insurance
goes past this contention. In case of a general wellbeing crisis, the mission for
admittance to significant medications advocates for less fortunate nations' more right
than wrong to utilize legitimate exchange measures. Compulsory licensing—the legal
authority to produce copyrighted medications in exchange for a royalty payment to the
patent holder—and parallel imports—the legal license to import patented goods from
a cheaper country—are two examples. These policies pose little risk to drug
development, especially as they are already in place under WTO rules and would have
no impact on patent protection in Western countries.
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7.1 SUGGESTIONS
OPEN LICENSE
In India, compulsory licensing is presented as the panacea for all ills. The legal case
for compulsory licensing in India is insufficient to solve the real issues.
Setting conditions that allow the manufacture of medications without government
involvement under the proposed Open License and a transparent process for paying a
fixed price to the patentee could be another option for compulsory licensing. TRIPS
Article 31, on the other hand, bans such an automatic method of providing an open
license.
PARALLEL IMPORTS
India could potentially strive to make it easier to import copyrighted pharmaceuticals
if they can buy them cheaper elsewhere on the planet via its legal system.
Allowing imports from the cheapest source will ensure that needed drugs are supplied
at the lowest possible price. In this case, parallel imports come in handy.
Most parallel imports are based on price differentials between two marketplaces or
arbitrage. The price difference could be attributable to the manufacturer's pricing or
various price constraints in different markets. Global free trade agreements should
include the ability to shop worldwide for the lowest prices. For smaller economies that
are underserved by the market, parallel imports are essential.
When the governments of poorer countries deem it appropriate, the concept of
universal exhaustion of rights might be a valuable tool for price control.
DIFFERENTIAL PRICING
Differential pricing is recommended as a solution. The differential pricing would
allow India to have lower drug prices while keeping higher prices in industrialized
nations.
Differential pricing could be a minor part of the solution to the drug access problem.
Its operation necessitates negotiations involving all parties, including patent holders,
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generic producers, and others. The debates should be done in an open and transparent
environment. This method should not be used to compel developing countries to make
concessions on required licenses or parallel imports.
ADMINISTRATIVE PROCESSES
TRIPS IN ADMINISTRATIVE PROCESSES Article 31 requires an "independent
evaluation by a higher authority" as part of the administrative process. For example,
the Minister of Health might appoint an officer to make independent decisions and an
independent body to review those decisions, with the power to overturn, change, or
remand the initial determinations. Another office could carry out the review, such as
the registrar of patents or the attorney general. The aim is to build a system that
accomplishes the objectives of forced licensing or government use while also ensuring
that the procedure is fair and straightforward. According to the World Trade
Organization, TRIPS is more about having a rules-based system than specific rules or
outcomes. Assuming they follow the procedural protections in good faith, many
different procedures and results will be acceptable to the WTO under a WTO dispute-
resolution process.
SETTING COMPENSATION
The patent owner is reimbursed when a patent is exploited under Article 31 of TRIPS.
Article 31(h) defines a basic rule: in each circumstance, the right holder must be
compensated adequately, taking into account the economic value of the authorization.
The most apparent path ahead is to construct a set of compensation principles based
on proper royalties in most cases, which will provide a framework for decision-
making and predictability, and transparency for the system. These regulations can be
administrative or even legal. A simple method of royalty standards will make it easy
to respond quickly. Government officials can select a royalty from the criteria that
closely match the facts, and the products can then be rapidly released to the market.
Patent owners or generic producers may appeal initial decisions, but the appeals
process should not prevent generic competitors from entering the market.
GENERIC COMPETITION
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Generic competition has resulted in significant price reductions in industrialized
countries. Emerging countries must acknowledge the importance and benefits of
generic competition in international trade.
GENERIC SUBSTITUTION
Generic substitution is pushing a pharmacist to prescribe a generic replacement.
The cheapest available form of non-patent-protected pharmaceuticals, unless the
patient explicitly requests the originator product rather than a generic alternative. This
is pretty common in wealthy countries like the United States, the Netherlands, and
Japan, and it should be used in developing countries like India as well.
SINGLE EXIT PRICE
Developing countries should form a pricing committee with the authority to set a
"single-exit price," or the price at which a pharmaceutical company must sell to all
private-sector purchasers. This is a kind of price control aiming at increasing pricing
transparency and reducing unethical prescribing practices, such as when a pharmacist
is enticed to administer a medicine because of (typically limited-time) discount offers.
EXEMPTION
During the failed WTO Ministerial in Seattle, one suggestion (by Venezuela) was
made to allow governments to exempt specific pharmaceuticals from patentability.
This suggestion should be seriously examined in future negotiations.
DURATION OF PATENTS
In underdeveloped countries, the term of patent protection for drugs should be reduced
(if not exempted from patentability).
CREATION OF AN INTERNATIONAL FUND
An international fund should be established for research, pharmaceutical cost
subsidization, and improving health services and delivery systems.
MORATORIUM OR WAIVER
The possibility of developing countries being brought before the World Trade
Organization's (WTO) dispute settlement system is always present. According to one
proposal, dispute proceedings aimed at restricting or limiting a member's attempt to
address pharmaceutical access or similar health issues should be excused. This has
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never endeavoured, and it should be accurately worked out as per the general
inclination of all WTO individuals to succeed.
8 BIBLIOGRAPHY
ARTICLES
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BOOKS
• The Making of the TRIPS Agreement Personal insights from the Uruguay
Round negotiations Edited by Jayashree Watal and Antony Taubman
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EDITORIALS
Dhar B.& Anuradha R.V. Economic & Political Weekly, March 26, 2005.
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Rangnekar D, Economic & Political Weekly, February 4, 2006
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