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PATENT WARS IN THE PHARMACEUTICAL INDUSTRY: BALANCING ACCESS TO MEDICINE AND INNOVATION
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PATENT WARS IN THE PHARMACEUTICAL
INDUSTRY: BALANCING ACCESS TO MEDICINE AND INNOVATION
AUTHORED BY - NEHA SHARMA & DR SUPERNA VENAIK
LLB (3YR), 6TH SEM
AMITY LAW SCHOOL
AMITY UNIVERSITY, NOIDA
ACKNOWLEDGMENT
I owe a
sincere thank you to everyone who gave me assistance and encouragement when I
was writing my research paper. They all had trust
in me and provided me with direct or indirect support as I conducted the
necessary research and study. I want to thank Amity University in Noida, Uttar
Pradesh, for giving me groundwork and a chance to be a member of the
university. I want to firstly express my profound appreciation to my mentor Dr
Superna Venaik ma'am for her unwavering support of my research paper throughout
study and research, as well as for his patience, inspiration, excitement, and
vast expertise. His advice was helpful to me throughout the whole research and
writing process for this book. Last, but certainly not least, I would like to express
my sincere gratitude to my family and friends for their unwavering
encouragement throughout my life.
INTRODUCTION
India and
the Patent Wars examines struggles over patents and medical access among
pharmaceutical producers, activists, and others under a new global intellectual
property regime. India, one of the world’s largest pharmaceutical exporters,
has been at the center of these struggles. This book explores multiple
perspectives on these controversies including those of Indian pharmaceutical
companies, which have long offered low-cost medicines to customers around the
world, multinational pharmaceutical companies, which pursue patent claims in
Indian courts and license drugs to Indian producers, and practitioners of
ayurveda, India’s largest indigenous medical system, who are concerned about
how their knowledge and practices relate to the new patent system.
The
introduction opens with a discussion of the current state of intellectual
property law which has been greatly expanded around the world at the behest of
corporate interests and the World Trade Organization, imposing limitations on
the sharing of medical, scientific, and artistic creations. A brief discussion
of India’s large pharmaceutical sector and multinational big pharma is
presented followed by a depiction of the practice of ayurvedic medicine in
India and concerns about biopiracy, or the commercial exploitation of
indigenous medical knowledge. The introduction also offers a discussion of
problems of resistance and the intelligibility of power in a complex global
system such as the new patent regime and cautions against simplistic depictions
of an all-powerful “big pharma” in analyzing the global economy of
pharmaceutical production.
THE INVENTION AND EXPANSION OF INTELLECTUAL
PROPERTY
This
chapter depicts the emergence of the concept of intellectual property starting
with analyses of intangible property in pre-capitalist societies and the
development of patents and copyrights in 15th-18th century Europe. Court decisions
that expanded the scope of intellectual property in the last few decades in the
U.S. are presented followed by a review of the development of patent treaties
from the Paris Convention of 1883 to the current World Trade Organization TRIPS
legislation which required a rewriting of patent laws in India and around the
world. India’s 1970 Patents Act, the reigning law until the TRIPS regime,
prohibited product patents on medications, allowing only patents on the process
of making a drug to prevent monopoly control of medications. In 2005, India had
to change its law to comply with the WTO by allowing product patents and
exclusive market control of medications.
THE NEW PATENT REGIME
This
chapter examines efforts to resist the implementation of the new patent regime
in India out of concern for the price of essential medicines. The Indian
pharmaceutical sector has been a principal source of low-cost medicines for
developing countries, but may no longer be able to produce inexpensive copies
of medications patented elsewhere. India’s WTO-compliant patent law has a
silver lining, however, since it requires companies to demonstrate increased
effectiveness of new drugs over the standard of care, provisions against
“evergreening” of patents that are not required by US patent laws. Activists in
India have been able to defeat several recent patent applications under this
provision. The pharmaceutical giant Novartis challenged this provision in the
Indian Supreme Court while at the same time, the company was holding patents
for medical products that were derived from India’s indigenous Ayurvedic
medical system.
AYURVEDIC DILLEMAS-INNOVATION &
OWNERSHIP
The chapter
opens with the history of the sharing and stealing of biological knowledge
between India and the West including the story of how the drug reserpine made
its way from practitioners of ayurvedic medicine to Novartis’ patent portfolio.
The chapter then moves to a discussion of how Ayurvedic medicine fits and does
not fit, the requirements of patent law using the perspectives of Ayurvedic
practitioners and manufacturers I interviewed. Modern patent law leaves Ayurvedic
medical knowledge unprotected because Ayurvedic doctors use plant materials and
do not isolate active chemical ingredients that may exist in these materials
and also because Ayurvedic practice is believed to be communal and traditional
and not based on individual invention. I also show how ayurvedic doctors and
producers of ayurvedic pharmaceuticals have developed diverse responses to the
new regime including efforts to create proprietary ayurvedic drugs and compile
their knowledge in a digital library.
THE GILEAD MODEL AND THE PERSPECTIVE
OF BIG PHARMA
Here this
study takes into account the perspective of multinational pharmaceutical
companies. I first discuss the difficulties I encountered in getting access to
individuals from pharmaceutical companies who would speak on patent issues and
how I was eventually able to speak with representatives from Gilead and Pfizer.
Gilead Sciences, a mid-size US-based company, is voluntarily allowing 16 Indian
generic pharmaceutical producers to manufacture their drug, tenofovir, a
crucial WHO-recommended therapy for HIV/AIDS. As a result, the price of
tenofovir has gone down dramatically. This chapter assesses the meaning of
these events and argues that the priority of pharmaceutical companies under the
new patent regime is not to get people in poor countries to start paying high
drug prices but to protect their markets in wealthy and middle-income
countries. The real problem of access under the new patent regime may turn out
to be for the poor who live in middle-income countries.
THE “INDIAN” PHARMACEUTICAL
INDUSTRY AND THE NEW PATENT REGIME
The boom
town of Hyderabad is the center of India’s pharmaceutical industry, and this
was where I met with representatives from two Indian pharmaceutical companies
to discuss topics such as economies of scale in pharmaceutical production—the
special capacity of the Indian pharma sector licenses with foreign
multinationals such as Gilead and prospects for new research and development.
This chapter argues that those who anticipate a simple takeover by “multinational”
companies of “Indian” companies, which are also multinational, simplify what
are complex and surprising emergences negotiated by quite powerful India-based
corporate actors. The chapter also examines the first two patented drugs
developed in India under the new patent regime, an anti-malarial medication and
a cancer drug, and considers whether new research by Indian companies will
focus on medical problems affecting low-income countries or on products for high-income
markets.
CONCLUSION
The
conclusion reiterates the problems with analyzing this new constellation of
power and predicting its outcomes. Certain effective provisions are highlighted
such as Section 3d of India’s new Patents Act which maintains rigorous
standards of inventiveness and efficacy, preventing the “evergreening” of
patents and “me too” drugs that have been awarded patents elsewhere. The study
ends with a brief comparison to similar patent struggles in Brazil and an
assessment of programs that offer more equitable approaches to innovation and
ownership such as the Health Impact Fund and the Open-Source Drug Discovery
program.
Article Information
PATENT WARS IN THE PHARMACEUTICAL INDUSTRY: BALANCING ACCESS TO MEDICINE AND INNOVATION
Authors: NEHA SHARMA, DR SUPERNA VENAIK
- Journal IJLRA
- ISSN 2582-6433
- Published 2024/04/15
- Issue 7
About Journal
International Journal for Legal Research and Analysis
- Abbreviation IJLRA
- ISSN 2582-6433
- Access Open Access
- License CC 4.0
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