Open Access Research Article
PHARMACEUTICAL PATENTING: COVID-19 LESSONS OF TRIPS WAIVER (By-Ashish Jain)
Published Paper
Article Details
PHARMACEUTICAL PATENTING: COVID-19 LESSONS OF TRIPS WAIVER
Authored By-Ashish Jain
5th Year Law
Student
School of Law, AURO University
BBA LLB 2018
Introduction
The humanitarian history of the world
has noted the non-selfish demands of India and South Africa, that had piloted
the proposal to waive key provisions of the TRIPS agreement on Covid 19
vaccines, drugs, therapeutics, and related technologies, This proposal was
initially opposed by the world, as they were eyeing over it as disturbance to
the IPR Laws and damage to the objective of TRIPS agreement in the long run
future. However, US had to back this proposal, when they realized the gravity
of Covid 19 situation worldwide, which was seen especially in poor, under
developed and even developing nations. However, the pharmacy companies in
Europe, specially Germany and UK, were opposing this proposal, on the grounds
of economic interests.
Patents are monopoly rights granted
under a statue normally for a period of 20 years, after which it comes into
public domain existence. Patents have an important role to play in stimulating
innovation in healthcare products in countries where financial and
technological capabilities exists. The rights of the patentee are normally
subject to national legislations, however there are a few exceptions, such as
Bolar Exemption.
So the core idea behind the proposal
of TRIPS waiver, was that the IPR should not become barrier in scaling up the
production of medical products essential to combat covid 19. However, the
Government of India was beaten over this unethical business activity, as they
were asking for international support to waive off trips agreement, however,
domestically, not implementing compulsory licensing as to enable vaccine
manufacturers to expand production and reduce inefficiencies in procurement and
distribution.
This introduction is to conclude that
my research problem is established on the pillars that whether it is relevant
to waive of patent rights in critical upcoming situations, or rather the
authorities should wait and watch, as to provide a fulfillment of objective of
patent rights granted, until the situation become worrisome.
Patent Law In
India
The first legislation in India
relating to patents was the Act VI of 1856. The objective of this
legislation was to encourage inventions of new and useful manufactures and to
induce inventors to disclose secret of their inventions. In modern terms, the
patent is usually referred to as the right granted to an inventor for his
Invention of any new, useful, non-obvious process, machine, article of
manufacture, or composition of matter. [1]
In India, the Patents Act, 1970, more
broadly exempts acts relating to the development and submission of information
required by law in India or abroad. The Patents (Amendment) Act, 2002, inserted
a new provision, i.e. Section 107-A in the Patents Act, 1970, which provides
for certain acts not to be considered as infringement. This provision is
interpreted in liberal construction and exempts certain acts for the purpose of
development and submission of information required under any law in India or
abroad. This provision is very useful for the generic drug producers in India.
A patent claim relating to a
pharmaceutical product may relate to an active ingredient as such independently
of or jointly with formulations, salts, pro-drugs, isomers, etc., or cover any
of these subject matters separately. It may also solely cover a manufacturing
process or include both a process and a product.[2]
Trips
Agreement And Indian Laws:
The TRIPS agreement was negotiated in 1995 at
the WTO, it requires all its signatory countries to enact domestic law. It
guarantees minimum standards of IP protection. Such legal consistency enables
innovators to monetize their intellectual property in multiple countries. In
2001, the WTO signed the Doha Declaration, which clarified that in a public
health emergency, governments could compel
companies to license their patents to manufacturers, even if they did not think
the offered price was acceptable.[3]
This provision, commonly referred to as “compulsory licensing”, was already
built into the TRIPS Agreement and the Doha declaration only clarified its
usage.
Under Section 92 of the 1970 Indian Patents Act,
the central government has the power to allow compulsory licenses to be issued
at any time in case of a national emergency or circumstances of extreme
urgency.[4]
India and South Africa’s current proposal seeks greater flexibilities than
those provided in the TRIPS Agreement. The vaccine manufacturing process is
complex and exercising flexibilities on patents will be insufficient to enhance
production. It will require relaxation on other forms of intellectual property
as well just like India has proposed at the WTO.
The trips agreement which lays down the minimum
standards for the Member states also allows the use of limited exemption.
Article 30[5]
states that “Members may provide limited exceptions to the exclusive rights
conferred by a patent, provided that such exceptions do not unreasonably
conflict with a normal exploitation of the patent and do not unreasonably
prejudice the legitimate interests of the patent owner, taking account of the
legitimate interest of third parties.” Article 30, thus enables Member states
to provide for certain exceptions in their national legislation subject to the
condition that they do not unreasonably conflict with a normal exploitation of
the patent or prejudice the legitimate interest of the patent owner.
What Is The
Trips Waiver For Covid-19 Vaccines?
The TRIPS waiver refers to a proposal, advanced
by the governments of South Africa and India, to the World Trade Organization
to waive intellectual property rights protection for technologies needed to
prevent, contain, or treat COVID-19 until widespread vaccination is in place
globally, and the majority of the world’s population has developed
immunity. [6]
The stricter standards provided by the TRIPs
Agreement caused a lot of hardship on most of
the Member states, particularly the developing
countries to address the public health issues. Recognizing this state of issues
and gravity of the problem, Doha Declaration on TRIPs Agreement and Public
Health was adopted in 2001. The declaration recognized the gravity of the
public health problems afflicting world-wide, and forced the requirement for
the TRIPs agreement to be particulate for wider national and international
action to address public health problems.
In October 2020, India and South Africa had approached
the World Trade Organization (WTO) seeking a waiver on intellectual property
rights on Covid-related innovations to enhance access to tests, drugs, and
vaccines.[7]
Thereafter, a revised proposal was submitted in the second half of May. The
revised proposal aims to increase global access to several crucial medical
products to help countries tackle more effectively the contagious virus with
affordable and accessible tools.[8]
India is among 62 World Trade Organization (WTO)
members that are pushing this draft, which limits the waiver period to three
years, with a provision to review the duration. TRIPS waiver will accelerate
scaling up some COVID-19 vaccines where the untapped capacity for vaccine
production still exists, and it may also encourage existing vaccine producers
to step up their technology transfer efforts.
Supporters And
Oppositions To This Draft
Most developing countries have supported the
proposal. The US has also given its weight behind the TRIPS waiver, but only on
the vaccine and not on other medical equipment and medicines.[9]
European Union is also considering the proposal. However, some developed
countries, including Japan and the UK, have opposed the move. Multinational
pharmaceutical companies have also opposed this draft because they fear losing
their market share and revenue earned on vaccines and medicines as well.
However, as the difficult time has passed away
for Majority of the countries, the view over this draft has also tilted around
a lot, such as example I read at that time was: Even Yusuf Hamied of Cipla Ltd,
the daring knight exemplar of generic production, is no longer a challenger.
The man who stunned the world by producing
life-saving drugs at a fraction of the original cost, today dismisses the idea
of Compulsory Licensing’s. Cipla is a spent warrior of the good fight against
exploitative drug majors, having joined the queue for the voluntary license
handouts.
Therefore, my purview over this research problem
would be to consider a long run situation, and keeping up the exemptions of
emergency. Be it pandemic or other virus leaks, sharing of data, and medical
formula should be compulsory under some extent or review of an international
board.
The Stance Of
Compulsory License
The Doha Declaration recognizes the rights of
the developing countries which are members of the WTO to make provisions in
their national legislations for the grant of the compulsory licence to address
the problem of public health. The provisions for grant of compulsory licence
are under Article 31 of the TRIPS Agreement[10].
The developing countries amended their laws for compulsory licensing, based on
the Doha Declaration. India, a major generic drug manufacturer, also amended
its laws for the grant of compulsory licenses taking into account the flexibilities
identified by the Doha Declaration.[11]
Section 92 and 92A of the Indian Patents Act,
1970 are relevant to the compulsory licensing, wherein Section 92 provides that
in circumstances of national emergency or extreme urgency or in case of public
non-commercial use, if the Central Government is satisfied that it is necessary
that compulsory licences should be granted at any time after the sealing
thereof to work the invention, it may a declaration to that effect by
notification in Official Gazette.
Conclusion
Human Rights and
intellectual property rights are two distinct areas of law. These have evolved
separately over the years. The relationship and conflict between the two have
become subject matter of increasing debate. It is the first and foremost duty
of nations to promote and protect human rights. The nations are under an
obligation to provide inter alia the right to food and health to their
people.
At the junction of the
medical sciences, public health, economics, political science, business and law
lies a fascinating crisis facing much of the developing areas of the world. The
question of providing access to essential medications for the third world is a
complex one and faces many barriers to a solution. Diseases like AIDS, malaria,
and tuberculosis have been ravaging the developing world for decades; despite
the efforts of NGO’s, governments, health professionals, lawyers and even major
pharmaceutical companies, a solution to these problems is nowhere in sight.[12]
The effect of patents on
the ability of nations to comply with their obligations under human rights law,
most particularly, the obligation to ensure access to affordable medicines has
been a subject-matter of debate. The balanced approach is highly recommended
for orderly development of society.[13]
Patents are originally
intended to encourage innovators and maximize the greater good and if we want
to help people and make healthcare more affordable, we need an even more rapid
process for approval of generics. Branded pharma companies need to obtain
patent protection for their products to garner investments. Therefore, patents
must be a fundamental incentive to innovative activities in the pharmaceuticals
and biotechnology industry, hence they need to be safeguarded.[14]
Handling HIV-AIDS took
20 years, mainly due to complexities involved in compulsory licensing and
challenging patents associated with drugs concerned with this.
This could not have been
repeated in the case of the COVID pandemic, given the havoc it has wrecked on
life and the economy across the world. All countries and other stakeholders
should collaborate to fight the pandemic and medical emergencies at the
earliest to constraint the unforeseen circumstances
However, the other side
of the coin is that, Patents are originally intended to encourage innovators
and maximize the greater good and if we want to help people and make healthcare
more affordable, we need an even more rapid process for approval of generics.
It is very important for branded pharma companies to obtain patent protection
for their products in order to garner the investments. Therefore, it is
important that patents are a fundamental incentive to innovative activities in
the pharmaceuticals and biotechnology industry, hence it needs to be
safeguarded.
Article Information
PHARMACEUTICAL PATENTING: COVID-19 LESSONS OF TRIPS WAIVER (By-Ashish Jain)
Authors: Ashish Jain
- Journal IJLRA
- ISSN 2582-6433
- Published 2022/09/20
- Volume 2
- Issue 7
About Journal
International Journal for Legal Research and Analysis
- Abbreviation IJLRA
- ISSN 2582-6433
- Access Open Access
- License CC 4.0
All research articles published in International Journal for Legal Research and Analysis are open access and available to read, download and share, subject to proper citation of the original work.
Disclaimer: The opinions expressed in this publication are those of the authors and do not necessarily reflect the views of International Journal for Legal Research and Analysis.