The paper talks about Intellectual Property Laws and takes into account the
Coronavirus Vaccine in the same regard. The paper also discusses about
Organizations which protect and safeguard intellectual property rights. One such
is the TRIPS Agreement.
The pharmaceutical inventions which must be patented, rights of the patent
owner, term of the patent, its limitations/exceptions have also been talked
about in the paper. The paper aims to provide information regarding
complications and measures of the patent right of the pharmaceutical drugs, one
such would be coronavirus vaccine, which is the need of the hour.
The reason for the lack of access to essential medicines are manifold, but in
many cases the higher price of drugs are a barrier to needed treatments.
Prohibitive drug prices are often the result of strong intellectual property
protection. Governments in developing countries that attempt to bring the price
of medicines down have come under pressure from the industrialized countries and
the multinational pharmaceutical industry.
The World Trade Organization (WTO) Trade-Related Aspects of Intellectual
Property Rights Agreement (TRIPS) sets out the minimum standards for the
protection of intellectual property, including patents for pharmaceuticals.
TRIPS offers safeguard to remedy negative effects of patent protection or patent
abuse, but in practice it is unclear whether and how countries can make use of
these safeguards when patents increase barriers to medicine access.
Taking into account the current pandemic situation the world is facing due to
the spread of Coronavirus which emerged in Wuhan, China in the mid December of
2019, the need of easy access to the vaccine is a must. A lot of countries are
doing heavy research for production of the vaccine and a few are on their third
trials, the confirm news for the arrival of the vaccine has not been received
India and South Africa have jointly presented an ambitious proposal to the
Geneva-based WTO that seeks relaxation for intellectual property, patents and
other such provisions for coronavirus medicines and vaccines. These provisions
are laid out under the Agreement of TRIPS, that came into effect in January
1995. The decision to make the joint submission was taken with the objective of
making Covid-19 drugs affordable as well as accessible
and least-developed countries or LDCs.
The idea, they added, is to ensure that Covid-19 drugs and vaccines, once
available in the market, should not come under unnecessary
and delay their procurement. Under the joint submission, India has sought
removal, or waiver, of Section 1,4,5 and 7 of Part II of the TRIPS Agreement
that pertain to copyright, industrial designs, patents and protection of
undisclosed information or trade secrets, for drugs and vaccines amid Covid-19.
The countries have also proposed that the waiver should continue till such time
that the Covid-19 medicines and vaccines are available easily and in the mass
market. Considering the WTO norms, a proposal can be passed only if it is
accepted by all 164-member countries. This is not going be any easy task, but
has to be done quickly as it cannot be dragged on for a long period, because we
are talking about a pandemic here and it needs immediate redressal.
There is a very high chance that the vaccine and medicines once released, which
are going to be vital for survival of millions are going to cost a fortune and
would not be accessible to the vast majority of people in poor countries. A lot
of rich nations that are able to spend on research and development of drugs
would choose to sell it at higher prices in the world market, and will try to
create a sort of monopoly, whereas research and development towards the health
needs has come to a standstill in poor countries.
Developing countries, where three-quarters of the world population lives,
account for less than 10% of the global pharmaceutical market. If the joint
proposal is not approved the world will surely be seeing a rat race among the
rich nations for securing monopoly of the drugs and vaccine, thereby earning
huge profits. The Intellectual Property Rights would here play an major major
Intellectual Property is basically an intangible property which refers to
inventions, innovative designs, products of human creativity, identifiers or
organizations or their products and services or some unique products that have a
geographical attribute. Intellectual Property Rights are those rights which are
given to persons for creations of their minds. They give exclusive rights to the
creators over the use of his/her creation for a certain period of time. IPR is
not just a right which excludes others from using, selling or producing the
protected asset, it is designated to provide the holder with the right to assign
or license the rights for commercial or other bonafide uses.
TRIPS, is one such organization which was established in 1995 to set out minimum
standards and requirements for the protection of intellectual property rights,
including trademarks, copyrights, and patents. Drugs, medicines or vaccines all
are a form of intellectual property, which need to be protected. The companies
producing these drugs own rights over the procedure of the drug production, the
components and their measures used while producing the drug, their clinic trials
and a lot more.
Organizations like WTO TRIPS protect and safeguard such rights. But again there
are a few concerns, which cannot be ignored. Medicins sans Frontieres (MSF),
together with other non-governmental organizations (NGOs), formulated the
following concerns related to TRIPS:
- Increased patent protection leads to higher drug prices. The number of
essential drugs would increase, but the drugs will remain out of reach of
the people in the developing countries, as the prices would be high,
widening the access gap between developed and developing countries.
- Enforcement of WTO rules will have a negative effect on local manufacturing
capacity and will remove a source of generic, innovative, quality drugs on which
developing nations depend.
It is quite uncertain whether or not TRIPS will encourage adequate R&D in
developing countries, as poor countries often do not provide sufficient profit
potential to motivate R&D investment by the pharmaceutical industry. They are
mostly under pressure from industrialized countries and the industry to
implement patent legislation that goes beyond the obligation of TRIPS.
To set this discussion in context, we need to have a look on certain important
aspects of the TRIPS Agreement.
Pharmaceutical Inventions which must be patented under the TRIPS Agreement:
Patents are available for all the inventions, whether a product or process, in
all fields of technology without discrimination, where those inventions meet the
standard substantive criteria for patent-ability; namely, novelty, inventive
step and industrial applicability. In addition, members are required to grant a
patent dependent on adequate disclosure of the invention and may require
information on the best mode for carrying it out.
Disclosure is a key part of
the social contract as it makes publicly available important technical
information which may be of use to others in advancing technology in the area,
even during the patent term, and ensures that, after the expiry of the patent
term, the invention truly falls into the public domain because others have the
necessary information to carry it out.
To the above rules on patentable subject-matter, three exclusions are allowed.
Considering public health perspective these may be of interest.
Invention whose prevention for commercial exploitation is necessary to protect
ordre public or morality, including the protection of animal or plant life or
Diagnostic, therapeutic and surgical methods for the treatment of humans or
Certain plant and animal inventions.
Rights conferred by a patent under the TRIPS Agreement:
The minimum rights conferred by the TRIPS Agreement are mostly those which are
found in most patent laws, namely the right of patent owner to prevent
unauthorized persons from using the patented process and making, using, offering
for sale, or importing the patented product or a product obtained directly by
the patented process.
Term of Protection:
Under the TRIPS Agreement, the available term of protection must not expire
prior to completion of 20 years from the date of filing the patent application.
Although the issue of patent term extension to compensate for regulatory delays
in the marketing of new pharmaceutical products was raised in the Uruguay Round
negotiations, the TRIPS Agreement does not contain an obligation to introduce
such a system.
Limitations or Exceptions to these rights:
Under the TRIPS Agreement Patent rights are no absolute but subject to certain
limitations and exceptions. They can be basically put into 4 categories.
The Agreement allows limited exceptions to made by members provided that such
exceptions do not unreasonably prejudice the legitimate interests of the patent
owner, taking account of the legitimate interests of the third parties.
The Agreement also allows members to authorize use by third parties (compulsory
licenses) or for public non-commercial purposes (government use) without the
authorization of the patent owner. Unlike what was sought by some countries in
the negotiations, the grounds on which this can be done are not limited by the
agreement, but the agreement contains a number of conditions that have to met in
order to safeguard the legitimate interests of the patent owner.
Two of the main such conditions are; an effort must first have been made to
obtain a voluntary license on reasonable commercial terms and conditions and
that the remuneration paid to the right holder shall be adequate in the
circumstances of each case, taking into account the economic value of the
The Agreement recognizes the right of Members to take measures, consistent with
its provisions, against anti-competitive practices and provides more flexible
conditions for the grant of compulsory licenses where a practice has been
determined after due process of law to be anti-competitive. It also provides for
consultation and cooperation between members in taking action against
The TRIPS Agreement makes it clear that the practices of WTO Members in regard
to the exhaustion of intellectual property rights cannot be challenged under the
WTO dispute settlement system, provided that they do not discriminate on the
grounds of the nationality of right holders.
After reading this we have got a rough idea of who complicated the situation is
for the Covid-19 vaccine even when it is not yet found. After its release the
story is going to different. What we are discussing today probably would be
The very fact that public health and access to medicines have been singled out
as a major issues needing special attention in TRIPS implementation indicates
Care and health care products need to treated differently from other products.
The need of greater transparency in the pricing of the medicines and vaccines
has also increased.
The pharmaceuticals need to be able to argue for the value of the products they
bring to the market. There are measures the countries can take in this context
and regarding the rise of prices of the drugs and vaccines. Ten years ago access
to medicine was an issue exclusively for the developing countries but that is no
longer the case. Today, many high-income countries can't afford the medicines
they need and are even rationing certain medicines on the World Health
Organization's Essential Medicines List. Clearly something needs to be done. In
this Pandemic situation we have all seen the situation.
Almost all the major countries are struggling for the vaccine for coronavirus
and non has successfully emerged yet. Hoping after the release of the vaccine
all the countries have an equal access to it, whether developed. Developing or
least developed countries, without any discrimination!