IP Laws and COVID-19 Vaccine

Synopsis:

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 yet.

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” for developing 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” regulations 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 role.

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:

I) 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.

II) 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 health.
• Diagnostic, therapeutic and surgical methods for the treatment of humans or animals
• 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 license.

• 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 anti-competitive practices.

• 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 witnessing tomorrow.

Conclusion:

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 that health

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!