This post is written by Kavya Agrawal a student of Gujrat National Law University, Gandhinagar.
In the wake of this covid-19 pandemic, the countries are facing a lot of scarcity and insufficiency in the supply of a large number of commodities like medicines, sanitizers, PPE’s, diagnostic kits and ventilators. This outbreak has led the whole world to battle for a drug to cure the virus and prevent it’s further community spread. The world health organisation (WHO) has been planning to carry out a clinical trial of vaccine on a huge mass of people. It has been experimented on animals and it has turned out to be pretty effective. The drugs which are to be tested include Remdesivir, Lopinavir,Chloroquine and Hydroxychloroquine. The availability of all these commodities is not only affected by the sealing of the National and International borders but also the patent law under the intellectual property rights. A patent is a right granted to an inventor by the federal government that permits the inventor to exclude others from making, selling or using the invention for a period of time. The patent system is designed to encourage inventions that are unique and useful to society. The existence of this law restricts the manufacturing of these essential commodities in the wake of this pandemic by other companies and hence, almost all the countries today have shifted to the compulsory licensing system.
Compulsory licensing is when a government allows someone else to produce a patented product or process without the consent of the patent owner or plans to use the patent-protected invention itself. In india, this system is read under Chapter XVI of the Indian Patent Act, 1970. There are certain conditions required for the provision of compulsory licensing which are discussed below:
Under section 84, it states that any person can file a request for compulsory licensing from 3 years after grant of patent if any of the following conditions satisfy:
- Requirements of the public aren’t getting fulfilled
- The invention has not worked within the Indian territory
- The invention isn’t available to the public at an affordable price.
Section 92(4)(1), states that the Government of India can grant compulsory license in case of any patent in the case of a National emergency or if it feels that the patent is not being used effectively by the patent company. If the only purpose of granting the license is controlling the emergency, then the license comes to an end as soon as the emergency is in control. Any person who is interested manufacturing the patented products can do so by applying a request for compulsory licensing but should in turn, assure that the products manufactured by them would be available to the public at an affordable price and they would not take any undue advantage of the same.
Section 100 of the Patents Act provides that if the Government is unable to reach an agreement with the patents owner about the royalty that would be paid to them, the matter can be refered to the High Court also. The amount decided should be communicated with the patent owner as early as possible except when there is a national emergency being faced.
India has always been following the concept of compulsory licensing whereas in a number of countries they donot have laws regarding the same as this is a totally new concept for them which has arisen in the wake of this pandemic.
India is currently facing a shortage of Personal Protective Equipment(PPE) kits and has requested the international suppliers to supply the same but there is a lack of PPE kits because of the scarcity of the raw materials for the same. There are many Indian manufacturers involved in the process of making sanitizers as that is one of the most profitable businesses one can think about in today’s time. But unfortunately, counterfeit sanitizers are being produced by them as these people do not have the accurate technical know how and expertise of these drugs. Moreover, the Food and Drugs Administration of Haryana has already busted the manufacturers of counterfeit products. This would be a big issue worldwide and intellectual property rights owners would have to deal with this in order to maintain public interest.
Under the EU law, all the EU member states are automatically granted compulsory license on the condition that they would deliver the manufacture and deliver the medicine to the under developed and the developing nations. There are however certain grounds for obtaining a compulsory license, these are:
Firstly, when there’s a danger to the State and measures have to be taken to protect areas like health, human life, environment etc. Secondly, when the State discovers the the patent owner has been misusing his right to patent by creating a monopoly and overcharging his customers, compulsory licensing may be applied. Thirdly, compulsory licensing can be allowed when the original patent holder can not meet the demands in the market as he has already been held by an earlier patent or whatsoever reason.
Under the U.S. Law, compulsory licensing is granted to people if the patent was federally funded and the owner of the patent does not take into consideration the health and safety of the society, does not take effective steps for practical application of his patent and does not meet the essential public requirements as stated by the federal regulations. Compulsory licensing provides an incentive to the institutes that are involved in research, such as Big Pharma about Covid-19 as they can now develop an effective vaccine against covid-19 without the fear of infringement of any patent rights.
The whole world is going on to survive this pandemic and the governments are putting all their efforts to come with a vaccine at it’s earliest and compulsory licensing is one of the best ways to overcome this situation.