This article is written by Vikash Dhaka who is pursuing a Diploma in Intellectual Property, Media and Entertainment Laws from LawSikho.
Table of Contents
Introduction
Covaxin is a vaccine developed by Bharat Biotech in collaboration with the National Institute of Virology (NIV). NIV is one of the major institutes of the Indian Council of Medical Research (ICMR).
When a government or its institution is sponsoring any project, the ownership rights in the product rests with the concerned ministry as per Rule 233(i) of General Finance Rule, 2017. When it comes to Covaxin, it is unclear or vague, when it comes to owning the rights in the project. Bharat Biotech is a private company and NIV is part of the government institution ICMR. Since it is the collaboration of private and public institutions, we can conclude that the government can retain some IP rights.
But there is a deal between Bharat Biotech and an American Pharmaceutical Company over the development of Covaxin for US citizens. This shows that Bharat Biotech possesses the requisite IP rights in the Covaxin.
Patent Right as a Barrier?
Since the Covid vaccine is the need of the hour, the government is active in removing the patent right barrier, making the information in making vaccines in the public domain. The government can remove the patent barrier if it is the funding party or it is one of its institutions. But when it comes to a private company, the Government didn’t have any right to remove the patent barrier. But section 157A of the Patents Act, 1970 empowers the government to remove the patent rights in any sector whether it is public or private.
Since India favors waiving of Intellectual property rights in Covid Vaccines but many countries including the US are against the same. The alternate solution will be compulsory licensing under Article 31 of TRIPS. But according to the TRIPS agreement, for acquiring the license an adequate amount for the same hast to be paid. But the term ‘adequate’ is not defined under TRIPS. So, the parties will indulge in negotiation and conclude the price. The negotiation process is quite time-consuming and the world is already facing a pandemic. This can’t be a prudent alternative. When there will be a licensing scenario, the quantities of covid vaccines will be defined, the party will have a limited number of vaccines which prohibit mass production of the vaccine.
Many pharmaceutical companies are against the waiving of IP rights on covid vaccines because they want to be compensated for the amount that they have invested in the development and research of the vaccine. But when it comes to Covaxin, it involves government agencies, there is funding by the government. There are more chances of waiving the IP rights in the Covaxin. Since India has asked to waive intellectual property rights at the international level under Article 73 of TRIPS. It is reasonably presumed that India will waive IP rights on Covaxin.
In case, India waives the IP rights in Covaxin, a large amount of money has to be paid to Bharat Biotech for its contribution in making the vaccine. Indian economy is still in the state of revival because of the impact of covid, how will the government be able to pay such a hefty amount to the Company, and from where the funds will come. This needs to be answered. Apart from the funds received by selling the Covaxin to common people, a large amount of revenue is generated because of licensing the IP rights of Covaxin to any other pharmaceutical company. This whole revenue will vanish if the government waives the IP rights in Covaxin.
If the government waives the IP rights in Covaxin, the other contemporary competitors will leave no chance of copying the process of Covaxin and selling the same in the market at a hefty price. Since Covid is a pandemic, there is a huge market for the covid vaccine at the international level. The competitors will sell their vaccines at their price and earn an exceptional profit for the same. The government will be staking or jeopardizing the hard work of NIV and Bharat Biotech if it waives the IP rights in Covaxin. There are great possibilities of misusing the IP rights in Covaxin if the same is removed.
Know-How Disclosure
Since we live in a democracy and we have fundamental rights. One of the fundamental rights is the right to life with dignity. If tomorrow’s vaccine is made by a private company, only rich people can afford the same. So, the state must provide a good health facility and environment, for that they have to provide the vaccine. Trade Secrets are protected under contract law in India. In absence of the contract, it is protected under an equitable duty of confidence. If the government removes the protection of trade secrets or know-how disclosure, the government companies or other private companies can manufacture the same. This will result in more production of the vaccine which is the need of the hour. However, many pharmaceutical companies are bent on not sharing their trade secrets because of financial and competitive reasons. Even the manufacturing units don’t disclose the information fearing the relations with the respected company may hamper.
So, the government can put aside the protection of the IP rights of Covaxin during this pandemic to reach large masses but such waiving will not help unless the company voluntarily shares the trade secrets.
Clinical Trials of Covaxin
The Covid Vaccine Covaxin was approved in a clinical trial before the third phase’s data and evidence has been taken into consideration. This is because of the emergency and need of the hour.
There were many applications filed under RTI asking for the data, evidence, and other information related to Covaxin’s emergency approval. Many applications were rejected on the ground that it will hamper the commercial exploitation of Bharat Biotech. Section8(1)(d) of Right to Information Act, 2005 exempts sharing the information concerning Intellectual property rights associated with trade secrets or any commercial benefit attached to the same, to the citizens of India.
Whenever any new drug is produced or formed, the clinical trial will take place and all the data of the trial will be shared with the Drug Controller’s office by the virtue of section 122D of the Drugs and Cosmetic Act, 1945. The approval of any vaccine takes place in three-phase. The first phase involves testing off the drug on the 20-100 human beings. The second phase involves the testing of the drug on 300 human beings observing the side effects and effectiveness and finally, in the third stage, drugs are given to different medical centers to know the benefits attached to the same.
This humongous data is given to the office of the Drug Controller. These data help them to analyze, evaluate the risk and benefit attached to the manufacturing of the drugs. The company incurs a lot of expenses for collecting the data and the same is recouped by claiming the patent protection and protection on Clinical trial data.
By Article 39(3) of TRIPS, the tested data is protected against unfair commercial use. So, India is under an obligation to follow the same. But for non-commercial purposes, the clinical data can be shared as stated under section 47 of the Patent Act. Many researchers may need data for their research. So, the government can reveal the data without infringing on the TRIPS agreement.
Conclusion
Covaxin is a vaccine developed by the Bharat Biotech in collaboration with the National Institute of Virology to fight against the Covid. Since Bharat Biotech is a private pharmaceutical company and the National Institute of Virology being a government institute, it is not clear yet who owns the IP rights in Covaxin. Generally, the government sponsor projects are owned by the government only but the amalgamation is of private and public companies, the government will not have all rights. Bharat Biotech has made a deal with one of the American Pharmaceutical Company for the production of Covaxin for US citizens. This shows that Bharat Biotech has requisite IP rights.
I strongly believe that the government should not waive the IP rights in Covaxin rather the government can sell the vaccine to the people of India at a very cheap or meager rate. The government can provide Covaxin free of cost to the poor people of the country. Since the government is also the party in the making of Covaxin, the government can convince Bharat Biotech to give some concessions while licensing the IP rights of Covaxin to other Pharmaceutical Companies. Such licensing will boost the production of Covaxin and meet the demands of today.
References
2 https://health.economictimes.indiatimes.com/
3 https://m.economictimes.com/
4 http://www.legalserviceindia.com/
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