Compulsory Licensing and Treatment to Covid-19

In the current scenario the race to find treatments and ultimately a vaccine for COVID-19 intensifies. During such pandemic where the whole world whether developing countries or developed countries, both need a proper vaccine to get over with such wide destruction. But there arises a need of proper policies by which the drugs are affordable and available to everyone. The WHO recently announced a large multi-country clinical trial to test drugs for the treatment of Covid-19. The drugs to be tested include Remdesivir, Lopinavir and Ritonavir in combination; Lopinavir/Ritonavir plus interferon-beta; and Chloroquine and Hydroxychloroquine. All are known medicines originally developed for other indications. The products have shown some efficacy in laboratory and animal experiments but unless a large human trial is carried out it is not possible to make an evidence-based recommendation and authorized about their use in the treatment of Covid-19. WHO have send them for Solidarity trial?

It has to be noted that one of the products that will be tested in the trial is Remdesivir, a Gilead product originally developed for other viral infections, including Ebola and the Marburg virus. Recently USA made it an Orphan Drug under the Orphan Drug Act, 1983 in order to give benefits to their Drug Manufacturers and help Patent system in the Intellectual Property Regime in USA. Remdesivir is widely patented, including in countries that have large scale production capacity for medicines such as India and China.

In order to deal with the situation, it is recommended that Compulsory Licensing should be provided to Indian Pharmaceutical Companies by the Indian Government if the Solidarity Trial by WHO shows some successful response.

What is Compulsory Licensing?

Compulsory Licensing authorizes a third party to produce patented product without approval from the patent holder. The product can be used by any government in dealing public health emergency or national emergency by bringing down cost of essential drug by producing generic drug. It is a legal measure that can be utilised by governments to suspend patents on a product in times of emergency or in the public interest. Therefore, it is a possible mechanism to obtain equal and affordable access to COVID-19 treatment worldwide.

As per Section 84 of Indian Patent Act,1970 any person regardless of whether he is the holder of the license of the patent can make a request to the controller for grant of compulsory license on expiry of 3 years, when any of the following conditions is fulfilled:

(1) The reasonable requirement of the public with respect to the patented invention have not
been satisfies.

(2) The patented invention is not available to the public at reasonably affordable price.

(3) The patented invention is not worked in territory of India

Further compulsory licensing can also be issued suo moto by the controller under Section 92, pursuant to a notification issued by the Central Government if there is either – “National emergency of extreme urgency or in cases of public noncommercial use”

Conclusion

It is the need of the hour that Indian Government take some positive steps in order to make the vaccine available and affordable, also the domestic manufacturers are kept in view The battle against worldwide manufacturers would also become a big issue that Intellectual Property Rights owners will have to deal with, not just for commercial interests, but also in public interest.

Authored by: Aman Durga