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Compulsory Licensing: The Way Forward in the Battle Against COVID-19

Written by Aditya Maheshwari [i] and Harshita Sharma [ii]

[i] Second Year, National Law University, Jodhpur [ii] Second Year, Dr. Ram Manohar Lohiya National Law University, Lucknow



Disclaimer: Please note that the views expressed below represent the opinions of the article's author. The following does not necessarily represent the views of Law & Order.


Introduction

COVID-19 is creating havoc across the world and still with the state-of-the-art Research & Technology (R&D), the search for a perfect drug to combat and cure COVID-19 is at full tilt.

The World Health Organization (WHO) to find a cure to this virus declared a worldwide clinical trial to test drugs that have shown some positive results in preliminary research.[1] 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.[2]

Though the shutdown of the physical boundaries of the international border has posed a big and challenging encounter to this problem, it is not the only barrier to the faster development of a vaccine. The other major challenge is the patent regime and the patent laws prevailing in various countries.

The counter to this issue of patent law is Compulsory Licensing.

What is compulsory licensing?

Compulsory licenses are authorizations by a sovereign state that allow a third party to manufacture, use, sell and/or distribute a product which has been patented, without obtaining consent or explicit permission/license of the patent owner. [3]


The provisions relating to compulsory licensing are administered by WTO among all the member countries via an international agreement called Trade-Related Aspects of Intellectual Property Rights (TRIPS).

In India, Chapter XVI of the Indian Patent Act, 1970 deals with Compulsory Licensing and conditions for the same are enlisted under Sections 84 and 92 of the Patent Act.

Section 84 provides 3 grounds for a grant of a compulsory licensing. Any person can make an application for a license after three years from the date of grant of that patent on grounds as stated: [4]

a) The reasonable requirements of the public with respect to the patented invention have not been satisfied.

b) The patented invention is not available to the public at a reasonably affordable price.

c) The patented invention has not worked in the territory of India.

But in the present situation, the applicability of Section 84 is not of much relevance and the Government of India should have the onus to bring in these licenses to favor and protect the needs of the citizens.

Section 92(1)[4] of the Act talks about circumstances wherein a situation of National Emergency, extreme urgency, or public non-commercial use, the Government of India if satisfied, may grant Compulsory Licenses in respect of any patent in force. [5]

Upon such stagnation in the nation, any interested person can apply for a compulsory license to the controller, which needs to be granted without any protracted process.[6] However, the patentee cannot be left at a disadvantage due to these compulsory licenses and has to balance out the things. Also, the articles manufactured under these licensed patents should be available to the public at the lowest prices to achieve the purpose behind them.[7]

Apart from these provisions, Section 100[5] of the Act allows the Central government to authorize specific companies to use any patents or any pending application for the same for the “purpose of government.”[8]

The only condition that these authorized companies have to comply with is to negotiate with the patent owners for royalties. In case of any discrepancy where the central government or the authorized company fails to reach a consensus in regard to the fixation of royalty then under Section 100[3] of the Patents Act, a reference to the High Court, under Section 100[6], may be made to fix a royalty which is reasonable for the patent owner as well as the court.

The Centre is under an obligation to inform the patent owner about the same, the only exception being in the case of national Emergency, in circumstances of extreme urgency, or in case of public non-commercial use.

Finally, the central government is endowed with the power under Section 102 of the Patent Act, to take over the patents in question along with their stockpile. Upon the notification in the gazette about the same the rights are transferred to the center.

The worldwide wave of compulsory licensing

In the wake of the pandemic, many countries around the world have resorted to the mechanism of compulsory licensing in this emergency situation.

Israel, on March 19, 2020, issued compulsory licenses related to Lopinavir/Ritonavir (brand name Kaletra), a medicine used to treat HIV, which as mentioned above, is currently being tested for effectiveness in the treatment of COVID-19 in combination with other drugs. The license allows for the importation of lopinavir/ritonavir from a generic company.[9]

On March 25, 2020, Canada assented to the COVIS-19 Emergency Response Act, which brings an amendment in the patents act about providing a new compulsory licensing regime.[10]

Apart from these, Chile and Germany have also made changes to their existing systems to facilitate the quick issuance of compulsory licenses.[11]

Situation in India

Remdesivir and Favipiravir- these are the two medicines that are proving very essential in the treatment of COVID-19 and are still under patent protection in India.[12] The generic availability of these medicines can facilitate tender use which also ensures that clinical trials in India can go on without depending on supply from the patent holders. Remdesivir is a broad-spectrum antiviral drug that can be effective even when a person is in the initial stage of infection.

Conclusion

After looking at this barrier of Patent Law, it can be concluded that the means and the way ahead is through the means of Compulsory Licensing. As we can see from this article that there are provisions in the Patent Act that have been amended to be in compliance with WTO’s TRIPS agreement to grant patents to the pharmaceutical sector. The world is further making changes to their patent laws to ensure that this provision of Compulsory Licensing is present in their respective national patent laws there.

Thus, to ensure a win against this pandemic, compulsory licensing is a weapon that cannot be ignored to counter the high prices of essential drugs.






[1] Kai Kupferschmidt, Jon Cohen, WHO launches global megatrial of the four most promising coronavirus treatments, American Association for the Advancement of Science, https://www.sciencemag.org/news/2020/03/who-launches-global-megatrial-four-most-promising-coronavirus-treatments. [2] Id. [3] Dhruv Nayar, Compulsory Licensing during a pandemic: Patent Law and COVID-19, Law & policy columns- Bar and bench, https://www.barandbench.com/columns/policy-columns/compulsory-licensing-at-the-time-of-pandemic-patent-law-and-covid-19. [4] Indian Patent Act, 1970. [5] Id. [6] Chapter XVI of the Indian Patent Act, 1970. [7] Rahul Chaudhary, Dealing with compulsory licensing in India, World Trademark Review, https://www.worldtrademarkreview.com/dealing-compulsory-licensing-india. [8] Section 100 in The Patents Act, 1970. [9] Supra note 2. [10] Powell & Paul E., CIPO Pandemic Response and Canada's New Compulsory, Dickinson Wright, https://www.dickinson-wright.com/news-alerts/cipo-pandemic-response. [11] K.M Gopakumar, Drugs That Could Be Used To Beat COVID-19 Have Another Barrier – Patents, The Wire, https://thewire.in/law/remdesivir-favipravir-covid-19-patents-indian-patents-act-ustr. [12] Id.


BIBLIOGRAPHY


Statutes

  1. Indian Patents Act, 1970.

Articles

1. Kai Kupferschmidt, Jon Cohen, WHO launches global megatrial of the four most promising coronavirus treatments, American Association for the Advancement of Science, https://www.sciencemag.org/news/2020/03/who-launches-global-megatrial-four-most-promising-coronavirus-treatments.

2. Dhruv Nayar, Compulsory Licensing during a pandemic: Patent Law and COVID-19, Law & policy columns- Bar and bench, https://www.barandbench.com/columns/policy-columns/compulsory-licensing-at-the-time-of-pandemic-patent-law-and-covid-19

3. Rahul Chaudhary, Dealing with compulsory licensing in India, World Trademark Review, https://www.worldtrademarkreview.com/dealing-compulsory-licensing-india.

4. Powell & Paul E., CIPO Pandemic Response and Canada's New Compulsory, Dickinson Wright, https://www.dickinson-wright.com/news-alerts/cipo-pandemic-response.

5. K.M Gopakumar, Drugs That Could Be Used To Beat COVID-19 Have Another Barrier – Patents, The Wire, https://thewire.in/law/remdesivir-favipravir-covid-19-patents-indian-patents-act-ustr.

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