By Ananya Singh
The patent regime in India ensures protection for certain inventions and as an implicit rule, also grants certain exclusive rights and privileges to the patentee with respect to his invention. This protection vests monopoly rights in the creator to use, manufacture, and sell his invention. The same provisions extend to pharmaceutical products as well. However, compulsory licensing in the pharmaceutical sector involves an important aspect of health concern.
Compulsory licenses are sovereign state authorizations which enable a third party to make, use, or sell a patented product without the consent of the patent holder.[1] They are an essential government instrument used to intervene in the market and limit patent and other intellectual property rights in order to correct market failures. They permit the generic companies to manufacture the generic version of patented drug, ensuring that exclusive patent rights do not hinder access to medicines by the countries in need.[2]
The WTO’s Agreement on Trade Related Aspects of Intellectual Property Rights [“TRIPS”] sets out the framework for national laws on use of patented inventions without the authorization of the patent owner under Article 31. Though compulsory licensing has not been formally and explicitly defined, it is implicit and flows from the phrase other use without authorization of the right holder. Some circumstances under which a compulsory license may be granted include: national emergencies, other circumstances of extreme urgency, public non-commercial use or anti-competitive practices[3]. It also abstains from seeking a voluntary license under these circumstances before seeking a compulsory license. This exception has also been endorsed by the Doha Declaration on TRIPs and Public Health.
In India, Chapter XVI of the Indian Patent Act, 1970 deals with compulsory licensing while the conditions which need to be fulfilled for the grant of a compulsory license are laid down under Sections 84 to 92 of the Act.
Coronavirus [“COVID-19”] is now over 210 countries with reported cases of more than two million and around 150 thousand deaths that are mounting day by day.[4] The World Health Organisation [“WHO”] has declared COVID-19 as a pandemic. Currently, there is no vaccine for COVID-19. Some of the products that are currently being tested are older products that were originally developed for other infections, cheap to produce, indicating that a lower price is possible. However, if a company has a monopoly on the use of the medicines for COVID-19, the market position rather than production costs will determine the price.[5]
The WHO has published a landscape of therapeutics that could be used for treating COVID-19, and some of them are undergoing clinical trials as well.[6] A few molecules that have undergone trial are under patent protection. In a time when the world is suffering from a health crisis, it has become essential that countries issue compulsory licenses to facilitate compassionate use and generic production of such medicines.
Given the seriousness of the current health crisis, few countries have relaxed their patent law barriers. For instance, the Government of Israel has issued a permit,[7]which allows the State to import a generic version of AbbVie’s Kaletra from India for the treatment of coronavirus patients. This has been done by invoking Section 104 and Section 105 of the Israeli Patents Law, 1967 under which, the State can circumvent the law in the interests of the National security or for the maintenance of essential supplies and services.[8] The backdrop behind such a step was the concerns that AbbVie would not be able to supply Israel with sufficient quantities of the drug.
Similarly, in the interest of public welfare, countries like Canada and Germany have made amendments to their patent laws- Bill C-13, the COVID-19 Emergency Response Act[9] and Prevention and Control of Infectious Diseases in Humans Act[10],respectively to facilitate the quick issuance of compulsory licenses by avoiding prior negotiation with rights holders or establishing one’s own ability to supply the product. Along similar lines, Chile and Ecuador have also passed resolutions to allow the government to sidestep patents related to COVID-19 medical technologies.[11]
Very recently, the WHO had launched a mega trial, ‘SOLIDARITY’[12], of four promising drugs and their combinations -an experimental antiviral compound called Remdesivir; the malaria medications chloroquine and hydroxychloroquine; a combination of two HIV drugs, lopinavir and ritonavir; and that same combination plus interferon-beta, an immune system messenger that can help cripple viruses to cure COVID-19 pandemic.[13]
The pandemic has led to revival of Remdesivir drug that was widely used to combat Ebola virus in the Democratic Republic of the Congo. The drug is developed and patented by the US pharmaceutical giant, Gilead Science which is infamous for charging high price for it. The drug was granted patent protection in India in 2020 that will expire only in 2035.
Under the Indian Patent Act, any interested person can apply to the Controller to seek a compulsory license citing any one of the following three grounds: unmet reasonable public demands, excessive price or lack of local manufacturing.[14] However, this option is not available for Remdesivir drug because application for a compulsory license can be granted only after three years from the date of grant of patent.[15]
Similarly, another drug Favipiravir, developed by the Fujifilm Toyama Chemical corporation, is already a part of five patents in India out of which one has expired. The drug can reportedly treat RNA viruses like SARS-CoV2.[16] In the case of Favipiravir, a compulsory license application can be made under section 84 of Indian Patents Act, after failure to obtain a voluntary license within a reasonable period which should not exceed six months. But considering the pandemic outbreak, this is a long period. Further, this process involves a requirement of hearing of the patent holder which can further delay the issuance of the license.
However, under section 92, the Central Government can make a declaration for issuing compulsory license provided there is a national emergency or a situation of extreme urgency.[17] Moreover, under section 92A, the Controller General of Patents may grant a compulsory licence solely for manufacture and export of the concerned pharmaceutical product to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, provided a compulsory licence has been granted by such country or it has allowed importation of the patented pharmaceutical products from India.[18]
The generic availability of these medicines can facilitate compassionate use and clinical trials in India without depending on supply from the patent holders.[19] COVID-19 has created a global health emergency and the Indian Government should ensure that the right of the people to have access to medicines and public health is secure. Further, international cooperation has become essential to subdue the increasing detrimental impact of the deadly virus. A rapid global cooperation can be built by increasing the production and distribution of such drugs that can provide promising remedies. Moreover, by using global supply chains, pooling resources and equipment, they can be allocated as the need for them shifts from one country to another.[20]Therefore, it has become essential for the Indian Government to exercise its well- established right of compulsory licensing to provide access to such medicines.
The history of patent laws in India, as well as other countries, shows that ‘public interest’ covers a wide ambit of national interests and social welfare. The institutions of compulsory licensing have developed under the influence of various philosophies, one of which is that the government should intervene in certain situations of extreme emergencies for the sake of public health and welfare.[21]
The author is a third year student, currently pursuing their law degree from the National Law University, Jodhpur.
[1] Dr. B.L. Wadhera, Law relating to Intellectual Property (5th ed. 2019); Dr. Sheetal Chopra, Indian Patenting System and Patent Agent Examination 217 (1st ed. 2018).
[2] Bayer Corporation v. Union of India, 2014 SCC OnLine SC 1709.
[3] Trade Related Aspects of Intellectual Property Rights art,31, Apr. 15, 1994, 1869 U.N.T.S. 299.
[4] Worldometer, COIVD-19 CORONAVIRUS PANDEMIC (Mar. 23, 2020), https://www.worldometers.info/coronavirus/?utm_campaign=CSauthorbio?.
[5] Ellen ‘t Hoen , COVID-19 and the comeback of compulsory licensing, MEDIcINES, LAW & POLICY (Mar.23, 2020)https://medicineslawandpolicy.org/2020/03/covid-19-and-the-come-back-of-compulsory-licensing/.
[6] Landscape analysis of therapeutics, WORLD HEALTH ORGANISATION, (Mar. 17, 2020), https://www.who.int/blueprint/priority-diseases/key-action/Table_of_therapeutics_Appendix_17022020.pdf.
[7]Thiru, Israel issues compulsory license to allow the government to import generic versions of Kaletra, Knowledge Ecology International (Mar. 23, 2020), https://www.keionline.org/32503.
[8] State of Israel Patents Law, 5727-1967, §104, §105.
[9] Bill C13, Statutes of Canada, Parliament of Canada, https://www.parl.ca/DocumentViewer/en/43-1/bill/C-13/royal-assent?_sm_au_=iVVvns5WHQ11sMDPvMFckK0232C0F (last visited Apr. 5, 2020).
[10]Act to Prevent and Control Infectious Diseases in Humans (Infection Protection Act – IfSG),2000
https://www.gesetze-im-internet.de/ifsg/index.html?_sm_au_=iVVvns5WHQ11sMDPvMFckK0232C0F(last visited Apr. 5, 2020).
[11]Adam Houldsworth, The key covid-19 compulsory licensing developments so far, IAM,(Apr. 07,2020), https://www.iam-media.com/coronavirus/the-key-covid-19-compulsory-licensing-developments-so-far
ED Silverman, Ecuador becomes the latest country to eye compulsory licensing for Covid-19 products website, STAT (Mar. 23,2020), https://www.statnews.com/pharmalot/2020/03/23/ecuador-compulsory-licensing-covid19-coronavirus/.
[12] “Solidarity” clinical trial for COVID-19 treatments, World Health Organisation, (Mar. 26, 2020), https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments.
[13] Kai Kupferschmidt & Jon Cohen Mar , WHO launches global megatrial of the four most promising coronavirus treatments, SCIENCE (Mar. 22, 2020),
[14] The Patents Act, No. 39 of 1970, § 84 (India).
[15] Id.
[16] K.M. Gopakumar & Prathibha Sivasubramanian, Drugs That Could Be Used to Beat COVID-19 Have Another Barrier – Patents, THE WIRE, (Mar.29, 2020), https://thewire.in/law/remdesivir-favipravir-covid-19-patents-indian-patents-act-ustr.
[17] The Patents Act, No. 39 of 1970, §92 (India).
[18] The Patents Act, No. 39 of 1970, § 92A (India).
[19] Supra note xv.
[20] Ngaire Woods, There is only one option for a global coronavirus exit strategy, world economic forum, (Apr.11, 2020), https://www.weforum.org/agenda/2020/04/there-s-only-one-option-for-a-global-coronavirus-exit-strategy.
[21] Hiroko Yamane, Interpreting TRIPS- Globalization of Intellectual Property Rights and Access to Medicine 212 (1st ed. 2011).
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