Analysis of Compulsory Licensing in India and its Perceived Impact During the Covid Era
Compulsory licensing can be defined as a mechanism which would enable the State to use the invention without the prior consent from the inventor or the patent right holder. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement provides provisions for patenting of drugs, it also provides certain provisions for compulsory licensing mechanism, to keep a check on the possible abuse of patent rights. There has been an imbalance between profits and drug accessibility to people throughout the world, including India. The Indian patent regime has changed drastically since the landmark Judgment of Bayer v. Natco , it was evident that the judicial approach upheld the public interest and ensured that the pharmaceutical companies do not abuse their position. Granting patent security to pharmaceuticals particularly fundamental medications has dependably been a challenged one. Further, the subsequent judgements on the said subject matter has created confusion as far as the stance of compulsory licensing standards in India are concerned. The inborn tussle between profit driven medication organizations and welfare arranged governments trying to guarantee less expensive access to fundamental prescriptions has as often as possible involved the worldwide attention. The Covid 19 pandemic has disrupted many lives all over the world, but since the invention of numerous vaccines, there has been a ray of hope to cure the virus at a large scale. However, the governments and the pharma companies need to have an agreement in order to provide vaccine and healthcare to vast majority of population. Thus, the compulsory licensing route is being explored by various governments in order to provide healthcare, this paper aims to explore the fundamentals of compulsory licensing in India and its possible application in the Covid 19 scenario.
TRIPS: Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994)
Supra note 1
World Trade Organization, Ministerial Declaration of 14 November 2001, WTO Doc. WT/MIN(01)/DEC/1, 41 ILM 746 (2002)
Supra note 1
Indian Patents Act, 1970 § 84, No 39, Acts of Parliament, 1970 (India).
Dewan M, Compulsory license revisited-India, RK Dewan & Co, 10 September 2014, http://www.lexology.com/library/ detail.aspx?g=fc41db30-6793-4f92-90ae-a0bb82e6fdaa, (accessed on 27 October 2020).
Bayer Corporation v. Natco Pharma Ltd., Order No. 45/2013, Para.16, available at http://www.ipabindia.in/pdfs/order-45-2013.pdf, last visited on June 5th, 2019.
Bayer Corporation v. Natco Pharma Ltd., Order No. 45/2013, Para 35, available at http://www.ipabindia.in/pdfs/order-45-2013.pdf, last visited on June 5th, 2017.
Bayer Corporation v. Natco Pharma Ltd, Order No. 45/2013, Para 40, available at http://www.ipab.tn.nic.in/045-2013.htm Last visited on June 5th, 2017.
Bayer Corporation v. Natco Pharma Ltd., Order No. 45/2013, Para 25-26 available at http://www.ipab.tn.nic.in/045-2013.htm (Last visited on May 12, 2013)
C.L.A. No. 1 of 2015
Onglyza – A Saxagliptin drug, available at http://www.diabetes.co.uk/diabetes-medication/diabetes-and-onglyza.html, last visited on June 8th, 2017.
US Patent No - US 7,943,656 B2, dated May 17th, 2011, available at https://patents.google.com/patent/US7943656B2/en, (last visited on June 23, 2021).
S 84(1)- (a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or(b) that the patented invention is not available to the public at a reasonably affordable price, or(c) that the patented invention is not worked in the territory of India.
Compulsory License Application by Lee Pharmaceuticals, Pg 10, available at https://spicyip.com/wp-content/uploads/2015/07/Saxagliptin-CL.pdf, (last visited on June 8, 2021)
Compulsory Licensing application filed over AstraZeneca's Saxagliptin- available at https://spicyip.com/2015/07/compulsory-licence-application-filed-over-astrazenecas-saxagliptin.html, last visited on June 8, 2021
Compulsory License Application by Lee Pharmaceuticals, available at https://spicyip.com/wp-content/uploads/2015/07/Saxagliptin-CL.pdf, last visited on June 8, 2021
Order by Controller in rejecting compulsory licensing, available at https://www.jetro.go.jp/ext_images/world/asia/in/ip/pdf/Lee-prima-facie-notice_en20160119.pdf, last visited on June 11 2021.
Hayek, F.A. (1967) The theory of complex phenomena, in Hayek, F.A. (1967) Studies in philosophy, politics and economics, London: Routledge
england.nhs.uk, available at https://www.england.nhs.uk/statistics/statistical-work-areas/covid-19-vaccinations/, last visited on 21 May,2021.
European Centre for Disease Prevention and Control- qap.ecdc.europa.eu, available at https://qap.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html#uptake-tab, last visited on 21 May, 2021.
United Kingdom’s Department of Health and Social Care- UK Covid -19 vaccines delivery plan, published on January 11, 2021, www.gov.uk, available at https://www.gov.uk/government/publications/uk-covid-19-vaccines-delivery-plan, last visited on 21st May, 2021.
“Does Compulsory Licensing Discourage Invention? Evidence from German Patents After WWI,” National Bureau of Economic Research Working Paper no. 21442, July 2015.
Beall, Reed & Kuhn, Randall & Attaran, Amir. (2015). Compulsory Licensing Often Did Not Produce Lower Prices For Antiretrovirals Compared To International Procurement. Health Affairs. 34. 493-501. 10.1377/hlthaff.2014.0658.
Public Citizen. Compulsory licenses and right to health litigation: Kaletra campaign [Internet]. Washington (DC): Public Citizen; c2014 [cited 2015 Jan 13]. Available from: http:// citizen.org/Kaletra-campaign
Friedman MA, den Besten H, Attaran A. Out-licensing: a practical approach for improvement of access to medicines in poor countries.