Journal of Intellectual Property Rights

Open Access Open Access  Restricted Access Subscription Access

Patent Law and Compulsory Licensing: Indian Perspective


Affiliations
1 Dr. Ambedkar Government Law College, Kalapet - 605 014, Puducherry, India
2 Jindal Global Law School, O.P. Jindal Global University, Sonipat - 131 001, Haryana, India
 

This Paper seeks to critically analyze and evaluate the concept of compulsory licensing under the Indian Patents and Designs Act, 1911, and the Patents Act, 1970. The Paper further: (i) traces its evolution from the French Patent Law of 1791 to the amendment of the TRIPS Agreement in 2017 that introduced Article 31bis; (ii) analyzes the detailed procedure and consideration for the grant of compulsory license in India; and (iii) in the light of Natcov Bayer decision, discusses the rejection of the compulsory license applications on the grounds of procedural non-compliance. In the end, paper develops an argument that the provisions relating to compulsory license under the Indian patent regulatory framework have remained a dead letter during COVID-19 pandemic at the cost of public health and welfare.

Keywords

Patent, Compulsory License, TRIPS, Article 31bis, Conventions, Doha Declaration, Labour Theory, Utilitarian Theory, The Patents and Designs Act, 1911,Bakshi Tek Chand Committee, N Rajagopa Ayyangar Committee, The Patents Act, 1970, Controller of Patents,
User
Notifications
Font Size

  • Bayer Corporation v Union of India AIR 2014 BOM 178.

  • Council for Trade-Related Aspects of Intellectual Property Rights, Waiver from certain Provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19: Communication from Indiaand South Africa; https://docs.wto.org/dol2fe/Pages/SS/ directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True (accessed on 1 August 2021).

  • Natco Pharma v Bayer Corporation, Controller of Patents, Mumbai, 2011; https://patentdocs.typepad.com/files/ compulsory-license-application.pdf (accessed on 1 August 2021).

  • For more detailed discussion on theoretical underpinnings of intellectual property law, see:Raza A, Theoretical underpinnings of Patent Law: Decisions of the Supreme Court of India, Journal of Intellectual Property Rights, 27 (4) (2022) 285–289; Raza A, Theoretical underpinnings of Copyright and Design Laws: Decisions of the Supreme Court of India, Journal of Intellectual Property Rights, 26 (4) (2021) 220–234; Raza A and Alam G, Theoretical Underpinnings of Copyright and Design Laws Post-KrishikaLulla and Godrej Sara Lee: Decisions of the Supreme Court of India,Journal of Intellectual Property Rights,27 (6) (2022) 434–441.

  • Ayyangar N R, Report on the Revision of the Patents Law, September 1959; https://ipindia.gov.in/writereaddata/Portal/ Images/pdf/1959-Justice_N_R_Ayyanar_committee_report.pdf (accessed on 1 August 2021).

  • Paris Convention for the Protection of Industrial Property, as last revised at the Stockholm Revision Conference, 20 March 1883; https://www.unido.org/sites/default/files/2014-04/Paris_Convention_0.pdf (accessed on 1 August 2021).

  • TRIPS Agreement 15 April 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C (1994); https://www.wto.org/english/docs_e/legal_e/27-trips.pdf (accessed on 1 August 2021).

  • Doha WTO Ministerial 2001: TRIPS, Declaration on the TRIPS Agreement and Public Health; https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm (accessed on 1 August 2021).

  • WTO General Council, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health; https://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm (accessed on 1 August 2021).

  • WTO General Council, Amendment of the TRIPS Agreement; https://www.wto.org/english/tratop_e/trips_e/wtl641_e.htm (accessed on 1 August 2021).

  • William N, It‘s official: TRIPS Health Amendment in effect, First ever to a WTO Agreement, Intellectual Property Watch; https://www.ip-watch.org/2017/01/23/official-trips-health-amendment-effect-first-ever-wto-agreement/ (accessed on 1 August 2021).

  • WTO, Annex and Appendix to the TRIPS Agreement https://www.wto.org/english/docs_e/legal_e/31bis_trips_annex_e.htm (accessed on 1 August 2021).

  • History of Indian Patent System, IP India; https://ipindia.gov.in/history-of-indian-patent-system.htm (accessed on 1 August 2021).

  • Bakshi T C, Report of the Patents Enquiry Committee (1948-50); https://indianculture.gov.in/report-patents-enquiry-committee-1948-50 (accessed on 1 August 2021).

  • Cancer Patients Aid Association, Revocation of Patent No. 332280 in Patent Application No. 201727012821 under Section 66 and 64(1) of the Patents Act, 1970; https://cancer.org.in/images/CPAA-Rev-of-Patent-2020.pdf (accessed on 1 August 2021).

  • Twelfth Session of Ministerial Conference, WTO Ministerial Decision on the TRIPS Agreement; https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/WT/MIN22/30.pdf&Open=True (accessed on 28 December 2022).

  • Section 84(2) of the Patents Act, 1970, states that a licensee would not be stopped from raising the grounds under Section 84(1) and seeks a compulsory license. The acceptance of the terms of the license by the licensee would not prevent him from filling an application for compulsory license.

  • Bayer Corporation v Union of India, Intellectual Property Appellate Board, Chennai, 2013; https://spicyip.com/wp-content/uploads/2018/02/Natco-v.-Bayer-INTELLECTUAL-PROPERTY-APPELLATE-BOARD-CHENNAI-–-4th-March-2013.pdf (accessed on 1 August 2021).

  • BDR Pharmaceuticals v Bristol Myers Squibb, Controller of Patents, Mumbai, 2013 https://ipindia.gov.in/writereaddata/ Portal/News/355_1_Order_30October2013.pdf (accessed on 1 August 2021).

  • The inventor/patentee of an orphan drug is entitled to reimburse either by tax credit or otherwise to the extent of 50% of the cost incurred by the inventor/patentee on research and development of the patented drug.

  • Bayer Corporation v Union of India, SLP (C) No. 30145 of 2014.

  • Lee Pharma v AstraZeneca AB, Controller of Patents, Mumbai, 2016 (accessed on 1 August 2021).

  • Office of the United States Trade Representative, 2022 Special 301 Report; https://ustr.gov/sites/default/files/ IssueAreas/IP/2022%20Special%20301%20Report.pdf (accessed on 28 December 2022).

  • Department of Industrial Policy & Promotion, National Intellectual Property Rights Policy 2016; https://dpiit.gov.in /sites/default/files/National_IPR_Policy_English.pdf (accessed on 1 August 2021).

  • United Nations, Sustainable Development Goals 3: Ensure healthy lives and promote well-being for all at all ages; https://sdgs.un.org/goals/goal3 (accessed on 1 August 2021).


Abstract Views: 72

PDF Views: 37




  • Patent Law and Compulsory Licensing: Indian Perspective

Abstract Views: 72  |  PDF Views: 37

Authors

Abhinav Gupta
Dr. Ambedkar Government Law College, Kalapet - 605 014, Puducherry, India
Aqa Raza
Jindal Global Law School, O.P. Jindal Global University, Sonipat - 131 001, Haryana, India

Abstract


This Paper seeks to critically analyze and evaluate the concept of compulsory licensing under the Indian Patents and Designs Act, 1911, and the Patents Act, 1970. The Paper further: (i) traces its evolution from the French Patent Law of 1791 to the amendment of the TRIPS Agreement in 2017 that introduced Article 31bis; (ii) analyzes the detailed procedure and consideration for the grant of compulsory license in India; and (iii) in the light of Natcov Bayer decision, discusses the rejection of the compulsory license applications on the grounds of procedural non-compliance. In the end, paper develops an argument that the provisions relating to compulsory license under the Indian patent regulatory framework have remained a dead letter during COVID-19 pandemic at the cost of public health and welfare.

Keywords


Patent, Compulsory License, TRIPS, Article 31bis, Conventions, Doha Declaration, Labour Theory, Utilitarian Theory, The Patents and Designs Act, 1911,Bakshi Tek Chand Committee, N Rajagopa Ayyangar Committee, The Patents Act, 1970, Controller of Patents,

References