Open Access Open Access  Restricted Access Subscription Access

Compulsory Licensing For Public Health And USA’s Special 301 Pressure: An Indian Experience


Affiliations
1 National Law School of India University, Nagarbhavi, Bangalore, Karnataka- 560 072, India
 

The TRIPS Agreement concluded with a win-win situation where both the developed and developing countries could incorporate their supportive provisions. But the inclusion of a broad compulsory licensing provision, which is a supportive provision for the developing countries, was against the wishes of United States which was always against any form of restrictions on the rights of the patentee. In order to achieve its aims which it had failed in the TRIPS Agreement, USA began to use its new strategy to prevent countries from using this TRIPS flexibility, by the threat of trade retaliations through Special 301 Report. India being one of the victims of US strategy had many a times faced this intimidation from USA. The researcher has thoroughly analysed the Indian position in the Special 301 Report till 2018. Also, the researcher scrutinized the effect such an act on India and how the Indian Government responded to such situation. The researcher could found that such unwelcomed behaviour on the part of the luring market in the world had affected the public health and access to patented life saving drugs in India. Any such activity is in violation of principles embodied in the TRIPS Agreement and similar international commitments and also against the basic human right to health. The researcher suggests for a strong protest against such activities either by putting the matter before WTO-DSB or by forming a regional collaboration with other similarly affected countries and take retaliatory action against US.

Keywords

Compulsory License, TRIPS Agreement, Special 301, Trade Sanction, United States Trade Representative, WTO, U.S.-India Business Council, Pharmaceutical Research And Manufacturers of America, Indian Intellectual Property Appellate Board, Department of Industrial Policy And Promotion, Doha Declaration, Priority Foreign Countries, Priority Watch List, US Generalized System of Preferences.
User
Notifications
Font Size

  • Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1867 U.N.T.S. 154, 15 April 1994), https://www.wto.org/english/tratop_e/trips_e/public_health_ faq_e.htm (17 October 2017).
  • Correa C M, Intellectual property rights and the use of compulsory licenses: Options for developing countries 3 (South Centre, October 1999) http://www.iatp.org/files/Intellectual_Property_Rights_and_the_Use_of_Co.pdf (1 March 2018).
  • Doha Declaration on the TRIPS Agreement and Public Health, Adopted on 14 November 2001WT/MIN(01)/DEC/2.
  • 2017 Special 301 Report, 1 https://ustr.gov/sites/default/files/301/2017%20Special%20301%20Report%20FINAL.PDF (accessed on 7 September 2018).
  • Shreerupa Mitra‐Jha, US Report puts India on ‘Priority Watch List,’ raises concerns over pharma sector, Firstpost, 29 April 2016, http://www.firstpost.com/world/united-statesuspriority-watch-list-ipr-pharma-2756774.html (accessed on 23 August 2016).
  • Drahos P & Braithwaite J, Information Feudalism: Who Owns The Knowledge Economy? (Earthscan Publications, UK Ltd), 2002, 100.
  • Understanding on Rules and Procedures Governing the Settlement of Disputes, 15 April 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 2, 33 I.L.M. 1125.
  • 19 U.S.C. § 2242(d)(4).
  • Flynn S M, Special 301 of the Trade Act of 1974 and global access to medicine, Journal of Generic Medicine, 7 (4) (2010) 321.
  • 1991 Special 301 Report, 2 https://ustr.gov/sites/default/files/1991%20Special%20301%20Report.pdf (accessed on 14 August 2018).
  • United States Trade Representative, 1994 National Trade Estimate Report on Foreign Trade Barriers, 122-123.
  • United States Trade Representative, 2013 National Trade Estimate Report on Foreign Trade Barriers, 182.
  • 2012 Special 301 Report, 35 https://ustr.gov/sites/default/files/2012%20Special%20301%20Report_0.pdf (accessed on 20 August 2018).
  • The PhRMA in its 2013 submission recommended the same, one of the major reason being the issuance of compulsory license by India in 2013, Pharmaceutical Research and Manufacturers of America (PhRMA) Special 301 Submission 2013, 35-36, https://www.keionline.org/sites/default/files/PhRMASpecial301Submission2013.pdf (accessed on 4 September 2018).
  • 2013 Special 301 Report, 39 https://ustr.gov/sites/default/files/05012013%202013%20Special%20301%20Rep ort.pdf (accessed on 4 September 2018).
  • 2014 Special 301 Report, 340-41 https://ustr.gov/sites/default/files/USTR%202014%20Special%20301%20Report %20to%20Congress%20FINAL.pdf (accessed on 4 September 2018).
  • Pharmaceutical Research and Manufacturers of America (PhRMA) Special 301 Submission 2014, 47, 49-50, https://www.keionline.org/wp-content/uploads/PhRMA_2015_Special_301_Review_Comment.pdf (accessed on 4 September 2018).
  • U.S.-India Business Council Hearing Statement to the Office of the Us Trade Representative Concerning The 2016 Special 301 Review, 5-6, http://freepdfhosting.com/6dd037b8b4.pdf (accessed on 2 September 2018).
  • Press Information Bureau, Government of India, Ministry of Commerce & Industry Ministry of Commerce & Industry, Clarification on Media Reports Regarding Compulsory Licence, March 22, 2016 http://pib.nic.in/newsite/erelease.aspx?relid=138271 (accessed on 5 September 2018).
  • Subramanian B, Busting the drug mafia: Commerce Ministry responds on CL assurance, Spicyip, 23 March 2016, https://spicyip.com/2016/03/busting-the-drug-mafiacommercemin-responds-on-cl-assurance.html (accessed on 5 September 2018).
  • Letter to Michael Froman by Union for Affordable Cancer Treatment (UACT), 4 (29 October 2014), https://www.cancerunion.org/files/UACT-FromanOct292014-dasatinib.pdf (accessed on 1 September 2018).
  • Letter to Michael Froman by Union for Affordable Cancer Treatment (UACT), 4-5 (29 October 2014), https://www.cancerunion.org/files/UACT-Froman-Oct292014dasatinib.pdf (accessed on 1 September 2018).
  • 2016 Special 301 Report, 42, https://ustr.gov/sites/default/files/301/2017%20Special%20301%20Report%20FI NAL.PDF (accessed on 11 August 2018).
  • Pharmaceutical Research and Manufacturers of America (PhRMA), Special 301 Submission 2018, 88, file:///C:/Users/HP/Downloads/PhRMA-2018-Special-301-Submission.pdf, Biotechnology Innovation Organization 2018, Special 301 Submission, 31 https://www.keionline.org/wp-content/uploads/2018/02/2018_BIO_301_Submission_Final.pdf, Alliance For Fair Trade With India (AFTI), 2018 Special 301 Review, 6-7, http://aftindia.org/wpcontent/uploads/2018/02/AFTI_2018-Special-301_Review_ Comment.pdf (accessed on 27 August 2018).
  • Love J, KEI testimony at 8 March 2018, USTR Special 301 hearing, focusing on us compulsory licensing of patents, Knowledge Economy International, 8 March 2018 https://www.keionline.org/27147 (accessed on 28 August 2018).
  • Bhuyan A, New Government report affirms India’s patientfirst commitment on pharma patents, The Wire, 7 March 2018, https://thewire.in/health/new-government-reportaffirmsindias-patient-first-commitment-on-pharma-patents (accessed on 27 August 2018).
  • Urias E M P, Improving Access To Hiv/Aids Treatment In Brazil: When Are Compulsory Licenses Effective In Price Negotiations? (Datawyse/UniversitairePers Maastricht.), 2015.
  • This ended up in an agreement between US and Brazil under which Brazil will notify the US government in advance if in the event that it finds it necessary to issue a compulsory license under Article 68 of its Patent Law.
  • Yamabhai I et al., Government use licenses in Thailand: An assessment of the health and economic impacts, Global Health, 7 (28) (2011) 2, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3176479/pdf/1744-8603-7-28.pdf (accessed on 7 August 2018). Ho C M, Access to Medicine in the Global Economy. International Agreements on Patents and Related Rights, 151 (Oxford University Press, UK), 2011, 151, the author noted that there is some dispute as to whether this is directly a result of the licenses..
  • Maybarduk P, Public citizen hearing testimony for the 2015 Special 301 Review, Public Citizen, 6 February 2015, https://www.keionline.org/wp-content/uploads/Public_ Citizen_2015_Special_301_Review_Hearing_Testimony.pdf (accessed on 2 September 2018).
  • Knowledge Ecology International, Special 301 Review Public Hearing 2015, 101, https://ustr.gov/sites/default/files/02242015-Special301.pdf (accessed on 2 September 2018).
  • A matter of life and death: The role of patents in access to essential medicines, Medecins Sans Frontieres, November 2001), https://www.msf.org/sites/msf.org/files/doha_112001.pdf (accessed on 6 September 2018).
  • In 2001 US Government had threatened to issue a compulsory license to produce a stockpile of ciprofloxacin (Cipro) enough to treat 10 million people in the face of an Anthrax scare and also Number of United States Statues provide for compulsory license. For example, the United States government can issue a compulsory license for air pollution control patents (42 U.S.C. § 7608 (2006)), for nuclear power patents (42 U.S.C. § 2183 (2006)), for public health related patents (35 U.S.C. § 203) and for items needed for government use (28 U.S.C. S 1498)1, the Antitrust law of US. Adding the number, the United States routinely issues such licences, albeit through their courts which refuse to grant patent injunctions on grounds of public interest. This is nothing but a defacto compulsory license where the Courts deny injunctive relief for a patent infringement and allows the infringer to continue practicing the patented technology without the patentee’s consent.
  • Drahos P & Braithwaite J, Information Feudalism: Who Owns The Knowledge Economy? (Earthscan Publications, UK Ltd), 2002, 101.
  • ‘Technological Progress And American Rights: Trade Policy And Intellectual Property Protection’, Testimony of Ambassador Richard W. Fisher, Deputy U.S. Trade Representative, Subcommittee on International Economic Policy and Trade House Committee on International Relations, Washington DC, 13 October 1999, 3, Drahos P, Bilateralism in Intellectual Property 4 (Oxfam GB, 4 December 2001), file:///C:/Users/HP/Downloads/bilateralism-intellectual-property-041201-en.pdf (accessed on 6 September 2018).

Abstract Views: 110

PDF Views: 92




  • Compulsory Licensing For Public Health And USA’s Special 301 Pressure: An Indian Experience

Abstract Views: 110  |  PDF Views: 92

Authors

Aswathy Asok
National Law School of India University, Nagarbhavi, Bangalore, Karnataka- 560 072, India

Abstract


The TRIPS Agreement concluded with a win-win situation where both the developed and developing countries could incorporate their supportive provisions. But the inclusion of a broad compulsory licensing provision, which is a supportive provision for the developing countries, was against the wishes of United States which was always against any form of restrictions on the rights of the patentee. In order to achieve its aims which it had failed in the TRIPS Agreement, USA began to use its new strategy to prevent countries from using this TRIPS flexibility, by the threat of trade retaliations through Special 301 Report. India being one of the victims of US strategy had many a times faced this intimidation from USA. The researcher has thoroughly analysed the Indian position in the Special 301 Report till 2018. Also, the researcher scrutinized the effect such an act on India and how the Indian Government responded to such situation. The researcher could found that such unwelcomed behaviour on the part of the luring market in the world had affected the public health and access to patented life saving drugs in India. Any such activity is in violation of principles embodied in the TRIPS Agreement and similar international commitments and also against the basic human right to health. The researcher suggests for a strong protest against such activities either by putting the matter before WTO-DSB or by forming a regional collaboration with other similarly affected countries and take retaliatory action against US.

Keywords


Compulsory License, TRIPS Agreement, Special 301, Trade Sanction, United States Trade Representative, WTO, U.S.-India Business Council, Pharmaceutical Research And Manufacturers of America, Indian Intellectual Property Appellate Board, Department of Industrial Policy And Promotion, Doha Declaration, Priority Foreign Countries, Priority Watch List, US Generalized System of Preferences.

References