Abstract
Compulsory licensing is a well-recognised institution for striking a balance between patent and copyright protection and social or economic goals in general. For a compulsory licence to work effectively, three conditions must be met at first: competent licensees with sufficient capacities, adequate market size, and access to necessary know-how. If the third condition is missing, the authority granting such licences may issue a know-how transfer order to fill in the gap. Ancillary orders may also direct non-voluntary licensees to address specific harms to public interest, ensuring the attainment of their policy goals. In addition, the granting authority can issue a side effect averting order to alleviate unnecessary impact that the licence may impose on the patent or copyright holders. Given that no exception to the protection of undisclosed information is expressly acknowledged in the TRIPS Agreement, there are some doubts about the know how transfer orders' compatibility with the TRIPS. These doubts are not well founded. On the other hand, orders requiring local manufacturing are likely to violate the principle of non-discrimination between imports and local production as enshrined in Article 27.1 of the TRIPS Agreement.
R.L.-d. Wang is Associate Professor of Law; S.J.D. 2007, Indiana University Maurer School of Law.
This chapter was previously published in Marquette Intellectual Property Law Review, vol. 18, Number 1, pp. 88–105 (March 2014).
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
As of 2 March 2013, the WTO has 159 members.
- 2.
- 3.
Article I(1) of the Appendix of the Berne Convention (1971).
- 4.
Declaration on the TRIPS Agreement and Public Health, para. 5.b, WT/MIN(01)/DEC/2 (20 November 2001).
- 5.
Id. para. 4.
- 6.
Brazil issued a compulsory licence against Merck & Co. for its HIV/AIDS drug, efavirenz, in May 2007; Quadir (2009), pp. 437, 459. For more details, see the chapter “The Use of Compulsory Licences in Latin America” by Carlos M. Correa, in this volume.
- 7.
On 9 March 2012, the Indian patent authority granted generics manufacturer Natco Pharma Ltd. the right to produce and sell Bayer’s Sorafenib, a patented medicine that is useful in treating liver and kidney cancers at an advanced stage; Bonadio (2012), pp. 719, 719. For more details, see the chapter “Compulsory Licence Under Indian Patent Law” by N.S. Gopalakrishnan and Madhuri Anand, in this volume.
- 8.
In the wake of the avian flu crisis, Tamiflu was considered an effective remedy for the H5N1 virus. Failing to secure sufficient supply from F. Hoffmann-La Roche Ltd., the Taiwanese Government granted a compulsory licence on Tamiflu on December 2005. For more details, see the chapter “Compulsory Licence and Government Use in Taiwan: A Regress” by Kung-Chung Liu, in this volume; also Liu (2008), p. 760 n. 12; Kane (2009), pp. 1137, 1167.
- 9.
Thailand granted a couple of compulsory licences in 2006 and 2007, including the patented HIV/AIDS drugs efavirenz (from Merck) and Kaletra (from Abbott), and Plavix, which is used for treating heart disease; Osenga (2012), pp. 309, 319.
- 10.
- 11.
- 12.
Mengistie (2010), p. 179.
- 13.
General Council (2003).
- 14.
General Council (2005).
- 15.
As of now, about 70 WTO members have issued notification that they accept of this amendment. Since less than two-thirds of the WTO members have formally accepted the amendment, Article 31bis has not yet taken effect and replaced the 2003 waiver. The deadline for WTO members to accept this revision has been extended to 31 December 2013; General Council (2011).
- 16.
Rwanda (2007).
- 17.
- 18.
See Kettler and Collins (2002), pp. 12–39.
- 19.
- 20.
Article 29.1 of the TRIPS Agreement provides: “Members shall require that an applicant for a patent shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art . . .”.
- 21.
Wang (2004), p. 237.
- 22.
Regrettably, the author has not found any national practice that adopts orders similar to what the chapter proposes here.
- 23.
Rule 34(b)(1) of Federal Rules of Civil Procedure: “The request [to produce any designated documents or electronically stored information]: (A) must describe with reasonable particularity each item or category of items to be inspected; . . .”.
- 24.
In re Natco Pharma Ltd and Bayer Corp., C.L.A. No. 1 of 2011, at 60–61 (Order item a & h) (Controller of Patents March 9, 2012), available at http://www.ipindia.nic.in/ipoNew/compulsory_License_12032012.pdf.
- 25.
Id. at 61 (Order item i). See also the chapters “The Use of Compulsory Licences in Latin America” and “Scope and Duration of Compulsory Licensing: Lessons from National Experiences” by Professor Carlos M. Correa and Ida Madieha bt. Abdul Ghani Azmi, in this volume.
- 26.
In re Natco Pharma Ltd and Bayer Corp., C.L.A. No. 1 of 2011, at 5–6 (Controller of Patents March 9, 2012), available at http://www.ipindia.nic.in/ipoNew/compulsory_ License_12032012.pdf.
- 27.
Id. at 61–62 (Order item k); see also Bonadio (2012), p. 721.
- 28.
General Council (2005), Annex to the TRIPS Agreement, para. 2(b)(ii).
- 29.
Article IV(3) of the Appendix of the Berne Convention (1979).
- 30.
Unif. Trade Secrets Act (1985) § 3(a) & § 3 cmt. The exception excludes from compensation damages accruing after the trade secret has been revealed or otherwise no longer sustains an advantage over competitors.
- 31.
Article 43.1 of the TRIPS Agreement: “The judicial authorities shall have the authority, where a party has presented reasonably available evidence sufficient to support its claims and has specified evidence relevant to substantiation of its claims which lies in the control of the opposing party, to order that this evidence be produced by the opposing party, subject in appropriate cases to conditions which ensure the protection of confidential information.”
- 32.
For the significance of treaty context in construing disputed treaty terms, see infra text accompanying footnotes 39–40.
- 33.
Bodenhausen (1968), p. 71.
- 34.
Panel Report, Canada—Patent Protection of Pharmaceutical Products, para. 7.91, WT/DS114/R (March 17, 2000).
- 35.
See Article 3 (MFN) and Article 4 (national treatment) of the TRIPS Agreement. See also, e.g., Trebilcock and Howse (2005), pp. 28–30.
- 36.
E.g., Appellate Body Report, United States—Standards for Reformulated and Conventional Gasoline, 15, WT/DS2/AB/R (April 29, 1996); Appellate Body Report, Japan—Taxes on Alcoholic Beverages, 9, WT/DS8/AB/R, WT/DS10/AB/R, WT/DS11/AB/R (October 4, 1996).
- 37.
Oxford Dictionaries, Definition of Work, available at http://oxforddictionaries.com/definition/english/work?q=work (last visited June 6, 2013); Merriam-Webster, Definition of Work (Transitive Verb), available at http://www.merriam-webster.com/dictionary/work (last visited June 6, 2013).
- 38.
For similar conclusion, see Straus (1996), p. 205.
- 39.
Panel Report, United States—Section 110(5) of the US Copyright Act, para. 6.92, WT/DS160/R (June 15, 2000).
- 40.
Id. para. 6.94.
- 41.
See the chapter “The Use of Compulsory Licences in Latin America” by Professor Carlos M. Correa, in this volume.
- 42.
Article 32 of the Vienna Convention on the Law of Treaties provides for supplemental means of treaty interpretation: “Recourse may be had to supplementary means of interpretation, including the preparatory work of the treaty and the circumstances of its conclusion, in order to confirm the meaning resulting from the application of article 31, or to determine the meaning when the interpretation according to article 31: (a) leaves the meaning ambiguous or obscure; or (b) leads to a result which is manifestly absurd or unreasonable”.
- 43.
Watal (2001), p. 318.
- 44.
Report of the Panel, United States—Section 337 of the Tariff Act of 1930, L/6439 (November 7, 1989).
- 45.
See Section 4 of Part 3 of the TRIPS Agreement: Special Requirements Related to Border Measures.
- 46.
For a similar view, see Bonadio (2012), p. 723. For an opposing view, see Mercurio and Tyagi (2010), pp. 275, 313 (the differential treatment resulting from local working requirements does not amount to an unjustified disadvantage and hence is not a discrimination under Article 27.1 of the TRIPS Agreement).
References
Bodenhausen GHC (1968) Guide to the application of the Paris Convention for the protection of industrial property. WIPO, Geneva
Bonadio E (2012) Compulsory licensing of patents: the Bayer-Natco case. Eur Intellect Prop Rev 34:719
Correa CM (2000) Intellectual property rights, the WTO and developing countries: the TRIPS Agreement and policy options. Zed Books, London
General Council (2003) Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health Decision, WT/L/540 and Corr.1, 1 September 2003. http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm
Kane EM (2009) Achieving clinical equality in an influenza pandemic: patent realities. Seton Hall Law Rev 39:1137
Kettler HE, Collins C (2002) Using innovative action to meet global health needs through existing intellectual property regimes. Available at http://www.iprcommission.org/papers/word/study_papers/sp2b_kettler_study.doc. Last visited 25 Nov 2012
Liu KC (2008) Rationalising the regime of compulsory patent licensing by the essential facilities doctrine. Int Rev Intellect Prop Comp Law 39:760
Liu KC (2012) The need and justification for a general competition-oriented compulsory licensing regime. Int Rev Intellect Prop Comp Law 43:679
Mengistie G (2010) The patent system in Africa: its contribution and potential in stimulating innovation, technology transfer and fostering science and technology: part 2. Int Trade Law Rev 16:175
Mercurio B, Tyagi M (2010) Treaty interpretation in WTO dispute settlement: the outstanding question of the legality of local working requirements. Minn J Int Law 19:275
Osenga K (2012) Get the balance right! Squaring access with patent protection. Pac McGeorge Global Bus Dev Law J 25:309
Pacón AM (1996) What will TRIPS do for developing countries? In: Beier F-K, Schricker G (eds) From GATT to TRIPS—the agreement on trade-related aspects of intellectual property rights. VCH, Weinheim, pp 329–356
Quadir R (2009) Patent stalemate? The WTO’S essential medicines impasse between pharmas and least developed countries. Rutgers Law Rev 61:437
Rwanda (2007) Notification under paragraph 2(a) of the decision of 30 August 2003 on the implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health, IP/N/9/RWA/1. http://www.wto.org/english/tratop_e/trips_e/ta_docs_e/3_ipn9rwa1_e.pdf
Straus J (1996) Implications of the TRIPS Agreement in the field of patent law. In: Beier F-K, Schricker G (eds) From GATT to TRIPS—the agreement on trade-related aspects of intellectual property rights. VCH, Weinheim, pp 160–215
Trebilcock MJ, Howse R (2005) The regulation of international trade, 3d edn. Routledge, London, pp 28–30
Wang RL (2004) Functions and restraints of compulsory licensing: perspective from TRIPS Agreement and public health. Technol Law Rev 1:215 (in Chinese)
Watal J (2001) Intellectual property rights in the WTO and developing countries. Kluwer, The Hague
WTO General Council (2005) Amendment of the TRIPS Agreement, WT/L/641. Available at http://www.wto.org/english/tratop_e/trips_e/wtl641_e.htm
WTO General Council (2011) Amendment of the TRIPS Agreement – third extension of the period for the acceptance by members of the protocol amending the TRIPS Agreement, WT/L/829. http://www.wto.org/english/tratop_e/trips_e/ta_docs_e/3_wtl829_e.pdf
Acknowledgements
The author would like to express his gratitude to Professor Byungil Kim, Mark Janis, Michael Mattioli, Donald Knebel, and Kung-Chung Liu for their invaluable views and comments. The draft of this chapter was presented at the Symposium on International Trade, Technology and Business Law, June 14, 2013, Taipei, Taiwan, jointly organised by the Institute of Technology Law, National Chiao Tung University and Faculty of Law, Chinese University of Hong Kong. Many thanks to Justice Chang-Fa Lo and Professor Bryan Mercurio for their insightful suggestions at that event. Shortcomings of this chapter, if any, should still be attributed to the author.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2015 Springer-Verlag Berlin Heidelberg
About this chapter
Cite this chapter
Wang, R.Ld. (2015). Ancillary Orders of Compulsory Licensing and Their Compatibility with the TRIPS Agreement. In: Hilty, R., Liu, KC. (eds) Compulsory Licensing. MPI Studies on Intellectual Property and Competition Law, vol 22. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-54704-1_10
Download citation
DOI: https://doi.org/10.1007/978-3-642-54704-1_10
Published:
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-642-54703-4
Online ISBN: 978-3-642-54704-1
eBook Packages: Humanities, Social Sciences and LawLaw and Criminology (R0)