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Compulsory Licenses in Patent Law

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Mechanisms to Enable Follow-On Innovation

Part of the book series: Munich Studies on Innovation and Competition ((MSIC,volume 15))

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Abstract

The chapter reviews the conditions for compulsory licenses for functional efficiency set in international law and the instruments’ adequacy to address the market failures that hinder follow-on innovation. Under the TRIPS Agreement, compulsory licenses (Art. 31) are a mechanism distinct from exceptions to patent protection (Art. 30). Of the general and procedural conditions of Art. 31 TRIPS, the requirement of prior effort to obtain a license before using a patent largely precludes the application of compulsory licenses to hold-up problems. Otherwise, TRIPS features considerable, albeit underused, procedural flexibilities for the application process of a compulsory license. Compulsory licenses for dependent patents (Art. 31 (l) TRIPS) have too narrow a scope of application to sustain the interests of follow-on innovators adequately. In theory, the market failures resulting from the deliberate conduct of a patent holder could be addressed on the grounds of abuse of rights. However, the instrument is toothless due to the requirement of prior effort. Essentially, only compulsory licenses that aim at remedying an anti-competitive practice are liberated from the condition of preliminary effort to obtain a license and could address the broadest range of market failures that hinder follow-on innovation.

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Notes

  1. 1.

    With regard to process patents, a patent owner has a right to prevent third parties from using a process without her consent; in addition, she can also prevent them from using, selling, and/or importing for these purposes at least the product obtained directly by the patented process (Art. 28 (1) (b) TRIPS).

  2. 2.

    See Sect. 4.1.

  3. 3.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 462, 468; Lamping et al., “Declaration on Patent Protection,” 688. Semiconductor technology is the only field that is explicitly regulated in the TRIPS agreement. Under TRIPS Art. 31 (c), compulsory licenses to such technology can only be granted for public non-commercial use or as remedies to practices that have been determined to be anti-competitive after a judicial or administrative process. The scope of the field of semiconductor technology has been suggested to exceed that of semiconductor topography rights. Semiconductor technology thus represents an exception to the non-discrimination principle of the TRIPS Agreement, and should hence be interpreted narrowly. Straus and Prinz zu Waldeck und Pyrmont, “Survey of Compulsory Licensing Legislation,” 16.

  4. 4.

    See Sect. 6.4.5.

  5. 5.

    Ansgar Ohly, ““Patenttrolle” Oder : Der patentrechtliche Unterlassungsanspruch unter Verhältnismäßigkeits-vorbehalt? - Aktuelle Entwicklungen im US-Patentrecht und ihre Bedeutung für das deutsche und europäische Patentsystem,” Gewerblicher Rechtsschutz und Urheberrecht Internationaler Teil 57 (2008): 790.

  6. 6.

    Report of the Panel, Canada – Patent Protection of Pharmaceutical Products, WTO Doc. WT/DS114/R (adopted 17 March 2000) [hereinafter Canada Pharmaceuticals], 7.91.

  7. 7.

    Lionel Bently and Brad Sherman, “Limiting Patents,” in Compulsory Licensing: Practical Experiences and Ways Forward, ed. Reto M. Hilty and Kung-Chung Liu (Heidelberg: Springer Verlag, 2015), 319.

  8. 8.

    According to Art. 30 TRIPS, “Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.” In comparison to Art. 30 TRIPS, Art. 9 (2) of the Berne Convention for the Protection of Literary and Artistic Works (as amended on September 28 1979), adopted 28 September 1979, WIPO Lex No. TRT/BERNE/001 (entered into force 19 November 1984), [hereinafter BC], does not include the qualification of “not unreasonably conflict[ing] with the normal exploitation of the patent”, as well as the last passage concerning the interests of third parties.

  9. 9.

    Canada Pharmaceuticals 7.20-7.21. See also Appellate Body Report and Panel Report, United States - Standards for Reformulated and Conventional Gasoline, WTO Doc. WT/DS2/9 (adopted 20 May 1996), 23, fn 24 (and the references there).

  10. 10.

    Lamping et al., “Declaration on Patent Protection,” 687.

  11. 11.

    Chung-Lun Shen and Jyh-An Lee, “Review of Granted Compulsory Licences,” in Compulsory Licensing: Practical Experiences and Ways Forward, ed. Reto M. Hilty and Kung-Chung: Liu (Heidelberg: Springer Verlag, 2015), 304-306, 308, fns 65 and 67.

  12. 12.

    Polyferon, BGH, 5 December 1995, IIC, 1997, 242, 246.

  13. 13.

    For commentators who share the same view, see Straus, “Implications of the TRIPS Agreement,” 204, fn 185.

  14. 14.

    Canada Pharmaceuticals, 7.91.

  15. 15.

    Rodrigues Jr, The General Exception Clauses of the TRIPS Agreement, 68; Gervais, TRIPS Agreement, 2.396. Cf. Justin Malbon, Charles Lawson, and Mark Davison, WTO Agreement on Trade-Related Aspects of Intellectual Property : A Commentary (Northhampton, MA: Edward Elgar Publishing, 2014), 31.01.

  16. 16.

    de Carvalho, TRIPS Regime of Patent Rights; TRIPS Regime of Patent Rights, 1st ed. (The Hague: Kluwer Law International, 2002), 251; TRIPS Regime of Patents and Test Data, 4th ed. (Alphen aan den Rijn: Kluwer Law International, 2014), 388.

  17. 17.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 462. From a more pragmatic point of view, a compulsory license may be implemented in national legislation as a lenient alternative to an exception to patent protection, especially considering the fact that compulsory licensing provisions are rarely used.

  18. 18.

    Straus and Prinz zu Waldeck und Pyrmont, “Survey of Compulsory Licensing Legislation,” 11.

  19. 19.

    Cf. Carlos M. Correa, Intellectual Property Rights and the Use of Compulsory Licenses : Option for Developing Countries (Geneva: South Centre, 1999), 7, in which the author views Art. 30 TRIPS as only covering uncompensated uses.

  20. 20.

    “Report on the Work of Main Committee I (Substantive Provisions of the Berne Convention : Articles 1 to 20),” in Records of the Intellectual Property Conference of Stockholm (1967) Volume II, ed. World Intellectual Property Organization (Geneva: WIPO), para 85.

  21. 21.

    See Canada Pharmaceuticals, 7.14-17.15, 17.70-17.73 and fn 419.

  22. 22.

    Cf. Rodrigues Jr, The General Exception Clauses of the TRIPS Agreement, 68-69, who argues that a compulsory license is the only legislative instrument that allows the uses and the implementation of the objectives specifically identified in Art. 31 TRIPS and the Decision of the General Council.

  23. 23.

    For example, the misuse doctrine in the US, which is discussed in Sect. 7.4, features a zero-sum liability rule (Hilty, “Legal Remedies against Abuse,” 377, 393) which is applied as a defence in infringement proceedings; this rule features elements of an exception to a patent right (Art. 30 TRIPS), a compulsory license for anticompetitive practices (Art. 31 (k) TRIPS), and a limitation to injunctive relief (Art. 44 TRIPS).

  24. 24.

    See UNCTAD-ICTSD, Resource Book on TRIPS and Development, 469.

  25. 25.

    Xiuqun Lin, “Prior Negotiation and Remuneration for Patent Compulsory Licensing : Practice, Problem, and Proposal,” in Compulsory Licensing: Practical Experiences and Ways Forward, ed. Reto M. Hilty and Kung-Chung Liu (Heidelberg: Springer Verlag, 2015), 170. This enables a prospective user to provide evidence of his efforts to obtain a license, even in the event that patent holder remains passive with regard to the user’s attempt to conclude a licensing agreement. Ibid, 169-170.

  26. 26.

    See ibid, 167-170 for a review of the negotiation history supporting this view. Similarly, see § 24 (1) PatG; Polyferon, IIC 1997, 242, 244; Rogge and Kober-Dehm, “§ 24,” § 24 para 12. Cf. Lin, “Prior Negotiation and Remuneration for Patent Compulsory Licensing,” 167-168 who views Art. 31 (b) TRIPS as an independent ground for compulsory licenses. I support the procedural view, as treating a mere refusal as a ground for a compulsory license would open the door to the creation of a much wider intervention in the exclusive rights of the patent holder than that which the existing grounds for compulsory licenses, such as failure to work (Art. 5 A (4) PC), allow for. For example, the specific criteria for dependent patents (Art. 31 (l) TRIPS) would have been redundant had the member states intended to establish prior effort as a general ground for a compulsory license. Conditioning the grant of a compulsory license on a mere refusal to provide a license on reasonable terms would risk diminishing a patent holder’s incentives when the right to exclude is critical in order to recoup his investments in innovation.

  27. 27.

    See Sect. 4.3.3, on patent evaluation problems associated with compulsory licenses.

  28. 28.

    See Lin, “Prior Negotiation and Remuneration for Patent Compulsory Licensing,” 170.

  29. 29.

    On indirect effect, see Sect. 4.3.6.

  30. 30.

    See Art. 31 (c)-(f), (h).

  31. 31.

    See Lin, “Prior Negotiation and Remuneration for Patent Compulsory Licensing.”

  32. 32.

    Ibid, 170-171.

  33. 33.

    Raltegravir, BGH 11 July 2017, IIC, 2018, 94, para 19.

  34. 34.

    Lin, “Prior Negotiation and Remuneration for Patent Compulsory Licensing,” 170.

  35. 35.

    Rogge and Kober-Dehm, “§ 24,” § 24 para 13.

  36. 36.

    RG, 11 March 1926, 113 RGZ 115 (Ger.); Rogge and Kober-Dehn, “§ 24,” § 24 para 13.

  37. 37.

    Raltegravir, IIC 2018, 94, para 19.

  38. 38.

    § 24 (1) PatG defines the conditions for granting compulsory licenses in the public interest, which, generally, are subject to an exception from requirement of prior effort (Art. 31 (b) TRIPS). Hence, the German patent law has established more demanding conditions for granting compulsory licenses in the public interest than what TRIPS requires. However, BGH’s interpretation of the timing of the prior effort requirement in Raltegravir, IIC 2018, 94, is also applicable to compulsory licenses granted under § 24 (2) PatG; the grant of compulsory licenses for dependent patents has thus become subject to more lenient criteria than the minimum standards established by TRIPS.

  39. 39.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 469.

  40. 40.

    Lin, “Prior Negotiation and Remuneration for Patent Compulsory Licensing,” 174.

  41. 41.

    Ibid, 172, 174, 179.

  42. 42.

    Gervais, TRIPS Agreement, 2.409.

  43. 43.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 469.

  44. 44.

    Ibid, 470.

  45. 45.

    Rogge and Kober-Dehm, “§ 24,” § 24 para 13. It is no longer necessary, but possible, to lodge a security. Ibid. See also Raltegravir, IIC 2018, 94, para 17.

  46. 46.

    Polyferon, IIC 1997, 242, 244.

  47. 47.

    Peter R. Slowinski, “Comment on the German Federal Supreme Court Decision “Raltegravir”,” IIC - International Review of Intellectual Property and Competition Law 49, no. 1 (2018): 127.

  48. 48.

    In Raltegravir, the fact that the offer for a royalty payment made by the applicant of a compulsory license was different the patent holder’s offer or involved the proposition of a lump sum payment did not disqualify the applicant’s attempt to obtain a license for the patent. In this particular case, the BGH took into consideration the questionable validity of the patent. Raltegravir, IIC 2018, 94, paras 22-24; Slowinski, “Comment” 127.

  49. 49.

    For more detailed discussion, see Sect. 8.6.5.

  50. 50.

    The qualification should address both the interests of the prospective licensee and the patent holder. For example, in certain situations, it may be very difficult for a follow-on innovator to make a “reasonable” offer if he is not familiar with the licensing practices of the industry in question. In such a situation, active inquiry into a patent holder’s license rates with an interest in negotiating a license should suffice as an initial effort to obtain a license. A patent holder must not be expected to accept unreasonably low offers.

  51. 51.

    Lin, “Prior Negotiation and Remuneration for Patent Compulsory Licensing,” 172.

  52. 52.

    Ibid.

  53. 53.

    Ibid, 174.

  54. 54.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 470.

  55. 55.

    Ibid.

  56. 56.

    Raltegravir, IIC 2018, 94, para 19.

  57. 57.

    Lin, “Prior Negotiation and Remuneration for Patent Compulsory Licensing,” 176, 179.

  58. 58.

    However, an effect similar to that of a compulsory license may be achieved by limiting the right to injunctive relief pursuant to Art. 44 TRIPS. For a more detailed discussion see Sect. 7.2.

  59. 59.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 475.

  60. 60.

    Ibid, 476. Art. 31 (h) and Art. 31 (k) TRIPS reflect a balance between the objective of patent law to incentivise innovation and that of competition law to maintain healthy competition. Antony Taubman, “Rethinking TRIPS : ‘Adequate Remuneration’ for Non-Voluntary Patent Licensing,” Journal of International Economic Law 11, no. 4 (2008): 945.

  61. 61.

    Nuno Pires de Carvalho, TRIPS Regime of Antitrust and Undisclosed Information (The Hague: Kluwer Law International, 2008), 142.

  62. 62.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 477; Implementation of Paragraph 6 Doha Declaration, para 3.

  63. 63.

    See Taubman, “Rethinking TRIPS,” 931-932. However, the author discusses compulsory licenses that aim at enhancing functioning competition, rather than the general functional efficiency of the patent system.

  64. 64.

    For further discussion, see for example Michelle McGrath, “Patent Provisions in TRIPS : Protecting Reasonable Remuneration for Services Rendered - or the Latest Development in Western Colonialism?,” European Intellectual Property Review 18, no. 7 (1996); Susan Vaughan, “Compulsory Licensing of Pharmaceuticals under TRIPS : What Standard of Compensation?,” Hastings International and Comparative Law Review 25 (2001); Elli Välimäki, “Calculation of Royalties in Compulsory Licensing of Pharmaceutical Patents in Europe - How Much Is Justified?,” Nordic Journal of Commercial Law 1, no. special edition (2011).

  65. 65.

    Taubman, “Rethinking TRIPS,” 945, 953; Välimäki, “Calculation of Royalties,” 24; Lin, “Prior Negotiation and Remuneration for Patent Compulsory Licensing,” 189.

  66. 66.

    Taubman, “Rethinking TRIPS,” 951.

  67. 67.

    Gervais, TRIPS Agreement, 2.409.

  68. 68.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 475. This view represents a literal reading of Art. 31 (h) TRIPS. Taubman, “Rethinking TRIPS,” 952-953.

  69. 69.

    Taubman, “Rethinking TRIPS,” 952-953.

  70. 70.

    Robert Weissman, “Long, Strage TRIPS : The Pharmaceutical Industry Drive to Harmonize Global Intellectual Property Rules, and the Remaining WTO Legal Alternatives Available to Third World Countries,” University of Pennsylvania Journal of International Economic Law 17 (1996): 1114-1116; UNCTAD-ICTSD, Resource Book on TRIPS and Development, 477; Vaughan, “What Standard of Compensation?,” 100, fn 110.

  71. 71.

    See Lemley, “Contracting around Liability Rules,” 476, 497.

  72. 72.

    Taubman, “Rethinking TRIPS,” 956.

  73. 73.

    See Sect. 6.2.

  74. 74.

    “The normal practice of exploitation by patent owners, as with owners of any other intellectual property right, is to exclude all forms of competition that could detract significantly from the economic returns anticipated from a patent’s grant of market exclusivity.” Canada Pharmaceuticals, 7.55. In the opinion of de Carvalho, the panel’s view, which equates “normal exploitation” with the exclusion of competition, was mistaken and excessive. The correct reference point for “normal” exploitation should have been “exploitation that conforms with the general standards and objectives of the law”, which would exclude abusive exploitation or exploitation that violates anti-trust law. de Carvalho, TRIPS Regime of Patent Rights, 419.

  75. 75.

    Taubman, “Rethinking TRIPS,” 957.

  76. 76.

    With the exception of compulsory licenses intended to remedy anti-competitive conduct (Art. 31 (k) TRIPS). Ibid.

  77. 77.

    Lin, “Prior Negotiation and Remuneration for Patent Compulsory Licensing,” 180-181, 189. Similarly, Taubman, “Rethinking TRIPS,” 954. Cf. Gervais, TRIPS Agreement, 2.409, who interprets the concept as referring to the economic circumstances in a particular member state.

  78. 78.

    de Carvalho, TRIPS Regime of Patent Rights, 366; Lin, “Prior Negotiation and Remuneration for Patent Compulsory Licensing,” 184.

  79. 79.

    See Reichmann, Non-Voluntary licensing of patent inventions: historical perspective, legal framework under TRIPS and an overview of the practice in Canada and the USA; UNCTAD-ICTSD Project on IPRS and sustainable development, 2003, (as cited in Lin, “Prior Negotiation and Remuneration for Patent Compulsory Licensing,” 184-185); Lin, “Prior Negotiation and Remuneration for Patent Compulsory Licensing,” 184-185. See also James Love, Remuneration Guidelines for Non-Voluntary Use of a Patent on Medical Technologies, Health Economics and Drugs. TCM Series No. 18 (Geneva: World Health Organization, 2005), 62.

  80. 80.

    Lin, “Prior Negotiation and Remuneration for Patent Compulsory Licensing,” 180-181, 189.

  81. 81.

    See Gervais, TRIPS Agreement, 2.409; Taubman, “Rethinking TRIPS,” 953-954.

  82. 82.

    Taubman, “Rethinking TRIPS,” 954-955.

  83. 83.

    See ibid, 955-956.

  84. 84.

    Ibid, 955; similarly, de Carvalho, TRIPS Regime of Patent Rights, 366.

  85. 85.

    Lin, “Prior Negotiation and Remuneration for Patent Compulsory Licensing,” 182.

  86. 86.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 475.

  87. 87.

    Gervais, TRIPS Agreement, 2.409.

  88. 88.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 477.

  89. 89.

    See, for example ibid, 476-477; Castro Bernieri, Ex-Post Liability Rules in Modern Patent Law, 238-245; Välimäki, “Calculation of Royalties,” 8-18; Lin, “Prior Negotiation and Remuneration for Patent Compulsory Licensing,” 181-184.

  90. 90.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 476.

  91. 91.

    Ibid.

  92. 92.

    Ibid. For example, see Love, Remuneration Guidelines for Non-Voluntary Use of a Patent on Medical Technologies, 51-57, 62-65.

  93. 93.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 476.

  94. 94.

    de Carvalho, TRIPS Regime of Patent Rights, 366.

  95. 95.

    See Taubman, “Rethinking TRIPS,” 946. See also Castro Bernieri, Ex-Post Liability Rules in Modern Patent Law, 241-242. Cf. Straus and Prinz zu Waldeck und Pyrmont, “Survey of Compulsory Licensing Legislation,” 115-116, who note that little data were available concerning the determination of the royalty rates in European jurisdictions; this is due to the fact that the relevant statutes did not address the issue, the instruments were rarely used and in many cases did not mention licenses, and possibly also because the licenses granted are typically not subject to further litigation.

  96. 96.

    Castro Bernieri, Ex-Post Liability Rules in Modern Patent Law, 259.

  97. 97.

    See Sect. 4.3.3.

  98. 98.

    Lin, “Prior Negotiation and Remuneration for Patent Compulsory Licensing,” 189.

  99. 99.

    Market rate can be qualified with reference to “what the licensee would have been required to pay as compensation to the patent holder for a commercial licence under ordinary circumstances.” UNCTAD-ICTSD, Resource Book on TRIPS and Development, 476.

  100. 100.

    Gervais, TRIPS Agreement, 2.409.

  101. 101.

    An excessive royalty rate may also reflect an offensive intention to preclude a follow-on innovator’s access to a patent in a manner that equates to an unjustified refusal.

  102. 102.

    Lin, “Prior Negotiation and Remuneration for Patent Compulsory Licensing,” 181.

  103. 103.

    See Arora, Fosfuri, and Gambardella, Markets of Technology, 192-193, 195.

  104. 104.

    Gervais, TRIPS Agreement, 2.409.

  105. 105.

    One example of such an alternative method would be “requiring each patent holder to present a detailed justification for its royalty request.” UNCTAD-ICTSD, Resource Book on TRIPS and Development, 476. Another could be “considering licence fees in similar situations with a comparable market environment”. Straus and Prinz zu Waldeck und Pyrmont, “Survey of Compulsory Licensing Legislation,” 116-117.

  106. 106.

    Gervais, TRIPS Agreement, 2.409.

  107. 107.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 472.

  108. 108.

    Carlos M. Correa, “Patent Rights,” in Intellectual Property and International Trade: The TRIPS Agreement, ed. Carlos M. Correa and Abdulqawi A. Yusuf (Alphen aan den Rijn: Kluwer Law International, 2016) [hereinafter “Patent Rights 2016”], 298.

  109. 109.

    de Carvalho, TRIPS Regime of Patent Rights, 328.

  110. 110.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 473.

  111. 111.

    de Carvalho, TRIPS Regime of Patent Rights, 327.

  112. 112.

    In the case of dependent patents, assignability is subject to even stricter condition; the first patent may be assigned only with the second patent (Art. 31 (l) (iii) TRIPS).

  113. 113.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 473. Cf. Helfer “New Innovation Frontier,” 64.

  114. 114.

    de Carvalho, TRIPS Regime of Patent Rights, 328-329; Gervais, TRIPS Agreement, 2.409. However, the differences in the wording of Art. 5 A (4) PC and Art. 31 (e) TRIPS could also allow for the interpretation that the latter permits sub-licenses.

  115. 115.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 474.

  116. 116.

    Implementation of Paragraph 6 Doha Declaration.

  117. 117.

    Ullrich, “Mandatory Licensing under Patent Law and Competition Law,” 355. See also Richard Li-dar Wang, “Anchillary Orders of Compulsory Licensing and Their Compatibility with the TRIPS Agreeent,” 203, who argues in favour of adding an obligation to transfer know-how to compulsory licenses. However, such an ancillary order would be unjustifiable, as there is no legal entitlement to know-how. Hence, a patent holder cannot be obliged to share her trade secrets on the basis of a compulsory license, which is a carefully calibrated instrument that is intended to balance the patent system from the perspectives of functional efficiency and other policy goals.

  118. 118.

    Ullrich, “Mandatory Licensing under Patent Law and Competition Law : Different Concerns, Complementary Roles,” 355.

  119. 119.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 473.

  120. 120.

    Correa, “Patent Rights 2016,” 298.

  121. 121.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 475.

  122. 122.

    Gervais, TRIPS Agreement, 2.409.

  123. 123.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 474-475.

  124. 124.

    For a discussion on the interrelationship of Art. 30 and Art. 31 TRIPS, see Sect. 6.2.

  125. 125.

    Gervais, TRIPS Agreement, 2.409.

  126. 126.

    Michael Blakeney, Trade Related Aspects of Intellectual Property Rights : A Concise Guide to the TRIPS Agreement (London: Sweet & Maxwell, 1996), 91.

  127. 127.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 468. Also, with regard to governmental use, the review on individual merits can also take place ex post, after a license has been granted. Ibid.

  128. 128.

    Correa, Trade Related Aspects of Intellectual Property Rights, 320. Similarly, according to Gervais, “the provision would not prevent a license that would apply to a group of patents that a contractor would need to produce a product.” Gervais, TRIPS Agreement, 2.409.

  129. 129.

    Ullrich, “Mandatory Licensing under Patent Law and Competition Law,” 355, fn 111.

  130. 130.

    Shen and Lee, “Review of Granted Compulsory Licences,” 295.

  131. 131.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 477-478.

  132. 132.

    Ibid, 478.

  133. 133.

    Shen and Lee, “Review of Granted Compulsory Licences,” 295.

  134. 134.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 478.

  135. 135.

    Ibid.

  136. 136.

    Similarly ibid.

  137. 137.

    Carlos M. Correa, “Patent Rights,” in Intellectual Property and International Trade: The TRIPS Agreement, ed. Carlos M. Correa and Abdulqawi A. Yusuf (Alphen aan den Rijn: Kluwer Law International, 2008) [hereinafter “Patent Rights 2008]”, 252, fn 263.

  138. 138.

    Correa, “Patent Rights 2016,” 300.

  139. 139.

    Abello, La License, 217-218.

  140. 140.

    TRIPS does not employ the terms “dependent patents” or “blocking patents” in Art. 31 (k).

  141. 141.

    Friedrich-Karl Beier, “Exclusive Rights, Statutory Licenses and Compulsory Licenses in Patent and Utility Model Law,” IIC - International Review of Intellectual Property and Competition Law 30, no. 3 (1999): 266.

  142. 142.

    Straus, “Implications of the TRIPS Agreement,” 206-207; Matthias Leistner, “Requirements of Compulsory Dependency Licences : Learning from the Transformative Use Doctrine in Copyright Law,” in Compulsory Licensing: Practical Experiences and Ways Forward, ed. Reto M. Hilty and Kung-Chung Liu (Heidelberg: Springer Verlag, 2015), 222. In 1996, Straus identified nine industrialized countries in which the threshold for granting compulsory licenses on the basis of dependency was lower than that established in Art. 31 (l) (i) TRIPS. Straus, “Implications of the TRIPS Agreement,” 206. Cf. an overview of compulsory licenses for dependent patents in Europe prior to TRIPS provided by Walter, “Compulsory Licenses,” 537-538. See also Straus and Prinz zu Waldeck und Pyrmont, “Survey of Compulsory Licensing Legislation,” 49, 56, 103. Sweden and Finland’s provisions with regard to dependent patents remain much more lenient than Art. 31 (l) TRIPS would require; see ch. 6 § 46 Patentlag 1967: 837 (Svensk färfattnigssamling [SFS] 2018:19. (Swed.); ch. 6 § 46 Patenttilaki 15.12.1967/550 (Fin.)

  143. 143.

    Straus and Prinz zu Waldeck und Pyrmont, “Survey of Compulsory Licensing Legislation,” 16. The underlying objective of these instruments was also often to enable local companies to access patented technology. Correa, Trade Related Aspects of Intellectual Property Rights, 317; Gervais, TRIPS Agreement, 2.409.

  144. 144.

    Blakeney, Trade Related Aspects of Intellectual Property Rights, 93.

  145. 145.

    Focke Höhne, “Artikel 31,” in TRIPS - Internationales und europäisches Recht des Geistigen Eigentums : Kommentar, ed. Jan Busche, Peter-Tobias Stoll, and Andreas Wiebe (Cologne: Carl Heymanns-Verlag, 2013), 591. See also Walter, “Compulsory Licenses,” 532.

  146. 146.

    See also Rodrigues Jr, The General Exception Clauses of the TRIPS Agreement, 69.

  147. 147.

    Höhne, “Artikel 31,” 591.

  148. 148.

    Similarly, see Ullrich, “Mandatory Licensing under Patent Law and Competition Law,” 342; Abello, La License, 217-222.

  149. 149.

    Since the amendment of the PatG in 2005 following the implementation of the Biotechnology Directive, only the general condition of previous attempt to grant a license has been applied to dependent patents (§ 24 (2) no.1 PatG). See Mes, Patentgesetz, Gebrauchmustergesetz. § 24 at 20.

  150. 150.

    Polyferon, IIC 1997, 242, 245-248.

  151. 151.

    See Lamping et al., “Declaration on Patent Protection,” 688.

  152. 152.

    Ullrich, “Mandatory Licensing under Patent Law and Competition Law,” 340.

  153. 153.

    Ibid.

  154. 154.

    Ibid, 339, 341-342. Cf. de Carvalho, TRIPS Regime of Antitrust and Undisclosed Information, 145, in which the author rejects the competition-neural view of the instrument, claiming that Art. 31 (l) TRIPS showcases the scepticism of the drafters of TRIPS about “the efficient work of market forces”. The cross-licensing obligation, in his opinion, may even have the effect of increasing prices for end-consumers. De Carvalho also associates Art. 31 (l) TRIPS with the essential facilities doctrine. Ibid, 145-147. In my opinion, de Carvalho’s consideration disregards the narrowness of the instrument and the potential strategic interest of the holder of a first patent in obtaining a license to a second patent. The entitlement to a cross-license of Art. 31 (l) (ii) TRIPS benefits the first patent holder and ensures consumers access to the improved technology. Furthermore, compulsory licenses granted on the basis of the essential facilities doctrine are governed by Art. 31 (k) TRIPS.

  155. 155.

    Straus, “Implications of the TRIPS Agreement,” 206; Beier, “Patent and Utility Model Law,” 266; Leistner, “Requirements of Compulsory Dependency Licences,” 222. Hence, a mere economic interest is not sufficient to fulfil the requirement. Höhne, “Artikel 31,” 591-592.

  156. 156.

    Ullrich, “Mandatory Licensing under Patent Law and Competition Law,” 339.

  157. 157.

    Ibid, 340.

  158. 158.

    Leistner, “Requirements of Compulsory Dependency Licences : Learning from the Transformative Use Doctrine in Copyright Law,” 223, fn 6.

  159. 159.

    Ibid, 223. In many European jurisdictions, the adoption of the new criteria was accelerated via the Biotechnology Directive, ibid, 223-224. Art. 12 (3) b) of the Biotechnology Directive, which concerns compulsory cross-licensing of dependent patents and plant variety rights. It requires a dependent invention or a plant variety right to display “significant technical progress of considerable economic interest” in relation to the right it depends upon. The Directive is viewed to extend the minimum requirements of TRIPS by mandating the EU member states to enact compulsory licensing provisions, instead of leaving the question to their own discretion. Straus and Prinz zu Waldeck und Pyrmont, “Survey of Compulsory Licensing Legislation,” 27-28.

  160. 160.

    Straus, “Implications of the TRIPS Agreement,” 208.

  161. 161.

    Ibid.

  162. 162.

    Prior to the amendment of § 24 (2) PatG, compulsory licenses for dependent patents were subject to narrower interpretation; this drew from the earlier German doctrine of strict general public interest criteria for compulsory licenses, which also applied to dependent patents. This so-called “absolute interpretation” would have subjected the requirements for a dependent compulsory license, and especially finding of considerable economic significance, to the public interest criterion. Leistner, “Requirements of Compulsory Dependency Licences,” 223, fn 9, and 227, fn 27, with references.

  163. 163.

    Rodrigues Jr, The General Exception Clauses of the TRIPS Agreement, 69.

  164. 164.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 481.

  165. 165.

    Ibid.

  166. 166.

    Straus and Prinz zu Waldeck und Pyrmont, “Survey of Compulsory Licensing Legislation,” 41. Cf. Eikermann, “Article 31,” 578.

  167. 167.

    Walter, “Compulsory Licenses,” 534.

  168. 168.

    Leistner, “Requirements of Compulsory Dependency Licences,” 228-229.

  169. 169.

    Ullrich, “Mandatory Licensing under Patent Law and Competition Law : Different Concerns, Complementary Roles,” 340-342.

  170. 170.

    See Leistner, “Requirements of Compulsory Dependency Licences : Learning from the Transformative Use Doctrine in Copyright Law,” 229; Ullrich, “Mandatory Licensing under Patent Law and Competition Law : Different Concerns, Complementary Roles,” 340-341.

  171. 171.

    Ullrich, “Mandatory Licensing under Patent Law and Competition Law,” 340.

  172. 172.

    Gervais, TRIPS Agreement, 2.409.

  173. 173.

    de Carvalho, TRIPS Regime of Antitrust and Undisclosed Information, 144.

  174. 174.

    Correa, Trade Related Aspects of Intellectual Property Rights, 318.

  175. 175.

    Straus and Prinz zu Waldeck und Pyrmont, “Survey of Compulsory Licensing Legislation,” 41.

  176. 176.

    de Carvalho, TRIPS Regime of Antitrust and Undisclosed Information, 144.

  177. 177.

    Leistner, “Requirements of Compulsory Dependency Licences,” 222, 228, and fn 31-33.

  178. 178.

    Ibid, 230.

  179. 179.

    Ullrich, “Mandatory Licensing under Patent Law and Competition Law : Different Concerns, Complementary Roles,” 341-342. Ullrich, however, makes a contradictory statement, suggesting that “the economic significance may be determined by reference to the relevant (national?) markets.” Ibid, 341, fn 33.

  180. 180.

    Eikermann, “Article 31,” 578.

  181. 181.

    Ullrich, “Mandatory Licensing under Patent Law and Competition Law,” 342.

  182. 182.

    de Carvalho, TRIPS Regime of Antitrust and Undisclosed Information, 144.

  183. 183.

    Eikermann, “Article 31,” 578. Similarly, de Carvalho, TRIPS Regime of Antitrust and Undisclosed Information, 144-145. with reference to Art. 31 (c) TRIPS (sic).

  184. 184.

    Ullrich, “Mandatory Licensing under Patent Law and Competition Law,” 343.

  185. 185.

    See Ullrich, “Mandatory Licensing under Patent Law and Competition Law,” 339, 341-342.

  186. 186.

    Abello, La License, 217-218.

  187. 187.

    See Ullrich, “Mandatory Licensing under Patent Law and Competition Law,” 339, 341-342.

  188. 188.

    Straus, “Implications of the TRIPS Agreement,” 208.

  189. 189.

    See Leistner, “Requirements of Compulsory Dependency Licences,” 226-227, fn 26, with references, on the relevance of the indirect effect in the sphere of genetic inventions.

  190. 190.

    Ullrich, “Mandatory Licensing under Patent Law and Competition Law : Different Concerns, Complementary Roles,” 355-356.

  191. 191.

    The BGH confirmed the possibility to grant a interim compulsory license in the public interest in preliminary proceedings. Raltegravir, IIC 2018, 94; Slowinski, “Comment” 128.

  192. 192.

    Hans Peter Walter, “Compulsory Licenses in Respect of Dependent Patents under the Law of Switzerland and Other European States,” IIC - International Review of Intellectual Property and Competition Law. 21 (1990): 536, fn 12, with the following references.

  193. 193.

    Ullrich, “Mandatory Licensing under Patent Law and Competition Law,” 355-356.

  194. 194.

    Ibid, 340, fn 27.

  195. 195.

    See Van Overwalle et al., “Models for Facilitating Access to Patents on Genetic Inventions,” 147.

  196. 196.

    See Rodrigues Jr, The General Exception Clauses of the TRIPS Agreement, 69.

  197. 197.

    Ullrich, “Mandatory Licensing under Patent Law and Competition Law,” 340-343.

  198. 198.

    [Emphasis added].

  199. 199.

    Bodenhausen, Guide to the Appliction of the Paris Convention, 71, and the following references.

  200. 200.

    Malbon, Lawson, and Davison, WTO Agreement, 31.03.

  201. 201.

    Hilty, “Legal Remedies,” 387.

  202. 202.

    Ibid, 385.

  203. 203.

    Straus, “Implications of the TRIPS Agreement,” 204-205. Cf. Correa, Trade Related Aspects of Intellectual Property Rights, 315.

  204. 204.

    The BGH confirmed that public interest is a ground for a compulsory licence independent of Art. 5 A 2 PC. Polyferon, IIC 1997, 242, 245-246. See also Eikermann, “Article 31,” 564.

  205. 205.

    Art. 8 (1) TRIPS, paras 4 and 5 b) of the Doha Declaration. In addition, compulsory licenses issued on the basis of dependency do not require abusiveness on the part of a patent holder. See Ullrich, “Mandatory Licensing under Patent Law and Competition Law,” 339, 341-342.

  206. 206.

    Hilty, “Legal Remedies,” 384-385.

  207. 207.

    UNCTAD-ICTSD, Resource Book on TRIPS and Development, 548.

  208. 208.

    Hilty, “Legal Remedies,” 381.

  209. 209.

    Ibid, 387.

  210. 210.

    Straus, “Implications of the TRIPS Agreement,” 205.

  211. 211.

    Bodenhausen, Guide to the Appliction of the Paris Convention, 70.

  212. 212.

    Ibid, 73.

  213. 213.

    Ibid, 71.

  214. 214.

    Frankel and Lai, “Recognized and Appropriate Grounds for Compulsory Licenses,” 154.

  215. 215.

    See Ullrich, “Mandatory Licensing under Patent Law and Competition Law : Different Concerns, Complementary Roles,” 343-348.

  216. 216.

    Straus and Prinz zu Waldeck und Pyrmont, “Survey of Compulsory Licensing Legislation,” 3.

  217. 217.

    Bodenhausen, Guide to the Appliction of the Paris Convention, 70.

  218. 218.

    Blakeney, Trade Related Aspects of Intellectual Property Rights, 88.

  219. 219.

    Beier, “Patent and Utility Model Law,” 263.

  220. 220.

    Ibid, 262.

  221. 221.

    For example, in the context of developing countries, such a compulsory license could provide a means to access foreign technology and to develop a local technological base. See Rec. 6 TRIPS Preamble.

  222. 222.

    Bodenhausen, Guide to the Appliction of the Paris Convention, 71.

  223. 223.

    Blakeney, Trade Related Aspects of Intellectual Property Rights, 90-91. See also Frankel and Lai, “Recognized and Appropriate Grounds for Compulsory Licenses.” 155. During the drafting process, the topic was subject to intense debate in both developed and developing countries; see Carlos M. Correa, “Use of Compulsory Licenses in Latin America,” in Compulsory Licensing: Practical Experiences and Ways Forward, ed. Reto M. Hilty and Kung-Chung Liu (Heidelberg: Springer Verlag, 2015), 47, fn 14 for a history of the negotiations conducted during the Uruguay round.

  224. 224.

    Frankel and Lai, “Recognized and Appropriate Grounds for Compulsory Licenses,” 155.

  225. 225.

    Ana María Pacón, “What Will TRIPS Do for Developing Countries,” in From GATT to TRIPS - the Agreement on Trade-Related Spects on Intellectual Property Rights, ed. Friedrich-Karl Beier and Gerhard Schicker (Munich: VCH, 1996), 340.

  226. 226.

    The US initiated dispute resolution proceedings against Brazil, claiming that its local working requirement for patents violated Art. 27 and Art. 28 TRIPS. However, the matter was settled before the panel reached a decision on the matter. See Request for the Establishment of a Panel by the United States, Brazil - Measures Affecting Patent Protection, WTO Doc. WT/DS199/3 (adopted 9 January 2000); Notification of Mutually Agreed Solution, Brazil - Measures Affecting Patent Protection, WTO Doc. WT/DS199/4 (adopted 19 July 2001).

  227. 227.

    de Carvalho, TRIPS Regime of Patent Rights, 436; Straus, “Implications of the TRIPS Agreement,” 205; Gervais, TRIPS Agreement, 2.409. An even more restrictive view is taken by Wang, who views the principle of non-discrimination to apply also to Art. 5 A (4) PC on the basis of Art. 31 (1) VCLT in the light of the panel’s view in Canada Pharmaceuticals, see Wang, “Anchillary Orders of Compulsory Licensing,” 201-204, relying on Canada Pharmaceuticals, 7.91. Similar outcome derives from interpretation of Art. 2 (2) TRIPS, which prevents derogation of the obligations derived from a PC. However, since Art. 5 A (4) PC creates a right and not an obligation, Art. 27.1 TRIPS can be interpreted as enabling restrictions to compulsory licenses on the basis of their discriminatory character Art. 5 A (4) PC. UNCTAD-ICTSD, Resource Book on TRIPS and Development, 483, fn 947.

  228. 228.

    Correa, “Use of Compulsory Licenses in Latin America,” 48-49. Cf. Wang, “Anchillary Orders of Compulsory Licensing and Their Compatibility with the TRIPS Agreeent,” 202-203.

  229. 229.

    Lamping et al., “Declaration on Patent Protection,” 688-689.

  230. 230.

    Correa, Trade Related Aspects of Intellectual Property Rights, 317.

  231. 231.

    See Hartford-Empire Co. v. United States, 323 U.S. 386, 432-433 (1945).

  232. 232.

    See Frankel and Lai, “Recognized and Appropriate Grounds for Compulsory Licenses,” 154-155.

  233. 233.

    Straus and Prinz zu Waldeck und Pyrmont, “Survey of Compulsory Licensing Legislation,” 21.

  234. 234.

    Case C-235/89, Commission v. Italian Republic, 1992 E.C.R. I-777, para 29; Case C-30/90, Commission v. UK and Northern Ireland, 1992 E.C.R. I-829, para 33.

  235. 235.

    Similarly, Castro Bernieri, Ex-Post Liability Rules in Modern Patent Law, 87-88.

  236. 236.

    Beier, “Patent and Utility Model Law,” 263.

  237. 237.

    Castro Bernieri, Ex-Post Liability Rules in Modern Patent Law, 87-88.

  238. 238.

    Andreas Heinemann, “Antitrust Law of Intellectual Property in the TRIPS Agreement of the World Trade Organization,” in From GATT to TRIPS - the Agreement on Trade-Related Aspects on Intellectual Property Rights, ed. Friedrich-Karl Beier and Gerhard Schicker (Munich: VCH, 1996), 244. Cf. Mor Bakhoum and Beatriz Conde Gallego, “TRIPS and Competition Rules : From Transfer of Technology to Innovation Policy,” in TRIPS Plus 20: From Trade Rules to Market Principles, ed. Hanns Ullrich, et al. (Heidelberg: Springer Verlag, 2016), 554 in which the authors argue that the drafters of TRIPS had an inimical view of the interrelationship of competition and IP law.

  239. 239.

    Bakhoum and Conde Gallego, “TRIPS and Competition Rules,” 530-531, 538, 544-545.

  240. 240.

    Reichmann views Art. 8 (2) TRIPS as referring to the concrete measure of Art. 31 (k) TRIPS. Jerome H. Reichman, “Universal Minimum Standards of Intellectual Property Protection under the TRIPS Component of the WTO Agreement,” in Intellectual Property and International Trade: The TRIPS Agreement, ed. Carlos M. Correa and Abdulqawi A. Yusuf (Alphen aan den Rijn: Kluwer Law International, 2008), 34-35. In contrast, de Carvalho holds the views that Art. 8 (2) TRIPS does not address the situations regulated under Art. 31 (k) TRIPS because the instrument of Art. 31 (k) TRIPS is used to remedy anti-competitive practices, whereas Art. 8.2 TRIPS regulates measures that are aimed at their prevention. de Carvalho, TRIPS Regime of Antitrust and Undisclosed Information, 106, fn 187.

  241. 241.

    Bakhoum and Conde Gallego, “TRIPS and Competition Rules,” 553. When interpreted in conjunction with Art. 7 and Art. 8 TRIPS, Art. 40 (1) and Art. 40 (2) TRIPS are deemed to allow for measures that seek to ensure access to FRAND-encumbered SEPs. Peter Picht, “From Transfer of Technology to Innovation through Access,” in TRIPS Plus 20: From Trade Rules to Market Principles, ed. Hanns Ullrich, et al. (Heidelberg: Springer Verlag, 2016), 518.

  242. 242.

    Frankel and Lai, “Recognized and Appropriate Grounds for Compulsory Licenses,” 161. For examples of anti-competitive practices, see United Nations Conference on Trade and Development, United Nations Set of Principles and Rules on Competition, United Nations Conference on Trade and Development, Td/Rbp/Conf/10/Rev.2 (Geneva: United Nations, 2000):10-15.

  243. 243.

    Pacón, “What Will TRIPS Do for Developing Countries,” 340, fn 72.

  244. 244.

    Lin, “Prior Negotiation and Remuneration for Patent Compulsory Licensing,” 178.

  245. 245.

    Cf. de Carvalho, TRIPS Regime of Patent Rights, 436, who considers compulsory licenses targeting refusals to license altogether as unjustified under the TRIPS system.

  246. 246.

    As in the case of compulsory licenses against the abuse of the rights conferred by a patent, the instrument cannot address market failures that do not involve an active practice on the part of a right holder, such as underuse due to excessive transaction costs or royalty stacking. See Sect. 6.4.2.

  247. 247.

    See Bakhoum and Conde Gallego, “TRIPS and Competition Rules,” 524.

  248. 248.

    Straus, “Implications of the TRIPS Agreement,” 206-207.

  249. 249.

    de Carvalho, TRIPS Regime of Antitrust and Undisclosed Information, 142-143.

  250. 250.

    Picht, “From Transfer of Technology,” 520.

  251. 251.

    See de Carvalho, TRIPS Regime of Antitrust and Undisclosed Information, 142-143.

  252. 252.

    Cf. Picht, “From Transfer of Technology,” 520. However, whether such a decision would also fulfil the procedural requirement of Art. 31 (k) TRIPS for applicants for compulsory licenses who have not been parties to proceedings is uncertain. Ibid.

  253. 253.

    de Carvalho, TRIPS Regime of Antitrust and Undisclosed Information, at 31-12-31.12. de Carvalho therefore views the provision as allowing for compulsory licenses as a means of exercising preventive control over mergers. Ibid, 31-15.

  254. 254.

    de Carvalho, TRIPS Regime of Patent Rights, 504.

  255. 255.

    Lamping et al., “Declaration on Patent Protection,” 689.

  256. 256.

    Reichman, “Universal Minimum Standards of Intellectual Property Protection,” 35, fn 73. However, the conventional compulsory licenses, which are subject to the constraints of Art. 31 (b), (c) and (f) TRIPS would be inefficient in terms of interfering with market failures involving SEPs, particularly if they concern semiconductor technology. Picht, “From Transfer of Technology,” 525.

  257. 257.

    See Sect. 6.4.5. See also Esther van Zimmeren and Geertrui Van Overwalle, “Paper Tiger? Compulsory License Regimes for Public Health in Europe,” IIC - International Review of Intellectual Property and Competition Law 42 (2011): 24-26, 32-37.

  258. 258.

    Lamping et al., “Declaration on Patent Protection - Regulatory Sovereignity under TRIPS,” 688.

  259. 259.

    Government use is sometimes also referred to as Crown use. However, the scopes of of compulsory licenses for crown use in the U.K. and for government use in the U.S. are different. Celeste C. Yang, “Crown Use and Government Use,” in Compulsory Licensing: Practical Experiences and Ways Forward, ed. Reto M. Hilty and Kung-Chung Liu (Heidelberg: Springer Verlag, 2015): 397-398.

  260. 260.

    Cf. de Carvalho, who argues that Art. 31 TRIPS represents an “internal” exception to the rights conferred, and, as a result, it is not subject to the criteria of Art. 8 (1) TRIPS, which regulates the “external” exceptions and limitations that are based on the public interest. Therefore, only Art. 7 TRIPS on objectives and paragraph 4 of the Preamble have the effect of restricting the use of compulsory licenses to cases, in which the grant of a compulsory license is justified by social and collective interests. de Carvalho, TRIPS Regime of Patent Rights, 432-433, 436. This interpretation counters the panel’s view in Canada Pharmaceuticals that “[b]oth the goals and the limitations stated in Articles 7 and 8.1 […] as well as those of other provisions of the TRIPS Agreement which indicate its object and purposes” must be kept in mind when interpreting limitations to exclusive rights. Canada Pharmaceuticals, 7.26. Frankel and Lai also note that fn 5 (a) of the Doha Declaration highlighted the status of Art. 7 and 8 as the most central sources for identifying the object and purpose of TRIPS. Frankel and Lai, “Recognized and Appropriate Grounds for Compulsory Licenses,” 159.

  261. 261.

    Such use, however, is subject to an obligation to notify or inform the patent holder; see Art. 31 (b) TRIPS.

  262. 262.

    More generally, Art. 8 (1) TRIPS aims to ensure flexibility via the use of positive measures. This objective is further reinforced in the Doha Declaration with respect to health issues (Art. 4 Doha Declaration). Yusuf, “TRIPS,” 13-14. The Doha Declaration Art. 5 c) further specifies that public health crises can constitute emergencies under the meaning of Art. 31(b) TRIPS.

  263. 263.

    Lamping et al., “Declaration on Patent Protection,” 688.

  264. 264.

    Ibid, 690.

  265. 265.

    See Correa, Trade Related Aspects of Intellectual Property Rights, 313.

  266. 266.

    The preamble and Art. 7 TRIPS affect the interpretation of the notion of “the public interests in sectors of vital importance”. Yusuf, “TRIPS,” 13-14. In addition, Rec. 5 of the preamble recognizes societal and technological objectives as a part of both the societal and public policy objectives that member states have with regard to the protection of IP. See Florian Keßler, “Preamble,” in WTO: Trade-Related Aspects of Intellectual Property Rights, ed. Peter-Tobias Stoll, Jan Busche, and Katrin Arend (Leiden: Martinus Nijhoff Publishers, 2009), 71-72. Likewise, Rec. 6 of the TRIPS Preamble emphasizes the least developed countries’ flexibilities with respect to the domestic implementation of laws and remedies in order to facilitate the development of a “sound and viable technological base”.

  267. 267.

    For example, a compulsory license may respond to a refusal to license crucial technology for the establishment or development of a local sector. Lamping et al., “Declaration on Patent Protection,” 688.

  268. 268.

    See Correa, Trade Related Aspects of Intellectual Property Rights, 313. In addition, the different public policy objectives may also operate simultaneously. For example, Art. 66 (1) TRIPS and Rec. 6 of the Preamble, when read in conjunction with Art. 7 and 8 TRIPS, empower the least developed countries to determine compulsory licenses for sectors of vital importance for socio-economic and technological development with the purpose of ensuring technology transfer in order to develop a sound and viable technological base. Reichman, “Universal Minimum Standards of Intellectual Property Protection,” 36. Hence, the flexibilities provided in TRIPS for developmental policy purposes are at least indirectly intended to serve the general objectives of TRIPS with regard to the enforcement and protection of IP and in order to promote innovation, technology transfer, and the dissemination of technological knowledge in a manner conducive of social and economic welfare (Art. 7 TRIPS).

  269. 269.

    Castro Bernieri, Ex-Post Liability Rules in Modern Patent Law, 38.

  270. 270.

    Polyferon, IIC 1997, 242, 245-246. In the court’s view, neither national or international law, § 14 GG on the right to property, nor the Art. 5 A PC or Art. 30 TRIPS required the use of the patent to be of an abusive nature in order to fulfil the requirement of public interest of PatG § 24 (1). Other justifications may “include other circumstances, particularly of a technical, economic, socio-political and medical nature [citations omitted]. Account must be thereby be taken of the well-being of the general public, particularly in the field of general health care”; Polyferon, IIC 1997, 242, 246.

  271. 271.

    Beier, “Patent and Utility Model Law,” 265.

  272. 272.

    Bundesgesetz über die Erfindungspatente [SPatG] [Federal Law on Patents for Inventions] 25 June 1954, SR 232.14 (Switz.).

  273. 273.

    SPatG Art. 40 (e).

  274. 274.

    Kur and Schovsbo, Expropriation or Fair Game for All?, 23-24.

  275. 275.

    van Zimmeren and Van Overwalle, “A Paper Tiger? Compulsory License Regimes for Public Health in Europe,” 17.

  276. 276.

    Kur and Schovsbo, Expropriation or Fair Game for All?, 24.

  277. 277.

    van Zimmeren and Van Overwalle, “A Paper Tiger? Compulsory License Regimes for Public Health in Europe,” 12-17, 24. For further discussion on BRCA controversy, see Gert Matthijs, “The European Opposition against BRCA Gene Patents,” Familiar Cancer 5, no. 1 (2006): 97-99, 101; Miri Yoon, “Gene Patenting Debate: The Meaning of Myriad,” John Marshall Review of Intellectual Property law 9 (2010): 969-974.

  278. 278.

    See van Zimmeren and Van Overwalle, “A Paper Tiger? Compulsory License Regimes for Public Health in Europe,” 39.

  279. 279.

    SPatG Art. 40 (c). The anti-competitiveness was intended to encompass the foreclosure of diagnostic services through the exercise of fundamental gene patents, with the consequence of increasing prices for diagnostic testing, to the detriment of patients’, and hence public, health. van Zimmeren and Van Overwalle, “A Paper Tiger? Compulsory License Regimes for Public Health in Europe,” 28.

  280. 280.

    See ibid, 28-29. Code de la propriété intellectuelle [Intellectual Property Code] version consolidée au 1 juin 2019, Arts. L. 613-16-L 613-17 (Fr.); Code De Droit Économique/Wetboek van Economisch Recht [Code of Economic Law] Art. XI.38 (Belg.).

  281. 281.

    See van Zimmeren and Van Overwalle “A Paper Tiger? Compulsory License Regimes for Public Health in Europe,” 35.

  282. 282.

    Ibid, 39.

  283. 283.

    Lamping et al., “Declaration on Patent Protection”, 688.

  284. 284.

    Abello, La License, 217-218.

  285. 285.

    For a discussion controversy over local working requirement, see Sect. 6.4.3.2.

  286. 286.

    Rodrigues Jr, The General Exception Clauses of the TRIPS Agreement, 197-199.

  287. 287.

    Abello, La License, 217-218.

  288. 288.

    See also Areeda and Hovenkamp, Antitrust Law, X, at 1782g fn 204.

  289. 289.

    This is approach is taken in connection with the normative recommendation for a novel compulsory licensing instrument, see Sect. 9.4.

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Wernick, A. (2021). Compulsory Licenses in Patent Law. In: Mechanisms to Enable Follow-On Innovation. Munich Studies on Innovation and Competition, vol 15. Springer, Cham. https://doi.org/10.1007/978-3-030-72257-9_6

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