A paper tiger? Compulsory license regimes for public health in Europe

IIC International Review of Intellectual Property and Competition Law

Volumn 42, Issue 1, 2011, Pages 4-40

  Van Zimmeren, Esther ^a   Van Overwall, Geertrui ^b  

^a RESEARCH FOUNDATION FLANDERS FWO   (Belgium)

^b TILBURG UNIVERSITY   (Netherlands)

Author keywords

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EID: 79952134295     PISSN: 00189855     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (106)

1. See also VAN ZIMMEREN & REQUENA, "Ex-officio Licensing in the Medical Sector: The French Approach", in: VAN OVERWALLE (ed.), "Gene Patents and Public Health" 123-147 (Bruylant, Brussels 2007).
2. Debrulle Del Court Petit La licence obligatoire beige pour raisons de santé publique", in: VAN OVERWALLE (ed.), supra note 1, at 161-198.
3. See also GERMANN, "The Swiss Approach to Compulsory Licensing for Diagnostic Products and Processes", in: VAN OVERWALLE (ed.), supra note 1, at 149-157.
4. Association for Molecular Pathology (AMP) et al. v. United States Patent and Trademark Office (USPTO) et al., No. 09-4515 (S.D.N.Y. 29 March 2010).
5. "Biotech company monopoly on cancer genes is unlawful: Australian test case overpatents", press release 8 June 2010, available at http://www.mauriceblackburn.com.au/news/press-releases-announcements/ biotech-company-monopoly-on-cancer-genes-is-unlawful-australian-test-case-over- patents.aspx
6. Court of Justice of the European Union, 6 July 2010, Case C-428/08, Monsanto Technology LLC v. Cefetra BV, Cefetra Feed Service BV, Cefetra Futures BVand Alfred C. Toepfer International GmbH, [2010) ECR I-n.y.r. (referred by the 's Gravenhage District Court) and Case C-34/10, Briistle v. Greenpeace (referred by the German Federal Supreme Court).
7. Directive No. 98/44/EC of the European Parliament and of the Council of July 1998 on the legal protection of biotechnological inventions, [1998] OJ L213/13.
8. These questions concern the interpretation of the scope of protection granted to patents on biological material and the concept of
9. Annex 1C to the Agreement establishing the WTO, Marrakesh Declaration of April 14, 1994, TRIPs Agreement, available at http://www.wto.org/english/docs-e/ legal-e/27-trips. pdf.
10. For the purposes of this article, the terms "inventive step" and "capable of industrial application" may be deemed by a Member State to be synonymous with the terms "non-obvious" and "useful" respectively. See for instanceArt. 52(1) of the European Patent Convention (EPC) (Convention on the Grant of European Patents adopted by the Administrative Council on 28 June 2001, Munich, European Patent Office (EPO), 13th ed., July 2007, available at http://www.epo.org/patents/law/legal- texts/epc.html) "European patents shall be granted for any inventions, in all fields of technology, provided that they are new, involve an inventive step and are susceptible of industrial application". For the US, see 35 United States Code (U.S.C.) § 101 "Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title". Moreover, a patent may not be obtained even though the invention is novel, "if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art [⋯]" (35 U.S.C. § 103(a)).
11. We note that the term "European patent" is somewhat misleading. First, it is not a single patent, which is valid for the whole of Europe: indeed, the application and granting procedure is uniform, yet after the grant of the patent, it is split up into a "bundle" of national patents. These national patents are subject to national legislation and national invalidity and infringement procedures. Second, European patentsare not part of the European Union (EU) legal system. Apart from the fact that all EU Members States have signed up to the EPC - an international treaty - European patents have nothing to do with the EU. Neither is the EPO an agency or institution of the EU.
12. For an overview of the policy of the EPO on granting biotechnological inventions before the enactment of the EU Biotechnology Directive, see VAN OVERWALLE, "The Legal Protection of Biotechnological Inventions in Europe and in the United States: Current Framework and Future Developments" (University Press, Leuven 1997).
13. See old Rule 23 (cf. new Rule 29) of the Implementing Regulations to the EPC, which was inserted by decision of the Administrative Council of 16 June 1999, which entered into force on 1 September 1999.
14. EPO Technical Board of Appeal, 22 October 2002, T272/95, RelaxinlHoward Florey Institute, available at http://legal.european-patent-office.org/dg3/pdf/ t950272eu2.pdf.
15. Diamond v. Chakrabarty, 447 U.S. 303 (1980).
16. Parke-Davis &Co. v. H.K. Mulford Co., 189 F.95; 1911 U.S. App. LEXIS 5245 (S.D.N.Y. 28 April 1911).
17. EPO Technical Board of Appeal, 25 September 1987, T385/86, BRUKER/Non-Invasive Measurement, [1988] OJ EPO 308 and EPO Technical Board of Appeal, 29 June 2001, T964/99 CYGNUS/ Device and method for sampling of substances using alternating polarity [2002] OJ EPO 4.
18. EPO Enlarged Board of Appeal, 16 December 2005, Gl/04, Diagnostic Methods, available at http://legal.european-patent-office.org/dg3/pdf/g040001 e.pdf.
19. These steps include: (1) the collection of data (examination phase); (2) the comparison of found data with standard values (comparison phase); (3) the finding of any significant deviation; (4) the attribution of the deviations to a particular clinical picture (deductive medical decision phase).
20. Diamond v. Chakrabarty, 447 U.S. 303, at 309 (1980)
21. For an extensive analysis of the product of nature doctrine, see for instance CONLEY &MAKOWSKI, "Rethinking theProduct of Nature Doctrine as a Barrier to Biotechnology Patents in the United States - And Perhaps Europe as Well", 13 Information &Communications Technology Law 3-40 (2004).
22. In re Bernard L. Bilski and Rand A. Warsaw, 545 F.3d 943 (Fed. Cir. 2008), available at http://www.cafc.uscourts.gov/opinions/07-1130.pdf.
23. Bernard L. Bilski and Rand A. Warsaw v. David J. Kappos, Under Secretary of Commerce for Intellectual Property and Director, Patent and Trademark Office, No. 08-964, 130 U.S. 3218, available at http://www.supremecourt.gov/opinions/ 09pdf/08-964.pdf.
24. See for instance: Prometheus Laboratories, Inc. v. Mayo Collaborative Services dba Mayo Medical Laboratories and May Clinic Rochester, No. 2008-1403 (Fed. Cir. 2009), available at http://www.cafc.uscourts.gov/opinions/08-1403. pdf.
25. This is definitely not true for many countries outside Europe, which often do not have a statutory research exemption. For instance, in the United States the research exemption is not part of the patent act but exists as a judicially created theory. The theory has a very narrow scope of application. In the landmark case Madey v. Duke University (Madey v. Duke University, No. 01-1567, 307 F.3d 1351 (Fed. Cir. 2002), it was recalled that:"Regardless of whether a particular institution or entity is engaged in an endeavor for commercial gain, so long as the act is in furtherance of the alleged infringer's legitimate business and is not solely for amusement, to satisfy idle curiosity, or for strictphilosophical inquiry, the act does not qualify for the very narrow and strictly limited experimental use defense." Furthermore, the profit or nonprofit status of the user is not decisive for the applicability of the doctrine. Research projects that are financedby major research universities but that have no prospect of commercialization further theinstitution's legitimate business objectives, including: "educating and enlighteningstudents and faculty participating in these projects", and "serve to increase the status of the institution and lure lucrative research grants, students and faculty". This means that, after the Madey v. Duke University case, universities can no longer invoke experimental use in their defense. Concerns have been raised about this extremely limited interpretation.
26. Originally, this text was laid down in the Community Patent Convention. This convention was signed in Luxembourg on 15 December 1975, with the aim of creating a community patent: a single patent that is legally valid throughout the European Community. The expected advantages of this system include a substantial reduction in patenting costs (particularly those relating to translation and filing), simplification of application procedure (one single application procedure) and harmonization of interpretation (thanks to the establishment of a single centralized system of litigation). The convention has never enteredinto force. The discussions were resumed in 1989, but the convention is still not in place. The initiative has in the meantime become obsolete in light of the negotiations on an EU Patent and an EU Patent Court.
27. (Pubitemid 43128899)
28. Centre for intellectual property policy(CIPP), "The research or experimental use exemption: a comparative analysis" (Centre for Intellectual Property Policy Publications, Montreal 2004,), available at http://www.ipgen.un-montreal.ca/CIPP/007.pdf; CORNISH, "Experimental Use of Patented Inventions in European Community States", 29 IIC 735-753 (1998); VAN OVERWALLE, "Patent Law and Medicines", in: VAN OVERWALLE (ed.), "Octrooirecht en Geneesmiddelen" 65-91 (Bruy-lant, Brussels 2000); and CHROCZIEL, "Die Benutzung patentierte Erfindungen zu Ver-suchs- und Forschungszwecken" (Carl Heymanns Verlag, Cologne 1986).
29. Matthijs, "DNA Diagnostics in Practice", in: VAN OVERWALLE (ed.), "Gene Patents and Public Health" 27-44 (Bruylant, Brussels 2007).
30. VAN OVERWALLE, VAN ZIMMEREN, VERBEURE &MATTHIJS, "Models for facilitating access to patents on genetic inventions", 17 Nat. Rev. Genet. 143-148 (2006). (Pubitemid 43128899)
31. MERZ, KRISS, LEONARD &CHO, "Diagnostic testing fails the test", 415 Nature 577-579 (2002). (Pubitemid 34136365)
32. Matthijs &Halley, "European-wide opposition against the breast cancer gene patents", 10 Eur. J. Hum. Genet. 783-784 (2002) (Pubitemid 36054557)
33. Herrlinger, "Die Patentierung von Krank-heitsgenen" (Carl Heymanns Verlag, Cologne 2005) (in German).
34. EP0705902 (BRCA1), EP0705903 (BRCA1), EP0785216 (BRCA2). For more information, see: https://register.epoline.org/. EP0705902 related to "Nucleic acid probes comprising a fragment of the 17q-linked breast and ovarian cancer susceptibility gene" and was granted on 28 November 2001; opposition was filed in August 2002; appeal against the decision in opposition was filed on 15 November 2005 (T1213/05) but was rejected on 27 September 2007. The patent is maintained as amended in opposition. EP0705903 related to "Mutations in the 17q-linked breast and ovarian cancer susceptibility gene" and was granted on 23 May 2001; opposition was filed in February 2002; an appeal was lodged on 1 August 2005 (T0666/05) and led to a considerable limitation of the scope of the patent (13 November 2008). EP0785216 related to "Chromosome 13-linked breast cancer susceptibility gene BRCA2" and was granted on 8 January 2003; opposition was filed on 8 October2003 and led to the decision that the patent will be maintained in amended form (B2 New Specification of the European patent on 7 June 2006).
35. EP0699754 (BRCA1). EP0699754 related to a "Method for diagnosing a predisposition for breast and ovarian cancer" and was granted on 10 January 2001, opposition was filed (Contd. on page 13)in October 2001; appeal against the decision in opposition was filed on 14 January 2005 (T0080/05). In opposition the patent was revoked, but in the appeal initiated by the applicant the EPO allowed the applicant to reformulate the inventionresulting in an amendment of the original patent, which now only covers a diagnostic method for a specific type of mutation.
36. See for instance European patent EP699754(B2) claiming a method for diagnosing a predisposition for breast and ovarian cancer in a human subject which comprises determining in a tissue sample whether there is a germline alteration that is a frameshift mutation inthe sequence of the BRCA1 gene coding for a BRCA1 polypeptide altering the open reading frame for SEQ ID NO:2, said alteration being indicative of predisposition for breast and ovarian cancer (Claim 1).
37. Personal communication GERT MATTHIJS.
38. Editorial, "Myriad Genetics Targets Europe for Growth", Genomeweb Daily News, 12 August 2010, available at http://www.genomeweb.eom// node/947221?hq-e=el&hq-m= 785791&hq-l=l&hq-v=alb34dbcll.
39. ESHG working party on patenting and licensing, "Patenting and licensing in genetic testing - Recommendations of the European Society of Human Genetics", 16 Eur. J. Hum. Gen. s3-s9 (2008).
40. See also GOLD &CARBONE, "Case Study, Myriad Genetics: In the Eye of the Policy Storm", (International Expert Group on Biotechnology, Innovation and Intellectual Property, September 2008), available at http://www.theinnovationpartnership.org/en/ieg/cases/.
41. Community Affairs Committee Reference, Senator Parry, (Senate, 11 November 2008), available at http://www.aph.gov.aU/senate/pubs/daily/2008/ 111108.pdf.
42. Company Announcement, "Further Information re BRCA testing" (GTG, 24 November 2008), available at http://www.gtg.com.au/index.asp?menuid= 060.070.130&artid=10747 8cfunction=NewsArticle.
43. Company Announcement, "New Position re BRCA testing" (GTG, 2 December 2008), available at http://www.gtg.com.au/index.asp?menuid=060.070. 130&artid=10748&func-tion=NewsArticle.
44. AMP et al. v. USPTO et al., at 125.
45. Myriad Defendant's Notice of Appeal, 16 June 2010, available at http://www.genomicslawreport.com/wp-content/uploads/2010/06/Myriad-Genetics- Notice-of-Appeal.pdf.
46. SACGHS, "Revised Draft Report on Gene Patents and Licensing Practices and TheirImpact on Patient Access to Genetic Tests" (National Institutes of Health, Washington, D.C. 2010), available at http://oba.od. nih.gov/oba/SACGHS/SACGHS%20Patents%20Consul tation%20Draft%203%209%202009.pdf.
47. Even though in the UK, when the license of right was introduced into the domestic law by the Patents and Designs Act of 1919, not only could the patent owner register the patent as being available as of right, but also any interested parry could request the comptroller to issue a license of right on the ground that there had been an abuse of monopoly rights under the patent. Hence, at this moment in time, the distinction based on the voluntary or non-voluntary nature of the license did not apply.
48. 76/76/EEC: Convention for the European patent for the common market (Community Patent Convention), 26 January 1976, [1967] OJ L 17/1.
49. 89/695/EEC: Agreement relating to Community patents - Done at Luxembourg, 15 December 1989, [1989] OJ L 401/1.
50. For more information, see http://ec.europa.eu/internal-market/indprop/ patent/index-en. htm#system.
51. IBM The European Community Patent - A Realisable Dream, IBM Discussion Paper, available at http://www.epip.eu/conferences/epip02/lectures/ European%20Interoperabily% 20Patent%201.1.pdf. The authors of the discussion paper promote "soft IP", which would serve both open and proprietary innovation, and argue in favor of a Community patent which endorses a license of right in line with the idea of "soft IP".
52. PCR is a common technique to amplify a single or few copies of a piece of Deoxyribonucleic acid (DNA) generating thousands or millions of copies of a particular DNA sequence.
53. World Intellectual Property Organization (WIPO), Paris Convention for the Protectionof Industrial Property (of 20 March 1883, as revised at Brussels on 14 December 1900, at Washington on 2 June 1911, at The Hague on 6 November 1925, at London on 2 June 1934, at Lisbon on 31 October 1958, and at Stockholm on 14 July 1967, and as amended on 28 September 1979), available at http://www.wipo.int/treaties/en/ip/paris/trtdocs-wo020.html.
54. According to Art. 30 TRIPs, the three conditions have to be met in order to allow any exception to the exclusive patent right. Exceptions that have been stated by a WTO panel as falling within the scope of Art. 30 TRIPs are for instance use of the patented invention for research; for teaching purposes; in experiments on the invention to test or to improve it; in experiments for the purposes of seeking regulatory approval for marketing of the patented product after expiration of the patent, etc. Arts. 30 and 31 are mutually exclusive (WTO Report of the Panel, Canada - Patent Protection of Pharmaceutical Products, 17 March 2000, WT/DS114/R, at para. 7.20, available at http://www.wto.org/english/ tratop-e/dispu-e/7428 d.pdf).
55. See also CORREA & YUSUF, "Intellectual Property and International Trade: The TRIPs Agreement" 208 (Kluwer Law International, London-The Hague-New York 1998).
56. "Question 202, The Impact of Public Health Issues on Exclusive Patent Rights, Summary Report", 7-8, available at http://www.aippi.org/ download/comitees/202/SR202English.pdf.
57. For example government use, 28 U.S.C. § 1498; Atomic Energy Act, 42 U.S.C. § 2183, Clean Air Act, 42 U.S.C. § 7608; Plant Variety Protection Act, 7 U.S.C. § 2404 and the "march in right" in the so-called Bayh-Dole Act, 35 U.S.C. § 203.
58. Failure to work includes insufficient exploitation of the patent.
59. AIPPI, supra note 52, at 5.
60. This does not preclude that other acts may foresee compulsory licenses, for instance for reasons of national defense (Art. 31 §4 BPA).
61. Article 31 §1(3) of the Bill on Invention Patents: "The Minister can, in accordance with Arts. 32-36, grant a license for exploitation of an invention which is protected by a patent: [⋯] 3. when the patent manifests a particular public interest and when the grant of a compulsory license is indispensable to meet the country's needs" (Pari. Doc, Chamber, 1980-81, 919/1) [our italics].
62. Legislative Proposal on invention patents, Pari. Doc., Chamber, 1982-83, 9715/2, at 22
63. Legislative Proposal on invention patents, amendment proposed by the government, Pari. Doc, Chamber, 1980-81, 919/1, at 1.
64. See also VAN OVERWALLE, "The Implementation of the Biotechnology Directive in Belgium and Its After-Effects. The Introduction of a New Research Exemption and a Compulsory License for Public Health", 37 IIC 909 (2006).
65. Verschaeve, "Naar een nieuw oc-trooirecht", 2241-2258 Rechtskundig Weekblad (1984-85).
66. AIPPI, supra note 52, at 7.
67. "Ministerial declaration adopted on 14 November 2001" (WT/MIN(01)/DEC/1), at point 17, available at http://www.wto.org/english/thewto- e/rninist-e/min01-e/mindecl-e.htm.
68. "Declaration on the TRIPS Agreement and Public Health, adopted on 14 November 2001" (WT/MIN(01)/DEC/2), at point 5(b), available at http://www.wto.org/english/thew-to-e/minist-e/min01-e/mindecl-trips-e.htm.
69. "4. We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted andimplemented in a manner supportive of WTO members' right to protect public health and, inparticular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility [our italics] for this purpose."
70. See for instance: WHO World Health Assembly, "Global strategy and plan of action on public health, innovation and intellectual property" (WHO, Geneva, Sixty-firstWorld Health Assembly, 24 May 2008, WHA61.21), available at http://www.who.int/gb/ebwha/ pdf-files/A61/A61-R21-en.pdf.
71. See also MUSUNGU &OH, "The Use of Flexibilities in TRIPs by Developing Countries: Can They Promote Access to Medicines?" (Commission on Intellectual Property Rights Innovation and Public Health (CIPIH), Study 4C, August 2005), available at http://www.who.int/intellectualproperty/studies/ TRIPSFLEXI.pdf.
72. By then the ex-officio license could relate to medicines and processes for obtaining those medicines, to products necessary for obtaining medicines and processes for the manufacture of such products, but not to diagnostics tests. See Art. 1 of Decree No. 53-971 of 30 September 1953 (1 October 1953 French OJ 8632, rectification 4 October 1953 French OJ 8718) and Art. L.604 of Ordinance No. 59-250 of 4 February 1959 (8 February 1959 French OJ 1756-1759) and decree No. 60-507 of 30 May 1960 (31 May 1960 French OJ 4923-4925).
73. Article 18 of Act No. 2004-800 of 6 August 2004 (7 August 2004 French OJ) and Art. 10 of Act No. 2004-1338 of 8 December 2004 (9 December 2004 French OJ), both available at http://www.legifrance.fr.
74. Even though Switzerland is not a Member State of the European Union and thus formally not obliged to comply with European legislation.
75. WIPO, Patent Law Treaty, adopted at Geneva on 1 June 2000, available at http://www.wipo.int/treaties/en/ip/plt/trtdocs-wo038.html.
76. See for an explanation of the context and background of this review and the articleswhich were proposed: Botschaft zur Anderung des Patentgesetzes und zum Bundesbe-schluss iiber die Genehmigung des Patentrechtsvertrags und der Ausfiihrungsordnung, 23 November 2005, No. 05.082, available at http://www.admin.en/ch/d/ff/2006/l.pdf.
77. Act of 22 June 2007 to modify the Patent Act of 25 June 1954, AS 2008, 2551-2584, available at http://www.admin.ch/ch/d/as/2008/2551.pdf.
78. Act of 28 April 2005 to modify the Act of 28 March 1984 on Invention Patents, with regard to the Patentability of Biotechnological Inventions, Official Gazette, 13 May 2005.
79. Federal Act on Cartels and Other Restraints of Competition (Cartel Act; LCart) of 6 October 1995 (position as of 13 June 2006). For an English version, see http://www.weko.admin.ch/.
80. Translation provided by VAN OVERWALLE &HAASL, see VAN OVERWALLE (ed.), "Gene Patents and Public Health" (Bruylant, Brussels 2007).
81. The countries would, however, have some slight leeway, as some exports might be permitted unless the exports constitute the main use of the compulsory license. Any eventual surpluses may be exported. GERVAIS, "The TRIPS Agreement: Drafting History and Analysis" 166 (Sweet &Maxwell, London 2003); and PIRES DE CARVALHO, "The TRIPs Regime of Patent Rights" 241 (Kluwer Law International, London, The Hague, New York 2002). However, we can assume that for serious, long-term health problems and outbreaks ofdangerous diseases this leeway is manifestly insufficient.
82. WTO Ministerial Conference, Fourth Session, "Ministerial Declaration on the TRIPS Agreement and Public Health", 14 November 2001, WT/MIN(01)/DEC/1, available at http://www.wto.org/english/thewto-e/minist-e/ min01-e/mindecl-e.pdf.
83. WTO General Council, "Implementation of Paragraph 6 of the Doha Declaration on the TRIPs Agreement and Public Health", 30 August 2003, WT/L/540, available at http:// www.wto.org/english/tratop-e/trips-e/implem- para6-e.htm.
84. WTO General Council, "Amendment of the TRIPs Agreement, Implementation of Paragraph 6 of the Doha Declaration", 6 December 2005, WT/L/641, available at http://docs online.wto.org/DDFDocumen ts/t/WT/L/641.doc.
85. Annex to the TRIPs Agreement, Art. 1(a), available at http://www.wto.org/english/tratop-e/trips-e/wtl64l-e.htm.
86. Australia, Canada, the European Communities with its Member States, Iceland, Japan, New Zealand, Norway, Switzerland, and the United States. See http://www.wto.org/english/tratop-e/trips-e/wtl641e.htm#fnt3.
87. For all the ratifications, see http://www.wto.org/english/tratop-e/TRIPS- e/amendment-e.htm.
88. Switzerland applies a very developed form of so-called "monism" regarding the effect of international treaties in its domestic law. The essence of this monist approach is that a treaty may, without the need for further national legislation, become part of the domestic law once it has been concluded in accordance with the constitution and has entered into force.
89. Council of the European Union, 2007/768/EC: Council Decision of 19 November 2007 on the acceptance, on behalf of the European Community, of the Protocol amending the TRIPS Agreement, done at Geneva on 6 December 2005, [2007] OJ L 311/35.
90. Regulation (EC) No. 816/2006 of the European Parliament and of the Council of 17 May2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems, [2006] OJ L 157/1.
91. See e.g., VANDOREN &RAVILLARD, "A New EC Initiative to Allow Export of Medicines under Compulsory Licenses to Poor Countries", 8 The Journal of World Intellectual Property 103-121 (2005).
92. Two thirds of the Members should formally accept the amendment, before the amendmentcan take effect and replace the 2003 waiver decision. Until that moment, the waiver will apply. For now not even half of the required number of ratifications has been received, see http://www.wto.org/english/tratop-e/TRIPS- e/amendment-e.htm.
93. For more information, see http://www.wto.org/english/tratop-e/trips-e/ public-health-e.htm and http://www.apotex.com/be/en/aboutapotex/sept23.asp.
94. Nine Canadian patents cover these drugs. Four of these are owned by the GlaxoSmith Kline Group, two by the Wellcome Foundation, two by Shire Biochem and one by Boeh-ringer Ingelheim and Dr. Karl Thomae GmbH.
95. HESTERMEYER, "Canadian-made Drugs for Rwanda: The First Application of the WTO Waiver on Patents and Medicines", 11 The American Society of International Law, Issue 28 (2007), available at http://www.asil.Org/ insights071210.cfm#-ednref8.
96. Only disputes regarding the remuneration or requests for review might end up before the court.
97. In practice, the patent holder may already have granted exclusive/non-exclusive licenses. The interests of those licensees, provided they are registered in the national patent register, will be taken into consideration in the grant of a compulsory license. We refer to these licensees as "prior licensees".
98. See https://portal.health.fgov.be/portal/page?-pageid=56,S126768c-dad= portal&-schema=portal.
99. Pires De Carvalho, supra note 75, at 233; and CORREA &YUSUF, supra note 51, at 213.
100. Cf. PIRES DE CARVALHO, supra note 75, at 234-236
101. Differently CORREA 8C YUSUF, supra note 51, at 210-211.
102. See also VAN OVERWALLE, supra note 59, at 889-919; and VAN OVERWALLE &VAN ZIM-MEREN, "Reshaping Belgian Patent Law: The Revision of the Research Exemption and the (Contd. on page 36)
103. Introduction of a Compulsory License for Public Health", 2006 Institute of Intellectual Property (IIP) Forum (Japan) 42-49 (Publication in Japanese; For an English translation
104. see http://www.iip.or.Jp/e/index.html). 96 Cf. CORREA, "The GATT Agreement on Trade-related Aspects of Intellectual Property Rights: New Standards for Patent Protection", 16 European Intellectual Property Review (EIPR) 327-335, at 333 (1994).
105. We note however, that in special circumstances, like a public health crisis, the King may decide to speed up the procedure. One of the ways to do this, according to the BPA, is to drop the opinion from the Advisory Committee.
106. See Art. 31bis §6 BPA.