An exception to infringement for genetic testing - Addressing patient access and divergence between law and practice

IIC International Review of Intellectual Property and Competition Law

Volumn 43, Issue 6, 2012, Pages 641-661

  Hawkins, Naomi ^a  

^a UNIVERSITY OF EXETER   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84867019666     PISSN: 00189855     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (94)

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3. T CAULFIELD, RM COOK-DEEGAN, FS KIEFF & JP WALSH, "Evidence and anecdotes: an analysis of human gene patenting controversies", 24 Nature Biotechnology 1091-1094 (2006). (Pubitemid 44359715)
4. For a discussion of BRCA patents see S PARTHASARATHY, "Building Genetic Medicine: Breast Cancer, Technology and the Comparative Politics of Health Care", (MIT Press 2007);
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16. sent back to the CAFC for further consideration in light of the US Supreme Court decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc (decided 20 March 2012).
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21. Association for Molecular Pathology et al v. United States Patent and Trademark Office et al. 669 F. Supp. 2d 365 (2010) (United States District Court for the Southern District of New York);
22. Association for Molecular Pathology v. United States Patent and Trademark Office 653 F.3d 1329 (US CAFC)
23. sent back to the CAFC for further consideration in light of the US Supreme Court decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc (decided 20 March 2012);
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38. J KAYE, N HAWKINS & J TAYLOR, "Patents and Translational Research in Genomics", 25 Nature Biotechnology 739-741 (2007). (Pubitemid 47053866)
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40. This was one of the concerns raised in the Myriad litigation, and discussed in Secretary's Advisory Committee on Genetics Health and Society, "Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests", (2010).
41. Secretary's Advisory Committee on Genetics, Health and Society, "Gene Patent and Licensing Practices and Their Impact on Patient Access to Genetic Tests" 3 (2010).
42. The situation is somewhat different in the USA, which has a very different system of medical care to Europe. For a discussion of the impact of gene patents on genetic testing in the USA, see Secretary's Advisory Committee on Genetics, Health and Society, "Gene Patent and Licensing Practices and Their Impact on Patient Access to Genetic Tests" (2010) and the reports of case studies published at 12 (4) Genetics in Medicine S1-S211 (2010).
43. N HAWKINS, "The impact of human gene patents on genetic testing in the United Kingdom", 13 Genetics in Medicine 320-324 (2011);
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51. The NHS Constitution (Department of Health, London 2009); Great Britain Ministry of Health, "A National Health Service", (Cmd 6502, 1944).
52. Asahi Kasei Kogyo [1991] RPC 485 (HL) 523.
53. N HAWKINS, "The impact of human gene patents on genetic testing in the United Kingdom", 13 Genetics in Medicine 320-324 (2011).
54. Because this paper takes a different perspective to that traditionally advanced in relation to the "gene patent problem", many of the solutions often advanced (such as recourse to compulsory licensing) will therefore be of limited value, and they are therefore not discussed in this paper. For a discussion of such solutions in relation to gene patents see G VAN OVERWALLE, "Gene Patents and Collaborative Licensing Models: Patent Pools, Clearinghouses, Open Source Models, and Liability Regimes", (Cambridge University Press, Cambridge 2009).
55. N HAWKINS, "The impact of human gene patents on genetic testing in the United Kingdom", 13 Genetics in Medicine 320-4 (2011).
56. JP WALSH, C CHO & WM COHEN, "Patents, Material Transfers and Access to Research Inputs in Biomedical Research, Final Report to the National Academy of Sciences' Committee Intellectual Property Rights in Genomic and Protein-Related Inventions" (National Academy of Sciences, Chicago 2005).
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61. Diagnostic Methods (G1/04) [2006] EPOR 15 (EPO (Enlarged Board of Appeal)) [4].
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67. J PILA, "Methods of Medical Treatment within Australian and United Kingdom Patents Law", 24 U OF NEW SOUTH WALES LJ 420-461 (2001).
68. B DOMEIJ, "Pharmaceutical Patents in Europe" 310 (Stockholm Studies in Law, Kluwer Law International, The Hague 2000).
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72. The Frist-Gankse medical procedures exemption: 35 USC § 287 (c).
73. Secretary's Advisory Committee on Genetics, Health and Society, "Public Consultation Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests" 38 (2009).
74. For a discussion of the compulsory licensing provisions in European jurisdictions see E VAN ZIMMEREN & G VAN OVERWALLE, "A Paper Tiger? Compulsory License Regimes for Public Health in Europe", 42 IIC 4-40 (2011).
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79. WR CORNISH, M LLEWELYN & M ADCOCK, "Intellectual Property Rights (IPRs) and Genetics: A Study into the Impact and Management of Intellectual Property Rights within the Healthcare Sector", Section C (2) (c) (Public Health Genetics Unit, Cambridge Genetics Knowledge Park, Cambridge 2003).
80. Secretary's Advisory Committee on Genetics, Health and Society, "Public Consultation Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests" (2009).
81. L. BENTLY, "Exclusions from Patentability and Exceptions to Patentees' Rights: Taking Exceptions Seriously", 64 Current Legal Problems 315-347 (2011) 319.
82. Diagnostic Methods (G1/04) [2006] EPOR 15 (EPO (Enlarged Board of Appeal)).
83. See, for example, the Authority's guidance on the meaning and parameters of "relevant material", available at: "Human Tissue Authority "Definition of Relevant Material" http://www.hta.gov. uk/legislationpoliciesandcodesofpractice/definitionofrelevantmaterial.cfm accessed 13 June 2012.
84. L BENDEKGEY & D HAMLET-COX, "Gene Patents and Innovation", 77 Academic Medicine 1373-1380 (2002). (Pubitemid 36019279)
85. This question was raised before the US Supreme Court in Laboratory Corporation of America Holdings v. Metabolite Laboratories Inc 26 S. Ct 2921 (2006) (US Supreme Court).
86. RC DREYFUSS AND JP EVANS, "From Bilski Back to Benson: Preemption, Inventing Around, and the Case of Genetic Diagnostics", 63 Stanford Law Review 1349-1376 (2011).
87. L. BENTLY, "Exclusions from Patentability and Exceptions to Patentees' Rights: Taking Exceptions Seriously", 164 Current Legal Problems 315-347 (2011) 344.
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90. L BENTLY, "Exclusions from Patentability and Exceptions to Patentees' Rights: Taking Exceptions Seriously", 64 Current Legal Problems 315-347(2011), 346.
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92. Although authors have questioned their compliance: L BENTLY, "Exclusions from Patentability and Exceptions to Patentees' Rights: Taking Exceptions Seriously", 64 Current Legal Problems 315-347 (2011);
93. EC MELVIN, "An Unacceptable Exception: The Ramifications of Physician Immunity from Medical Procedure Patent Infringement Liability", 91 Minnesota L Rev 1088-1112 (2007).
94. Although there is some political interest potentially developing: Parliamentary Office of Science and Technology, POSTnote 401, "Biomedical Patents" (2012).