Gene patents and personalized medicine - what lies ahead?

Genome Medicine

Volumn 1, Issue 9, 2009, Pages

  Chandrasekharan, Subhashini ^a   Cook Deegan, Robert ^a  

^a DUKE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COMPLEMENTARY DNA;

ADVISORY COMMITTEE; COST; DNA DETERMINATION; DNA SEQUENCE; EVIDENCE BASED MEDICINE; GENE EXPRESSION PROFILING; GENETIC SCREENING; GENETIC VARIABILITY; GENETICS; GENOMICS; GENOTYPE; HUMAN; JURISPRUDENCE; LAW; LAW SUIT; LICENCE; NOTE; PATENT; POLICY; PRIORITY JOURNAL; UNCERTAINTY;

EID: 77953404006     PISSN: None     EISSN: 1756994X     Source Type: Journal    
DOI: 10.1186/gm92     Document Type: Note

References (30)

1. Georgetown University: DNA Patent Database [http://dnapat-ents.georgetown.edu/] (accessed 10 September 2009).
2. Jensen K, Murray F: Intellectual property. Enhanced: intel-lectual property landscape of the human genome. Science 2005, 310:239-240.
3. Hopkins MM, Mahdi S, Patel P, Thomas SM: DNA patenting: the end of an era? Nat Biotechnol 2007, 25:185-187.
4. Holman CM: Genetics. Trends in human gene patent litiga-tion. Science 2008, 322:198-199.
5. Caulfield T, Bubela T, Murdoch CJ: Myriad and the mass media: the covering of a gene patent controversy. Genet Med 2007, 9:850-855.
6. Marshall E: Biotechnology. Lawsuit challenges legal basis for patenting human genes. Science 2009, 324:1000-1001.
7. Nuffield Council on Bioethics: The Ethics of Patenting DNA. London: Nuffield Council on Bioethics; 2002 [http://www.nuff-ieldbioethics.org/fileLibrary/pdf/theethicsofpatentingd na.pdf] (accessed 10 September 2009).
8. Australian Law Reform Commission: Genes and Ingenuity: Gene Patenting and Human Health Report 99. Canberra; 2004. [http://www.austlii.edu.au/au/other/alrc/publications/reports/99/]
9. Organization for Economic Co-operation and Development (OECD): Guidelines for the Licensing of Genetic Inventions. Paris: OECD; 2006 [http://www.oecd.org/dataoecd/39/ 38/ 36198812.pdf] (accessed 10 September 2009).
10. Aymé S, Matthijs G, Soini S; ESHG Working Party on Patenting and Licensing: Patenting and licensing in genetic testing: recommendations of the European Society of Human Genetics. Eur J Hum Genet 2008, 16(Suppl 1):S10-19.
11. Merz JF, Kriss AG, Leonard DG, Cho MK: Diagnostic testing fails the test. Nature 2002, 415:577-579.
12. Parthasarathy S: Architectures of genetic medicine: com-paring genetic testing for breast cancer in the USA and the UK. Soc Stud Sci 2005, 35:5-40.
13. Parthasarathy S: Building Genetic Medicine: Breast Cancer, Technology, and the Comparative Politics of Health Care. Cambridge MA: MIT Press, 2007.
14. Matthijs G, Hodgson S: The impact of patenting on DNA diagnostic practice. Clin Med 2008, 8:58-60.
15. Sevilla C, Moatti JP, Julian-Reynier C, Eisinger F, Stoppa-Lyonnet D, Bressac-de Paillerets B, Sobol H: Testing for BRCA1 mutations: a cost-effectiveness analysis. Eur J Hum Genet 2002, 10:599-606.
16. Sevilla C, Julian-Reynier C, Eisinger F, Stoppa-Lyonnet D, Bressac-de Paillerets B, Sobol H, Moatti JP: Impact of gene patents on the cost-effective delivery of care: the case of BRCA1 genetic testing. Int J Technol Assess Health Care 2003, 19:287-300.
17. Cho MK, Illangasekare S, Weaver MA, Leonard DG, Merz JF: Effects of patents and licenses on the provision of clinical genetic testing services. J Mol Diagn 2003, 5:3-8.
18. 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. Bethesda: SACGHS; 2009 [http://oba.od.nih. gov/oba/SACGHS/SACGHS%20Patents%20Consultation%20 Draft%203%209%202009.pdf] (accessed 10 September 2009).
19. Cook-Deegan R, Chandrasekharan S, Angrist M: The dangers of diagnostic monopolies. Nature 2009, 458:405-406.
20. Secretary's Advisory Committee on Genetics Health and Society Public Consultation Draft Report Appendix 1, Compendium of Case Studies. Bethesda: SACGHS; [http://oba.od.nih. gov/oba/SACGHS/Appendix%201%20SACGHS%20Patents%20Consultation%20Draft%20 Compendium%20of%20 Case%20Studies.pdf] (accessed 10 September 2009).
21. United States Patent and Trademark Office: Utility examina-tion guidelines. Fed Regist 2001, 66:1092-1099.
22. United States Patent and Trademark Office: Guidelines for written description requirement. Fed Regist 2001, 66:1099-1111.
23. KSR International Co. v. Teleflex, Inc., 127 S. Ct. 1727 (2007).
24. eBay Inc. v. MercExchange, LLC, 547 U.S. 388 (2006).
25. Bilski v. Kappos, 545 F.3d 943 3d 943 (Fed. Cir. 2008), cert. granted, 556 U.S. 2009 (No. 08-964).
26. Prometheus v. Mayo 2008 WL 878910 (S.D. Cal.). US CAFC 2008-1403, 16 September 2009.
27. Birgit Verbeure, Gert Matthijs, Geertrui Van Overwalle: Analysing DNA patents in relation with diagnostic genetic testing. Eur J Hum Genet 2006,14:26-33.
28. Gaisser S, Hopkins MM, Liddell K, Zika E, Ibarreta D: The phantom menace of gene patents. Nature, 2009, 458:407-408.
29. Huys I, Berthels N, Matthijs G, van Overwalle G: Uncertainty in the area of genetic diagnostic testing. Nat Biotechnol 2009, in press.
30. National Research Council, Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation: Reaping the Benefits of Genomic and Proteomic Research. Washington: National Academies Press; 2005 [http://www.nap.edu/catalog/11487.html] (accessed 10 September 2009).