Collaborative licensing in biotechnology: A survey of knowledge, experience, and attitudes in Australia

Biotechnology Law Report

Volumn 29, Issue 5, 2010, Pages 465-483

  Nicol, Dianne ^a  

^a UNIVERSITY OF TASMANIA   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 77958022466     PISSN: 0730031X     EISSN: None     Source Type: Journal    
DOI: 10.1089/blr.2010.9930     Document Type: Article

References (68)

1. For further discussion, see Nicol D and Nielsen J (2003). Patents and Medical Biotechnology: An Empirical Analysis of Issues Facing the Australian Industry. Hobart: Centre for Law and Genetics Occasional Paper No. 6 at 82-85. Available at www.lawgenecentre.org/pub.php.
2. See, for example, The International Expert Group on Biotechnology, Innovation and Intellectual Property (2008). Towards a New Era of Intellectual Property: from Confrontation to Negotiation, particularly at 35. Available at: http://www.theinnovationpartnership.org/en/ieg/report/.
3. See Nicol and Nielsen, above note 1 at 38-49.
4. Senate Community Affairs Committee (2009). Inquiry into Gene Patents. Available at www.aph.gov. au/senate/committee/clac-ctte/gene-patents/tor.htm.
5. The first instance decision in Association for Molecular Pathology v United States Patent and Trademark Office US District Court Southern District of New York (2010) was handed down by Sweet J on 29 March 2010. This case related to patents held by Myriad Genetics, claiming isolated DNA sequences coding for BRCA 1 and BRCA 2 genes, both of which are associated with hereditary forms of breast cancer, together with other patents claiming methods of analyzing those sequences. The judge held that both the product and the method claims were not patentable subject matter, as required under 35 USC § 101 (see 29 BLR 303 and 317 2010).
6. For the position in Australia, see Australian Law Reform Commission (2004). Genes and Ingenuity: Gene Patenting and Human Health. Report 99. Canberra: Commonwealth of Australia. Available at www.austlii.edu.au/au/other/ alrc/publications/reports/99/;
7. Nicol D. On the legality of gene patents. Melbourne University Law Review 2005;29:809-842;
8. for the U. S., see Secretary's Advisory Committee on Genetics, Health and Society (SACGHS) (2010). Gene Patents and Licensing Practices and Patient Access to Genetic Tests. Available at http://oba. od.nih.gov/SACGHS/sacghs- documents.html#GHSDOC-011;
9. for Europe, see Nuffield Council on Bioethics (2002). The Ethics of Patenting DNA. A Discussion Paper. London: Nuffield Council on Bioethics. Available at www.nuffieldbioethics.org/fileLibrary/pdf/theethicsofpatentingdna. pdf;
10. Van Overwalle G (2008). Biotechnology and patents: global standards, European approaches and national accents. In Wuger D and Cottier T (eds.) Genetic Engineering and the World Trade System. Cambridge, U. K.: Cambridge University Press, 77-108.
11. Holman CM. Trends in human gene patent litigation. Science 2008;322:198-199.
12. Jensen K and Murray F. Intellectual property landscape of the human genome. Science 2005;310:239-240.
13. Also see Chandrasekharan S and Cook-Deegan R. Gene patents and personalized medicine-what lies ahead? Genome Medicine 2009;1: # 92.
14. Hopkins MM, Mahdi S, Patel P, Thomas SM (2006). The Patenting of Human DNA: Global Trends in Public and Private Sector Activity. A Report for the European Commission. Brighton, UK: SPRU at 14. Available at www.sussex.ac.uk/ spru/documents/patgen-finalreport.pdf.
15. Walsh JP, Arora A, Cohen WM (2001). Effects of research tool patents and licensing on biomedical innovation. In Cohen WM and Merrill SA (Eds.). Patents in the Knowledge-Based Economy. Washington, DC: The National Academies Press, 285-340, particularly at 332-335.
16. Heller MA and Eisenberg RS. Can patents deter innovation? The anticommons in biomedical research. Science 1998;280:698-701.
17. Walsh JP, Cho C, and Cohen WM. View from the bench: patents and material transfers. Science 2005;309:2002-2003.
18. Lei Z, Juneja R, and Wright B. Patents versus patenting: implications of intellectual property protection for biological research. Nature Biotechnol 2009;7:36-40.
19. Nicol and Nielsen, above note 1, at 251-256.
20. Above note 10.
21. See particularly on the U. S. perspective: Walsh, Arora and Cohen, above note 10; and on the U. K. perspective: Intellectual Property Institute (2004). Patents for Genetic Sequences: the Competitiveness of Current UK Law and Practice. London: Department of Trade and Industry.
22. For information on other studies, see OECD (2002). Genetic Inventions, Intellectual Property Rights and Licensing Practices: Evidence and Policies. Paris: OECD. Available at www.oecd.org/dataoecd/42/21/2491084.pdf;
23. National Research Council, Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation (2005). Reaping the Benefits of Genomic and Proteomic Research. Washington, DC: National Academies Press;
24. Caulfield T, Cook-Deegan RM, Keiff FS, and Walsh JP. Evidence and anecdotes: an analysis of human gene patenting controversies. Nature Biotechnol 2006;24:1091-1094; SACGHS, above note 6.
25. For further information on the HapMap Project, see http://hapmap. ncbi.nlm.nih.gov/;
26. on the Structural Genomics Consortium, see www.thesgc.org/;
27. on the 1000 Genomes Project, see www.1000genomes.org/page.php.
28. Edwards AE, Bountra C, Kerr DJ, and Wilson TM. Open access chemical and clinical probes to support drug discovery. Nature Chemical Biology 2009;5:436-440.
29. Nicol D (2009). Strong patent rights, weak patent standards and innovation in biomedicine. In: Arup C and van Caenegem W (eds). Intellectual Property Policy Reform: Fostering Innovation and Development, Cheltenham, U. K.: Edward Elgar 55-79 at 63.
30. Nicol D. Navigating the molecular diagnostic patent landscape. Expert Opinion on Therapeutic Patents 2008;18:461-472.
31. Pisano G (2006). Science Business: the Promise, the Reality and the Future of Biotech. Cambridge, MA: Harvard Business School Press, particularly at 81-109.
32. Edwards A. Open-source science to enable drug discovery. Drug Discovery Today 2008;13:731-733.
33. Nicol and Nielsen, above note 1 at 111.
34. Nicol and Nielsen, above note 1 at 198.
35. Nicol D and Hope J. Cooperative strategies for facilitating use of patented inventions in biotechnology. Law in Context 2006;24:85-112;
36. Hope J (2008). Biobazaar: the Open Source Revolution and Biotechnology. Cambridge, MA: Harvard University Press;
37. Hope J, Nicol D, and Braithwaite J (2008). Regulatory capitalism, business models and the knowledge economy. In: Braithwaite J. Regulatory Capitalism. Chapter 5. Cheltenham, U. K.: Edward Elgar.
38. Van Overwalle G, van Zimmeren E, Verbeure B, and Matthijs G. Models for facilitating access to patents on genetic inventions. Nature Rev Genet 2006;7:143-148;
39. van Zimmeren E, Verbeure B, Matthijs G, and Van Overwalle G. A clearing house for diagnostic testing: the solution to ensure access to and use of patented genetic inventions? Bulletin of the World Health Organization 2006;84:352-359;
40. Verbeure B, van Zimmeren E, Matthijs G, and Van Overwalle G. Patent pools and diagnostic testing. Trends Biotechnol 2006;24:115-120;
41. Van Overwalle G (2009). Gene Patents and Collaborative Licensing Models: Patent Pools, Clearing Houses, Open Source Models and Liability Regimes. Cambridge, U. K.: Cambridge University Press.
42. OECD, above note 16; OECD (2006). Guidelines for the Licensing of Genetic Inventions. Paris: OECD. Available at www.oecd.org/dataoecd/39/38/36198812.pdf;
43. Human Genome Organisation (2003). Statement on the scope of gene patents, research exemption and licensing of patented gene sequences for diagnostics. Available at www.hugo-international.org/img/ip-gene-2003.pdf;
44. World Health Organization (WHO) (2008). Report of the Intergovernmental Working Group on Public Health, Innovation, and Intellectual Property. Geneva: World Health Assembly. Available at www.who.int/gb/ebwha/pdf-files/A61/A61-9-en. pdf.
45. Clark J, Piccolo J, Stanton B, Tyson K, Critharis M, and Kunin S (2000). Patent pools: a solution to the problem of access in biotechnology patents. Available at www.uspto. gov/web/offices/pac/dapp/opla/patentpool.pdf;
46. Resnik DB. A biotechnology patent pool: an idea whose time has come? Journal of Philosophy. Science & Law 2003;3. Available at www6.miami.edu/ethics/jpsl/archives/papers/biotechPatent.ht ml;
47. Ebersole TJ, Guthrie MC, and Goldstein JA. Patent pools and standard setting in diagnostic genetics. Nature Biotechnol 2005;23:937-938.
48. For example, see Ebersole et al., above note 28 and the various publications by the Van Overwalle group, above note 26.
49. Shapiro C (2001). Navigating the patent thicket: cross licenses, patent pools, and standard-setting. In Jaffe A, Lerner J, and Stern S (eds.) Innovation Policy and the Economy. Cambridge, MA: MIT Press, 119-150.
50. Graff GD and Zilberman D. Towards an intellectual property clearinghouse for ag-biotechnology. An issues paper. IP Strategy Today 2001;1:1-38.
51. In Australia, for example, see Howard J (2005). The Emerging Business of Knowledge Transfer: Creating Value from Intellectual Products and Services. Canberra: Commonwealth of Australia.
52. Pressman L, Burgess R, Cook-Degan RM, McCormack SJ, Nami-Wolk I, Soucy M, et al. The licensing of DNA patents by US academic institutions: an empirical survey. Nature Biotechnol 2006;24:31-29.
53. Chesbrough HW (2003). Open Innovation: The New Imperative for Creating and Profiting from Technology. Cambridge, MA: Harvard Business School Press;
54. Chesbrough HW (2006). Open Business Models: How to Thrive in the New Innovation Landscape. Cambridge, MA: Harvard Business School Press.
55. For a detailed account of the potential role of open source-style licensing strategies in biotechnology, see Hope, above note 25.
56. Further information on survey design is provided in van Zimmeren E, Vanneste S, and Van Overwalle G. Patent Licensing in Medical Biotechnology in Europe. Leuven: Centre for Intellectual Property Rights (in press).
57. The decision to use an online survey may need to be reconsidered in light of response rates and failures to complete. Nicol and Nielsen obtained somewhat higher response rates in their 2003 study using mail outs of hard copy surveys to research organizations (59% response rate), companies (27% response rate), and diagnostics laboratories (35% response rate), suggesting that this may be a better way of ensuring a reasonably good response rate (it should be noted that the database of companies used in that study was updated and used for the present survey). It seems unlikely, however, that high response rates will be achieved in any study of this nature, which requests information from industry participants that is likely to be considered to be highly sensitive commercially. Assurances of anonymity may not be sufficient to persuade some would-be participants to engage in sharing of such information.
58. Nicol and Nielsen, above note 1 at 69.
59. On this point, see Nicol and Nielsen, above note 1, at 105-107.
60. National Institutes of Health, U. S. Department of Health and Human Services (2005). Best practices for the licensing of genomic inventions: final notice. Federal Register 70:68, 18413;
61. Association of University Technology Managers (2007). In the Public Interest: Nine Points to Consider in Licensing University Technology. Available at www.autm.net/AM/Template. cfm?Section=Nine-Points-to-Consider;
62. Organization for Economic Co-operation and Development (2006). Guidelines for the Licensing of Genetic Inventions. Paris: OECD. Available at www.oecd.org/dataoecd/39/38/36198812.pdf
63. Nicol and Nielsen, above note 1 at 219-222.
64. On the issues associated with project abandonment, see generally Nicol and Nielsen, above note 1 at 186-191.
65. Nicol and Nielsen, above note 1 at 93-123.
66. Nicol and Nielsen, above note 1 at 137-195.
67. Nicol and Nielsen, above note 1 at 100-123.
68. See generally Scotchmer S (2004). Innovation and Incentives. Cambridge, MA: Massachusetts Institute of Technology, at 127-159.