Duke GELP Workshop: April 4th, 2009
“Diagnostic DNA Patents: What Lies Ahead?”
Presented by the Duke University Center for Public Genomics, in collaboration with the McGill University Centre for Intellectual Property Policy
This workshop brought together experts in DNA patent scholarship and university and government licensing to consider the future of university licensing of DNA diagnostics. Topics addressed included how university licensing might avoid patent thickets, log-jams, intolerable royalty-stacking, and the anticommons effect—all possible consequences of having many patents whose claims, particularly DNA-sequence claims, were based on methods of past genetics but whose legacy will linger into the era of multi-allele genetic testing, personal genomics, and full-genome sequence analysis.
Starting with the general presumption of nonexclusive licensing of genomic inventions found in policy documents (see below), we considered conditions under which exclusive licensing would be particularly problematic or preferable.
Background Materials
We have collected some relevant publications as a resource for workshop participants and others.
Materials available online:
(1) Australia. Australian Law Reform Commission. Gene Patenting and Human Health.Issues Paper 27. Paragon Printing Australasia, 2003.
Paragraphs 10.15-10.19 (Click to view, after accessing link scroll down for relevant paragraphs)
Paragraphs 11.4-11.18, and 11.39-11.48 (Click to view, after accessing link scroll down for relevant paragraphs)
(2) Australia. Australian Law Reform Commission. Genes and Ingenuity. Report 99. SOS Printing Group, 2004.
Paragraphs 18.9-18.49 (Click to view, after accessing link scroll down for relevant paragraphs)
Paragraphs 20.1-20.81 (Click to view)
Paragraphs 21.27-21.32 (Click to view, after accessing link scroll down for relevant paragraphs)
(3) Australia. Australian Law Reform Commission. Gene Patenting and Human Health. Discussion Paper 68. SOS Printing Group, February 2004.
Paragraphs 21.1-21.135 (Click to view).
(4) Michelle R. Henry, Mildred K. Cho, Meredith A. Weaver, and Jon F. Merz. “A Pilot Survey on the Licensing of DNA Inventions.” Journal of Law, Medicine & Ethics Vol. 31 (2003): 442 – 449. Manuscript version available here.
(5) In the Public Interest: Nine Points to Consider in Licensing University Technology. 2007. Available here.
(6) Mildred K. Cho, Samantha Illangasekare, Meredith A. Weaver, Debra G. B. Leonard, and Jon F. Merz. “Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Services.” Journal of Molecular Diagnostics Vol. 5, no.1 (2003): 3 – 8. Available here.
(7) Nuffield Council of Bioethics. The Ethics of Patenting DNA: A Discussion Paper. London, UK: Nuffield Council on Bioethics, 2002. Pp 39 – 40, 48 – 53, and 70 – 71. Available here.
(8) Ontario Ministry of Health and Long-Term Care. Genetics, Testing & Gene Patenting: Charting New Territory in Healthcare: Report to the Provinces and Territories. 2002. Pp. 37-45. Available here.
(9) Organisation for Economic Co-operation and Development. OECD Guidelines for the Licensing of Genetic Inventions. 2006. Pp. 9, 11-12, 19-21. Available here.
(10) Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health. Ed. Stephen A. Merrill and Anne-Marie Mazza. Washington, DC: The National Academies Press, 2006. Pp. 59 – 68, pp. 116 – 119, pp. 131 – 132, pp. 137 – 138, and pp. 147 – 149. Text available here.
(11) United States. National Institutes of Health. NIH Best Practices for the Licensing of Genomic Inventions – Final Notice. Federal Register Vol. 70, no. 68 (April 11, 2005): 18413 – 18415. Available here.
(12) E. Richard Gold and Julia Carbone. Myriad Genetics: In the Eye of the Policy Storm. International Expert Group on Biotechnology, Innovation and Intellectual Property, September 2008 (Click to view).
(13) Christopher M. Holman. “The Impact of Human Gene Patents on Innovation and Access: A Survey of Human Gene Patent Litigation.” UMKC Law Review Vol. 76 (2007): 295-361. Available here.
(14) Dianne Nicol and Jane Nielsen. Patents and Medical Biotechnology: An Empirical Analysis of Issues Facing the Australian Industry. University of Tasmania. Centre for Law and Genetics Occasional Paper No. 6 (2003): 115-122, 150-156, 198-205, and 233. Available here.
(15) Secretary’s Advisory Committee on Genetics, Health, and Society. (Office of Biotechnology Activities, National Institutes of Health.) Homepage available here.
(16) Secretary’s Advisory Committee on Genetics, Health, and Society. (Office of Biotechnology Activities, National Institutes of Health.) Patents and Access project page, with transcripts of past meetings and presentation materials, available here.
(17) Case studies on the impact of gene patents and licensing practices on access to genetic testing for breast and ovarian cancers, Alzheimer’s disease, cystic fibrosis, hearing loss, hereditary hemochromatosis, Long QT syndrome, spinocerebellar ataxia, Tay-Sachs disease, and Canavan disease. The Center for Public Genomics was commissioned by the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) to prepare these case studies, which are currently posted for public comment here. The case studies are an appendix to a document available here.
(18) S. Ayme, G. Matthijs, and S. Soini, on behalf of the ESHG Working Party onPatenting and Licensing. Patenting and Licensing in Genetic Testing. European Journal of Human Genetics Vol. 16, no. S1 (2008): S3 S9. Available here.
Additional Bibliography:
(1) Geertrui Van Overwalle. "The Implementation of the Biotechnology Directive in Belgium and its After-Effects. The Introduction of a New Research Exemption and a Compulsory Licence for Public Health." International Review of Intellectual Property and Competition Law Vol. 37, no. 8 (2006): 889-1008.
(2) Kathleen Liddell, Stuart Hogarth, David Melzer, and Ron L. Zimmern. "Patents as Incentives for Translational and Evaluative Research: The Case of Genetic Tests and Their Improved Clinical Performance." Intellectual Property Quarterly Vol. 3 (2008): 286-327. Published in 2008 by Thomson Reuters (Legal) Limited.
(3) Timothy Caulfield, Robert M. Cook-Deegan, F. Scott Kieff, and John P. Walsh. "Evidence and Anecdotes: An Analysis of Human Gene Patenting Controversies." Nature Biotechnology Vol. 29, no. 9 (2006): 1091 - 1094.
(4) Timothy Caulfield, Tania Bubela, and C.J. Murdoch. "Myriad and the Mass Media: The Covering of a Gene Patent Controversy." Genetics in Medicine Vol. 9, no.12 (2007): 850 - 855.
(5) Sirpa Soini, Segolene Ayme, and Gert Matthijs. "Patenting and Licensing in Genetic Testing: Ethical, Legal and Social Issues." European Journal of Human Genetics Vol. 16, no. S1 (2008): S10-S50.
(6) Jordan Paradise, Lori Andrews, and Timothy Holbrook. "Patents on Human Genes: An Analysis of Scope and Claims." Science Vol. 307 (2005): 1566 - 1567.
(7) Gert Matthijs. "The European Opposition Against the BRCA Gene Patents." Familial Cancer Vol. 5, no.1 (2006): 95 - 102.
(8) Birgit Verbeure, Gert Matthijs, and Geertrui Van Overwalle. "Analysing DNA Patents in Relation with Diagnostic Genetic Testing." European Journal of Human Genetics Vol. 14 (2006): 26-33.
(9) Subhashini Chandrasekharan, Sapna Kumar, Cory M. Valley, and Arti Rai. "Proprietary Science, Open Science and the Role of Patent Disclosure: The Case of Zinc-Finger Proteins." Nature Biotechnology Vol. 27, no. 2 (2009): 140 - 144.
(10) Michael A. Heller and Rebecca S. Eisenberg. "Can Patents Deter Innovation? The Anticommons in Biomedical Research." Science Vol. 280, no. 5364 (1998): 698 - 701.
(11) Christopher M. Holman "Trends in Human Gene Patent Litigation." Science Vol. 322, no. 5899 (2008): 198 - 199.
(12) Jane Kaye, Naomi Hawkins, and Jenny Taylor. "Patents and Translational Research in Genomics." Nature Biotechnology Vol. 25, no. 7 (2007): 739 - 741.
(13) Lori Pressman, Richard Burgess, Robert M. Cook-Deegan, Stephen J. McCormack, Io Nami-Wolk, Melissa Soucy, and LeRoy Walters. "The Licensing of DNA Patents by US Academic Institutions: An Empirical Survye." Nature Biotechnology Vol. 24, no. 1 (2006): 31 - 39.
(14) Geertrui Van Overwalle, Esther van Zimmeren, Birgit Verbeure, and Gert Matthijs. "Models for Facilitating Access to Patents on Genetic Inventions." Nature Reviews Genetics Vol. 7 (2006): 143 - 148.
(15) Brandon L. Pierce, Christopher S. Carlson, Patricia C. Kuszler, Janet L. Stanford, and Melissa A. Austin. "The Impact of Patents on the Development of Genome-Based Clinical Diagnostics: An Analysis of Case Studies." Genetics in Medicine Vol. 11, no. 3 (2009): 202 - 209.
(16) "Property Rights." Editorial. Nature Vol. 458 (2009): 385.
(17) Robert Cook-Deegan, Subhashini Chandrasekharan, and Misha Angrist." The Dangers of Diagnostic Monopolies." Nature Vol. 458 (2009): 405 - 406.
(18) Sibylle Gaisser, Michael M. Hopkins, Kathleen Liddell, Eleni Zika, and Dolores Ibarreta. "The Phantom Menace of Gene Patents." Nature Vol. 458 (2009): 407 - 408.