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Genetic Discovery and the Need for Compulsory Licensing

Genetic Discovery and the Need for Compulsory Licensing. Jon F. Merz Department of Medical Ethics and Center for Bioethics University of Pennsylvania School of Medicine. Acknowledgements. NHGRI/ELSI for funding

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Genetic Discovery and the Need for Compulsory Licensing

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  1. Genetic Discovery and the Need for Compulsory Licensing Jon F. Merz Department of Medical Ethics and Center for Bioethics University of Pennsylvania School of Medicine

  2. Acknowledgements • NHGRI/ELSI for funding • Collaboration of Mildred Cho, Debra Leonard, Michelle Henry, and other research staff • Survey respondents

  3. Overview • Background to DNA patents • Review several survey studies examining licensing and use of DNA-based inventions • all studies approved by Penn or Stanford IRBs • copies of papers available • Ethical concerns

  4. Definition • Human gene patents result from the cloning and description of the sequence of a gene, the role of which is “known” • Gene patents claim 2 types of “invention”: • Diagnostics – the characterization of an individual’s genetic makeup at a disease-associated locus when done for the purpose of diagnosis or prognosis • Therapeutics – use of the isolated and purified gene and derivative products (e.g., recombinant drugs, gene transfer)

  5. Background • Focus on diagnostic use of gene patents • emerging predominance of diagnostics patents (Thomas et al. Nature 1996; 380:387; Nature 1997; 388:709)

  6. source: Mother Jones

  7. Background • Focus on diagnostic use of gene patents • emerging predominance of diagnostics patents (Thomas et al. Nature 1996; 380:387; Nature 1997; 388:709) • Celera, Incyte, and Athersys have filed 10s of thousands of provisional applications on SNPs having diagnostic potential (The Scientist 2000; 14[5]:8)

  8. Empirical Studies • Small interview study showed that, for a small sample of diagnostics patents, 14/27 had been licensed, all exclusively, all by universities (Schissel A, Merz JF, Cho MK. Nature 1999; 402:118) • Larger interview study examining the patenting and licensing of DNA-based inventions found: • universities appear to be generating greater number of inventions than firms (163 vs. 37), but are much less likely to file patent applications (15% vs. 86%) • with similar licensing rates (51% vs. 42%), universities are much more likely to grant exclusive licenses than are firms (68% vs. 27%) • Henry MR, Cho MK, Weaver MA, Merz JF. Science 2002; 297:1279. Full results under review.

  9. Empirical Studies (continued) • Pilot survey of convenience sample of 74 laboratory staff found that ~1/4 reported being prevented from performing a patented test, and ~1/2 reported not developing/ validating a test because of known patents (Cho, M. K. in Preparing for the Millennium: Laboratory Medicine in the 21st Century 47-53 (AACC Press, 1998) • Interview study of 117/129 US labs regarding performance of HFE test for hemochromatosis showed many labs had adopted test before patent issued, and 26% of labs reported not developing/offering test and 4% reported dropping the test (Merz JF, Kriss AG, Leonard DGB, Cho MK. Nature 2002; 415:577-579)

  10. Empirical Studies (continued) • Interview study of 132/211 US labs; 122 of which perform genetic testing • 79 (65%) had been contacted by a patent holder • 30 (25%) stated they stopped performing a test service • 17 for one test, 12 for more than one test • for-profit labs more likely stopped than university labs (P=0.001) • 64 (53%) decided not to develop or perform a clinical genetic test because of a patent Cho MK, Illangasekare S, Weaver MA, Leonard DGB, Merz JF., Molecular Diagnostics 2003; forthcoming

  11. Patents may impact lab medicine • ability to prescribe nationwide medical standard of care • may restrict access by requiring prepayment, charging higher prices, refusing Medicaid reimbursement • may subvert education, counseling of providers/patients • potential lack of adequate quality control • may limit types of “permissible” testing • increase prices and hospital costs • royalty demands • stacking of royalties

  12. Patents may inhibit research • inhibit widespread clinical use and observation • external study/validation and new discovery • impose reach-through conditions (e.g., royalties, rights of first refusal, back-licensing of downstream discoveries) • impose unethical constraints (e.g., limit clinical uses of research results) • constrain new testing technologies (e.g., DNA chips) • Heller & Eisenberg’s “tragedy of the anticommons” • many owners of pieces of the genome inhibit use by anyone

  13. Summary • 1996 amendment of patent law exempts physicians and institutions from infringement liability for “pure process” patents • do not apply to CLIA lab services or to “biotech” patents • Gene patents are having a measurable effect on physician practices • laboratorians are willing to pay reasonable royalties, but want to be free to practice medicine • Professional services should be subject to compulsory licenses • a law analogy

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