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How does emerging patent case law in the US and Europe affect precision medicine?

How will today’s patent law affect tomorrow’s innovation in the areas of biomarkers and nature-based products; diagnostics; and algorithms, big data and AI?

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References

  1. 1.

    Hogarth, S. Personalized Medicine – A Typology Briefing for CADTH (CADTH, 2016).

  2. 2.

    BIS Research. Global Precision Medicine Market – Analysis and Forecast, 2018–2028 (BIS Research, 2019).

  3. 3.

    FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource (FDA, 2016).

  4. 4.

    Ioannidis, J. P. A. & Bossuyt, P. M. M. Clin. Chem. 63, 963–972 (2017).

    CAS  Article  Google Scholar 

  5. 5.

    Breastcancer.org. Oncotype DX test. https://www.breastcancer.org/symptoms/testing/types/oncotype_dx (accessed 2 September 2019).

  6. 6.

    Horak, F. B. & Mancini, M. Mov. Disord. 28, 1544–1551 (2013).

    Article  Google Scholar 

  7. 7.

    Price, W. N. Harv. J. Law Technol. 28, 419–467 (2015).

    Google Scholar 

  8. 8.

    Mayo Collaborative Services v. Prometheus Laboratories, Inc. in S. Ct., Vol. 132 1289 (Supreme Court, 2012).

  9. 9.

    Association for Molecular Pathology v. Myriad Genetics, Inc. in S. Ct., Vol. 133 2107 (Supreme Court, 2013).

  10. 10.

    Sherkow, J. S. & Greely, H. T. Annu. Rev. Genet. 49, 161–182 (2015).

    CAS  Article  Google Scholar 

  11. 11.

    Holman, C. M. George Mason Law Rev. 23, 901–940 (2016).

    Google Scholar 

  12. 12.

    Schwartz, R. M. & Minssen, T. Intell. Prop. Q. 3, 189–241 (2015).

    Google Scholar 

  13. 13.

    Alice Corp. v. CLS Bank International. in S. Ct., Vol. 134 2347 (Supreme Court, 2014).

  14. 14.

    Bilski v. Kappos. in S. Ct., Vol. 130 3218 (Supreme Court, 2010).

  15. 15.

    Diamond v. Diehr. in S. Ct., Vol. 101 1048 (Supreme Court, 1981).

  16. 16.

    In re Abele and Marshall. in F.2d, Vol. 684 902 (United States Court of Customs and Patent Appeals, 1982).

  17. 17.

    2019 revised patent subject matter eligibility guidance. Fed. Regist. 84, 50–57 (2019); https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf

  18. 18.

    Aboy, M., Liddell, K., Liddicoat, J. & Crespo, C. Nat. Biotechnol. 34, 1119–1123 (2016).

    CAS  Article  Google Scholar 

  19. 19.

    Aboy, M., Liddicoat, J., Liddell, K., Jordan, M. & Crespo, C. Nat. Biotechnol. 35, 820–825 (2017).

    CAS  Article  Google Scholar 

  20. 20.

    Aboy, M., Crespo, C., Liddell, K., Liddicoat, J. & Jordan, M. Nat. Biotechnol. 36, 1146–1149 (2018).

    CAS  Article  Google Scholar 

  21. 21.

    Aboy, M., Crespo, C., Liddell, K., Minssen, T. & Liddicoat, J. Nat. Biotechnol. 37, 513–518 (2019).

    CAS  Article  Google Scholar 

  22. 22.

    Gold, R. E., Cook-Deegan, R. & Bubela, T. Sci. Transl. Med. 5, (192ed9 (2013).

    Google Scholar 

  23. 23.

    Ariosa Diagnostics, Inc. v. Sequenom, Inc. in F.3d, Vol. 588 1371 (Federal Circuit, 2015).

  24. 24.

    Norton, M. E. et al. N. Engl. J. Med. 372, 1589–1597 (2015).

    CAS  Article  Google Scholar 

  25. 25.

    Vanda Pharmaceuticals Inc., v. West-Ward Pharmaceuticals International Ltd. in F.3d, Vol. 887 1117 (Federal Circuit, 2018).

  26. 26.

    Fox, J. L. Nat. Biotechnol. 30, 373–374 (2012).

    CAS  Article  Google Scholar 

  27. 27.

    Malecek, M.J. et al. On Petition for a Writ of Certiorari to the United States Court of Appeals for the Federal Circuit (2016); https://www.scotusblog.com/wp-content/uploads/2016/04/Sequenom-Cert-Petition.pdf

  28. 28.

    In re Grams. in F.2d, Vol. 888 835 (Federal Circuit, 1989).

  29. 29.

    Gottschalk v. Benson. in S. Ct., Vol. 93 253 (Supreme Court, 1972).

  30. 30.

    Parker v. Flook. in S. Ct., Vol. 98 2522 (Supreme Court, 1978).

  31. 31.

    McRO, Inc. v. Bandai Namco Games America Inc. in F.3d, Vol. 837 1299 (Federal Circuit, 2016).

  32. 32.

    Enfish, LLC v. Microsoft Corp. in F.3d, Vol. 822 1327 (Federal Circuit, 2016).

  33. 33.

    FairWarning IP, LLC v. Iatric Systems, Inc. in F.3d, Vol. 839 1089 (Federal Circuit, 2016).

  34. 34.

    EPO Guidelines, G II, 2 Examination practice (1 November 2018).

  35. 35.

    Implementing Regulations to the European Patent Convention 2000 as adopted by decision of the Administrative Council of 7 December 2006 (2006); http://documents.epo.org/projects/babylon/eponet.nsf/0/1DED81EC77DDD845C1257283003E3208/$File/oj1_07_se_103_195.pdf

  36. 36.

    EPC Implementing Rules, ss.27(a) and 29(2) (2006); http://documents.epo.org/projects/babylon/eponet.nsf/0/1DED81EC77DDD845C1257283003E3208/$File/oj1_07_se_103_195.pdf

  37. 37.

    EPO Guidelines, G-II, 3.1 Exclusion of discoveries (1 November 2018).

  38. 38.

    EPO Guidelines, G-II, 5.2 Exclusions and exceptions for biotechnological inventions (1 November 2018).

  39. 39.

    T0272/95 Relaxin/Howard Florey Institute (EPO Boards of Appeal, 2002).

  40. 40.

    T 0666/05 Mutation/University of Utah (EPO Boards of Appeal, 2008).

  41. 41.

    Case No. X ZR 141/13 (German Federal Court of Justice (Bundesgerichtshof), 2016).

  42. 42.

    Cole, P. Cold Spring Harb. Perspect. Med. 5, a020891 (2015).

    Article  Google Scholar 

  43. 43.

    EPO Guidelines, G-II, 4.2 Exclusion of diagnostic methods (1 November 2018).

  44. 44.

    EPO Guidelines, G-II, 3.3 Exclusion of mathematical methods (1 November 2018).

  45. 45.

    Matthijs, G., Huys, I., Van Overwalle, G. & Stoppa-Lyonnet, D. Nat. Biotechnol. 31, 704–710 (2013).

    CAS  Article  Google Scholar 

  46. 46.

    Illumina, Inc. v. Premaitha Health, Plc. in EWHC, Vol. 2930 (Chancery Division (Patents Court), 2017).

  47. 47.

    EPO Guidelines, G-II, 3.3 Exclusion of mathematical methods; 3.51 Schemes, rules and methods for performing mental acts; and 3.77 Presentations of information (1 November 2018).

  48. 48.

    EPO Guidelines, G-II, 3.6 Exclusion of computer programs (1 November 2018).

  49. 49.

    Minssen, T. & Pierce, J. in Big Data, Health Law, and Bioethics (eds. Cohen, I.G. et al.) (Cambridge Univ. Press, 2018).

  50. 50.

    EPO Guidelines, G-VII, 5.4 Claims comprising technical and non-technical features (1 November 2018).

  51. 51.

    Minssen, T. in Research Handbook on Intellectual Property and the Life Sciences (eds. Matthews, D. & Zech, H.) 26–39 (Edward Elgar Publishing, 2017).

  52. 52.

    Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) Art. 27(1); https://www.wto.org/english/docs_e/legal_e/27-trips.pdf

  53. 53.

    Minssen, T. & Schwartz, R. M. J. Law Biosci. 3, 365–372 (2016).

    Article  Google Scholar 

  54. 54.

    EPO Guidelines for Examination, Part G–Patentability (2018); https://www.epo.org/law-practice/legal-texts/html/guidelines2018/e/g_ii_3_3_1.htm

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Aboy, M., Liddell, K., Crespo, C. et al. How does emerging patent case law in the US and Europe affect precision medicine?. Nat Biotechnol 37, 1118–1125 (2019). https://doi.org/10.1038/s41587-019-0265-1

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