The changing life science patent landscape

Journal name:
Nature Biotechnology
Volume:
34,
Pages:
292–294
Year published:
DOI:
doi:10.1038/nbt.3504
Published online

What have we learned from 20 tumultuous years of patent law in the life sciences? Is patenting likely to be as important for the industry in the future?

References

  1. Heller, M.A. & Eisenberg, R.S. Science 280, 698701 (1998).
  2. Rai, A. Duke Law J. 61, 12371281 (2012).
  3. Cook-Deegan, R., Chandrasekharan, S. & Angrist, M. Nature 458, 405406 (2009).
  4. Hemphill, C.S. & Sampat, B. Science 339, 13861387 (2013).
  5. Kapczynski, A. N. Engl. J. Med. 373, 201203 (2015).
  6. Novartis AG v. Union of India, Civil Appeal No. 2706–2716 (Supreme Court of India, 2013).
  7. Bessen, J. & Meurer, M. Patent Failure (Princeton Univ., 2008).
  8. 132 S. Ct. 1289 (2012).
  9. 133 S. Ct. 2107 (2013).
  10. 788 F.3d 1371 (Fed. Cir. 2015).
  11. 133 S. Ct. 2223 (2013).
  12. Merges, R.P. Berkeley Technol. Law J. 27, 10231046 (2012).
  13. Hemphill, T.P. Regulation 38, 68 (2015).
  14. Rai, A.K. & Sherkow, J.S. Letter to US Senate Committee on the Judiciary Concerning Inter Partes Review and Orange Book-Listed Patents http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2623736 (June 18, 2015).
  15. Eisenberg, R. & Crane, D. Mich. Telecomm. Tech. Law Rev. 21, 197262 (2015).
  16. Grabowski, H. et al. FDA Law J. 67, 373391 (2012).
  17. Sharfstein, J. J. Am. Med. Assoc. 313, 667668 (2015).
  18. FDA Fed. Regist. 79, 5977659779 (2014).
  19. USPTO. Fed. Regist. 97, 7461874633 (2014).
  20. DiMasi, J.A., Grabowski, H.G. & Hansen, R.W. Innovation in the pharmaceutical industry: new estimates of R&D costs http://csdd.tufts.edu/news/complete_story/cost_study_press_event_webcast (Tufts Center for the Study of Drug Development, Boston, November 18, 2014).
  21. Public Law No. 111–148, 124 Stat. 199 (2010).
  22. Price, W.N. II & Rai, A.K. Science 348, 188189 (2015).
  23. Cook-Deegan, R., Conley, J.M., Evans, J.P. & Vorhaus, D. Eur. J. Hum. Genet. 21, 585588 (2013).
  24. Micheel, C.M, Nass, S.J. & Omenn, G.S. (eds.) Evolution of Translational Omics: Lessons Learned and the Path Forward (Institute of Medicine, The National Academies Press, Washington, 2012).
  25. Brüstle v. Greenpeace eV, Opinion of Advocate General. Case C-34/10 (CJEU Mar. 10, 2011).
  26. Int'l Stem Cell Corp. v. Comptroller Gen. of Patents. Case C-364/13 (CJEU Dec. 18, 2014).
  27. 28 U.S.C. § 1498.
  28. Sherkow, J.S. Wash. Law Rev. 90, 205269 (2015).
  29. Reichman, J.H. J. Law Med. Ethics 37, 247263 (2009).

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Affiliations

  1. Arti K. Rai is at the Center for Innovation Policy, Duke University School of Law, Durham, North Carolina, USA

  2. Jacob S. Sherkow is at the Innovation Center for Law and Technology, New York Law School, New York, New York, USA.

Competing financial interests

The authors declare no competing financial interests.

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