Intellectual Property and Medical Biotechnologies

  • Alexandre L. D. Pereira
Reference work entry


Biotechnology offers relevant applications in the medical sector. In particular, genetic engineering provides new methods of diagnosis and therapeutic processes which are very important in such areas as preventing and fighting cancer. Concurrently, biomedical technologies are at the core of important economic activities, generally known as biotech industries. High-risk investment in research and development (R&D) activities is required, and companies claim intellectual property protection for their biotechnological assets, both as a shield and sword against free riders and pirates. Gene patenting is a sensitive issue, not only in what concerns the distinction between inventions and “products of nature” but also concerning implications of public morality and ordre public. This chapter discusses these issues, focusing on intellectual property (IP) protection of biotechnology, in special gene patents, under EU legislation [1].


European Union Intellectual Property Human Embryo Legal Protection Patent Protection 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


  1. 1.
    See also Pereira ALD. Human genes as biotech corporate assets? Nature, morals and the role of intellectual property in healthcare innovation. Boletim da Faculdade de Direito 87: Universidade de Coimbra; 2011. p. 213–42.Google Scholar
  2. 2.
    United States Court of Appeals for the Federal Circuit. The Association for Molecular Pathology (Et al.) v. United States Patent and Trademark Office and Myriad Genetics, Inc. (Et. al.), July 29, 2011 –
  3. 3.
    See notably Williams-Jones B. History of a gene patent: tracing the development and application of commercial BRCA testing. Health Law J. 2002;10:123–46PubMedGoogle Scholar
  4. 4.
    Conley J, Vorhaus D. Pigs fly: federal court invalidates myriad’s patent claims. Genomics Law Report, March 30; 2010.Google Scholar
  5. 5.
    Abbott A. Europe to pay royalties for cancer gene – BRCA1 patent decision may be ignored in clinics. Nature, 2 Dec 2008.
  6. 6.
    Colston C, Middleton K. Modern intellectual property law. New York: Cavendish Publishing; 2006. p. 31.Google Scholar
  7. 7.
    Dawkins R. The ancestor’s tale. New York: Houghton-Mifflin; 2004.Google Scholar
  8. 8.
    Loureiro JC. O direito à identidade genética do ser humano. In: Portugal-Brasil Ano 2000. Coimbra: Coimbra Editora; 1999. p. 263.Google Scholar
  9. 9.
    World Health Organization. Genetics, genomics and the patenting of DNA. Review of potential implications for health in developing countries. Geneva: WHO Press; 2005.Google Scholar
  10. 10.
    WHO. Public health innovation and intellectual property rights. Geneva: WHO Press; 2006.Google Scholar
  11. 11.
    Yahong L. Human gene patenting and its implications to medical research. In: Yu, editor. Intellectual property and information wealth. Westport/London: Praeger; 2007. p. 347–76.Google Scholar
  12. 12.
    Gollin M. Driving innovation – intellectual strategies for a dynamic world. Cambridge: Cambridge University Press; 2008. p. 21.CrossRefGoogle Scholar
  13. 13.
    Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, OJ L 213, 30.7.1998, p. 13–21.Google Scholar
  14. 14.
    Stiglitz J. Knowledge as a global public good. In: Kaul I, Grunberg I, Stern MA, editors. Global Public goods – international cooperation in the 21st century. Oxford/New York: Oxford University Press; 1999. p. 320–1.Google Scholar
  15. 15.
    Landes W, Posner R. The economic structure of intellectual property law. Cambridge, MA: Harvard University Press; 2003.Google Scholar
  16. 16.
    Jaffe A, Lerner J. Innovation and its discontents: how our broken patent system is endangering innovation and progress, and what to do about it. Princeton: Princeton University Press; 2004.Google Scholar
  17. 17.
    O’Rourke M. Toward a doctrine of fair use in patent law. Columbia Law Rev. 2000;100:1177–250.CrossRefGoogle Scholar
  18. 18.
    Heller M, Eisenberg R. Can patents deter innovation? The anticommons in biomedical research. Science. 1998;280:698–70.PubMedCrossRefGoogle Scholar
  19. 19.
    Marques JPR. Introdução ao problema das invenções biotecnológicas (algumas considerações). In: Direito Industrial I, Coimbra: Almedina; 2001. p. 177–333.Google Scholar
  20. 20.
    Boyle J. Shamans software and spleens: law and the construction of the information society. Cambridge: Harvard University Press; 2003.Google Scholar
  21. 21.
    Opderbeck D. The penguins genome, or coase and open source biotechnology. Harvard J Law Technol. 2004;18:168–98.Google Scholar
  22. 22.
    Adelman DE. A fallacy on the commons in biotech patent policy. Berkeley Technol Law J. 2005;20:985–1030.Google Scholar
  23. 23.
    Bovenberg JA. Property rights in blood, genes & data: naturally yours. Boston: Martinus Nijhoff Academic Publishers; 2006.CrossRefGoogle Scholar
  24. 24.
    Engel C. Innovationsanreize aus Wettbewerb und Kollusion. In: Ohly A, Klippel D, editors Geistiges Eigentum und Gemeinfreiheit. Tübingen: Mohr Siebeck; 2007. p. 19–43.Google Scholar
  25. 25.
    Sumikura K. Intellectual property rights policy for gene-related inventions – toward optimum balance between public and private ownership. In: Castle D, editir. The role of intellectual property rights in biotechnology innovation. Cheltenham/Northampton: Edward Elgar; 2009. p. 73–97.Google Scholar
  26. 26.
    Yahong L. Intellectual property and public health: two sides of the same coin. Asian J WTO Int Health Law Policy. 2011; 6(2):390.Google Scholar
  27. 27.
    Caulfield T. Policy conflicts: gene patents and health care in Canada. Commun Genet 2005;8:223–27.CrossRefGoogle Scholar
  28. 28.
    Heath A. Preparing for the genetic revolution – the effect of gene patents on healthcare and research and the need for reform. Canterbury Law Rev. 2005;11:59–90.Google Scholar
  29. 29.
    Marques JPR. Biotecnologia(s) e propriedade intelectual, 2 vols. Coimbra: Almedina; 2007.Google Scholar
  30. 30.
    Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, Oviedo, 4.IV, 1997.Google Scholar
  31. 31.
    Additional Protocols to the Convention on Human Rights and Biomedicine, on the Prohibition of Cloning Human Beings (Paris, 12.I.1998), and concerning Genetic Testing for Health Purposes (Strasbourg, 27.XI.2008).Google Scholar
  32. 32.
    Ascensão JO. Intervenções no genoma humano. Revista da Ordem dos Advogados. 2003;63:25–49.Google Scholar
  33. 33.
    Marques JPR. Patentes de Genes Humanos. In: Direito Industrial, vol. III, APDI. Coimbra: Almedina; 2003. p. 143.Google Scholar
  34. 34.
    Piper T. Watch what you export: the history of medical exceptions from patentability. In: Castle D, editor. The role of intellectual property rights in biotechnology innovation. Cheltenham/Northampton: Edward Elgar; 2009. p. 437–55.Google Scholar
  35. 35.
    C‑34/10 (Brüstle), 18/10/2011, European Court reports 2011.
  36. 36.
    Ertelt S. European union court bans stem cell patents if embryo destroyed., Luxembourg, 18 Oct 2011.Google Scholar
  37. 37.
    Bardehle/Pagenberg. ECJ: Exclusion from patentability of all human embryonic stem cell-related inventions in Europe (Brüstle v Greenpeace), 2011.

Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  1. 1.Faculty of LawUniversity of CoimbraCoimbraPortugal

Personalised recommendations