Quasi-Patents and Semi-Patents in Biobanking

Chapter

Abstract

Until recently, genetic researchers were like early mapmakers charting the world’s coastlines with only compasses and notepads. The map of the human genome, like an ancient map of the world, was sketched in crooked and uncertain strokes. In the year 2000, things changed. The completion of the Human Genome Project yielded the first-ever molecular blueprint of the human body. In time, this blueprint may develop into a detailed atlas of preventions, diagnoses, and cures for deadly diseases. The research necessary to reach this goal will rely on biobanks—repositories of biological materials and associated data. Today, wide varieties of such facilities are in operation at universities, hospitals, corporations, and non-profit entities worldwide. Some examples include the United Kingdom Biobank, the Duke Biobank, the University of Pennsylvania Tumor Tissue Bank, the National Gene Vector Biorepository at the Indiana University School of Medicine, the Mayo Clinic Biobank, the da Vinci European Biobank, and Genetic Alliance Biobank. Often suspended in paraffin wax or liquid nitrogen, the tissue samples in biobanks come from a variety of sources: participants in clinical trials, patients who undergo surgery or routine medical tests, recruited donors, and contributions from patients’ families. These samples are usually accompanied by useful information, such as a tissue donor’s age, sex, race, cancer history, family medical history, allergies, and medications [Heaney C et al. (2009) The perils of taking property too far. http://www.stanford.edu/group/sjlsp/cgi-bin/orange_web/articles/index.php?CatID=1009. Accessed 7 May 2010]. Today, the storage of human tissues and associated data is a sophisticated practice. Even as biobanks grow in size and sophistication, their future is uncertain. At most biobanks, critical questions regarding the allocation of property, both real and intangible, remain unanswered. Who should own physical samples and data? Who should have access to samples, data, and research findings, and on what terms? Patents present further quandaries: who should have access to patented inventions stemming from research? Should exceptions be made for the non-commercial use of patented ideas? Should the fruits of biobank research be shared with donors in order to encourage future donations? In this article, we formulate possible answers to these questions.

References

  1. Bell A, Parchomovsky G (2008) Reconfiguring property in three dimensions. Univ Chicago Law Rev 75:1015–1033Google Scholar
  2. Collins F (2010) Has the revolution arrived? Nature 464:674–675CrossRefGoogle Scholar
  3. Contreras JL (2010) Timing is everything: latency analysis and the design of the genome commons. http://www.law.msu.edu/ipclp/workshop/papers/Latency.pdf. Accessed 7 May 2010
  4. Feldman MP, Colaianni A, Kang Liu C (2007) Lessons from the commercialization of the Cohen-Boyer patents: the Stanford University licensing program. http://www.iphandbook.org/handbook/about/attachment_files/ipHandbook%20Executive%20Guide%20Final.pdf. Accessed 7 May 2010
  5. Gold ER, Carbone J (2008) Myriad genetics: in the eye of the policy storm. Genet Med 12:S39–S70CrossRefGoogle Scholar
  6. Heaney C et al (2009) The perils of taking property too far. http://www.stanford.edu/group/sjlsp/cgi-bin/orange_web/articles/index.php?CatID=1009. Accessed 7 May 2010
  7. Lessig L (2001) The future of ideas: the fate of the commons in a connected world. http://the-future-of-ideas.com. Accessed 7 May 2010
  8. Parchomovsky G, Mattioli M (2011) Partial Patents. Colum L Rev 111:207–53Google Scholar
  9. Polk Wagner R, Parchomovsky G (2005) Patent Portfolios. U Pa L Rev 154:1–77CrossRefGoogle Scholar
  10. Simon BM (2009) How to get a fair share. http://www.stanford.edu/group/sjlsp/cgi-bin/orange_web/articles/index.php?CatID=1009. Accessed 7 May 2010
  11. Statyn S (2009) Biobanking of blastocysts. http://www.stanford.edu/group/sjlsp/cgi-bin/orange_web/articles/index.php?CatID=1009. Accessed 7 May 2010
  12. Winickoff D E, Winickoff R N (2003) The charitable trust as a model for genomic biobanks. N Eng J Med 349:1180–1184CrossRefGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2013

Authors and Affiliations

  1. 1.University of Pennsylvania Law SchoolPhiladelphiaUSA
  2. 2.Faculty of LawBar-Ilan UniversityRamat-GanIsrael
  3. 3.Indiana University Maurer School of LawBloomingtonUSA

Personalised recommendations