Goldstein, Jorge A. --- "Biotechnology Patent Pools and Standards Setting" [2009] ELECD 260; in Takenka, Toshiko (ed), "Patent Law and Theory" (Edward Elgar Publishing, 2009)

Book Title: Patent Law and Theory

Editor(s): Takenka, Toshiko

Publisher: Edward Elgar Publishing

ISBN (hard cover): 9781845424138

Section: Chapter 25

Section Title: Biotechnology Patent Pools and Standards Setting

Author(s): Goldstein, Jorge A.

Number of pages: 10

Extract:

25 Biotechnology patent pools and standards
setting
Jorge A. Goldstein*



Introduction
Diagnostic genetic tests are increasingly used to identify specific human
genetic mutations (for example, in the BRCA-1 human gene) in an attempt to
assess the risks of a given disease (for example, breast cancer). There are often
multiple mutations correlated with a particular disease; we will refer to such
situations as polymutational correlations. It often arises that the diagnostic
correlations between disease and individual gene mutations in a polymuta-
tional test are patented by different patent holders. This may give rise to the
phenomenon known as a patent thicket, where a potential market entrant needs
to seek and obtain licenses, which may not always be available, from the
different patent holders in order to broadly test for the disease.1
Problems associated with patents on diagnostic genetics
Many diseases can be correlated with a genetic variation such as a nucleotide
sequence permutation, known as single nucleotide polymorphism (SNP),
within an individual's makeup.2 The International Haplotype Mapping Project
estimates that there are close to ten million commonly occurring SNPs in the
human genome.3 The use of specific SNPs in diagnostics, or of the probes
useful for their detection, have been the subject of patents. Thus, to accurately
study or test for a particular disease that is correlated to multiple patented
SNPs or SNP fragments, it may be necessary to obtain a license from each of
several patentees of the multiple SNP-based tests. The transaction costs ...