Patent Law and Theory
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Patent Law and Theory

A Handbook of Contemporary Research

Edited by Toshiko Takenka

This major Handbook provides a comprehensive research source for patent protection in three major jurisdictions: the United States, Europe and Japan. Leading patent scholars and practitioners join together to give an innovative comparative analysis both of fundamental issues such as patentability, examination procedure and the scope of patent protection, and current issues such as patent protection for industry standards, computer software and business methods. Keeping in mind the important goal of world harmonization, the contributing authors challenge current systems and propose necessary changes for promoting innovation.
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Chapter 25: Biotechnology Patent Pools and Standards Setting

Jorge A. Goldstein


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 polymutational 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 of investigating and obtaining multiple licenses to multiple mutations, SNPs and diagnostic tests in...

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