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Patents, genomics, research, and diagnostics.

John H Barton1

  • 1Stanford University Law School, Stanford, California 94305, USA. jbarton@stanford.edu

Academic Medicine : Journal of the Association of American Medical Colleges
|December 14, 2002
PubMed
Summary

Genomic patents on single nucleotide polymorphisms (SNPs) and computational genomic data may hinder medical research. Legislative action or court rulings are needed to protect research use of genetic information and genotype-phenotype correlations.

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Area of Science:

  • Biotechnology Law
  • Genomic Medicine
  • Intellectual Property Law

Background:

  • Current genomic patents, particularly those on single nucleotide polymorphisms (SNPs) and computational genomic data, pose significant challenges to medical research.
  • These patents may restrict the use of genetic information and the inference of phenotypic characteristics from genotypes, impacting research progress.

Purpose of the Study:

  • To analyze the potential interference of specific genomic patents with ongoing medical research.
  • To propose actionable strategies for mitigating the encumbrances posed by these patents on scientific advancement.

Main Methods:

  • Review of existing genomic patent types, including those on SNPs and computer-based genomic information.
  • Analysis of legal and legislative approaches to address patent limitations in the context of medical research.
Keywords:
Biomedical and Behavioral ResearchGenetics and ReproductionLegal Approach

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Main Results:

  • Patents on SNPs and computational genomic data present greater obstacles to research than patents on expressed sequence tags (ESTs).
  • Two primary approaches are identified: redefining patentable subject matter in intangible areas and establishing legislative exemptions for research use.

Conclusions:

  • Reconsideration of patent law extensions into intangible genomic information is crucial.
  • A narrow legislative exemption is recommended to safeguard the use of SNPs and genotype-phenotype relationships in medical research, especially where clinical practice is involved.