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Related Experiment Videos

Human gene patents.

Jorge A Goldstein1, Elina Golod

  • 1Sterne, Kessler, Goldstein & Fox P.L.L.C. (SKGF), Washington, DC 20005, USA.

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

Gene patents are legally permissible for isolated human genes, but raise complex ethical and practical questions. Clarifying patent scope and exemptions is crucial for innovation and research accessibility.

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Patent pools and standard setting in diagnostic genetics.

Nature biotechnologyยท2005
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Area of Science:

  • Biotechnology Law
  • Intellectual Property
  • Human Genetics

Background:

  • Gene patenting is a complex and often misunderstood area of intellectual property law.
  • Public confusion exists regarding gene ownership and patent rights.
  • Patents historically incentivize innovation.

Purpose of the Study:

  • To clarify the scope and limitations of human gene patents.
  • To examine proposed and existing exemptions for gene patent use.
  • To address the question of gene ownership and patent enforceability.

Main Methods:

  • Review of historical patent origins and legal criteria for patentability.
  • Analysis of U.S. statutory and judicially-created exemptions for research.
  • Examination of patent enforcement for gene-based diagnostic tests.

Main Results:

  • Isolated and purified human genes meet legal criteria for patentability.
  • No U.S. statutory exemption exists for non-commercial research on patented genes, but a narrow judicial exemption applies.
  • Patents on gene-based diagnostic tests are enforceable, requiring licenses for practice.

Conclusions:

  • Drawing sharp distinctions for patentability of certain genes or uses is ineffective.
  • Excluding specific genes from patentability would be shortsighted and potentially regrettable.
  • An effective legal system must balance innovation incentives with research and clinical access.
Keywords:
Biomedical and Behavioral ResearchGenetics and ReproductionLegal Approach

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