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Gene Patenting

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The term “gene patent” refers to intellectual property protections that currently cover non-naturally occurring DNA molecules such as cDNA and recombinant DNA molecules, as well as isolated genes or small portions of DNA from a gene. Patents on the non-naturally occurring DNA molecules such as cDNA and recombinant DNA protect the vast majority of medically and commercially important biotechnology products that have been developed over the half-quarter century. The availability of intellectual property protections for such genetic material can have significant implications for the research and manufacture of potential treatments for diseases, such as the artificial creation of therapeutic proteins. However, there has been significant controversy over the patent-ability of naturally occurring DNA fragments that are isolated from the human genome. With the immense technological advances of commercially available whole genome sequencing, it is becoming more affordable for a patient to have his or her own relevant genetic information sequenced for use in connection with the patient’s own medical care.

Why support the patent-ability of non-naturally occurring DNA molecules?

  • Patents provide incentives and protections for biomedically important research.
  • Patents on naturally occurring fragments of DNA could be exploited against the interest of the patients.
  • The patentability of non-naturally occurring DNA molecules and the patent ineligibility of isolated genes or DNA fragments strikes a difficult but appropriate balance between supporting the advancement of research and development of genetic treatments and the interests of patients.
  • Though it is the right of companies to create proprietary databases of the variation they discover, it is not ethical to keep this information as trade secrets. Not only the genes, but the variation that comes from genes belongs to the people. We actively work toward freeing this data and placing it in open databases.

What has Genetic Alliance done to support the patent-ability of non-naturally occurring DNA molecules?

Sharon Terry testified at House Appropriations Committee Hearing, January 29, 2010.

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