Policy/Position Papers

Gene Patenting: NORD Policy Position

Background
On June 26, 2000, the publicly financed Human Genome Project, along with the privately financed company Celera Genomics, jointly announced that they had successfully mapped more than 95 percent of the human genetic code. This new knowledge is expected to lead to development of new treatments and cures for numerous health conditions, especially genetic diseases.

Problem
In the past, the United States Patent and Trademark Office (“PTO”) has allowed scientists and corporations to patent genes and gene sequences before any uses were known. NORD feels that exclusive patents on genes and sequences will limit scientific research and the development of needed pharmaceuticals, biologics and other therapies for millions of people throughout the world. Patent holders are able to prevent or delay research on a gene, charge fees to scientists for access to a gene, and force researchers to sign confidentiality agreements that prohibit publication of their research results. NORD believes the ability to prevent research on any disease is unethical, especially when the commercial use of a gene is not yet known.

Policy Position

• The code for the human genome belongs to the entire human race and should not be the property of any one individual or corporation. A gene is not an invention; all information regarding the human genetic code should be freely available to all scientists thus allowing for the unimpeded and creative development of new and better treatments for diseases.
  
  
• NORD supports patents for genes that have been changed or engineered by scientists to create a commercial use, and for commercial products developed from genetic information, but not for genes as they exist in nature.
  
  
• PTO should prohibit any future patenting of genes or gene sequences. Any failure or hesitation by PTO to stop issuing gene patents should lead to Congress taking appropriate legislative action to protect the freedom of scientific inquiry and the tens of millions of Americans with genetic diseases who rely on future medical discoveries.
  
  
• The Federal government must actively engage in monitoring current gene patent holders to ensure that those persons engaged in research on patented genes are not burdened with royalty payments or secrecy agreements unless or until a commercial product is developed that effectively utilizes the gene.
  
  
• If currently patented genes are not made accessible to scientists who wish to study such genes, Congress should enact a “compulsory licensing” law that requires free access by researchers without royalties or confidentiality agreements. When a commercial use for a gene is developed, the patent holder should be compelled to license the use of the gene to any company that wishes to sell the treatment.

Whom We Represent
NORD is a federation of approximately 140 not-for-profit health organizations and thousands of individuals and medical professionals serving people with rare diseases. Most rare disorders are genetic. As a voluntary health agency dedicated to helping people with rare disorders, NORD works to ensure that biomedical research will not be hampered or delayed, and that the fruits of genome discoveries will be made available to patients who need them.

For more information, contact: Diane E. Dorman, Senoir Director for Public Policy at (301) 421-0018 or via e-mail at ddorman@rarediseases.org.

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