NIH and Private Industry in Legal Battle over Breast Cancer Gene Patent

WASHINGTON--The National Institutes of Health (NIH) is disputingthe commercial rights to the newly discovered breast cancer geneBRCA1. In a move that could affect how much women pay for screeningwhen such a test becomes available, scientists at the Universityof Utah and Myriad Genetics, Inc. failed to include NIH as a collaboratorwhen it applied to patent the gene. The NIH has filed a counterapplication.

BRCA1 was discovered partly by NIH scientists using taxpayer funds,but unless NIH is successful in its legal effort, the federalgovernment would have no control over how commercial results ofthe discovery are marketed. A patent arising out of discoveryof the new gene would give the patent holder a 17-year monopolyon the sale of diagnostic tests and/or pharmaceuticals developedfrom it.

According to NIH Director Harold Varmus, agency lawyers will tryto resolve the dispute in an effort to avoid going to court.