Bill to exempt researchers from patent restrictions

Doctors and medical researchers who want to work with disease-causing genes to develop new treatments and diagnostic tests may soon be exempt from patent protections that currently prohibit them from doing so.

On March 14, Reps. Lynn Rivers (D-MI) and David Weldon (R-FL) co-sponsored a bill in the U.S. House of Representatives that would prevent entities that own patents on human genes from barring the use of those genes in noncommercial genetics research or diagnostic disease testing.

The U.S. Patent and Trademark Office has issued some 8,000 patents on genes, allowing holders to control the use of genes or demand royalties and license fees for their use in research. Some medical researchers have been sued to prevent them from performing research on specific human genes or DNA sequences covered by patents.

The House bill applies only to diagnostic tests and academic research and does not exempt the development of drugs or other treatments.

The exemptions in the bill would go no further than "fair-use" exemptions that allow copyrighted intellectual property to be used in a noncommercial way by the public, Rivers told Reuters Health.

Researchers developing genetic tests under the exemption would not be permitted to commercially market the tests without the clearance of the patent holder, she said.

Rivers also introduced a second bill that would require the White House Office of Science and Technology to perform an in-depth study on genetics patent law and whether the laws affect the cost or innovation of new products.