U.S. government reverses stance on gene patents

In a surprising turn of events, the U.S. Department of Justice filed a friend-of-the-court brief Friday arguing that human genes should not be eligible for patents because they are found in nature. The amicus brief was provided for a court case launched by the ACLU and Public Patent Foundation that questions the patent rights currently held by Myriad Genetics and the University of Utah to the BRCA I and II genes, which are used to screen for breast and ovarian cancers. The Patent and Trademark Office has previously awarded patents for genes, including to National Institutes of Health, which then can be used for human screening tests for diseases such as cancer. The companies and organizations can then charge a sizable fee to use the gene product for clinical diagnostic purposes.

ACSH's Dr. Elizabeth Whelan worries that if companies are no longer able to patent human genes, it could have a negative impact on the biotech industry. “If you can’t have a patent to a natural human product, why would a company invest in finding the gene?”

“What about a very rare gene mutation?” asks ACSH's Dr. Gilbert Ross. “A lot of effort and investment is needed to pursue such an undertaking. If a company cannot patent these genes, will they have the motivation to isolate it? The example of rare mutations complicates the gene patent issue.”

Still, this writer suspects there’s plenty of incentive to develop beneficial—and lucrative—methods to assay for genes and gene products, even if the gene itself cannot be patented.