Supreme Court Votes Against Human Gene Patents

CURE, Fall 2013, Volume 12, Issue 3

The U.S. Supreme Court decides against patents on human genes.

The unanimous decision in June by the U.S. Supreme Court against patents on human genes made some wonder how DNA, a product of nature that defines identity and personal traits, could have been patented in the first place. Proponents claim that patent protection in research is needed to continue efforts to isolate and identify genes in order to develop diagnostic tests and therapies for the good of the general public.

Such was the case with Myriad Genetics, a molecular diagnostic company whose patents on the breast and ovarian susceptibility genes BRCA 1 and 2 were invalidated by the Supreme Court ruling. Myriad’s research into BRCA 1 and 2 helped thousands of patients know their cancer risk and allowed the medical community to better understand which mutations are actually harmful—something that requires access to large amounts of pooled information.

However, the prices commanded for testing no longer reflect the state-of-the-art of gene sequencing, the costs of which have dropped precipitously with newer “next-generation” sequencing technology. Furthermore, the discovery of the BRCA genes were not made in isolation. Rather, the discovery builds upon decades-long research that pinpointed the general location of these genes.

The Supreme Court decision is not sweeping and its effects will not be seen overnight. Myriad and other companies still retain significant intellectual property and will probably switch over to offering more complex tissue assays and tests of gene panels that go beyond the effect of a single gene mutation and focus on the biological impact on tissues. This too, will move the field forward. But will competition in the free market lower prices of testing at the cost of reciprocal stifling of investment and innovation? Only time will tell, but history seems to be on the side of healthy competition leading to continuing improvements both in quality and value.