Angelina Jolie recently made headlines for her preemptive mastectomy after learning that she carried the BRCA genes, which are linked to breast cancer. It is not often that pop culture intersects with patent law, but on June 13, 2013, the U.S. Supreme Court handed down an opinion that had been anxiously awaited by many in the scientific community and had ties to Jolie's news.
The case involved patents held by Myriad Genetics for the BRCA genes. Through its patents, Myriad held a monopoly over testing for the presence of these genes in an individual (like Jolie whose genetic status was identified using Myriad's test). The patents also prevented others from conducting research on the genes. The Court found that while it is important to identify the function of genes, isolating a naturally occurring segment of DNA (gene) is not patentable.
The opinion does not spell complete defeat for Myriad or others that study and isolate genes. Instead, it reaches a middle ground, finding that synthetic DNA molecules corresponding to genes, known as cDNA, can be patented, because extra human intervention is required to create cDNA.
While the Court did find that some of Myriad's patents were invalid, the research company still has significant patent protection for its BRCA-related technology-including patents for cDNA molecules related to the BCRA genes and its BCRA tests.
The challengers of Myriad's patents can also claim victory with the decision, as the door is now open for researchers to study the BRCA genes without running afoul of Myriad's patents. This new freedom applies broadly to the entire biotech research community regardless of the genes being studied, from billion dollar companies to university researchers and small startups.
There has long been a debate over gene patents, from those who take the position that companies who invest millions in research should be rewarded with a monopoly over their discoveries, to those who believe that everyone should have the freedom to conduct research and use others' discoveries to advance technology for the global good. The Court's opinion certainly doesn't end the debate, but does make some concessions to those on both sides.