A U.S. Supreme Court decision last June invalidated patents on naturally occurring genes and removed a major barrier to studying and testing them.
The ruling in the Association for Molecular Pathology v. Myriad Genetics Inc. case did not address methods of using DNA sequences and leaves intact patents on manmade composite DNA, which is valuable in drug development. Parties on both sides of the protracted legal battle, which focused on Myriad's exclusive right to patents on the BRCA1 and BRCA2 genes, claim victory. Plaintiffs say the decision allows patients to seek second opinions and will result in lower BRCA testing costs because of expected, increased market competition among labs.
A day following the decision, three labs announced their intentions to market BRCA tests. Myriad says that although the court ruled that five of its claims covering isolated DNA are not patent eligible, it still has “more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection” for its test.
The decision removes patent thickets that kept some key genes off panel tests for certain conditions that affect children, such as hereditary hearing loss.
More coverage of the impact of this Supreme Court decision will be featured in our September issue.