The Federal Circuit has twice ruled that human genes can be patented. Now, it's the Supreme Court's turn to decide.
Last week, the Court granted certiorari in Association for Molecular Pathology v. Myriad Genetics, Inc.
The case will resolve whether seven existing patents on two genes associated with increased breast and ovarian cancer risk -- BRCA1 and BRCA2 -- are valid, or whether the genes can't be patented because they are products of nature.
Myriad Genetics, the company that holds the patents, claims that the act of isolating the genes from a person produces a new material that has utility beyond the DNA that naturally occurs in the human body. According to Myriad, extracting the genome makes it patentable.
The Federal Circuit Court of Appeals agrees, but the appellate court's rulings on the matter seem to conflict with the Court's Mayo v. Prometheus Laboratories decision from the 2011 Term.
In Mayo, the Court ruled that naturally occurring phenomena are not patentable. While that reasoning could seemingly be applied to determine that genes cannot be patented, the Federal Circuit believes that Mayo either isn't applicable or is outweighed by the longstanding U.S. Patent and Trademark Office policy on granting patents on isolated genes, Reuters reports.
Does the Supreme Court's decision to hear the case mean that the Federal Circuit will be reversed? Not necessarily.
The Court has been known to summarily reverse lower courts when they openly defy Supreme Court precedent, so it's significant that the justices want to hear the case.
But, considering that the Court was unanimous on Mayo, we're guessing that the Court will find that genes are not patentable.
- Association for Molecular Pathology v. USPTO (Federal Circuit Court of Appeals)
- Myriad's Medical Patent Case Sent Back After Prometheus Decision (FindLaw's Federal Circuit Blog)
- Court Partially Rejects Myriad Gene Patent Claims (FindLaw's Federal Circuit Blog)