On June 13, 2013, the U.S. Supreme Court issued its long-awaited decision in the “ACLU/Myriad” gene patents case (Association For Molecular Pathology v. Myriad Genetics, Inc.). In a unanimous opinion authored by Justice Thomas, the Court held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.” Thus, the Court held that human genes may not be patented.
This case stems from a declaratory judgment action brought to challenge certain claims in seven patents related to Myriad’s discovery of the BRCA1 and BRCA2 genes, and t [...]
In a divided en banc decision, the U.S. Court of Appeals for the Federal Circuit affirmed the district court’s holding that the claims at issue in CLS Bank v. Alice Corporation are invalid under the “abstract idea” exception to 35 USC § 101. While a majority of the judges agreed that the method and computer-readable medium claims are invalid, they disagreed as to why. Further, the court was evenly split as to whether the systems claims are invalid. (With no majority agreement on that issue, the district court decision is affirmed). Even if this case makes its way to the U.S. Supreme Court, patent-eligibility will remain a murky area of U.S. patent law for the foreseeable future.
On November 30, 2012, the U.S. Supreme Court granted certiorari in the “ACLU/Myriad” gene patenting case (Association for Molecular Pathology v. Genetics, Inc.), taking on the debate over the patent-eligibility of human genes. The Court will review the August 16, 2012 Federal Circuit decision that held for the second time that Myriad’s claims directed to isolated DNA sequences satisfy 35 USC § 101.
The Court’s order granting certiorari is limited to the following question:
Are human genes patentable?
However, in order to assess Myriad’s patents, it will have to decide whether Myriad’s claims, which are directed to “isolated DNA” that encompass genomic DNA const [...]