In Association for Molecular Pathology and ACLU v. USPTO and Myriad Genetics the U.S. District Court for the Southern District of New York recently ruled that claims to isolated DNA sequences coding for BRCA1 and BRCA2 genes are unpatentable because the DNA sequences do not qualify as patentable subject matter under 35 U.S.C. § 101. Additionally, the district court invalidated several diagnostic method claims, covering methods of screening cells by comparing the BRCA1 or BRCA2 sequences isolated from the cells to specific BRCA1 and BRCA2 sequences as not patentable subject matter. If the ruling is upheld, issued patents covering isolated DNA sequences and diagnostic methods may be jeopardized. The decision will likely be taken up by the U.S. Court of Appeals for the Federal Circuit.
The claims at issue cover isolated “naturally-occurring” sequences for the BRCA1 and BRCA2 genes and mutations in the sequences, as well as diagnostic methods for detecting certain mutations. Mutations in BRCA1 and BRCA2 correlate with increased risk for breast or ovarian cancer. The court found that “in light of DNA’s unique qualities as a physical embodiment of information, none of the structural and functional differences cited by [the defendants] between native BRCA1/2 DNA and the isolated BRCA1/2 DNA claimed in the patents-in-suit render the claimed DNA “markedly different.” Slip opinion at 125. The court found that because the sequences were not “markedly different,” the claims are not patentable under an established line of case law stemming from 35 U.S.C. § 101. This ruling, however, runs afoul of established U.S. Patent Office rules allowing patenting of isolated DNA sequences.
The court also held that the claims directed to diagnostic methods were invalid for failure to satisfy the Federal Circuit's "machine or transformation" test under In re Bilski. Under this test, a process claim must either 1) be tied to a specific machine, or 2) cause a transformation of matter to be patent-eligible under 35 U.S.C. § 101. Citing In re Bilski and Prometheus v. Mayo, the court held that the claims requiring only “analyzing” and/or “comparing” sequences were not valid because they were not tied to a specific machine and do not cause a transformation of matter. The validity of the "machine or transformation" test is in question, however, as the U.S. Supreme Court has taken up an appeal of the In re Bilski ruling. A final ruling on the “machine or transformation” test is expected soon.
Prior to review of this decision by the U.S. Court of Appeals for the Federal Circuit, Association for Molecular Pathology and ACLU v. USPTO and Myriad Genetics is unlikely to affect the validity of patents claiming isolated DNA sequences. Nonetheless, the case merits monitoring, and we will continue to update you with developments.