Federal Circuit Rules Breast Cancer Gene Patentable Subject Matter
On July 29, the Federal Circuit held that isolated genetic sequences fall within the scope of patentable subject matter under 35 U.S.C. § 101, reversing a previous district court decision.
The claims at issue were directed to isolated DNA sequences corresponding to the BRCA1 and BRCA2 genes, which are associated with an increased risk for breast cancer. In 2010, a district court had previously ruled that the isolated DNA sequences claimed by Myriad did not fall within the realm of patentable subject matter, because the individual genes were not substantially different from the original DNA sequence found in nature.
Writing for the majority of the three-judge panel, Judge Lourie noted that "isolation" of the genetic sequences falling within the scope of the claims requires the breaking of covalent bonds, which attach the claimed sequences to the remainder of the DNA molecule in its natural state. The majority found that this distinction was enough to create patentable subject matter, holding that:
"[T]he claimed isolated DNA molecules do not exist as in nature within a physical mixture to be purified. They have to be chemically cleaved from their chemical combination with other genetic materials. . . . Thus, when cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity."
The majority distinguished the process of "isolation"—which involves the breaking of covalent chemical bonds—from mere "purification," in which the claimed chemical structure already exists in nature, but must be separated from other components before it has practical utility. The breaking of covalent bonds to obtain an isolated product is therefore crucial to the Federal Circuit's definition of patentable subject matter, and is confirmed by Judge Lourie's statement that "a covalent bond is the defining boundary between one molecule and another."
Also at issue were several claims directed to methods of use of the claimed sequences. The Federal Circuit upheld Myriad's claim for a method of screening potential cancer therapies by measuring cell growth rates, finding that growing and manipulating cell cultures is a transformative action that passes the machine-or-transformation test. However, Myriad's remaining method claims were rejected by the court as based on abstract mental processes. For example, Myriad's claim for a method of comparing a patient's DNA sequence to isolated BRCA1 and BRCA2 sequences was rejected as reciting "nothing more than the abstract mental steps necessary to compare two different nucleotide sequences.”
The case is The Association of Molecular Pathology et al. v. USPTO et al., case number 2010-1406, in the U.S. Court of Appeals for the Federal Circuit. The patents-in-suit are U.S. Patent Numbers 5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,710,001; 5,753,441; and 6,033,857.