Court of Appeals for the Federal Circuit, Decision of 16 August 2012, No. 2010-1406, Association for Molecular Pathology et al. v. U.S.P.T.O. et al.

The Supreme Court will now have to decide whether human genes can be patented, a long-disputed legal question that has implications for the future of personalized health care.

In this closely followed case involving the patentability of isolated DNA sequences from the BRCA1 and BRCA2 genes, which account for most forms of inherited breast and ovarian cancer, the Federal Circuit issued a decision on 16 August 2012 that largely followed its prior 2011 ruling and again held that isolated DNA sequences are patent eligible subject matter.

Plaintiffs had sought a declaratory judgment that 15 claims from seven different patents held by Myriad were drawn to patent ineligible subject matter. The issue was whether the claims to isolated BRCA DNA, to methods for comparing DNA sequences, and to a process for screening potential cancer therapeutics met the threshold test for patent-eligible subject matter under 35 U.S.C. §101 in light of various Supreme Court holdings.

Addressing Myriad’s composition of matter claims, the Federal Circuit noted that while the Supreme Court has consistently interpreted §101 of the Patent Act broadly, it has also consistently held that it is not unlimited and its precedents provide three judicially created exceptions to §101’s broad patent-eligibility principles: "Laws of nature, natural phenomena, and abstract ideas are not patentable." Mayo Collaborative Services v. Prometheus Laboratories, 132 S.Ct. at 1293.

Relying on the Supreme Court’s ruling in Diamond v. Chakrabarty, 447 U.S. at 313, 100 S.Ct. 2204, 65 L.Ed.2d 144 (1980), which held a genetically engineered bacteria to be patent eligible whereas a naturally occurring bacteria is not, the Federal Circuit decided that the isolated DNA at issue is patent eligible because it is not just "purified" DNA as it exists in the body but rather "result[] from human intervention to cleave or synthesize a discrete portion of a native chromosomal DNA, imparting on that isolated DNA a distinctive chemical identity as compared to native DNA."

With regard to Myriad’s method claims for analyzing and comparing BRCA DNA sequences, the Federal Circuit recognized that those claims recite only the mental steps of "comparing" and "analyzing" and were almost indistinguishable from those in "Mayo". The claims in "Mayo" required the steps of "administering" a drug dosage, "determining" the level of drug metabolites and "comparing" that level to predetermined levels to optimize drug dosage. The Supreme Court held such claims patent ineligible because they were "not sufficiently transformative of what was otherwise a claim to a natural law." Following "Mayo", the Federal Circuit similarly held Myriad’s method claims invalid under §101.

Finally, the Federal Circuit addressed Myriad’s method claim for screening potential cancer therapeutics via changes in cell growth in transformed cells. The court held the method claim patent-eligible because it includes the step of "growing host cells transformed with an altered BRCA 1 gene in the presence or absence of a potential cancer therapeutic." Because the claim includes the step of growing transformed cells that do not occur in nature, the court held that the claim is more than just the abstract mental step of "comparing."

Judge Bryson, in dissent, took the diametrically opposed position to the majority with regard to the patent eligibility of isolated gene sequences. He would have affirmed the district court’s decision and held Myriad’s claims to the BRCA gene sequences and to the shorter probe sequences patent-ineligible. But, he would have held patentable the claims to complementary DNA sequences because they do not occur in nature.

The Supreme Court has granted certiorari and a decision is likely this year.