Are Human Genes Patentable?

The Supreme Court has long held that laws of nature, natural phenomenon, and abstract ideas are not patent eligible under 35 U.S.C. § 101. See, e.g., Diamond v. Diehr, 450 U.S. 175 (1981); Diamond v. Chakrabarty, 447 U.S. 303 (1980). Since 2010, the Supreme Court has twice more considered this issue, both times reversing the Federal Circuit. Mayo Collaborative Serv. v. Prometheus, Inc. 132 S. Ct. 1289 (2012) (a method of optimizing the efficacy of a drug is an unpatentable law of nature); Bilski v. Kappos 130 S. Ct. 3218 (2010) (a method of hedging risk in trading commodities constitutes an unpatentable abstract idea). On April 15th, the Supreme Court will hear yet another case concerning patent eligible subject matter, this time on an issue of great importance to the biotechnology industry; namely, the patentability of human genes. Ass'n for Molecular Pathology v. Myriad Genetics, Inc., U.S. No 12-398, (Nov. 30, 2012).

The claims at issue involve two genes known as BRCA1 and BRCA2. The Myriad inventors discovered that mutations in these genes are associated with a predisposition to breast and ovarian cancers. Women having BRCA mutations are said to have a cumulative risk of fifty (50%) to eighty (80%) percent of developing breast cancer and a cumulative risk of twenty (20%) to fifty (50%) percent of developing ovarian cancer. The discovery of these gene mutations and methods of diagnosing them are of paramount importance to millions of women.

The gene claims in the disputed patents are of two types: claims directed to "isolated" DNA encompassing full-length or genomic DNA sequences that are identical to the naturally-occurring BRCA1 and BRCA2 genes, and claims to shorter "isolated" DNA sequences including cDNA sequences as well as DNA fragments as small as fifteen (15) nucleotides.

In the District Court, Judge Sweet ruled that the "isolated" DNA sequences were unpatentable "products of nature." Ass'n for Molecular Pathology v. U.S.P.T.O., 702 F. Supp. 2d 181 (S.D.N.Y. 2010). Myriad appealed to the Federal Circuit, arguing, inter alia, that DNA isolated from the human body "differs markedly" from naturally-occurring DNA and that, unlike native DNA, the isolated BRCA DNA can be used for other purposes such as probes for diagnosing cancer. Ass'n for Molecular Pathology v. U.S.P.T.O. 653 F. 3d 1329 (Fed. Cir. 2011) (Myriad I).

Writing for the majority, Judge Lourie held that "isolated" BRCA1 and BRCA2 DNAs differ in chemical nature from BRCA...