"Patent Eligibility Considerations Following the Supreme Court’s Myriad Ruling"

On June 13, 2013, the Supreme Court issued its long-awaited decision in Assoc. for Molecular Pathology v. Myriad Genetics, Inc., U.S., No. 12–398 (Myriad). In a unanimous opinion, the Court held that a naturally occurring DNA segment is a product of nature and therefore not patent-eligible, reversing, in part, the prior holding of the Federal Circuit (Association for Molecular Pathology v. PTO, 689 F.3d 1303 (Fed. Cir. 2012)). Additionally, the Court affirmed the Federal Circuit’s finding that laboratory-created cDNA, which is not present in nature, is indeed patentable subject matter. In distinguishing patent-eligible subject matter from the natural phenomena it can be based on, the Supreme Court offered the biotechnology industry, and the patent community generally, some guidance about the susceptibility of patent claims to challenges under Section 101 of the Patent Act (35 U.S.C. §101) but failed to clarify its prior jurisprudence on the bounds of Section 101.

Myriad Genetics, Inc. (Myriad) made a major breakthrough in the cancer screening industry when it identified the precise location and nucleotide sequences of the BRCA1 and BRCA2 genes. Mutation of these genes has been linked to hereditary breast and ovarian cancer. Using this discovery, Myriad designed medical screening tests to detect such mutations and obtained a number of related patents, three of which were before the Supreme Court.

Myriad’s patent claims at issue relate to two types of DNA products. The first is isolated portions of the DNA code for the BRCA1 and BRCA2 genes. Other than the minor chemical changes that occur during the process of isolation of the claimed DNA sequences (as a result of severing the covalent bonds holding together the naturally occurring DNA), the claimed DNA code is identical to DNA in its natural state.

The second set of DNA products claimed in Myriad’s patents are cDNA sequences. cDNA is a synthetic DNA molecule, which is made in a laboratory by allowing nucleotides to bind to an isolated mRNA molecule. The resulting cDNA contains certain parts of the code of the underlying DNA but is a different molecule and cannot be found in nature.

When deciding a declaratory judgment action seeking to invalidate Myriad’s patents, the district court found Myriad’s patent claims to isolated DNA and cDNA invalid in light of the Supreme Court’s prior line of cases on patentable subject matter under Section 101. The Federal Circuit initially reversed the district court, but after a remand from the Supreme Court in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 556 U.S. __ (2012), the Federal Circuit affirmed in part and reversed in part, finding that both isolated DNA and cDNA are patent eligible under Section 101. The three judges on the panel each offered distinct rationales for their positions on isolated DNA. Judge Lourie found isolated DNA patentable because of the chemical alteration that takes place when severing the chemical bonds that hold together the DNA molecule. Judge Moore agreed that isolated DNA is patentable but relied instead on the Patent and Trade Office’s (PTO) established practice of granting gene patents and the attendant reliance interests of patent owners. Judge Bryson dissented from the panel’s finding on isolated DNA and concluded that isolated DNA is not patent-eligible, finding neither the chemical change nor the PTO policy dispositive. All three judges agreed that patent claims on cDNA meet the patent eligibility requirements of Section 101.

In its Myriad decision, the Supreme Court drew a sharp line between what it determined to be a “product of nature” ineligible for patent protection and the wide range of related inventions that may be entitled to patent protection. In doing so, the Court provided some limited direction to the patent community on how to draft patent claims that may involve eligibility issues, while failing to provide any meaningful guidance on the underlying inquiry of...