Association for Molecular Pathology v. Myriad Genetics, Inc.

Association for Molecular Pathology v. Myriad Genetics, Inc.
Supreme Court of the United States
Argued April 15, 2013 Decided June 13, 2013
Full case name	Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al.
Docket no.	12-398
Citations	569 U.S. 576 (more) 133 S. Ct. 2107; 186 L. Ed. 2d 124; 2013 U.S. LEXIS 4540; 81 USLW 4388; 106 U.S.P.Q.2d 1972; 13 Cal. Daily Op. Serv. 5951; 2013 Daily Journal D.A.R. 7484; 24 Fla. L. Weekly Fed. S 276
Case history
Prior	The District Court for the Southern District of New York denied the USPTO's motion to dismiss, 669 F. Supp. 2d 365 (S.D.N.Y. 2009), and found that patents were ineligible, 702 F. Supp. 2d 181, 192–211 (S.D.N.Y. 2010). On appeal, the Federal Circuit reversed the decision and found 2-1 in favor of Myriad, 653 F.3d 1329 (Fed. Cir. 2011); vacated and remanded, 566 U.S. 902 (2012); 689 F.3d 1303 (Fed. Cir. 2012); cert. granted, 568 U.S. 1045 (2012).
Holding
Naturally occurring DNA sequences, even when isolated from the body, cannot be patented, but artificially created DNA is patent eligible because it is not naturally occurring.
Court membership
Chief Justice John Roberts Associate Justices Antonin Scalia · Anthony Kennedy Clarence Thomas · Ruth Bader Ginsburg Stephen Breyer · Samuel Alito Sonia Sotomayor · Elena Kagan
Case opinions
Majority	Thomas, joined by Roberts, Kennedy, Ginsburg, Breyer, Alito, Sotomayor, Kagan; Scalia (in part)
Concurrence	Scalia (in part)
Laws applied
U.S. Const. Article I, Section 8, Clause 8, 35 U.S.C. § 101

Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), was a Supreme Court case, which decided that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.”^[1] However, as a "bizarre conciliatory prize" the Court allowed patenting of complementary DNA, which contains exactly the same protein-coding base pair sequence as the natural DNA, albeit with introns removed.^[2]

The lawsuit in question challenged the validity of gene patents in the United States, specifically questioning certain claims in issued patents owned or controlled by Myriad Genetics that cover isolated DNA sequences, methods to diagnose propensity to cancer by looking for mutated DNA sequences, and methods to identify drugs using isolated DNA sequences.^[3] Prior to the case, the U.S. Patent Office accepted patents on isolated DNA sequences as a composition of matter. Diagnostic claims were already under question through the Supreme Court's prior holdings in Bilski v. Kappos and Mayo v. Prometheus. Drug screening claims were not seriously questioned prior to this case.

Notably, the original lawsuit in this case was not filed by a patent owner against a patent infringer, but by a public interest group (American Civil Liberties Union) on behalf of 20 medical organizations, researchers, genetic counselors, and patients as a declaratory judgement.

The case was originally heard in Southern District Court of New York. The District Court ruled that none of the challenged claims were patent eligible. The majority opinion called patenting isolated or purified natural products a “lawyer's trick” to circumvent the prohibitions on the direct patenting of products of nature.^[4]

Myriad then appealed to the United States Court of Appeals for the Federal Circuit (CAFC). The Federal Circuit reversed the district court in part and affirmed in part, ruling that isolated DNA, which does not occur by itself in nature, can be patented, and that the drug screening claims were valid, but that Myriad's diagnostic claims were not patentable. The CAFC considered the valid gene claims as directed toward compositions of matter rather than toward information, like the District Court did.

On appeal, the Supreme Court vacated and remanded the case back to the Federal Circuit to reconsider the issues in light of Mayo v. Prometheus. On remand, the Federal Circuit held that Mayo v. Prometheus did not affect the outcome of the case, so the American Civil Liberties Union and the Public Patent Foundation filed a petition for certiorari. The Supreme Court granted certiorari and unanimously invalidated Myriad's claims to isolated genes. The Supreme Court held that merely isolating genes (even with introns removed), which are found in nature, does not make them patentable. However, the SCOTUS agreed with the “friend of the court brief” submitted by the USPTO, that complementary DNA should be patent eligible, because it does not exist in Nature but rather was “engineered by man,” even though this decision lacks scientific consistency. A prominent US biotech patent lawyer commented on the SCOTUS decision: "It is inconsistent to conclude that isolated DNA and naturally occurring DNA are not markedly different because their information content is the same, and at the same time find that cDNA is patent eligible despite having virtually identical information content to naturally occurring mRNA."^[4]

This decision was not devastating for Myriad Genetics, since the Court only “invalidated five [of its 520] patent claims covering isolated naturally occurring DNA, ... thereby reducing [its] patent estate to 24 patents and 515 patent claims.” ^[5] Myriad continued suing its competitors. However, it was unable to get preliminary injunctions per eBay Inc. v. MercExchange, L.L.C., and most of these lawsuits were settled out of court.^[2]