Association for Molecular Pathology v. Myriad Genetics, Inc.

(Redirected from Association for Molecular Pathology v. Myriad Genetics )

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." However, 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.

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. 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.

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 ."

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." 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.

Contents

• 1 Background

  • 1.1 Relevant case law precedents

  • 1.2 Litigants

  • 1.3 Arguments

• 2 Decision of the District Court

• 3 First hearing in the Court of Appeals for the Federal Circuit

• 4 First petition to the Supreme Court

• 5 Second hearing in the Court of Appeals for the Federal Circuit

• 6 Second petition to the Supreme Court

• 7 Decision of the Supreme Court

• 8 Reactions to the decision

• 9 References

• 10 Further reading

• 11 External links

Background

(https://en.wikipedia.org/w/index.php?title=Association_for_Molecular_Pathology_v._Myriad_Genetics,_Inc.&action=edit&section=1 "Edit section: Background")

The global search for a genetic basis for breast and ovarian cancer began in earnest in 1988. In 1990, at a meeting of the American Society of Human Genetics , a team of scientists led by Mary-Claire King , from the University of California, Berkeley announced the localization through linkage analysis of a gene associated with increased risk for breast cancer (BRCA1 ) to the long arm of chromosome 17. It was understood at the time that a test for these mutations would be a clinically important prognostic tool. Myriad Genetics was founded in 1994 as a startup company out of the University of Utah , by scientists involved in the hunt for the BRCA genes. In August 1994, Mark Skolnick , a founder of Myriad and scientist at University of Utah, and researchers at Myriad, along with colleagues at the University of Utah, the

…