Cases & Deals

Myriad Genetics obtains Supreme Court patent victory on synthetic DNA molecules relating to its breast and ovarian cancer test

Client(s) Myriad Genetics, Inc.

In a closely-followed and highly-publicized case, Jones Day secured an important Supreme Court victory for Myriad Genetics, Inc. on the patent-eligibility of its composition-of-matter claims directed to complementary DNA, or cDNA—synthetic DNA molecules created by scientists in a laboratory. The Court upheld Myriad's cDNA claims, which it uses to test whether a patient has a mutation in her BRCA1 or BRCA2 genes predisposing her to a risk of hereditary breast or ovarian cancer. Unlike other recent decisions in which the Supreme Court struck down all patent claims at issue in those cases, the Myriad decision marks the first time since 2001 that the Court has upheld patent claims as patent-eligible subject matter under Section 101 of the Patent Act.

The Myriad case began in 2009 when the ACLU assembled 20 plaintiffs to challenge certain of Myriad's patent claims, and initiated a declaratory-judgment lawsuit against Myriad. The U.S. District Court for the Southern District of New York entered summary judgment against Myriad, holding that all of the challenged composition-of-matter claims, including the four directed to cDNA molecules, did not constitute patent-eligible subject matter, because the DNA molecules were allegedly patent-ineligible "products of nature." After the Federal Circuit agreed with Myriad and upheld all of the challenged composition claims, the Supreme Court granted the ACLU's petition for review on those nine claims. The case attracted over 40 amicus briefs filed with the Supreme Court on both sides of the dispute.

On June 13, 2013, the Supreme Court issued its decision, upholding the four cDNA claims, which are vital to the tests Myriad has developed for diagnosing cancer risk and used to test more than one million patients since the patents issued in the 1990s. Although the Court struck down five other claims directed to isolated genomic DNA—DNA molecules separated from other cellular matter as they exist in the body—the Court underscored that other types of claims not at issue in the case deserve strong patent protection along with the cDNA claims, such as methods and applications of knowledge about natural products. Thus, Myriad's many other patent claims directed to methods of use and applications of what Myriad learned about the BRCA1 and BRCA2 genes are not affected by the Court's ruling on claims to isolated genomic DNA. Moreover, in an era of significant advances in personalized medicine and companion diagnostics, the Court recognized the important "medical breakthrough" that all of Myriad's work represented.

Myriad's victory on its cDNA claims and the Court's acknowledgement of the need for innovation and patent protection for genetic-based research and development are important to the company as well as to the biotechnology industry in general, including the ability to attract investors with the assurance of strong patent protection in return for their investment.

The Jones Day team representing Myriad included Greg Castanias, who argued the case before the Supreme Court, and Jennifer Swize of Washington, D.C.; Brian Poissant and Laura Coruzzi of New York; and Sasha Mayergoyz and Dennis Murashko of Chicago.

Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al., 569 U.S. ____ (2013)