American Journal of Law & Medicine

Federal Circuit Holds Isolated DNA Is Patent-Eligible - Association for Molecular Pathology V. United States Patent and Trademark Office (Myriad III)

Federal Circuit Holds Isolated DNA Is Patent-Eligible--Association for Molecular Pathology v. United States Patent and Trademark Office (Myriad 111) (1) --On August 12, 2012, after remand from the Supreme Court, the U.S. Court of Appeals for the Federal Circuit held that the following is patent-eligible: 1) isolated DNA; 2) a method claim for detecting germline/somatic genetic alterations by comparing DNA sequences; and 3) a method claim for screening cancer therapeutics by measuring transformed cells' growth rate. (2)

Myriad Genetics, Inc. ("Myriad"), a provider of diagnostic testing services for breast cancer, holds patents covering the genetic basis for the services it provides. (3) A group of medical institutions, researchers, and patients (the "Plaintiffs") brought suit against Myriad for declarative judgment on the validity of seven patents covering two breast cancer genes ("Breast Cancer Patents"). (4) The Plaintiffs alleged that the Breast Cancer Patents are patent-ineligible under 35 U.S.C. [section] 101. (5) Although the statute recognizes a broad scope of patentable subject matter, the Supreme Court requires a patent-eligible subject matter to have a "distinctive name, character and use" that is markedly different from a natural product or manifestation. (6)

Myriad's Breast Cancer Patents encompass roughly two kinds of claims: composition claims and method claims. (7) Composition claims cover the isolated DNA constituting any portions of the breast cancer genes or the breast cancer genes in their entirety. …

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