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United States Court of Appeals for the Federal Circuit
April 8, 2016, Decided
[***1542] [*1371] Dyk, Circuit Judge.
Genetic Technologies Limited ("GTG") brought suit against Merial L.L.C. ("Merial") and Bristol-Myers Squibb ("BMS") (together, "appellees"). GTG alleged that appellees had infringed U.S. Patent No. 5,612,179 ("the '179 patent"), which relates to methods of detecting genetic variations. The district court granted appellees' motions to dismiss for failure to state a claim and entered final judgment that claims 1-25 [**2] and 33-36 of the '179 patent are ineligible for patenting under 35 U.S.C. § 101. For purposes of this appeal, the parties have stipulated that claim 1 is representative of all of the invalidated claims. Because we agree that claim 1 is directed to unpatentable subject matter, we affirm.
The '179 patent claims methods of analyzing sequences of genomic deoxyribonucleic acid ("DNA"). Genetic information is encoded in DNA, which carries instructions for the development and function of all life. DNA sequences spell out instructions for synthesis of shorter sequences of ribonucleic acid ("RNA"), which in turn provide templates for synthesis of proteins. An individual's complete set of DNA is known as his genome, and a particular sequence of DNA within the genome that codes for a given protein (or functional RNA molecule) is referred to as a gene. Genes are the individual units defining heredity, and a person's overall collection of genes is known as his genotype. The site on a chromosome occupied by a particular gene is the genetic locus. Genes typically contain both coding regions, called exons, and non-coding regions, [*1372] called introns. Exons are regions of the DNA sequence of the gene that are expressed, i.e., ultimately [**3] "decoded" and translated into the protein sequence. Introns are regions that are not expressed; these regions do not code for protein.
Each individual has his own unique genotype, inherited from his two parents. Variation of the precise genetic sequence within a particular gene among different people is known as genetic polymorphism, and the various alternative forms (mutations) of the gene are referred to as individual alleles. Detection of specific alleles can be useful for a variety of purposes, including diagnosis and treatment of genetic disorders and diseases correlated with those alleles, e.g., sickle-cell anemia, hemophilia, and cystic fibrosis.
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818 F.3d 1369 *; 2016 U.S. App. LEXIS 6407 **; 118 U.S.P.Q.2D (BNA) 1541 ***
GENETIC TECHNOLOGIES LIMITED, Plaintiff-Appellant v. MERIAL L.L.C., BRISTOL-MYERS SQUIBB COMPANY, Defendants-Appellees
Subsequent History: US Supreme Court certiorari denied by Genetic Techs. Ltd. v. Merial L.L.C., 2016 U.S. LEXIS 4643 (U.S., Oct. 3, 2016)
Prior History: [**1] Appeals from the United States District Court for the District of Delaware in Nos. 1:12-cv-00396-LPS, 1:12-cv-00394-LPS Chief Judge Leonard P. Stark.
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Civil Procedure, Appeals, Standards of Review, De Novo Review, Patent Law, Jurisdiction & Review, Defenses, Demurrers & Objections, Motions to Dismiss, Failure to State Claim, Subject Matter, Infringement Actions, Claim Interpretation