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Genetic Techs. Ltd. v. Merial L.L.C.

United States Court of Appeals, Federal Circuit

April 8, 2016


          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.

         BENJAMIN B. LIEB, Sheridan Ross, PC, Denver, CO, argued for plaintiff-appellant. Also represented by ROBERT R. BRUNELLI, HIWOT M. COVELL.

         GREGORY A. CASTANIAS, Jones Day, Washington, DC, argued for defendant-appellee Merial L.L.C. Also represented by JOHN PATRICK ELSEVIER, PHILIP SHENG, San Diego, CA; JUDY CATHERINE JARECKI-BLACK, Merial Limited, Atlanta, GA.

         AMY K. WIGMORE, Wilmer Cutler Pickering Hale and Dorr LLP, Washington, DC, argued for defendant-appellee Bristol-Myers Squibb Company. Also represented by THOMAS SAUNDERS, TRACEY COTE ALLEN; WILLIAM F. LEE, ALLISON TRZOP, Boston, MA.

         Before PROST, Chief Judge, DYK, and TARANTO, Circuit Judges.


          [ 118U.S.P.Q.2D 1542] 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 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, called introns. Exons are regions of the DNA sequence of the gene that are expressed, i.e., ultimately " 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.

         In the 1980s, Dr. Malcolm J. Simons, the named inventor of the '179 patent, working with GTG,[1] discovered an interesting feature of genomic DNA. Dr. Simons discovered that certain DNA sequences in coding regions (exons) of certain genes are correlated with non-coding regions (introns) within the same gene, non-coding regions in different genes, or non-coding regions of the genome that are not part of any gene. Non-coding DNA regions between genes are referred to by the '179 patent as " intergenic spacing sequences" and have been referred to colloquially as " junk DNA," because, at least historically, they appeared to serve no function. '179 patent col. 5 ll. 42-46.

          [ 118U.S.P.Q.2D 1543] Dr. Simons found that the correlated coding and non-coding regions tend to be inherited together, with only rare shuffling. In other words, the regions are in " linkage disequilibrium," meaning that the coding and non-coding regions appear " linked" together in individuals' genomes more often than probability would dictate. '179 patent col. 5 ll. 20-32; see also, e.g., Henderson's Dictionary of Biology 366 (14th ed. 2008) (" [L]inkage disequilibrium [is a] condition in which certain alleles at two linked loci are non-randomly associated with each other." ). The correlated coding and non-coding regions may be linked even though the two sequences are located far apart from one another on the chromosome.

         Dr. Simons concluded that alleles of a particular gene may be detected, using well-established laboratory techniques, not by looking for the coding region of the gene itself but instead by amplifying and analyzing non-coding regions known to be linked to the coding region. Between 1989 and 1992, Dr. Simons and GTG filed several patent applications related to the discovery. One of these applications ultimately became the '179 patent. Claim 1 of the '179 patent recites:

1. A method for detection of at least one coding region allele of a multi-allelic genetic locus comprising:
a) amplifying genomic DNA with a primer pair that spans a non-coding region sequence, said primer pair defining a DNA sequence which is in genetic linkage with said genetic locus and contains a sufficient number of non-coding region sequence nucleotides to produce an amplified DNA sequence characteristic of said allele; and
b) analyzing the amplified DNA sequence to detect the allele.

         '179 patent col. 59 ll. 57-67. Claim 1 is thus broad in scope; it encompasses methods of detecting a coding region allele by amplifying and analyzing any linked non-coding region, which could be found within the same gene as the coding region, within a different gene, or within an intergenic region.

         According to GTG, the methods of the '179 patent have various advantages over prior art methods involving direct analysis of a coding region. For example, GTG stated that " analysis of relatively short regions of non-coding sequences, of a size which can be amplified, can provide more information than prior art analyses such as cDNA RFLP analyses which involve the use of significantly larger DNA sequences . . . ." '179 Patent Prosecution History, Applicant's Amendment and Remarks of Jan. 14, 1993, at 6.

         In 2011, GTG sued several pharmaceutical and biotechnology companies, including Merial and BMS, in the United States District Court for the District of Colorado for infringement of the '179 patent. GTG's claims against Merial and BMS were severed and transferred to the District of Delaware. GTG alleged infringement of at least one claim of the '179 patent and, in BMS's case, infringement of a second patent not at issue in this appeal. Merial and BMS subsequently moved to dismiss under Federal Rule of Civil Procedure 12(b)(6) (" Rule 12(b)(6)" ...

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