Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc.

United States Court of Appeals, Federal Circuit

June 20, 2019

ENZO LIFE SCIENCES, INC., Plaintiff-Appellant
v.
ROCHE MOLECULAR SYSTEMS, INC., ROCHE DIAGNOSTICS CORPORATION, ROCHE DIAGNOSTICS OPERATIONS, INC., ROCHE NIMBLEGEN, INC., BECTON, DICKINSON AND COMPANY, AKA BECTON DICKSON AND COMPANY, BECTON DICKINSON DIAGNOSTICS INC., AKA BECTON DICKSON DIAGNOSTICS, GENEOHM SCIENCES INC., ABBOTT LABORATORIES, ABBOTT MOLECULAR, INC., Defendants-Appellees

          Public Opinion Issued: July 5, 2019 [*]

          Appeals from the United States District Court for the District of Delaware in Nos. 1:12-cv-00106-LPS, 1:12-cv-00274-LPS, 1:12-cv-00275-LPS, 1:13-cv-00225-LPS, Chief Judge Leonard P. Stark.

          Justin P.D. Wilcox, Desmarais LLP, New York, NY, argued for plaintiff-appellant. Also represented by John M. Desmarais; Peter Curtis Magic, San Francisco, CA.

          Matthew Wolf, Arnold & Porter Kaye Scholer LLP, Washington, DC, argued for defendants-appellees Roche Molecular Systems, Inc., Roche Diagnostics Corporation, Roche Diagnostics Operations, Inc., Roche NimbleGen, Inc., Becton, Dickinson and Company, Becton Dickinson Diagnostics Inc., GeneOhm Sciences Inc.

          John C. O'Quinn, Kirkland & Ellis LLP, Washington, DC, argued for defendants-appellees Abbott Laboratories, Abbott Molecular, Inc. Also represented by Michael Pearson, Jason M. Wilcox; James F. Hurst, Amanda J. Hollis, Chicago, IL; Benjamin Adam Lasky, New York, NY.

          Omar Khan, Wilmer Cutler Pickering Hale and Dorr LLP, New York, NY, for defendants-appellees Roche Molecular Systems, Inc., Roche Diagnostics Corporation, Roche Diagnostics Operations, Inc., Roche NimbleGen, Inc., Becton Dickinson and Company, Becton Dickinson Diagnostics Inc., GeneOhm Sciences Inc. Also represented by Robert J. Gunther, Jr., Christopher R. Noyes; William G. McElwain, Thomas Saunders, Washington, DC.

          Before Prost, Chief Judge, Reyna and Wallach, Circuit Judges.

          Prost, Chief Judge.

         Enzo Life Sciences, Inc. ("Enzo") appeals the decision of the U.S. District Court for the District of Delaware granting summary judgment against Enzo and holding that the asserted claims are invalid for lack of enablement.

         We affirm as to non-enablement and do not reach the other issues presented on appeal.

         I

         Deoxyribonucleic acid ("DNA") and ribonucleic acid ("RNA") are nucleic acids. They are made of a series of building blocks, called nucleotides, linked together in a chain. A single nucleotide is made up of a sugar, a phosphate, and a nitrogenous base. DNA nucleotides have one of four nitrogenous bases: adenine (A); guanine (G); cyto-sine (C); and thymine (T). RNA has the same bases, except it uses uracil (U) instead of thymine (T).

         A polynucleotide refers to multiple nucleotides linked together in a chain.[1] The nucleotides located at each end of a polynucleotide chain are referred to as terminal nucle-otides. All other nucleotides in a polynucleotide chain are referred to as internal nucleotides.

         Two strands of polynucleotides can pair with each other, i.e., hybridize, through hydrogen bonding between the bases on each polynucleotide strand. The bases T and U pair with A, while G pairs with C. This is referred to as complementary base pairing or "Watson-Crick base pairing," and this pairing is how the now-familiar double helix shape is formed. Two polynucleotide strands will hybridize if the arrangement of nucleotides in each strand is such that enough bases can pair with each other. For example, whether two strands will hybridize depends in part on the number of complementary base pairs that exist between the two polynucleotides.

         Hybridization techniques are used to detect the presence of certain nucleic acid sequences of interest, i.e., target sequences, such as genetic alterations. In such procedures, scientists use a hybridization "probe"-i.e., a labeled poly-nucleotide that is hybridizable and remains detectable after hybridization occurs-that is sufficiently complementary to the target sequence. The probe will hybridize with the target sequence if the target sequence is present, and the label on the probe then allows scientists to detect the hybridized probe.

         Nucleic acid hybridization was well understood by June 1982, which is the claimed priority date of the patents at issue in this appeal. The prevailing method of labeling probes at that time was via radioactive labeling. Radioactive labeling generally involved replacing certain atoms in the nucleotide sequence with corresponding radioactive isotopes.

         Non-radioactive labeling was just developing at the time of the claimed inventions. In 1981, Dr. David Ward and others at Yale University successfully developed a non-radioactive probe by attaching a label to a polynucleotide via a chemical linker at a base position of a nucleotide. See J.A. 4129-33 (publication by Dr. Ward and others titled "Enzymatic synthesis of biotin-labeled polynucleotides: Novel nucleic acid affinity probes"). Dr. Ward demonstrated that attaching labels at certain positions of the nu-cleotide ("the Ward positions") would not disrupt the polynucleotide's ability to hybridize and be detected upon hybridization.

         In December 1981, Enzo licensed the exclusive rights to the patent portfolio covering Dr. Ward's discovery. See J.A. 4258-75. Shortly thereafter, in June 1982, Enzo filed a patent application covering non-radioactive labeling at additional positions on a nucleotide. The two patents in this appeal issued from applications filed in 1995 that claim priority from this 1982 application.

         Both patents in this appeal generally relate to the use of non-radioactively labeled polynucleotides in nucleic acid hybridization and detection applications. The patents share ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.