Opinion ID: 215718
Heading Depth: 1
Heading Rank: 3

Heading: Fig 4C

Text: Also, the '130 patent describes genetic tests for hemochromatosis utilizing the mutations and sequence variants identified within the patent. Id. col.23 ll.10-67. BioRad is the assignee of the '130 patent and licenses it to ARUP, a laboratory at the University of Utah that provides genetic testing services. Dr. Feder and his team published their discovery while ARUP was continuing to search for the hemochromatosis gene and its mutations. In October 1998, a medical director at ARUP published a paper describing how the genetic probes for the H63D mutation also accidentally identified the nucleotide sequence A193T, which corresponds to the S65C mutation. ARUP developed this assay into the genetic test presently accused of infringing the patents-in-suit. The assay detected the C282Y, H63D, and S65C mutations in samples from patients. At the same time, the Billups researchers also used the genetic sequences discovered by Dr. Feder and his team to refine their own experiments. On March 26, 1999, Dr. Rothenberg, Dr. Sawada-Hirai, and collaborator Dr. James Barton filed the application that matured into the '425 patent. The '425 patent claims a method for diagnosing an iron disorder by testing for genetic mutations including S65C. Claim 1 of the '425 patent appears below: 1. A method of diagnosing an iron disorder or a genetic susceptibility to developing said disorder in a mammal, comprising determining the presence of a mutation in exon 2 of an HFE nucleic acid in a biological sample from said mammal, wherein said mutation is not a C → G substitution at nucleotide 187 of SEQ ID NO: 1 and wherein the presence of said mutation is indicative of said disorder or a genetic susceptibility to developing said disorder. '425 patent col.59 ll.19-26. Table 1 of the '425 patent labels a genetic sequence identical to the genetic sequence in Figure 4A of the '130 patent as S65C. Cf. '425 patent col.1-2 Table 1 (gag agt cgcc); '130 patent fig.4A (gag agt cgcc). Additionally, the '425 patent explains that two of the twenty hemochromatosis patients had the S65C mutation. '425 patent col.31 ll.20-37 table 6, col.32 l.8 (Probands 3 and 4 had a S65C mutation.) The inventors of the '425 patent concluded that the S65C mutation could be used to diagnose hemochromatosis. Id. col.32 ll.8-13. In 2009, Billups sued ARUP and Bio-Rad for infringement of the patents-in-suit. Billups amended its complaint and alleged that ARUP and Bio-Rad infringe the patents-in-suit by providing and/or using diagnostic assays or kits for detecting hemochromatosis associated with one or both of the C282Y and S65C mutations. Am. Compl. ¶ 14. After completion of discovery, a Markman hearing, and claim construction by the court, the parties filed cross-motions for summary judgment. The district court granted summary judgment of invalidity for lack of a written description to ARUP and Bio-Rad. The district court found it undisputed that: The DNA sequence of the hemochromatosis gene and/or sequence of the C282Y mutation were not expressly specified in the '681 patent. Summ. J. Order 3. Further, the district court noted that it is undisputed by the parties that no species of the genus of DNA mutations, the presence of which would identify an individual as having or being predisposed to having hemochromatosis, were disclosed in the '681 patent specification. Id. at 6. The district court further stated that [d]escribing the structure of the resulting protein is not the same as describing the structure of the DNA and its mutations. The invention claimed in the '681 patent is a method to test for a DNA mutation, not a test for a defective protein. Id. Additionally, the district court explained that the patentee has merely directed the person of ordinary skill in the art to a general location of a mutation on a chromosome and suggested that the mutation may be found in that vicinity. Id. at 8. The district court held the asserted claims of the '681 patent invalid for lack of written description. The district court concluded that ARUP and Bio-Rad's enablement arguments were persuasive, but declined to rule on them in light of its ruling that the claims failed the written description requirement. Id. at 9. The district court also granted summary judgment of invalidity of the '425 patent. First, it held that Bio-Rad's '130 patent was prior art under 35 U.S.C. § 102(e) because it was filed on May 23, 1996, which is before the March 1999 filing date of the '425 patent. Id. at 3-4, 10. Then, the district court determined that the asserted claims of the '425 patent are anticipated because they claim the same genetic test for S65C as is disclosed in the '130 patent. Id. at 10. The district court entered final judgment in favor of ARUP and Bio-Rad dismissing the case. This court has jurisdiction over Billups's timely filed appeal pursuant to 28 U.S.C. § 1295(a)(1).