Chinta & Fratangelo LLP

Billups-Rothenberg – Another Biotech Patent Invalid for Lack of Written Description

In Billups-Rothenberg, Inc. v.  Assoc’d Regional Univ. Pathologists, Inc., No. 2010-1401 (Fed. Cir. 4/29/2011), U.S. Patent Nos. 5,674,681 (the ’681 patent) and 6,355,425 (the ’425 patent) describe genetic tests for Type I hereditary hemochromatosis, an iron disorder characterized by excessive iron absorption by the body. The defective gene in hemochromatosis is the High Fe (“HFE”) gene. The claims at issue are directed to a mutation in the HFE gene, known as the C282Y mutation.

At the time the original patent applications were filed, the applicant claimed methods of detecting mutations responsible for hemochromatosis but had not yet identified any specific disease-causing mutations. Following this filing, other groups published relevant research on hemochromatosis. On 3/26/1999, Billups inventors filed a second application that matured to the ‘425 patent claiming a method of diagnosing an iron disorder by determining the presence of a specific mutation in the HFE gene.

In 2009, Billups sued ARUP for patent infringement. After a Markman hearing and claim construction, the court granted summary judgment of invalidity for lack of a written description to ARUP. The district court found that the DNA sequence of the hemochromatosis gene and/or sequence of the C282Y mutation were not expressly specified in the ’681 patent. Slip op. at 8. The court further stated that “[t]he invention claimed in the ’681 patent is a method to test for a DNA mutation, not a test for a defective protein.” Id. The district court also concluded that defandants’ enablement arguments were persuasive, but declined to rule on them in light of its ruling that the claims failed the written description requirement.  Id.  The district court also held that the ’425 patent was invalid as anticipated by US 6,025,130 (the ‘130 patent), which was § 102(e) prior art. Id. at 9. The ’130 patent disclosed the exact genetic sequences for the three mutations at issue in this case.

Billups appealed.  The Federal Circuit panel (Gajarsa, Linn, and Moore, opinion by Gajarsa) upheld the district court in all respects.

Gajarsa concludes that the ‘681 patent was only a research plan, and failed the written description test.  The ‘681 patent disclosed the mutation as a general location “within less than a 300 base pair region of a defined exon of a well studied multi-gene family,” but the specification disclosed neither the hemochromatosis gene sequence nor any specific mutations within that gene. Slip op. at 10-11. Billups conceded these were “adequately described the envisioned, but then unknown, mutations.”  Id. at 11. Gajarsa concludes that “Billups cannot satisfy the written description requirement merely through references to later-acquired knowledge. This case is like Regents [of the Univ. of Cal. v. Eli Lilly & Co.], and Fiers [v. Revel], in which the DNA sequences at issue were unknown in the art.”

Furthermore, the ’681 patent had unsupported genus claims to methods of identifying a genus of unknown genetic mutations.  Id. at 11. But under Ariad, a patent must set forth “either a representative number of species falling within the scope of the genus or structural features common to the members of the genus,” which the ‘681 patent did not do.  Id. at 12.  The later discovery of the the C282Y mutation within the claimed genus is not adaquate written description.  Id.

Additionally, the ‘681 patent failed the written description requirement because the claims have functional claim language without a correlation between structure and function.  Id. at 12. The general location disclosed in the ‘681 patent was too “imprecise to constitute structural features necessary to meet the written description requirement.” Id.

With regard to the holding that the ‘425 patent anticipated, Billups argued that the ‘130 patent taught away from the genetic sequences relevant to the ‘425 patent.  Gajarsa rejects this argument, holding that “whether a reference ‘teaches away’ from the invention is inapplicable to an anticipation analysis.”  Id. at 15, citing Celeritas Techs., Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998).  Thus, since the ’130 patent disclosed a diagnostic test for hemochromatosis that included identification of the S65C mutation, the ’425 patent’s claims are anticipated.  Furthermore, Billups failed to present evidence of nonenablement of the ‘130 patent. Accordingly, the ‘130 patent is an anticipatory reference. Id. at 16.