Billups-Rothenberg, Inc. v. Associated Regional and University Pathologists, Inc.

May 10, 2011 – Blog Post

Affirming a Central District of California infringement suit finding the patents at issue invalid, the Federal Circuit issued a decision in Billups-Rothenberg, Inc. v. Associated Regional and University Pathologists, Inc. on Friday, April 29.

Plaintiff Billups-Rothenberg (“Billups”) filed a patent application in 1994 that led to the issuance of U.S. Patent No. 5,674,681 (“the ‘681 patent”) for methods of genetic testing for hemochromatosis. The ‘681 patent claimed methods for detecting a mutation in a certain gene, but did not identify any such mutations or disclose the sequences of the genes or mutations. At the time it filed the application, Billups undisputedly had not yet isolated the gene or any mutations of it. In 1996, a separate group of scientists isolated and sequenced the gene, publishing their results and filing applications for patents, one of which led to the issuance of U.S. Patent No. 6,025,130 (“the ‘130 patent”). The ‘130 patent discloses the genetic sequences of the mutations at issue in this case as well as testing methods making use of the mutation sequences. The owners of the ‘130 patent assigned it to Bio-Rad Labs (“Bio-Rad”), who licenses it to Associated Regional and University Pathologists (“ARUP”), a University of Utah lab that performs genetic testing. In 1999, Billups filed another patent application that led to the issuance of U.S. Patent No. 6,355,425 (“the ‘425 patent”). The ‘425 patent claims methods for diagnosing hemochromatosis by testing for genetic mutations, including one of the mutations disclosed in the ‘130 patent.

Billups brought suit in 2009 against Bio-Rad and ARUP for infringement of the ‘681 and ‘425 patents. The district court found both patents invalid on summary judgment. With respect to the ‘681 patent, the court found failure to meet the written description requirement of the first paragraph of 35 U.S.C. § 112. The district court declined to rule on the defendants’ “persuasive” arguments that the ‘681 patent also did not meet the enablement requirement of the same paragraph. Turning to the ‘425 patent, the district court found that the ‘130 patent anticipated it under 35 U.S.C. § 102(e). Billups appealed to the Federal Circuit.

In its opinion, the Federal Circuit cited its precedent that written description of DNA “requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it; what is required is a description of the DNA itself.” (citing Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566-67 (Fed. Cir. 1997)). Billups argued that the ‘681 patent nonetheless provided adequate written description, based on knowledge in the art, the genetic basis of hemochromatosis, protein interactions involved in the disorder, and the general location of the mutation. The court found that this information was not sufficient, in this case, to describe the claimed methods.

The court then went on to find that the ‘130 patent anticipated the ‘425 patent. Claim 1 of the ‘425 patent essentially claims a method of diagnosing an iron disorder by finding a mutation, one type of which was disclosed in the ‘130 patent. The ‘130 patent also discloses use of the mutation in diagnosis. Billups argued that the ‘130 patent stated that the mutation at issue correlated poorly with hemochromatosis. The Federal Circuit, however, applied its precedent stating that a “reference is no less anticipatory if, after disclosing the invention, the reference then disparages it.” (citing Celeritas Techs., Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998)). Thus the court found the ‘425 patent invalid for anticipation by the ‘130 patent.

Though Billups spent time and effort in developing its hemochromatosis diagnosis methods, it did not first isolate or sequence the key genes and mutations. These developments are critical to meeting the requirements for a method patent in which DNA plays an essential role. Thus, the ‘681 patent was invalid because the Billup had not yet isolated (and hence could not describe) the DNA molecules involved and the ‘425 patent was invalid because the ‘130 patent had already described the DNA molecules and disclosed their use. Researchers seeking patent protection for genetic diagnosis methods should strive to isolate and sequence the relevant DNA before other parties, then quickly progress toward disclosing description of that DNA in a patent application. More generally, patent applicants should wait to apply until they are able to disclose the essential aspects of their inventions, at which point they should apply without delay.