Affirming a district court’s summary judgment of invalidity for lack of written description, the U.S. Court of Appeals for the Federal Circuit held that written description requires a description of the DNA sequence itself and not just a reference to a potential method for isolating it. The Federal Circuit also affirmed the district court’s summary judgment of invalidity as to anticipation, ruling that a reference is no less anticipatory just because it discounts the utility of the invention after disclosing the invention. Billups-Rothenberg, Inc. v. Associated Regional and University Pathologists, Inc. et al., Case No. 10-1401 (Fed. Cir., Apr. 29, 2011) (Gajarsa, J.).

Billups-Rothenberg (Billups) brought suit against Associated Regional and University Pathologists, Inc. (ARUP) and Bio-Rad Laboratories, Inc. (Bio-Rad) alleging infringement of two patents that describe genetic tests for Type I hereditary hemochromatosis that involve the detection of specific mutations, C282Y and S65C, in a gene involved in regulating iron absorption.

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 written description finding it undisputed that the DNA sequence of the hemochromatosis gene and/or sequence of the C282Y mutation were not expressly specified in one of the patents-in-suit. The district court also granted summary judgment of invalidity of the other patent holding that a prior art reference, filed nearly three years earlier, disclosed the same genetic test for S65C as disclosed in the second of the patents-in-suit. Billups appealed.

First, the Federal Circuit affirmed the district court’s ruling on written description, noting that the first Billups patent claimed a test for mutations, but failed to disclose the hemochromatosis gene sequence or any specific mutations within that gene. The Court noted that the patent further failed to disclose the exact location or sequence of the mutation. The Federal Circuit held that Billups could not satisfy the written description requirement merely through references to later-acquired knowledge “given the lack of knowledge of sequences for the hemochromatosis gene and its mutations in the field, the limited extent and content of the prior art, and the immaturity and unpredictability of the science when the […] patent was filed.”

Turning to the second Billups patent and the issue of anticipation, the Federal Circuit agreed with the district court’s findings that the prior art patent anticipated the asserted claims of the Billups patent. The Federal Circuit determined that the prior art disclosed a method of diagnosing an iron disorder by detecting mutations, including the S65C mutation disclosed in the Billups patent, despite uncertainty voiced by the prior art inventor regarding the utility of the S65C mutation because of their small sample size. Applying precedent, the Federal Circuit held that “[a]lthough the [prior art] patent discounts the utility of the S65C mutation in diagnosing hemochromatosis, we have held that a ‘reference is no less anticipatory if, after disclosing the invention, the reference then disparages it.’”

Practice Note: To satisfy the written description requirement for genetic diagnosis methods, patentees should be aware of the importance of isolating or sequencing the key genes and/or mutations before seeking patent protection.