By Jason Rantanen
Billups-Rothenberg, Inc. v. Associated Regional and University Pathologists, Inc. (Fed. Cir. 2011) Download 10-1401
Panel: Gajarsa (author), Linn, and Moore
Billups is a classic example of the difficulties companies face when engaging in patent races. Patent races occur when two or more entities are in competition to be the first to develop and patent a new technology. In these sitautions, companies race to file patent applications, hoping to gain a competitive advantage. Sometimes, however, the applications are filed before the inventors have really developed a patentable invention; othertimes, the applications are filed too late, after a competitor has filed its own application or published crucial information. In this case, Billups filed Patent No. 5,674,681 too early and Patent No. 6,355,425 too late, losing on both ends.
The patents-in-suit relate to a genetic test for Type I hereditary hemochromatosis that involves the detection of specific mutations in genes involved in regulating iron absorption. The district court granted summary judgment of no written description for the '681 patent and anticipation of the '425 patent.
Lack of Written Description of Earlier Patent
On appeal, the CAFC first affirmed the district court's ruling that the '681 patent lacked written description, applying its customary approach to biotechnology inventions. Here, Billups disclosed only the approximate location of the relevant mutation in the '681 patent, a disclosure that it argued was sufficient to place the inventor in possession of the invention (which in this case included the step of detecting the mutation) when combined with the knowledge that existed at the time of invention. The CAFC disagreed. "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 '681 patent was filed, Billups cannot satisfy the written description requirement merely through references to later-acquired knowledge." Slip Op. at 11.
The panel also, unnecessarily in my opinion, addressed the problem in genus-disclosure terms. After quoting the relevant case law regarding disclosure of genus claims, the court concluded that the the patent failed because it "does not not identify even a single species that satisfies the claims. In this case, the eventual discovery of only one species…within the claimed genus does not constitute adquate written description of that genus." It is opaque to me what relevance a post-filing discovery of a species, let alone one by a third party, has to a species-genus analysis.
Anticipation of Later Patent
At the same time that Billups was conducting its research, another group of scientists isolated and sequenced the hemochromatosis gene, published their results, and obtained Patent No. 6,025,130, filed nearly three years before the '425 patent. The CAFC agreed with the district court that the '130 patent was anticipatory.
The inquiry focused on whether the '130 patent disclosed the diagnosis of an iron disorder using a specific mutation, the S65C mutation. The '130 patent reports the genetic sequence of the S65C mutation, among with others that the inventors believed relevant to hemochromatosis, and describes techniques for conducting genetic assays that it states can be used to design a diagnostic device and method for screening the mutations. Billups argued that this disclosure was not anticipatory because the '130 patent did not conclude that the S65C mutation was related to a hemochromatosis disease state, merely that there was a correlation and thus, Billups argued, the S65C mutation may have been only a clinically insignificant polymorphism.
Relying on the doctrine that a "reference is no less anticipatory if, after disclosing the invention, the reference then disparages it" (Slip Op. at 15), the CAFC rejected BIllups argument. Here, "the '130 patent disclosed using the S65C mutation when diagnosing hemochromatosis, but qualifies that disclosure with the obseravation that the mutation "may only be a polymorphic variant." Id., quoting '130 patent (emphasis in opinion). Although the prior art questioned the utility of the application of the disclosed invention, it nevertheless disclosed it, thus rendering the '425 patent anticipated.