Federal Circuit Review - January 2022
In Novartis Pharmaceuticals v. Accord Healthcare Inc. Appeal No. 21-1070, the Federal Circuit held that a patent application that was silent about a “loading dose” of a drug provided written description support for a negative claim limitation requiring the absence of such a dose.
HEC Pharm Co., Ltd. and HEC Pharm USA Inc. (collectively, “HEC”) filed an Abbreviated New Drug Application (“ANDA”) for a generic drug to treat multiple sclerosis. Novartis Pharmaceuticals Corp. (“Novartis”) sued HEC, alleging that HEC’s ANDA infringed U.S. Patent No. 9,187,405 (“the ’405 patent”). The district court found that the ’405 patent was not invalid and that the ANDA infringed. HEC appealed to the Federal Circuit, arguing that the ’405 patent was invalid because its claims violated the written description requirement of 35 U.S.C. § 112(a).
The Federal Circuit affirmed, finding sufficient written description support for excluding a “loading” (larger than normal) dose from the claimed treatment method. The ’405 patent described dosing regimens for both an experiment on rats and a potential clinical trial on humans, without mentioning a loading dose for either regimen. The Federal Circuit found no clear error in the district court’s finding, based on expert testimony, that these dosing regimens would have indicated to a person of ordinary skill that the claimed invention lacked a loading dose.
Chief Judge Moore dissented, arguing that the patent’s silence about loading doses could not support the negative limitation requiring their absence.
In Evolusion Concepts, Inc. v. Hoc Events, Inc. Appeal No. 21-1963, the Federal Circuit held that a claim requiring the removal of a “factory-installed catch bar” before installation of “a catch bar” did not exclude reuse of the original factory-installed bar.
Evolusion Concepts sued Juggernaut Tactical for infringement of a patent related to firearm magazine conversion kits. On dueling motions for summary judgment of infringement and non-infringement, the parties disputed only whether the term “magazine catch bar” could encompass a factory-installed catch bar. The district court relied on one sentence of the specification to conclude in Juggernaut’s favor that the claim excluded a factory-installed magazine catch bar: “The invention is a permanent fixture added to a semi-automatic firearm by removing the standard OEM magazine catch assembly and installing the invention.” Evolusion appealed.
On appeal, Juggernaut argued that the district court construction was correct and that the disputed term excluded factory-installed catch bars. It argued that, because the claim used “a” before “magazine catch bar,” instead of antecedent-basis language such as “said” or “the,” the two magazine catch bars must be different. The Federal Circuit disagreed and reversed the district court’s grant of Juggernaut’s motion and denial of Evolusion’s. The Federal Circuit explained that, under the ordinary meaning of “a magazine catch bar,” the bar could be “either the removed catch bar or a new or different catch bar.”
In Nature Simulation Systems Inc. v. Autodesk, Inc. Appeal No. 20-2257, the Federal Circuit held that it was improper for the district court to find patent claims indefinite without considering the specification and prosecution history.
Nature Simulation Systems, Inc. (“NSS”) sued Autodesk, Inc. alleging patent infringement. After a claim construction hearing, the district court found various claims invalid as indefinite. The district court recited several “unanswered questions” about terms in those claims and stated that such unanswered questions render a claim term indefinite as a matter of law, even if the specification answers those questions. NSS appealed.
The Federal Circuit reversed in a 2-1 decision. The majority held that the district court’s analysis involving “unanswered questions” applied an incorrect standard for indefiniteness. The majority emphasized that patent claims are viewed in light of the specification, the prosecution history, and other relevant evidence, and it faulted the district court for relying on the claim language alone. The majority noted that, during prosecution, indefiniteness rejections had been resolved by adding limitations to the claims, including by examiner’s amendment. After also considering the specification, the majority concluded that the claim terms at issue were not indefinite.
Judge Dyk dissented, arguing that the district court had read the patent claims in light of the specification and had properly determined the claim terms at issue were indefinite. According to Judge Dyk, the specification does not explain certain claim limitations that the patent examiner suggested during prosecution, and the majority improperly relied on the fact that the examiner suggested those terms instead of requiring that the specification explain them.