Cases & Deals

Histogen wins Federal Circuit appeal in biotech patent dispute

Clients Histogen Inc.

Jones Day represented Histogen Inc., Histogen Aesthetics LLC, and Histogen's CEO, Gail K. Naughton, in a successful appeal to the U.S. Court of Appeals for the Federal Circuit that upheld a San Diego federal court's ruling that the Histogen defendants did not infringe two patents now owned by Histogen's competitor SkinMedica, Inc.

Histogen focuses on the research, development, and production of products derived from the growing of cells under simulated embryonic conditions. SkinMedica, a Histogen competitor, owns two patents that generally relate to methods for producing pharmaceutical products containing cell-culture medium compositions. Dr. Naughton, in fact, is named as the lead inventor on both patents, which resulted from her prior work at the tissue-engineering company that first obtained the patents-in-suit before the patent rights were acquired by SkinMedica.

The crux of the dispute between the parties involved the proper construction of the patent term "culturing . . . cells in three-dimensions." The Jones Day team representing Histogen successfully urged the district court that, in the context of the two SkinMedica-owned patents, "culturing in three dimensions" excluded a form of culturing using microcarrier beads, because the written description of the patent excluded, on multiple occasions, culturing systems that operated in "monolayers" or on (or using) "beads." Because Histogen's technology uses beads, the district court granted summary judgment in its favor.

On SkinMedica's appeal to the Federal Circuit, the Federal Circuit agreed with Histogen's position and affirmed the district court’s ruling in all respects, "find[ing] no basis to disturb the district court's construction of the phrase 'culturing . . . cells in three-dimensions'. The specification clearly proves that the patentees defined the three-dimensional culturing required by the claims to exclude culturing with beads, because the patent expressly confines culturing with beads to two-dimensional culturing.  Whether viewed as a matter of disclaimer or of lexicography, the result is the same: the kind of three-dimensional culturing protected by the patent excludes use of beads.  Because the accused method employs beads, it cannot infringe the patents in suit."

The Federal Circuit's 41-page precedential opinion addressed a number of patent issues, including plain and ordinary meaning, disclaimer, inventor as her own lexicographer, incorporation by reference, waiver, intrinsic-versus-extrinsic evidence, and use of expert testimony in claim construction.

Greg Castanias (Washington, DC) led the cross-office, cross-practice appeal team and argued the case before the Federal Circuit. Randy Kay (San Diego) is Histogen’s lead trial counsel and obtained the favorable claim construction in the district court.

Skinmedica, Inc. v. Histogen, Inc., et al., Appeal No. 2012-1560 (Fed. Cir. Aug. 23, 2013)