The Federal Circuit reversed the District of Delaware's denial of judgment as a matter of law and held that U.S. Patent No. 6,596,296, owned by the Board of Regents of the University of Texas System and asserted against Boston Scientific Corporation's drug-eluting coronary stent systems, was invalid for anticipation by prior art U.S. Patent No. 5,364,627 (Song). The court also held that BSC was entitled to JMOL of noninfringement. After a jury verdict finding infringement of asserted claims 1, 11, 17, and 26 and rejecting BSC's anticipation defense, the district court set aside the jury's willfulness finding but otherwise upheld the verdict. On appeal, the Federal Circuit concluded that Song disclosed every limitation of the asserted claims, including a "biodegradable polymer fiber" with two immiscible phases—a polymer portion and discrete drug-containing regions dispersed throughout the fiber—because Song expressly taught noncontiguous active agent phases, which as a matter of plain language constitute "discrete" regions under the district court's claim construction, and because UT's expert testimony focused on unclaimed features such as the mechanism of drug release rather than the spatial arrangement of drug-containing regions required by the claims.
The decision clarifies that anticipation analysis turns on what a prior art reference substantively discloses to a person of ordinary skill, not on superficial differences in application or mechanism that fall outside claim scope. The court rejected UT's attempt to distinguish Song based on its chewing gum application and expert testimony about radial versus axial drug elution, holding that Song's broad teachings of biodegradable polymer fibers and drug delivery were not limited by specific embodiments and that the claim construction requiring "discrete" drug-containing regions was satisfied by Song's express disclosure of "noncontiguous" active agent phases. The holding reinforces that claim limitations must actually appear in the claims to avoid anticipation, and that expert testimony about differences in operation or application cannot salvage validity when the prior art expressly discloses all claimed structural elements. The court did not reach UT's cross-appeal challenging the district court's setting aside of the willfulness verdict.