Background
The Board of Regents of the University of Texas System (UT) sued Boston Scientific Corp. (BSC), alleging that BSC’s drug-eluting coronary stent systems infringed U.S. Patent No. 6,596,296. The patent claims a composition containing a drug-releasing biodegradable polymer fiber, where the fiber is composed of two immiscible phases.
Following a trial in the U.S. District Court for the District of Delaware, a jury found that BSC infringed the patent claims and that the infringement was willful. The jury also rejected BSC’s argument that the patent was invalid. The district court judge subsequently set aside the willfulness finding but otherwise upheld the jury’s verdict on liability and damages.
BSC appealed the judgment against it, arguing the patent claims were invalid and not infringed. UT cross-appealed the court’s decision to overturn the willfulness finding.
The Court’s Holding
The U.S. Court of Appeals for the Federal Circuit reversed the district court’s judgment. The court held that BSC was entitled to judgment as a matter of law (JMOL) that the patent claims were invalid and, separately, that they were not infringed. This decision nullified the verdict for UT, making its cross-appeal on willfulness moot.
On the issue of invalidity, the Federal Circuit concluded that the asserted claims were anticipated by a prior-art patent (Song, U.S. Patent No. 5,364,627). The court determined that Song disclosed every element required by UT’s patent claims, including a “biodegradable polymer fiber,” two “immiscible phases,” discrete drug-containing regions, and release at “varying rates.” The court found UT’s expert testimony to the contrary was insufficient to support the jury’s verdict, stating that no reasonable jury could have found the claims were not anticipated.
As an alternative and independent ground for reversal, the court also held that BSC was entitled to JMOL of non-infringement. The district court had construed the term “fiber” to mean a “thread-like structure.” The Federal Circuit found that no reasonable jury could find that the drug coating on BSC’s stent met this definition. The court noted that UT’s infringement theory relied on artificially isolating a zigzag-shaped portion of the coating, which is formed by dipping the stent in liquid and never exists as an independent “thread-like” structure. This interpretation was deemed unreasonable, leading to a finding of non-infringement.
Key Takeaways
- A patent claim is invalid for anticipation if a single prior art reference discloses, either expressly or inherently, every limitation of the claim.
- Expert testimony cannot overcome the clear and express disclosures within a prior art document to defeat an anticipation challenge on appeal.
- For a finding of patent infringement, the accused product’s structure must correspond to the patent’s claim terms as construed by the court; strained or artificial characterizations of a product’s features are unlikely to be sustained.
Why It Matters
This decision highlights the Federal Circuit’s authority to reverse jury verdicts in patent cases when it finds a lack of sufficient evidentiary support, particularly on legal questions like claim construction and its application. It serves as a stark reminder that a jury win can be vulnerable on appeal if the underlying validity or infringement theories are weak. Patentees are reminded that prior art containing significant overlap with their claimed invention poses a substantial risk, and infringement arguments must be grounded in a reasonable interpretation of both the patent claims and the physical reality of the accused product.