The verdict that the patent was valid and infringed was upheld, after the Federal Circuit found the verdict to be supported by substantial evidence. The District Court’s refusal to enter an injunction was vacated on appeal, because the refusal was premised on a representation—that defendant would cease infringing activities—later shown to be false.

The patented invention is a prosthetic device called a “transcatheter heart valve.” At trial, the accused infringers challenged validity on the basis that the only working example in the patent specification demonstrated the use of the invention in a pig and therefore the full scope of the invention (including use in humans) was not enabled. The jury found that the accused valve infringed the patent, which remained valid. The district court entered judgment on the verdict of validity and infringement, refused to enhance damages for willful infringement, and declined to issue an injunction. The patentee appealed the denying of enhanced damages for willfulness and an injunction, and the alleged infringer appealed infringement, validity, and damages.

The Federal Circuit upheld the entry of judgment on validity and infringement. The court found that the jury verdict was supported by substantial evidence, including expert testimony on the use of pigs as a standard experimental animal and the nature of the ongoing experimentation. On infringement, the Federal Circuit held that the district court’s construction comports with the patent specification, and that the jury’s finding of infringement was supported by substantial evidence.

The Federal Circuit also upheld the jury award of damages, rejecting the defendant’s argument that it could have avoided liability by moving its manufacturing overseas. The Federal Circuit also held that the district court’s refusal to enhance damages where issues were close was not an abuse of discretion. However, the Federal Circuit did reverse the district court’s holding that an injunction was unnecessary based on representations that defendant was moving its manufacturing overseas. In part because this representation proved to be false and circumstances had changed, the Federal Circuit vacated the denial of injunction and remanded to the district court.

Judge Prost filed a concurring opinion. She joined in the majority opinion in all respects except to the extent that the majority implied that there exists a presumption that a successful plaintiff is entitled to an injunction, which presumption must be rebutted by the defendant.

A copy of the opinion can be found here.