Public use bar inappropriate when participants in clinical trials do not discern specifics of new product
Sung-Hoon Kim | May 22, 2013
Dey, L.P. v. Sunovion Pharmaceuticals, Inc.
May 20, 2013
Panel: Bryson, O’Malley, and Newman. Opinion by Bryson. Dissent by Newman.
The Federal Circuit reversed and remanded the holding of the District Court that some of Dey’s patents were invalid because a Sunovion’s clinical trial, where Sunovion tested its own product, constituted an invalidating public use. The Federal Circuit determined that although some of test samples were lost and clinical trial was not perfectly confidential, Sunovion’s clinical trial is not an invalidating public use as long as participants do not recognize the specifics of a new drug.
연방지방법원 뉴욕 남부지원(U.S. District Court for the Southern District of New York)은 Sunovion의 임상실험 (clinical trial)이 공용 (public use)에 해당된다고 판단하여, Dey의 특허가 무효 (invalid)라도 판결하였다.
이에 불복하여, 원고는 연방항소법원 (U.S. Court of Appeals for the Federal Circuit)에 상고 (appeal)하였다. 연방항소법원은 임상실험 도중 test sample이 분실되었거나 임상실험이 완벽히 비공개로 진행되지 않았더라도 실험참가자가 신약에 대한 자세한 정보를 모른다면Sunovion의 임상실험은 공용에 해당되지 않는다고 판결하였다.