Plaintiff showed a substantial controversy as to accused products that had never been made or sold.

The court could exercise subject matter jurisdiction over plaintiff's declaratory judgment claim for products that had never been made or sold. Where plaintiff "invested what was likely a significant amount of time and effort in the development of the [product] and [was] on the verge of manufacturing that product, [plaintiff] was in the position of having to either pursue arguably illegal behavior or abandon that path altogether, which is sufficient to give rise to declaratory judgment jurisdiction."

RyMed Technologies, Inc. v. Laboratoires Pharm. Vygon, 3-07-cv-01077 (TNMD December 18, 2008, Memorandum)