Listing Patent in Orange Book Alone Does Not Create Justiciable Controversy as to ANDA Holder

In granting a third-party defendant's motion to dismiss for lack of subject matter jurisdiction, the court found "Filing a patent in the Orange Book signals that a person who is not licensed to manufacture, use, or sell the patented item but does so may be subject to an infringement suit. But only the patentee or its exclusive licensee has standing to sue for infringement. It is the fact that the ANDA holder is exposed to suit by the patent holder or exclusive licensee, not the mere act of listing a patent in the Orange Book, that gives rise to a justiciable controversy. Thus, [the third-party plaintiff's] broad claims that the [third-party defendant's New Drug Application] and the listing of the [patent-in-suit] adversely affected its ability to market [its product] do not give rise to a justiciable controversy."

Galderma Laboratories, LP et al v. Paddock Laboratories Inc., 4-09-cv-00002
(TXND June 18, 2009, Order) (Means, J.)