On Friday, the Federal Circuit issued a decision in AIDS Healthcare Foundation, Inc. v. Gilead Sciences, Inc., opinion by Judge Newman joined by Judges Dyk and Stoll. The plaintiff, a provider of medical care, sought a declaratory of invalidity of five patents relating to TAF, an antiviral agent used in the treatment of AIDS. Problem: there's no case or controversy at this point, since the plaintiff is only a potential future purchaser of any generic TAF products. Under FDA law, any potential maker of a generic version of the drugs at issue will have to wait until November 2019 at the earliest just to file an ANDA, let alone start marketing any generic TAF products. Healthcare's argument that "in view of the lengthy time consumed by litigating patent validity, such litigation needed to start well in advance of expiration of the . . . exclusivity period," isn't enough to make this an actual case or controversy sufficient for declaratory judgment jurisdiction. Further, "the mere possibility of future infringement does not meet the immediacy and reality criteria" (p.7).
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