Whether the 'actual controversy' requirement of the Declaratory Judgment Act requires a party seeking to introduce a generic drug product to file an application for FDA approval before filing suit for declaratory relief on patent invalidity

QUESTION PRESENTED Many patients with HIV depend on lifesaving, low-cost drugs provided by Petitioner AIDS Healthcare Foundation, Inc. (“AHF”), a non-profit organization. Respondent Gilead Sciences, Inc. has patented HIV drugs including Tenofovir Alafenamide (“TAF”). In addition to its patents on TAF, Gilead also obtained five years of exclusivity for drugs containing TAF from the U.S. Food and Drug Administration (“FDA”). During this five-year exclusivity period, AHF and its generic drug suppliers are prevented from filing an application with the FDA for approval of generic TAF. AHF seeks to introduce generic TAF to its patients as soon as possible (once Gilead’s exclusivity period runs out) but is prevented from doing so by Gilead’s patents on TAF. AHF filed a declaratory judgment action alleging invalidity of the patents, but the lower courts found that AHF lacked jurisdiction. This case presents the following question: In the context of patent cases involving pharmaceutical products, does the “actual controversy” requirement of the Declaratory Judgment Act, 28 U.S.C. § 2201(a), require a party seeking to introduce a generic drug product to file an application for FDA approval of that generic drug product before it can file suit for declaratory relief for patent invalidity?