Gilead AIDS Patent Question Before the Supreme Court

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?

https://www.aidshealth.org/wp-content/uploads/2018/08/36429-cert-petition.pdf