Bayer Covenants Not To Sue, Still Has Headache

Bayer's '053 patent on its drug Xarelto^® expires in November 2024, and Bayer granted Mylan a covenant not to sue. Bayer has a second patent that is subject to a pediatric exclusivity that expires later - February 2025 - and Mylan concedes that the second patent blocks approval for its generic version of Xarelto^® until that time. How could a district court possibly have subject matter jurisdiction to adjudicate Mylan's suit seeking a declaratory judgment of noninfringement on the '053 patent? The answer lies in the interplay of patent, regulatory, and constitutional issues that often arise in Hatch-Waxman cases.

Magistrate Judge Hatcher's Report and Recommendation, No. 23-556-RGA, 2024 WL 359468 (D. Del. Jan. 31, 2024), makes clear that, outside the Hatch-Waxman context, the court would lack jurisdiction: Unconditional covenants not to sue typically dictate that there is no case or controversy as Article III requires to establish standing. But Hatch-Waxman cases are