Holding: A court may not determine patent validity based on issues that were not brought forth by the parties-in-suit. In particular, patent eligibility under Section 101 should only be addressed if this issue is raised by one of the parties.
Astellas markets an extended release mirabegron tablet for treatment of overactive bladder under the brand name Myrbetriq®. These tablets are covered by US Pat. No. 10,842,780, which is generally directed to a pharmaceutical composition comprising mirabegron, a method of treating overactive bladder using that composition, and a tablet comprising that composition. Astellas sued Sandoz and several other generic pharmaceutical companies for patent infringement based on Abbreviated New Drug Applications filed by those companies. Sandoz asserted that the claims of the ‘780 Patent were invalid under Section 102, Section 103, and Section 112. However, in its final decision, the District Court found the ‘780 Patent invalid as directed to patent-ineligible subject matter under Section 101.
The Federal Circuit reversed the District Court’s decision, stating that the District Court disregarded the longstanding principle of party presentation. Under this principle, it is up to the parties to frame the issues for decision. There are some instances where a court may have a small role in determining the issues to be addressed, but the court does not have this role when deciding on the validity of a patent. The Federal Circuit bases its decision on 35 U.S.C. §282, which holds that a patent shall be presumed valid and that it is the burden of the party asserting invalidity to prove invalidity. The role of the court is to decide whether the patent challenger has met this burden. Therefore, it was improper for the District Court to determine that the ‘780 Patent was directed to patent ineligible subject matter under Section 101, as this issue was never raised by Sandoz.
Citation: Astellas Pharma, Inc. v. Sandoz Inc., 117 F.4th 1371 (Fed. Cir. 2024)
Federal Circuit Precedential 
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