Myrbetriq® Patent Invalidated On Grounds Not Asserted by Any Party Violating Party Presentation Principle

Attorney: Richard D. Kelly
October 2, 2024

In Astellas Pharma Inc. v. Sandoz Inc,, et al, following a five-day patent claims bench trial the court found asserted claims 5, 20, and 25 invalid under 35 U.S.C. § 101 even though Sandoz had not asserted 101 as defense at any time during the case.  The parties had agreed to limit the issue to claims 5, 20, and 25 and the defense to invalidity under 35 U.S.C. § 112.  Neither party had notice that patent eligibility was an issue.  In making his ruling Judge Bataillon relied upon a statement in Astellas post-trial brief that the “inventive concept of the ’780 Patent was discovering the dissolution rate that would address the food effect and achieving it using previously known formulation technology.”  Thus, because the claimed invention “reflects merely the discovery of the food-effect-resolving dissolution profile,” the district court deemed the asserted claims invalid as patent ineligible.  Not only had the issue of patent eligibility not been raised by the defendant, but the claims were also to a specific composition.  Recognizing the district court had gone on astray Sandoz moved the court to make additional findings of fact  advising the court that the § 101 defense had not been raised as a defense and that the decision must be based on the language in the claims.  The motion was denied.<... Read more