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.
The Federal Circuit began its discussion by citing Greenlaw v. United States, 554 U.S. 237, 243 (2008) for the proposition “[i]n our adversary system, in both civil and criminal cases, in the first instance and on appeal, we follow the principle of party presentation. That is, we rely on the parties to frame the issues for decision and assign to courts the role of neutral arbiter of matters the parties present.” The Federal Circuit relied upon the presumption of validity and that the party asserting an invalidity defense must prove that defense by clear and convincing evidence. Microsoft Corp. v. I4I Ltd. P’ship, 564 U.S. 91, 95 (2011). The Court then noted that it is for the parties - not the court - to chart the course of the litigation. See Lannom Mfg. Co. v. U.S. Int’l Trade Comm’n, 799 F.2d 1572, 1579 (Fed. Cir. 1986) (“It is beyond cavil that a district court does not have authority to invalidate a patent at its own initiative if validity is not challenged by a party.”).
The Federal Circuit noted that the district court believed patent eligibility under 35 U.S.C. § 101 to be a threshold inquiry that it had a duty to address - even in the silence of the parties - akin to, for example, subject-matter jurisdiction. But the presumption of validity afforded to patents under § 282 applies equally to all grounds of validity, including the eligibility of the claimed subject-matter. Cellspin Soft, Inc. v. Fitbit, Inc., 927 F.3d 1306, 1319 (Fed. Cir. 2019). It should be noted that In re Comiskey, 554 F.3d 967, 973 (Fed. Cir. 2009) a court reviewing an agency decision may affirm the decision on grounds not raised by the agency citing SEC v. Chenery Corp., 318 U.S. 80 (1943), which “made clear that a reviewing court can (and should) affirm an agency decision on a legal ground not relied on by the agency if there is no issue of fact, policy, or agency expertise.” Id. at 974 (emphases added).
Thus, a completely different result is possible in cases arising from a PTAB decision. In contrast in district court litigation, it is the parties who frame the issues for decision.