Vascular Solutions LLC, et al. v. Medtronic, Inc., et al., No. 2024-1398 (Fed. Cir. (D. Minn.) Sept. 16, 2024). Opinion by Mazzant (sitting by designation), joined by Moore and Prost.
Vascular Solutions, Teleflex, and others (collectively, Teleflex) filed a patent infringement suit against Medtronic, asserting forty claims across seven patents related to a guide catheter. The parties disputed the meaning of the claim term “substantially rigid portion/segment” found in all asserted claims. Some of the claims require a “side opening” located within the “substantially rigid portion,” while the remaining claims place the “side opening” distal to the “substantially rigid portion.” The district court viewed these two groups of claims as “mutually exclusive.”
After a lengthy claim construction process (which included the district court appointing former USPTO Director Andrei Iancu as an expert to analyze the disputes and provide a construction), the district court found all claims indefinite. As part of the analysis, the court rejected Teleflex’s proposed construction of “substantially rigid portion/segment” because it would result in the same accused products simultaneously infringing mutually exclusive claims. The parties stipulated to final judgment, and Teleflex appealed.
The Federal Circuit vacated the final judgment and remanded. First, the court held that “the district court erred when it determined the asserted claims were ‘mutually exclusive’ and indefinite.” The Federal Circuit explained that under the district court’s conclusion, “(1) claims in a patent cannot vary in the way they claim the disclosed subject matter, and (2) independent claims must be totally consistent with other independent claims.” The court ruled that “claiming is not restricted in this way.”
Second, the court held that “the boundary of the ‘substantially rigid portion/segment’ does not have to be consistent across claims.” The limitation is “a functional limitation, meaning the substantially rigid portion is a portion of the catheter that is substantially rigid enough to achieve some function.”
The Federal Circuit acknowledged that the “law indicates that ‘a claim term should be construed consistently with its appearance in other places in the same claim or in other claims of the same patent.’” The court said that its ruling here “does not diverge from our law on the matter.” “Rather, this decision clarifies that the term ‘substantially rigid portion’ be construed the same way across the patents, but that construction can be a functional construction that does not specify the boundary of the ‘substantially rigid portion.’”
Astellas Pharma, Inc., et al. v. Sandoz Inc., et al., Nos. 2023-2032, -2063, -2089 (Fed. Cir. (D. Del.) Sept. 18, 2024). Opinion by Lourie, joined by Prost and Reyna.
Astellas owns a patent directed to a sustained-release pharmaceutical composition comprising mirabegron, which it markets and sells under the brand name Myrbetriq® for the treatment of overactive bladder. Astellas sued Sandoz and others for infringement based on the Abbreviated New Drug Applications they had filed seeking FDA approval to market and sell generic versions of Myrbetriq.
During a five-day bench trial and subsequent post-trial briefing, “there was no discussion, let alone argument, from the parties as to the patent eligibility of the asserted claims” under 35 U.S.C. § 101. Yet the district court issued a final decision holding three of the claims invalid as directed to patent-ineligible subject matter under § 101. Astellas appealed.
The Federal Circuit vacated and remanded, ruling that the district court had abused its discretion: “By rendering its decision on a ground not raised by any party at any stage of the proceedings, and by expressly declaring that it ‘sits not as an arbiter to resolve the disputes on the parties’ favored terrain,’ the district court disregarded the longstanding principle of party presentation and, in doing so, abused its discretion.”
The Federal Circuit recognized that, “to be sure, ‘the party presentation principle is supple, not ironclad,’ and there are circumstances in which it may be appropriate for a court to take a ‘modest initiating role’ in the shape of the litigation. But rendering a patent invalid on a basis not advanced by any party is not such a circumstance.” The Federal Circuit explained that “it is for the parties—not the court—to chart the course of the litigation.” The district court’s role “is simply ‘to determine whether the patent’s challenger carried the burden of establishing invalidity.’”
Lastly, the Federal Circuit addressed Astellas’s request that the case be reassigned to a different district court judge on remand. The Federal Circuit “decline[d] to order the extraordinary remedy of reassignment in this case.” The court “trust[ed] that, upon remand, the district court can and will take an objective, measured, and thorough look into the legal issues and evidence of record to resolve only those disputes that exist between the parties.”