Supernus Pharmaceuticals, Inc. v. TWi Pharmaceuticals, Inc. et al.

Docket No. 2017-2513

September 6, 2018

Brief summary: DC finding that TWi’s ANDA to Supernus’s Oxtellar XR® would infringe the asserted OB-listed patents and that the claims are not invalid affirmed.

Summary: TWi appealed DC holding that Supernus’s Orange Book-listed US 7,772,989; 7,910,131; and 8,821,930 relating to sustained-release formulations of oxcarbazepine (Oxtellar XR®) are not invalid and would be infringed by TWi’s ANDA product (these patents were also held infringed and not invalid in an earlier-decided suit against Actavis). The FC panel opinion explains that the common patent specification explains that immediate release formulations “were disadvantageous because they require multiple daily administrations and can result in increased side effects” and “sustained release formulations were preferred, but were purportedly difficult to achieve because oxcarbazepine is poorly soluble in water.” Representative claim 1 of the ‘898 patent claims an oxcarbazepine formulation as a “homologous matrix” (preamble term) including “a matrix-forming polymer” (Markush listing), “at least one agent that enhances the solubility of oxcarbazepine” (Markush listing), and “at least one release promoting agent comprising a polymer having pH-dependent solubility” (Markush listing). The DC “found that TWi’s proposed tablets satisfied the ‘homogenous matrix’ and the solubility agent limitations under its constructions of those terms, and that the common specification and prosecution histories…demonstrate that the ‘homogenous matrix’ limitation is not indefinite and does not lack adequate written description support”, and “at times, referenced its decision in Actavis.” The FC panel reviewed the DC’s “conclusions of law de novo and its findings of fact for clear error” (Vanda, FC 2018). TWi argued the DC erred in giving “its decision in Actavis de facto preclusive effect in this case” and in its infringement and invalidity determinations. The FC panel concluded that the DC did not err with respect to its reliance on the Actavis decision since it did so “only to the extent that the records were similar or the parties had agreed to be bound by a subsidiary conclusion of Actavis” and “only made a passing reference to the Oxtellar XR® tests” performed in Actavis “and based its infringement determination solely on tests and evidence admitted in this litigation”. TWi also argued its product “cannot satisfy the solubility agent limitation” as it is a “‘non-enhanced’ formulation”, which the patents’ specification differentiates from “enhanced” formulations using the term “and/or”, which in that context “means ‘and’ or ‘or,’” while “Supernus contends that ‘and/or’ means solely ‘and’”, as did the DC (“in the context of the specification, ‘and/or’ means solely ‘and’”). The FC panel agreed with the DC, finding that “‘enhanced’ formulations, in the context of the common specification,” requires “both a ‘combination of solubility and release promoters’” (“identifies both agents as essential to enhancing the bioavailability…‘non-enhanced’formulations can include formulations that do not contain either”) and “even [TWi’s] own citation to a legal style manual’ describes ‘and/or ‘as a grammatical abomination; that can mean ‘and,’ ‘or,’ or ‘and/or.’” The FC panel also found the DC did not err in finding infringement (“it made the necessary findings”). TWi also argued the DC “changed its construction of ‘homogenous matrix’” from the Markman construction but the FC panel disagreed, finding the DC only “clarified what was already inherent in its construction, as permitted” (Cordis, FC 2011). The FC panel also found the DC did not err in finding the “‘homogenous matrix’ limitation was not indefinite” (“the specification, prosecution history, and expert testimony support” the DC’s conclusions). Accordingly, the DC decision was affirmed.

This entry was posted in Claim Construction, Generics / ANDA, Infringement, Prosecution History Estoppel. Bookmark the permalink.

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