September 7, 2018 – Article

      In an interesting, but non-precedential, decision from the Court of Appeals for the Federal Circuit (Supernus Pharmaceuticals, Inc. v TWI Pharmaceuticals, Inc  et al (Fed. Cir., September 6, 2018-http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/17-2513.Opinion.9-6-2018.pdf), the Court affirmed a decision from the U.S. District Court of New Jersey.

      This arose out of an ANDA filing by TWi for patents owned by Supernus covering formulations of oxcarbazepine for the treatment of partial epileptic seizures.

Representative Claim 1 of one of the asserted patents:

1. A pharmaceutical formulation for once-a-day administration of oxcarbazepine comprising a homogeneous matrix comprising:

(a) oxcarbazepine;

(b) a matrix-forming polymer selected from the group consisting of cellulosic polymers, alginates, gums, cross-linked poly-acrylic acid, carageenan, polyvinyl pyrrolidone, polyethylene oxides, and polyvinyl alcohol;

(c) at least one agent that enhances the solubility of oxcarbazepine selected from the group consisting of surface active agents, complexing agents, cyclodextrins, pH modifying agents, and hydration promoting agents; and

(d) at least one release promoting agent comprising a polymer having pH dependent solubility selected from the group consisting of cellulose acetate phthalate, cellulose acetate succinate, methylcellulose phthalate, ethylhydroxycellulose phthalate, polyvinylacetate phthalate, polyvinylbutyrate acetate, vinyl acetate-maleic anhydride copolymer, styrene-maleic mono-ester copolymer, and Eudragit L100-55 (Methacrylic Acid-Ethyl Acrylate Copolymer (1:1)), and methyl acrylate-methacrylic acid copolymers.

      There were multiple Supernus patents with a common specification and a parallel litigation with the same patents but different litigant (Actavis Inc). The initial part of the Court’s decision focused on TWi's challenge that the District Court’s opinion in this case relied too heavily on the findings and conclusions that arose from the Actavis litigation (decided after Markman in the TWi litigation but before the final decision of validity and infringement). The Court was not convinced:

. . .the district court referenced Actavis only to the extent that the records in the two cases were the same. For these reasons, the district court did not err in referencing Actavis in its decision in this case. The Actavis decision also does not color our decision-making on appeal.

      The Court then addressed TWi’s contention that their product containing an “accused agent” does not read on the solubility agent in the Supernus patents:

. . .the common specification,  at Table 1, characterizes a formulation that contains the accused agent, but not a release-promoting agent, as a “non-enhanced” formulation. ’898 patent, col. 9, ll. 10–33. TWi contends that the specification defines “non- enhanced” formulations as formulations that contain neither a release promoter nor a solubility agent, and “enhanced” formulations as formulations that contain a release promotor, solubility agent, or both. In other words, TWi contends that the accused agent cannot satisfy the solubility agent limitation because the common specification admits that a formulation containing the accused agent is a “non-enhanced” formulation, i.e. is a formulation that contain neither a solubility agent nor a release promoting agent.

      The Court was not persuaded of an error by the District Court:

We agree with the district court. We read “enhanced” formulations, in the context of the common specification, to require both a “combination of solubility and release promoters.” Id. at col. 4, ll. 14–16. Indeed, as Supernus notes, 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.’” . . .

Here, the common specification indicates that the use of “and/or” must mean solely “and” because the common specification identifies both agents as essential to enhancing the bioavailability of oxcarbazepine.

In this way, the common specification describes the presence of both a solubility agent and a release-promoting agent as essential to formulating an “enhanced” formulation.

Accordingly, “non-enhanced” formulations can include formulations that do not contain either a solubility agent or a release promoter. Applied to Table 1, the “nonenhanced” formulation containing the accused agent does not preclude a finding that the accused agent is a solubility agent.