Supernus Pharms., Inc. v. TWi Pharms., Inc.

October 20, 2017

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name: Supernus Pharms., Inc. v. TWi Pharms., Inc., 15-369 (RMB/JS), 2017 U.S. Dist. LEXIS 154446 (D.N.J. Sept. 21, 2017) (Bumb, J.) 

Drug Product and Patent(s)-in-Suit: Oxtellar XR® (oxcarbazepine); U.S. Patents Nos. 7,722,898 (“the ’898 patent”), 7,910,131 (“the ’131 patent”), and 8,821,930 (“the ’930 patent”)

Nature of the Case and Issue(s) Presented: The patents-in-suit relate to the formulation and administration of oxcarbazepine to treat partial epilepsy seizures. Each asserted claim includes an element requiring a “homogeneous matrix,” which the Court construed to mean “a matrix in which the ingredients or constituents are uniformly dispersed,” as well as an “agent that enhances the solubility of oxcarbazepine.” The parties disputed whether those elements were present in Defendants’ generic oxcarbazepine tablets. The court determined that the elements were present, that Defendants’ infringed the patents-in-suit, and that the patents-in-suit were not invalid.

Why Plaintiffs Prevailed: Defendants argued that their tablets did not contain a “homogenous matrix” because the tablets included granules and thus could not be homogenous. Plaintiffs responded that Defendants’ process resulted in uniform granules in the tablet and that, when the tablet is viewed as a whole, the tablet is homogenous. The court agreed with Plaintiffs. Viewed at a proper scale, i.e., looking at the whole tablet, the granules were uniformly distributed by Defendants’ own design. Accordingly, the table consisted of a homogenous matrix, including granules. This conclusion was confirmed by expert testimony showing the uniformity of Defendants’ tablets.

Defendants’ tablets also contained an “agent that enhances the solubility of oxcarbazepine.” Looking at Defendants’ internal solubility testing, the court found evidence that Defendants’ included specific ingredients to enhance to oxcarbazepine’s solubility in the final formulation. Defendants did not dispute this testing. Further, the state of the art at the time indicated that the redacted solubility enhancing agent did indeed function to increase the solubility of the oxcarbazepine. Thus, both disputed elements were present in Defendants’ tablets, which infringed that patents-in-suit.

Defendants’ also contested the validity of the patent arguing that the term “homogenous matrix” lacked written description in the specification and rendered the claims indefinite. The court disagreed, finding sufficient support in the specification. Further, the prosecution history made clear that one of ordinary skill would appreciate that the examples set forth in the specification constituted a homogenous matrix. For these reasons, Defendants failed to meet their burden to demonstrate that the asserted claims were invalid.

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