In re Sebela Patent Litigation

One of the patents-in-suit was not infringed because the IR spectrum of the generic product did not include each claimed peak, and the remaining patents-in-suit were invalid as obvious.

October 20, 2017

GENERICally Speaking

Case Name: In re Sebela Patent Litigation, 14-6414 (CCC) (MF), 2017 U.S. Dist. Lexis 128258 (D.N.J. Aug. 11, 2017) (Cecchi, J.) 

Drug Product and Patents-in-Suit: Brisdelle® (paroxetine mesylate); U.S. Patents Nos. 7,598,271 (“the ’271 patent”), 8,658,663 (“the ’663 patent”), and 8,946,251 (“the ’251 patent”)

Nature of the Case and Issue(s) Presented: The ’271 patent claims a crystalline form of paroxetine mesylate. The ’663 and ’251 patents claim methods to treat thermoregulatory dysfunction (hot flashes). Plaintiff alleged that Defendants’ generic paroxetine mesylate product infringed the patents-in-suit. Defendants argued that their product did not infringe the ’271 patent and, even if it were to, the ’271 patent was invalid. Defendants stipulated to infringement of the ’663 patent and the ’251 patent, but argued that both patents were invalid. The court found that the ’271 patent was not infringed and the ’663 and ’251 patents were invalid.

Why Defendants Prevailed: The parties’ dispute relating to the infringement of the ’271 patent centered on a single issue: whether the generic products produced spectra with peaks that corresponded to the peaks claimed in the ’271 patent for IR spectroscopy. Citing to the Federal Circuit’s decision in Glaxo, Inc. v. Novopharm, Ltd., 180 F.3d 1562 (Fed. Cir. 1997), the court reasoned that each spectrum peak constituted an independent limitation that must be met for the generic products to infringe. Because, despite various contrary arguments, the generic products were missing at least one of the claimed spectrum peaks, and Plaintiff confirmed there was no mistake in the peaks listed in the claims, Defendants’ did not infringe the ’271 patent.

To invalidate the ’663 and ’251 patents, the court relied on four prior-art references. In combination, the prior art taught each treatment dosage claimed by the patents. While one dosage, 7.5 mg/day, was not explicitly disclosed in the prior art, the prior art taught a range of doses that include the 7.5 mg/day amount. Accordingly, each limitation of the claims was obvious in light of the prior art, and no secondary considerations countered obviousness.

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