Indivior Inc. v. Mylan Techs. Inc.

Defendants did not infringe the patents-in-suit because plaintiff failed to present statistically significant evidence to show that all of the asserted claims were infringed.

March 22, 2018

GENERICally Speaking

Case Name: Indivior Inc. v. Mylan Techs. Inc., 15-cv-1016-RGA, 15-cv-0477-RGA, 2018 U.S. Dist. LEXIS 47151 (D. Del. Mar. 22, 2018) (Andrews, J.) 

Drug Product and Patents-in-Suit: Suboxone® (buprenorphine and naloxone); U.S. Patents Nos. 8,900,497 (“the ’497 patent”) and 8,603,514 (“the ’514 patent”)

Nature of the Case and Issue(s) Presented: Indivior makes and sells Suboxone, a sublingual film used for maintenance treatment of opioid dependence. Plaintiffs also own the patents-in-suit, which are directed to a process for drying a sublingual film and a composition prepared using that process. Defendant Alvogen Pine Brook, Inc. (“Alvogen”) filed an ANDA seeking to market a generic version of Suboxone. In turn, Plaintiffs sued Alvogen for patent infringement.

The parties agreed that Alvogen infringed all the limitations of the asserted claims except for two: the dried/drying limitation and the visco-elastic film limitation. After reviewing the evidence, including expert testimony from both sides, the court held that Alvogen did not infringe the patents-in-suit.

Why Alvogen Prevailed: Based on the court’s claim construction, the dried/drying limitation required that the film be dried “without solely employing conventional convection air drying from the top.” Plaintiffs argued that Alvogen’s drying process was unconventional because it avoided a “rippling” effect of the film. There was not sufficient evidence, however, from Plaintiffs’ expert that the rippling effect could not be avoided by conventional drying means. Nor was Alvogen’s multi-zone drying unconventional, as Alvogen presented evidence that multi-zone driers were regularly used at the time of invention. For those reasons, Plaintiffs failed to meet their burden of proving infringement regarding this element.

Additionally, Plaintiffs did not meet their burden of proving that Alvogen substantially dried the film from the bottom. While Alvogen used a conventional convection air drying method, which would provide some drying from the bottom, there was no evidence that the drying from the bottom was substantial. Accordingly, Plaintiffs had not established that Alvogen performed this element.

Finally, Plaintiffs failed to establish that Alvogen prepared a visco-elastic solid film. Plaintiffs’ only evidence for this point was their expert’s slope calculations. These calculations, however, were not based on a linear regression or similar mathematical calculation. Rather, Plaintiffs’ expert calculated the slope of a viscosity plot by using “a ruler to draw a line” through points. The court concluded that this measurement was not precise and, accordingly, was not statistically significant. Plaintiffs thus failed to meet their burden, and the court concluded that Alvogen did not infringe the patents-in-suit.

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