Orexo AB v. Actavis Elizabeth LLC

Case Name: Orexo AB v. Actavis Elizabeth LLC, No. 17-205-CFC, 2019 U.S. Dist. LEXIS 213415 (D. Del. Dec. 11, 2019) (Connolly, J.) 

Drug Product and Patent(s)-in-Suit: Suboxone® and Subutex® (buprenorphine); U.S. Patent No. 8,454,996 (“the ’996 patent”)

Nature of the Case and Issue(s) Presented: Orexo filed suit, alleging that Actavis’s anti-opioid-addiction ANDA product infringed the ’996 patent. After a five-day trial, the jury found that Actavis did not induce or contribute to infringement of the ’996 patent. Thereafter, Orexo moved, under Rule 59(e), for a new trial “on the issues of infringement, willfulness, and damages.” In particular, Orexo argued that a new trial was warranted because: (i) the judge incorrectly precluded evidence that in a previous case (“the Zubsolv® case”) the ’996 patent was found not invalid and was infringed by a generic version of another anti-opioid-addiction drug and (ii) the judge incorrectly excluded the introduction of Orexo’s patent and published patent applications that were related to, but were not, the patent-in-suit. The court denied Orexo’s motion.

Why Actavis Prevailed: As to the decision to exclude evidence of the Zubsolv® case, Orexo’s motion for a new trial failed for two reasons. First, the court found that Orexo waived the argument. Although Orexo “revisited” the judge’s ruling on multiple occasions, “it never argued or suggested that” the judge should reconsider the ruling. And although Actavis agreed to forego its invalidity defense subsequent to the judge’s ruling to exclude the Zubsolv® case—thereby potentially altering the court’s Rule 403 analysis—Orexo never sought reconsideration of the judge’s ruling to exclude the evidence. Second, even if Orexo had not waived the argument, it still would have excluded the evidence, as it would be unfairly prejudicial “to allow Orexo to attempt to prove that [the accused products] infringed the ’996 patent by adducing evidence about their similarities with Zubsolv® and then linking that evidence to [the prior] decision that Zubsolv® infringed the same patent.”

As to the exclusion of Orexo’s patent and published patent applications, the court explained they were not relevant unless Actavis had knowledge of their existence. The court further noted that at trial, it explained that if an Actavis witness were to admit that s/he was aware of a particular patent or publication, then it could be put into evidence. Orexo chose, however, to ask only two Actavis witnesses, and none had knowledge of the excluded patents and publications. In sum, the court explained that “Orexo has not identified a single publication that an Actavis witness was aware of that was excluded from evidence. It was the lack of evidence, not [the court’s ruling] that prevented Orexo from overcoming Actavis’s defense.”