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Judge Griesa Grants Endo an Injunction Against Generic Manufacturers of Opioid Opana ER

On April 29, 2016, S.D.N.Y. District Judge Thomas P. Griesa granted Defendants Actavis, Inc., Actavis South Atlantic LLC (together “Actavis”) and Roxane Laboratories, Inc.'s motion to correct the court’s August 14, 2015 judgment by ruling that Endo was not entitled to relief because its patents had not issued at the time Actavis and Roxane filed their ANDAs.  The court held that it would not alter Actavis and Roxane’s ANDA filing date but would still enjoin them from making or selling their generic products until Endo’s patents expire.

Judge Griesa explained that upon a finding of infringement, § 271(e)(4)(A) requires a court to delay any ANDA approval until the infringed patent has expired, but only if the patent issued before the generic manufacturer filed its ANDA.  In granting this part of Actavis and Roxane’s motion, the court explained:  “Ultimately, there is no textual support for the notion that the statute was drafted to provide post-ANDA patent holders with a ‘gotcha’ cause of action based on the filing of the ANDA when the patent issues years after.”

The court held, however, that its finding of infringement warranted enjoining Actavis and Roxane “from making or selling their generic products prior to the expiration of the ‘122 and ‘216 patents.”  The court found that Endo would suffer irreparable harm for which there was no adequate remedy at law, citing Endo’s loss of 40 percent of the oxymorphone market, “11 percent of which is directly attributable to Actavis alone.”  The court also pointed out that “Actavis launched its infringing product ‘at-risk’ in the face of a potential injunction after trial” and that the launch “has already encroached on Endo’s bottom line [and] portends more harm to Endo if the court declines to grant Endo an injunction.”

The court denied Endo’s request to schedule a damages trial, explaining that instead “[i]t is prudent to await the resolution of any appeal” of the liability determination.

Case:  Endo Pharms., Inc. v. Pharms., LLC, No. 12 Civ. 8115 (TPG) (S.D.N.Y. Apr. 29, 2016).  The patents-in-suit are U.S. Patent No. 8,309,122 and U.S. Patent No. 8,329,216.