Endo Pharm. Inc. v. Amneal Pharms. LLC

Plaintiff is awarded injunctive relief following analysis of the eBay factors, but said relief cannot be awarded under § 271(e)(4)(A) because the patents-in-suit issued after Defendants’ ANDAs were filed.

July 21, 2016

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Endo Pharm. Inc. v. Amneal Pharms. LLC, Civil Nos. 12 Civ. 8115 (TPG),12 Civ. 8060 (TPG),12 Civ. 8317 (TPG),12 Civ. 8985 (TPG),13 Civ. 435 (TPG),13 Civ. 436 (TPG),13 Civ. 3288 (TPG),13 Civ. 4343 (TPG),13 Civ. 8597 (TPG), 2016 U.S. Dist. LEXIS 57420 (S.D.N.Y. Apr. 29, 2016) (Griesa, J.) 

Drug Product and Patents-in-Suit: Opana ER® (oxymorphone hydrochloride); U.S. Patents Nos. 8,309,122 (“the ’122 Patent”) and 8,329,216 (“the ‘’216 patent”)

Nature of the Case and Issue(s) Presented: Shortly after this court held, in relevant part, that Defendants Actavis’ and Roxane’s (“the Moving Defendants”) generic products infringed Endo’s ’122 and ’216 patents, Moving Defendants filed separately to alter or amend the court’s judgment per Fed. R. Civ. P. 59(e) or, in the alternative, for a stay pending appeal. Plaintiff Endo filed its own post-trial motions to amend and correct the judgment under Rules 52(b) and 60(a). The court declined to alter the effective dates of Moving Defendants’ ANDAs, but exercised its equitable power to enjoin Moving Defendants. In addition, the court denied Actavis’ request for a stay and Plaintiff Endo’s request to schedule a damages trial and order discovery.

Why Endo Prevailed:  Rule 52(b) provides a method to dispute underlying facts that resulted in faulty factual findings or conclusions of law based on those facts. Rule 59(e) provides for a broad request for reconsideration of the judgment itself. Endo’s arguments in its Rule 52(b) motion were legal in nature because they asked the court to address the eBay factors related to injunctive relief. Thus, the court construed Endo’s Rule 52(b) motion under Rule 59(e). The two issues to be decided were: (i) whether the effective date of Moving Defendants’ ANDAs should be altered under 35 U.S.C. § 271(e)(4)(A); and (ii) whether the court should issue an injunction against Moving Defendants. Upon the finding of infringement under Hatch-Waxman, the statute provides that “the court shall order the effective date of any approval of the drug…involved in the infringement to be a date which is not earlier than the date of the expiration of the patent which has been infringed.” § 271(e)(4)(A). The court may also grant additional remedies, including a permanent injunction or the award of monetary damages. § 271(e)(4)(B)-(C). The ’122 and ’216 patents issued years after Moving Defendants filed the relevant ANDAs. Accordingly, Endo could be awarded relief under § 271(e)(4)(A) because it was not eligible for infringement liability under § 271(e)(2), which makes it an act of infringement to submit an ANDA for a drug claimed in “a patent,” not a provisional patent application or a patent-pending. Therefore, the court will amend its findings of fact and law accordingly.

Next, the court addressed the Supreme Court’s eBay factors: (i) whether the patentee would be irreparably harmed without an injunction; (ii) whether the patentee has an adequate remedy at law; (iii) whether the balance of hardships favors an injunction; and (iv) whether granting the injunction is in the public interest. The court found that Endo and the Moving Defendants were direct competitors in the oxymorphone market. Endo had substantiated its irreparable harm claims by showing that Endo has lost eleven percent of its market share to Actavis, alone, and was also forced to cut its pain sales force by one quarter, to reduce its promotional expenses, and to alter its research and development strategies. Next, the court found that Endo had demonstrated that it had suffered and would continue to suffer difficult-to-quantify harms resulting from Moving Defendants’ infringement:, namely, Endo claimed that it had had to lay off twenty-five percent of its relevant sales force, which may damage Endo’s reputation in its market segment and had also made the company less attractive to potential new hires. Endo also provided reasons why the public interest would affirmatively favor an injunction. Crushable tablets, like the ones marketed by Moving Defendants, were more easily abused by patients. To the extent that the injunction also served the interest of making a heavily-abused opioid less susceptible to abuse (in light of Endo’s non-crushable tablet formulation), the public interest was served. Therefore, the eBay factors favored injunctive relief.

The court next addressed Actavis’ motion to stay the injunction pending appeal. In deciding whether to suspend its injunction pending appeal, a court considers the following: (i) whether the moving party has made a strong showing that it is likely to succeed on the merits; (ii) whether the moving party will be irreparably injured absent a stay; (iii) whether issuance of the stay will substantially injure the non-moving party; and (iv) where the public interest lies. Actavis stated that on appeal it was likely to succeed based on the court’s failure to analyze the eBay factors in its original opinion. But the court had since applied those factors to the case, and they weighed against Actavis. As to the second factor, when Actavis launched at-risk, it knew there was a patent-infringement action against it and further knew or should have known that there was a possibility that it may someday be barred from marketing the product in question. Delaying Endo its due remedy would impose further harm on it; the court weighed factor (iii) against Actavis. Therefore, the injunction would remain pending appeal.

Finally, Endo moved to correct the judgment under Rule 60(a), which allows a court to “correct a clerical mistake or a mistake arising from oversight or omission whenever one is found in a judgment, order, or other part of the record.” The opposition argued that Endo’s requested amendments were outside the scope of Rule 60(b) because they were unnecessary and because the existing language was already clear. The court had found that certain of Endo’s corrections were well taken because they helped to clarify the court’s intent at the time of issuing the judgment and did not rely on new evidence or reasoning. Accordingly, undisputed clerical errors and certain disputed amendments under Rule 60(b) would be made in a judgment to be docketed under a separate ECF number.

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