Somaxon Pharmaceuticals Inc. v. Actavis Elizabeth LLC

CourtDistrict Court, D. Delaware
DecidedJune 25, 2020
Docket1:10-cv-01100
StatusUnknown

This text of Somaxon Pharmaceuticals Inc. v. Actavis Elizabeth LLC (Somaxon Pharmaceuticals Inc. v. Actavis Elizabeth LLC) is published on Counsel Stack Legal Research, covering District Court, D. Delaware primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Somaxon Pharmaceuticals Inc. v. Actavis Elizabeth LLC, (D. Del. 2020).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

SOMAXON PHARMACUTICALS, INC., and PROCOM ONE, INC.,

Plaintiffs,

Civil Action No. 10-1100-RGA v.

ACTAVIS ELIZABETH LLC, et al.,

Defendants.

MEMORANDUM OPINION

Jack B. Blumenfeld, Jeffrey J. Lyons, Jennifer A. Ward, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE; Jack E. Pace III, Amanda M. Murphy, Holly Tao, WHITE & CASE LLP, New York, NY; Attorneys for Plaintiffs.

John C. Phillips, Jr., Megan C. Hanley, PHILLIPS, GOLDMAN, MCLAUGHLIN & HALL, P.A, Wilmington, DE; David Steuer, Nicole Stafford, Stuart A. Williams, WILSON SONSINI GOODRICH & ROSATI, P.C., Palo Alto, CA, Austin, TX, New York, NY; Attorneys for Defendants.

June 24, 2020 /s/ Richard G. Andrews ANDREWS, UNITED STATES DISTRICT JUDGE:

Before me is a Report & Recommendation (the “Report”) of a United States Magistrate Judge. (D.I. 316). The Report pertains to a motion to enforce a Settlement and License Agreement by the Defendants (Mylan). (D.I. 290). The Report recommends Defendants’ motion be granted. (D.I. 316 at 1). Plaintiffs, Somaxon and ProCom, filed objections to the report.1 (D.I. 318). Defendants responded to Plaintiffs’ objections. (D.I. 320). The Magistrate Judge’s Report is comprehensive, and I will largely adopt the factual findings and legal conclusions in the Report with the exception of the Magistrate Judge’s order for specific performance by the Plaintiff. I do not separately recite any of the Magistrate Judge’s factual findings or legal conclusions except as I think necessary to explain my decision. I. BACKGROUND I will not restate the full background of this case as it has been thoroughly described by the Magistrate Judge in the Report. (D.I. 316 at 1-5). Briefly, this action began with a patent infringement suit initiated by Plaintiffs Somaxon and ProCom against Mylan as well as three other generic pharmaceutical companies.2 (D.I. 1). Plaintiffs and Mylan entered into the

1 Currax became Somaxon’s successors-in-interest to the Agreement in April 2019. (D.I. 316 at 4). The brief in opposition to Defendants’ motion to enforce the Settlement and License Agreement and the objections to the Report were filed by counsel for Currax. (D.I. 302; D.I. 318). When the Court refers to Plaintiffs it is referring to Currax. 2 The other three companies were: Par Pharmaceutical, Zydus Pharmaceuticals, and Actavis. (D.I. 302 at 4). Each of these companies filed an Abbreviated New Drug Application (ANDA) that triggered the litigation. (Id.). An ANDA is filed for a drug that is bioequivalent to a drug that has been previously approved and filed pursuant to §355(b)(1) of the Federal Food, Drug, and Cosmetic Act. 21 U.S.C. § 355(b)(1) (2020); 21 U.S.C. § 355(j) (2020). “Bioequivalence is the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.” U.S. Food & Drug Admin., Orange Book Preface: Approved Drug Products with Therapeutic Equivalence Evaluations §1.2 (Feb. 2, 2020), Agreement on July 17, 2012, and the Court then dismissed Plaintiffs’ case against Mylan. (D.I. 234). In April 2019, Currax became Somaxon’s successor-in-interest to the Agreement. (D.I. 316 at 4). The parties’ dispute revolves around §5.1(a) of the Agreement. (D.I. 292-1 ex. A §

5.1(a)). Section 5.1(a) provides Mylan with the semi-exclusive right to sell an authorized generic (AG)3 version of Currax’s drug, Silenor® 3 mg and 6 mg doxepin hydrochloride, for 180 days beginning on January 1, 2020 (the “AG License Initial Period”).4 (D.I. 292-1 ex. A §1.12, § 1.14(a), § 1.18, § 1.2, § 5.1(a)). In October 2019, Currax informed Mylan that Currax planned to launch its own AG product “on or around January 1, 2020.” (D.I. 303 ¶ 14). Mylan filed the pending motion to enforce the Agreement on December 23, 2019. (D.I. 290). The Court must determine whether Currax’s plan to market and sell its own AG constitutes a breach of the

https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface; 21 U.S.C. § 355(j)(8)(B) (2020). Each company settled with Somaxon and ProCom. (D.I. 302 at 4; D.I. 233; D.I. 235; D.I. 237; D.I. 283). 3 "‘Authorized Generic Product’ means a Generic Product that is manufactured, used, sold, offered for sale or distributed pursuant to the Somaxon [New Drug Application], but that is not marketed under the Trademark.” (D.I. 292-1 ex. A § 1.3). A New Drug Application (NDA) refers to stand-alone applications submitted under § 355(b)(1) of the Federal Food, Drug, and Cosmetic Act. 21 U.S.C. § 355(b)(1). 4 Somaxon and ProCom “[may also] grant one (1) additional License for the AG License Initial Period to a product that is AB rated to Silenor 3 mg and 6 mg doxepin hydrochloride tablets, but such product shall not be an Authorized Generic Product.” (D.I. 292-1 ex. A § 5.1(a)). An AB rated generic is a “[d]rug product[] that FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products . . . ." U.S. Food & Drug Admin., Orange Book Preface: Approved Drug Products with Therapeutic Equivalence Evaluations §1.7 (Feb. 2, 2020), https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface. The company selling the generic must submit “in vivo and/or in vitro evidence supporting bioequivalence” to receive the AB designation. (Id.). Pursuant to § 5.1(a) of the Agreement Currax granted another generic company, Actavis, the right to launch the AB-rated generic version of Silenor® beginning on January 1, 2020, and Actavis’ generic product is currently on the market. (D.I. 303 at ¶ 18; 3/3/2020 Tr. at 6:4-14). parties’ Agreement, if § 5.1(a) of the Agreement is enforceable, and if Defendants are entitled to specific performance.5 II. LEGAL STANDARD Magistrate Judges have the authority to make recommendations as to the appropriate

resolution of a motion for summary judgment. 28 U.S.C. § 636(b)(1)(B). “The court shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). A motion to enforce a settlement agreement resembles a motion for summary judgment. Orthophoenix, LLC v. Stryker Corp., 2017 WL 1197675, at *4 (D. Del. Mar. 28, 2017); Tiernan v. Devoe, 923 F.2d 1024, 1031- 32 (3d Cir. 1991). Both a motion to enforce a settlement agreement and a motion for summary judgment deprive the non-moving party of their right to be heard at trial. Tiernan, 923 F.2d at 1031. A motion to enforce a settlement agreement is case-dispositive, meaning this Court reviews the objected-to recommendations de novo. Fed. R. Civ. P. 72(b)(3); D. Del. LR 72.1(a)(3). A motion to enforce a settlement agreement may be granted if the record shows that “the

moving party is entitled to judgment as a matter of law.” Frederick v. Avantix Labs., Inc., 2017 WL 995430, at *2 (D. Del. Mar. 14, 2017); Fed. R.

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