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Purdue Pharma L.P. v. Collegium NF, LLC

United States District Court, D. Delaware

June 19, 2019

PURDUE PHARMA L.P., PURDUE PHARMACEUTICALS L.P., and THE P.F. LABORATORIES, INC., Plaintiffs,
v.
COLLEGIUM NF, LLC and COLLEGIUM PHARMACEUTICAL, INC., Defendants.

          Jack B. Blumenfeld, Rodger D. Smith II, Megan E. Dellinger, Jeffrey J. Lyons, MORRIS, NICHOLS, ARSHT, & TUNNEL LLP, Wilmington, Delaware; Bruce J. Koch, PURDUE PHARMA L.P., Stamford, Connecticut Counsel for Plaintiffs

          Frederick L. Cottrell, III, Kelly E. Farnan, Christine D. Haynes, RICHARDS, LAYTON & FINGER, P.A., Wilmington, Delaware; Jake M. Holdreith, Christopher A. Pinahs, ROBINS KAPLAN LLP, Minneapolis, Minnesota Counsel for Defendants

          MEMORANDUM OPINION

          COLM F. CONNOLLY UNITED STATES DISTRICT JUDGE

         Purdue Pharma L.P., Purdue Pharmaceuticals L.P., and The P.F. Laboratories, Inc. (collectively "Purdue") initiated this action with the filing of a three-count complaint against Defendants Collegium NF, LLC and Collegium Pharmaceutical, Inc. (collectively "Collegium") for patent infringement of U.S. Patent No. 9, 861, 583 ("#583 patent"), U.S. Patent No. 9, 867, 784 ("#784 patent"), and U.S. Patent No. 9, 872, 836 ("#836 patent"). On December 10, 2018, at the request of all the parties, I stayed the case "with the exception of briefing on and resolution of Defendants' anticipated motion for judgment on the pleadings and any discovery related to that motion." D.I. 39 at 2. Later that day, Collegium filed a Motion for Judgment on the Pleadings pursuant to Federal Rule of Civil Procedure 12(c), asking that I dismiss the complaint and enter judgment in Collegium's favor. D.I. 42. For the following reasons, I will deny the motion.

         I. BACKGROUND[1]

         Purdue alleges in its complaint that "[s]ince at least January 10, 2018," Collegium has infringed the asserted patents "by using, offering for sale, selling, and/or distributing" certain Nucynta® and Nucynta® ER tablets (collectively, "the Nucynta Products"). D.I. 1 at ¶¶ 46, 59, 72. Purdue further alleges that Collegium induced Assertio Therapeutics, Inc. to infringe the asserted patents.[2] Assertio is the holder of the New Drug Applications (NDAs) approved by the FDA for the manufacturing, marketing, and sale of the Nucynta Products. Id. at ¶¶ 16-17, 20- 21. Collegium sold the Nucynta Products pursuant to a Commercialization Agreement it had with Assertio.

         When Collegium and Assertio signed the Commercialization Agreement in December 2017, section 3.2(c)(viii) of the agreement provided in relevant part:

(c) Supply by [Assertiol. [Assertio] has obtained and will continue to use commercially reasonable efforts to obtain supply of the [Nucynta] Products for Commercialization in the [United States] pursuant to one or more CMO Supply Agreements, and from and after the Closing Date shall supply the [Nucynta] Products in finished goods form to Collegium on a pass-through basis, under the terms and conditions applicable to the supply of the [Nucynta] Products, as applicable, to [Assertio] under the applicable CMO Supply Agreements. Collegium and its Affiliates and any other Sublicensees shall purchase all of their [Nucynta] Product requirements for Commercialization in the [United States] from [Assertio] in accordance with the terms and conditions of the applicable CMO Supply Agreements, unless otherwise agreed to by Collegium and [Assertio]....
(viii) To the extent permitted under the applicable CMO Supply Agreement, title to the [Nucynta] Products ordered hereunder by or on behalf of Collegium shall transfer to Collegium ... upon fulfillment of the applicable CMO's delivery obligation pursuant to the applicable CMO Supply Agreement... and at no time shall title to such [Nucynta] Products transfer to [Assertio].

D.I. 44-1, Ex. A at 0055578, 0055580 (emphasis added).

         On August 28, 2018-six months after Purdue filed this lawsuit-Purdue and Assertio entered into a Settlement Agreement to settle their "disputes relating to" a patent case they had been litigating in the District of New Jersey since 2013. See id, Ex. C. Three sections of the Settlement Agreement are relevant to the pending motion.

         First, in section 6 of the Settlement Agreement, Purdue granted Assertio a covenant not to sue Assertio and certain related entities. The covenant not to sue expressly carved out Collegium. It reads in relevant part:

Purdue Covenant Not to Sue. The Purdue Entities[]... hereby covenant that neither the Purdue Entities nor any of their Associated Companies will sue, assert or purport to assert any claim or counterclaim against or otherwise assist, encourage, facilitate or participate in any action or proceeding in the [United States] against Assertio or its Associated Companies or their direct or indirect customers, users, licensees, agents, service providers, distributors, retailers, or their direct or indirect manufacturers or suppliers (excluding Collegium) claiming or otherwise asserting that any of the making, having made, using, marketing, selling, offering for sale, importing and/or other distributing of any Assertio Product [including the Nucynta Products] in the [United States] infringes any Purdue Patents, or other patent rights that are or have been owned or controlled (including any right of enforcement) by any of the Purdue Entities or any of their Associated Companies, including any patent rights that are owned or controlled by the Purdue Entities or any of their Associated Companies in the future. ... The covenant contained in this Section 6 shall also not apply to Collegium.

Id. at 00251341 (bolded and underscored typeface in original).

         Second, in section 7 of the Settlement Agreement, Purdue agreed to release Assertio and certain related entities from infringement claims related to the Nucynta Products. The release expressly carved out Collegium. It reads in relevant part:

Purdue Release. The Purdue Entities, on behalf of themselves and each of their Associated Companies, hereby release and forever discharge Assertio, each of its Associated Companies (as of Signing Date), and their respective current and former directors, officers, employees, attorneys, other representatives or their direct or indirect customers, users, licensees, service providers, distributors, retailers, or their direct and indirect manufacturers or suppliers (excluding Collegium) (collectively the "Assertio Releasees") from any and all actions, causes of action, suits, claims and liabilities whatsoever, in law, admiralty or equity against the Assertio Releasees relating to (i) any claim of infringement of the Purdue Patents ... arising from the making, having made, using, marketing, selling, offering for sale, importing and/or other distributing of any Assertio Product [including the Nucynta Products] in or for the [United States], on or prior to the Signing Date, (ii) any claims in the [United States] that were made or could have been made against the Assertio Releasees in the Civil Action or the Related Inter Partes Review Proceedings, including in each case, any claim for attorneys' fees or costs, and (iii) any other claims or counterclaims related to the Purdue Patents or other patent rights that are or have been owned or controlled (including any right of enforcement) by the Purdue Entities or their Associated Companies (as of the Signing Date) that could have been brought in the [United States] on or prior to the Signing Date with respect to the Assertio Products [including the Nucynta Products]. For the avoidance of ambiguity, the release provided by this Section 7 will not apply to any action to enforce any provision of this Agreement. The release contained in this Section 7 will also not apply to Collegium.

Id. at 00251342 (bolded and underscored typeface in original).

         Third, in section 15 of the Settlement Agreement, Purdue and Assertio agreed to the following:

No Exhaustion of Rights as to Collegium. Any activity by Collegium (and solely with respect to Collegium and not any Third Party engaging in such activity), including the making, having made by any Third Party other than by or on behalf of Assertio or its Associated Companies, using, offering to sell, selling, shipping, distributing or importing in or outside the [United States] of NUCYNTA® or NUCYNTA® ER shall not be authorized and no determination that any of the Purdue Patents or any other patent rights or other intellectual property owned or controlled by any of the Purdue Entities or any of their Associated Companies have been terminated or exhausted as to Collegium shall be based upon any provision of this Agreement. For the sake of clarity, none of the activities described above with respect to NUCYNTA® or NUCYNTA® ER by Collegium is authorized by any of the Purdue Entities or any of their Associated Companies and no release or covenant not to sue given by any of the Purdue Entities or any of their Associated Companies shall be applicable to Collegium. Neither Assertio nor any of its Associated Companies shall assert, in any context, alone or in cooperation with Collegium or any other Third Party, that any of the Purdue Patents or any other patent rights or other intellectual property owned or controlled by any of the Purdue Entities or any of their Associated Companies have been exhausted with respect to Collegium by any of its activities relating to NUCYNTA® or ...

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