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Amgen Inc. v. Amneal Pharmaceuticals LLC

United States District Court, D. Delaware

September 18, 2019

AMGEN INC., Plaintiff,
v.
AMNEAL PHARMACEUTICALS LLC, et al., Defendants.

          MEMORANDUM OPINION

          GOLDBERG, J.

         The current dispute between the parties revolves around a settlement agreement in a Hatch-Waxman patent infringement case.

         Plaintiff Amgen, Inc. (“Amgen”) originally brought claims against Defendants Sun Pharmaceutical Industries, Ltd., Sun Pharma Global Fze, and Sun Pharmaceutical Industries, Inc. (collectively, “Sun”) in response to Sun filing an Abbreviated New Drug Application (“ANDA”) for its generic Cinacalcet tablets. The Parties settled, entered into a Litigation Settlement Agreement (“Agreement”) on October 24, 2017, and thereafter stipulated to dismissal of all claims against Sun. As detailed more fully below, part of this Agreement set forth Amgen’s obligations if other manufacturers of generic Cinacalcet entered the market at risk.

         From December 28, 2019 to January 2, 2019, generic manufacturer Watson Laboratories, Inc. (“Watson”) and its corporate parent Teva Pharmaceutical Industries Ltd. (“Teva”) released a generic Cinacalcet into the market. In response to Teva’s launch, Sun filed the present motion to enforce the Agreement. Sun asserts that, based on Teva’s market activity and Amgen’s deficient response, the Agreement grants a license to Sun and allows it to launch and sell its generic Cinacalcet product.[1] (Oral Ar. Tr. at 21, ECF No. 481, June 13, 2019). For the reasons set forth below, I conclude that Sun has misconstrued its rights under the Agreement, and that the Agreement does not entitle Sun to a license to sell and market its generic Cinacalcet product.

         I. BACKGROUND

         A. The ’405 Patent

         The ’405 patent, entitled “Rapid Dissolution Formulation of Calcium Receptor-Active Compound,” was issued on June 28, 2016 and assigned to Amgen. Amgen also holds an approved New Drug Application (“NDA”) No. 21-688 for Cinacalcet hydrochloride tablets. (Id.) Amgen ® sells Cinacalcet hydrochloride tablets in the United States under the tradename Sensipar®. (Id.)

         On September 29, 2016 Amgen sued Sun, alleging that Sun infringed the ’405 patent. (Compl., ECF No. 1 in C.A. No. 16-cv-882, at ¶ 7.)[2] The original complaint asserted that Sun committed an act of infringement under 35 U.S.C. § 271(e)(2)(A) by submitting an ANDA to obtain approval to engage in the manufacture, use, sale, or importation of its generic Cinacalcet hydrochloride before the expiration of the ’405 patent. (Id. at ¶ 40.) On February 23, 2017, Amgen’s suit against Sun was consolidated with other cases brought against several other drug manufacturers that filed similar ANDAs for generic Cinacalcet products.

         On October 24, 2017, Sun and Amgen settled this infringement action by entering into the Agreement at issue. (Agreement, ECF No. 437-1.) The parties do not dispute that the Agreement is binding, enforceable, and governs the present dispute. Under the Agreement, Sun filed a stipulation of dismissal conceding that the ’405 patent was valid and enforceable, and would be infringed by “the manufacture, use, sale, offer to sell, importation or distribution [of its generic Cinacalcet product] in or for the United States ....” (Stip. of Dismissal, ECF No. 248, at ¶ 4.) The Honorable Gregory M. Sleet (now retired), who was originally assigned to this case, signed the aforementioned stipulation of dismissal on November 2, 2017, terminating the civil case against Sun. (Dismissal Order, ECF No. 253.)[3]

         B. The Teva Launch and Subsequent Amgen-Teva Settlement Agreement

         After the Amgen-Sun settlement and dismissal of Sun’s claims, other defendants in the consolidated infringement action proceeded to trial. On August 24, 2018, I entered a judgment of non-infringement in favor of Piramal Healthcare UK Ltd., Amneal Pharmaceuticals LLC, and Watson.[4] (J. Order, ECF No. 386.) Despite this judgment, Watson could not yet enter the market because its ANDA was still pending approval of the Food and Drug Administration. (Amgen’s Br., ECF No. 455, at 7.)

         On December 27, 2018, the FDA approved Watson’s Cinacalcet ANDA. (Id.) On December 28, 2018, Watson, through its corporate parent, Teva, launched a generic Cinacalcet product, infiltrating the market with approximately six-weeks-worth of stock through its distribution network. (Id.). Shortly thereafter, on January 2, 2019, Amgen and Teva reached a settlement agreement whereby Teva acknowledged that its generic product infringed the ’405 patent and agreed that it would immediately cease sales of this product. (Id.) Importantly, downstream distributors who had received Teva’s generic product were not involved in these negotiations, nor were they parties to the Agreement. (See Agreement, ECF No. 437). Also, on January 2, 2019, in order to comply with its notification duties outlined in section 5.3 of the Agreement, Amgen notified Sun of Teva’s launch and of their subsequent settlement. (Agreement, ECF No. 437-1, § 5.3; Letter, ECF No. 455-1, Ex. D.)

         C. Relevant Portions of the Litigation Settlement Agreement

         Sun premises its position that it is entitled to a license on Section 5 of the Agreement, which is titled “LICENSE.” I will briefly summarize the relevant terms of Section 5.

         Section 5.1 states that from “the Entry Date through the expiration of the last to expire claim of the Licensed Patents,” Sun and its Affiliates will be given a right and license to “make, have made, use, sell, offer to sell, import and distribute the Defendant’s Product in or for the United States.” (Agreement, ECF No. 437-1, § 5.1.)

         Section 5.2 defines the “Entry Date” as the earlier of certain events which are set forth in sections 5.2(a) and (b). Section 5.2(a) is not pertinent to resolution of this motion. Section 5.2(b) states that the “Entry Date” could be the earlier of “the Launch of a Generic Cinacalcet Product by a Third Party, Amgen, or an Amgen Affiliate, except as provided under Section 5.5.” (Id. at § 5.2(b) (emphasis added). Section 1 of the Agreement further defines the underlined terms.

         According to Section 1, the term “Launch” means the “first sale in the United States, with regard to a Generic Cinacalcet Product.” (Id. at § 1.9.) The term “Generic Cinacalcet Product” means “an oral drug product containing Cinacalcet HCL that is sold, offered for sale or distributed in the United States as an Authorized Generic or under an FDA finally approved ANDA that refers to and is AB rated with the Amgen Product as the reference-listed drug.” (Id. at § 1.4.) Finally, “Third Party” is defined as “any entity or person that is not a Party or an Affiliate of a Party.” (Id. at § 1.6.) Substituting these definitions into Section 5.2(b), as I have done in bold below, provides a clearer understanding of the meaning of this Section 5.2(b):

         For the purposes of this Settlement Agreement, the “Entry Date” shall mean the earlier of:

the first sale in the United States, with regard to a Generic Cinacalcet Product (an oral drug product containing Cinacalcet HCL that is sold, offered for sale, or distributed in the United States as an authorized generic or under an FDA finally approved ANDA that refers to and is AB rated with the Amgen Products as the referenced listed drug) by any entity or person that is not a Party or an Affiliate of a Party, Amgen or an Amgen Affiliate, except as provided by section 5.5.

         Importantly, the last portion of Section 5.2(b) references Section 5.5. Section 5.5 outlines Amgen’s obligations if a Third Party ...


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