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Amgen Inc. v. Amneal Pharmaceuticals LLC

United States District Court, D. Delaware

April 19, 2018

AMGEN INC., Plaintiff,


          Goldberg, J.

         This is a consolidated case for patent infringement brought by Plaintiff Amgen Inc. (“Amgen”) against Defendants Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals of New York LLC (together, “Amneal), Piramal Healthcare UK Ltd. (“Piramal”), Watson Laboratories, Inc., Actavis, Inc., and Actavis Pharma, Inc. (together, “Watson”), and Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Ltd. (together, “Zydus, ” and collectively with all other defendants, “Defendants”).[1] Amgen claims that Defendants infringed United States Patent No. 9, 375, 405 (“the '405 patent”) titled “Rapid Dissolution Formulation of a Calcium Receptor-Active Compound.” Trial on Amgen's infringement claims was held between March 5, 2018 and March 9, 2018.[2]

         Presently before the court are two motions filed around the start of trial: (i) Amgen's Motion for Reargument of the Court's February 27, 2018 Memorandum and Order which construed the meaning of the Markush groups in the '405 patent; and (ii) Zydus' Motion in Limine to preclude the introduction of a new theory of infringement-the doctrine of equivalents-which was not asserted against it before trial. (D.I. 323, D.I. 307). For the reasons set forth below, Amgen's Motion for Reargument is denied, and Zydus' Motion in Limine is granted.


         A. Background

         In its Motion for Reargument, Amgen contends that the court “misconstrued [its] position on claim construction” and “misapprehended the claim construction issue.” (D.I. 323 at 1-2). A brief recitation of the procedural history in this matter and the court's prior rulings on claim construction are necessary to provide the proper context for Amgen's motion.

         1. The '405 Patent

         The '405 patent issued from U.S. Patent Application No. 12/942, 646 (the “'646 application”), filed on November 9, 2010. (D.I. 293-1, Ex. 1 ¶ 7). The parties have agreed that infringement in this case will be decided based on claim 1 of the '405 patent, which states:

(1) A pharmaceutical composition comprising:
(a) from about 10% to about 40% by weight of cinacalcet HCl in an amount of from about 20 mg to about 100 mg;
(b) from about 45% to about 85% by weight of a diluent selected from the group consisting of microcrystalline cellulose, starch, dicalcium phosphate, lactose, sorbitol, mannitol, sucrose, methyl dextrins, and mixtures thereof;
(c) from about 1% to about 5% by weight of at least one binder selected from the group consisting of povidone, hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, and mixtures thereof; and
(d) from about 1% to 10% by weight of at least one disintegrant selected from the group consisting of crospovidine (sic), sodium starch glycolate, croscarmellose sodium, and mixtures thereof, wherein the percentage by weight is relative to the total weight of the composition, and wherein the composition is for the treatment of at least one of hyperparathyroidism, hyperphosphonia, hypercalcemia, and elevated calcium phosphorus product.

(D.I. 294-1, Ex. 7 at 4; D.I. 336).

         2. Procedural History of Claim Construction

          The Honorable Gregory M. Sleet held a Markman hearing in this matter in the spring of 2017. The only claim construction dispute presented to and resolved by Judge Sleet at that time was the meaning of “relative to the total weight of the composition, ” which appears in claim 1's “wherein clause.” (D.I. 186). By the fall of 2017, however, the parties had another claim construction dispute that had not been resolved. That dispute involved the Markush groups for the binder and disintegrant elements in claim 1.[3] (D.I. 356 at 1069:15-17). The parties became aware of the claim construction dispute when they exchanged expert reports. Some of Defendants' experts opined that there was no literal infringement, because the ANDA product contained binders or disintegrants not listed in the Markush groups. (See, e.g., D.I. 355 at 642:13-643:8; Id. at 780:20-782:22). No party, however, sought a further claim construction ruling from the court.

         On January 24, 2018, Amgen's expert, Dr. Davies, was deposed. Dr. Davies testified that Defendants with unlisted binders or disintegrants still literally infringed, because the “comprising language” in the preamble of claim 1 permitted unlisted binders or disintegrants. (D.I. 356 at 1067:16-23). Despite the fact that there was no claim construction to support this opinion, Amgen did not seek a second claim construction from the court or make clear that, for those defendants against whom it had only asserted literal infringement, it would now also assert the doctrine of equivalents in the alternative. (D.I. 354 at 458:18-23).

         On February 5, 2018, the parties filed a Proposed Joint Pretrial Order, which made clear that the claim construction dispute over the Markush groups was still in play.[4] (D.I. 293; D.I. 294). In the section setting forth the parties' proposed findings of fact and conclusions of law, Defendants asked the court to construe the Markush groups as closed to unlisted excipients. (D.I. 294-1, Ex. 7.1 at 316-22). Defendants also explained why they thought three arguments they expected Amgen to make should fail. (Id.). Defendants expected Amgen to argue that the Markush groups were not closed due to (1) the term “comprising” in the preamble, (ii) the phrase “at least one” before the Markush group elements, and (iii) the phrase “mixtures thereof” in the Markush group elements. (Id.).

         In its part of the Proposed Joint Pretrial Order, Amgen did not make all of the arguments Defendants expected. Instead, Amgen primarily argued that Defendants should be precluded from raising the claim construction dispute, because it was “not raised at the Markman hearing.” (See D.I. 294-1, Ex. 8 at 1). Amgen also argued that the Markush groups were not closed sets due to the claim term “comprising.” (Id.; see also D.I. 294-1, Ex. 7 at 226 (citing Mannesmann Demag Corp. v. Engineered Metal Prods. Co., 793 F.2d 1279, 1282-1283 (Fed. Cir. 1986) and In re Crish, 393 F.3d 1253, 1257 (Fed. Cir. 2004))). Finally, Amgen teed-up the claim ...

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