United States District Court, D. Delaware
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”). 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.
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.
MOTION FOR REARGUMENT
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.
The '405 Patent
'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
(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).
Procedural History of Claim Construction
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. (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
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).
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. (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.
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