United States District Court, D. Delaware
MITCHELL S. GOLDBERG, J.
before me are several evidentiary issues raised by the
parties in connection with a patent infringement trial
commencing on March 5, 2018. (D.I. 294-1, Ex. 8 & Ex.
8.1). I will address two of these evidentiary issues below.
Proposed Joint Pretrial Order, Plaintiff Amgen, Inc.
(“Amgen”) argues that the Markush groups in the
binder and disintegrant limitations should be “open
sets.” (D.I. 294-1, Ex. 8 at ¶
2(b)). Amgen also urges that Defendants should be precluded
from raising any claim construction issues,
and that the time to raise this issue was at the Markman
hearing. Id at ¶ 2. Conversely, Defendants urge
that the Markush groups are “closed.” (D.I.
294-1, Ex. 7.1 at p. 318-19, ¶¶ 32-33).
construction is a “fluid process, ” Cadence
Pharma., Inc. v. Innopharma Licensing LLC, 2016 WL
3661751, at *3 n.2 (D. Del. July 8, 2016), and that process
is “not final until judgment is entered, ”
Eaton Corp. v. Parker-Hannifin Corp., 292 F.Supp.2d
555, 572 n.2 (D. Del. 2003). Until then, “[t]he court
may re-construe the claims if it finds the original claim
construction to be in error based upon a more developed
record, ” and/or “may add claim constructions for
terms that become disputed through the course of
trial.” Eaton Corp., 292 F.Supp.2d at 572 n.2.
the claim construction issues Defendants now raise appear to
have developed after the Markman hearing. Because these
issues will substantially effect how the parties present
their theories of infringement or non-infringement at trial,
I will resolve this dispute now.
claims 1 and 20 of United States Patent No. 9, 375, 405
(“the '405 patent”) contain three Markush
groups defining the list of excipients permitted for use as
diluents, binders, and disintegrants. (D.I. 294-1, Ex. 7.1 at
p. 36, ¶ 21).
(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 ...