United States District Court, D. Delaware
SUN PHARMACEUTICAL INDUSTRIES LTD. and RANBAXY SIGNATURE, LLC, Plaintiffs,
SAPTALIS PHARMACEUTICALS, LLC, Defendant.
REDACTED MEMORANDUM OPINION AND ORDER
WILLIAM C. BRYSON UNITED STATES CIRCUIT JUDGE.
the Court in this Hatch-Waxman Act patent infringement action
is a motion for summary judgment filed by defendant Saptalis
Pharmaceuticals, LLC (“Saptalis”). Dkt. No. 69.
Plaintiff Ranbaxy Signature, LLC, is the sole owner of U.S.
Patent No. 6, 890, 957 (“the '957 patent”).
Dkt. No. 1, at 3. Plaintiff Sun Pharmaceutical Industries
Ltd. has exclusive marketing, promotion, distribution, and
sales rights to products covered by the '957 patent on a
worldwide basis. Id. The plaintiffs (collectively,
“Sun”) have asserted claims 1, 2, 7, and 9-15 of
the '957 patent against Saptalis. Dkt. No. 70, at 3.
Saptalis seeks summary judgment of non-infringement as to all
of the claims asserted against it, arguing that the asserted
claims of the '957 patent are not infringed, either
literally or under the doctrine of equivalents. In this
order, the Court construes the disputed terms of the asserted
claims, but defers decision of the motion for summary
judgment until after the close of discovery on July 19, 2019.
The Asserted Claims
'957 patent is entitled “Liquid Formulation of
Metformin.” It issued on May 10, 2005, from an
application that was a continuation of an application that
issued as U.S. Patent No. 6, 559, 187 (“the '187
patent”). See Dkt. No. 70, at 2; Dkt. No. 79,
at 4. The '957 patent claims priority to U.S. Provisional
Application No. 60/223, 391, which was filed on August 7,
2000. See Dkt. No. 71-12, at 2.
'957 patent “relates to a liquid formulation of
metformin and salts thereof” and to the use of that
formulation “in treating hyperglycemia and/or
diabetes.” '957 patent, col. 1, ll. 15-17. Claim 1
is the only independent claim of the '957 patent. Dkt.
No. 70, at 3-4; Dkt. No. 79, at 4.
states as follows:
1. A liquid pharmaceutical composition for oral
administration which comprises a therapeutically effective
amount of metformin or its pharmaceutically acceptable salt;
a sweetener that does not increase the blood glucose level of
a subject after ingestion thereof; a polyhydroxy alcohol
present in an amount of about 15 to about 55% by weight; a
mineral acid and bicarbonate salt both present in sufficient
amounts to maintain the pH of the composition in the range of
about 4.0 to about 9.0; and a pharmaceutically acceptable
2003, the U.S. Food and Drug Administration approved
Sun's New Drug Application No. 021591 for the drug
protected by the '957 patent. The agency then listed the
patent in its publication entitled Approved Drug Products and
Therapeutic Equivalence Evaluations, also known as “the
Orange Book, ” as covering Sun's product bearing
the trade name Riomet®. Dkt. No. 1, at 3. Saptalis
subsequently submitted an Abbreviated New Drug Application
(“ANDA”) seeking approval to market a generic
version of Riomet®. Sun then filed this action under the
infringement provision of the Hatch-Waxman Act, 35 U.S.C.
§ 271(e)(2), alleging that Saptalis's ANDA product
infringes the '957 patent.
Sun's Infringement Contentions
first amended initial infringement claim charts, Sun argues
that Saptalis's ANDA product meets each asserted claim
limitation, either literally or under the doctrine of
equivalents. The summary judgment briefing focuses on two
limitations in claim 1: the sweetener limitation and the
polyhydroxy alcohol limitation. Sun argues that the sweetener
limitation-“a sweetener that does not increase the
blood glucose level of a subject after ingestion thereof-is
met by either (or both) of two ingredients in Saptalis's
ANDA product, (Xxxxx) and an
ingredient known as (Xxxxx) Flavor
(Xxxxx) Those ingredients allegedly
provide a sweetening effect without increasing the
patient's blood glucose level. Sun argues that the
polyhydroxy alcohol limitation-“a polyhydroxy alcohol
present in an amount of about 15 to about 55% by
weight”- is met by two ingredients in Saptalis's
ANDA product, (Xxxxx) and
(Xxxxx) which allegedly perform the
same function as the polyhydroxy alcohol ingredient in the
recited formulation of the '957 patent by helping to mask
the unpleasant taste of the active metformin ingredient and
making the formulation more viscous. Dkt. No. 71-3, at 5.
original infringement contentions, Sun asserted that
(Xxxxx) was the only sweetener in the
accused ANDA product, and that the (Xxxxx) and (Xxxxx) in
Saptalis's ANDA product were polyhydroxy alcohols. Dkt.
No. 71-4, at 5. On January 14, 2019, Sun served an amended
initial infringement claim chart on Saptalis, in which it
amended its infringement contentions. Dkt. No. 80-1, at
64-70. In the amended infringement contentions, Sun alleged
that both (Xxxxx) and (Xxxxx) Flavor (Xxxxx)
satisfied the sweetener limitation. In addition, Sun's
amended infringement contentions retreated from the position
that (Xxxxx) and (Xxxxx) are polyhydroxy alcohols, and contended
instead that they are equivalent to the polyhydroxy alcohol
recited in the '957 patent. Id. In light of the
amended infringement contentions, Sun argues that
Saptalis's ANDA product infringes the '957 patent
under the doctrine of equivalents.
contends that Sun amended its original infringement
contentions without any explanation. Dkt. No. 70, at 4;
see also Id. at 26-27. Sun responds that it provided
Saptalis with a letter dated January 18, 2019, “which
explained in detail why Sun's contentions were
supplemented.” Dkt. No. 79, at 8; see Dkt. No.
80-1, at 52-54. To the extent that Saptalis objects to
Sun's amendment of its infringement contentions, the
Court rejects Saptalis's argument. Sun amended its
infringement contentions early in the case, giving Saptalis
ample time to address Sun's new allegations in its motion
for summary judgment, and there is no suggestion that
Sun's amended infringement contentions were the product
of bad faith on Sun's part. See Fed. R. Civ. P.
26(e); see also Dist. Of Del., Default Standard
for Discovery § 4(c), n.3 (“As these [initial
claim chart] disclosures are ‘initial,' each party
shall be permitted to supplement.”); AVM Techs.,
LLC v. Intel Corp., Civil Action No. 15-33, 2016 WL
7177614, at *2 (D. Del. Dec. 9, 2016).
Claim Construction and Summary Judgment
October 10, 2018, the Court issued a Revised Scheduling Order
assigning dates for, inter alia, claim construction
briefing and a hearing on claim construction. See
Dkt. No. 39. On December 28, 2018, in a letter brief to the
Court, Saptalis requested that the Court modify the Revised
Scheduling Order to replace the briefing and hearing on claim
construction with briefing and a hearing on Saptalis's
motion for summary judgment based on non-infringement. Dkt.
No. 61. In its letter brief in response, Sun opposed
Saptalis's request to permit early summary judgment
proceedings. Dkt. No. 62. On January 4, 2019, the Court held
a telephonic hearing on Saptalis's request. During the
telephonic hearing, the Court granted Saptalis's request
to modify the Revised Scheduling Order, permitting Saptalis
to move for an early summary judgment, in conjunction with
the claim construction proceedings. See Dkt. No. 64.
The Court instructed the parties to address the remaining
claim construction disputes in their summary judgment motion