United States District Court, D. Delaware
FOREST LABORATORIES, LLC, FOREST LABORATORIES HOLDINGS, LTD., and ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD., Plaintiffs,
SIGMAPHARM LABORATORIES, LLC, et al., Defendants.
current controversy in this ongoing Hatch-Waxman case
involves a motion by defendant Sigmapharm Laboratories, LLC
(“Sigmapharm”) to vacate a finding of
infringement pursuant to Fed.R.Civ.P. 60(b) based on a
post-trial amendment to its Abbreviated New Drug Applications
(“ANDA”). (D.I. 411). Plaintiffs Forest
Laboratories LLC, Forest Laboratories Holdings, Ltd., and
Allergan Pharmaceuticals International Ltd. (collectively,
“Forest”) oppose Sigmapharm's motion and have
filed a cross motion to enter final judgment. (D.I. 413). For
the reasons stated below, Sigmapharm's motion will be
denied and Forest's motion will be denied without
The Consolidated Case
September 2014, Forest initiated several patent infringement
actions against companies that had filed ANDAs under the
Hatch-Waxman Act, 21 U.S.C. § 355, seeking FDA approval
to market generic versions of Saphris®, an
asenapine maleate tablet. Among other issues raised, Forest
asserted that the defendants infringed claim 1 of U.S. Patent
No. 5, 763, 476 (“the '476 patent”), which
requires that the pharmaceutical composition
“disintegrate within 30 seconds in water at 37°
C.” (D.I. 409 at 5, 7). These actions were consolidated
and originally overseen by the Honorable Sue L. Robinson, now
retired. (Id. at 3).
first ANDA, filed in August 2013, had a disintegration
specification of “not more than 5
minutes”-Specification 1. (PTX 525 at 9). In August
2015, the FDA issued a Complete Response, rejecting
Specification 1 because the disintegration time was not
“within seconds” as required by the Reference
Listed Drug. (PTX 414 at 2). Because disintegration times
directly implicated the issue of infringement, Forest sought
emergency relief from Judge Robinson's scheduling order
“to avoid prejudice to Forest and a waste of resources
by the Court.” (D.I. 419-1, Ex. A at 1).
January 29, 2016, Judge Robinson issued an order, stating:
[F]or this case to go forward with some semblance of
certainty, Sigmapharm must provide a declaration from one of
its executives (binding Sigmapharm) stating that Sigmapharm
will not reformulate its product and that Sigmapharm risks
the costs of litigation if it does.
response, Sigmapharm submitted a declaration from its CEO,
Spiridon Spireas, Ph.D. stating that it will not
“reformulate its ANDA products.” (D.I. 157-1).
There was some discussion at a subsequent status conference
as to what the term “reformulate” would cover.
(D.I. 419-1, Ex. B at 7:7-11:25). Judge Robinson made clear
that any definition of reformulation created by Sigmapharm
was not binding on her “so that if there are changes
that hold up the case that in my mind constitute a
reformulation, then I am saying that Sigmapharm is at risk
for whatever costs that entailed.” (Id. at
10:15-21). Sigmapharm acknowledged Judge Robinson's
pronouncement and noted that it was only trying to exclude
from the binding declaration “some small change that
has nothing to do with disintegration.” (Id.
month later, in February of 2016, Sigmapharm responded to the
FDA's rejection of Specification 1 by amending its
disintegration specification to “not more than 75
2. (PTX 416 at 1, 13). Based on Specification
2, Forest prepared and served its opening expert reports,
which included testing of lots PD 54:33 and 54:34.
(See D.I. 409 at 11).
2016, three months before trial was scheduled to start before
Judge Robinson, Sigmapharm again amended its disintegration
specification from “not more than 75 seconds” to
“35 to 75 seconds”-Specification
3. (PTX 632 at 2). Forest again sought relief
from Judge Robinson, asserting that if the FDA accepted
Sigmapharm's Specification 3, Forest would need
additional fact and expert discovery. (D.I. 419-1, Ex. C).
Sigmapharm took the position that no further discovery was
needed. (Id.). According to Sigmapharm, “It is
impossible for Forest to prove literal infringement because
the specification precludes it.” (Id.). Judge
Robinson was understandably troubled by Sigmapharm's
position that “everything that that happened before
this is not relevant anymore, because you changed your label
on your specification.” (D.I. 419-1, Ex. D at
28:15-18). In reference to Sigmapharm's tactics, she
noted that “maybe you've wasted a lot of time here
and a lot of money.” (Id. at 29:23-24). In
order to give Forest time to take additional discovery
regarding Sigmapharm's Specification 3, the trial date
for all defendants was moved from August 2016 to October
2016. (D.I. 419-1, Ex. E at 5-6, 9:9-12).
September 2016, the FDA rejected Sigmapharm's
Specification 3, reiterating its recommendation that
Sigmapharm reformulate its drug product so that it
demonstrated “a disintegration time that is in-line
with the labeling requirement of ‘within
seconds.'” (D.I. 384-1, Ex. 1 at ¶ 32; PTX 629
at 2). With trial set to commence in less than a month,
Forest requested that any infringement issues as to
Sigmapharm be stayed in order “to avoid prejudice to
Forest and waste of the Court's and Forest's
resources trying infringement of a product the FDA has twice
not approved.” (D.I. 419-1, Ex. G). On October 13,
2016, Judge Robinson granted Forest's request and trial
on infringement as to Sigmapharm was stayed. (Id.).
Meanwhile, Judge Robinson proceeded to trial in October 2016
on infringement as to the remaining defendants and validity
as to all defendants. (Id.).
response to the FDA's September 2016 Complete Response,
Sigmapharm again amended its disintegration specification in
March 2017-Specification 4. (D.I.
384-1, Ex. 1 at ¶ 33). Sigmapharm changed the single
disintegration test to two separate tests and lowered the
upper time limit to under a minute. (PTX 630 at 15). Thus,
the “35 seconds to 75 seconds” became:
(1) at 30 seconds “fail” USP <701> (the
“30-Second Test”), and
(2) at 55 seconds “pass” USP <701> (the
25, 2017, having been designated as a visiting judge to
assist with the Delaware Court's docket, I was assigned
this case. I rejected Sigmapharm's motion to lift the
stay in November 2017, because there was not enough certainty
as to whether there would be further changes to
Sigmapharm's specification. (D.I. 341; D.I. 349; D.I.
351). But in January of 2018, I granted a renewed motion to
lift the stay after Sigmapharm received correspondence from
the FDA classifying any remaining deficiencies in its ANDA as
“minor.” (D.I. 353; D.I. 358). I also granted
Forest's request for additional fact discovery and
supplemental expert reports on Specification 4, and the
parties proceeded to trial before me in June 2018. (D.I.
The Infringement Trial
trial, Forest asserted that Sigmapharm infringed claims 1-2,
4-6, and 9-10 of the '476 patent. (D.I. 384-1, Ex. 4).
The parties agreed that Sigmapharm's infringement of
claims 2, 5, and 6 rose and fell with infringement of claim
1. (D.I. 362 at ¶ 3). The parties further agreed that
infringement of claims 4, 9, and 10 would be resolved by
applying to Sigmapharm any findings of infringement or
non-infringement made against two other defendants in the
consolidated case. (Id. at ¶ 4). Given these
agreements, the sole issue before me at the infringement
trial was whether Sigmapharm infringed claim 1 of the
'476 patent either literally or under the doctrine of
equivalents. (Id. at ¶ 3).