United States District Court, D. Massachusetts
MOMENTA PHARMACEUTICALS, INC. AND SANDOZ INC., Plaintiffs,
AMPHASTAR PHARMACEUTICALS, INC. AND INTERNATIONAL MEDICATION SYSTEMS, LTD., Defendants.
MEMORANDUM & ORDER
Nathaniel M. Gorton United States District Judge
case plaintiffs Momenta Pharmaceuticals, Inc. and Sandoz Inc.
(collectively, “Momenta” or
“plaintiffs”) allege that defendants Amphastar
Pharmaceuticals, Inc. and International Medication Systems,
Ltd. (collectively, “Amphastar” or
“defendants”) infringed Momenta's U.S. Patent
No. 7, 575, 886 (“the ‘886 patent”). This
Court convened a status conference on June 21, 2017, and took
under advisement the issue of the scope of the pending jury
trial, i.e. the extent to which Amphastar's
equitable defenses will be addressed at that trial.
asserts that the equitable defenses should be addressed in a
separate hearing after the trial because the issues that the
jury must decide, infringement, validity and damages, are
separate from the equitable defenses which examine whether
there was a duty to disclose the ‘886 patent to the
United States Pharmacopeia (“the USP”) and
whether Momenta breached that duty. Amphastar contends that
there is substantial commonality between the evidence of its
defenses to Momenta's claims and the evidence of
equitable defenses. Because the Court agrees that there is a
substantial overlap rendering separation of the evidence
problematic, the defendants will be permitted to offer
evidence relative to their equitable defenses at the trial.
defenses involve matters of law and thus “factual
issues [underlying such defenses] ordinarily are not jury
questions.” Baxter Healthcare Corp. v. Spectramed,
Inc., 49 F.3d 1575, 1584 (Fed. Cir. 1995). Although the
Federal Circuit Court of Appeals (“Federal
Circuit”) has stated that it is “not the
preferred course”, it upholds a district court's
decision to “delegate aspects of the inequitable
conduct inquiry to juries” as long as such delegation
does not result in prejudice or an unfair trial. Rothman
v. Target Corp., 556 F.3d 1310, 1322-23 (Fed. Cir.
is warranted if the claims and equitable defenses "are
distinct and without commonality either as claims or in a
relation to the underlying fact issues." DeKalb
Genetics Corp. v. Syngenta Seeds, Inc., 2008 WL 382385,
at *2 (E.D. Mo. Feb. 12, 2008) (quoting Old Town Canoe
Co. v. Confluence Holdings Corp., 448 F.3d 1309, 1322
(Fed.Cir. 2006)). Conversely, when there is
“overlapping of evidence on all issues, ” courts
have conducted one trial with respect to the claims and
equitable defenses. Genentech, Inc. v. Wellcome Found.
Ltd., No. 88-330, 1990 WL 69187, at *14 (D. Del. Mar. 8,
1990). When evidence of equitable defenses overlaps with
matters that are clearly for the jury to decide, such as
issues of infringement, validity and damages in this case,
courts have availed themselves of advisory jury verdicts.
See Qualcomm Inc. v. Broadcom Corp., 548 F.3d 1004,
1009 (Fed. Cir. 2008). Nevertheless, the equitable defenses
ultimately remain a question of law for the Court to decide.
contends that the evidence as to equitable defenses
significantly overlaps with the jury questions. Its argument
addresses five specific examples.
Whether the Failure of Momenta and Dr. Shriver to Disclose
the ‘886 Patent is an Admission of
Amphastar's view, Momenta did not disclose the ‘886
patent to the USP for either of two reasons: 1) it did not
believe the patent covered the <207> method or 2) it
knew that the patent covered <207> but did not disclose
it anyway. Thus, argues Amphastar, the non-disclosure is
relevant to both its non-infringement and its waiver and
equitable estoppel defenses.
replies that 1) Amphastar's argument assumes that there
was a duty to disclose, 2) Amphastar concedes that the
so-called DDB procedure is not the equivalent of UPS
<207> and thus the waiver defense does not apply to it
and 3) Amphastar's contention that the allegedly
infringing 15-25% procedures are essentially the same as USP
<207> is part of its waiver defense, not an undisputed
further asserts that the only relevant comparison for
infringement is 1) the language of the claims as construed by
the Court and 2) Amphastar's conduct. In its view, Dr.
Shriver's opinions are irrelevant to infringement.
Amphastar responds that, in support of its invalidity
defense, it plans to seek testimony from Dr. Shriver about
whether the specification of the ‘886 patent would
“allow persons of ordinary skill in the art to
recognize that [the inventor] invented what is
claimed.” See Ariad Pharm., Inc. v. Eli Lilly &
Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (internal
quotations and citations omitted).
contention that its claim of non-infringement and its
equitable defenses of estoppel and waiver are inextricable is
well taken. While the existence of a duty to disclose is
factually disputed, if there was such a duty, Dr.
Shriver's non-disclosure bears on whether a person of
ordinary skill in the art would understand what the patentee