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.
July, 2017, after a nine-day trial, the jury returned a
verdict in favor of defendants Amphastar Pharmaceuticals,
Inc. and International Medication Systems, Ltd.
(collectively, “Amphastar” or
“defendants”). Although that jury found that
Amphastar had infringed the patent held by plaintiffs Momenta
Pharmaceuticals, Inc. and Sandoz Inc. (collectively,
“Momenta” or “plaintiffs”) during the
course of defendants' manufacture and sale of generic
enoxaparin, it also found that the infringed patent claims
were invalid because they were not enabled and had inadequate
same case, this Court sought an advisory verdict from the
jury with respect to the equitable defenses of waiver and
estoppel and the jury found in favor of defendants as to both
defenses. Amphastar's motion for the Court to adopt the
jury's advisory verdict with respect to the equitable
defenses is currently pending before the Court. For the
reasons that follow, that motion will be allowed, in part,
and denied, in part.
The Patent and Infringing Procedures
is an anticoagulant used to prevent blood clots. Momenta is
the assignee of U.S. Patent No. 7, 575, 886 (“the
'886 patent”), issued in August, 2009, which is
directed at a set of manufacturing quality control processes
that ensure that each batch of generic enoxaparin includes
the individual sugar chains characteristic of Lovenox. The
individual sugar chains are referred to in the patent as
“a structural signature associated with the non
naturally occurring sugar associated with peak 9” and
have since been identified as 1, 6-anhydro rings.
received FDA approval to market its generic enoxaparin
product in September, 2011. Two days later, Momenta filed a
complaint alleging that Amphastar infringed its ‘886
patent by manufacturing generic enoxaparin for commercial
sale using its patented method. Momenta alleged that three of
Amphastar's manufacturing control procedures infringe the
‘886 patent: 1) the Disaccharide Building Block
(“DBB”) procedure, 2) the 15-25% procedure which
Amphastar performed at the time of FDA approval of its
generic version of enoxaparin (“the 15-25%
procedure”) and 3) the revised 15-25% procedure which
it adopted after FDA approval (“the revised 15-25%
Momenta's Non-Disclosure of the ‘886 Patent to
the United States Pharmacopeia
United States Pharmacopeia (“USP”) is a
scientific, standard-setting organization
(“SSO”). Pursuant to the Federal Food, Drug, and
Cosmetics Act, 21 U.S.C. § 301 et seq., drugs
sold in the United States must conform to USP National
Formulary (“USP-NF”) standards. In 2006, the USP
began looking for a method to test compounds with 1,
6-anhydro rings to incorporate into the enoxaparin monograph.
Although Momenta had already applied for its ‘886
patent, in April, 2008, it began participating on the
advisory panel that chose the 1, 6-anhydro test method as
Chapter <207> of the USP-NF (“USP
<207>”). Specifically, Zachary Shriver, the
inventor of the ‘886 patent, participated in the panel.
Momenta did not disclose to the USP the ‘886 patent
and Dr. Shriver opposed the adoption of USP <207> and
stated that, at least, alternative methods should be allowed.
The USP ultimately approved USP <207> as the official
test to determine whether enoxaparin conforms to the
structure in the USP monograph but also announced that
manufacturers would be able to use alternative tests. In
Amphastar's view, Momenta had a duty to disclose that its
‘886 patent would cover USP <207> and, because it
did not, the equitable defenses of waiver and estoppel apply.
October, 2011, this Court enjoined Amphastar from advertising
or selling the allegedly infringing enoxaparin. That decision
included a preliminary finding that the safe harbor provision
in 35 U.S.C. § 271(e)(1) did not protect Amphastar's
infringing activities. In August, 2012, the Federal Circuit
Court of Appeals (“the Federal Circuit”) vacated
the preliminary injunction and found that this Court applied
“an unduly narrow interpretation” of the safe
harbor provision. Momenta Pharm., Inc. v. Amphastar
Pharm., Inc., 686 F.3d 1348, 1349 (Fed. Cir. 2012). It
explained that Amphastar's post-approval use of the
patented process to run quality control tests fell within the
scope of the safe harbor provision because it generated
information for records that Amphastar needed for continued
FDA approval. Id. at 1357-61.
July, 2013, this Court entered summary judgment in
Amphastar's favor finding, at the direction of the
Federal Circuit, that Amphastar's activities were
protected by the safe harbor provision and therefore did not
infringe. Because, apparently, no act of obeisance goes
unpunished, a different panel of the Federal Circuit then
vacated this Court's grant of summary judgment to
Amphastar and held, in November, 2015, that the safe harbor
provision did not apply to its infringing activities.
Momenta Pharm., Inc. v. Teva Pharm. USA Inc., 809
F.3d 610, 613 (Fed. Cir. 2015).
April, 2017, defendants moved for summary judgment of
invalidity and non-infringement and plaintiffs cross-moved
for summary judgment of dismissal of the equitable defenses
of waiver and estoppel or, alternatively, for a separate
hearing on those defenses. In June, 2017, this Court denied
all three motions. The nine-day jury trial in July, 2017
resulted in a verdict as previously described.
Motion for the Court to Adopt the Jury's Advisory
Advisory Jury Verdict
trial is held before a district court with an advisory jury,
the court must support its determination with sufficiently
comprehensive factual findings. Transmatic, Inc. v.
Gulton Indus., Inc., 53 F.3d 1270, 1275 (Fed. Cir.
1995). Under Fed.R.Civ.P. 52(a),
[i]n all actions tried upon the facts without a jury or with
an advisory jury, the court shall find the facts specially
and state separately its conclusions of law thereon.
Fed. R. Civ. P. 52(a). A court can permissibly give to a jury
a legal issue for an “advisory” resolution whose
“ultimate determination is reserved for the
court”. Kinetic Concepts, Inc. v. Smith &
Nephew, Inc., 688 F.3d 1342, 1358 (Fed. Cir. 2012)
(reviewing the district court's order granting judgment
as a matter of law after an advisory verdict on
nonobviousness) (citing Spectralytics, Inc. v. Cordis
Corp., 649 F.3d 1336, 1341-42 (Fed. Cir. 2011)). While
the Court must make its own findings of fact and conclusions
of law, the findings of the jury made in an advisory capacity
are entitled to some deference. See e.g., Felker
v. Pepsi-Cola Co., 899 F.Supp. 882, at 888-89 (D. Conn.
1995) (noting that “it would be purposeless to have an
advisory jury unless some degree of deference was shown to
as required by Fed.R.Civ.P. 52(a), this Court will make
findings of fact and conclusions of law with reference to the
jury's advisory verdict.
succeed on a waiver defense, a defendant must prove either
express or implied waiver by clear and convincing evidence.
Qualcomm Inc. v. Broadcom Corp., 548 F.3d 1004, 1020
(Fed. Cir. 2008). Express waiver requires a showing that a
plaintiff intentionally waived its right to enforce a patent.
Id. Implied waiver occurs if the behavior of the
was so inconsistent with an intent to enforce its rights as
to induce a reasonable belief that such right has been
Hynix Semiconductor Inc. v. Rambus Inc., 645 F.3d
1336, 1348 (Fed. Cir. 2011) (quoting Qualcomm, 548
F.3d at 1020).
Federal Circuit has determined that a finding of implied
waiver is warranted if a patent owner 1) had a duty to
disclose information to an SSO and 2) breached that duty.
Id. In evaluating whether such a duty existed, the
Federal Circuit has adopted a two-step approach, first
examining whether the policies of the SSO unambiguously
impose a duty to disclose on participants and second, if the
policies are ambiguous, evaluating whether participants in
the SSO understood them to impose a duty to disclose.
Qualcomm, 548 F.3d at 1012. Courts apply an
objective standard when evaluating whether a duty to disclose
existed, asking whether the patent at issue “reasonably
might be necessary” to comply with the standard.
Id. 1018 (quoting Rambus Inc. v. Infineon Techs.
Ag, 318 F.3d 1081, 1100 (Fed. Cir. 2003)).