Momenta Pharmaceuticals, Inc. et al v. Amphastar Pharmaceuticals, Inc. et al

Filing 898

Judge Nathaniel M. Gorton: ENDORSED ORDER entered. MEMORANDUM AND ORDERIn accordance with the foregoing, defendants motion for summary judgment (Docket No. 823) and plaintiffs motions for summary judgment and for a separate hearing (Docket Nos. 817, 819) are DENIED.(Caruso, Stephanie)

United States District Court
District of Massachusetts
)
)
)
)
Plaintiffs,
)
)
v.
)
)
AMPHASTAR PHARMACEUTICALS, INC. )
and INTERNATIONAL MEDICATION
)
SYSTEMS, LTD.,
)
)
Defendants.
)
)
MOMENTA PHARMACEUTICALS, INC.
and SANDOZ INC.,

Civil Action No.
11-11681-NMG

MEMORANDUM & ORDER
GORTON, J.
This is a patent infringement case in which plaintiffs,
Momenta Pharmaceuticals, Inc. and Sandoz Inc. (collectively,
“Momenta” or “plaintiffs”), claim that defendants, Amphastar
Pharmaceuticals, Inc. and International Medication Systems,
Ltd., (collectively, “Amphastar” or “defendants”), infringed
their patent during the course of defendants’ manufacture and
sale of generic enoxaparin products.
Pending before the Court are Amphastar’s motion for summary
judgment of invalidity and non-infringement and Momenta’s
motions for summary judgment dismissing Amphastar’s equitable
defenses and for a hearing.

For the reasons that follow, those

motions will be denied.

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I.

Background
In July, 2010, after receiving approval from the United

States Food and Drug Administration (“the FDA”), Momenta began
to market the first generic version of Lovenox (otherwise known
as enoxaparin) in the United States.

Enoxaparin 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.
Amphastar 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 alleges 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% procedure”).
In October, 2011, this Court allowed Momenta’s motion for a
preliminary injunction and enjoined Amphastar from advertising
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or selling allegedly infringing enoxaparin products.

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 because Amphastar used the patented
process to test products after it had already obtained FDA
approval, such that the use was not “reasonably related to the
development and submission of information” to the FDA.
In August, 2012, the Federal Circuit Court of Appeals (“the
Federal Circuit”) vacated this Court’s 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.

The Federal Circuit denied Momenta’s

petition for a rehearing en banc in November, 2012.
In July, 2013, this Court entered summary judgment in
Amphastar’s favor finding, at the direction of the Federal
Circuit, that its activities were protected by the safe harbor
provision and therefore did not infringe.

Because, apparently,

no act of obeisance goes unpunished, the Federal Circuit then
vacated this Court’s grant of summary judgment to Amphastar and
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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).1

The

Federal Circuit also suggested that:
the district court may choose to reconsider on remand
its denial of leave [to amend the infringement
contentions] in light of our holding.
Id. at 622.
In June, 2016, this Court allowed plaintiffs’ renewed
motion to amend its infringement contentions with respect to the
DBB test.

Further litigation maneuvering ensued and, in April,

2017, this Court allowed defendants’ motion to amend their noninfringement contentions as to the DBB test.
That month, defendants moved for summary judgment of
invalidity and non-infringement.

Plaintiffs timely opposed that

motion and cross-moved for summary judgment of dismissal of the
equitable defenses of waiver and estoppel or, alternatively, for
a separate hearing on those defenses.

This memorandum and order

addresses those motions all of which, for the following reasons,
will be denied.

In that decision, the Federal Circuit addressed the findings of this Court in
both the instant case, in which Momenta alleges that Amphastar infringed the
’886 patent, and the companion case, in which Momenta alleged that Teva
Pharmaceuticals USA Inc. infringed the ’886 patent. Id.
1

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II.

Motions for Summary Judgment
The role of summary judgment is “to pierce the pleadings

and to assess the proof in order to see whether there is a
genuine need for trial.” Mesnick v. Gen. Elec. Co., 950 F.2d
816, 822 (1st Cir. 1991).

The burden is on the moving party to

show, through the pleadings, discovery and affidavits, “that
there is no genuine dispute as to any material fact and that the
movant is entitled to judgment as a matter of law.” Fed. R. Civ.
P. 56(a).

A fact is material if it “might affect the outcome of

the suit under the governing law.” Anderson v. Liberty Lobby,
Inc., 477 U.S. 242, 248 (1986).

A genuine issue of material

fact exists where the evidence with respect to the material fact
in dispute “is such that a reasonable jury could return a
verdict for the nonmoving party.” Id.
If the moving party has satisfied its burden, the burden
shifts to the non-moving party to set forth specific facts
showing that there is a genuine, triable issue. Celotex Corp. v.
Catrett, 477 U.S. 317, 324 (1986).

The Court must view the

entire record in the light most favorable to the non-moving
party and indulge all reasonable inferences in that party’s
favor. O’Connor v. Steeves, 994 F.2d 905, 907 (1st Cir. 1993).
Summary judgment is appropriate if, after viewing the record in
the non-moving party’s favor, the Court determines that no

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genuine issue of material fact exists and that the moving party
is entitled to judgment as a matter of law.
A. Amphastar’s Motion for Summary Judgment
Amphastar moves for summary judgment on the grounds of 1) a
lack of patentable subject matter, 2) indefiniteness and
3) non-infringement.
1. Legal Standard for Patentable Subject Matter
The parties agree that the two-step framework for
patentable subject matter described in Mayo Collaborative Servs.
v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012),
controls.

First, the Court must determine whether the patent

claims are “directed” to a patent-ineligible concept, such as a
natural law, natural phenomenon or abstract idea. Rapid Litig.
Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1047 (Fed. Cir.
2016) (quoting Mayo, 132 S. Ct. at 1296-97).
not so directed, they are patentable. Id.

If the claims are

If the claims are

directed to an ineligible concept, then the Court determines
whether the elements of the invention, individually and
combined, “transform” the claims into an application eligible
for a patent. Id.
2. Application
Applying the first Mayo factor to the ‘886 patent,
Amphastar contends that each of the four steps of the ‘886
patent involves non-patentable subject matter.
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According to

Amphastar, step one of the patent involves the digestion of
enoxaparin, which is a law of nature, and in step two the
outcome of that natural process is identified and separated.
Amphastar further claims that steps three and four of the
patent, which consist of a comparison between the tested product
and a standard product, are comparisons of abstract ideas.
Momenta responds that the ‘886 patent claims a series of
laboratory steps that establish the quality of enoxaparin by
confirming the presence of its structural signature.
Specifically, it claims that, at step one of the process, the
exhaustive digestion of enoxaparin does not occur naturally.

To

facilitate the exhaustive digestion, the enoxaparin sample is
exposed to a chemical cocktail for a certain time and at a
specific temperature.

That process results in a mixture of long

and short sugar chains that do not individually exist in nature.
With respect to the second step, according to Momenta, a
laboratory instrument conducts a facilitation method such as
capillary electrophoresis or high performance liquid
chromatography.

The separation method shows enoxaparin’s unique

structural signature which is a result of the chemical process
used to manufacture enoxaparin and does not exist in nature.
Momenta submits that the inventors of the ‘886 patent were the
first individuals to use the separation process in a way that
permits the identification of enoxaparin’s structural signature.
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Finally, Momenta asserts that the third and fourth steps of
the claimed patent involve comparing the structural signature
exposed in step two to an enoxaparin reference standard.

Then,

relying on that determination, manufacturers take a collection
of enoxaparin from the sample.

According to Momenta, the

inventors of the ‘886 patent created the four-step process to
control the quality of each batch of enoxaparin.
Viewing the facts in the light most favorable to Momenta,
it persuasively contends that the ‘886 patent “[is] directed to
a new and useful method” of ensuring the quality of enoxaparin
and thus Amphastar’s motion for summary judgment on the basis of
patent-ineligibility will be denied. See CellzDirect, 827 F.3d
at 1048.
3. Legal Standard for Indefiniteness
A patent’s specification must be sufficiently “definite” in
that it must include at least one claim that “particularly
point[s] out and distinctly claim[s] the subject matter which
the applicant regards as [the] invention.” 35 U.S.C. § 112
(2002).

Pursuant to Nautilus, Inc. v. Biosig Instruments, Inc.,

134 S. Ct. 2120, 2124 (2014),
[a] patent is invalid for indefiniteness if its claims,
read in light of the specification delineating the patent,
and the prosecution history, fail to inform, with
reasonable certainty, those skilled in the art about the
scope of the invention.

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Although “[s]ome modicum of uncertainty” is permissible, the
“patent must be precise enough to afford clear notice of what is
claimed.”

Trusted Knight Corp. v. Int'l Bus. Machines Corp.,

No. 2016-1510, 2017 WL 899890, at *3 (Fed. Cir. Mar. 7, 2017)
(quoting Nautilus, 134 S. Ct. at 2128-29).
The Federal Circuit has explained that indefiniteness is a
question of law. Microprocessor Enhancement Corp. v. Tex.
Instruments Inc., 520 F.3d 1367, 1374 (Fed. Cir. 2008).

To the

extent that the legal conclusion entails questions of fact, the
party claiming invalidity by way of indefiniteness must prove
those facts by clear and convincing evidence. Tech. Licensing
Corp. v. Videotek, Inc., 545 F.3d 1316, 1338 (Fed. Cir. 2008).
4. Application
Amphaster contends that all claims are indefinite because
they are limited to “the non naturally occurring sugar
associated with peak 9 of FIG. 1” and there is no specific “FIG.
1” in the ‘886 patent.

Momenta responds that “FIG. 1” refers to

two parts of the ‘886 patent: “Figures 1A-1B”.

Momenta further

submits that, according to its expert witnesses, those skilled
in the art typically refer to figures with multiple parts by one
name, such as “Figure 1”.

Viewing the facts in the light most

favorable to Momenta, this Court agrees that those skilled in
the art would be afforded clear notice of what was claimed.

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Thus, Amphastar’s motion for summary judgment on the grounds of
indefiniteness will be denied.
5. Legal Standard for Non-infringement
An infringement analysis requires 1) the Court to
determine, as a matter of law, the meaning and scope of the
patent claims asserted to be infringed and 2) the trier of fact
to compare the properly construed claims to the device accused
of infringing. Markman v. Westview Instruments, Inc., 52 F.3d
967, 976 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996).
Summary judgment of non-infringement is appropriate where
on the correct claim construction, no reasonable jury
could have found infringement on the undisputed facts or
when all reasonable factual inferences are drawn in
favor of the patentee.
Netword, LLC v. Centraal Corp., 242 F.3d 1347, 1353 (Fed. Cir.
2001).
6. Application
Amphastar contends that summary judgment on noninfringement is warranted because 1) it does not compare the
peak area for the compounds in peak 9 to a reference standard
and 2) Momenta’s redefinitions of the claims are legally and
factually wrong.
a. Reference Standard
Amphastar asserts that this Court construed “reference
standard” to mean “preselected values”.

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It further asserts that

comparing a structural signature of the compound in peak 9 to
pre-selected values is a required element of all the claims and
it does not make such a comparison.

Therefore, contends

Amphastar, summary judgment of non-infringement is appropriate.
Specifically, with respect to its 15-25% tests, Amphastar
submits that Momenta alleges that the “preselected values” are
that 15%-25% of the oligosaccharides in the enoxaparin have
sugars including a 1,6-anhydro ring on their reducing ends.

It

asserts, however, that, in its 15-25% tests, the structural
signature for peak 9 alone is not compared to the 15%-25%.
Instead, the peak areas of all four 1,6-anhydro compounds in the
sample, including peak 9, are combined to determine whether they
are in the 15%-25% range.
Momenta responds that Amphastar ignores this Court’s
construction of the claim language by asserting that the
structural signature for peak 9 alone must be the reference
standard.

According to Momenta, the claim limitation is

a structural signature which bears a relationship to the
non-naturally occurring sugar which corresponds to Peak 9
[of Fig. 1].
Momenta submits that because the “structural signature that
bears a relationship to the non-naturally occurring sugar” is a
1,6-anhdyro ring structure, which is the structure that
Amphastar identifies in the four compounds and compares to the
15-25% reference standard, it infringes on the claimed process.
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Construing reasonable inferences in Momenta’s favor, this
Court agrees that a factfinder could determine that Amphastar’s
process infringes on the patent because the structural signature
associated with peak 9, which is the 1,6-anhydro ring that is
also associated with the other three compounds, is the reference
point for Amphastar’s test.

At the least, a genuine issue of

material fact persists with respect to infringement.

Thus,

summary judgment of non-infringement is unwarranted with respect
to the 15-25% tests.
Next, with respect to the DBB test, Amphastar contends
that, because it simply determines whether the peak 9 compound
is detectable, it does not infringe the asserted claims because
it does not compare the peak 9 compound to “preselected values”.
Momenta rejoins that Amphastar’s own Rule 30(b)(6) witness
testified that all 23 peaks, including the peaks for the four
1,6-anhydro rings, must fit into numeric ranges for the DBB
test.

Momenta further contends that a determination that peak 9

is detectable may infringe the ‘886 patent under the doctrine of
equivalents.
Viewing the record in the light most favorable to Momenta
and construing all reasonable inferences in its favor, a genuine
issue of material fact persists with respect to whether a test
that establishes the presence of the peak 9 compound constitutes

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a comparison to a “preselected value”.

Consequently, summary

judgment that the DBB test is non-infringing is unwarranted.
b. Purported Redefinitions of Claims
Amphastar also contends that Momenta is attempting
improperly to broaden the scope of its claims with new
constructions.

Amphastar particularly takes issue with the

purported redefinition of 1) the non-naturally occurring sugar
depicted by peak 9 to include any compound with a 1,6-anhydro
ring structure and 2) “reference standard” to include both
preselected values” (plural) and “preselected value” (singular).
With respect to the purported redefinition of the nonnaturally occurring sugar at peak 9, Momenta replies that the
‘886 patent is not limited to one non-naturally occurring sugar
but instead protects the method of using a structural signature
that is associated with the non-naturally occurring sugar
associated with peak 9.

Thus, according to Momenta, its patent

has always covered the 1,6-anhydro ring structure which is the
structural signature of the non-naturally occurring sugar
associated with peak 9.

Momenta submits that the structural

signature had not been identified as a 1,6-anhydro ring at the
date of the filing of the patent but asserts that the structural
signature in its patent was identified as a 1,6-anhydro ring
structure after the patent issued.

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Momenta’s contention that it is not attempting to expand
its patent but merely providing the name of the structural
signature to which it refers is well taken. See Novozymes A/S v.
Danisco A/S, 2011 U.S. Dist. LEXIS 157568, *40 (W.D. Wis. July
7, 2011) (“[P]laintiffs are not attempting to take advantage of
new technology to expand the scope of the patent, but are simply
using developments in the art to show what a Bacillus
stearothermophilus alpha-amylase is and what it always has
been.”) (emphasis in original); Chiron Corp. v. Genentech, Inc.,
266 F. Supp. 2d 1172, 1191 (E.D. Cal. 2002) (“Thus, Chiron is
not claiming a different invention than that disclosed in the
priority applications; Chiron is merely claiming a laterdeveloped embodiment of the same invention.”).
With respect to “preselected values”, Amphastar claims that
finding a detectable amount of peak 9 is not a preselected
value.

Amphastar also claims that this court construed

“reference standard” to include only “preselected values”
(plural), not “preselected value” (singular).
Momenta asserts that 1) this Court’s claim construction
order states that a “reference standard” is defined as a “preselected value” and 2) the construction of the term “reference
standard” as “pre-selected values” does not preclude a reference
standard that is a single value.

This Court agrees that

reference standard may include both singular and plural
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preselected values.

Thus, Amphastar is not entitled to summary

judgment based upon the purported redefinitions.
B. Momenta’s Motion for Summary Judgment Dismissing
Amphastar’s Equitable Defenses
1. Background
The United States Pharmacopeia (“USP”) is a scientific,
nonprofit, standard-setting organization (“SSO”).

It

establishes standards to identify drugs and ensure they meet
certain quality prerequisites.

The Federal Food, Drug, and

Cosmetics Act, 21 U.S.C. § 301 et seq., recognizes the USP
National Formulary (“USP-NF”), which is a book of pharmacopeia
standards, as the official compendia for drugs sold in the
United States.

Drugs sold in this country must conform to USP-

NF standards.
In 2006, the USP began looking for a method to test
compounds with 1,6-anhydro ring structures 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 method embodied in the ‘886
patent, participated as an expert on the panel.

Despite the

fact that the Momenta employees involved in the USP process
signed a form declaring that intellectual property rights that

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could create the appearance of a conflict of interest should be
disclosed, Momenta and Dr. Shriver failed to disclose to the USP
the ‘886 patent application.
In comments to the advisory panel, Momenta and Dr. Shriver
opposed the adoption of USP <207> and stated that, at least,
alternative methods to identify the 1,6-anhydro ring structures
in enoxaparin should be allowed.

The USP ultimately approved

USP <207> as a way to determine whether enoxaparin conforms to
the structure stated in the USP enoxaparin monograph.

Although

the USP announced that manufacturers would be able to use
alternative tests, it stated that “the General Chapter <207>
will provide the official test for 1,6-Anhydro Derivative”.
Before the USP <207> test was approved, Amphastar developed
its own test, the 15-25% procedure, to examine the 1,6-anhydro
structures in enoxaparin.

According to Amphastar, in or about

2009 or 2010, it compared its own test to the USP <207> test and
determined that the tests were substantially the same.
Amphastar avers that it switched to the USP <207> test with
respect to its revised 15-25% procedure in 2011 because the FDA
required it to use that test in order to be approved to sell its
enoxaparin.
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.
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Momenta

retorts that it was not required to disclose the patent
application.

Momenta further asserts that Amphastar adopted its

first 15-25% procedure before USP <207> was approved and the
revised 15-25% procedure, which is more similar to USP <207>, in
response to this lawsuit.

Momenta moves for summary judgment on

the equitable defenses of waiver and estoppel.
2. Waiver Defense
To 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 patent owner
was so inconsistent with an intent to enforce its rights as
to induce a reasonable belief that such right has been
relinquished.

Hynix Semiconductor Inc. v. Rambus Inc., 645 F.3d 1336, 1348
(Fed. Cir. 2011) (quoting Qualcomm, 548 F.3d at 1020).

The

Federal Circuit has determined that a finding of implied waiver
is warranted if a patent owner had 1) a duty to disclose
information to an SSO and 2) breached that duty. Id.
The parties vigorously dispute whether Momenta had a duty
to disclose the patent application to the USP.

Momenta argues

that experts like Dr. Shriver were only required to disclose a
conflict of interest if it would necessitate abstaining from a
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vote and that Dr. Shriver disclosed that he worked for Momenta
and refrained from voting on USP <207>.

Amphastar retorts that

there was an express written duty, as well as an expectation,
for USP members and participants to identify intellectual
property interests.

Viewing the facts in the light most

favorable to Amphastar, a genuine issue of material fact remains
with respect to whether Momenta had a duty to disclose.
Momenta also contends that summary judgement of dismissal
of the waiver defense is warranted because it opposed the
adoption of method <207> and supported allowing alternative
methods.

Amphastar rejoins that Momenta’s opposition to the

method and advocacy for alternative methods was simply tactical
to ensure the FDA approval of its own process, which does not
include USP <207>.

Momenta was thus purportedly protecting its

own financial interests by not disclosing its pending patent
application.
This Court agrees that a genuine issue of material fact
remains with respect to whether Momenta took those stances to
protect its own interests in which case it should have disclosed
the pending patent application.

Momenta’s non-disclosure may be

found to have
[f]orc[ed] a party [i.e. Amphastar] to accept a license and
pay whatever fee the licensor demands, or to undergo the
uncertainty and cost of litigation

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if it used the only standard identified by the USP for the
enoxaparin quality control process. Qualcomm, 548 F.3d at 1021.
Accordingly, summary judgment on waiver is unwarranted.
3. Equitable Estoppel Defense
With respect to equitable estoppel, first, the defendant
must prove that the owner of the patent engaged in “misleading
conduct” that resulted in the reasonable inference that the “the
patentee [did] not intend to enforce its patent against the
alleged infringer.” Hynix, 645 F.3d at 1348 (quotation and
citation omitted).

Misleading conduct includes “silence where

there was an obligation to speak.” Id.
The parties dispute the remaining elements of an equitable
estoppel defense.

Amphastar, relying on Hynix, contends that,

in the context of an SSO, in addition to the first element, the
alleged infringer need only show a duty to disclose and a breach
of that duty. See id.

Momenta asserts that in addition to

demonstrating 1) misleading conduct that resulted in the
reasonable inference of non-enforcement, the purported infringer
must also show 2) reliance and 3) that it will be materially
prejudiced if the patent owner’s claim is allowed. E.g., Radio
Sys. Corp. v. Lalor, 709 F.3d 1124, 1130 (Fed. Cir. 2013).
This Court agrees that the three elements identified by
Momenta are required and concludes that the approach of the
Hynix Court can be subsumed in the reliance analysis, i.e., if
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there is a duty to disclose and the patent owner breaches that
duty, there may be an inference of reliance.
Momenta contends that summary judgment on the estoppel
defense is warranted because 1) Momenta did not disclaim its
intention to to enforce the patent and 2) Amphastar cannot show
reliance because it only adopted USP <207> after Momenta had
filed suit against it.

Viewing the facts in the light most

favorable to Amphastar and drawing reasonable inferences in its
favor, those contentions are unavailing.
First, a factfinder could conclude that Momenta’s failure
to disclose the patent to the USP was misleading and resulted in
a reasonable inference of non-enforcement.

Second, genuine

issues of material fact persist with respect to reliance.

For

instance, Momenta contends that Amphastar adopted the USP <207>
procedure only after the lawsuit was filed but Amphastar submits
that the USP published method <207> before it was officially
adopted and that Amphastar concluded that its method and UPS
<207> were essentially the same in 2009 or 2010.

Moreover,

Momenta contends that the FDA merely required Amphastar to use a
method to identify 1,6-anhyrdo rings while Amphastar rejoins
that it was specifically required to comply with USP <207>.
Perhaps most compelling is Amphastar’s argument that it
reasonably believed it could use and rely on the method
published by the USP.

Consequently, there is at least a genuine
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issue of material fact with respect to reliance and therefore
Momenta is not entitled to summary judgment on the equitable
estoppel defense.
III.

Motion for a Separate Hearing
As an alternative to its motion for summary judgment,

Momenta moves for a separate hearing on the equitable defenses.
It asserts that the equitable defenses involve questions of law,
are irrelevant to the jury issues and will be used to prejudice
the jury against it.
Amphastar responds that the evidence in support of its
defenses to the jury questions of infringement, validity and
damages is inseparable from the evidence of its equitable
defenses.

For instance, according to Amphastar, Momenta’s

failure to disclose the ‘886 patent to the USP constitutes
evidence that it did not believe that USP <207> was covered by
that patent which is inconsistent with its allegation that
Amphastar infringes the patent by using a procedure identical to
USP <207>.

Moreover, says Amphastar, plaintiffs made statements

disparaging USP <207> which are relevant to its invalidity
defense.

Amphastar further suggests that the USP situation is

relevant to both witness credibility and damages and that if any
prejudice results, it is not unfair.
This Court agrees that there is significant overlap between
the evidence of infringement, validity and damages on the one
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hand, and the equitable defenses on the other hand.

Courts have

availed themselves of advisory jury verdicts on equitable
defenses when such evidence overlaps with jury questions, see
Qualcomm, 548 F.3d 1020, and bifurcated trials have been deemed
unnecessary. See Genentech, Inc. v. Wellcome Found. Ltd., No.
88-330, 1990 WL 69187, at *14 (D. Del. Mar. 8, 1990).

This

Court is of like mind and, accordingly, will submit the
equitable defenses to the jury for an advisory verdict. Fed. R.
Civ. P. 39(c)(1).
IV.

Recommendation

In accordance with the foregoing, defendants’ motion for
summary judgment (Docket No. 823) and plaintiffs’ motions for
summary judgment and for a separate hearing (Docket Nos. 817,
819) are DENIED.

ORDER

So ordered.
/s/ Nathaniel M. Gorton
Nathaniel M. Gorton
United States District Judge
Dated June 16, 2017

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