Momenta Pharmaceuticals, Inc. et al v. Teva Pharmaceuticals Industries Ltd. et al

Filing 205

Judge Nathaniel M. Gorton: ORDER entered. MEMORANDUM AND ORDER, granting 144 MOTION to Strike Plaintiffs' Third Amended Infringement Contentions filed by Teva Pharmaceuticals USA Inc, granting 135 MOTION for Summary Judg ment (Teva Pharmaceuticals USA, Inc.'s Motion for Judgment on the Pleadings, or, in the Alternative, Summary Judgment of Non-Infringement on Safe Harbor Grounds filed by Teva Pharmaceuticals USA Inc, denying 161 MOTION to Amend filed by Momenta Pharmaceuticals, Inc., Sandoz Inc. (Patch, Christine)

United States District Court
District of Massachusetts
________________________________
)
MOMENTA PHARMACEUTICALS, INC.,
)
SANDOZ INC.,
)
Plaintiffs,
)
)
Civil Action No.
v.
)
10-12079-NMG
)
TEVA PHARMACEUTICALS USA, INC., )
Defendant.
)
________________________________ )
MEMORANDUM & ORDER
GORTON, J.
Plaintiffs Momenta Pharmaceuticals, Inc. and Sandoz Inc.
(collectively, “Momenta”) bring suit against Teva Pharmaceuticals
USA, Inc. (“Teva”) for infringement of U.S. Patent No. 7,575,886
(“the ’886 patent”).1
I.

Background
In July, 2010, after receiving FDA approval, plaintiffs

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.

In February, 2010,

Teva announced its intention to sell a generic enoxaparin as soon
as it obtained FDA approval.

Chemi S.p.A (“Chemi”) an Italian

1

Momenta originally also asserted infringement of U.S.
Patent No. 7,790,466 (“the ’466 patent”) but indicated in its
opposition to defendants’ motion for summary judgment that it is
withdrawing that claim. Thus, this Court need not address that
claim.
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company located in Patricia, Italy is responsible for
manufacturing, analyzing, testing, packaging and labeling of
Teva’s generic enoxaparin before Teva imports it into the United
States.
Momenta is the assignee of the ’886 patent, issued in
August, 2009, which is directed at a set of manufacturing control
processes that ensure that each batch of generic enoxaparin
includes the individual sugar chains characteristic of Lovenox.
Momenta alleges that Teva has infringed its patents by making
material preparations to sell a generic enoxaparin product that
has been manufactured using the methods in plaintiffs’ patents.
II.

Procedural History
Plaintiffs filed their complaint on December 2, 2010 and

moved for expedited discovery on December 28, 2010. On January
19, 2011, Teva Pharmaceuticals Industries Ltd. was dismissed as a
defendant and the following month this Court denied the motion
for expedited discovery.
The Court held a joint Markman hearing in this case and
Momenta Pharm. Inc, v. Amphastar Pharm., C.A. No. 11-cv-11681-NMG
(“Amphastar Litigation”), in May, 2012, and issued a Markman
Order in June, 2012.

At the joint request of the parties, this

case was stayed from August 10, 2012 until January 15, 2013,
during an appeal to the Court of Appeals for the Federal Circuit
in the Amphastar litigation which raised issues relating to the

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so called “safe harbor” provision, 35 U.S.C. § 271(e)(1) (“§
271(e)(1)”), which is also at issue in this case.
On January 31, 2013, defendants filed a motion for Judgment
on the Pleadings or in the alternative Summary Judgment.

On

March 18, 2013, defendants moved to strike plaintiffs’ third
amended infringement contentions.

Shortly thereafter, plaintiffs

filed a cross-motion for leave to amend their infringement
contentions.

The Court heard oral argument on all three motions

at a hearing on July 1, 2013 and took the matter under
advisement.

The Court now announces its ruling on those three

motions.
III. Motion for Summary Judgment2
A.

Standard

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) (quoting Garside v. Osco Drug, Inc., 895 F.2d 46,
50 (1st Cir. 1990)).

The burden is on the moving party to show,

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

2

Defendants filed a motion for Judgment on the Pleadings or
in the alternative Summary Judgment. The Court treats the motion
as one for Summary Judgment.
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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).

“Factual disputes that are irrelevant

or unnecessary will not be counted.” Id.

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.
Once 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 make 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 nonmoving party’s favor, the Court determines that no genuine issue
of material fact exists and that the moving party is entitled to
judgment as a matter of law.
B.

Application

In their Complaint plaintiffs allege that Teva must be
infringing the ‘886 patent because the Food and Drug
Administration (“FDA”) requires Teva to perform the methods
claimed in the patent.

Defendant moves for summary judgment on

the grounds that all of its allegedly infringing activity is

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subject to the § 271(e)(1) safe harbor as interpreted by the
Federal Circuit in Momenta Pharm. v. Amphastar Pharm., 686 F.3d
1348 (2012) and thus cannot constitute patent infringement.
Plaintiffs oppose on several grounds.
Three of Momenta’s arguments in opposition to summary
judgment are based on claims that Teva’s activities are not
subject to the § 271(e)(1) safe harbor.

In brief, Momenta

contends that: 1) the FDA does not require Teva to use “any
particular test” and thus Teva cannot be “required” to perform a
test that infringes the ‘866 patent, 2) the routine commercial
manufacturing records kept by Teva are not actually submitted or
intended to be submitted to the FDA and 3) the maintenance of
records is not “solely” for uses “reasonably related to
development and submission of information”.

Momenta made all

three of these arguments in its opposition to summary judgment in
the Amphastar case.

The Court again rejects them for the reasons

explained in its Memorandum and Order in that case. Order on
Motion for Summary Judgment (Docket No. 497), Momenta Pharm. Inc,
v. Amphastar Pharm., C.A. No. 11-cv-11681-NMG.
Momenta’s other arguments in opposition are also unavailing.
Momenta asserts that even if the testing done to achieve FDA
approval is subject to the § 271(e)(1) safe harbor, Teva’s sales
activity is a separate form of patent infringement under 35
U.S.C. § 271(g).

That statute states in part that

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Whoever without authority imports into the United States
or offers to sell, sells, or uses within the United
States a product which is made by a process patented in
the United States shall be liable as an infringer.
Plaintiffs assert that defendants are “liable as...infringer[s]”
because they offer to sell and sell a product made by a process
patented in the United States.
Momenta’s attenuated interpretation of § 271(g) incorrectly
relies on the illogical assertion that practicing a process
abroad could somehow constitute an act of infringement even
though, due to the protections of the safe harbor provision, that
same process would not constitute infringement when practiced
within the United States.

Such a construction of the statute

would lead to extra-territorial application of U.S. patent law in
a way not intended by Congress.

Instead,

congressional reports make clear that the principal
purpose of [§ 271(g)] was to prevent a patent owner's
competitors from avoiding the patent by producing
products outside the United States and then importing
them.
Mycogen Plant Sci., Inc. v. Monsanto Co., 252 F.3d 1306, 1318
(Fed. Cir. 2001), vacated on other grounds, 535 U.S. 1109 (2002).
As a result,

§ 271(g) was “intended to grant patent holders the

same protection against overseas infringers as they already
enjoyed against domestic entities”, not to create a cause of
action where none existed domestically. Id.

Thus, it would be

contrary to Congressional intent if § 271(g) were interpreted to
apply in situations in which there would be no domestic
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liability.
This Court also agrees with defendants that § 271(g) does
not apply in this case because there is no product that is “made”
by the accused tests and sold in the United States.

Momenta

asserts that the testing does result in the product being “made”
because it is conducted as part of the broader “manufacturing
process.” Yet, that argument is without merit because, while the
quality control release testing is a regulatory requirement for
sale of enoxaparin in the United States, it is not a method for
making enoxaparin.
All of the asserted claims of the ‘866 patent require that
an enoxaparin sample exist prior to the allegedly infringing
testing.

For example, Claim 53 claims a

method for analyzing an enoxaparin sample for the
presence or amount of a non naturally occurring sugar
. . . that results from a method of making enoxaparin.
In other words, that claim presupposes that enoxaparin has
already been made by a previous method not covered by the patent.
Without a pre-existing sample of enoxaparin the allegedly
infringing testing could not take place.

What is “made” by the

process claimed in the ‘866 patent is 1) a digested sample of
enoxaparin and 2) information about that sample, neither of which
is subsequently sold by Teva.

Thus, § 271(g) is inapplicable and

summary judgment of non-infringement is appropriate.

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IV.

Cross Motions to Strike and Amend Infringement Contentions
On February 28, 2013, Momenta served its Third Amended

Infringement Contentions (“Amended Contentions”).

In those

Amended Contentions Momenta added a second test, the Disaccharide
Building Block Procedure (“DBB test”), that it claimed also
infringed the ‘866 patent.

The DBB test is the same as the 15-

25% procedure except that it compares the presence and amount of
particular digested sub-chains to individual reference standards
for those specific sub-chains rather than to the 15-25% reference
standard.

Teva moved to strike the Amended Contentions on the

ground that they were untimely in light of the Court’s scheduling
order.

Momenta then filed a cross motion for leave to file the

Amended Contentions.
A scheduling order may be modified only for good cause and
with the judge's consent. Fed. R. Civ. P. 16(b)(4).

Here the

Court finds no good cause to allow a modification to that order.
The § 271(e)(1) safe harbor also applies to the DBB test.

Thus,

for reasons explained in the Court’s Memorandum and Order in the
Amphastar case, the amendment would be futile.

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ORDER
In accordance with the foregoing,
1)

Defendant’s Motion for Summary Judgment (Docket No.
135) is ALLOWED,

2)

Defendant’s Motion to Strike Plaintiffs’ Third
Infringement Contentions (Docket No. 144) is ALLOWED,
and

3)

Plaintiffs’ Motion for Leave to Amend Infringement
Contentions (Docket No. 161) is DENIED.

So ordered.

/s/ Nathaniel M. Gorton
Nathaniel M. Gorton
United States District Judge

Dated July 19, 2013

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