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

Filing 497

Judge Nathaniel M. Gorton: ORDER entered. MEMORANDUM AND ORDER, denying 456 MOTION to Amend filed by Momenta Pharmaceuticals, Inc., Sandoz Inc., granting 346 MOTION for Summary Judgment and Judgment on the Pleadings filed by Watson Pharma, Inc., Amphastar Pharmaceuticals, Inc., Actavis, Inc., International Medication Systems, Ltd. (Patch, Christine)

United States District Court
District of Massachusetts
________________________________
)
MOMENTA PHARMACEUTICALS, INC.,
)
SANDOZ INC.,
)
Plaintiffs,
)
)
Civil Action No.
v.
)
11-11681-NMG
)
AMPHASTAR PHARMACEUTICALS, INC., )
INTERNATIONAL MEDICATION
)
SYSTEMS, LTD., WATSON
)
PHARMACEUTICALS, INC.,
)
Defendants.
)
________________________________ )
MEMORANDUM & ORDER
GORTON, J.
Plaintiffs Momenta Pharmaceuticals, Inc. (“Momenta”) and
Sandoz Inc. (“Sandoz”) (collectively, and for simplicity,
“Momenta”) bring suit against Amphastar Pharmaceuticals, Inc.
(“Amphastar”), International Medication Systems, Ltd., Actavis,
and Watson Pharma, Inc. (collectively, and for simplicity,
“Amphastar”) for infringement of U.S. Patent No. 7,575,886 (“the
’886 patent”) and declaratory judgment of infringement.1

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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I.

Background
The facts of this case have previously been extensively

described both by this Court and by the United States Court of
Appeals for the Federal Circuit and need not be repeated at
length here.

In brief, 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.
Amphastar received FDA approval to market its generic enoxaparin
product on September 19, 2011.
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 Amphastar infringes the ‘886 patent by
manufacturing generic enoxaparin for commercial sale using the
claimed methods of the patent.
II.

Procedural History
Plaintiffs filed the instant action on September 21, 2011,

two days after Amphastar received FDA-approval of its generic
enoxaparin product.

Shortly thereafter, plaintiffs moved for a

temporary restraining order and preliminary injunction to prevent
Amphastar from marketing its product, which the Court allowed.
Defendants appealed that ruling to Federal Circuit.
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On January

25, 2012, the Federal Circuit stayed the preliminary injunction
pending appeal.
This Court held a joint Markman hearing in this case and
Momenta Pharm. Inc, v. Teva Pharm., C.A. No. 11-cv-12079-NMG, in
May, 2012, and issued a Markman Order in June, 2012.

On August

3, 2012, the Federal Circuit vacated the preliminary injunction.
Shortly thereafter, on August 14, 2012, at the request of the
parties, this Court stayed the case pending an en banc appeal in
the Federal Circuit.

In November, 2012, the Federal Circuit

denied the petition for an en banc hearing.
a motion to remove the stay.

Amphastar then filed

This Court delayed ruling on that

motion due to a petition for certiorari to the Supreme Court in
Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1303 (Fed
Cir. 2011), which also raised issues relating to the so called
“safe-harbor” under 35 U.S.C. § 271(e)(1) (“§ 271(e)(1)”).

After

the Supreme Court denied cert in Classen, this Court lifted the
stay in this case on January 15, 2013.
On January 16, 2013, Amphastar moved for Summary Judgment
and Judgment on the Pleadings.

Recently, Momenta requested leave

to amend its infringement contentions and on July 1, 2013 the
Court heard oral argument on both motions and took the matter
under advisement.

The Court now announces its ruling on both

motions.

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III. Federal Circuit Decision
In overturning this Court’s determination that Momenta had
proven a likelihood of success on the merits sufficient to
warrant a preliminary injunction, the Federal Circuit ruled that
the “safe harbor” provision of § 271(e)(1) applied to this case.
That provision states that
It shall not be an act of infringement to make, use,
offer to sell, or sell within the United States or import
into the United States a patented invention . . . solely
for uses reasonably related to the development and
submission of information under a Federal law which
regulates the manufacture, use, or sale of drugs or
veterinary biological products.
In interpreting § 271(e)(1), the Federal Circuit explained
that Congress broadly defined the scope of the safe harbor and
thus the protection provided by the safe harbor is not limited to
“activities necessary to seek approval of a generic drug”, but
rather encompasses all “materials the FDA demands in the
regulatory process.” Momenta Pharm. v. Amphastar Pharm., 686 F.3d
1348, 1356 (2012).

Therefore, the Federal Circuit determined

that even post-FDA approval activities are covered by the safe
harbor, as long as they are “reasonably related to the
development and submission of information under a Federal law
which regulates the manufacture, use or sale of drugs.” Id. at
1358-60.
Citing the requirements in 21 C.F.R. § 211.180(a) that
testing records from each batch of generic enoxoparin must be

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“retained for at least 1 year after the expiration date of the
batch” and in 21 C.F.R. § 211.180(c) that those records “shall be
readily available for authorized inspection” by the FDA, the
Federal Circuit held that the requirement to maintain records for
FDA inspection satisfies the “requirement that the uses be
reasonably related to the development and submission of
information to the FDA.”

The Federal Circuit also held that

“the fact that the FDA does not in most cases actually inspect the
records does not change” that reasoning. Momenta, 686 F.3d at 1357
(citing § 271(e)(1)).
In light of it’s decision the Federal Circuit instructed
this Court to consider on remand
whether Momenta’s admission that Amphastar’s use of the
patented invention is to ‘satisfy the FDA’s requirements’
makes this case amenable to summary judgment of noninfringement in favor of Amphastar.
Momenta Pharma. v. Amphastar Pharma., 686 F.3d 1348, 1361 (Fed.
Cir. 2012).
IV.

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

2

Although defendants filed a motion for Judgment on the
Pleadings and Summary Judgment, in light of the fact that the
Federal Circuit requested that this Court consider whether the
case is “amenable to summary judgment of non-infringement”, and
the fact that the outcome would be the same, the Court treats the
motion as one for Summary Judgment.
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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).
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

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judgment as a matter of law.
B.

Application
i. 35 U.S.C. § 271(e)(1)

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

Defendants move for summary judgment on

the grounds that all of their allegedly infringing activity is
subject to the § 271(e)(1) safe harbor and thus cannot constitute
patent infringement.

Plaintiffs oppose on several grounds.

First, plaintiffs argue that summary judgment is not
appropriate because the safe harbor does not apply if the FDA has
not mandated the use of the particular infringing test.

Momenta

contends that “Amphastar’s use of Momenta’s patented process was
entirely voluntary” because the FDA has not specifically required
Amphastar to use the test covered by the ‘866 patent.
argument is unavailing.

This

There is no language in § 271(e)(1) that

limits the application of the safe harbor to situations in which
the FDA has expressly required an applicant to use a particular
infringing test.

Instead, the Federal Circuit construed the safe

harbor such that it provides a “wide berth.” Id. at 1356.

Thus,

as long as the use of the patented invention is done to
generate information that will be submitted pursuant to
a relevant federal law, that use falls within the safe
harbor.
Id.

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Furthermore, the Federal Circuit explicitly held that the
safe harbor “does not mandate the use of a noninfringing
alternative when one exists.”

Momenta, 686 F.3d at 1359.

The

Court further noted that Momenta is
incorrect that the possibility that the FDA would
accept the use of other, non-patented, testing methods
for the development and submission of information
precludes Amphastar from relying on the safe harbor in
this case.
Id. at 60.

Moreover, if the safe harbor covered only infringing

tests that are required by the FDA, it would be in conflict with
the Supreme Court’s holding in Merck v. Integra Lifesciences I,
LTD, 545 U.S. 193 (2005).

In that case the Court held that pre-

filing tests that were not ultimately submitted to the FDA were
still covered by the safe harbor because such pre-filing tests
could never have been required by the FDA.
Second, plaintiffs argue that Amphastar’s “[r]outine, postapproval recordkeeping” is not “submission of information” to the
FDA because Amphastar does not actually “submit” these results
and thus such maintenance is not covered by the safe harbor.
Plaintiffs cite numerous dictionary definitions to attempt to
distinguish “submission” from mere “maintenance”.

These

definitions do not, however, negate the fact that the Federal
Circuit expressly held that the maintenance of records for FDA
inspection “satisfies the requirement that the uses be reasonably
related to the development and submission of information to the

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FDA.” Id. at 1357 (emphasis added).

The Court further noted that

“the fact that the FDA does not in most cases actually inspect
the records does not change” the fact that the records are
reasonably related to “submission” of information to the FDA. Id.
(citing Merck, 545 U.S. 193 at 207).
Momenta also avers that Amphastar’s alleged use of the
patented method during manufacturing “so that it can sell
[enoxaparin] and earn profit” makes that use not “solely” for
“uses reasonably related to the development and submission of
information” to the FDA.

Plaintiffs assert that Amphastar’s

routine commercial manufacturing conducted “long after FDA
approval” therefore makes that use “well beyond” the reach of the
safe harbor.

Unfortunately for plaintiffs, the Federal Circuit

found that such an argument is “not a tenable reading of the
statute” and is “contrary to precedent.” Id. at 1360.

For

example, the Federal Circuit has previously held that “alternate
uses [of test data] are irrelevant to [the] qualification to
invoke the section 271(e)(1) shield” because the safe harbor
allows alleged infringers to use test data for “more than FDA
approval.”

Abtox, Inc. v. Exitron Corp., 122 F.3d 1019, 1030

(Fed. Cir. 1997).

Defendants’ activities are thus protected by

the safe harbor.
ii. 35 U.S.C. § 271(g)
Momenta also asserts that summary judgment of non-

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infringement is inappropriate on the ground that defendants are
conducting infringing activity under 35 U.S.C. § 271(g).

That

statute provides, in relevant part, that:
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 argue 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.
Plaintiffs rely on the plain language of 35 U.S.C. § 271(g)
to contend that the statute “makes no distinction between the use
of a patented process inside or outside the United States.”

Such

an argument ignores the fact that the Federal Circuit has
explicitly stated that § 271(g)
requires importation or sale of the product of a patented
process practiced abroad, before infringement can be
established under that provision.
Cardiac Pacemakers, Inc. v. St. Jude Med., Inc., 576 F.3d 1348,
1369 (Fed. Cir. 2009).

That reasoning is supported by the

language of § 271(g) which provides that it is only applicable to
the infringement of a process patent if “there is no adequate
remedy under this title for infringement.”

Section 271(a)

applies to the making or use of a patented invention within the
United States, and therefore § 271(g) would not apply in those
circumstances.

Because there is no suggestion that Amphastar

manufactures enoxaparin abroad, § 271(g) is inapplicable in this
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case.

As a result, Amphastar cannot be liable for infringement

pursuant to § 271(g).
V.

Motion to Amend Infringement Contentions
In their preliminary Infringement Contentions served on

February 7, 2012, plaintiffs accused two of Amphastar’s
procedures: the “Approved 15-25% Procedure” which Amphastar
performed at the time of FDA approval, and its “Revised 15-25%
Procedure” which it adopted after FDA approval.

In its Amended

Infringement Contentions served on February 12, 2013, Momenta
accuses two additional Amphastar procedures.

The first is the

Disaccharide Building Block Procedure (“DBB test”).

The DBB test

is the same as the two 15-25% procedures 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.

The second test

plaintiffs seek to add is the “Batch-to-Batch” procedure.

This

method seems to involve a simple comparison between the results
obtained through one of the other three tests on a particular
batch of enoxaparin and the results obtained on another batch.
In its Second Amended Infringement Contentions served on May
24, 2013, Momenta added further documentary support for the newly
added infringement contentions.

Momenta now seeks leave from the

Court for both its Amended and Second Amended Infringement
Contentions having failed to seek leave prior to serving them as

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required by the scheduling order in this case (Docket No. 139).
A.

Standard

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

In

determining whether to grant leave to amend, a court generally
considers 1) the explanation for the failure to move timely for
leave to amend 2) the importance of the amendment 3) the
potential for prejudice caused by allowing the amendment and 4)
the opportunity to cure such prejudice. E.g. S&W Enterprises,
L.L.C. v. SouthTrust Bank of Alabama, NA, 315 F.3d 533, 536 (5th
Cir. 2003).
B.

Application

The Court is concerned by Momenta’s allegations that the
documents necessary to discover the additional tests were
intentionally concealed by defendants, possibly in violation of a
court order.

Despite those concerns, however, the Court will

deny the motion to amend because the proposed amendments would be
futile in any event.
First, the reasoning of this Court’s summary judgment
holding that the 271(e)(1) safe harbor provision applies to the
15-25% procedures also applies to the DBB test.

Despite

plaintiffs contention that the “FDA has no requirement that
Amphastar use a method that infringes the ‘886 patent” the FDA
did actually require defendants to perform the DBB test as part

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of their ANDA application, in addition to performing the 15-25%
tests.

Thus, such testing as required by the FDA cannot

constitute infringement.

Any post-approval DBB testing is also

covered by the safe harbor because, as explained by the Federal
Circuit, the resulting maintenance of test records for FDA
inspection “satisfies the requirement that the uses be reasonably
related to the development and submission of information to the
FDA.” Momenta, 686 F.3d at 1357.
Second, plaintiffs’ proposed amendment to add the batch-tobatch test would also be futile. Plaintiffs assert that because
no records are kept, and thus there is no possible submission of
information to the FDA, the batch-to-batch test does not qualify
for the 271(e)(1) safe harbor and as such assert that the
amendment would not be futile.
This Court is, however, skeptical that the so called batchto-batch test is even a separate testing procedure.

It

apparently involves a simple comparison of results of previously
conducted release tests across multiple batches of enoxaparin to
identify trends.

No records are created precisely because no

additional testing is conducted. Because the “test” simply
involves comparing data that has already been produced it cannot
possibly require repeating all of the steps of the ‘866 patent
that would be required for infringement.

E.g. EMI Group N. Am.,

Inc. v. Intel Corp., 157 F.3d 887, 896 (Fed.Cir.1998)(“For

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infringement of a process invention, all of the steps of the
process must be performed, either as claimed or by an equivalent
step.”)

As a result, a mere comparison of already produced data

could not possibly infringe the ‘866 patent.
Plaintiffs argue that the declaration of their expert Dr.
Jian Liu provides “a detailed, step-by-step explanation of why
the Batch-to-Batch Procedure infringes claim 1 of the ‘866
patent.” Yet, his declaration states only that Amphastar conducts
a “batch to batch comparison of its release test results.”
Noticeably Dr. Liu does not even refer to that step as a separate
“batch-to-batch test” nor does he distinguish it as a separate
test rather than a procedure conducted following the 15-25%
analysis.
Finally, it is illogical to suggest that conducting the
original release tests is not an act of infringement due to the
safe harbor but simply looking at the data produced by those
tests is somehow an act of infringement.

Therefore, plaintiffs

proposed amendment would be futile and the motion will be denied.

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ORDER
In accordance with the foregoing,
1)

Defendants’ Motion for Summary Judgment (Docket No.
346) is ALLOWED, and

2)

Plaintiffs’ Motion for Leave to Amend Infringement
Contentions (Docket No. 456) is DENIED.

So ordered.

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

Dated July 19, 2013

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