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

Filing 658

Judge Nathaniel M. Gorton: ENDORSED MEMORANDUM & ORDER entered granting 624 Motion to Amend (Renewed Motion for Leave to Amend Infringement Contentions) "plaintiffs renewed motion for leave to amend its infringement contentions with respect to the DBB test (Docket No. 624) is ALLOWED. So ordered." (Caruso, Stephanie)

United States District Court
District of Massachusetts
)
)
)
)
Plaintiffs,
)
)
v.
)
)
AMPHASTAR PHARMACEUTICALS, INC., )
INTERNATIONAL MEDICATION
)
SYSTEMS, LTD., ACTAVIS, INC. and )
WATSON PHARMA, INC.,
)
)
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., International Medication Systems, Ltd.,
Actavis, Inc. and Watson Pharma, Inc. (collectively, “Amphastar”
or “defendants”) infringed their patent during the course of
defendants’ manufacture and sale of generic enoxaparin products.
Pending before the Court is Momenta’s renewed motion for
leave to amend its infringement contentions with respect to the
Disaccharide Building Block Procedure (“DBB test”).
following reasons, that motion will be allowed.

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For the

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 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.

Momenta initiated this

lawsuit two days later by filing a complaint alleging that
Amphastar infringed its ‘886 patent by manufacturing generic
enoxaparin for commercial sale using the patented methods.
In October, 2011, this Court allowed Momenta’s motion for
injunctive relief by enjoining Amphastar from advertising,
offering for sale 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 it used the patented
process to test products after it had already obtained FDA

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approval, such that the use was not “reasonably related to the
development and submission of information” to the FDA.
Momenta served Amphastar in February, 2012 with its initial
infringement contentions which accused two Amphastar procedures:
the “Approved 15-25% Procedure” which Amphastar performed at the
time of FDA approval and the “Revised 15-25% Procedure” which it
adopted after FDA approval.
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)(“Momenta I”).

It explained that Amphastar’s post-approval

use of the patented process to run quality control tests on its
products fell within the scope of the safe harbor provision
because its use generated information for records that Amphastar
needed for continued FDA approval. Id. at 1357-61.
In mid-August, 2012, this Court stayed the case pending the
completion of appellate proceedings and denied all outstanding
motions without prejudice.

The Federal Circuit denied Momenta’s

petition for a rehearing en banc in November, 2012.
This Court removed the stay in mid-January, 2013.
Amphastar moved for summary judgment.

Momenta served Amphastar

with amended infringement contentions in February, 2013 which
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additionally accused the DBB test and a “Batch-to-Batch
Procedure”.

In May, 2013, Momenta served Amphastar with its

second amended infringement contentions adding “further
documentary support” for its DBB and Batch-to-Batch contentions
based upon Amphastar’s delayed production of the testing records
and Abbreviated New Drug Application (“ANDA”) materials.
Momenta did not seek leave to amend its infringement contentions
on either occasion but did so in June, 2013.
In July, 2013, this Court entered summary judgment in
Amphastar’s favor, finding that its activities were protected by
the safe harbor provision and therefore did not infringe.

The

Court also denied Momenta leave to amend the infringement
contentions with respect to the DBB test as “futile” because
Amphastar’s use of that test fell within the safe harbor
provision pursuant to 35 U.S.C. § 271(e)(1).
The Federal Circuit vacated this Court’s grant of summary
judgment to Amphastar in November, 2015 and held this time 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:

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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Given our vacation of summary judgment on the reach of
§ 271(e)(1), 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.
Momenta now renews its motion for leave to amend its
infringement contentions with respect to the DBB test, having
failed to seek leave prior to serving the amended and second
amended infringement contentions as required by the scheduling
order in this case (Docket No. 139).
II.

Motion to amend infringement contentions
A.

Legal standard

A scheduling order may be modified only for good cause and
with the court’s consent. Fed. R. Civ. P. 16(b)(4). In
determining whether to grant leave to amend after a deadline in
the scheduling order has expired, a court may consider 1) the
explanation for the movant’s 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 Enters., L.L.C. v.
SouthTrust Bank of Alabama, NA, 315 F.3d 533, 536 (5th Cir.
2003).
B.

Application

Momenta seeks to amend its infringement contentions to
accuse Amphastar’s use of the DBB test as an infringing

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activity.

It contends that 1) the scheduling order allowed it

to amend its preliminary infringement contentions, as of right,
within 30 days of the Court’s ruling on claim construction,
2) the 30-day period expired on February 11, 2013, 3) “[n]othing
substantive occurred between February 11 and 12, 2013 that could
have possibly prejudiced Amphastar” and 4) it served Amphastar
with the amended infringement contentions on February 12, 2013.
Momenta further submits that it promptly served Amphastar with
the second amended infringement contentions, which added further
support for the existing contentions but not new theories of
liability, after receiving Amphastar’s delayed disclosures.
Momenta’s motion to amend will be allowed.

The Court

remains concerned by Momenta’s allegations that Amphastar
intentionally withheld and concealed, perhaps in violation of a
court order, the documents necessary for Momenta to discover
Amphastar’s use of the DBB test.

Given the Federal Circuit’s

finding that the safe harbor provision does not protect
Amphastar from liability, the Court no longer deems the proposed
amendment “futile”.

Momenta credibly asserts that the amendment

will not unduly prejudice Amphastar because 1) it does not
affect the fact discovery conducted after the belated
disclosure, 2) no expert discovery has yet occurred and
3) Amphastar will have the opportunity to address the amended
infringement contentions at the summary judgment stage.
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Defendants’ statement that the amended contentions would
“substantially” broaden the scope of the claims and present new
issues of claim construction is unpersuasive.

As the Court

found when it considered Momenta’s prior motion to amend, the
DBB test uses a different reference standard but is otherwise
the same as the two 15-25% procedures identified in the initial
set of infringement contentions.
Accordingly, Momenta’s renewed motion to amend with respect
to the DBB test will be allowed.

ORDER

For the foregoing reasons, plaintiffs’ renewed motion for
leave to amend its infringement contentions with respect to the
DBB test (Docket No. 624) is ALLOWED.
So ordered.
/s/ Nathaniel M. Gorton
Nathaniel M. Gorton
United States District Judge
Dated June 21, 2016

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