United States District Court, D. Massachusetts
MOMENTA PHARMACEUTICALS, INC. and SANDOZ INC., Plaintiffs,
AMPHASTAR PHARMACEUTICALS, INC., INTERNATIONAL MEDICATION SYSTEMS, LTD., ACTAVIS, INC. and WATSON PHARMA, INC., Defendants.
MEMORANDUM & ORDER
Nathaniel M. Gorton Judge
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
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").
For the following reasons, that motion will be allowed.
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.
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.
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 approval, such that the use was not
"reasonably related to the development and submission of
information" to the FDA.
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
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.
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
Court removed the stay in mid-January, 2013. Amphastar moved
for summary judgment. Momenta served Amphastar with amended
infringement contentions in February, 2013 which 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.
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.
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). The Federal
Circuit also suggested that:
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 ...