Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc. ( 2015 )

United States Court of Appeals
for the Federal Circuit
______________________
MOMENTA PHARMACEUTICALS, INC.,
SANDOZ INC.,
Plaintiffs-Appellants
v.
TEVA PHARMACEUTICALS USA INC.,
Defendant-Appellee
______________________
2014-1274, 2014-1277
______________________
Appeals from the United States District Court for the
District of Massachusetts in No. 1:10-cv-12079-NMG,
Judge Nathaniel M. Gorton.
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MOMENTA PHARMACEUTICALS, INC.,
SANDOZ INC.,
Plaintiffs-Appellants
v.
AMPHASTAR PHARMACEUTICALS, INC.,
INTERNATIONAL MEDICATION SYSTEMS, LTD.,
ACTAVIS, INC., ACTAVIS PHARMA, INC., FKA WATSON
PHARMA, INC.,
Defendants-Appellees
2 MOMENTA PHARM., INC. v. TEVA PHARM., INC.
______________________
2014-1276, 2014-1278
______________________
Appeals from the United States District Court for the
District of Massachusetts in No. 1:11-cv-11681-NMG,
Judge Nathaniel M. Gorton.
______________________
Decided: November 10, 2015
______________________
DEANNE MAYNARD, Morrison & Foerster LLP, Washing-
ton, DC, argued for plaintiffs-appellants. Also represented by
BRIAN ROBERT MATSUI, MARC A. HEARRON. Plaintiff-
appellant Momenta Pharmaceuticals, Inc. also represent-
ed by ROBERT S. FRANK, JR., DANIEL C. WINSTON, Choate,
Hall & Stewart LLP, Boston, MA. Plaintiff-appellant Sandoz
Inc. also represented by THOMAS P. STEINDLER, McDermott,
Will & Emery LLP, Washington, DC.
HENRY C. DINGER, Goodwin Procter LLP, Boston, MA ar-
gued for defendant-appellee Teva Pharmaceuticals USA Inc.
Also represented by JAMES C. REHNQUIST, EMILY L.
RAPALINO, ELAINE BLAIS, ROBERT FREDERICKSON, III;
DAVID M. HASHMALL, JOSHUA AARON WHITEHILL, New
York, NY.
PRATIK A. SHAH, Akin, Gump, Strauss, Hauer & Feld,
LLP, Washington, DC, argued for defendants-appellees Am-
phastar Pharmaceuticals, Inc., et al. Also represented by
EMILY CURTIS JOHNSON, ANTHONY TOBIAS PIERCE, JAMES
EDWARD TYSSE.
MARK R. FREEMAN, Appellate Staff, Civil Division, United
States Department of Justice, Washington, DC, for amicus
curiae United States. Also represented by CAROLINE D.
MOMENTA PHARM., INC. v. TEVA PHARM., INC. 3
LOPEZ, BENJAMIN C. MIZER; DAVID J. HOROWITZ,
ELIZABETH H. DICKINSON, ANNAMARIE KEMPIC, WENDY
VICENTE, Office of the General Counsel, Food and Drug
Division, United States Department of Health and Human
Services, Silver Spring, MD; THOMAS W. KRAUSE, SCOTT C.
WEIDENFELLER, FARHEENA YASMEEN RASHEED, WILLIAM
LAMARCA, Office of the Solicitor, United States Patent and
Trademark Office, Alexandria, VA.
______________________
Before DYK, MOORE, and WALLACH, Circuit Judges.
Opinion for the court filed by Circuit Judge WALLACH.
Opinion concurring in part and dissenting in part filed by
Circuit Judge DYK.
WALLACH, Circuit Judge.
Plaintiffs-appellants Momenta Pharmaceuticals, Inc.
and Sandoz Inc. (collectively, “Momenta”) appeal the
district court’s decision finding Teva Pharmaceuticals
USA Inc. (“Teva”) does not infringe U.S. Patent No.
7,575,886 (“the ’886 patent”). In a companion case, Mo-
menta appeals the district court’s decision finding Am-
phastar Pharmaceuticals, Inc., International Medication
Systems, Ltd., Actavis, Inc., and Actavis Pharma, Inc.
(collectively, “Amphastar”) do not infringe the ’886 patent.
For the reasons set forth below, this court affirms the
district court’s holdings that neither Teva nor Amphastar
infringes under 35 U.S.C. § 271(g) (2012). However, this
court vacates the district court’s grant of summary judg-
ment in favor of Amphastar to the extent it was based on
the erroneous determination that Amphastar’s activities
fall within the § 271(e)(1) safe harbor and therefore do not
infringe under 35 U.S.C. § 271(a). We accordingly re-
mand as to Amphastar for further proceedings consistent
with this opinion.
4 MOMENTA PHARM., INC. v. TEVA PHARM., INC.
BACKGROUND
Enoxaparin is an anticoagulant that helps to prevent
blood clots that was first approved for marketing in the
United States in 1993 under the trade name Lovenox. In
2010, Momenta became the first company to market a
generic version of enoxaparin. Momenta is also the
assignee of the ’886 patent, which is directed to a process
used to ensure each batch of generic enoxaparin meets
certain quality standards.
Teva, another generic manufacturer, sought to enter
the enoxaparin market. It does not manufacture enoxap-
arin itself, but sources the product from Chemi S.p.A., an
Italian company that manufactures, analyzes, tests,
packages, and labels Teva’s generic version of enoxaparin,
which Teva then imports into the United States. Momen-
ta sued Teva for infringement of the ’886 patent on the
grounds it intended to market in the United States an
enoxaparin product that was manufactured using a
process covered by the ’886 patent.
The district court found Teva’s conduct did not in-
fringe because it fell within the safe harbor from in-
fringement provided by 35 U.S.C. § 271(e)(1), which states
it is not infringement for a party to use a patented inven-
tion “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.” 35
U.S.C. § 271(e)(1). 1 The district court also rejected Mo-
menta’s contention that Teva’s sales in the United States
constitute infringement under § 271(g), which prohibits
selling “within the United States a product which is made
by a process patented in the United States.” Id. § 271(g)
1 Section 271(e)(1) was not amended by the Leahy-
Smith America Invents Act, Pub. L. No. 112-29, 125 Stat.
284 (2011).
MOMENTA PHARM., INC. v. TEVA PHARM., INC. 5
(emphasis added). The district court reasoned that the
patented process related to “quality control release test-
ing” and was “not a method of making enoxaparin.” J.A.
(-1274, -1277) 7.
Amphastar is also a generic manufacturer of enoxapa-
rin. Unlike Teva, however, Amphastar manufactures its
enoxaparin product within the United States. Momenta
asserts the district court erred in granting summary
judgment of non-infringement of the ’886 patent in favor
of Amphastar. According to Momenta, Amphastar’s use of
the patented method in the United States as part of the
manufacture of enoxaparin infringes the ’886 patent, and
this infringement does not fall within the safe harbor of
35 U.S.C. § 271(e)(1). It further argues Amphastar’s sale
of enoxaparin in the United States infringes under 35
U.S.C. § 271(g).
In a prior appeal by Amphastar at the preliminary in-
junction phase, this court held that it was “unlikely that
Momenta will succeed on the merits of its infringement
claim.” Momenta Pharm., Inc. v. Amphastar Pharm., Inc.
(Momenta I), 686 F.3d 1348, 1361 (Fed. Cir. 2012). On
remand from Momenta I, the district court found “[Am-
phastar’s] activities are . . . protected by the safe harbor”
of § 271(e)(1), which decision forms the basis of the pre-
sent appeal. J.A. (-1276, -1278) 9.
Momenta appeals the district court’s grants of sum-
mary judgment in favor of Teva and Amphastar. This
court has jurisdiction under 28 U.S.C. § 1295(a) (2012). 2
2 We invited the United States to present its views
as amicus curiae on the statutory interpretation issues
raised in these cases. In response, the government ar-
gued that the routine use of a patented testing process in
the commercial manufacture of a drug is not “reasonably
related to the development and submission of information
6 MOMENTA PHARM., INC. v. TEVA PHARM., INC.
DISCUSSION
I. Standard of Review
This court reviews summary judgment decisions un-
der the law of the regional circuit. MicroStrategy Inc. v.
Bus. Objects, S.A., 429 F.3d 1344, 1349 (Fed. Cir. 2005).
The First Circuit reviews such decisions de novo. Ad-
amson v. Walgreens Co., 750 F.3d 73, 78 (1st Cir. 2014).
II. Teva’s and Amphastar’s Enoxaparin Products Are Not
“Made By” Momenta’s Patented Process 3
Section 271(g) prohibits the unauthorized importation
into the United States, or sale or use within the United
States, of a “product which is made by a process patented
in the United States.” 35 U.S.C. § 271(g) (emphasis
added). A key issue on appeal is therefore whether Teva’s
and Amphastar’s enoxaparin products are “made by”
to [the] FDA” and thus not shielded from liability by
§ 271(e)(1). Brief for the United States as Amicus Curiae
8 (internal quotation marks omitted).
3 Momenta argues “Amphastar’s sales activity sep-
arately infringes under Section 271(g), which makes it an
act of infringement to ‘offer[] to sell’ or ‘sell[] . . . within
the United States a product which is made by a process
patented in the United States.’” Appellants’ Br. (14-1276,
14-1278) 53 (quoting 35 U.S.C. § 271(g)). Amphastar
replies that its manufacturing occurs within the United
States, and therefore “[§] 271(g) does not apply for the
independent reason that Amphastar does not manufac-
ture enoxaparin abroad.” Appellees’ Br. (14-1276, 14-
1278) 50. Because we hold the accused products are not
“made by” the patented process within the meaning of
§ 271(g), we do not reach the question of whether that
subsection applies if the patented process is practiced
domestically rather than abroad.
MOMENTA PHARM., INC. v. TEVA PHARM., INC. 7
Momenta’s patented process within the meaning of
§ 271(g). We conclude they are not.
Momenta argues that “made” means “manufactured,”
and that its patented method is “a crucial interim step
used directly in the manufacture of [Teva’s] product[s].”
Appellants’ Br. (-1274, -1277) 59 (internal quotation
marks and citation omitted); see also Appellants’ Br.
(-1276, -1278) 54 (“Amphastar uses Momenta’s method as
an intermediate step in the multi-step process of manu-
facturing its drug.”). Specifically, Momenta asserts its
“method is used [by Teva] to select and separate batches
of intermediate drug substance that conform to [United
States Pharmacopoeial Convention] requirements for
enoxaparin from batches that do not,” and that selected
batches are then “further process[ed].” Appellants’ Br.
(-1274, -1277) 59, 62; see also Appellants’ Br.
(-1276, -1278) 54 (“Amphastar uses Momenta’s method . . .
to select the individual batches of interim enoxaparin
preparation it will further process into final drug prod-
uct.”). Momenta also notes “[t]he [U.S. Food and Drug
Administration’s (‘FDA’)] Good Manufacturing Practice
[‘GMP’] regulations define ‘[m]anufacture’ and ‘processing’
of drug products as including ‘testing[] and quality control
of drug products.’” Appellants’ Br. (-1274, -1277) 59
(quoting 21 C.F.R. § 210.3(b)(12)); see also Appellants’ Br.
(-1276, -1278) 54.
Although Momenta’s arguments are not without mer-
it, it is more consonant with the language of the statute,
as well as with this court’s precedent, to limit § 271(g) to
the actual “ma[king]” of a product, rather than extend its
reach to methods of testing a final product or intermedi-
ate substance to ensure that the intended product or
substance has in fact been made. See 35 U.S.C. § 271(g)
(“made by”). “In patent law, as in all statutory construc-
tion, [u]nless otherwise defined, words will be interpreted
as taking their ordinary, contemporary, common mean-
ing.” Bilski v. Kappos, 561 U.S. 593, 603 (2010) (altera-
8 MOMENTA PHARM., INC. v. TEVA PHARM., INC.
tion in original) (internal quotation marks and citations
omitted). Dictionaries define the verb forms of “make” to
involve the creation or bringing into existence of some-
thing. See, e.g., Make, Webster’s Third New International
Dictionary of the English Language Unabridged (Philip
Babcock Gove et al. eds., 1986) (“Webster’s”) (“to bring (a
material thing) into being by forming, shaping, or altering
material : FASHION, MANUFACTURE”); Make, The American
Heritage Dictionary (2d college ed. 1982) (“The American
Heritage Dictionary”) (“To cause to exist or happen;
create;” “To bring into existence by forming or modifying
materials;” “To create by putting together component
parts”); see also Make, Black’s Law Dictionary (10th ed.
2014) (“To cause (something) to exist”).
This court has previously equated the word “made” in
§ 271(g) with “manufacture.” Bayer AG v. Housey Pharm.,
Inc., 340 F.3d 1367, 1373 (Fed. Cir. 2003) (“[T]he statute
clearly contemplates that ‘made’ means ‘manufactured.’”).
As with the word “make,” dictionaries define the verb
form of “manufacture” to involve the creation or bringing
into existence of something. See, e.g., Manufacture,
Webster’s (“to make (as raw material) into a product
suitable for use”); Manufacture, The American Heritage
Dictionary (“To make or process (a raw material) into a
finished product”). In American Fruit Growers, Inc. v.
Brogdex Co., the Supreme Court quoted with approval the
definition of “manufacture” provided in the Century
Dictionary, namely, “giving [raw or prepared materials]
new . . . qualities [or] properties.” 283 U.S. 1, 11 (1931)
(emphases added).
In light of the foregoing, the ordinary meaning of
“made” as used in § 271(g) means “manufacture,” and
extends to the creation or transformation of a product,
such as by synthesizing, combining components, or giving
raw materials new properties. However, “ma[king]” does
not extend to testing to determine whether an already-
synthesized drug substance possesses existing qualities or
MOMENTA PHARM., INC. v. TEVA PHARM., INC. 9
properties. See Phillip M. Adams & Assocs., LLC v. Dell
Comput. Corp., 519 F. App’x 998, 1005 (Fed. Cir. 2013)
(unpublished) (“[E]ven assuming the certification testing
constituted infringement . . . , the motherboards were not
‘made by’ the certification testing pursuant to 35 U.S.C.
§ 271(g).”); see also Momenta Pharm., Inc. v. Teva Pharm.
USA, Inc., No. 10-cv-12079-NMG, at 7 (D. Mass. July 19,
2013) (J.A. 1–9) (“[W]hile . . . quality control release
testing is a regulatory requirement for sale of enoxaparin
in the United States, it is not a method for making
enoxaparin [within the meaning of § 271(g)].”); Shara-
fabadi v. Univ. of Idaho, No. C09-1043JLR, 2009 WL
4432367, at *1, *5 (W.D. Wash. Nov. 27, 2009) (finding
the plaintiff failed to state a claim under § 271(g) when he
alleged the defendant used the patented process “[d]uring
various stages of productions and processing of IdaGold
yellow mustard seeds . . . to produce [sufficient mustard
gum] for measuring its viscosity as a means to ensure the
quality characteristics of the . . . seeds”); David L. Hitch-
cock & Craig Allen Nard, The Process Patent Amendments
Act: The Labyrinth, 3 Fordham Ent. Media & Intell. Prop.
L.F. 441, 446 (1993) (“[I]t follows from the terms of the
[Process Patent Amendments Act of 1988]” that products
subjected to a patented method of quality control are
“not . . . worthy of . . . protection” under § 271(g).).
The samples of enoxaparin that are the subject of test-
ing are “exhaustively digest[ed]” into “sub-chains” and the
sub-chains are then separated. Appellants’ Br.
(-1274, -1277) 9. Based on the test performed on this
sample, an enoxaparin batch from which the samples
were extracted may be selected for incorporation into the
finished product. No assertion is made, however, that the
enoxaparin samples on which tests are performed are
themselves incorporated into the finished product or
10 MOMENTA PHARM., INC. v. TEVA PHARM., INC.
imported into the United States, 4 nor do the tests create
or give new properties to the enoxaparin substance in
batches that are selected for further processing.
Our conclusion finds support in this court’s precedent.
In Housey, we held a product was not “made by” a process
patented in the United States for purposes of § 271(g)
where “the patented process [was] not used in the actual
synthesis of the drug product.” 340 F.3d at 1377 (empha-
sis added). Housey involved patents directed to “a method
of screening for substances which specifically inhibit or
4 The dissent asserts this was also true in Bio-
Technology General Corp. v. Genentech, Inc., which in-
volved a patent “directed to a method for constructing a
replicable cloning vehicle (e.g., a plasmid)” that could be
introduced into a microbial organism to enable it to
produce human growth hormone. 80 F.3d 1553, 1557
(Fed. Cir. 1996). The analogy fails. Unlike Bio-
Technology General, where the patented process created a
tangible product used directly in the manufacture of a
final polypeptide product (e.g., human growth hormone),
the patented process in the present matter creates only
information; it does not create enoxaparin samples that
are used in subsequent steps of the manufacturing pro-
cess. In any event, Bio-Technology General differs from
the present matter because the legislative history of
§ 271(g) explicitly states that a polypeptide is “made by” a
patented process, within the meaning of § 271(g), where
the patented process is used to produce a DNA molecule
that is incorporated into a plasmid and that plasmid is
inserted into a host organism to produce the polypeptide.
See id. at 1561 (quoting at length S. Rep. No. 100-83, at
51 (1987)); see also id. (“The legislative history precisely
anticipated this fact situation . . . .”). The dissent cites no
legislative history supporting the extension of § 271(g) to
quality control methods.
MOMENTA PHARM., INC. v. TEVA PHARM., INC. 11
activate a particular protein.” Id. at 1369 (internal quota-
tion marks and citation omitted). The screening method
enabled the identification of a particular drug as “useful,”
which drug could then be manufactured. Id. at 1377. The
court determined the process was too far removed from
the actual making of the product. Id. at 1378 (“[T]he
process must be used directly in the manufacture of the
product, and not merely as a predicate process to identify
the product to be manufactured.”).
Similarly, a product is not “made by” a patented pro-
cess within the meaning of § 271(g) if it is used merely to
determine whether the intended product of a separate
and perhaps separately-patented process has in fact
already been manufactured. Compare Housey, 340 F.3d
at 1377 (“[P]rocesses of identification and generation of
data are not steps in the manufacture of a final drug
product.” (emphasis added) (internal quotation marks and
citation omitted)), with Dissent at 8 (“after the identity of
the drug substance is confirmed” (emphasis added)); see
also Housey, 340 F.3d at 1378 (“A drug product, the
characteristics of which were studied using the claimed
research processes . . . is not a product ‘made by’ those
claimed processes.”). All of the asserted claims of the ’886
patent are directed to “[a] method for analyzing an
enoxaparin sample.” See, e.g., ’886 patent col. 63 l. 51, col.
64 ll. 10, 35, 58 (emphasis added). Use of the word “ana-
lyzing” indicates practicing the claimed invention requires
that the enoxaparin already be “made.”
It is true the FDA’s GMP regulations “define
‘[m]anufacture’ and ‘processing’ of drug products as in-
cluding ‘testing[] and quality control,’” as Momenta as-
serts. Appellants’ Br. (-1274, -1277) 59 (quoting 21 C.F.R.
§ 210.3(b)(12)). However, § 210.3 explicitly states that its
definitions apply when the terms are used in parts 210,
211, 225, and 226 of Chapter 1 of Title 21 (“Food and
Drugs”) of the Code of Federal Regulations. 21 C.F.R.
§ 210.3(a). They do not control the interpretation of 35
12 MOMENTA PHARM., INC. v. TEVA PHARM., INC.
U.S.C. § 271(g), which is part of a separate statutory
scheme directed to patented inventions. See Davis v.
Mich. Dep’t of Treasury, 489 U.S. 803, 809 (1989) (“It is a
fundamental canon of statutory construction that the
words of a statute must be read in their context and with
a view to their place in the overall statutory scheme.”).
This is not a case where the FDA has interpreted § 271(g)
or Chevron deference is owed. See Chevron U.S.A. Inc. v.
Nat. Res. Def. Council, Inc., 467 U.S. 837, 844 (1984)
(“[C]onsiderable weight should be accorded to an execu-
tive department’s construction of a statutory scheme it is
entrusted to administer.” (emphasis added)). The ordinary
meaning of the term “made by”—rather than an FDA
definition of “manufacture” crafted for purposes unrelated
to incentivizing invention—therefore controls. 5
For these reasons, Teva’s and Amphastar’s enoxapa-
rin products are not “made by” Momenta’s patented
process for purposes of § 271(g). Because Momenta’s
infringement claims against Teva are based on § 271(g),
the district court’s grant of summary judgment in favor of
Teva is affirmed.
5 The dissent expresses concern that our holding
could exclude purification processes from the scope of
§ 271(g). Dissent at 9. Although the application of
§ 271(g) to a particular purification process may be fact-
dependent, as a general matter purification processes
transform impure substances into more pure ones. Purifi-
cation therefore contrasts with the quality control process
at issue in the present case, which provides information
regarding a substance that has already been made but
does not transform it.
MOMENTA PHARM., INC. v. TEVA PHARM., INC. 13
III. The § 271(e)(1) Safe Harbor Does Not Shield the
Accused Use by Amphastar
Unlike Teva, Amphastar does not assert it manufac-
tures its enoxaparin product abroad. Momenta argues
Amphastar’s use of the patented method within the
United States infringes under 35 U.S.C. § 271(a) and is
not protected by the § 271(e)(1) safe harbor.
Section 271(e)(1) provides that it is not infringement
for a party to use 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.” 35 U.S.C. § 271(e)(1).
“Though the contours of [§ 271(e)(1)] are not exact in
every respect,” Merck KGaA v. Integra Lifesciences I, Ltd.,
545 U.S. 193, 202 (2005), “[t]here is no dispute as to the
statutory purpose,” namely, “to facilitate market entry
upon patent expiration,” Classen Immunotherapies, Inc. v.
Biogen IDEC, 659 F.3d 1057, 1072 (Fed. Cir. 2011). The
legislative history makes this purpose clear:
[Section 271(e)(1)] provides that it is not an act of
patent infringement for a generic drug maker to
import or to test a patented drug in preparation
for seeking FDA approval if marketing of the drug
would occur after expiration of the patent. . . .
This section does not permit the commercial sale
of a patented drug by the party using the drug to
develop such information . . . . The information
which can be developed under this provision is the
type which is required to obtain approval of the
drug. . . . The purpose of sections 271(e)(1) and (2)
is to establish that experimentation with a patent-
ed drug product, when the purpose is to prepare
for commercial activity which will begin after a
valid patent expires, is not a patent infringement.
14 MOMENTA PHARM., INC. v. TEVA PHARM., INC.
H.R. Rep. No. 98–857(I), at 15, 45 (1984), as reprinted in
1984 U.S.C.C.A.N. 2647, 2648 (emphasis added) (capitali-
zation omitted).
The language of § 271(e)(1) is “sufficiently broad” to
“leave[] adequate space for experimentation and failure
on the road to regulatory approval.” Merck, 545 U.S. at
206–07. The breadth of the exemption extends even to
activities the “actual purpose” of which may be “pro-
mot[ional]” rather than regulatory, at least where those
activities are “consistent with the collection of data neces-
sary for filing an application with the [FDA] . . . for ap-
proval.” AbTox, Inc. v. Exitron Corp., 122 F.3d 1019, 1027
(Fed. Cir. 1997). Moreover, notwithstanding the legisla-
tive focus on activities occurring prior to the approval of
generic drugs, the § 271(e)(1) exemption applies to medi-
cal devices, Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661
(1990), and “is not restricted to pre-approval activities,”
Momenta I, 686 F.3d at 1358–59. Section 271(e)(1) thus
“provides a wide berth for the use of patented drugs in
activities related to the federal regulatory process.”
Merck, 545 U.S. at 202.
Despite the broad contours of the exemption, some ac-
tivities are outside its protection. For example,
§ 271(e)(1) “does not apply to information that may be
routinely reported to the FDA, long after marketing
approval has been obtained.” Classen, 659 F.3d at 1070.
In addition, research tools or devices that are not them-
selves subject to FDA approval may not be covered.
Proveris Sci. Corp. v. Innovasystems, Inc., 536 F.3d 1256,
1265–66 (Fed. Cir. 2008).
We preliminarily addressed the issue of Amphastar’s
eligibility for the § 271(e)(1) safe harbor in Momenta I,
holding that, in light of the safe harbor and for purposes
of granting a preliminary injunction, “the district court
incorrectly concluded that Momenta was likely to succeed
on the merits of its infringement claim.” Momenta I, 686
MOMENTA PHARM., INC. v. TEVA PHARM., INC. 15
F.3d at 1352. Amphastar argues this court in Momenta I
“already decided that Amphastar’s safety testing is pro-
tected by the Section 271(e)(1) safe harbor” and that this
determination is law of the case. Appellees’ Br.
(-1276, -1278) 24.
According to the law of the case doctrine, “[a] court
will not generally revisit an issue once decided in the
litigation.” Mendenhall v. Barber-Greene Co., 26 F.3d
1573, 1582 (Fed. Cir. 1994). However, whether to apply
law of the case doctrine is “a matter which rests on discre-
tion.” Id. at 1583. “Although courts are often eager to
avoid reconsideration of questions once decided in the
same proceedings, it is clear that all federal courts retain
power to reconsider if they wish.” Hughes Aircraft Co. v.
United States, 86 F.3d 1566, 1581 (Fed. Cir. 1996) (inter-
nal quotation marks and citation omitted), vacated on
other grounds, United States v. Hughes Aircraft Co., 520
U.S. 1183 (1997).
For the doctrine to apply, the issue must have actual-
ly been decided. Findings of fact and fact-intensive con-
clusions of law made by a court in the preliminary
injunction context are not binding. See generally Belgium
v. United States, 452 F.3d 1289, 1294 (Fed. Cir. 2006)
(“On review of the denial of a preliminary injunction, our
judgment as to the merits of the plaintiff’s case is neces-
sarily tentative.”); Glaxo Grp. Ltd. v. Apotex, Inc., 376
F.3d 1339, 1346 (Fed. Cir. 2004) (“An appellate court’s
preliminary injunction opinion . . . is not binding on a
subsequent panel.”); see also Univ. of Tex. v. Camenisch,
451 U.S. 390, 395 (1981) (“[T]he findings of fact and
conclusions of law made by a court granting a preliminary
injunction are not binding at trial on the merits.”); Indus.
Bank of Wash. v. Tobriner, 405 F.2d 1321, 1324 (D.C. Cir.
1968) (“In reviewing [a preliminary injunction] determi-
nation, this court ordinarily will not consider the merits of
the case further than necessary to determine whether the
District Court abused its discretion.” (internal quotation
16 MOMENTA PHARM., INC. v. TEVA PHARM., INC.
marks and citation omitted)). Because Momenta is not
seeking to relitigate an issue that was already conclusive-
ly decided in Momenta I, law of the case does not apply.
Moreover, “it is not improper for a court to depart
from a prior holding if convinced that it is clearly errone-
ous and would work a manifest injustice.” Arizona v.
California, 460 U.S. 605, 618 n.8 (1983); see also Bard
Peripheral Vascular, Inc. v. W.L. Gore & Assocs., Inc., 776
F.3d 837, 842 (Fed. Cir. 2015) (“[T]here are exceptional
circumstances in which a panel may not adhere to the
decision in a prior appeal in the same case,” such as
when “the earlier ruling was clearly erroneous and would
work a manifest injustice.”). The court in Momenta I
described Amphastar’s submissions as “anything but
‘routine,’” 686 F.3d at 1358, a reference to Classen’s
statement that § 271(e)(1) “does not apply to information
that may be routinely reported to the FDA, long after
marketing approval has been obtained,” 659 F.3d at 1070
(emphasis added). With the benefit of additional briefing
in the current appeals, which reflects the full district
court record developed by all parties after the preliminary
injunction phase, we conclude Amphastar’s submissions
are appropriately characterized as “routine.”
Webster’s defines the adjective form of “routine” as “of
a commonplace or repetitious character.” Routine, Web-
ster’s. The American Heritage Dictionary similarly offers
a definition of “routine” as “[h]abitual; regular.” Routine,
The American Heritage Dictionary. These definitions
aptly describe the patented quality control method.
“[T]he ’886 patent . . . is directed at a set of manufactur-
ing control processes that ensure that each batch of gener-
ic enoxaparin” meets quality standards. See J.A.
(-1276, -1278) 2 (emphasis added). The information
generated as each batch of drug substance is tested is
routinely (i.e., habitually, regularly, and repeatedly)
recorded and retained as required by regulation. See 21
C.F.R. §§ 211.165, .180, .186, .188, .194 (2015).
MOMENTA PHARM., INC. v. TEVA PHARM., INC. 17
The routine record retention requirements associated
with testing and other aspects of the commercial produc-
tion process contrast with non-routine submissions that
may occur both pre- and post-approval, such as the sub-
mission of investigational new drug applications (“INDs”),
new drug applications (“NDAs”), supplemental NDAs, or
other post-approval research results. See, e.g., 21 U.S.C.
§ 356b (“Reports of postmarketing studies”); id.
§ 355c(b)(1) (post-approval pediatric data submissions);
id. § 355(e) (withdrawal of drug approval based upon “new
information”); id. § 355(o)(4) (labeling changes based upon
new safety information); id. § 355-1 (“Risk evaluation and
mitigation strategies”). The routine quality control test-
ing of each batch of generic enoxaparin as part of the post-
approval, commercial production process is therefore not
“reasonably related to the development and submission of
information” to the FDA, and it was clearly erroneous to
conclude otherwise.
Amphastar cites AbTox in support of its argument
that “as long as Amphastar’s safety testing is for a use
reasonably related to the development and submission of
information to the FDA,” whether the use is part of com-
mercial production makes no difference. Appellees’ Br.
(-1276, -1278) 42 (citing AbTox, 122 F.3d at 1030). How-
ever, AbTox stated “[a]s long as [an] activity is reasonably
related to obtaining FDA approval,” § 271(e)(1) “does not
look to the underlying purposes or attendant consequenc-
es of the activity.” 122 F.3d at 1030 (emphasis added).
Here, Amphastar makes no claim that its accused, post-
approval use of the patented method is related to obtain-
ing FDA approval. Although Momenta I held that “post-
approval studies” can fall within the § 271(e)(1) safe
harbor, 686 F.3d at 1359, whether such uses are “reason-
ably related” to a § 271(e)(1) “submission” requires more
critical analysis in the post-approval context.
The conclusion in Momenta I that Amphastar’s com-
mercial use of Momenta’s patented method falls within
18 MOMENTA PHARM., INC. v. TEVA PHARM., INC.
the safe harbor of § 271(e)(1) would result in manifest
injustice. Amphastar points to no case, until Momenta I,
extending immunity under § 271(e)(1) to encompass
activities related to ongoing commercial manufacture and
sale. See, e.g., Merck, 545 U.S. at 208 (Preclinical re-
search falls within the § 271(e)(1) safe harbor “as long as
there is a reasonable basis for believing that the experi-
ments will produce the types of information that are
relevant to an IND or NDA.” (internal quotation marks
and citation omitted)); Eli Lilly, 496 U.S. at 663–64
(Section 271(e)(1) exempts activities “necessary to obtain
marketing approval for a medical device.” (emphasis
added)); Classen, 659 F.3d at 1070 (“[Section] 271(e)(1)
provides an exception to the law of infringement in order
to expedite development of information for regulatory
approval of generic counterparts of patented products.”
(emphasis added)); AbTox, 122 F.3d at 1027 (Section
271(e)(1) applies where “[defendants] conducted limited
tests consistent with the collection of data necessary for
filing an application with the [FDA] . . . for approval of its
Class II medical device.” (emphasis added)); see also H.R.
Rep. No. 98–857, pt. 2, at 30 (1984), as reprinted in 1984
U.S.C.C.A.N. 2686, 2714 (Under § 271(e)(1) “the generic
manufacturer is not permitted to market the patented
drug product during the life of the patent; all that the
generic can do is test the drug for purposes of submitting
data to the FDA for approval.” (emphasis added) (capitali-
zation omitted)). 6
6 See also Telectronics Pacing Sys., Inc. v. Ventritex,
Inc., 982 F.2d 1520, 1523 (Fed. Cir. 1992) (The display of
accused devices to non-physicians at medical conferences,
where no sales were solicited, is “merely incidental” to the
undisputed purpose of the display—“obtain[ing] clinical
investigators for [pre-approval] trials”—and does not
preclude application of the § 271(e)(1) exemption); Char-
MOMENTA PHARM., INC. v. TEVA PHARM., INC. 19
IV. Momenta’s Motion to Amend
Momenta served amended infringement contentions
that accused two additional Amphastar testing proce-
dures and sought to provide additional documentary
support for the new infringement contentions. Thereaf-
ter, Momenta moved for leave from the district court to
file the amendments. J.A. (-1276, -1278) 11. The district
court denied leave, noting Momenta had “failed to seek
leave prior to serving [the amendments] as required by
the [district court’s] scheduling order,” and that the
amendments would in any event be “futile.” J.A.
(-1276, -1278) 11–12. The district court’s decision to deny
leave was based in part on its conclusion that its “sum-
mary judgment holding that the [§] 271(e)(1) safe harbor
provision applies to the 15–25% procedures also applies
to” one of the two additional accused testing procedures.
J.A. (-1276, -1278) 12.
Decisions whether to allow an amendment to plead-
ings after the scheduling order deadline are reviewed
under the law of the regional circuit. Aventis Pharma
S.A. v. Hospira, Inc., 675 F.3d 1324, 1333 (Fed. Cir. 2012).
In the First Circuit, a district court’s decision whether to
allow an amendment to pleadings after the scheduling
order deadline is reviewed for abuse of discretion.
O’Connell v. Hyatt Hotels of P.R., 357 F.3d 152, 154–55
trex Int’l PLC v. M.D. Pers. Prods. Corp., 5 F.3d 1505,
1993 WL 306169, at *2 (Fed. Cir. 1993) (unpublished
table decision) (Devices “made for FDA approval” do not
forfeit their § 271(e)(1) exemption “when used in other
noninfringing manners.”); Intermedics, Inc. v. Ventritex
Co., 991 F.2d 808, 1993 WL 87405, at *2 (Fed. Cir. 1993)
(unpublished table decision) (“All of [the defendant’s]
activities providing clinical units of the [accused device] to
its researcher in Germany were solely reasonably related
to generating data for FDA approval.”).
20 MOMENTA PHARM., INC. v. TEVA PHARM., INC.
(1st Cir. 2004). 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 in light of our
holding.
CONCLUSION
For these reasons, the decision of the district court
granting summary judgment to Teva is AFFIRMED and
the decision of the district court granting summary judg-
ment to Amphastar is
AFFIRMED-IN-PART, VACATED-IN-PART, AND
REMANDED
COSTS
Each party in the Amphastar litigation shall bear its
own costs.
United States Court of Appeals
for the Federal Circuit
______________________
MOMENTA PHARMACEUTICALS, INC.,
SANDOZ INC.,
Plaintiffs-Appellants
v.
TEVA PHARMACEUTICALS USA, INC.,
Defendant-Appellee
______________________
2014-1274, 2014-1277
______________________
Appeals from the United States District Court for the
District of Massachusetts in No. 1:10-cv-12079-NMG,
Judge Nathaniel M. Gorton.
------------------------------------------------------------------
MOMENTA PHARMACEUTICALS, INC.,
SANDOZ INC.,
Plaintiffs-Appellants
v.
AMPHASTAR PHARMACEUTICALS, INC.,
INTERNATIONAL MEDICATION SYSTEMS, LTD.,
ACTAVIS, INC., ACTAVIS PHARMA, INC., FKA
WATSON PHARMA, INC.,
Defendants-Appellees
______________________
2 MOMENTA PHARM., INC. v. TEVA PHARM., INC.
2014-1276, 2014-1278
______________________
Appeals from the United States District Court for the
District of Massachusetts in No. 1:11-cv-11681-NMG,
Judge Nathaniel M. Gorton.
______________________
DYK, Circuit Judge, concurring in part and dissenting in
part.
While I join the majority opinion insofar as it holds
that the 35 U.S.C. § 271(e)(1) safe harbor does not im-
munize Amphastar’s accused use of the ’886 patent in its
manufacturing process, I respectfully dissent from the
majority’s holding that Teva does not infringe the ’886
patent under 35 U.S.C. § 271(g). 1 The majority reasons
1 The majority also determined that Amphastar
does not infringe under § 271(g). This has little practical
consequence since the majority holds that the § 271(e)(1)
safe harbor does not shield Amphastar from liability
under § 271(a).
However, the parties dispute whether § 271(g) can
apply to products made in the United States. While the
primary purpose of § 271(g) was to impose infringement
liability for products shipped to the United States but
made abroad by a United States patented process, the
plain language of § 271(g) admits of no such geographic
limitation. And the legislative history is clear that
§ 271(g) includes situations where the process is practiced
in the United States. As the Senate Judiciary Committee
report stated, “the process patent bill was crafted to apply
equally to the use or sale of a product made by a process
patented in this country whether the product was made
. . . in this country or in a foreign country.” S. Rep. No.
100-83, at 46 (1987).
MOMENTA PHARM., INC. v. TEVA PHARM., INC. 3
that a patent related to quality control testing cannot be
infringed under § 271(g), which states, “[w]hoever 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.” 35 U.S.C. § 271(g) (2012) (empha-
sis added). Quality control, according to the majority, is
not used to “make” a product. This seems to me too lim-
ited a construction of § 271(g).
I
The central question here is whether quality control is
part of the process of “manufacturing” a product. The
majority holds that it is not, relying primarily on Bayer
AG v. Housey Pharmaceuticals, Inc., 340 F.3d 1367 (Fed.
Cir. 2003). There we held that § 271(g) “contemplates that
‘made’ means ‘manufactured.’” Id. at 1372. We also held
that “in order for a product to have been ‘made by a
process patented in the United States’ it must have been
a physical article.” Id. at 1377. Finally, Bayer held that
“the process must be used directly in the manufacture of
the product, and not merely as a predicate process to
identify the product to be manufactured.” Id. at 1378.
Thus in Bayer we held that a method for screening sub-
stances to identify promising products was not a method
used in the manufacture of a product. Id. at 1369, 1378.
“A drug product, the characteristics of which were studied
The cases on which Amphastar relies as suggesting
that the statute is limited to practicing a process abroad
hold no more than that § 271(g) applies to that circum-
stance. See, e.g., Ajinomoto Co. v. Archer-Daniels-Midland
Co., 228 F.3d 1338, 1347 (Fed. Cir. 2000). They do not
suggest that the sale of a product made by the practice of
a process in the United States would not be an infringe-
ment under § 271(g).
4 MOMENTA PHARM., INC. v. TEVA PHARM., INC.
using the claimed research processes . . . is not a product
‘made by’ those claimed processes.” Id. at 1378. 2
The patent here, however, is not utilized to identify
the product to be made, but rather is used in the manu-
facturing process. The quality control process of the ’886
patent is an intermediate step to determine which batches
of putative enoxaparin must be discarded, and which
batches may be incorporated in the final drug product. It
is distinctly part of the manufacturing process of the
product.
The dictionary definitions of “make” and “manufac-
ture” relied on by the majority at most suggest that
quality control, standing alone, is not making or manufac-
turing. But they hardly suggest that quality control is not
part of making or manufacturing. Nor can there be any
suggestion that the processes described in § 271(g) are
limited to those that cover the entire manufacturing
process. The majority opinion cites no authority that
quality control is not a part of manufacturing, other than
our non-precedential decision in Phillip M. Adams &
Associates, LLC v. Dell Computer Corp., 519 F. App’x 998
(Fed. Cir. 2013). In fact, quality control is, as a general
matter, considered to be a part of the drug manufacturing
2 Sharafabadi v. University of Idaho, No. C09-
1043JLR, 2009 WL 4432367 (W.D. Wash. Nov. 27, 2009),
relied on by the majority, is similar to Bayer and is equal-
ly beside the point. Maj. Op. at 9. In Sharafabadi, the
district court found that the patent holder “alleg[ed] only
that the Universities used the [patent] as a research tool
to test the characteristics of various yellow mustard
seeds” in the course of developing a new IdaGold mustard
seed and “[did] not allege that [any defendant] used the
[patent] to directly manufacture or produce the IdaGold
seeds.” Sharafabadi, 2009 WL 4432367, at *5 (citing
Bayer, 340 F.3d at 1378).
MOMENTA PHARM., INC. v. TEVA PHARM., INC. 5
process. That is the view of the Food and Drug Admin-
istration (“FDA”). The FDA, in its Good Manufacturing
Practice regulations, 21 C.F.R. §§ 210.1–210.3, defines
“[m]anufacture” as “includ[ing] packaging and labeling
operations, testing, and quality control of drug products.”
21 C.F.R. § 210.3(12) (2011) (emphasis added).
Similarly, statutes and regulations in other areas
have recognized that quality control is inherent in the
manufacturing process. For example, in the manufacture
of chemicals, the Toxic Substances Control Act provides
that the Administrator of the Environmental Protection
Agency may “require . . . [a] manufacturer or processor to
submit a description of the relevant quality control proce-
dures followed in the manufacturing or processing of [a]
chemical substance or mixture.” 15 U.S.C. § 2605(b). So,
too, in the manufacture of medical devices. A medical
device manufacturer, in order to obtain approval of a
device under the Investigational Device Exemption, must
submit an application with, inter alia, a “description of
the methods, facilities, and controls used for the manufac-
ture . . . of the device . . . so that a person generally famil-
iar with good manufacturing practices can make a
knowledgeable judgment about the quality control used in
the manufacture of the device.” 21 C.F.R. § 812.20 (2015).
In other words, quality control is “used in the manufac-
ture of the device.” Id.; see also United States v. Castillo,
928 F.2d 1106, 1108 (11th Cir. 1991) (“A device that is
used for ‘quality control’ in the manufacture of any item
can be considered a device used in the manufacture of the
product.”).
II
However, we need not reach the question here of
whether quality control is always part of a manufacturing
process. Our precedent suggests that we should resolve
the question of whether a product was “made by” a pro-
cess on a case-by-case basis. See Bio-Tech. Gen. Corp. v.
6 MOMENTA PHARM., INC. v. TEVA PHARM., INC.
Genentech, Inc., 80 F.3d 1553, 1561 (Fed. Cir. 1996).
Under the facts of this case, the quality control testing of
the ’886 patent is clearly an integral part of the manufac-
turing process of enoxaparin. In order to understand why,
it is helpful to understand how the final enoxaparin drug
product is made.
Heparin is a naturally occurring anticoagulant con-
sisting of a mixture of long chains of sugar molecules.
Heparin may be cleaved, using different methods, into
shorter sugar chains (“oligosaccharides”) to create differ-
ent low molecular weight heparins (“LMWHs”), each of
which is a different heterogeneous collection of oligosac-
charides. The different heterogeneous collections of oligo-
saccharides give each LMWH a different therapeutic
effect.
Enoxaparin is one type of LMWH, and was first sold
under the brand name Lovenox. As with any LMWH, the
sugar chains in enoxaparin may differ slightly from batch
to batch, but they have structural similarities determined
to be unique to that LMWH. One such signature structur-
al feature is a 1,6-anhydro ring structure that is present
at approximately 20% of the reducing ends of sugar
chains in the collection. The molecular diversity of
enoxaparin creates special problems for the manufactur-
ing of a generic version of the drug, which must be bio-
equivalent to and contain the same active ingredients as
the branded drug. Thus, as we previously described,
the FDA identified five criteria, or standards for
identity, that together provide sufficient infor-
mation to conclude that generic enoxaparin has
the ‘same’ active ingredient as Lovenox. These cri-
teria included, inter alia, [e]quivalence in disac-
charide building blocks, fragment mapping, and
sequence of oligosaccharide species. . . . Detecting
the presence of a 1, 6 anhydro ring structure is
MOMENTA PHARM., INC. v. TEVA PHARM., INC. 7
particularly important for proving equiva-
lence . . . .
Momenta Pharm., Inc. v. Amphastar Pharm., Inc. (Mo-
menta I), 686 F.3d 1348, 1350–51 (Fed. Cir. 2012) (cita-
tions and quotation marks omitted). As required by the
FDA, only batches in which 15–25% of the sugar chains
contain a 1,6-anhydro ring structure at the reducing end
may be released and combined for further processing to
become the finished drug product.
Momenta’s ’886 patent claims a method of analyzing
and selecting batches of intermediate enoxaparin drug
substance, based on the appropriate quantity of sugar
chains containing the 1,6-anhydro ring structure. The
patent contemplates the usage of its methods during the
manufacturing process, teaching, for example, a method
that “provides a way to both streamline manufacturing
and reduce costs while ensuring a more consistent, higher
quality product,” U.S. Patent No. 7,757,886 col. 34 ll. 43–
52. The specification also notes that the methods of the
claimed invention allow for the creation of “LMWH prepa-
rations with low batch-batch variability and a desired
structural signature,” id. at col. 60 l. 66–col. 61 l. 3. It
compares the claimed method of conducting a structural
characterization of LMWHs with the prior art “current
manufacturing practices for . . . LMWHs [which] use
functional assays . . . and gross physical characterization
to provide quality control,” id. at col. 48 ll. 1–7.
As the majority characterizes it, “‘ma[king]’ does not
extend to testing to determine whether an already syn-
thesized drug product possesses existing qualities or
properties.” Maj. Op. at 8–9. While I do not agree with the
majority’s cabining of the term “making,” even under the
majority’s test, the quality control process is an integral
part of the manufacturing of the enoxaparin drug product.
The enoxaparin drug substance that is tested using the
method of the ’886 patent is far from being a finished
8 MOMENTA PHARM., INC. v. TEVA PHARM., INC.
product. The FDA defines a “drug product” as the “fin-
ished dosage form, for example, tablet, capsule, solution,
etc.” 21 C.F.R. § 210.3(4) (2015). Even after the identity of
the drug substance is confirmed utilizing the quality
control steps of the ’886 patent, further processing steps
remain: “weighing, combining the enoxaparin in one batch
with other batches of enoxaparin that have been similarly
processed and selected by use of the claimed method,
compounding the resulting mixture with specially-
purified water, sterilizing this compound, placing it into
syringes, and labeling and packaging the finished prod-
uct.” J.A. 12440. Only after these additional processing
steps are completed is the drug product ready for com-
mercial sale. See 21 C.F.R. § 210.3(4). Thus, the quality
control testing method of the ’886 patent is a necessary
intermediate step in the manufacture of enoxaparin.
In this respect this case is similar to Bio-Technology,
where we considered whether a manufacturer’s importa-
tion of human growth hormone (“hGH”) could infringe two
Genentech patents under § 271(g). 80 F.3d at 1558. The
first patent was a method of producing hGH in bacterial
hosts by inserting a semi-synthetic gene (e.g., a “plas-
mid”), encoding for hGH and one additional amino acid,
into bacterial cells that could then express the hGH
product. Id. at 1556–57. The second patent’s claims were
directed to the method for constructing a plasmid, in
other words, a method for creating information that the
bacterial cells could use to generate the product. Id. at
1557. Notably, there was no doubt that the “plasmid
product of the claimed process and hGH are entirely
different materials.” Id. at 1561. Nonetheless, we noted
that the manufacturer “use[d] the claimed process of
making a [plasmid] as an essential part of an overall
process for producing hGH,” and held that “it cannot be
said as a matter of law that the production of hGH is too
remote from the claimed process of making a replicable
cloning vehicle.” Id.
MOMENTA PHARM., INC. v. TEVA PHARM., INC. 9
In Bio-Technology, the practice of the plasmid patent
was an essential intermediate component of the overall
process for producing hGH. Similarly, here, the quality
control step of the ’886 patent is an essential intermediate
step in the overall production of enoxaparin. In this case,
the majority states that “[n]o assertion is made . . . that
the enoxaparin samples on which tests are performed are
themselves incorporated into the finished product or
imported into the United States.” Maj. Op. at 9–10. But
this was also true in Bio-Technology, and provides no
ground for distinction.
III
Finally, limiting “made” in § 271(g) to “the creation or
transformation of a product, such as by synthesizing,
combining components, or giving raw materials new
properties,” Maj. Op. at 8, would lead to anomalous re-
sults. Patents on purification methods or the quality
control method at issue here, which may be integral to the
regulatory or commercial viability of a product, but which
do not create or transform a product, combine compo-
nents, or confer new properties, could be freely infringed
simply by outsourcing those processes abroad. Congress
could not have intended to create this loophole when it
sought to protect process patent owners from foreign
competitors using U.S. manufacturing processes abroad.
See generally Eli Lilly & Co. v. Am. Cyanamid Co., 82
F.3d 1568, 1571–72 (Fed. Cir. 1996).
I respectfully dissent.