Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-14-01276/USCOURTS-ca13-14-01276-0/pdf.json

Parties Involved:
Actavis Pharma, Inc.
Appellee
Actavis, Inc.
Appellee
Amphastar Pharmaceuticals, Inc.
Appellee
International Medication Systems, Ltd.
Appellee
Momenta Pharmaceuticals, Inc.
Appellant
Sandoz Inc.
Appellant
Watson Pharma, Inc.
Appellee

Document Text:

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

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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, Washington, DC, argued for plaintiffs-appellants. Also represented by 

BRIAN ROBERT MATSUI, MARC A. HEARRON. Plaintiffappellant Momenta Pharmaceuticals, Inc. also represented 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 argued 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 Amphastar 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.

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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, Momenta appeals the district court’s decision finding Amphastar 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 judgment 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 remand as to Amphastar for further proceedings consistent 

with this opinion. 

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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 enoxaparin 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. Momenta 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 infringe because it fell within the safe harbor from infringement provided by 35 U.S.C. § 271(e)(1), which states 

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).1 The district court also rejected Momenta’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 LeahySmith America Invents Act, Pub. L. No. 112-29, 125 Stat. 

284 (2011). 

 

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(emphasis added). The district court reasoned that the 

patented process related to “quality control release testing” and was “not a method of making enoxaparin.” J.A. 

(-1274, -1277) 7. 

Amphastar is also a generic manufacturer of enoxaparin. 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 injunction 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 “[Amphastar’s] activities are . . . protected by the safe harbor” 

of § 271(e)(1), which decision forms the basis of the present appeal. J.A. (-1276, -1278) 9.

Momenta appeals the district court’s grants of summary 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 argued 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 

 

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6 MOMENTA PHARM., INC. v. TEVA PHARM., INC. 

DISCUSSION

I. Standard of Review

This court reviews summary judgment decisions under 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. Adamson 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 Process3

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 separately 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 manufacture 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. 

 

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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 manufacturing 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 product.”). 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 merit, 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 intermediate 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 construction, [u]nless otherwise defined, words will be interpreted 

as taking their ordinary, contemporary, common meaning.” Bilski v. Kappos, 561 U.S. 593, 603 (2010) (alteraCase: 14-1276 Document: 120-2 Page: 7 Filed: 11/10/2015
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 something. 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 alreadysynthesized drug substance possesses existing qualities or 

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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)].”); Sharafabadi 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. Hitchcock & 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 testing 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 

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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 (emphasis 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 BioTechnology General Corp. v. Genentech, Inc., which involved 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 BioTechnology 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 process. 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. 

 

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activate a particular protein.” Id. at 1369 (internal quotation 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 process 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 “analyzing” 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 including ‘testing[] and quality control,’” as Momenta asserts. 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 

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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 executive 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 enoxaparin 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 factdependent, as a general matter purification processes 

transform impure substances into more pure ones. Purification 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.

 

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III. The § 271(e)(1) Safe Harbor Does Not Shield the 

Accused Use by Amphastar

Unlike Teva, Amphastar does not assert it manufactures 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 patented drug product, when the purpose is to prepare 

for commercial activity which will begin after a 

valid patent expires, is not a patent infringement.

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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) (capitalization 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 “promot[ional]” rather than regulatory, at least where those 

activities are “consistent with the collection of data necessary for filing an application with the [FDA] . . . for approval.” AbTox, Inc. v. Exitron Corp., 122 F.3d 1019, 1027 

(Fed. Cir. 1997). Moreover, notwithstanding the legislative focus on activities occurring prior to the approval of 

generic drugs, the § 271(e)(1) exemption applies to medical 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 activities 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 themselves 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 

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F.3d at 1352. Amphastar argues this court in Momenta I 

“already decided that Amphastar’s safety testing is protected 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 discretion.” 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) (internal 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 actually been decided. Findings of fact and fact-intensive conclusions 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 necessarily 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] determination, 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 

Case: 14-1276 Document: 120-2 Page: 15 Filed: 11/10/2015
16 MOMENTA PHARM., INC. v. TEVA PHARM., INC. 

marks and citation omitted)). Because Momenta is not 

seeking to relitigate an issue that was already conclusively 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 erroneous 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, Webster’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 manufacturing control processes that ensure that each batch of generic 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). 

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MOMENTA PHARM., INC. v. TEVA PHARM., INC. 17

The routine record retention requirements associated 

with testing and other aspects of the commercial production process contrast with non-routine submissions that 

may occur both pre- and post-approval, such as the submission 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 testing of each batch of generic enoxaparin as part of the postapproval, 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 commercial production makes no difference. Appellees’ Br. 

(-1276, -1278) 42 (citing AbTox, 122 F.3d at 1030). However, 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 consequences of the activity.” 122 F.3d at 1030 (emphasis added). 

Here, Amphastar makes no claim that its accused, postapproval use of the patented method is related to obtaining FDA approval. Although Momenta I held that “postapproval studies” can fall within the § 271(e)(1) safe 

harbor, 686 F.3d at 1359, whether such uses are “reasonably related” to a § 271(e)(1) “submission” requires more 

critical analysis in the post-approval context.

The conclusion in Momenta I that Amphastar’s commercial use of Momenta’s patented method falls within 

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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 research falls within the § 271(e)(1) safe harbor “as long as 

there is a reasonable basis for believing that the experiments 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) (capitalization 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-

 

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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 procedures and sought to provide additional documentary 

support for the new infringement contentions. Thereafter, 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 “summary 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 pleadings 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.”).

 

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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 judgment to Amphastar is

AFFIRMED-IN-PART, VACATED-IN-PART, AND 

REMANDED

COSTS

Each party in the Amphastar litigation shall bear its 

own costs.

Case: 14-1276 Document: 120-2 Page: 20 Filed: 11/10/2015
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.

------------------------------------------------------------------

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

______________________ 

Case: 14-1276 Document: 120-2 Page: 21 Filed: 11/10/2015
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 immunize 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). 

 

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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) (emphasis added). Quality control, according to the majority, is 

not used to “make” a product. This seems to me too limited 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 substances 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 circumstance. 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 infringement under § 271(g). 

 

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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 manufacturing 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 “manufacture” relied on by the majority at most suggest that

quality control, standing alone, is not making or manufacturing. 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 equally 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).

 

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process. That is the view of the Food and Drug Administration (“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 procedures 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 manufacture . . . of the device . . . so that a person generally familiar 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 manufacture 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 process on a case-by-case basis. See Bio-Tech. Gen. Corp. v. 

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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 manufacturing 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 consisting of a mixture of long chains of sugar molecules. 

Heparin may be cleaved, using different methods, into 

shorter sugar chains (“oligosaccharides”) to create different low molecular weight heparins (“LMWHs”), each of 

which is a different heterogeneous collection of oligosaccharides. The different heterogeneous collections of oligosaccharides 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 structural 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 manufacturing of a generic version of the drug, which must be bioequivalent 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 information to conclude that generic enoxaparin has 

the ‘same’ active ingredient as Lovenox. These criteria included, inter alia, [e]quivalence in disaccharide building blocks, fragment mapping, and 

sequence of oligosaccharide species. . . . Detecting 

the presence of a 1, 6 anhydro ring structure is 

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MOMENTA PHARM., INC. v. TEVA PHARM., INC. 7

particularly important for proving equivalence . . . . 

Momenta Pharm., Inc. v. Amphastar Pharm., Inc. (Momenta I), 686 F.3d 1348, 1350–51 (Fed. Cir. 2012) (citations 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 preparations 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 synthesized 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 

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8 MOMENTA PHARM., INC. v. TEVA PHARM., INC. 

product. The FDA defines a “drug product” as the “finished 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 speciallypurified water, sterilizing this compound, placing it into 

syringes, and labeling and packaging the finished product.” J.A. 12440. Only after these additional processing 

steps are completed is the drug product ready for commercial 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 importation 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 “plasmid”), 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.

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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 results. 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 components, 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. 

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