United States Court of Appeals 

for the Federal Circuit 

__________________________ 

MOMENTA PHARMACEUTICALS, INC., 

Plaintiff-Appellee, 

and 

SANDOZ, INC., 

Plaintiff-Appellee, 

v. 

AMPHASTAR PHARMACEUTICALS, INC., 

INTERNATIONAL MEDICATION SYSTEMS, LTD., 

WATSON PHARMACEUTICALS, INC., 

AND WATSON PHARMA, INC., 

Defendants-Appellants. 

__________________________ 

2012-1062, -1103, -1104 

__________________________ 

Appeals from the United States District Court for the 

District of Massachusetts in case no. 11-CV-11681, Judge 

Nathaniel M. Gorton. 

__________________________ 

Decided: August 3, 2012 

___________________________ 

ROBERT S. FRANK, JR., Choate Hall & Stewart LLP, of 

Boston, Massachusetts, argued for both plaintiffsappellees. With him on the brief was ERIC J. MARANDETT. 

Of counsel on the brief for plaintiff-appellee for Sandoz, 
MOMENTA PHARMA v. AMPHASTAR PHARMA 2

Inc., was THOMAS P. STEINDLER, McDermott, Will & 

Emery LLP, of Washington, DC. 

PATRICIA A. MILLETT, Akin Gump Strauss Hauer & 

Feld LLP, of Washington, DC, argued for plaintiffsappellants. With her on the brief were ANTHONY T.

PIERCE, MARK MANSOUR, EMILY C. JOHNSON and JAMES E.

TYSSE; and L. RACHEL LERMAN, of Los Angeles, California. 

__________________________ 

Before RADER, Chief Judge, DYK and MOORE, Circuit 

Judges. 

Opinion for the court filed by Circuit Judge MOORE. 

Dissenting opinion filed by Chief Judge RADER. 

MOORE, Circuit Judge. 

Amphastar Pharmaceuticals, Inc., International 

Medication Systems, Ltd., Watson Pharmaceuticals, Inc., 

and Watson Pharma, Inc. (collectively, Amphastar) appeal 

the district court’s order denying the Emergency Motion 

to Dissolve or Stay the preliminary injunction entered in 

this case. Because the district court applied an unduly 

narrow interpretation of the Hatch-Waxman safe harbor, 

35 U.S.C. § 271(e)(1), we vacate the grant of a preliminary 

injunction and remand for further proceedings consistent 

with this opinion. 

BACKGROUND

This case is a patent litigation involving a generic 

version of Lovenox (enoxaparin), a drug that prevents 

blood clots. Enoxaparin is a low molecular weight version 

of heparin, a naturally occurring molecule. Heparin is a 

polymer, known as a polysaccharide, made up of long 

chains of sugar molecules. Heparin is not a single defined 

molecule. Instead, heparin molecules have considerable 
3 MOMENTA PHARMA v. AMPHASTAR PHARMA

diversity in (1) the length of the polysaccharide chain and 

(2) in the component disaccharide units and the corresponding distribution of disaccharide unit sequences in 

the polysaccharide chains. FDA Letter to Aventis Pharmaceuticals, Inc., July 23, 2010, FDA Docket No. FDA2003-P-0273 (FDA Letter), J.A. 291. For example, the 

molecular weight of heparin molecules varies between 

5,000 and 40,000 daltons. Id. Likewise, the disaccharide 

units can vary between two different uronic acid components, and each of four positions on the disaccharide unit 

can be modified. Id., J.A. 291-92. The natural diversity 

inherent to heparin stems from the biosynthetic pathway 

used to produce the molecule. Id., J.A. 292. 

Enoxaparin is produced by breaking the heparin polysaccharide into smaller pieces, called oligosaccharides. 

Because the heparin starting material is a diverse set of 

molecules, enoxaparin is also made up of different chain 

lengths and disaccharide units corresponding to the 

diversity in the original mix of heparin molecules. Id. 

Additional diversity is introduced based on the way in 

which the heparin molecule is broken down into the low 

molecular weight heparin product. Id., JA 292-93. Thus, 

unlike a typical small molecule drug like penicillin, enoxaparin is made up of a range of different molecules. 

This molecular diversity raises a potential problem in 

light of the Food and Drug Administration’s (FDA’s) 

abbreviated new drug application (ANDA) approval 

process. ANDAs are typically used by generic companies 

to obtain approval to market a generic version of an 

existing drug. Unlike a new drug application (NDA), an 

ANDA applicant is not required to submit the same 

extensive clinical studies typically needed to prove the 

drug’s safety and efficacy. Instead, the ANDA applicant 

must submit studies to establish that its drug is bioequivalent to the reference drug. The ANDA must also 
MOMENTA PHARMA v. AMPHASTAR PHARMA 4

include sufficient information to establish that the generic 

drug has the same active ingredients as the reference 

drug. 

The obvious complication with using an ANDA application to gain approval for enoxaparin is that it is a 

mixture of a number of different low molecular weight 

heparin molecules. In fact, Aventis, which marketed 

Lovenox, asked the FDA to deny approval for a generic 

version of enoxaparin via an ANDA unless the applicant 

either (1) completely characterized enoxaparin by isolating, purifying, and sequencing each of its unique polysaccharide chains, which Aventis claimed was impossible; 

(2) used Aventis’s manufacturing process; or (3) conducted 

clinical trials to prove safety and efficacy (the very type of 

duplicative studies the ANDA approval process was 

designed to avoid). FDA Letter, J.A. 286. The FDA 

rejected Aventis’s arguments, and instead explained that 

the ANDA “statutory provisions do not describe the type 

or amount of information that an ANDA applicant must 

submit to demonstrate that the active ingredient in the 

generic drug product is the same as the active ingredient 

in the [reference drug].” Id., J.A. 294. As a result, the 

FDA concluded that Congress recognized that the FDA 

has “broad discretion with respect to the information [it] 

may consider in making a finding on the ‘sameness’ of an 

active ingredient.” Id. 

Consistent with this discretion, 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.” 

Id., J.A. 295. These criteria included, inter alia, 

“[e]quivalence in disaccharide building blocks, fragment 

mapping, and sequence of oligosaccharide species.” Id. 

The FDA explained that such equivalence is proven by 

“exhaustive digestion of enoxaparin with purified heparin 
5 MOMENTA PHARMA v. AMPHASTAR PHARMA

digesting enzymes (heparinases I, II, III) and nitrous acid, 

among other means, to yield the constituent disaccharide 

building blocks comprising enoxaparin.” Id., J.A. 300. 

These disaccharides can then potentially be “separated 

and quantified” by a number of techniques, including 

capillary electrophoresis (CE), reverse phase high performance liquid chromatography (RP-HPLC), and strong 

anion exchange high performance liquid chromatography 

(SAX-HPLC). Id. 

The FDA also suggested the identity of the disaccharides could be determined via standard techniques, including mass spectroscopy, NMR spectroscopy, modifying 

reagents, or modifying enzymes. These techniques identify the nature of the constituent sugars and their substitution patterns, including the sulfation and acetylation 

patterns, as well as “whether the disaccharide possesses, 

among other structures, a . . . 1,6 anhydro ring” structure. 

Id., J.A. 300-01. Detecting the presence of a 1,6 anhydro 

ring structure is particularly important for proving 

equivalence because “[e]quivalence in disaccharide building blocks together with equivalence in molecular weight 

distribution shows that generic enoxaparin contains the 

1,6 anhydro ring structure at the reducing ends of between 15 percent and 25 percent of its 

poly(oligo)saccharide chains.” Id. n.68, J.A. 301. 

Amphastar was the first company to file an ANDA for 

a generic version of enoxaparin. It submitted its ANDA to 

the FDA in March 2003, and subsequently engaged in a 

lengthy patent litigation with Sanofi-Aventis. Amphastar 

received FDA approval to market its generic enoxaparin 

on September 19, 2011. Despite the fact that Amphastar 

was the first company to file an ANDA, Momenta Pharmaceuticals, Inc. and Sandoz, Inc. (collectively Momenta), 

who collaborated to develop a generic enoxaparin product, 

were the first to bring generic enoxaparin to the market-
MOMENTA PHARMA v. AMPHASTAR PHARMA 6

place. Momenta received FDA approval to market enoxaparin in July 2010, more than a year before Amphastar’s 

approval. Being the only generic version of enoxaparin 

has it benefits: its sales generated revenues of $260 

million per quarter. J.A. 189. The approval of Amphastar’s version of enoxaparin, and the resultant ruinous 

competition of another generic version of the drug, threatened this unique market position. Understandably unwilling to give up a billion dollars in yearly revenue, 

Momenta initiated the present litigation two days after 

Amphastar received final FDA approval to market its 

generic enoxaparin. 

Momenta is the assignee of United States Patent No. 

7,575,886 (’886 patent). The ’886 patent generally relates 

“to methods for analyzing heterogeneous populations of 

sulfated polysaccharides, e.g. heparin [and] . . . LMWH 

[e.g., enoxaparin.]” ’886 patent col.4 ll.53-55. Claim 6 is 

typical. It is a method for analyzing an enoxaparin sample “for the presence or amount of a non naturally occurring sugar . . . that results from a method of making 

enoxaparin that included β-eliminative cleavage with a 

benzyl ester and depolymerization.” Id. col.64 ll.35-39. 

Momenta also asserted independent claims 15, which 

assesses the level of non-naturally occurring sugar, and 

53, which allows selection of an appropriate batch. These 

claims are similar to claim 6. The asserted claims generally require digestion of an enoxaparin sample with a 

heparin degrading enzyme, followed by the use of a separation method to detect the presence of the non-naturally 

occurring sugar resulting from the β-eliminative cleavage. 

The signal corresponding to the non-naturally occurring 

sugar can then be used to analyze the test sample based 

on a comparison with a reference standard. Id. col.64 

ll.40-57. 
7 MOMENTA PHARMA v. AMPHASTAR PHARMA

Momenta alleged that Amphastar infringed the ’886 

patent by “manufacturing generic enoxaparin for commercial sale” using the claimed methods. J.A. 58. Momenta asserted that Amphastar “included in their process 

for manufacturing batches of enoxaparin sodium . . . a 

method for determining that a defined percentage of the 

oligosaccharide chains that make up enoxaparin include 

. . . a non-naturally occurring sugar that includes a 1,6-

anhydro ring structure, which method infringes the ’886 

patent.” J.A. 57. Momenta also alleged that this infringing testing was necessary because the “FDA requires a 

generic manufacture to include in its manufacturing 

process the analysis of each batch of its enoxaparin drug 

substance to confirm that . . . [it] includes a 1,6-anhydro 

ring structure.” J.A. 56. Momenta moved for and received a temporary restraining order to prevent the 

irreparable harm of additional generic entry from Amphastar. J.A. 4. The district court subsequently granted 

Momenta a preliminary injunction based on its belief that 

Amphastar’s quality control batch testing infringed the 

’886 patent. J.A. 30. Amphastar later filed two emergency motions for relief from the preliminary injunction, 

which the district court denied. 

Amphastar sequentially appealed the preliminary injunction and the two denials for relief from the preliminary injunction. These three appeals were consolidated. 

We have jurisdiction to hear these appeals pursuant to 28 

U.S.C. § 1292. After hearing oral argument in this case, 

we stayed the preliminary injunction. This stay, however, 

was not a final decision on the merits of Amphastar’s 

appeal. We now explain why the district court incorrectly 

concluded that Momenta was likely to succeed on the 

merits of its infringement claim, and conclude that the 

preliminary injunction must be vacated. 
MOMENTA PHARMA v. AMPHASTAR PHARMA 8

ANALYSIS

“The issuance of a preliminary injunction . . . is a matter of discretion for a district court. That discretion, 

however, is not absolute and must be reviewed in light of 

the equitable standards governing the issuance of injunctions.” Intel Corp. v. ULSI Sys. Tech., Inc., 995 F.2d 1566, 

1568 (Fed. Cir. 1993). To determine whether a preliminary injunction is appropriate, the district court weighs 

factors including “(1) whether the movant has sufficiently 

established a reasonable likelihood of success on the 

merits; (2) whether the movant would suffer irreparable 

harm if the injunction were not granted; (3) whether the 

balance of hardships tips in the movant's favor; and (4) 

the impact, if any, of the injunction on the public interest.” Id. The grant of a preliminary injunction can be 

overturned “by showing that the court made a clear error 

of judgment in weighing relevant factors or exercised its 

discretion based upon an error of law or clearly erroneous 

factual findings.” Genentech, Inc. v. Novo Nordisk A/S, 

108 F.3d 1361, 1364 (Fed. Cir. 1997). As the party seeking the injunction, the burden is on Momenta to establish 

it is entitled to this extraordinary relief. Id. In order to 

prove a likelihood of success on the merits, Momenta must 

prove that Amphastar likely infringes its patent. Id. 

Conversely, if Amphastar establishes that Momenta is 

unlikely to succeed on its claim of infringement, a preliminary injunction is likely not appropriate. Id.

In its opposition to the preliminary injunction, Amphastar argued, among other things, that its testing falls 

within the scope of the Hatch-Waxman safe harbor, 35 

U.S.C. § 271(e)(1). Section 271(e)(1) indicates that “[i]t 

shall not be an act of infringement 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 
9 MOMENTA PHARMA v. AMPHASTAR PHARMA

of drugs . . . .” The district court found that “the alleged 

infringing activity involves the use of plaintiffs’ patented 

quality control testing methods on each commercial batch 

of enoxaparin that will be sold after FDA approval.” J.A. 

31; see also J.A. 56 (Momenta’s complaint alleging that 

the “FDA requires” the testing). While acknowledging 

that Amphastar’s use of the patented method was for the 

purpose of developing information to submit to the FDA, 

the district court nevertheless concluded that the safe 

harbor does not apply to Amphastar’s testing: “although 

the safe harbor provision permits otherwise infringing 

activity that is conducted to obtain regulatory approval of 

a product, it does not permit a generic manufacturer to 

continue in that otherwise infringing activity after obtaining such approval.” J.A. 23. In reaching this conclusion, 

the district court focused primarily on the legislative 

history of the safe harbor, as quoted in one of our prior 

cases, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 

F.3d 1057 (Fed. Cir. 2011). J.A. 23. 

On appeal, Amphastar argues that the district court 

took an unduly restrictive view of the safe harbor, and 

that its activities fall within the plain language of 35 

U.S.C. § 271(e)(1). Momenta counters that the district 

court correctly held that the safe harbor does not apply to 

Amphastar’s testing for two reasons. First, Momenta 

argues that that the safe harbor does not apply to postapproval activity: “In Classen, this court squarely held 

that ‘[t]he [safe harbor] does not apply to information that 

may be routinely reported to the FDA long after marketing approval has been obtained.’” Appellee’s Br. at 43 

(quoting Classen, 659 F.3d at 1070, alterations made by 

Momenta)). Because Amphastar’s batch testing is carried 

out as a condition for the post-FDA approval sale of 

enoxaparin, Momenta argues it falls outside the scope of 

the safe harbor. 
MOMENTA PHARMA v. AMPHASTAR PHARMA 10

Second, despite its allegations and concessions, Momenta asserts the safe harbor does not apply because “the 

FDA does not require the use of the particular procedure 

that is claimed in the ’886 patent.” Id. at 41. Instead, 

Momenta claims that the FDA’s interpretation of its 

statutory mandate in its letter response to Aventis’s 

petition, J.A. 300-01, allows a variety of testing methods 

to be used to establish equivalence, both for the submission of an ANDA and for the undisputedly required batch 

testing. Appellee’s Br. at 41. Momenta argues that the 

availability of other acceptable testing methods means 

that Amphastar’s alleged use of the patented method is 

not required by the FDA, and is therefore outside of the 

safe harbor provision. 

The parties thus present us with conflicting views 

about the scope of the safe harbor. If Amphastar is correct that its post-approval activities actually fall within 

the scope of 35 U.S.C. § 271(e)(1), Momenta is unlikely to 

succeed on its claim of infringement and the preliminary 

injunction is likely inappropriate. Genentech, 108 F.3d at 

1364. In order to determine whether the preliminary 

injunction was appropriate in this case, we must first 

ascertain the scope of the Hatch-Waxman safe harbor 

provision, 35 U.S.C. § 271(e)(1). 

I. 

“[A]ll statutory construction cases . . . begin with the 

language of the statute.” Barnhart v. Sigmon Coal Co., 

534 U.S. 438, 450 (2002). The “first step in interpreting a 

statute is to determine whether the language at issue has 

a plain and unambiguous meaning with regard to the 

particular dispute in the case.” Robinson v. Shell Oil Co., 

519 U.S. 337, 340 (1997). If the language of the statute is 

unambiguous, there is no second step: “Our inquiry must 

cease if the statutory language is unambiguous and ‘the 
11 MOMENTA PHARMA v. AMPHASTAR PHARMA

statutory scheme is coherent and consistent.’” Id. (quoting United States v. Ron Pair Enters., Inc., 489 U.S. 235, 

240 (1989)). Whether the text of a statute is plain or 

ambiguous “is determined by reference to the language 

itself, the specific context in which the language is used, 

and the broader context of the statute as a whole.” Id. at 

341. 

The Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act), Public Law No. 98-417 

(1984) (codified in relevant part at 35 U.S.C. § 271(e)) set 

up a statutory system to “balance the need to stimulate 

innovation against the goal of furthering the public interest.” H.R. Rep. 98-857, pt. 2, at 2714 (Aug. 1, 1984). This 

balance is embodied, in part, in the “safe harbor” provision of 35 U.S.C. § 271(e)(1), which provides (with emphasis added) that: 

It shall not be an act of infringement to make, use, 

offer to sell, or sell within the United States or 

import into the United States a patented invention (other than a new animal drug or veterinary 

biological product (as those terms are used in the 

Federal Food, Drug, and Cosmetic Act and the Act 

of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, 

hybridoma technology, or other processes involving site specific genetic manipulation techniques) 

solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or 

sale of drugs or veterinary biological products. 

Congress could not have been clearer in its choice of 

words: as long as the use of the patented invention is 

solely for uses “reasonably related” to developing and 

submitting information pursuant to “a Federal law” 
MOMENTA PHARMA v. AMPHASTAR PHARMA 12

regulating the manufacture, use, or sale of drugs, it is not 

“an act of infringement.” 

Although the Hatch-Waxman safe harbor provision 

was enacted in the context of the then-novel ANDA approval process, 35 U.S.C. § 271(e)(1) does not reference 

the portion of the Federal Food, Drug, and Cosmetic Act 

describing the ANDA requirements, e.g., 21 U.S.C. 

§ 355(j). Instead, Congress used more flexible and expansive language to define the scope of § 271(e)(1), referring 

generally to “the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.” This broad language 

unambiguously applies to submissions under any federal 

law, providing that the law “regulates the manufacture, 

use, or sale of drugs.” Limiting the scope of 35 U.S.C. 

§ 271(e)(1) to just the submission of information pursuant 

to the Federal Food, Drug, and Cosmetic Act generally, or 

to the ANDA provision of the Federal Food, Drug, and 

Cosmetic Act in specific, would read words into the statute in violation of the express language chosen by Congress. 

This interpretation is also consistent with the rest of 

the statutory scheme. When Congress wanted to impose 

a limitation based on the Federal Food, Drug, and Cosmetic Act, it expressly referenced the Act. For example, 

in the safe harbor provision, Congress excluded “a new 

animal drug or veterinary biological product (as those 

terms are used in the Federal Food, Drug, and Cosmetic 

Act and the Act of March 4, 1913)” made using certain 

genetic techniques. 35 U.S.C. § 271(e)(1) (emphasis 

added). Likewise, when Congress wanted to limit the 

statute to just a certain kind of submission, for example 

the submission of an ANDA application under 21 U.S.C. 

§ 355(j), it specifically referenced the statutory section 

governing those submissions. For example, in the subsec-
13 MOMENTA PHARMA v. AMPHASTAR PHARMA

tion immediately following the safe harbor, Congress 

defined as an act of infringement the submission of “an 

application under section 505(j) of the Federal Food, 

Drug, and Cosmetic Act [codified at 21 U.S.C. § 355(j)] or 

described in section 505(b)(2) of such Act for a drug 

claimed in a patent or the use of which is claimed in a 

patent.” 35 U.S.C. § 271(e)(2)(A). 

Unlike the closely related infringement provision, 35 

U.S.C. § 271(e)(2), Congress did not link the safe harbor 

to the submission of an application for approval under the 

Federal Food, Drug, and Cosmetic Act. Compare 35 

U.S.C. § 271(e)(1) (not an act of infringement when used 

for “the development and submission of information under 

a Federal law”) with 35 U.S.C. § 271(e)(2)(A) (it is an act 

of infringement to submit “an application under section 

505(j) of the Federal Food, Drug, and Cosmetic Act or 

described in section 505(b)(2) of such Act”). We cannot 

change the statutory language. We will not import the 

limitation of § 271(e)(2) into § 271(e)(1). “[O]ur obligation 

is to take statutes as we find them.” Diamond v. Chakrabarty, 447 U.S. 303, 315 (1980); see also, e.g., Reiter v. 

Sonotone Corp., 442 U.S. 330, 344 (1978) (“We must take 

the statute as we find it.”). The statute here applies to 

any use of a patented invention as long as the use is 

“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). 

In light of these provisions, the only coherent and 

consistent interpretation of “a Federal law which regulates the manufacture, use, or sale of drugs” is that it 

must be broad enough to encompass submissions made 

pursuant to the Federal Food, Drug, and Cosmetic Act. 

Since there is no ambiguity in the language used by 

Congress in 35 U.S.C. § 271(e)(1), our inquiry into the 
MOMENTA PHARMA v. AMPHASTAR PHARMA 14

scope of the safe harbor is complete. Robinson, 519 U.S. 

at 340. When the intent of Congress is expressed so 

clearly and consistently throughout the statute, there is 

neither the need nor the occasion to refer to the legislative 

history. Id. The scope of the Hatch-Waxman safe harbor 

does not stop at activities reasonably related to development of information submitted in an ANDA. Instead, the 

safe harbor applies “to the development and submission of 

information under a Federal law which regulates the 

manufacture, use, or sale of drugs or veterinary biological 

products.” As long as the allegedly infringing use is “for 

uses reasonably related” to the development and submission of that information it is not an act of infringement, 

regardless of where that requirement resides in the law. 

This analysis is not groundbreaking: the Supreme 

Court came to essentially the same conclusion in 1990. In 

Eli Lilly & Co. v. Medtronic, Inc., the Court explained 

that “the phrase ‘a Federal law which regulates the 

manufacture, use, or sale of drugs’ more naturally summons up the image of an entire statutory scheme of regulation,” and not just a particular provision of the law. 496 

U.S. 661, 666 (1990) (emphasis added). Although the 

legislative history of the safe harbor only mentioned 

drugs, id. at 669 n.2, the Court nevertheless concluded 

that the safe harbor also extended to medical devices, 

which were also part of “a Federal law which regulates 

the manufacture, use or sale of drugs,” namely the Federal Food, Drug, and Cosmetic Act, id. at 674. 

The Court later reaffirmed this expansive view, explaining: “we think it apparent from the statutory text 

that § 271(e)(1)’s exemption from infringement extends to 

all uses of patented inventions that are reasonably related 

to the development and submission of any information 

under the FDCA [(Food, Drug, and Cosmetic Act)].” 

Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 
15 MOMENTA PHARMA v. AMPHASTAR PHARMA

202 (2005) (citing Eli Lilly, 496 U.S. at 665-69). Merck 

KGaA expressly rejected the notion that the safe harbor 

only applies to information developed during a clinical 

trial. 545 U.S. at 202 n.6. Instead, “the statutory text 

makes clear that it provides a wide berth for the use of 

patented drugs in activities related to the federal regulatory process.” Id. at 202 (emphasis added). In light of the 

unqualified exemption for uses reasonably related to the 

development and submission of information, “[t]here is 

simply no room in the statute for excluding certain information from the exemption on the basis of the phase of 

research in which it is developed or the particular submission in which it could be included.” Id. (emphasis added). 

The use of the word “under” in the statute is expansive. 

Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 

__, 132 S. Ct. 1670, 1683-84 (2012). “Under a federal law” 

extends beyond just the “most barebones information” 

required by the FDA, and instead encompasses all “materials the FDA demands in the regulatory process.” Id. 

While it is clear that the safe harbor applies to a 

broad set of “activities related to the federal regulatory 

process,” Merck KGaA, 545 U.S. at 202, there is an important limitation: the use must be “for uses reasonably 

related to the development and submission of information,” 35 U.S.C. § 271(e)(1). “Reasonably related,” however, does not mean that the use of the patented invention 

must necessarily result in submission of information to 

the FDA: “Congress did not limit § 271(e)(1)’s safe harbor 

to the development of information for inclusion in a 

submission to the FDA; nor did it create an exemption 

applicable only to the research relevant to filing an ANDA 

for approval of a generic drug.” Merck KGaA, 545 U.S. at 

206. Instead, the Court explained that the safe harbor 

“exempted from infringement all uses of patented compounds ‘reasonably related’ to the process of developing 
MOMENTA PHARMA v. AMPHASTAR PHARMA 16

information for submission under any federal law regulating the manufacture, use, or distribution of drugs.” Id.

(emphasis in original). Thus, the Court explicitly rejected 

the notion that § 271(e)(1) was limited “to the activities 

necessary to seek approval of a generic drug.” Id. As long 

as the accused infringer “has a reasonable basis for believing” that use of the patented invention might yield information that “would be appropriate to include in a 

submission to the FDA, that use is ‘reasonably related’ to 

the ‘development and submission of information under . . . 

Federal law.’” Id. at 207. 

II. 

At the outset we are met with the contention that the 

information in question was not “submitted” to the FDA, 

see 35 U.S.C. § 271(e)(1) (“. . . solely for uses reasonably 

related to the development and submission of information 

. . .”), but rather was retained by the ANDA holder. We 

do not agree. Amphastar, as a generic drug manufacturer 

under an ANDA, cannot sell a batch of enoxaparin unless 

it has established that its strength and quality is consistent with the standards set forth in the relevant official 

compendium. See 21 U.S.C. §§ 331(a), 351(b). FDA 

regulations require that all records associated with a 

produced batch of drugs, including these batch records, 

“be retained for at least 1 year after the expiration date of 

the batch.” 21 C.F.R. § 211.180(a). These records “shall 

be readily available for authorized inspection” by the FDA 

at any time. 21 C.F.R. § 211.180(c). We think that the 

requirement to maintain records for FDA inspection 

satisfies the requirement that the uses be reasonably 

related to the development and submission of information 

to the FDA. It is not disputed by the parties that these 

records are produced in order to develop and submit to the 

FDA proof that the Amphastar products comply with a 

Federal law. The fact that the FDA does not in most 
17 MOMENTA PHARMA v. AMPHASTAR PHARMA

cases actually inspect the records does not change the fact 

that they are for the “development and submission of 

information under a Federal law.” 35 U.S.C. § 271(e)(1); 

cf. Merck KGaA, 545 U.S. at 207 (holding that uses which 

are not ultimately included in a submission to the FDA 

are nonetheless exempted by the safe harbor). Thus, we 

consider this information “submitted” for purposes of the 

statute. We turn then to the question of whether these 

submissions are within the safe harbor. 

In Merck KGaA v. Integra Lifesciences I, Ltd., 545 

U.S. 193 (2005), the Supreme Court held that uses of 

patented inventions in preclinical research, the results of 

which are not ultimately included in a submission to the 

FDA, are nevertheless exempted from infringement by the 

safe harbor provision. Id. at 208. The Court explained 

that 

Congress did not limit §271(e)(1)’s safe harbor to 

the development of information for inclusion in a 

submission to the FDA; nor did it create an exemption applicable only to the research relevant 

to filing an ANDA for approval of a generic drug. 

Rather, it exempted from infringement all uses of 

patented compounds “reasonably related” to the 

process of developing information for submission 

under any federal law regulating the manufacture, use, or distribution of drugs. 

Id. at 206. Thus, it was not an act of infringement to use 

patented compounds in preclinical studies which were not 

ultimately submitted to the FDA where “there [was] a 

reasonable basis for believing that the experiments 

[would] produce the types of information that are relevant 

to an IND or NDA.” Id. at 208. 

However, in Classen Immunotherapies, Inc. v. Biogen 

IDEC, 659 F.3d 1057, 1070 (Fed. Cir. 2011), we held that 
MOMENTA PHARMA v. AMPHASTAR PHARMA 18

§ 271(e)(1) “does not apply to information that may be 

routinely reported to the FDA, long after marketing 

approval has been obtained.” At issue in Classen were 

studies to evaluate the association between the timing of 

childhood vaccinations and the risk of developing certain 

immune-mediated disorders. The studies themselves 

were not mandated by the FDA, but any vaccine license 

holder was required to report to the FDA “adverse experience information,” such as adverse side effects, it acquired 

as a result of vaccine studies. See 21 C.F.R. § 600.80. We 

found that the studies conducted by the vaccine license 

holder according to patented methods were not insulated 

by the safe harbor because the studies did not facilitate 

marketing a generic drug by “expedit[ing] development of 

information for regulatory approval.” Classen, 659 F.3d 

at 1070. We, of course, are bound by the Classen decision 

unless it is overruled en banc or by the Supreme Court. 

Accordingly, the scope of the safe harbor provision does 

not extend to “information that may be routinely reported 

to the FDA, long after marketing approval has been 

obtained.” 

This case, however, fits well within Classen because 

the information submitted is necessary both to the continued approval of the ANDA and to the ability to market 

the generic drug. Here, the submissions are not “routine 

submissions” to the FDA, but instead are submissions 

that are required to maintain FDA approval. Amphastar 

is required to conduct a laboratory determination of 

identity and strength of the active ingredient for each 

batch of enoxaparin. See 21 C.F.R. § 211.165(a). This test 

must be done according to the patented methods described in an official compendium, in this case the United 

States Pharmacopeia (USP). See 21 U.S.C. § 351(b) (Any 

“determination as to strength, quality, or purity shall be 

made in accordance with the tests or methods of assay set 
19 MOMENTA PHARMA v. AMPHASTAR PHARMA

forth in such compendium.”). Moreover, as described 

above, FDA regulations require that all such batch records “be retained for at least 1 year after the expiration 

date of the batch,” 21 C.F.R. § 211.180(a), and that such 

records “shall be readily available for authorized inspection” by the FDA at any time, 21 C.F.R. § 211.180(c); see 

also 21 C.F.R. §§ 211.186, 211.188, 211.194 (requiring 

“master production and control records,” “batch production and control records,” and “laboratory records”). 

Failure to comply with these requirements could result in 

suspension or revocation of Amphastar’s ANDA approval 

to market the drug. See 21 U.S.C. §§ 335a(g), 355(e). 

Furthermore, such testing is “a condition for [the drug’s] 

approval and release” into commerce, 21 C.F.R. 

§ 211.165(d), thus acting as a predicate to the ability to 

market the ANDA-approved drug to the public. 

The submissions to the FDA in this case are anything 

but “routine”—they implicate Amphastar’s very ability to 

continue its FDA approval for its ANDA and to continue 

manufacturing and marketing enoxaparin under its 

ANDA. We also note that, unlike in Classen where the 

patented studies performed were not mandated by the 

FDA, the information here is not generated voluntarily by 

the manufacturer but is generated by FDA requirements 

the manufacturer is obligated under penalty of law to 

follow. Under such circumstances, the information can be 

said to have been gathered solely for submission to the 

FDA and not, as in Classen, primarily for non-FDA purposes. While Momenta urges us to adopt the pre-/postapproval distinction used by the district court, we cannot: 

Classen did not turn on this artificial distinction, and the 

plain language of the statute is not restricted to pre-
MOMENTA PHARMA v. AMPHASTAR PHARMA 20

approval activities.1 We therefore hold that post-approval 

studies that are “reasonably related to the development 

and submission of information under a Federal law which 

regulates the manufacture, use, or sale of drugs” fall 

within the scope of the § 271(e)(1) safe harbor. 

In this case, Momenta concedes that Amphastar’s 

tests “are conducted in order to satisfy the FDA’s requirements that each batch of enoxaparin that is sold commercially after FDA approval is actually the same as the 

brand name drug.” Appellee’s Br. at 40-41 (emphasis 

added); see also J.A. 56 (allegation that the “FDA requires” the accused testing). Under a proper construction 

of 35 U.S.C. § 271(e)(1), the fact that Amphastar’s testing 

is carried out to “satisfy the FDA’s requirements” means 

it falls within the scope of the safe harbor, even though 

the activity is carried out after approval. Unlike Classen, 

where the allegedly infringing activity “may” have eventually led to an FDA submission, there is no dispute in 

this case that Amphastar’s allegedly infringing activities 

are carried out to “satisfy the FDA’s requirements.” The 

district court’s interpretation of § 271(e)(1) was erroneous. 

Under the correct construction, Momenta cannot establish 

a likelihood of success on infringement and the preliminary injunction must be vacated. Genentech, Inc., 108 

F.3d at 1364. 

 1 We are puzzled by the dissent’s claim that the use 

of the words “solely” and “submitted” require us to limit 

the statute to pre-approval activities. This is not the 

plain meaning of those words. For example, if the FDA 

required post-approval testing with subsequent submission of those test results, those test results were clearly 

generated “solely” for an FDA submission and equally 

clearly were “submitted” to the agency. “Solely” and 

“submitted” in no manner limit § 271(e)(1) to “preapproval testing.” 
21 MOMENTA PHARMA v. AMPHASTAR PHARMA

Momenta also argues that even if 35 U.S.C. 

§ 271(e)(1) extends to post-approval activities, Amphastar’s testing is not protected because there are FDA 

endorsed non-infringing alternatives available. The safe 

harbor, however, does not mandate the use of a noninfringing alternative when one exists. The only limitation in the safe harbor is that the use must be “reasonably 

related to the development and submission of information” pursuant to a federal law regulating the “manufacture, use, or sale of drugs or veterinary biological 

products.” 35 U.S.C. § 271(e)(1). The safe harbor’s protection is not limited to the dire situation where the 

patented invention is the only way to develop and submit 

the information. Instead, the safe harbor expressly allows 

the submitter the freedom to use an otherwise patented 

means to develop the necessary information demanded by 

the “Federal law.” This makes good sense because it 

eliminates liability for infringement when that act of 

infringement is, in effect, required by the federal government as part of the continuing safety and efficacy monitoring of an approved drug. It also avoids the situation 

here, where a drug has received approval, but is nevertheless kept from the market based on an FDA mandated 

testing requirement. 

Momenta’s interpretation is predicated upon the incorrect assumption that “solely” in the context of 35 

U.S.C. § 271(e)(1) means that the patented invention 

must be the “sole” means of providing the information for 

the safe harbor to apply. This is not the language of the 

statute: under 35 U.S.C. § 271(e)(1), as long as the use is 

“reasonably related to the development and submission of 

information” under a relevant statute, it is not an act of 

infringement. “Solely” modifies “uses reasonably related 

to the development and submission of information,” but 

does not place any other restriction on when the patented 
MOMENTA PHARMA v. AMPHASTAR PHARMA 22

invention may be used without infringing. As long as the 

use of the patented invention is done to generate information that will be submitted pursuant to a relevant federal 

law, that use falls within the safe harbor. Merck KGaA, 

545 U.S. at 205-206. Momenta is therefore incorrect that 

the possibility that the FDA would accept the use of other, 

non-patented, testing methods for the development and 

submission of information precludes Amphastar from 

relying on the safe harbor in this case.2

Even if Momenta’s strained reading of the statute was 

supportable, Amphastar’s allegedly infringing activities 

are clearly carried out according to the dictates of the 

Federal Food, Drug, and Cosmetic Act. Under the Act, 

Amphastar is prohibited from selling a drug if it is adul-

 2 Although the parties do not argue that FDAmandated quality control testing during manufacturing is 

not done “solely” for purposes of developing and submitting information to the FDA, the dissent suggests that 

because Amphastar uses the patented method while 

manufacturing a product to sell in commerce its infringing activity does not meet the “solely” limitation in the 

statute. This is not a tenable reading of the statute, and 

is indeed contrary to precedent. The Supreme Court cases 

interpreting the safe harbor make clear that the safe 

harbor is not limited to acts which only produce information for the FDA but protects all acts, even interim research steps and acts that might produce other useful 

data, “as long as there is a reasonable basis for believing 

that the [act] will produce the types of information that 

are relevant to [a submission to the FDA].” Merck, 545 

U.S. at 208. We have interpreted this language of the 

safe harbor to allow alleged infringers to use “data from 

tests for more than FDA approval,” such as for fund 

raising and other business purposes. Abtox, Inc. v. 

Exitron Corp., 122 F.3d 1019, 1030 (Fed. Cir. 1997) (holding that the alleged infringer’s “intent or alternate uses 

[of test data] are irrelevant to its qualification to invoke 

the section 271(e)(1) shield”). 
23 MOMENTA PHARMA v. AMPHASTAR PHARMA

terated. 21 U.S.C. § 331(a). A drug is adulterated if it 

purports to be a drug listed in an official compendium, for 

example the USP, but in actuality differs in composition. 

21 U.S.C. § 351(b); see also 21 U.S.C. § 321(j) (defining 

“official compendium”). In order to demonstrate that a 

drug is not adulterated, testing must be carried out 

pursuant to the methods articulated in the compendium, 

in this case the USP. See 21 U.S.C. § 351(b) (Any “determination as to strength, quality, or purity shall be made 

in accordance with the tests or methods of assay set forth 

in such compendium.”). “For each batch of drug product, 

there shall be appropriate laboratory determination of . . . 

the identity and strength of each active ingredient . . . .” 

21 C.F.R. § 21.165(a). FDA regulations characterize this 

testing as “a condition for [the drug’s] approval and 

release” into commerce. 21 C.F.R. § 211.165(d). The FDA 

also mandates maintenance of appropriate records related 

to this type of testing. See 21 C.F.R. § 211.180(a) (production, control, and distribution records associated with a 

batch of drug must be retained for at least one year after 

the expiration date of the batch); see also 21 C.F.R. 

§§ 211.186, 211.188, 211.194 (requiring “master production and control records,” “batch production and control 

records,” and “laboratory records”). 

The USP entry for enoxaparin, the drug at issue in 

this litigation, states: “About 20 percent of the materials 

contain a 1,6-anhydro derivative on the reducing end of 

the chain, the range being between 15 and 25 percent.” 

J.A. 365 (USP Revision Bulletin, Official December 1, 

2008). Thus, in order to be “enoxaparin” as defined in the 

USP entry, the marketed drug product must contain 

between 15 and 25 percent of the 1,6-anhydro derivative. 

Id.; see also 21 U.S.C. § 351(b) (drug adulterated if purports to be a drug in an official compendium but its 

strength, quality, or purity differs from the standard set 
MOMENTA PHARMA v. AMPHASTAR PHARMA 24

forth in the compendium). The USP also includes a 

specific test for the 1,6-anhydro derivative, which “involves HPLC analysis of a depolymerized enoxaparin 

sodium solution by a mixture of heparinases.” J.A. 369 

(USP Method <207>). As the district court explained: 

“Claims 6, 16, and 53 of the ’886 patent describe how to 

analyze a sample of enoxaparin to ensure its conformity to 

the USP Monograph standard.” J.A. 8. Amphastar is 

required by the FDA to use this test in order to ensure its 

enoxaparin is not adulterated. 21 U.S.C. § 351(b). This 

testing, which generates information for submission 

pursuant to the Food, Drug, and Cosmetic Act, therefore 

falls squarely within the scope of the safe harbor. 

Finally, the dissent suggests that we must reject any 

disequilibrium between sections 201 and 202 of the 

Hatch-Waxman Act, that is, the safe harbor should not be 

available unless a patent term extension is also available. 

Dissenting Op. at 19-20. This is not correct. The Supreme Court in Eli Lilly noted that equilibrium was not 

always achieved. See Eli Lilly, 496 U.S. at 671-72. We 

too have rejected this strict interpretation of the safe 

harbor, explaining that “statutory symmetry is preferable 

but not required.” Abtox, 122 F.3d at 1029 (holding that 

Class II medical devices, which are not subject to a “rigorous premarket approval process” and thus cannot receive 

patent term extensions, are nonetheless covered by the 

safe harbor). 

III. 

Under the correct interpretation of 35 U.S.C. 

§ 271(e)(1), Momenta’s admission that Amphastar’s 

testing is carried out to “satisfy the FDA’s requirements,” 

Appellee’s Brief at 40-41, makes it unlikely that Momenta 

will succeed on the merits of its infringement claim. The 

district court’s findings with respect to the irreparable 
25 MOMENTA PHARMA v. AMPHASTAR PHARMA

harm, balance of the hardships, and public interest factors were all, to some extent, predicated on its erroneous 

conclusion that Momenta’s patent was likely infringed by 

Amphastar’s product. See J.A. 24 (applying a presumption of irreparable harm in view of Momenta’s “showing of 

infringement and validity”); J.A. 29 (explaining that in 

light of the “showing of likelihood of success on the merits, 

the balance of hardship tips in [Momenta’s] favor”); J.A. 

30 (public interest favors protection of patent rights 

secured by valid patents). Because Momenta has not 

established a likelihood of success on its claim of infringement, the preliminary injunction must be vacated. 

On remand, the district court may want to consider 

whether Momenta’s admission that Amphastar’s use of 

the patented invention is to “satisfy the FDA’s requirements” makes this case amenable to summary judgment 

of non-infringement in favor of Amphastar. Because the 

safe harbor issue is dispositive, we need not reach the 

other arguments on appeal. 

VACATED AND REMANDED 

COSTS

Costs to Appellants. 
United States Court of Appeals 

for the Federal Circuit 

__________________________ 

 MOMENTA PHARMACEUTICALS, INC., 

Plaintiff-Appellee, 

and 

 SANDOZ, INC., 

Plaintiff-Appellee, 

v. 

 AMPHASTAR PHARMACEUTICALS, INC., 

INTERNATIONAL MEDICATION SYSTEMS, LTD., 

WATSON PHARMACEUTICALS, INC., 

AND WATSON PHARMA, INC., 

Defendants-Appellants. 

__________________________ 

2012-1062, -1103, -1104 

__________________________ 

Appeals from the United States District Court for the 

District of Massachusetts in Case No. 11-CV-11681, Judge 

Nathaniel M. Gorton. 

__________________________ 

RADER, Chief Judge, dissenting. 

By definition, a patent defines a right to exclude. 

Consistent with property principles, an infringer of a 

valid patent is an unlawful trespasser. The remedy for 

trespassing, in this area of property law as well as others, 

is removal of the trespasser. Indeed even the Constitution acknowledges the patent owner’s right to exclude 
MOMENTA PHARMA v. AMPHASTAR PHARMA 2

trespassers. U.S. Const. art. I, § 8, cl. 8. Thus, exceptions 

to the traditional property remedy amount to a get-out-ofjail-free card for the trespasser. Accordingly, such exceptions must occur only sparingly with awareness that this 

license allows the wrongdoer free reign to continue trespassing. 

The public readily applauds the role of patents in the 

development and delivery to the marketplace of lifesaving drugs or modern technology products like smartphones. At the same time, many incremental advances 

contribute to these monumental advances or, as in this 

case, enhance their delivery to the public. These incremental inventions also represent difficult and expensive 

advances in technology. For example, in this case, Amphastar had a strong incentive to invent this patented 

manufacturing method. As the first-filer, it would have 

obtained 180 days of market exclusivity as the only seller 

of the generic drug — a right worth $260 million per 

quarter. Nevertheless, Amphastar could not make that 

invention. Instead, the patentee Momenta made the 

investment, did the research, and engineered the new 

method disclosed in the '886 patent. 

At that point, Amphastar stepped in and took Momenta’s patented invention without permission and used 

it to manufacture each commercial batch it sells on the 

market. Indeed Amphastar continues to trespass and 

promises to trespass for years to come. In fact, as the 

court repeatedly acknowledges, Amphastar is only able to 

compete with Momenta by taking its patented invention. 

Amphastar has not developed its own method, but instead 

delights in trespassing and refuses to pay a reasonable 

royalty to make the trespass lawful. 

This court would allow this arrogance to continue by 

expanding the limited reach of 35 U.S.C. § 271(e)(1). This 
3 MOMENTA PHARMA v. AMPHASTAR PHARMA

expansion of the law circumvents the purpose of the law 

and ignores the binding precedent of Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 

2011). Sadly this result will render worthless manufacturing test method patents. Accordingly, I must respectfully dissent. 

I. 

The Supreme Court has observed that the text alone 

of § 271(e)(1) can be “not plainly comprehensible.” Eli 

Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 669 (1990). 

The purpose of this text, which ought to inform its application, however, is evident from the legislative history. 

The legislative history of § 271(e)(1) includes more than 2 

House reports, 25 statements and letters, and many pages 

of Congressional testimony. A review of this extensive 

material shows that section 202 of the Hatch-Waxman 

Act, enacted as § 271(e)(1), had the sole purpose of overruling this court’s holding in Roche Products, Inc. v. Bolar 

Pharmaceutical Co., 733 F.2d 858 (Fed. Cir. 1984). In 

particular, § 271(e)(1) applied only in limited situations, 

namely pre-approval experiments to obtain FDA approval: 

The purpose of 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. Since 

the Committee’s Subcommittee on Health and the 

Environment began consideration of this bill, the 

Court of Appeals for the Federal Circuit held that 

this type of experimentation is infringement. In 

Roche Products, Inc. v. Bolar Pharmaceutical Co., 

733 F.2d 858 (Fed. Cir. 1984), the Court of Appeals for the Federal Circuit held that the ex-
MOMENTA PHARMA v. AMPHASTAR PHARMA 4

perimental use of a drug product prior to the expiration date of a patent claiming that drug product constitutes patent infringement, even though 

the only purpose of the experiments is to 

seek FDA approval for the commercial sale of 

the drug after the patent expires. It is the Committee’s view that experimental activity does 

not have any adverse economic impact on the patent owner’s exclusivity during the life of a patent, 

but prevention of such activity would extend the 

patent owner’s commercial exclusivity beyond the 

patent expiration date. 

H.R. REP. NO. 98-857, pt. 1, at 45-46 (1984) (emphases 

added). 

The provisions of section 202 of the bill have the 

net effect of reversing the holding of the court in 

Roche Products, Inc. v. Bolar Pharmaceutical Co., 

733 F.2d 858 (Fed. Cir. 1984). 

H.R. REP. NO. 98-857, pt. 2, at 27 (1984). See also Innovation and Patent Law Reform: Hearing on H.R. 3605 Before 

the Subcomm. on Courts, Civil Liberties and the Admin. of 

Justice of the H. Comm. on the Judiciary, 98th Cong. 742 

(1984) (statement of Laurence H. Tribe, Professor of Law, 

Harvard Law School) (“Section 202, the thrust of which is 

to overturn Roche v. Bolar legislatively”); Innovation and 

Patent Law Reform: Hearing on H.R. 3605 Before the 

Subcomm. on Courts, Civil Liberties and the Admin. of 

Justice of the H. Comm. on the Judiciary, 98th Cong. 826 

(1984) (letter from Bernarr R. Pravel, President, American Intellectual Property Law Association) (“Section 202 

is intended to reverse the April 23, 1984, decision of the 

Court of Appeals for the Federal Circuit in Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. 

Cir. 1984).”); Memorandum from Congressional Research 
5 MOMENTA PHARMA v. AMPHASTAR PHARMA

Service, The Library of Congress, American Law Division 

to House Judiciary Committee, located at H.R. REP. NO. 

98-857, pt. 2, at 27 n.18 (1984). 

Roche v. Bolar held that the limited pre-approval experiments to obtain FDA approval still infringed a valid 

patent. See 733 F.2d at 861 (“The district court correctly 

recognized that the issue in this case is narrow: does the 

limited use of a patented drug for testing and investigation strictly related to FDA drug approval requirements during the last 6 months of the term of 

the patent constitute a use which, unless licensed, the 

patent statute makes actionable?” (emphasis added)). In 

overturning Roche v. Bolar, § 271(e)(1) allowed pharmaceutical companies to conduct such experiments to obtain 

FDA approval. The new section enabled those companies 

to begin the approval process while the patent is still in 

force, so that they can obtain FDA approval and begin 

selling immediately after the patent’s life. Otherwise, the 

safety testing processes would have to wait until after the 

patent’s life ends thus creating a lag in time when the 

patent would not be in force yet the companies could not 

enter the market pending FDA approval: 

In order to complete this application the 

generic manufacturer must conduct certain drug 

tests. In order to facilitate this type of testing, 

section 202 of the bill creates general exception to 

the rules of patent infringement. Thus, a generic 

manufacturer may obtain a supply of a patented 

drug product during the life of the patent and 

conduct tests using that product if the purpose 

of those tests is to submit an application to 

FDA for approval. 

130 CONG. REC. 23060 (1984) (statement of Rep. Robert 

W. Kastenmeier, Chairman of the Subcommittee on 
MOMENTA PHARMA v. AMPHASTAR PHARMA 6

Courts, Civil Liberties and the Administration of Justice, 

Committee on the Judiciary) (emphases added). 

The Pharmaceutical Manufacturers Association echoed the Chairman’s analysis of the purpose of the bill: 

The sponsors and supporters of the legislation 

have agreed from the beginning that generic 

products should not be approved for marketing 

prior to the expiration of a valid patent as extended under the legislation. In return, there has 

been a compromise agreement that preapproval

testing could be conducted prior to the expiration 

of the patent, as extended, so that marketing 

could begin immediately thereafter. Therefore, 

the bill reverses the Roche v. Bolar decision to 

permit a generic company to “use” a patented 

product for the limited purpose of completing 

the testing necessary for FDA approval. 

Innovation and Patent Law Reform: Hearing on H.R. 3605 

Before the Subcomm. on Courts, Civil Liberties and the 

Admin. of Justice of the H. Comm. on the Judiciary, 98th 

Cong. 696 (1984) (letter from Pharmaceutical Manufacturers Association) (emphases added). 

On the other side of the industry, the Generic Pharmaceutical Industry Association agreed that section 202 

is only for limited pre-approval experiments: 

The purpose of the foregoing provision is to permit 

a generic drug manufacturer to engage in the 

limited experimental activities which are 

necessary to obtain FDA pre-marketing approval before a patent expires so that actual 

competition between the generic drug and the 

original drug can begin immediately after the patent covering the original drug expires. Section 
7 MOMENTA PHARMA v. AMPHASTAR PHARMA

202 does not authorize any activity which 

would deprive the patent owner of the sale 

of a single tablet during the life of a valid 

patent. In fact, the limited testing activity 

required to obtain FDA approval of a generic drug would not normally result in the 

use of even a single generic tablet for its 

therapeutic purpose during the life of a 

valid patent. 

Innovation and Patent Law Reform: Hearing on H.R. 3605 

Before the Subcomm. on Courts, Civil Liberties and the 

Admin. of Justice of the H. Comm. on the Judiciary, 98th 

Cong. 926 (1984) (memorandum of Alfred B. Engleberg, 

Patent Counsel, Generic Pharmaceutical Industry Association) (emphases added). 

The executive branch favored an even more limited 

exception than the one proposed in section 202 and enacted as § 271(e)(1). Nevertheless, it clearly understood 

the boundaries of section 202 to be pre-approval experimental use. 

This letter sets forth the Administration’s views 

on H.R. 3605 ... First, section 202 of title II should 

be amended to permit experimental use of a drug 

by a non-patentee only during the period in which 

the affected patent is in restoration period. Existing patentees have relied upon accepted doctrine 

indicating that use of a patented invention for 

the purpose of obtaining regulatory approval infringes that patent. Upsetting expectations of this sort could only inhibit future 

innovation and investment, which depend upon 

the integrity of the patent laws. 

Innovation and Patent Law Reform: Hearing on H.R. 3605 

Before the Subcomm. on Courts, Civil Liberties and the 
MOMENTA PHARMA v. AMPHASTAR PHARMA 8

Admin. of Justice of the H. Comm. on the Judiciary, 98th 

Cong. 812 (1984) (letter from David A. Stockman, Director, Office of Management and Budget, to Rep. Edward R. 

Madigan, Subcomm. on Health and the Environment, H. 

Comm. on Energy and Commerce) (emphasis added). 

The pharmaceutical industry expressed concern about 

permitting trespass on exclusive rights, but this concern 

dissipated with promises that § 271(e)(1) only allowed 

“limited testing of drugs.” See H.R. REP. NO. 98-857, pt. 2, 

at 29 (1984). 

In this case the generic manufacturer is not permitted to market the patented drug 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. Thus, the nature of the interference is de minimis.

Id. at 30 (emphases added). 

Specifically, § 271(e)(1) won approval because it was 

limited in time, quantity, and type. First, as to time, 

§ 271(e)(1) only applies to pre-marketing approval. 130 

CONG. REC. 23060 (1984) (statement of Rep. Robert W. 

Kastenmeier, Chairman of the Subcommittee on Courts, 

Civil Liberties and the Administration of Justice, Committee on the Judiciary) (see block quote above); Innovation and Patent Law Reform: Hearing on H.R. 3605 Before 

the Subcomm. on Courts, Civil Liberties and the Admin. of 

Justice of the H. Comm. on the Judiciary, 98th Cong. 696 

(1984) (letter from Pharmaceutical Manufacturers Association) (see block quote above); Innovation and Patent 

Law Reform: Hearing on H.R. 3605 Before the Subcomm. 

on Courts, Civil Liberties and the Admin. of Justice of the 

H. Comm. on the Judiciary, 98th Cong. 742 (1984) (statement of Laurence H. Tribe, Professor of Law, Harvard 

Law School) (“Section 202, the thrust of which is to over-
9 MOMENTA PHARMA v. AMPHASTAR PHARMA

turn Roche v. Bolar legislatively, so as to provide that it is 

not an infringement to make, use, or sell a patented 

invention for purposes ‘reasonably related’ to the development and submission of information to obtain FDA’s 

premarketing approval to engage in the commercial 

manufacture, use, or sale of the drug after patent expiration”) (emphasis added); Innovation and Patent Law 

Reform: Hearing on H.R. 3605 Before the Subcomm. on 

Courts, Civil Liberties and the Admin. of Justice of the H. 

Comm. on the Judiciary, 98th Cong. 926 (1984) (memorandum of Alfred B. Engleberg, Patent Counsel, Generic 

Pharmaceutical Industry Association) (see block quote 

above); Memorandum from Congressional Research 

Service, The Library of Congress, American Law Division 

to House Judiciary Committee, located at H.R. REP. NO. 

98-857, pt. 2, at 27 n.18 (1984) (“In § 202, Congress would 

provide that it is not an infringement to make, use, or sell 

a patented invention solely for uses reasonably related to 

the development and submission of information for the 

purpose of obtaining FDA premarketing approval 

of a drug.”). 

Second, as to quantity and type, § 271(e)(1) only applies to experimentation — and therefore would have 

limited impact on the patentee’s exclusivity during the 

life of the patent. H.R. REP. NO. 98-857, pt. 1, at 45-46 

(1984) (see block quote above); Innovation and Patent Law 

Reform: Hearing on H.R. 3605 Before the Subcomm. on 

Courts, Civil Liberties and the Admin. of Justice of the H. 

Comm. on the Judiciary, 98th Cong. 696 (1984) (letter 

from Pharmaceutical Manufacturers Association) (see 

block quote above); Innovation and Patent Law Reform: 

Hearing on H.R. 3605 Before the Subcomm. on Courts, 

Civil Liberties and the Admin. of Justice of the H. Comm. 

on the Judiciary, 98th Cong. 742 (1984) (statement of 

Laurence H. Tribe, Professor of Law, Harvard Law 
MOMENTA PHARMA v. AMPHASTAR PHARMA 10

School) (quoted above); Innovation and Patent Law Reform: Hearing on H.R. 3605 Before the Subcomm. on 

Courts, Civil Liberties and the Admin. of Justice of the H. 

Comm. on the Judiciary, 98th Cong. 926 (1984) (memorandum of Alfred B. Engleberg, Patent Counsel, Generic 

Pharmaceutical Industry Association) (see block quote 

above). 

In particular, the authors made clear that section 

271(e)(1) would not apply to commercial sales, i.e., the 

“infringing” product would not enter the market until 

after the patent’s life. H.R. REP. NO. 98-857, pt. 1, at 45 

(1984) (“This section does not permit the commercial 

sale of a patented drug by the party using the drug to 

develop such information, but it does permit the commercial sale of research quantities of active ingredients to 

such party.”) (emphasis added); Innovation and Patent 

Law Reform: Hearing on H.R. 3605 Before the Subcomm. 

on Courts, Civil Liberties and the Admin. of Justice of the 

H. Comm. on the Judiciary, 98th Cong. 932 (1984) 

(memorandum of Alfred B. Engleberg, Patent Counsel, 

Generic Pharmaceutical Industry Association) (“The 

limited ‘experimental use’ permitted by Section 202 

does not, in any way, impinge on the exclusive right of the 

patent owner to make, use and sell the patented invention 

for all commercial purposes during the life of the patent. 

The permitted experimental use would not result in 

competitive commercial activity until all valid 

patents expired.”) (emphases added). 

The authors of this section (and I hesitate to add that 

I was present through this legislative process) did not 

imagine that § 271(e)(1) would allow continuous, commercial infringing sales during any portion of the life of the 

patent. As discussed below, Amphastar has already 

obtained FDA regulatory approval, and today this court 

rewrites the law to allow Amphastar to infringe Mo-
11 MOMENTA PHARMA v. AMPHASTAR PHARMA

menta’s patent throughout the entire life of Momenta’s 

patent and for the purpose of obtaining profits on commercial sales of a product that competes with the patentee. 

Nowhere in the legislative history can this court find 

any suggestion that § 271(e)(1) would apply other than in 

the limited scenario of conducting de minimis experiments pre-approval (i.e., to obtain FDA approval). Nowhere in the legislative history can this court find a hint 

that an “infringer” could continue to use its competitor's 

patented method in manufacture of each commercial 

batch for contemporaneous sale. Nowhere in the legislative history can this court find any mention of the postapproval, continuous, commercial sales allowed by this 

decision. Nowhere in the legislative history can this court 

find any suggestion that the mere maintenance or retention of information as part of a company’s records is 

considered a submission that would trigger § 271(e)(1). In 

fact, this court makes no attempt to examine the legislative history of this section at all — a very telling silence. 

Of course, this court proclaims that it finds no ambiguity requiring it to find out the purpose of the section it 

distorts. To the contrary, the Supreme Court found the 

statute can be ambiguous and “not plainly comprehensible.” See Eli Lilly, 496 U.S. at 669. Moreover the court 

strains to avoid ambiguity by discounting critical statutory phrases, namely “solely” and “submission.” 

To facilitate a post-approval, continuous, commercial 

use, the court discounts the word “solely.” Indeed, 

throughout its opinion, the court cites the language of the 

statute yet omits the word “solely.” See Majority Op. 13, 

14, 15, 16, 20, 21. If one properly reads “solely” as the 

statute says, the result must be that Amphastar’s activity 

is not within the statute. Its infringing activity is not 

solely for developing and submitting information to the 
MOMENTA PHARMA v. AMPHASTAR PHARMA 12

FDA. Instead, Amphastar uses this method for the purpose of manufacturing a product to sell on the market in 

commerce. 

Second, the court claims that the mere retention of records can satisfy the “submission” requirement in 

§ 271(e)(1). By essentially stating that “submission” can 

mean not really submitting, this new interpretation reads 

this requirement out of the statute as well. 

Specifically, despite the plain meaning of “submission 

of information” to mean the company actually submitting 

information to the FDA, the court interprets “submission 

of information” to mean the mere retention of information 

as part of a company’s records. Majority Op. 16 (“We 

think that the requirement to maintain records for FDA 

inspection satisfies the requirement that the uses be 

reasonably related to the development and submission of 

information to the FDA. Thus, we consider this information ‘submitted’ for purposes of the statute.” (emphasis 

added)), 19. Maintaining or keeping a document has the 

exact opposite meaning of submitting a document. In 

other words, “submission” means not really submitting 

anything — a strange construction of an “unambiguous” 

term. 

This new interpretation would allow almost all activity by pharmaceutical companies to constitute “submission” and therefore justify a free license to trespass. The 

FDA can inspect records of any drug manufacturer and 

seller. See 21 U.S.C. § 374. Thus, the drug manufacturer 

need only make a record, which could potentially be 

inspected by the FDA, and then any activity could satisfy 

this new meaning of “submission.” 

Therefore, a reading of all the words in the statute 

and a reading of those words in light of their legislative 

history shows that § 271(e)(1) only permits a limited 
13 MOMENTA PHARMA v. AMPHASTAR PHARMA

amount of pre-approval experiments to obtain FDA approval. Thus, the statute limits the exception to “solely 

for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary 

biological products.” 

II. 

This court has already decided the meaning of this 

statute in Classen. The Classen majority held “§ 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. The statute 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). As support, Classen looked to the legislative 

history: “The Report is replete with statements that the 

legislation concerns premarketing approval of generic 

drugs. The Report emphasizes that ‘The information 

which can be developed under this provision is the type 

which is required to obtain approval of the drug.’” Id.

at 1071 (emphases added). 

Classen also looked to Supreme Court precedent, such 

as Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 1047 (1990) 

and Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 

193 (2005): “Every decision examining the statute has 

appreciated that § 271(e)(1) is directed to premarketing 

approval of generic counterparts before patent expiration.” Id. at 1071 (emphasis added). In particular, Classen stated: 

Our colleague in dissent strays from statute and 

precedent, in arguing that any activity by any entity concerning any adversely patented product or 

method is exempted from infringement by 
MOMENTA PHARMA v. AMPHASTAR PHARMA 14

§ 271(e)(1), provided only that the information obtained is ‘reasonably related to submitting any information under the FDCA,’ [659 F.3d at 1083 

(Moore, J., dissenting)] (emphasis in dissent), ‘including information regarding post-approval

uses.’ Id. Such a massive enlargement of the 

statutory exemption is incorrect. 

Id. at 1072 n.4 (bold emphasis added). 

Here, Amphastar uses Momenta’s patented method in 

the manufacture of each commercial batch it sells. By 

definition, its use is not to obtain FDA approval. One can 

only market a drug that the FDA has already approved. 

Amphastar is not using Momenta’s patented method for 

pre-approval, limited experimental use. It is not preapproval because Amphastar has already obtained approval. See Appellant Br. 7 (Amphastar received FDA 

approval on September 19, 2011.); Majority Op. 21 (“It 

also avoids the situation here, where a drug has received 

approval ...”). Thus, its activity is post-approval. It is not 

limited because Amphastar uses Momenta’s invention on 

a continuous basis in the manufacture of each commercial 

batch and during the life of Momenta’s patent. It is not 

experimental because Amphastar uses Momenta’s invention in manufacturing each commercial batch of its product for contemporaneous sale on the market (in 

commerce) to obtain profits and to compete with Momenta. This is a commercial use of an invention by a 

competitor to compete and trespass on the inventor’s 

exclusive right. Amphastar’s use is not for premarketing 

FDA approval and therefore Classen definitively holds 

that § 271(e)(1) does not apply here. 

To come out the exact opposite way, the court first 

claims Classen did not turn on the pre-/post-approval 

distinction. Majority Op. 19. Second, the court claims 
15 MOMENTA PHARMA v. AMPHASTAR PHARMA

Classen merely held that § 271(e)(1) does not apply to 

“routine” submissions. Therefore, this court opines: “This 

case, however, fits well within Classen because the information submitted is necessary both to the continued 

approval of the ANDA and to the ability to market the 

generic drug. Here, the submissions are not ‘routine 

submissions’ to the FDA, but instead are submissions that 

are required to maintain FDA approval.” Majority Op. 18. 

At the outset, this court must stretch too far to claim 

Classen did not turn on a pre-/post-approval distinction. 

The dissent actually helps identify the holding in Classen. 

The Classen dissent stated: “The majority concludes that 

the district court incorrectly interpreted the safe harbor of 

§ 271(e)(1) because, according to the majority, § 271(e)(1) 

is limited to pre-approval activities. ... Accordingly, I 

conclude that the safe harbor extends to all uses that are 

reasonably related to submitting any information under 

the FDCA, including information regarding postapproval uses. ...” 659 F.3d at 1083 (emphases added). 

Further, the parties and the amici certainly thought 

Classen turned on a pre-/post-approval distinction. See, 

e.g., Classen’s Opposition to Petition for Rehearing En 

Banc, at *1 (“Plaintiff-Appellant agrees with HatchWaxman, The United States Supreme Court and the 

Federal Circuit: 35 USC §271(e)(1) applies only to premarket development activities, there is no safe harbor 

after the commencement of commercial sales of a drug. An 

extension of 271(e)(1) into the post-approval/postcommercialization period is outside the scope of the 

Drug Price Competition and Patent Term Restoration Act 

and would present unworkable difficulties in its application.”) (emphases added). 

Moreover, this court in Classen did not at any point 

state that § 271(e)(1) applies to information “necessary 
MOMENTA PHARMA v. AMPHASTAR PHARMA 16

both to the continued approval of the ANDA and to the 

ability to market the generic drug.” Majority Op. 18. 

Indeed, this post-approval, continuous, commercial use is 

the exact opposite of the Classen rule. Classen rested its 

holding on “premarketing approval,” 659 F.3d at 1070, 

1071, “limited amount of testing,” id. at 1071, and “experimentation,” id.

This decision (“post-approval studies”; “after approval”; “not restricted to pre-approval activities”) cannot 

be genuinely reconciled with Classen (“pre-marketing 

approval”). Instead, the court in this decision uses the 

same language as the dissent in Classen (“post-approval”; 

“I conclude that the safe harbor extends to all uses that 

are reasonably related to submitting any information 

under the FDCA, including information regarding postapproval uses”). This decision should instead request the 

entire court to resolve the issue en banc. 

The court distinguishes Classen by characterizing the 

activities in that case as not “mandated by the FDA,” 

while the activities here are. Some context is in order. 

The patented method here is “mandated” only in that 

Momenta thus far has created and developed the only 

successful method by which one can show the FDA’s 

requirement has been met. Amphastar is free to invent 

its own method to satisfy these requirements. Instead it 

chooses to trespass. Because it has not ventured to find 

another way to perform these tests, it is unfair to suggest 

that Amphastar’s hands are tied. Indeed, to the extent 

the court is creating a new expansion of the statute that 

covers anything “mandated” by the FDA, this would 

unfairly attack inventors of the newest and most successful method. Such a method would be adopted or “mandated” by the FDA and then trigger the court’s new 

infringement exception. Needless to say, that would be 
17 MOMENTA PHARMA v. AMPHASTAR PHARMA

the exact opposite from a system that incentivizes creation and improvement. 

III. 

This court’s interpretation of § 271(e)(1) would essentially render manufacturing method patents worthless. 

This court repeatedly states that the FDA’s adoption of 

Momenta’s patented method as a standard means that 

§ 271(e)(1) should apply. Majority Op. 19 (“the information here is not generated voluntarily by the manufacturer but is generated by FDA requirements the 

manufacturer is obligated under penalty of law to follow”), 

21 (“that act of infringement is, in effect, required by the 

federal government as part of the continuing safety and 

efficacy monitoring of an approved drug”), id. (“where a 

drug has received approval, but is nevertheless kept from 

the market based on an FDA mandated testing requirement”), 20 (“the fact that Amphastar’s testing is carried 

out to ‘satisfy the FDA’s requirements’ means it falls 

within the scope of the safe harbor, even though the 

activity is carried out after approval”), 22 (“Amphastar’s 

allegedly infringing activities are clearly carried out 

according to the dictates of the Federal Food, Drug, and 

Cosmetic Act”). 

In essence, this reasoning repeals the incentives and 

protections of the patent act in this area. A patentee 

invents the first and (at the time) best method. Because 

of the success and utility of the inventive method, the 

FDA adopts that method as a standard. Because that 

method is “required by the FDA,” this court would permit 

copiers to infringe. What incentive remains to invest in 

inventing a better test? Imagine a teacher who rewards 

the top student by allowing her peers to copy her exam 

answers. Needless to say, this approach does violence to 

patent law and future research incentives in this field. 
MOMENTA PHARMA v. AMPHASTAR PHARMA 18

And what happens if a second, less effective (patented) method appears? Will copiers be allowed to infringe that method, too? Or, instead, because it is not as 

good and the FDA does not adopt it as the standard, then 

the court’s new interpretation of § 271(e)(1) does not apply 

and copiers can infringe the first, best method but not the 

second, less effective method? 

IV. 

The Supreme Court cases Eli Lilly & Co. v. Medtronic, 

Inc., 496 U.S. 1047 (1990) and Merck KGaA v. Integra 

Lifesciences I, Ltd., 545 U.S. 193 (2005) support the 

holding in Classen and do not support this decision. Both 

holdings in Eli Lilly and Merck dealt with pre-approval

activity and submissions, meaning before obtaining FDA 

approval. Further, neither even suggested that the mere 

maintenance or retention of information as part of a 

company’s records could be a “submission” to the FDA. 

Nevertheless, the court takes phrases from those opinions 

out of context to allege that its new interpretation of 

§ 271(e)(1) is consistent with those cases. 

In Eli Lilly, the Supreme Court addressed whether 

§ 271(e)(1) applies to medical devices in addition to drugs. 

496 U.S. at 663-64 (“This case presents the question 

whether 35 U.S.C. § 271(e)(1) renders activities that 

would otherwise constitute patent infringement noninfringing if they are undertaken for the purpose of developing and submitting to the Food and Drug Administration 

(FDA) information necessary to obtain marketing approval for a medical device under § 515 of the Federal 

Food, Drug, and Cosmetic Act (FDCA), 90 Stat. 552, 21 

U.S.C. § 360e.”). 

The Supreme Court described how §§ 201 and 202 

should be read together. Section 201 concerns activity in 

the early years of a patent’s life. Section 202 concerns the 
19 MOMENTA PHARMA v. AMPHASTAR PHARMA

latter years. Each section is a reciprocal counter to the 

other. Importantly, Congress intended the sections to 

deal with “premarket regulatory approval”: 

The parties agree that the 1984 Act was designed 

to respond to two unintended distortions of the 17-

year patent term produced by the requirement 

that certain products must receive premarket 

regulatory approval. First, the holder of a patent relating to such products would as a practical 

matter not be able to reap any financial rewards 

during the early years of the term. ... Thus, if the 

discovery relates to a product that cannot be marketed without substantial testing and regulatory 

approval, the “clock” on his patent term will be 

running even though he is not yet able to derive 

any profit from the invention. The second distortion occurred at the other end of the patent term. 

In 1984, the Court of Appeals for the Federal Circuit decided that the manufacture, use, or sale of 

a patented invention during the term of the patent constituted an act of infringement, see 

§ 271(a), even if it was for the sole purpose of conducting tests and developing information necessary to apply for regulatory approval. See 

Roche Products, Inc. v. Bolar Pharmaceutical Co., 

733 F.2d 858 (Fed. Cir. 1984). Since that activity 

could not be commenced by those who planned to 

compete with the patentee until expiration of the 

entire patent term, the patentee’s de facto monopoly would continue for an often substantial period 

until regulatory approval was obtained. In other 

words, the combined effect of the patent law and 

the premarket regulatory approval requirement was to create an effective extension of the 

patent term. 
MOMENTA PHARMA v. AMPHASTAR PHARMA 20

496 U.S. at 669-670 (emphases added). Therefore: 

The 1984 Act sought to eliminate this distortion 

from both ends of the patent period. Section 201 

of the Act established a patent-term extension for 

patents relating to certain products that were subject to lengthy regulatory delays and could not be 

marketed prior to regulatory approval. ... Section 

201 provides that patents relating to these products can be extended up to five years ... The distortion at the other end of the patent period was 

addressed by § 202 of the Act. ... This allows 

competitors, prior to the expiration of a patent, to 

engage in otherwise infringing activities necessary to obtain regulatory approval.” 

Id. at 670-71 (emphasis added). 

The 1984 Act enacted the two sections to create a balance. The Supreme Court rejected the party’s attempt to 

create a “disequilibrium” between the two sections. Id. at 

672. 

This court’s new interpretation in this case would apply the disadvantage of § 202 to a patentee who would not 

be able to obtain the benefits of § 201. The patentee of a 

manufacturing patent does not obtain the patent extension created in § 201, yet this court’s new expansion of 

§ 202 would allow its competitors to infringe during the 

life of its patent. The Supreme Court rejected this sort of 

disequilibrium. See Proveris Scientific Corp. v. Innovasystems, Inc., 536 F.3d 1256 (Fed. Cir. 2008) (relying on 

Merck to hold that § 271(e)(1) does not apply to infringement of patented product not eligible to obtain patent 

extension). 

This court’s new interpretation does not reserve § 202 

for the “end of the patent term.” Instead, its interpreta-
21 MOMENTA PHARMA v. AMPHASTAR PHARMA

tion allows infringing activity continuously throughout 

the life of the patent, including the “early years” reserved 

for § 201. If, as the court claims, § 202 was meant to 

cover the continuous, commercial use throughout the life 

of the patent, there would be no balance between § 201 

and § 202. This decision improperly cuts short the life of 

Momenta’s patent. 

And, as already discussed, this new interpretation expands beyond “premarket regulatory approval.” See 496 

U.S. at 669-670. Its interpretation allows infringing 

activity after the product has already been approved for 

sale on the market. 

Surprisingly, the court claims that its “analysis is not 

groundbreaking: the Supreme Court came to essentially 

the same conclusion in 1990” and cites Eli Lilly. Majority 

Op. 14. It has been quoted that “Words are easy, like the 

wind.” Saying that something “is not groundbreaking” 

does not make it so. 

Nowhere in Eli Lilly does the Supreme Court come to 

“essentially the same conclusion” as the majority here. 

The Supreme Court does not say that the mere maintenance or retention of records — with no intention to 

submit to the FDA but that only could potentially be 

viewed by the FDA if the FDA requested it — would 

satisfy as a “submission” to the FDA. The Supreme Court 

does not sanction post-approval activity. The Supreme 

Court does not read the word “solely” out from the statute. 

It is more telling what the court’s reasoning omits 

than what it cites. The court only relies on a single 

sentence from Eli Lilly, which it quotes out of context. 

496 U.S. at 666 (“But the phrase ‘a Federal law which 

regulates the manufacture, use, or sale of drugs’ more 

naturally summons up the image of an entire statutory 
MOMENTA PHARMA v. AMPHASTAR PHARMA 22

scheme of regulation.”). The Supreme Court was not even 

referencing the same phrase that is at issue here: “a 

Federal law,” not “submission.” In fact, that sentence is 

not even in the section in the Supreme Court’s opinion 

that discusses the basis on which the Court decided the 

case. Instead, that sentence is in a prior section discussing the text of the statute, which the Supreme Court 

found “somewhat more naturally reads as the Court of 

Appeals determined, but that is not plainly comprehensible on anyone’s view.” Id. 

The sentence cited by this court is not even a definitive holding of the Supreme Court but instead a discussion of the parties’ arguments. In looking at the 

paragraphs following the one cited by this decision, the 

Supreme Court states the case for the opposing side: “On 

the other side of the ledger, however, one must admit that 

while the provision more naturally means what respondent suggests, it is somewhat difficult to understand why 

anyone would want it to mean that. Why should the 

touchstone of noninfringement be whether the use is 

related to the development and submission of information 

under a provision that happens to be included within an 

Act that, in any of its provisions, not necessarily the one 

at issue, regulates drugs?” Id. at 668. On other occasions, 

the Federal Circuit advises against this type of slanted 

wordsmithing. 

In Merck, the Supreme Court addressed whether 

§ 271(e)(1) applies to research intended for submission for 

FDA approval but ultimately not submitted to the FDA. 

545 U.S. at 195 (“This case presents the question whether 

uses of patented inventions in preclinical research, the 

results of which are not ultimately included in a submission to the Food and Drug Administration (FDA), are 

exempted from infringement by 35 U.S.C. § 271(e)(1).”). 

In other words, the case presented an instance of limited 
23 MOMENTA PHARMA v. AMPHASTAR PHARMA

experiments performed in the pre-approval stage of drug 

development. 

Nowhere does Merck suggest that post-approval, 

commercial, continuous infringing use would be permitted. Indeed, Merck clearly lays out that § 271(e)(1) is 

intended for pre-approval, experimental, limited use. 

Basic scientific research on a particular compound, performed without the intent to develop a 

particular drug or a reasonable belief that the 

compound will cause the sort of physiological effect the researcher intends to induce, is surely not 

‘reasonably related to the development and submission of information’ to the FDA. It does not follow from this, however, that § 271(e)(1)’s 

exemption from infringement categorically excludes either (1) experimentation on drugs that 

are not ultimately the subject of an FDA submission or (2) use of patented compounds in experiments that are not ultimately submitted to the 

FDA. Under certain conditions, we think the exemption is sufficiently broad to protect the use of 

patented compounds in both situations.” [205-06 

(emphasis added)] “Moreover, many of the uncertainties that exist with respect to the selection 

of a specific drug exist as well with respect to 

the decision of what research to include in an 

IND or NDA. As a District Court has observed, 

‘[I]t will not always be clear to parties setting out 

to seek FDA approval for their new product exactly which kinds of information, and in what 

quantities, it will take to win that agency’s approval.’ Intermedics, Inc. v. Ventritex, Inc., 775 

F.Supp. 1269, 1280 (N.D.Cal. 1991), aff’d, 991 

F.2d 808 (Fed. Cir. 1993). This is especially true 

at the preclinical stage of drug approval.” 
MOMENTA PHARMA v. AMPHASTAR PHARMA 24

545 U.S. at 207 (emphases added). 

This court relies on some text from Merck that appears superficially to suggest an expansive interpretation 

of § 271(e)(1). But, read in context, that language has 

another meaning entirely. This language appears to 

suggest that § 271(e)(1) covers any sort of information or 

submission. But, this language actually appears in the 

context of the issue in Merck of whether information 

intended for submission to the FDA for approval should be 

covered when the information was ultimately not submitted because the drug candidate in that case lacked potential. This context is apparent in the sentences next to the 

sentence quoted by the majority, which state: 

We decline to read the “reasonable relation” requirement so narrowly as to render § 271(e)(1)’s 

stated protection of activities leading to 

FDA approval for all drugs illusory. Properly 

construed, § 271(e)(1) leaves adequate space 

for experimentation and failure on the road 

to regulatory approval: At least where a drugmaker has a reasonable basis for believing that a 

patented compound may work, through a particular biological process, to produce a particular 

physiological effect, and uses the compound in research that, if successful, would be appropriate to 

include in a submission to the FDA, that use is 

“reasonably related” to the “development and 

submission of information under ... Federal law.” 

§ 271(e)(1). 

Id. at 207 (emphases added). 

Merck does not reduce the importance of the limitation that § 271(e)(1) is reserved “solely for uses reasonably related to the development and submission of 

information.” Holding that preclinical research reasona-
25 MOMENTA PHARMA v. AMPHASTAR PHARMA

bly expected to generate information for regulatory approval does not fall outside § 271(e)(1) simply because the 

research fails and does not result in a regulatory application, id. at 206-07, is a far cry from permitting infringement during manufacture of a commercial product merely 

because the infringing act also generates information that 

might someday be submitted to the FDA, long after 

marketing approval is granted. Here, Amphastar’s use of 

the patented method is primarily for production of a 

commercial product; it is not “solely for uses reasonably 

related to” development of information. 

As another point, this court claims that “the Court 

explicitly rejected the notion that § 271(e)(1) was limited 

‘to the activities necessary to seek approval of a generic 

drug.’” Majority Op. 16. But, it is important to understand what Merck was trying to distinguish. Read in 

context, that phrase is referring to allowing § 271(e)(1) to 

include pre-approval activities for a branded drug. It was 

not stating that § 271(e)(1) included post-approval activities for a generic drug. In other words, the Supreme 

Court was emphasizing the words “generic drug,” not the 

words “necessary to seek approval.” Imagine ordering a 

computer and stating that “I do not want it delivered to 

my house on Wednesday.” Then, the post office delivered 

it to your neighbor’s house on Thursday. Obviously, you 

meant to emphasize “Wednesday,” not “my house.” Similarly, this court must read the Supreme Court’s cases as a 

whole and in context. 

Just because Merck held that § 271(e)(1) could cover 

pre-approval activities for not only the ANDA but also the 

NDA and IND, does not mean that the mere retention of 

documents as part of a company’s records could be considered a “submission” to the FDA. In other words, if a 

house owner allows a hired painter to paint his house any
MOMENTA PHARMA v. AMPHASTAR PHARMA 26

and all shades of brown, that is not permission to choose 

neon orange or turquoise. 

Thus, while Merck said that as long as an activity was 

intended for submission to obtain approval, then 

§ 271(e)(1) applies even if the information is not actually 

submitted (because it is difficult to predict which drug 

candidates ultimately will be successful), it did not say 

that § 271(e)(1) applies even if the activity was never 

intended to obtain approval at all. Or if the information 

was not even intended for submission to the FDA. This 

court’s interpretation (that the mere retention of information as part of a company’s records can be a “submission” 

to the FDA) is indeed “groundbreaking” and the Supreme 

Court did not “come to essentially the same conclusion.” 

V. 

The safe harbor provision at issue in this case, due to 

its origin and purpose in reversing Roche v. Bolar, receives attention as an exception that permits experimentation. This link to experimentation and its role in 

advancing the progress of technology requires some 

commentary as well. Too often patent law is misunderstood as impeding more than promoting innovation. This 

academic proposition, called the tragedy of the Anticommons in some scholarly presentations, suggests that 

exclusive rights impede the flow of information and limit 

experimentation that might lead to the next generation of 

technological advance. Michael A. Heller & Rebecca S. 

Eisenberg, Can Patents Deter Innovation? The Anticommons in Biomedical Research, 280 SCIENCE 698 (1998). 

In the first place, in an era of empirical research, one 

might ask the reason that this academic notion has never 

actually been verified. Although studied, no research has 

substantiated this alleged attack on the patent system. 

In fact, “the effects predicted by the anti-commons hy-
27 MOMENTA PHARMA v. AMPHASTAR PHARMA

pothesis are not borne out in the available data.” Timothy 

Caulfield, Human Gene Patents: Proof of Problems?, 84 

Chi.-Kent L. Rev. 133, 137 (2009); see also American 

Association for the Advancement of Science, 

INTERNATIONAL INTELLECTUAL PROPERTY EXPERIENCES: A

REPORT OF FOUR COUNTRIES 12 (2007) (finding the results 

of a 2006 survey of U.S. and Japanese researchers “offer 

very little evidence of an ‘anticommons problem’” and that 

“IP-protected technologies remain relatively accessible to 

the broad scientific community”). Surveys of academic 

researchers have revealed that “only 1 percent . . . report 

having to delay a project, and none abandoned a project 

due to others’ patents.” Wesley M. Cohen & John P. 

Walsh, Real Impediments to Academic Biomedical Research, in 8 INNOVATION POLICY AND THE ECONOMY 1, 10-

11 (Adam B. Jaffe, Josh Lerner, & Scott Stern eds. 2008), 

available at

http://www.nber.org/~marschke/mice/Papers/cohenwalsh.

pdf (citing John P. Walsh et al., The View from the Bench: 

Patents, Material Transfers and Biomedical Research, 

309 SCIENCE 2002 (2005)). In other words, patents on 

research tools and biomedical innovations do not significantly slow the pace of research and do not deter researchers from pursuing promising projects. 

The reason that patents have not been proven to impede more than stimulate technological advance is simple: 

it does not happen. It does not happen for several reasons. First, experiments advancing technology rarely, if 

ever, generate commercial value. Thus patent owners 

have little, if any, incentive to license or inhibit research. 

Stated otherwise, even if a patent owner wanted to sue or 

license potential researchers, experiments do not produce 

income or a source of damages. See id. at 12. 

Second, in the modern age of technology, the character of technological advance has changed. The era when 
MOMENTA PHARMA v. AMPHASTAR PHARMA 28

the Bell Labs or some other tech center could hire the 

most promising engineers and essentially invent everything for the world has passed. With the vast specialization of all fields of research, advances in technology 

require great cooperation. A new product or a new direction in biotechnology or electronics will be produced by 

cooperation between a professor in Chengdu, China, a 

young programmer in Bangaluru, India, an engineer at a 

large corporation in Munich, Germany, a graduate student at Tokyo University, and a team at a small start-up 

company in Silicon Valley. The patent system can help 

inform each of them of the other and bring together their 

incremental advances to achieve the next generation of 

progress in some tiny corner of human progress. 

Thus, patents properly remain a tool for research and 

experimentation because the system encourages publication and sharing of research results. Disclosure of how to 

make and use the invention is the “quid pro quo” of the 

patent grant. See JEM Ag Supply, Inc. v. Pioneer Hi-Bred 

Int’l, Inc., 534 U.S. 124, 142 (2001). In exchange for 

disclosure, the inventor receives a limited term of exclusivity to benefit from commercialization of his invention. 

Without this promise of exclusivity, researchers at corporations would be forced to turn to secrecy as the best 

protection for their inventions. Even academic researchers may delay publication of results in order to maintain 

an edge over the competition, Cohen & Walsh, supra at 

14, and the race to the patent office helps counteract this 

tendency toward secrecy by rewarding earlier disclosure. 

“The information in patents is added to the store of 

knowledge with the publication/issuance of the patent. . . . [It] is not insulated from analysis, study, and 

experimentation for the twenty years until patent expiration.” Classen, 659 F.3d at 1072. Rather, information 

shared through patent applications is immediately avail-
29 MOMENTA PHARMA v. AMPHASTAR PHARMA

able for others to build upon. It speeds the progress of 

scientific endeavor. In other words, the patent system’s 

modern benefits facilitate experimentation far more than 

any hypothetical inhibition. 

VI. 

Every day, Amphastar, a competitor of Momenta, is 

infringing Momenta’s patent. This decision allows that 

trespass. Moreover, to reach that result, this court must 

ignore its own prior decision in Classen and the purpose of 

the statute explained in the legislative history. Sadly this 

decision abrogates Momenta’s hard-achieved property 

right and reallocates that entitlement to its competitors – 

a sad day for property owners and an undeserved victory 

for those who decline to invest in the expense and difficulty of discovery and invention.