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 plaintiffs-
appellees. 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 plaintiffs-
appellants. 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 corre-
sponding distribution of disaccharide unit sequences in
the polysaccharide chains. FDA Letter to Aventis Phar-
maceuticals, Inc., July 23, 2010, FDA Docket No. FDA-
2003-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 compo-
nents, 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 poly-
saccharide 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, enoxa-
parin 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 bio-
equivalent 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 appli-
cation 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 isolat-
ing, purifying, and sequencing each of its unique polysac-
charide 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 per-
formance liquid chromatography (RP-HPLC), and strong
anion exchange high performance liquid chromatography
(SAX-HPLC). Id.
The FDA also suggested the identity of the disaccha-
rides could be determined via standard techniques, in-
cluding mass spectroscopy, NMR spectroscopy, modifying
reagents, or modifying enzymes. These techniques iden-
tify the nature of the constituent sugars and their substi-
tution 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 build-
ing blocks together with equivalence in molecular weight
distribution shows that generic enoxaparin contains the
1,6 anhydro ring structure at the reducing ends of be-
tween 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 Phar-
maceuticals, 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 enoxa-
parin 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 Amphas-
tar’s version of enoxaparin, and the resultant ruinous
competition of another generic version of the drug, threat-
ened this unique market position. Understandably un-
willing 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 sam-
ple “for the presence or amount of a non naturally occur-
ring 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 gener-
ally require digestion of an enoxaparin sample with a
heparin degrading enzyme, followed by the use of a sepa-
ration 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 com-
mercial sale” using the claimed methods. J.A. 58. Mo-
menta 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 infring-
ing 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 re-
ceived a temporary restraining order to prevent the
irreparable harm of additional generic entry from Am-
phastar. 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 emer-
gency motions for relief from the preliminary injunction,
which the district court denied.
Amphastar sequentially appealed the preliminary in-
junction and the two denials for relief from the prelimi-
nary 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 mat-
ter 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 injunc-
tions.” Intel Corp. v. ULSI Sys. Tech., Inc., 995 F.2d 1566,
1568 (Fed. Cir. 1993). To determine whether a prelimi-
nary 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 inter-
est.” 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 seek-
ing 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 pre-
liminary injunction is likely not appropriate. Id.
In its opposition to the preliminary injunction, Am-
phastar 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 pat-
ented 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 obtain-
ing 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 post-
approval 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 market-
ing 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, Mo-
menta 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 submis-
sion 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 cor-
rect 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. (quot-
ing 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 Resto-
ration 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 inter-
est.” H.R. Rep. 98-857, pt. 2, at 2714 (Aug. 1, 1984). This
balance is embodied, in part, in the “safe harbor” provi-
sion of 35 U.S.C. § 271(e)(1), which provides (with empha-
sis 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 inven-
tion (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 manufac-
tured using recombinant DNA, recombinant RNA,
hybridoma technology, or other processes involv-
ing site specific genetic manipulation techniques)
solely for uses reasonably related to the develop-
ment and submission of information under a Fed-
eral 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 ap-
proval 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 expan-
sive language to define the scope of § 271(e)(1), referring
generally to “the development and submission of informa-
tion under a Federal law which regulates the manufac-
ture, 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 stat-
ute in violation of the express language chosen by Con-
gress.
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 Cos-
metic 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. Chakra-
barty, 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 regu-
lates 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 develop-
ment 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 submis-
sion 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 sum-
mons up the image of an entire statutory scheme of regula-
tion,” 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 Fed-
eral Food, Drug, and Cosmetic Act, id. at 674.
The Court later reaffirmed this expansive view, ex-
plaining: “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 regula-
tory 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 infor-
mation from the exemption on the basis of the phase of
research in which it is developed or the particular submis-
sion 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 “mate-
rials 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 impor-
tant limitation: the use must be “for uses reasonably
related to the development and submission of informa-
tion,” 35 U.S.C. § 271(e)(1). “Reasonably related,” how-
ever, 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 com-
pounds ‘reasonably related’ to the process of developing
MOMENTA PHARMA v. AMPHASTAR PHARMA 16
information for submission under any federal law regulat-
ing 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 believ-
ing” that use of the patented invention might yield infor-
mation 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 consis-
tent 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 ex-
emption 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 manufac-
ture, 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 experi-
ence 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 con-
tinued 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 de-
scribed 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 re-
cords “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 inspec-
tion” 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 produc-
tion 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 pur-
poses. While Momenta urges us to adopt the pre-/post-
approval 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 require-
ments that each batch of enoxaparin that is sold commer-
cially 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 re-
quires” 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 even-
tually 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 prelimi-
nary 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 submis-
sion 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 “pre-
approval 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, Amphas-
tar’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 non-
infringing alternative when one exists. The only limita-
tion in the safe harbor is that the use must be “reasonably
related to the development and submission of informa-
tion” pursuant to a federal law regulating the “manufac-
ture, use, or sale of drugs or veterinary biological
products.” 35 U.S.C. § 271(e)(1). The safe harbor’s pro-
tection 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 govern-
ment as part of the continuing safety and efficacy moni-
toring of an approved drug. It also avoids the situation
here, where a drug has received approval, but is neverthe-
less kept from the market based on an FDA mandated
testing requirement.
Momenta’s interpretation is predicated upon the in-
correct 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 informa-
tion 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 FDA-
mandated quality control testing during manufacturing is
not done “solely” for purposes of developing and submit-
ting information to the FDA, the dissent suggests that
because Amphastar uses the patented method while
manufacturing a product to sell in commerce its infring-
ing 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 informa-
tion for the FDA but protects all acts, even interim re-
search 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) (hold-
ing 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 “deter-
mination 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) (produc-
tion, 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 produc-
tion 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 pur-
ports 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 “in-
volves 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 Su-
preme 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 “rigor-
ous 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 fac-
tors 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 presump-
tion 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 in-
fringement, 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 require-
ments” 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 Constitu-
tion 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-of-
jail-free card for the trespasser. Accordingly, such excep-
tions must occur only sparingly with awareness that this
license allows the wrongdoer free reign to continue tres-
passing.
The public readily applauds the role of patents in the
development and delivery to the marketplace of life-
saving drugs or modern technology products like smart-
phones. At the same time, many incremental advances
contribute to these monumental advances or, as in this
case, enhance their delivery to the public. These incre-
mental inventions also represent difficult and expensive
advances in technology. For example, in this case, Am-
phastar 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 Mo-
menta’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 Immuno-
therapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir.
2011). Sadly this result will render worthless manufac-
turing test method patents. Accordingly, I must respect-
fully 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 appli-
cation, 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 over-
ruling 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 ap-
proval:
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 com-
mercial activity which will begin after a valid pat-
ent 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 Ap-
peals for the Federal Circuit held that the ex-
MOMENTA PHARMA v. AMPHASTAR PHARMA 4
perimental use of a drug product prior to the ex-
piration date of a patent claiming that drug prod-
uct 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 Com-
mittee’s view that experimental activity does
not have any adverse economic impact on the pat-
ent 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 Innova-
tion 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, Ameri-
can 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 Prod-
ucts, 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 ex-
periments 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 investi-
gation strictly related to FDA drug approval re-
quirements 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 pharma-
ceutical 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 ech-
oed 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 ex-
tended 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 Manufac-
turers Association) (emphases added).
On the other side of the industry, the Generic Phar-
maceutical 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 ap-
proval before a patent expires so that actual
competition between the generic drug and the
original drug can begin immediately after the pat-
ent 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 ge-
neric 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 Asso-
ciation) (emphases added).
The executive branch favored an even more limited
exception than the one proposed in section 202 and en-
acted as § 271(e)(1). Nevertheless, it clearly understood
the boundaries of section 202 to be pre-approval experi-
mental 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. Exist-
ing patentees have relied upon accepted doctrine
indicating that use of a patented invention for
the purpose of obtaining regulatory ap-
proval infringes that patent. Upsetting expecta-
tions 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, Direc-
tor, 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 per-
mitted 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 in-
terference 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, Com-
mittee on the Judiciary) (see block quote above); Innova-
tion 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 Asso-
ciation) (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) (state-
ment 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 devel-
opment and submission of information to obtain FDA’s
premarketing approval to engage in the commercial
manufacture, use, or sale of the drug after patent expira-
tion”) (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) (memo-
randum 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 ap-
plies 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 Re-
form: 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) (memo-
randum 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 commer-
cial 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, commer-
cial 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 commer-
cial 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 experi-
ments pre-approval (i.e., to obtain FDA approval). No-
where 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 legisla-
tive history can this court find any mention of the post-
approval, continuous, commercial sales allowed by this
decision. Nowhere in the legislative history can this court
find any suggestion that the mere maintenance or reten-
tion 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 legisla-
tive history of this section at all — a very telling silence.
Of course, this court proclaims that it finds no ambi-
guity 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 comprehensi-
ble.” See Eli Lilly, 496 U.S. at 669. Moreover the court
strains to avoid ambiguity by discounting critical statu-
tory 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 pur-
pose of manufacturing a product to sell on the market in
commerce.
Second, the court claims that the mere retention of re-
cords 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 informa-
tion ‘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 activ-
ity by pharmaceutical companies to constitute “submis-
sion” 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 ap-
proval. Thus, the statute limits the exception to “solely
for uses reasonably related to the development and sub-
mission of information under a Federal law which regu-
lates 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 Ҥ 271(e)(1)
provides an exception to the law of infringement in order
to expedite development of information for regula-
tory approval of generic counterparts of patented prod-
ucts. 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 expira-
tion.” Id. at 1071 (emphasis added). In particular, Clas-
sen stated:
Our colleague in dissent strays from statute and
precedent, in arguing that any activity by any en-
tity 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 ob-
tained is ‘reasonably related to submitting any in-
formation under the FDCA,’ [659 F.3d at 1083
(Moore, J., dissenting)] (emphasis in dissent), ‘in-
cluding 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 pre-
approval because Amphastar has already obtained ap-
proval. 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 inven-
tion in manufacturing each commercial batch of its prod-
uct for contemporaneous sale on the market (in
commerce) to obtain profits and to compete with Mo-
menta. 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 infor-
mation 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 post-
approval 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 Hatch-
Waxman, The United States Supreme Court and the
Federal Circuit: 35 USC §271(e)(1) applies only to pre-
market 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/post-
commercialization period is outside the scope of the
Drug Price Competition and Patent Term Restoration Act
and would present unworkable difficulties in its applica-
tion.”) (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 “ex-
perimentation,” id.
This decision (“post-approval studies”; “after ap-
proval”; “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 post-
approval 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 success-
ful method. Such a method would be adopted or “man-
dated” 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 crea-
tion and improvement.
III.
This court’s interpretation of § 271(e)(1) would essen-
tially 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 informa-
tion here is not generated voluntarily by the manufac-
turer 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 require-
ment”), 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 (pat-
ented) method appears? Will copiers be allowed to in-
fringe 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 nonin-
fringing if they are undertaken for the purpose of develop-
ing and submitting to the Food and Drug Administration
(FDA) information necessary to obtain marketing ap-
proval 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 pat-
ent 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 mar-
keted 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 distor-
tion occurred at the other end of the patent term.
In 1984, the Court of Appeals for the Federal Cir-
cuit decided that the manufacture, use, or sale of
a patented invention during the term of the pat-
ent constituted an act of infringement, see
§ 271(a), even if it was for the sole purpose of con-
ducting tests and developing information neces-
sary 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 monop-
oly 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 require-
ment 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 sub-
ject to lengthy regulatory delays and could not be
marketed prior to regulatory approval. … Section
201 provides that patents relating to these prod-
ucts can be extended up to five years … The dis-
tortion 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 neces-
sary to obtain regulatory approval.”
Id. at 670-71 (emphasis added).
The 1984 Act enacted the two sections to create a bal-
ance. 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 ap-
ply 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 exten-
sion 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. Innovasys-
tems, Inc., 536 F.3d 1256 (Fed. Cir. 2008) (relying on
Merck to hold that § 271(e)(1) does not apply to infringe-
ment 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 ex-
pands 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 mainte-
nance 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 stat-
ute.
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 discuss-
ing 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 comprehensi-
ble on anyone’s view.” Id.
The sentence cited by this court is not even a defini-
tive holding of the Supreme Court but instead a discus-
sion 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 respon-
dent 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 submis-
sion 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 permit-
ted. Indeed, Merck clearly lays out that § 271(e)(1) is
intended for pre-approval, experimental, limited use.
Basic scientific research on a particular com-
pound, performed without the intent to develop a
particular drug or a reasonable belief that the
compound will cause the sort of physiological ef-
fect the researcher intends to induce, is surely not
‘reasonably related to the development and sub-
mission of information’ to the FDA. It does not fol-
low from this, however, that § 271(e)(1)’s
exemption from infringement categorically ex-
cludes either (1) experimentation on drugs that
are not ultimately the subject of an FDA submis-
sion or (2) use of patented compounds in experi-
ments that are not ultimately submitted to the
FDA. Under certain conditions, we think the ex-
emption is sufficiently broad to protect the use of
patented compounds in both situations.” [205-06
(emphasis added)] “Moreover, many of the uncer-
tainties 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 ex-
actly which kinds of information, and in what
quantities, it will take to win that agency’s ap-
proval.’ 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 ap-
pears 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 submit-
ted because the drug candidate in that case lacked poten-
tial. This context is apparent in the sentences next to the
sentence quoted by the majority, which state:
We decline to read the “reasonable relation” re-
quirement 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 drug-
maker has a reasonable basis for believing that a
patented compound may work, through a particu-
lar biological process, to produce a particular
physiological effect, and uses the compound in re-
search 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 limita-
tion that § 271(e)(1) is reserved “solely for uses reasona-
bly 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 ap-
proval does not fall outside § 271(e)(1) simply because the
research fails and does not result in a regulatory applica-
tion, id. at 206-07, is a far cry from permitting infringe-
ment 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 under-
stand 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 activi-
ties 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.” Simi-
larly, 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 consid-
ered 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 informa-
tion 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, re-
ceives attention as an exception that permits experimen-
tation. This link to experimentation and its role in
advancing the progress of technology requires some
commentary as well. Too often patent law is misunder-
stood as impeding more than promoting innovation. This
academic proposition, called the tragedy of the Anti-
commons 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 Anticom-
mons 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 Re-
search, 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 signifi-
cantly slow the pace of research and do not deter re-
searchers from pursuing promising projects.
The reason that patents have not been proven to im-
pede more than stimulate technological advance is simple:
it does not happen. It does not happen for several rea-
sons. 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 charac-
ter 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 every-
thing for the world has passed. With the vast specializa-
tion of all fields of research, advances in technology
require great cooperation. A new product or a new direc-
tion 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 stu-
dent 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 publica-
tion 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 exclu-
sivity to benefit from commercialization of his invention.
Without this promise of exclusivity, researchers at corpo-
rations would be forced to turn to secrecy as the best
protection for their inventions. Even academic research-
ers 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 pat-
ent. . . . [It] is not insulated from analysis, study, and
experimentation for the twenty years until patent expira-
tion.” 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 diffi-
culty of discovery and invention.