Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/s

(Slip Opinion) OCTOBER TERM, 2011 1
Syllabus
NOTE: Where it is feasible, a syllabus (headnote) will be released, as is
being done in connection with this case, at the time the opinion is issued.
The syllabus constitutes no part of the opinion of the Court but has been
prepared by the Reporter of Decisions for the convenience of the reader.
See United States v. Detroit Timber & Lumber Co., 200 U. S. 321, 337.
SUPREME COURT OF THE UNITED STATES
Syllabus
CARACO PHARMACEUTICAL LABORATORIES, LTD.,
ET AL. v. NOVO NORDISK A/S ET AL.
CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR
THE FEDERAL CIRCUIT
No. 10–844. Argued December 5, 2011—Decided April 17, 2012
The Food and Drug Administration (FDA) regulates the manufacture,
sale, and labeling of prescription drugs. A brand-name drug manu-
facturer seeking FDA approval for a drug submits a new drug appli-
cation (NDA) containing, among other things, a statement of the
drug’s components and proposed labeling describing the uses for
which the drug may be marketed. See 21 U. S. C. §§355(b)(1), (d).
Once the FDA has approved a brand manufacturer’s drug, another
company may seek permission to market a generic version by filing
an abbreviated new drug application (ANDA). See §§355(j)(2)(A)(ii),
(iv). But the FDA cannot authorize a generic drug that would in-
fringe a brand manufacturer’s patent. To facilitate the approval of
generic drugs as soon as patents allow, the Hatch-Waxman Amend-
ments require a brand manufacturer to submit its patent numbers
and expiration dates, §355(b)(1); and FDA regulations require a de-
scription of any method-of-use patent, known as a use code, see 21
CFR §§314.53(c)(2)(ii)(P)(3), (e). The FDA does not attempt to verify
the accuracy of the use codes that brand manufacturers supply. In-
stead, it simply publishes the codes, patent numbers, and expiration
dates in a large volume known as the Orange Book.
After consulting the Orange Book, an ANDA applicant enters one
of several certifications to assure the FDA that its generic drug will
not infringe the brand’s patent. If the patent has not expired, an ap-
plicant may fulfill this requirement in one of two ways. First, it may
submit a so-called section viii statement asserting that it will market
the drug for only those methods of use not covered by the brand’s pa-
tent, see 21 U. S. C. §355(j)(2)(A)(viii), and proposing a label that
“carves out” the still-patented method(s) of use, see 21 CFR
2 CARACO PHARMACEUTICAL LABORATORIES, LTD. v.
NOVO NORDISK A/S
Syllabus
§314.94(a)(8)(iv). The FDA will not approve an ANDA with a section
viii statement if the proposed label overlaps at all with the brand’s
use code. Second, the ANDA applicant may file a so-called paragraph
IV certification stating that the brand’s patent “is invalid or will not
be infringed by the [generic drug’s] manufacture, use, or sale.” 21
U. S. C. §355(j)(2)(A)(vii)(IV). Such filing is treated as an act of in-
fringement, giving the brand an immediate right to sue and resulting
in a delay in the generic drug’s approval.
In 2002, the Federal Trade Commission (FTC) issued a study de-
tailing evidence that brands were submitting inaccurate patent in-
formation to the FDA in order to prevent or delay the marketing of
generic drugs. In response, Congress created a statutory counter-
claim available to generic manufacturers sued for patent infringe-
ment. The provision allows a generic manufacturer to “assert a coun-
terclaim seeking an order requiring the [brand] to correct or delete
the patent information submitted by the [brand] under subsection (b)
or (c) [of 21 U. S. C. §355] on the ground that the patent does not
claim . . . an approved method of using the drug.” 21 U. S. C.
§355(j)(5)(C)(ii)(I). This case concerns the scope of the counterclaim
provision.
Respondents (collectively Novo) manufacture the brand-name ver-
sion of the diabetes drug repaglinide. The FDA has approved three
uses of the drug, but Novo’s method-of-use patent claims only one.
Petitioners (collectively Caraco) wish to market a generic version of
the drug for the other two approved methods of use. Caraco initially
filed a paragraph IV certification and, considering this an act of in-
fringement, Novo brought suit. Caraco then submitted a section viii
statement and a proposed label carving out Novo’s patented therapy.
But before the FDA could approve Caraco’s ANDA, Novo changed its
use code to indicate that it held a patent on all three approved
methods of using repaglinide. Because Caraco’s proposed label now
overlapped with Novo’s use code, the FDA would not permit Caraco
to employ section viii to bring its drug to market.
Caraco filed a statutory counterclaim in the ongoing infringement
action, seeking an order requiring Novo to “correct” its use code be-
cause the patent did not claim two of the three approved methods of
using repaglinide. The District Court granted Caraco summary
judgment, but the Federal Circuit reversed. It read the counter-
claim’s phrase “the patent does not claim . . . an approved method of
using the drug” as requiring Caraco to demonstrate that Novo’s pa-
tent does not claim any approved method of use; because the patent
covers one approved method, the counterclaim was unavailable. The
court also ruled that the counterclaim provision does not reach use
codes because they are not “patent information submitted by the
Cite as: 566 U. S. ____ (2012) 3
Syllabus
[brand] under subsection (b) or (c)” of §355. That information, the
court concluded, consists only of the patent number and expiration
date expressly required by the statutory provisions.
Held: A generic manufacturer may employ the counterclaim provision
to force correction of a use code that inaccurately describes the
brand’s patent as covering a particular method of using a drug.
Pp. 10–24.
(a) The parties first dispute the meaning of “not an” in the phrase
“the patent does not claim . . . an approved method of using the drug.”
Novo contends that the counterclaim is available only if the patent
claims no approved method of use, but Caraco reads this language to
permit a counterclaim whenever a patent does not claim the particu-
lar method that the ANDA applicant seeks to market. In isolation,
either of these readings is plausible, so the meaning of the phrase
“not an” turns on statutory context, see Johnson v. United States, 559
U. S. ___, ___. This context favors Caraco: Congress understood that
a drug may have multiple methods of use, not all of which a patent
covers; and a section viii statement allows the FDA to approve a ge-
neric drug for unpatented uses so that it can quickly come to market.
The statute thus contemplates that one patented use will not fore-
close marketing a generic drug for other unpatented ones. Within
this scheme, the counterclaim naturally functions to challenge the
brand’s assertion of rights over whichever discrete uses the generic
company wishes to pursue; the counterclaim’s availability matches
the availability of FDA approval under the statute. Pp. 11–15.
(b) The parties further dispute whether use codes qualify as “pa-
tent information submitted by the [brand] under subsection (b) or (c)”
of §355. A use code, which is a description of the patent, surely quali-
fies as “patent information.” Novo nonetheless contends that use
codes are not “submitted under” subsections (b) and (c) because those
provisions expressly require an NDA applicant to provide only “the
patent number and the expiration date of any patent” claiming the
drug or a method of its use. But §§355(b) and (c) also govern the reg-
ulatory process by which brands provide additional patent infor-
mation to the FDA. The term “under” is broad enough to include pa-
tent information, like use codes, that brands submit as required by
this scheme. This reading draws support from the Court’s prior deci-
sions in e.g., Eli Lilly & Co. v. Medtronic, Inc., 496 U. S. 661, 665–
668, and Ardestani v. INS, 502 U. S. 129, 135; and it is bolstered by
Congress’s use of the narrower phrases “described in” and “prescribed
by” in neighboring provisions. See §§355(c)(2), (d)(6). Again, the con-
clusion that use codes are “submitted under” §§355(b) and (c) fits the
broader statutory context. Use codes are pivotal to the FDA’s imple-
mentation of the Hatch-Waxman Amendments, and so it is unsur-
4 CARACO PHARMACEUTICAL LABORATORIES, LTD. v.
NOVO NORDISK A/S
Syllabus
prising that the counterclaim provision’s language sweeps widely
enough to embrace them. Pp. 15–18.
(c) The counterclaim provision’s description of available remedies
dispatches whatever remains of Novo’s arguments. The Court’s read-
ing gives content to both remedies: It “delete[s]” a listing from the
Orange Book when the brand holds no relevant patent and “cor-
rect[s]” the listing when the brand has misdescribed the patent’s
scope. By contrast, Novo’s interpretation would all but read “correct”
out of the statute. If, as Novo contends, the counterclaim is available
only where the patent claims no approved method of use, the remedy
will always be to delete the patent information. And if the counter-
claim reaches only patent numbers and expiration dates, the Orange
Book will include few if any mistakes in need of correction. Pp. 18–
20.
(d) Novo advances two arguments relating to the counterclaim’s
drafting history, but neither overcomes the statutory text and con-
text. The company first points out that Congress failed to pass an
earlier bill that would have required brands to file descriptions of
method-of-use patents and would have allowed generic companies to
bring civil actions to “delete” or “correct” the information filed. Be-
cause that bill would have allowed a generic applicant to challenge
overbroad descriptions of a patent, Novo contends that this Court
cannot read the statute that was eventually enacted as doing the
same. But the earlier bill contained numerous items that may have
caused its failure. And the limited criticism of its mechanism for
challenging brands’ descriptions of their patents focused on the crea-
tion of an independent cause of action—stronger medicine than the
counterclaim at issue here. Finally, between that bill’s demise and
the counterclaim’s enactment, the FDA issued a rule requiring
brands to supply use codes. The counterclaim provision’s drafters
thus had no need to require this information.
Novo next contends that Congress established the counterclaim only
to address the impossibility of deleting an improperly listed patent
from the Orange Book—a problem that had come to light when the
Federal Circuit held in Mylan Pharmaceuticals, Inc. v. Thompson,
268 F. 3d 1323, that generics had no cause of action to delist a patent.
Novo thus contends that the counterclaim is a mere delisting provi-
sion. But this Court thinks Mylan alerted Congress to a broader
problem: that generic companies generally had no avenue to chal-
lenge the accuracy of brands’ patent listings, and that the FDA there-
fore could not approve proper applications to bring inexpensive drugs
to market. Again, the proof of that lies in the statute itself—its text
and context demonstrate that the counterclaim is available not only
(as in Mylan) when the patent listing is baseless, but also (as here)
Cite as: 566 U. S. ____ (2012) 5
Syllabus
when it is overbroad. Moreover, Congress’s equation of the two situa-
tions makes perfect sense. In either case, the brand submits mislead-
ing patent information to the FDA, delaying or blocking approval of a
generic drug that infringes no patent and thus, under the statute,
should go to market. Pp. 20–24.
601 F. 3d 1359, reversed and remanded.
KAGAN, J., delivered the opinion for a unanimous Court. SOTOMAYOR,
J., filed a concurring opinion.
Cite as: 566 U. S. ____ (2012) 1
Opinion of the Court
NOTICE: This opinion is subject to formal revision before publication in the
preliminary print of the United States Reports. Readers are requested to
notify the Reporter of Decisions, Supreme Court of the United States, Wash-
ington, D. C. 20543, of any typographical or other formal errors, in order
that corrections may be made before the preliminary print goes to press.
SUPREME COURT OF THE UNITED STATES
_________________
No. 10–844
_________________
CARACO PHARMACEUTICAL LABORATORIES, LTD.,
ET AL., PETITIONERS v. NOVO NORDISK A/S ET AL.
ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF
APPEALS FOR THE FEDERAL CIRCUIT
[April 17, 2012]
JUSTICE KAGAN delivered the opinion of the Court.
When the Food and Drug Administration (FDA) evalu-
ates an application to market a generic drug, it considers
whether the proposed drug would infringe a patent held
by the manufacturer of the brand-name version. To assess
that matter, the FDA requires brand manufacturers to
submit descriptions of the scope of their patents, known as
use codes. The FDA does not attempt to determine if that
information is accurate. Rather, the FDA assumes that
it is so and decides whether to approve a generic drug on
that basis. As a result, the breadth of the use code may
make the difference between approval and denial of a
generic company’s application.
In this case, we consider whether Congress has author-
ized a generic company to challenge a use code’s accuracy
by bringing a counterclaim against the brand manufac-
turer in a patent infringement suit. The relevant statute
provides that a generic company “may assert a counter-
claim seeking an order requiring the [brand manufac-
turer] to correct or delete the patent information [it]
submitted . . . under [two statutory subsections] on the
2 CARACO PHARMACEUTICAL LABORATORIES, LTD. v.
NOVO NORDISK A/S
Opinion of the Court
ground that the patent does not claim . . . an approved
method of using the drug.” 117 Stat. 2452, 21 U. S. C.
§355(j)(5)(C)(ii)(I). We hold that a generic manufacturer
may employ this provision to force correction of a use code
that inaccurately describes the brand’s patent as covering
a particular method of using the drug in question.
I
A
The FDA regulates the manufacture, sale, and labeling
of prescription drugs under a complex statutory scheme.
To begin at the beginning: When a brand manufacturer
wishes to market a novel drug, it must submit a new drug
application (NDA) to the FDA for approval. The NDA
must include, among other things, a statement of the
drug’s components, scientific data showing that the drug
is safe and effective, and proposed labeling describing
the uses for which the drug may be marketed. See
§§355(b)(1), (d). The FDA may approve a brand-name
drug for multiple methods of use—either to treat different
conditions or to treat the same condition in different ways.
Once the FDA has approved a brand manufacturer’s
drug, another company may seek permission to market
a generic version pursuant to legislation known as the
Hatch-Waxman Amendments. See Drug Price Competi-
tion and Patent Term Restoration Act of 1984, 98 Stat.
1585. Those amendments allow a generic competitor to
file an abbreviated new drug application (ANDA) piggy-
backing on the brand’s NDA. Rather than providing
independent evidence of safety and efficacy, the typical
ANDA shows that the generic drug has the same active
ingredients as, and is biologically equivalent to, the brand-
name drug. See §§355(j)(2)(A)(ii), (iv). As we have previ-
ously recognized, this process is designed to speed the
introduction of low-cost generic drugs to market. See Eli
Lilly & Co. v. Medtronic, Inc., 496 U. S. 661, 676 (1990).
Cite as: 566 U. S. ____ (2012) 3
Opinion of the Court
Because the FDA cannot authorize a generic drug that
would infringe a patent, the timing of an ANDA’s approval
depends on the scope and duration of the patents cover-
ing the brand-name drug. Those patents come in different
varieties. One type protects the drug compound itself.
Another kind—the one at issue here—gives the brand
manufacturer exclusive rights over a particular method of
using the drug. In some circumstances, a brand manufac-
turer may hold such a method-of-use patent even after its
patent on the drug compound has expired.
To facilitate the approval of generic drugs as soon as
patents allow, the Hatch-Waxman Amendments and FDA
regulations direct brand manufacturers to file information
about their patents. The statute mandates that a brand
submit in its NDA “the patent number and the expiration
date of any patent which claims the drug for which the
[brand] submitted the [NDA] or which claims a method of
using such drug.” §§355(b)(1). And the regulations issued
under that statute require that, once an NDA is approved,
the brand provide a description of any method-of-use
patent it holds. See 21 CFR §§314.53(c)(2)(ii)(P)(3), (e)
(2011). That description is known as a use code, and the
brand submits it on FDA Form 3542. As later discussed,
the FDA does not attempt to verify the accuracy of the
use codes that brand manufacturers supply. It simply pub-
lishes the codes, along with the corresponding patent
numbers and expiration dates, in a fat, brightly hued
volume called the Orange Book (less colorfully but more
officially denominated Approved Drug Products with
Therapeutic Equivalence Evaluations).
After consulting the Orange Book, a company filing an
ANDA must assure the FDA that its proposed generic
drug will not infringe the brand’s patents. When no pa-
tents are listed in the Orange Book or all listed patents
have expired (or will expire prior to the ANDA’s approval),
the generic manufacturer simply certifies to that effect.
4 CARACO PHARMACEUTICAL LABORATORIES, LTD. v.
NOVO NORDISK A/S
Opinion of the Court
See 21 U. S. C. §§355(j)(2)(A)(vii)(I)–(III). Otherwise, the
applicant has two possible ways to obtain approval.
One option is to submit a so-called section viii state-
ment, which asserts that the generic manufacturer will
market the drug for one or more methods of use not cov-
ered by the brand’s patents. See §355(j)(2)(A)(viii). A
section viii statement is typically used when the brand’s
patent on the drug compound has expired and the brand
holds patents on only some approved methods of using
the drug. If the ANDA applicant follows this route, it will
propose labeling for the generic drug that “carves out”
from the brand’s approved label the still-patented methods
of use. See 21 CFR §314.94(a)(8)(iv). The FDA may ap-
prove such a modified label, see §314.127(a)(7), as an ex-
ception to the usual rule that a generic drug must bear
the same label as the brand-name product, see 21 U. S. C.
§§355(j)(2)(A)(v), (j)(4)(G). FDA acceptance of the carve-
out label allows the generic company to place its drug
on the market (assuming the ANDA meets other require-
ments), but only for a subset of approved uses—i.e., those
not covered by the brand’s patents.
Of particular relevance here, the FDA will not approve
such an ANDA if the generic’s proposed carve-out label
overlaps at all with the brand’s use code. See 68 Fed. Reg.
36682–36683 (2003). The FDA takes that code as a given:
It does not independently assess the patent’s scope or
otherwise look behind the description authored by the
brand. According to the agency, it lacks “both [the] exper-
tise and [the] authority” to review patent claims; although
it will forward questions about the accuracy of a use code
to the brand,1 its own “role with respect to patent listing is
——————
1 Under the FDA’s regulations, any person may dispute the accuracy
of patent information listed in the Orange Book by notifying the agency
in writing. See 21 CFR §314.53(f). The FDA will then request that the
brand verify the information, but will make no changes “[u]nless the
[brand] withdraws or amends” the listing. Ibid.Cite as: 566 U. S. ____ (2012) 5
Opinion of the Court
ministerial.” Id., at 36683; see ibid. (“A fundamental
assumption of the Hatch-Waxman Amendments is that
the courts are the appropriate mechanism for the resolu-
tion of disputes about the scope and validity of patents”).2
Thus, whether section viii is available to a generic manu-
facturer depends on how the brand describes its patent.
Only if the use code provides sufficient space for the gener-
ic’s proposed label will the FDA approve an ANDA with a
section viii statement.
The generic manufacturer’s second option is to file a so-
called paragraph IV certification, which states that a
listed patent “is invalid or will not be infringed by the
manufacture, use, or sale of the [generic] drug.” 21
U. S. C. §355(j)(2)(A)(vii)(IV). A generic manufacturer will
typically take this path in either of two situations: if it
wants to market the drug for all uses, rather than carving
out those still allegedly under patent; or if it discovers, as
described above, that any carve-out label it is willing to
adopt cannot avoid the brand’s use code. Filing a para-
graph IV certification means provoking litigation. The
patent statute treats such a filing as itself an act of in-
fringement, which gives the brand an immediate right to
sue. See 35 U. S. C. §271(e)(2)(A). Assuming the brand
does so, the FDA generally may not approve the ANDA
until 30 months pass or the court finds the patent invalid
or not infringed. See 21 U. S. C. §355(j)(5)(B)(iii). Accord-
ingly, the paragraph IV process is likely to keep the gen-
eric drug off the market for a lengthy period, but may
eventually enable the generic company to market its drug
for all approved uses.
In the late 1990’s, evidence mounted that some brands
——————
2 Several courts have affirmed the FDA’s view of its ministerial role.
See, e.g., Apotex, Inc. v. Thompson, 347 F. 3d 1335, 1349 (CA Fed.
2003); aaaiPharma v. Thompson, 296 F. 3d 227, 242–243 (CA4 2002).
That question is not before us, and we express no view on it.
6 CARACO PHARMACEUTICAL LABORATORIES, LTD. v.
NOVO NORDISK A/S
Opinion of the Court
were exploiting this statutory scheme to prevent or delay
the marketing of generic drugs, and the Federal Trade
Commission (FTC) soon issued a study detailing these
anticompetitive practices. See FTC, Generic Drug Entry
Prior to Patent Expiration: An FTC Study, pp. iii–vi (July
2002) (hereinafter FTC Study). That report focused at-
tention on brands’ submission of inaccurate patent infor-
mation to the FDA. In one case cited by the FTC, Mylan
Pharmaceuticals, Inc. v. Thompson, 268 F. 3d 1323 (CA
Fed. 2001), a brand whose original patent on a drug was
set to expire listed a new patent ostensibly extending its
rights over the drug, but in fact covering neither the com-
pound nor any method of using it. The FDA, as was (and
is) its wont, accepted the listing at its word and accord-
ingly declined to approve a generic product. The generic
manufacturer sued to delete the improper listing from the
Orange Book, but the Federal Circuit held that the Hatch-
Waxman Amendments did not allow such a right of action.
See id., at 1330–1333. As the FTC noted, that ruling
meant that the only option for generic manufacturers in
Mylan’s situation was to file a paragraph IV certification
(triggering an infringement suit) and then wait out the
usual 30-month period before the FDA could approve an
ANDA. See FTC Study 40–45.
Congress responded to these abuses by creating a mech-
anism, in the form of a legal counterclaim, for generic
manufacturers to challenge patent information a brand
has submitted to the FDA. See Medicare Prescription
Drug, Improvement, and Modernization Act of 2003, 117
Stat. 2452. The provision authorizes an ANDA applicant
sued for patent infringement to
“assert a counterclaim seeking an order requiring the
[brand] to correct or delete the patent information
submitted by the [brand] under subsection (b) or (c) [of
§355] on the ground that the patent does not claim
Cite as: 566 U. S. ____ (2012) 7
Opinion of the Court
either—
“(aa) the drug for which the [brand’s NDA] was
approved; or
“(bb) an approved method of using the drug.” 21
U. S. C. §355(j)(5)(C)(ii)(I).
The counterclaim thus enables a generic competitor to
obtain a judgment directing a brand to “correct or delete”
certain patent information that is blocking the FDA’s
approval of a generic product. This case raises the ques-
tion whether the counterclaim is available to fix a brand’s
use code.
B
The parties to this case sell or seek to sell the diabetes
drug repaglinide. Respondents (collectively Novo) manu-
facture Prandin, the brand-name version of the drug. The
FDA has approved three uses of Prandin to treat diabe-
tes: repaglinide by itself; repaglinide in combination with
metformin; and repaglinide in combination with thiazoli-
dinediones (TZDs). Petitioners (collectively Caraco) wish
to market a generic version of the drug for two of those
uses.
Novo originally owned a patent for the repaglinide
compound, known as the ’035 patent, but it expired in
2009. In 2004, Novo also acquired a method-of-use patent
for the drug, called the ’358 patent, which does not expire
until 2018. That patent—the one at issue here—claims a
“method for treating [diabetes by] administering . . . rep-
aglinide in combination with metformin.” 601 F. 3d 1359,
1362 (CA Fed. 2010). Thus, Novo currently holds a patent
for one of the three FDA-approved uses of repaglinide—its
use with metformin. But Novo holds no patent for the use
of repaglinide with TZDs or its use alone.
In 2005, Caraco filed an ANDA seeking to market a
generic version of repaglinide. At that time, the Orange
Book entry for Prandin listed both the ’035 patent (the
8 CARACO PHARMACEUTICAL LABORATORIES, LTD. v.
NOVO NORDISK A/S
Opinion of the Court
drug compound) and the ’358 patent (the use of the drug
with metformin). Caraco assured the FDA that it would
not market its generic drug until the ’035 patent expired,
thus making that patent irrelevant to the FDA’s review of
the ANDA. Caraco filed a paragraph IV certification for
the remaining, ’358 patent, stating that it was “invalid or
[would] not be infringed.” §355(j)(2)(A)(vii)(IV); see supra,
at 5. In accord with the patent statute, Novo treated this
filing as an act of infringement and brought suit.
When Caraco filed its ANDA, Novo’s use code for the
’358 patent represented that the patent covered “ ‘[u]se of
repaglinide in combination with metformin to lower blood
glucose.’ ” 601 F. 3d, at 1362–1363. The FDA therefore
advised Caraco that if it did not seek to market repag-
linide for use with metformin, it could submit a section
viii statement. That would allow Caraco, assuming its
ANDA was otherwise in order, to market its generic drug
for the other two uses. Caraco took the FDA’s cue and in
2008 submitted a section viii statement, with proposed
labeling carving out Novo’s patented metformin therapy.
See App. 166–176.
Before the FDA took further action, however, Novo
changed its use code for the ’358 patent. The new use code
describes “ ‘[a] method for improving glycemic control in
adults with type 2 diabetes.’ ”3 601 F. 3d, at 1363. Be-
cause that code indicates that the ’358 patent protects all
three approved methods of using repaglinide to treat
diabetes, Caraco’s proposed carve-out of metformin ther-
apy was no longer sufficient; even with that exclusion,
——————
3 Novo asserts that it made the change so that its use code would
mirror its label, which the FDA had just asked it to alter. See Brief for
Respondents 14. But the FDA, in calling for new labeling, neither
requested nor required Novo to amend its use code. And indeed, Novo’s
counsel conceded before the Federal Circuit that Novo modified its use
code in part as “ ‘a response to the [FDA’s] section viii’ ” suggestion. 601
F. 3d, at 1380–1381.
Cite as: 566 U. S. ____ (2012) 9
Opinion of the Court
Caraco’s label now overlapped with Novo’s use code on the
other two uses. And Caraco could not carve out those uses
as well, because at that point nothing would be left for
it to market. The FDA has approved repaglinide for only
three uses, and Novo’s use code encompassed them all.
The FDA accordingly informed Caraco that it could no
longer employ section viii to bring its drug to market.
Caraco responded to Novo’s new, preclusive use code by
filing a statutory counterclaim in the ongoing infringe-
ment suit. The counterclaim sought an order requiring
Novo to “correct” its use code “on the ground that [the
’358] patent does not claim” two approved methods of
using repaglinide—alone and in combination with TZDs.
§355(j)(5)(C)(ii)(I); see supra, at 6–7. That order would
permit the FDA to accept Caraco’s proposed carve-out
label and approve the company’s ANDA. The District
Court granted summary judgment to Caraco, enjoining
Novo to “correct . . . its inaccurate description of the ’358
patent” by submitting a new Form 3542 to the FDA that
would “reinstat[e] its former” use code. App. to Pet. for
Cert. 65a–66a.
The Court of Appeals reversed, holding that Caraco
lacked “a statutory basis to assert a counterclaim.” 601
F. 3d, at 1360. The court first read the statutory phrase
“the patent does not claim . . . an approved method of
using the drug” to require Caraco to demonstrate that
the ’358 patent does not claim any approved method of
use. See id., at 1365 (“ ‘[A]n approved method’ means ‘any
approved method’ ”). Because the patent covers one ap-
proved method of use—repaglinide in combination with
metformin—the counterclaim was unavailable. The court
further ruled that the counterclaim provision does not
reach use codes because they are not “patent information
submitted by the [brand] under subsection (b) or (c).” On
the Federal Circuit’s view, that information consists only
of the patent number and expiration date. See id., at
10 CARACO PHARMACEUTICAL LABORATORIES, LTD. v.
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Opinion of the Court
1366–1367. Judge Dyk dissented. He would have read
the phrase “the patent does not claim . . . an approved
method of using the drug” to include situations where, as
here, the use code wrongly indicates that the patent covers
one or more particular approved methods of use. See id.,at 1376–1378. And he would have construed “patent in-
formation submitted . . . under subsection (b) or (c)” to
include use codes. See id., at 1370–1376.4
We granted certiorari, 564 U. S. ___ (2011), and now
reverse.
II
We begin “where all such inquiries must begin: with the
language of the statute itself.” United States v. Ron Pair
Enterprises, Inc., 489 U. S. 235, 241 (1989). This case
requires us to construe two statutory phrases. First, we
must decide when a “patent does not claim . . . an ap-
proved method of using” a drug. Second, we must deter-
mine the content of “patent information submitted . . .
under subsection (b) or (c)” of §355. We consider both of
those questions against the backdrop of yet a third statu-
tory phrase, providing that the remedy for a prevailing
counterclaimant is an order requiring the brand “to correct
or delete” that patent information. And we consider each
question in the context of the entire statute. See Robinson
v. Shell Oil Co., 519 U. S. 337, 341 (1997) (Statutory in-
terpretation focuses on “the language itself, the specific
context in which that language is used, and the broader
context of the statute as a whole”). We cannot say that the
counterclaim clause is altogether free of ambiguity. But
when we consider statutory text and context together, we
conclude that a generic manufacturer in Caraco’s position
——————
4 On remand from the Federal Circuit’s decision, the District Court
determined that the ’358 patent was invalid and unenforceable. See
775 F. Supp. 2d 985 (ED Mich. 2011). The Federal Circuit stayed
Novo’s appeal from that judgment pending the decision here.
Cite as: 566 U. S. ____ (2012) 11
Opinion of the Court
can use the counterclaim.5
A
An ANDA applicant sued for patent infringement may
bring a counterclaim “on the ground that the patent does
not claim . . . an approved method of using the drug.” 21
U. S. C. §355(j)(5)(C)(ii)(I). The parties debate the mean-
ing of this language. Novo (like the Federal Circuit) reads
“not an” to mean “not any,” contending that “the counter-
claim is available only if the listed patent does not claim
any (or, equivalently, claims no) approved method of using
the drug.” Brief for Respondents 29 (internal quotation
marks omitted). By that measure, Caraco may not bring
a counterclaim because Novo’s ’358 patent claims the use of
repaglinide with metformin. In contrast, Caraco reads
“not an” to mean “not a particular one,” so that the statute
permits a counterclaim whenever the patent does not
claim a method of use for which the ANDA applicant seeks
to market the drug. On that view, the counterclaim is
available here—indeed, is available twice over—because
——————
5 Before proceeding to the merits, we dispose of a recently raised ju-
risdictional argument. Novo now contends that the federal courts lost
subject-matter jurisdiction over this infringement action (including the
counterclaim) at the moment Caraco filed its section viii statement. On
Novo’s theory, such a statement (unlike a paragraph IV certification)
does not count as an act of infringement under the patent statute, see
35 U. S. C. §271(e)(2)(A), and so cannot provide a jurisdictional basis
for the suit. But that argument is wrong even assuming (as Novo con-
tends) that Caraco’s section viii filing terminated its paragraph IV
certification and that a section viii filing is not an act of infringement.
The want of an infringing act is a merits problem, not a jurisdictional
one. Nothing in the section of the statute defining certain filings as
acts of infringement suggests anything to the contrary. And “we are
not inclined to interpret statutes as creating a jurisdictional bar when
they are not framed as such.” Stern v. Marshall, 564 U. S. ___, ___
(2011) (slip op., at 13). In the absence of such a bar, the federal courts
have jurisdiction over this suit for a single, simple reason: It “ar[ose]
under a[n] Act of Congress relating to patents.” 28 U. S. C. §1338(a).
12 CARACO PHARMACEUTICAL LABORATORIES, LTD. v.
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Opinion of the Court
the ’358 patent does not claim the use of repaglinide with
TZDs or its use alone.
Truth be told, the answer to the general question “What
does ‘not an’ mean?” is “It depends”: The meaning of the
phrase turns on its context. See Johnson v. United States,
559 U. S. ___, ___ (2010) (slip op., at 5) (“Ultimately, con-
text determines meaning”). “Not an” sometimes means
“not any,” in the way Novo claims. If your spouse tells you
he is late because he “did not take a cab,” you will infer
that he took no cab at all (but took the bus instead). If
your child admits that she “did not read a book all sum-
mer,” you will surmise that she did not read any book (but
went to the movies a lot). And if a sports-fan friend be-
moans that “the New York Mets do not have a chance of
winning the World Series,” you will gather that the team
has no chance whatsoever (because they have no hitting).
But now stop a moment. Suppose your spouse tells you
that he got lost because he “did not make a turn.” You
would understand that he failed to make a particular turn,
not that he drove from the outset in a straight line. Sup-
pose your child explains her mediocre grade on a college
exam by saying that she “did not read an assigned text.”
You would infer that she failed to read a specific book, not
that she read nothing at all on the syllabus. And suppose
a lawyer friend laments that in her last trial, she “did not
prove an element of the offense.” You would grasp that
she is speaking not of all the elements, but of a particular
one. The examples could go on and on, but the point is
simple enough: When it comes to the meaning of “not an,”
context matters.6
——————
6 For this reason, we find Novo’s reliance on the occasional dictionary
definition of “a[n]” unconvincing. Although “an” sometimes means
“any” when used in negative structures, see, e.g., Microsoft Encarta
College Dictionary 1 (2001) (fifth definition), it sometimes does not. Cf.
FCC v. AT&T Inc., 562 U. S. ___, ___ (2011) (slip. op., at 3–5) (rejecting
a proposed definition of “personal” because it did not always hold in
Cite as: 566 U. S. ____ (2012) 13
Opinion of the Court
And the statutory context here supports Caraco’s posi-
tion. As described earlier (and as Congress understood), a
single drug may have multiple methods of use, only one
or some of which a patent covers. See, e.g., 21 U. S. C.
§355(b)(1) (requiring that an NDA applicant file infor-
mation about “any patent which claims the drug . . . or
which claims a method of using such drug” (emphasis
added)). The Hatch-Waxman Amendments authorize the
FDA to approve the marketing of a generic drug for par-
ticular unpatented uses; and section viii provides the
mechanism for a generic company to identify those uses,
so that a product with a label matching them can quickly
come to market. The statutory scheme, in other words,
contemplates that one patented use will not foreclose
marketing a generic drug for other unpatented ones.
Within that framework, the counterclaim naturally func-
tions to challenge the brand’s assertion of rights over
whichever discrete use (or uses) the generic company
wishes to pursue. That assertion, after all, is the thing
blocking the generic drug’s entry on the market. The
availability of the counterclaim thus matches the availa-
bility of FDA approval under the statute: A company may
bring a counterclaim to show that a method of use is un-
patented because establishing that fact allows the FDA to
authorize a generic drug via section viii.
Consider the point as applied to this case. Caraco wishes
to market a generic version of repaglinide for two (and
only two) uses. Under the statute, the FDA could approve
Caraco’s application so long as no patent covers those
uses, regardless whether a patent protects yet a third
method of using the drug. Novo agrees that Caraco could
bring a counterclaim if Novo’s assertion of patent protec-
tion for repaglinide lacked any basis—for example, if Novo
held no patent, yet claimed rights to the pair of uses for
——————
ordinary usage and the statutory context suggested it did not apply).
14 CARACO PHARMACEUTICAL LABORATORIES, LTD. v.
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Opinion of the Court
which Caraco seeks to market its drug. But because Novo
has a valid patent on a different use, Novo argues that
Caraco’s counterclaim evaporates. And that is so even
though, once again, Caraco has no wish to market its
product for that patented use and the FDA stands ready,
pursuant to the statute, to approve Caraco’s product for
the other two. To put the matter simply, Novo thinks the
counterclaim disappears because it has a patent for a
method of use in which neither Caraco nor the FDA is
interested at all. “It would take strong evidence to per-
suade us that this is what Congress wrought.” Eli Lilly,
496 U. S., at 673. That “not an” sometimes (but some-
times not) means “not any” is not enough.
Novo argues that our reading must be wrong because
Congress could have expressly “impose[d] additional . . .
qualifications” on the term “an approved method of
us[e]”—and indeed did so in another place in the statute.
Brief for Respondents 31; 21 U. S. C. §355(j)(5)(C)(ii)(I).
Novo points here to section viii itself, which applies when
the brand’s patent “does not claim a use for which the
[ANDA] applicant is seeking approval.” §355(j)(2)(A)(viii)
(emphasis added). But the mere possibility of clearer
phrasing cannot defeat the most natural reading of a
statute; if it could (with all due respect to Congress), we
would interpret a great many statutes differently than we
do. Nor does Congress’s use of more detailed language in
another provision, enacted years earlier, persuade us to
put the counterclaim clause at odds with its statutory
context. That is especially so because we can turn this
form of argument back around on Novo. Congress, after
all, could have more clearly expressed Novo’s proposed
meaning in the easiest of ways—by adding a single letter
to make clear that “not an” really means “not any.” And
indeed, Congress used a “not any” construction in the very
next subclause, enacted at the very same time. See
§355(j)(5)(C)(ii)(II) (“Subclause (I) does not authorize the
Cite as: 566 U. S. ____ (2012) 15
Opinion of the Court
assertion of a claim . . . in any [other] civil action”). So
if we needed any proof that Congress knew how to say
“not any” when it meant “not any,” here we find it. We think
that sees, raises, and bests Novo’s argument.
Our more essential point, though, has less gamesman-
ship about it: We think that the “not any” construction
does not appear in the relevant counterclaim provision
because Congress did not mean what Novo wishes it had.
And we think that is so because Congress meant (as it
usually does) for the provision it enacted to fit within
the statutory scheme—here, by facilitating the approval of
non-infringing generic drugs under section viii.
B
Novo contends that Caraco’s counterclaim must fail for
another, independent reason: On its view (as on the Fed-
eral Circuit’s), the counterclaim does not provide a way to
correct use codes because they are not “patent information
submitted by the [brand] under subsection (b) or (c)” of
§355. Once again, we disagree.
The statute does not define “patent information,” but
a use code must qualify. It describes the method of use
claimed in a patent. See 21 CFR §§314.53(c)(2)(ii)(P)(3),
(e). That fits under any ordinary understanding of the
language.7
——————
7 Novo’s only counter is to redefine a use code. Novo argues that a use
code need not be tied to the patent at all—that “[t]he relevant regula-
tion requires [NDA] applicants to provide [only] ‘a description of each
approved method of use or indication.’ ” Brief for Respondents 48
(quoting 21 CFR §314.53(c)(2)(ii)(P)(1)). Because an “indication” refers
generally to what a drug does (here, treat diabetes), see §201.57(c)(2),
Novo claims that a use code may sweep more broadly than the patent.
But that is incorrect. First, Novo does not cite the regulations that
specify the information required for publication—i.e., use codes. See
§314.53(c)(2)(ii)(P)(3) (requiring a “description of the patented method
of use as required for publication”); §314.53(e) (“[F]or each use patent,”
FDA will publish “the approved indications or other conditions of use
16 CARACO PHARMACEUTICAL LABORATORIES, LTD. v.
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Opinion of the Court
The more difficult question arises from the “submitted
under” phrase. The subsections mentioned there—(b) and
(c) of §355—require an NDA applicant to submit specified
information: “the patent number and the expiration date
of any patent” claiming the drug or a method of its use. 21
U. S. C. §§355(b)(1), (c)(2). According to Novo, only that
information comes within the counterclaim provision. But
subsections (b) and (c) as well govern the regulatory pro-
cess by which brands provide additional patent infor-
mation to the FDA, both before and after an NDA is ap-
proved. In particular, those subsections provide the basis
for the regulation requiring brands to submit use codes,
see 21 CFR §314.53; in issuing that regulation, the FDA
noted that “[o]ur principal legal authority . . . is section
505 of the act [codified at §355], in conjunction with our
general rulemaking authority.” 68 Fed. Reg. 36697–36698
(specifically referring to subsections (b) and (c)). And the
form (Form 3542) on which brands submit their use codes
states that the information appearing there is “provided
in accordance with Section [355](b) and (c).” App. 97. So
use codes fall within the counterclaim’s ambit if the phrase
“submitted under” reaches filings that not only subsec-
tions (b) and (c) themselves, but also their implementing
regulations require.
Several of our cases support giving “under” this broad
meaning. For example, in Eli Lilly, 496 U. S., at 665–668,
we examined a similar statutory reference to the “submis-
sion of information under a Federal law which regulates
——————
covered by a patent”). Those provisions (whether referring to methods
of use, conditions of use, or indications) all demand a description of the
patent. And second, even the provision Novo cites—which mandates
the submission of additional material, not listed in the Orange Book—
ties information about indications to patent coverage; that regulation
requires (when quoted in full) that the brand provide “a description of
each approved method of use or indication and related patent claim of
the patent being submitted.” §314.53(c)(2)(ii)(P)(1).
Cite as: 566 U. S. ____ (2012) 17
Opinion of the Court
the manufacture, use, or sale of drugs,” 35 U. S. C.
§271(e)(1). We noted there that submitting information
“under a Federal law” suggests doing so “in furtherance of
or compliance with a comprehensive scheme of regula-
tion.” 496 U. S., at 667. Likewise, in Ardestani v. INS,
502 U. S. 129, 135 (1991), we held that a regulatory pro-
ceeding “under section 554,” 5 U. S. C. §504(b)(1)(C)(i),
meant any proceeding “subject to,” “governed by,” or
conducted “by reason of the authority of ” that statutory
provision.
So too here. “Patent information submitted . . . under
subsection (b) or (c)” most naturally refers to patent in-
formation provided as part of the “comprehensive scheme
of regulation” premised on those subsections. Eli Lilly,
496 U. S., at 667. It includes everything (about patents)
that the FDA requires brands to furnish in the proceed-
ings “subject to,” “governed by,” or conducted “by reason of
the authority of ” §§355(b) and (c). Ardestani, 502 U. S., at
135. The breadth of the term “under” becomes particu-
larly clear when compared with other phrases—“described
in” and “prescribed by”—appearing in neighboring provi-
sions. See, e.g., 21 U. S. C. §355(c)(2) (“patent information
described in subsection (b)”); §355(d)(6) (“patent infor-
mation prescribed by subsection (b)”). Those phrases
denote a patent number and expiration date and nothing
more. In contrast, the word “under” naturally reaches
beyond that most barebones information to other patent
materials the FDA demands in the regulatory process.
Once again, that congressional choice fits the broader
statutory context. Use codes are pivotal to the FDA’s
implementation of the Hatch-Waxman Amendments—and
no less so because a regulation, rather than the statute
itself, requires their submission. Recall that those
Amendments instruct the FDA (assuming other require-
ments are met) to approve an ANDA filed with a section
viii statement when it proposes to market a drug for only
18 CARACO PHARMACEUTICAL LABORATORIES, LTD. v.
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Opinion of the Court
unpatented methods of use. To fulfill that charge, the
FDA must determine whether any patent covers a particu-
lar method of use; and to do that, the agency (which views
itself as lacking expertise in patent matters, see supra, at
4–5, and n. 2) relies on the use codes submitted in the
regulatory process. See 68 Fed. Reg. 36682–36683. An
overbroad use code therefore throws a wrench into the
FDA’s ability to approve generic drugs as the statute con-
templates. So it is not surprising that the language Con-
gress used in the counterclaim provision sweeps widely
enough to embrace that filing.
C
Another aspect of the counterclaim provision—its de-
scription of available remedies—dispatches whatever
remains of Novo’s arguments. According to the statute,
a successful claimant may obtain an order requiring
the brand to “correct or delete” its patent information.
§355(j)(5)(C)(ii)(I). Our interpretation of the statute gives
content to both those remedies: It deletes a listing from
the Orange Book when the brand holds no relevant patent
and corrects the listing when the brand has misdescribed
the patent’s scope. By contrast, Novo’s two arguments
would all but read the term “correct” out of the statute.
Consider first how Novo’s an-means-any contention
would accomplish that result. Recall that on Novo’s view,
a counterclaim can succeed only if the patent challenged
does not claim either the drug or any approved method of
using it. See supra, at 11. But when a generic manufac-
turer makes that showing, the remedy must be to “delete”
the listing; no correction would be enough. Novo agrees
with that proposition; “[a]t bottom,” Novo avers, “the
counterclaim is a delisting provision.” Brief for Respond-
ents 20. But that raises the obvious question: Why did
Congress also include the term “correct” in the statute?
Novo can come up with just one answer: The counter-
Cite as: 566 U. S. ____ (2012) 19
Opinion of the Court
claim, it proposes, can correct erroneous patent numbers.
Imagine, for example, that Novo mistakenly entered the
number ’359, instead of ’358, when submitting information
about its repaglinide patent for publication in the Orange
Book. Then, Novo suggests, Caraco could bring a counter-
claim to challenge the inaccurate listing (on the ground
that ’359 does not claim any method of use), and the rem-
edy would be “correct[ion]” (substituting an 8 for a 9). But
we think Novo’s admission that this scenario would be
“unusual,” Tr. of Oral Arg. 41, considerably understates
the matter. As Novo concedes, brands have every incen-
tive to provide the right patent number in the first place,
and to immediately rectify any error brought to their
attention. See id., at 40–41. By doing so, they place both
generic companies and the FDA on notice of their patents
and thereby prevent infringement. And conversely, gener-
ics have little or no incentive to bring a counterclaim that
will merely replace one digit in the Orange Book with
another. So we doubt Congress created a legal action to
“correct” patent information just to fix such scrivener’s
errors. See, e.g., TRW Inc. v. Andrews, 534 U. S. 19, 31
(2001) (refusing to adopt an interpretation of a statute
that would render a piece of it “insignificant, if not wholly
superfluous” (internal quotation marks omitted)). That
would have been, in the most literal sense, to make a
federal case out of nothing.
The same problem afflicts Novo’s alternative conten-
tion—that “patent information submitted . . . under sub-
section (b) or (c)” includes only numbers and expiration
dates (and not use codes). Once again, we cannot think
Congress included the remedy of “correct[ion]” so that
courts could expunge typos in patent numbers. And not
even Novo has proffered a way for the counterclaim to
“correct” an erroneous expiration date. Suppose, for ex-
ample, that a brand incorrectly lists the expiration date of
a valid patent as 2018 rather than 2015. The counter-
20 CARACO PHARMACEUTICAL LABORATORIES, LTD. v.
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Opinion of the Court
claim would be useless: It authorizes a remedy only “on
the ground that” the listed patent does not claim the drug
or an approved method of using it—and notwithstanding
the wrong expiration date, this patent does so. Alterna-
tively, suppose the brand lists a patent as having a 2018
expiration date when in fact the patent has already
lapsed. Then, a generic manufacturer could bring a coun-
terclaim alleging that the patent no longer claims the
drug or a method of using it—but the appropriate remedy
would be deletion, not correction, of the brand’s listing.
Novo’s reading of “patent information,” like its reading of
“not an,” effectively deletes the term “correct” from the
statute.
III
Novo finally advances two arguments relating to the
counterclaim’s drafting history. Neither contention, how-
ever, overcomes the statutory text and context. Indeed,
consideration of the provision’s background only strength-
ens our view of its meaning.
A
Novo first contends that our interpretation of the stat-
ute “effectively resurrect[s] the scheme rejected by Con-
gress.” Brief for Respondents 44 (quoting Smith v. United
States, 507 U. S. 197, 203, n. 4 (1993)). In 2002, Novo
notes, Congress failed to pass a bill that would have re-
quired brands to file specified “patent information,” in-
cluding, for method-of-use patents, a description of “the
approved use covered by the [patent] claim.” S. 812, 107th
Cong., 2d Sess., §103(a)(1), p. 7 (engrossed bill). That bill
would have allowed a generic company to bring its own
civil action—not merely a counterclaim in ongoing litiga-
tion—to “delete” or “correct” the information filed. Id.,
at 8. The Senate approved the bill, but the House of Repre-
sentatives took no action on it. Novo argues that because
Cite as: 566 U. S. ____ (2012) 21
Opinion of the Court
this failed legislation would have allowed a generic com-
pany to challenge overbroad descriptions of a patent, we
cannot read the statute Congress eventually enacted as
doing so.
We disagree. We see no reason to assume, as Novo does,
that Congress rejected S. 812 because it required brands
to submit patent information beyond a number and expi-
ration date. Indeed, Novo’s argument highlights the perils
of relying on the fate of prior bills to divine the meaning of
enacted legislation. “A bill can be proposed for any num-
ber of reasons, and it can be rejected for just as many
others.” Solid Waste Agency of Northern Cook Cty. v.
Army Corps of Engineers, 531 U. S. 159, 170 (2001)). S.
812 contained numerous items, including a title on import-
ing prescription drugs (no controversy there!), that may
have caused its failure. See S. 812, Tit. II. Moreover,
what criticism there was of the bill’s mechanism for chal-
lenging brands’ patent claims focused not on the specifica-
tion of “patent information,” but instead on the creation of
an independent cause of action—stronger medicine than
the counterclaim Congress ultimately adopted.8 And
finally, Novo ignores a likely cause for the redrafting of
the provision on submitting information. Between S. 812’s
demise and the counterclaim’s enactment, the FDA issued
a rule requiring brands to supply material concerning
method-of-use patents, including use codes. The drafters
of the counterclaim provision knew about that rule,9 and
——————
8 See, e.g., 148 Cong. Rec. 15424 (2002) (remarks of Sen. Gregg)
(“Probably the most significant issue is the fact that it creates a new
cause of action”); id., at 15431–15432 (remarks of Sen. Grassley)
(similar); id., at 14434 (remarks of Sen. Hatch) (similar).
9 See, e.g., Hearings on Barriers to Entry in the Pharmaceutical Mar-
ketplace before the Senate Committee on the Judiciary, 108th Cong.,
1st Sess., 5–8 (2003) (statement of Daniel Troy, Chief Counsel to the
FDA); id., at 19 (statement of Sen. Schumer) (“The bill provides a
critical complement to the work FDA has done in clarifying its regula-
tions on patent listing, but it goes much further”).
22 CARACO PHARMACEUTICAL LABORATORIES, LTD. v.
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Opinion of the Court
had no need to duplicate its list of mandated filings. So
the drafting history does not support Novo’s conclusion. If
anything, the statute’s evolution indicates that Congress
determined to enforce the FDA’s new listing provisions,
including its use-code requirement, through the new
counterclaim.
B
Novo next argues that Congress established the coun-
terclaim only to solve the problem raised by the Federal
Circuit’s decision in Mylan, 268 F. 3d 1323—the impossi-
bility of deleting an improperly listed patent from the
Orange Book. In Mylan, as earlier described, a generic
company alleged that a brand had listed a patent that
covered neither the approved drug nor any method of
using it, and brought an action seeking delisting. See
supra, at 6. The Federal Circuit held that no such action
was available, even assuming the allegation was true.
Because several legislators saw Mylan as “exemplif[ying]”
brands’ “perceived abuse” of the FDA’s patent listing prac-
tices, Brief for Respondents 35, Novo contends that we
should construe the counterclaim provision to aid only a
generic company that “finds itself in the same position as
Mylan was in Mylan,” Supp. Brief in Opposition 5–6.
Once again, we think not. Maybe Mylan triggered the
legislative effort to enact a counterclaim, or maybe it
didn’t: By the time Congress acted, it also had at hand an
FTC study broadly criticizing brands’ patent listings and
an FDA rule designed to address the very same issue. See
supra, at 6, 21. But even assuming Mylan “prompted the
proposal” of the counterclaim, “whether that alone ac-
counted for its enactment is quite a different question.”
Eli Lilly, 496 U. S., at 670, n. 3 (emphasis deleted). Here,
we think Mylan alerted Congress to a broader problem—
that generic companies generally had no avenue to chal-
lenge the accuracy of brands’ patent listings, and that the
Cite as: 566 U. S. ____ (2012) 23
Opinion of the Court
FDA therefore could not approve proper applications to
bring inexpensive drugs to market. The proof of that lies
in the statute itself (where the best proof of what Congress
means to address almost always resides). As we have de-
scribed, the statute’s text and context demonstrate that
the counterclaim is available not only (as in Mylan) when
the patent listing is baseless, but also (as here) when it is
overbroad. See supra, at 10–20. In particular, Congress’s
decision to allow a counterclaimant to seek “correct[ion]”
of patent information explodes Novo’s theory, because the
remedy for a Mylan-type impropriety is complete delisting.
And to make matters still easier, Congress’s equation of
the two situations—the one in Mylan and the one here—
makes perfect sense. Whether a brand lists a patent that
covers no use or describes a patent on one use as extend-
ing to others, the brand submits misleading patent in-
formation to the FDA. In doing so, the brand equally ex-
ploits the FDA’s determination that it cannot police patent
claims. And the brand’s action may in either case delay or
block approval of a generic drug that infringes no patent—
and that under the statute should go to market. See su-
pra, at 4. That is the danger Caraco faces here, as much
as it was the threat in Mylan: Novo seeks to preclude
Caraco from selling repaglinide for unpatented uses until
2018, when Novo’s patent on a different use expires.
Indeed, the need for the counterclaim is greater here
than in Mylan. When a brand lists a patent that covers no
use, a generic company has a pathway aside from the
counterclaim to challenge the listing. As described ear-
lier, the company may make a paragraph IV certification
stating that the listed patent “is invalid or will not
be infringed” by the generic drug. 21 U. S. C.
§355(j)(2)(A)(vii)(IV); see supra, at 5. If the brand sues,
the generic company can argue that its product would not
infringe the patent. Using the counterclaim may enable a
generic manufacturer to obtain delisting more quickly, see
24 CARACO PHARMACEUTICAL LABORATORIES, LTD. v.
NOVO NORDISK A/S
Opinion of the Court
Tr. of Oral Arg. 54; but even without it, the company can
eventually get a judgment of non-infringement enabling
the FDA to approve its ANDA. In contrast, where (as
here) a brand files an overbroad use code, a generic com-
pany cannot use paragraph IV litigation to that end. A
paragraph IV certification (unlike a section viii statement)
requires the generic company to propose labeling identical
to the brand’s; it cannot carve out any uses. See supra, at
4. And that proposed label will necessarily infringe be-
cause it will include the use(s) on which the brand does
have a patent. So here, a paragraph IV suit cannot lead to
a judgment enabling FDA approval; the counterclaim
offers the only route to bring the generic drug to market
for non-infringing uses. Novo’s view eliminates the coun-
terclaim where it has the greatest value.
IV
The statutory counterclaim we have considered enables
courts to resolve patent disputes so that the FDA can
fulfill its statutory duty to approve generic drugs that do
not infringe patent rights. The text and context of the
provision demonstrate that a generic company can employ
the counterclaim to challenge a brand’s overbroad use
code. We accordingly hold that Caraco may bring a coun-
terclaim seeking to “correct” Novo’s use code “on the
ground that” the ’358 patent “does not claim . . . an ap-
proved method of using the drug”—indeed, does not claim
two.
The judgment of the Court of Appeals is reversed, and
the case is remanded for further proceedings consistent
with this opinion.
It is so ordered.
Cite as: 566 U. S. ____ (2012) 1
SOTOMAYOR, J., concurring
SUPREME COURT OF THE UNITED STATES
_________________
No. 10–844
_________________
CARACO PHARMACEUTICAL LABORATORIES, LTD.,
ET AL., PETITIONERS v. NOVO NORDISK A/S ET AL.
ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF
APPEALS FOR THE FEDERAL CIRCUIT
[April 17, 2012]
JUSTICE SOTOMAYOR, concurring.
The Court today interprets the counterclaim set forth in
21 U. S. C. §355(j)(5)(C)(ii)(I) to permit generic manufac-
turers to force brand manufacturers to “correct” inaccurate
use codes. While I too find the counterclaim not “free of
ambiguity,” ante, at 10, I join the Court’s opinion because
I agree this is the most sensible reading in light of the
existing regulatory scheme. I write separately to add the
following observations.
I
I first underscore that the counterclaim can only lessen
the difficulties created by an overly broad use code; it
cannot fix them. The statutory scheme is designed to
speed the introduction of low-cost generic drugs to market.
See ante, at 2 (citing Eli Lilly & Co. v. Medtronic, Inc., 496
U. S. 661, 676 (1990)). To that end, the statute provides
for the rapid approval of a drug that a generic manufac-
turer seeks to market for unpatented methods of use. The
manufacturer need only submit an abbreviated new drug
application (ANDA) with a section viii statement and a
proposed label that “carves out” from the brand manufac-
turer’s label any patented methods of use. See ante, at 4.
So long as the use code is not overly broad (and all else is
in order), FDA may approve the application without re-
2 CARACO PHARMACEUTICAL LABORATORIES, LTD. v.
NOVO NORDISK A/S
SOTOMAYOR, J., concurring
quiring any further steps relating to the patent, and the
generic drug may reach the public without undue delay.
See ibid.An overly broad use code “throws a wrench” into that
scheme. Ante, at 18. The reason why is simple: FDA
relies on use codes in determining whether to approve an
ANDA, but it refuses to evaluate the accuracy of those use
codes. See ante, at 4–5. Thus, if the use code overlaps
with the generic manufacturer’s proposed carve-out label
(i.e., if the use code is overly broad), FDA will not approve
an ANDA with a section viii statement. See ibid.After today’s opinion, the generic manufacturer can re-
spond to this situation by taking the following steps: sub-
mit an ANDA with a paragraph IV certification (which
requires a proposed label materially identical to the brand
manufacturer’s label, see ante, at 24), wait for the brand
manufacturer to institute suit, file a counterclaim, litigate
the counterclaim, and, if successful in securing the correc-
tion of the use code, return to the start of the process and
do what it always wanted to do—file an ANDA with a
section viii statement and a carve-out label.
The problem with this process is twofold. First, it re-
sults in delay and expense the statutory scheme does not
envision. Second, there is no guarantee the process will
work. It depends on the brand manufacturer initiating
paragraph IV litigation, but it is not obvious the brand
will have any incentive to do so. In light of today’s hold-
ing, the upshot of such litigation will be the correction of
the use code through the assertion of a counterclaim—an
outcome that is desirable, to be sure, for the generic manu-
facturer, but perhaps less so for the brand manufacturer.
Meanwhile, it is not clear what happens if the brand
manufacturer does not file suit. FDA may approve
the generic manufacturer’s application, see 21 U. S. C.
§355(j)(5)(B)(iii), “without prejudice to infringement claims
the patent owner might assert when the ANDA applicant
Cite as: 566 U. S. ____ (2012) 3
SOTOMAYOR, J., concurring
produces or markets the generic drug.” Brief for United
States as Amicus Curiae 6 (hereinafter United States
Brief). But the generic manufacturer, having been forced
to proceed with a paragraph IV certification, will have se-
cured approval to market a drug with a label materially
identical to the brand manufacturer’s. That is not a posi-
tion I imagine a generic manufacturer wants to be in: As
the Solicitor General’s Office informed us at argument,
“[i]t would be inducement of infringement to sell a product
with labeling that suggests that the product be used for
a patented method of use.” Tr. of Oral Arg. 24; see also
United States Brief 32 (noting that in this situation, if
a generic manufacturer proceeded with a paragraph IV
certification, “[s]o long as the [new drug application
(NDA)] holder’s patent covers some approved method of
using the approved drug, the proposed labeling will be
infringing”).
In short, the counterclaim cannot restore the smooth
working of a statutory scheme thrown off kilter by an
overly broad use code. At best, it permits the generic
manufacturer to do what the scheme contemplates it
should do—file an ANDA with a section viii statement—
but only after expensive and time-consuming litigation. A
fix is in order, but it must come from Congress or FDA.
II
Precisely because the regulatory scheme depends on the
accuracy and precision of use codes, I find FDA’s guidance
as to what is required of brand manufacturers in use codes
remarkably opaque. The relevant regulation states simply
that a brand manufacturer must provide “[t]he description
of the patented method of use as required for publication.”
21 CFR §314.53(c)(2)(ii)(P)(3). The form on which brand
manufacturers submit that information provides some
additional detail, explaining that “[e]ach approved use
claimed by the patent should be separately identified . . .
4 CARACO PHARMACEUTICAL LABORATORIES, LTD. v.
NOVO NORDISK A/S
SOTOMAYOR, J., concurring
and contain adequate information to assist . . . applicants
in determining whether a listed method of use patent
claims a use for which the . . . applicant is not seeking
approval.” App. to Pet. for Cert. 214a. But it also provides
that brand manufacturers may “us[e] no more than 240
total characters including spaces,” id., at 213a, and else-
where FDA acknowledges “that in some cases 240 charac-
ters may not fully describe the use as claimed in the pa-
tent.” 68 Fed. Reg. 36683 (2003); see also ibid. (indicating
for this reason that use codes “are not meant to substitute
for the applicant’s review of the patent”).
Indeed, in some respects we are here today because
of FDA’s opacity in describing what is required of brand
manufacturers. In its initial NDA filing, Novo submitted
a use code for the ’358 patent that was not “overly broad”:
It described narrowly the single patented method of use.
App. 54–55, 99. Some years later FDA required that Novo
amend its label to “[r]eplace all the separate indications”
“with the following sentence: ‘Prandin is indicated as an
adjunct to diet and exercise to improve glycemic control in
adults with type 2 diabetes mellitus.’ ” Id., at 163–164,
215. Novo then amended its use code to track the new
label, id., at 482–486, explaining that the amendment
“correspond[ed] with the change in labeling required by
FDA,” id., at 483. Novo understood its amended use code
to comply with FDA regulations, likely on the ground it
pressed before us: that the regulations permit a brand
manufacturer to submit for publication in the Orange
Book a description of either the patented method of use or
the indication (which refers to “what a drug does,” ante,
at 15, n. 7). Brief for Respondents 10, 22, 48–50.
For the reasons explained by the Court, see ante, at 15,
n. 7, Novo is mistaken. But the company can hardly be
faulted for so thinking. The regulations also require sub-
mission of “a description of each approved method of use
or indication,” 21 CFR §314.53(c)(2)(ii)(P)(1), and the form
Cite as: 566 U. S. ____ (2012) 5
SOTOMAYOR, J., concurring
on which brand manufacturers submit use codes requires
“information on the indication or method of use for the
Orange Book ‘Use Code’ description.” App. to Pet. for
Cert. 213; see also ibid. (explaining brand manufacturers
should “[s]ubmit the description of the approved indication
or method of use that you propose FDA include as the ‘Use
Code’ in the Orange Book”). Those sources at the least
suggest (as Novo thought) that a method of use here is
distinct from an indication and that either suffices as a
use code.
Prior to enactment of the counterclaim provision, Con-
gress considered a bill that required brand manufacturers
to submit a “description of the approved use covered by the
[patent] claim,” and that allowed a generic manufacturer
to bring a civil action to correct that information. See
ante, at 20. Congress rejected the bill, in part over criti-
cism that it would encourage excess litigation.* Absent
greater clarity from FDA concerning what is required of
brand manufacturers in use codes, Congress’ fears of un-
due litigation may be realized.
——————
* See, e.g., 148 Cong. Rec. 13481 (2002) (remarks of Sen. Hatch);
id., at 15433 (remarks of Sen. McCain); Office of Management and
Budget, S. 812—Greater Access to Affordable Pharmaceuticals Act
(July 18, 2002) (statement of administration policy), online at http://
www.whitehouse.gov/omb/legislative_sap_107-2_S812-S (as visited Apr.
13, 2012, and available in Clerk of Court’s case file).