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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)
evaluates 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
authorized 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 counterclaim seeking an
order requiring the [brand manufac- turer] to correct or delete the
patent information [it] submitted . . . under [two
statutory subsections] on the ground that the patent does not claim
. . . an approved method of using the drug.”
117Stat. 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 Competition and Patent Term
Restoration Act of 1984, 98Stat. 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 previously
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).
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 manufacturer 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 patents 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. 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
statement, which asserts that the generic manufacturer will market
the drug for one or more methods of use not covered 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 approve 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 requirements), 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] expertise 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 ministerial.”
Id.,
at 36683; see
ibid. (“A fundamental assumption of the
Hatch-Waxman Amendments is that the courts are the appropriate
mechanism for the resolution of disputes about the scope and
validity of patents”).[
2]
Thus, whether section viii is available to a generic manufacturer
depends on how the brand describes its patent. Only if the use code
provides sufficient space for the generic’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
paragraph IV certification means provoking litigation. The patent
statute treats such a filing as itself an act of infringement,
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). Accordingly, 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 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 information 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 compound
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
mechanism, 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, 117Stat. 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 either—
“(aa) the drug for which the
[brand’s NDA] wasapproved; or
“(bb) an approved method of using the
drug.” 21U. 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
question 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)
manufacture 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 thiazolidinediones (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
. . . repaglinide 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 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. Because 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, 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
infringement 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
approved 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 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 approved method of using” a drug. Second,
we must determine 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 statutory 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 interpretation 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 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 meaning of this language. Novo (like the Federal
Circuit) reads “not an” to mean “not any,”
contending that “the counterclaim 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
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, context
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
summer,” you will surmise that she did not read any book (but
went to the movies a lot). And if a sports-fan friend bemoans 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. Suppose 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]
And the statutory context here supports
Caraco’s position. 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 information 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
particular 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
functions 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 availability of FDA approval under
the statute: A company may bring a counterclaim to show that a
method of use is unpatented 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 protection for repaglinide lacked
any basis—for example, if Novo held no patent, yet claimed
rights to the pair of uses for 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 persuade us that this is what Congress
wrought.”
Eli Lilly, 496 U. S., at 673. That
“not an” sometimes (but sometimes 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 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
gamesmanship 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
Federal 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]
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 process by which brands provide additional patent
information to the FDA, both before and after an NDA is approved.
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 subsections (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 “submission of information under a
Federal law which regulates 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 regulation.” 496 U. S.
,
at 667. Likewise, in
Ardestani v.
INS,
502 U.S.
129, 135 (1991), we held that a regulatory proceeding
“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 information 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 proceedings “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 provisions. See,
e.g., 21 U. S. C.
§355(c)(2) (“patent information described in subsection
(b)”); §355(d)(6) (“patent information 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 requirements are met) to approve an ANDA filed with
a section viii statement when it proposes to market a drug for only
unpatented methods of use. To fulfill that charge, the FDA must
determine whether any patent covers a particular 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 Congress used in the counterclaim provision sweeps widely
enough to embrace that filing.
C
Another aspect of the counterclaim
provision—its description 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 manufacturer
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 Respondents
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
counterclaim, 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 counterclaim to challenge
the inaccurate listing (on the ground that ’359 does not
claim any method of use), and the remedy 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
incentive 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, generics 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 contention—that “patent information
submitted . . . under subsection (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 example, that a brand incorrectly lists the expiration
date of a valid patent as 2018 rather than 2015. The counterclaim
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. Alternatively, 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 counterclaim 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,
however, overcomes the statutory text and context. Indeed,
consideration of the provision’s background only strengthens
our view of its meaning.
A
Novo first contends that our interpretation of
the statute “effectively resurrect[s] the scheme rejected by
Congress.” 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 required brands to file
specified “patent information,” including, 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 litigation—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 this failed legislation would have allowed a generic
company 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 expiration 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 number 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 importing 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 challenging
brands’ patent claims focused not on the specification 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 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
counterclaim only to solve the problem raised by the Federal
Circuit’s decision in
Mylan, 268 F. 3d
1323—the impossibility 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
accounted 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
challenge the accuracy of brands’ patent listings, and that
the 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 extending 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 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 company 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 because 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 counterclaim
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 counterclaim seeking to
“correct” Novo’s use code “on the ground
that” the ’358 patent “does not claim
. . . an approved 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.