Microsoft Corp. v. i4i Limited Partnership

OPINION OF THE COURT MICROSOFT CORP. V. I4I LTD. PARTNERSHIP 564 U. S. ____ (2011) SUPREME COURT OF THE UNITED STATES NO. 10-290 MICROSOFT CORPORATION, PETITIONER v. i4i
LIMITED PARTNERSHIP et al.

															on writ of certiorari to the united states court of
appeals for the federal circuit

															[June 9, 2011]

															   Justice Sotomayor delivered the
opinion of the Court.

															   Under §282 of the Patent Act of
1952, “[a] patent shall be presumed valid” and “[t]he burden of
establishing in-validity of a patent or any claim thereof shall
rest on the party asserting such invalidity.” 35 U. S. C.
§282. We consider whether §282 requires an invalidity defense to be
proved by clear and convincing evidence. We hold that it does.

															I

															A

															   Pursuant to its authority under
the Patent Clause, U. S. Const., Art. I, §8, cl. 8,
Congress has charged the United States Patent and Trademark Office
(PTO) with the task of examining patent applications, 35 U.
S. C. §2(a)(1), and issuing patents if “it appears that the
applicant is entitled to a patent under the law,” §131. Congress
has set forth the prerequisites for issuance of a patent, which the
PTO must evaluate in the examination process. To receive patent
protection a claimed invention must, among other things, fall
within one of the express categories of patentable subject matter,
§101, and be novel, §102, and nonobvious, §103. Most relevant here,
the on-sale bar of §102(b) precludes patent protection for any
“invention” that was “on sale in this country” more than one year
prior to the filing of a patent application. See generally Pfaff v. Wells Electronics, Inc. , 525 U. S. 55 , 67–68
(1998). In evaluating whether these and other statutory conditions
have been met, PTO examiners must make various factual
determinations—for instance, the state of the prior art in the
field and the nature of the advancement embodied in the invention.
See Dickinson v. Zurko , 527 U. S. 1 50, 153 (1999).

															   Once issued, a patent grants
certain exclusive rights to its holder, including the exclusive
right to use the invention during the patent’s duration. To enforce
that right, a patentee can bring a civil action for infringement if
another person “without authority makes, uses, offers to sell, or
sells any patented invention, within the United States.” §271(a);
see also §281.

															   Among other defenses under §282 of the Patent
Act of 1952 (1952 Act), an alleged infringer may assert the
invalidity of the patent—that is, he may attempt to prove that the
patent never should have issued in the first place. See §§282(2),
(3). A defendant may argue, for instance, that the claimed
invention was obvious at the time and thus that one of the
conditions of patentability was lacking. See §282(2); see also
§103. “While the ultimate question of patent validity is one of
law,” Graham v. John Deere Co. of Kansas City , 383 U. S. 1 , 17
(1966) (citing Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp. , 340 U. S. 147 , 155
(1950) (Douglas, J., concurring)); see post, at 1 (Breyer,
J., concurring), the same factual questions underlying the PTO’s
original examination of a patent ap-plication will also bear on an
invalidity defense in an in-fringement action. See, e.g. ,
383 U. S., at 17 (describing the “basic factual inquiries” that
form the “background” for evaluating obviousness); Pfaff ,
525 U. S., at 67–69 (same, as to the on-sale bar).

															   In asserting an invalidity defense, an alleged
infringer must contend with the first paragraph of §282, which
provides that “[a] patent shall be presumed valid” and “[t]he
burden of establishing invalidity … rest[s] on the party asserting
such invalidity.”[ Footnote 1 ]
Under the Federal Circuit’s reading of §282, a defendant seeking to
overcome this presumption must persuade the factfinder of its
in-validity defense by clear and convincing evidence. Judge Rich, a
principal drafter of the 1952 Act, articulated this view for the
court in American Hoist & Derrick Co. v. Sowa
& Sons, Inc. , 725 F. 2d 1350 (CA Fed. 1984). There,
the Federal Circuit held that §282 codified “the existing
presumption of validity of patents,” id. , at 1359
(internal quotation marks omitted)—what, until that point, had been
a common-law presumption based on “the basic proposition that a
government agency such as the [PTO] was presumed to do its job,” ibid . Relying on this Court’s pre-1952 precedent as to the
“force of the presumption,” ibid. (citing Radio Corp.
of America v. Radio Engineering Laboratories, Inc. , 293 U. S.
1 (1934) (RCA) ), Judge Rich concluded:

															“[Section] 282 creates a presumption that a patent
is valid and imposes the burden of proving invalidity on the
attacker. That burden is constant and never changes and is to
convince the court of invalidity by clear evidence.” 725
F. 2d, at 1360.

															In the nearly 30 years since American
Hoist , the Federal Circuit has never wavered in this
interpretation of §282. See, e.g., Greenwood v. Hattori Seiko Co. , 900 F. 2d 238, 240–241 (CA Fed.
1990); Ultra-Tex Surfaces, Inc. v. Hill Bros. Chemical
Co. , 204 F. 3d 1360, 1367 (CA Fed. 2000); ALZA
Corp. v. Andrx Pharmaceuticals, LLC, 603 F. 3d
935, 940 (CA Fed. 2010).

															B

															   Respondents i4i Limited
Partnership and Infrastructures for Information Inc. (collectively,
i4i) hold the patent at issue in this suit. The i4i patent claims
an improved method for editing computer documents, which stores a
document’s content separately from the metacodes asso-ciated with
the document’s structure. In 2007, i4i sued petitioner Microsoft
Corporation for willful infringement, claiming that Microsoft’s
manufacture and sale of certain Microsoft Word products infringed
i4i’s patent. In addition to denying infringement, Microsoft
counterclaimed and sought a declaration that i4i’s patent was
invalid and unenforceable.

															   Specifically and as relevant
here, Microsoft claimed that the on-sale bar of §102(b) rendered
the patent invalid, pointing to i4i’s prior sale of a software
program known as S4. The parties agreed that, more than one year
prior to the filing of the i4i patent application, i4i had sold S4
in the United States. They presented opposing arguments to the
jury, however, as to whether that software embodied the invention
claimed in i4i’s patent. Because the software’s source code had
been destroyed years before the commencement of this litigation,
the factual dispute turned largely on trial testimony by S4’s two
inventors—also the named inventors on the i4i patent—both of whom
testified that S4 did not practice the key invention disclosed in
the patent.

															   Relying on the undisputed fact that the S4
software was never presented to the PTO examiner, Microsoft
objected to i4i’s proposed instruction that it was required to
prove its invalidity defense by clear and convincing evidence.
Instead, “if an instruction on the ‘clear and convincing’ burden
were [to be] given,” App. 124a, n. 8, Microsoft re-quested the
following:

															“ ‘Microsoft’s burden of proving invalidity
and unenforceability is by clear and convincing evidence. However,
Microsoft’s burden of proof with regard to its defense of
invalidity based on prior art that the ex-aminer did not review
during the prosecution of the patent-in-suit is by preponderance of
the evidence.’ ” Ibid. Rejecting the hybrid standard of proof that
Microsoft advocated, the District Court instructed the jury that
“Microsoft has the burden of proving invalidity by clear and
convincing evidence.” App. to Pet. for Cert. 195a. The jury found that Microsoft willfully
infringed the i4i patent and that Microsoft failed to prove
invalidity due to the on-sale bar or otherwise. Denying Microsoft’s
post-trial motions, the District Court rejected Microsoft’s
contention that the court improperly instructed the jury on the
standard of proof. The Court of Appeals for the Federal Circuit
affirmed.[ Footnote 2 ] 598
F. 3d 831, 848 (2010). Relying on its settled interpretation
of §282, the court explained that it could “discern [no] error” in
the jury instruction requiring Microsoft to prove its invalidity
defense by clear and convincing evidence. Ibid . We granted
certiorari. 562 U. S. ___ (2010).

															II

															   According to Microsoft, a
defendant in an infringement action need only persuade the jury of
an invalidity defense by a preponderance of the evidence. In the
alternative, Microsoft insists that a preponderance standard must
apply at least when an invalidity defense rests on evidence that
was never considered by the PTO in the examination process. We
reject both contentions.[ Footnote
3 ]

															A

															   Where Congress has prescribed the
governing standard of proof, its choice controls absent
“countervailing constitutional constraints.” Steadman v. SEC , 450 U.
S. 91 , 95 (1981). The question, then, is whether Congress has
made such a choice here.

															   As stated, the first paragraph of
§282 provides that “[a] patent shall be presumed valid” and “[t]he
burden of establishing invalidity of a patent or any claim thereof
shall rest on the party asserting such invalidity.” Thus, by its
express terms, §282 establishes a presumption of patent validity,
and it provides that a challenger must overcome that presumption to
prevail on an invalidity defense. But, while the statute explicitly
specifies the burden of proof, it includes no express articulation
of the standard of proof.[ Footnote
4 ]

															   Our statutory inquiry, however, cannot simply
end there. We begin, of course, with “the assumption that the
ordinary meaning of the language” chosen by Congress “accurately
expresses the legislative purpose.” Engine Mfrs. Assn. v. South Coast Air Quality Management Dist. , 541 U. S. 246 , 252
(2004) (internal quotation marks omitted). But where Congress uses
a common-law term in a statute, we assume the “term … comes with a
common law meaning, absent anything pointing another way.” Safeco Ins. Co. of America v. Burr , 551 U. S. 47 , 58 (2007)
(citing Beck v. Prupis , 529 U. S. 494 , 500–501
(2000)). Here, by stating that a patent is “presumed valid,” §282,
Congress used a term with a settled meaning in the common law.

															   Our decision in RCA, 293 U. S.
1 , is authoritative. There, tracing nearly a century of case
law from this Court and others, Justice Cardozo wrote for a
unanimous Court that “there is a presumption of validity, a
presumption not to be overthrown except by clear and cogent
evidence.” Id. , at 2. Although the “force” of the
presumption found “varying expression” in this Court and elsewhere, id. , at 7, Justice Cardozo explained, one “common core of
thought and truth” unified the decisions:

															“[O]ne otherwise an infringer who assails the
validity of a patent fair upon its face bears a heavy burden of
persuasion, and fails unless his evidence has more than a dubious
preponderance. If that is true where the assailant connects himself
in some way with the title of the true inventor, it is so a
fortiori where he is a stranger to the invention, without
claim of title of his own. If it is true where the assailant
launches his attack with evidence different, at least in form, from
any theretofore produced in opposition to the patent, it is so a
bit more clearly where the evidence is even verbally the same.” Id. , at 8 (internal citation omitted).[ Footnote 5 ]

															The common-law presumption, in other words,
reflected the universal understanding that a preponderance standard
of proof was too “dubious” a basis to deem a patent invalid. Ibid.; see also id. , at 7 (“[A] patent … is
presumed to be valid until the presumption has been overcome by
convincing evidence of error”).

															   Thus, by the time Congress enacted §282 and
declared that a patent is “presumed valid,” the presumption of
patent validity had long been a fixture of the common law.
According to its settled meaning, a defendant raising an invalidity
defense bore “a heavy burden of persuasion,” requiring proof of the
defense by clear and convincing evidence. Id. , at 8. That
is, the presumption encompassed not only an allocation of the
burden of proof but also an imposition of a heightened standard of
proof. Under the general rule that a common-law term comes with its
common-law meaning, we cannot conclude that Congress intended to
“drop” the heightened standard proof from the presumption simply
because §282 fails to reiterate it expressly. Neder v. United States , 527 U. S. 1 , 23 (1999);
see also id. , at 21 (“ ‘Where Congress uses terms
that have accumulated settled meaning under . . . the common law,
[we] must infer, unless the statute otherwise dictates, that
Congress means to incorporate the established meaning of those
terms.’ ” (quoting Nationwide Mut. Ins. Co. v. Darden , 503
U. S. 318 , 322 (1992))); Standard Oil Co. of N. J. v. United Sates , 221 U. S. 1 , 59 (1911)
(“[W]here words are employed in a statute which had at the time a
well-known meaning at common law or in the law of this country they
are presumed to have been used in that sense …”). “On the contrary,
we must presume that Congress intended to incorporate” the
heightened standard of proof, “unless the statute otherwise
dictates.” Neder , 527 U. S., at 23 (internal quotation
marks omitted) . We recognize that it may be unusual to treat a
presumption as alone establishing the governing standard of proof.
See, e.g. , J. Thayer, Preliminary Treatise on Evidence at
the Common Law 336–337 (1898) (hereinafter Thayer) (“When … we read
that the contrary of any particular presumption must be proved
beyond a reasonable doubt, … it is to be recognized that we have
something superadded to the rule of presumption, namely, another
rule as to the amount of evidence which is needed to overcome the
presumption”). But given how judges, including Justice Cardozo,
repeatedly understood and explained the presumption of patent
validity, we cannot accept Microsoft’s argument that Congress used
the words “presumed valid” to adopt only a procedural device for
“shifting the burden of production,” or for “shifting both the
burden of production and the burden of persuasion.” Brief for
Petitioner 21–22 (emphasis deleted). Whatever the significance of a
presumption in the abstract, basic principles of statutory
construction require us to assume that Congress meant to
incorporate “the cluster of ideas” attached to the common-law term
it adopted. Beck , 529 U. S., at 501 (internal quotation
marks omitted). And RCA leaves no doubt that attached to
the common-law presumption of patent validity was an expression as
to its “force,” 293 U. S., at 7—that is, the standard of proof
required to overcome it.[ Footnote
6 ]

															   Resisting the conclusion that Congress adopted
the heightened standard of proof reflected in our pre-1952 cases,
Microsoft contends that those cases applied a clear-and-convincing
standard of proof only in two limited circumstances, not in every
case involving an invalidity defense. First, according to
Microsoft, the heightened standard of proof applied in cases
“involving oral testimony of prior invention,” simply to account
for the unreliability of such testimony. Brief for Petitioner 25.
Second, Microsoft tells us, the heightened standard of proof
applied to “invalidity challenges based on priority of invention,”
where that issue had previously been litigated between the parties
in PTO proceedings. Id. , at 28.

															   Squint as we may, we fail to see the
qualifications that Microsoft purports to identify in our cases.
They certainly make no appearance in RCA ’s explanation of
the presumption of patent validity. RCA simply said,
without qualification, “that one otherwise an infringer who assails
the validity of a patent fair upon its face bears a heavy burden of
persuasion, and fails unless his evidence has more than a dubious
preponderance.” 293 U. S., at 8; see also id. , at 7 (“A
patent regularly issued, and even more obviously a patent
issued after a hearing of all the rival claimants, is presumed to
be valid until the presumption has been overcome by convincing
evidence of error” (emphasis added)). Nor do they appear in any of
our cases as express limitations on the application of the
heightened standard of proof. Cf., e.g., Smith v. Hall , 301
U. S. 216 , 233 (1937) (citing RCA for the proposition
that a “heavy burden of persuasion … rests upon one who seeks to
negative novelty in a patent by showing prior use”); Mumm v. Jacob E. Decker & Sons , 301 U. S. 168 , 171
(1937) (“Not only is the burden to make good this defense upon the
party setting it up, but his burden is a heavy one, as it has been
held that every reasonable doubt should be resolved against him”
(internal quotation marks omitted)). In fact, Microsoft itself
admits that our cases “could be read as announcing a heightened
standard applicable to all invalidity assertions.” Brief for
Petitioner 30 (emphasis deleted).

															    Furthermore, we cannot agree that Microsoft’s
proposed limitations are inherent—even if unexpressed—in our
pre-1952 cases. As early as 1874 we explained that the burden of
proving prior inventorship “rests upon [the de-fendant], and every
reasonable doubt should be resolved against him,” without tying
that rule to the vagaries and manipulability of oral testimony. Coffin v. Ogden , 18 Wall. 120, 124 (1874). And,
more than 60 years later, we applied that rule where the evidence
in support of a prior-use defense included documentary proof—not
just oral testimony—in a case presenting no priority issues at all.
See Smith , 301 U. S., at 221, 233. Thus, even if Congress
searched for some unstated limitations on the heightened standard
of proof in our cases, it would have found none.[ Footnote 7 ]

															   Microsoft also argues that the Federal
Circuit’s interpretation of §282’s statement that “[a] patent shall
be pre-sumed valid” must fail because it renders superfluous the
statute’s additional statement that “[t]he burden of establishing
invalidity of a patent … shall rest on the party asserting such
invalidity.” We agree that if the presumption imposes a heightened
standard of proof on the patent challenger, then it alone suffices
to establish that the defendant bears the burden of persuasion. Cf. Director, Office of Workers’ Compensation Programs v. Greenwich Collieries , 512 U. S. 267 , 278
(1994) (“A standard of proof … can apply only to a burden of
persuasion”). Indeed, the Federal Circuit essentially recognized as
much in American Hoist . See 725 F. 3d, at 1359.

															   But the canon against superfluity assists only
where a competing interpretation gives effect “ ‘to every
clause and word of a statute.’ ” Duncan v. Walker , 533
U. S. 167 , 174 (2001) (quoting United States v. Menasche , 348 U. S. 528 , 538–539
(1955)); see Bruesewitz v. Wyeth LLC , 562 U. S.
___, ___ (2011) (slip op., at 12). Here, no interpretation of
§282—including the two alternatives advanced by Microsoft—avoids
excess language. That is, if the presumption only “allocates the
burden of production,” Brief for Petitioner 21, or if it instead
“shift[s] both the burden of production and the burden of
persuasion,” id. , at 22 (emphasis deleted), then it would be unnecessary in light of §282’s statement that
the challenger bears the “burden of establishing invalidity.” See
21B Fed. Practice §5122, at 401 (“[T]he same party who has the
burden of persuasion also starts out with the burden of producing
evidence”). “There are times when Congress enacts provisions that
are superfluous,” Corley v. United States , 556 U.
S. ___, ___ (2009) (Alito, J., dissenting) (slip op., at 3), and
the kind of excess language that Microsoft identifies in §282 is
hardly unusual in comparison to other statutes that set forth a
presumption, a burden of persuasion, and a standard of proof. Cf., e.g. , 28 U. S. C. §2254(e)(1).[ Footnote 8 ]

															B

															   Reprising the more limited
argument that it pressed below, Microsoft argues in the alternative
that a preponderance standard must at least apply where the
evidence before the factfinder was not before the PTO during the
examination process. In particular, it relies on KSR Int’l
Co. v. Teleflex Inc. , 550 U. S. 398 (2007),
where we ob-served that, in these circumstances, “the rationale
underlying the presumption—that the PTO, in its expertise, has
approved the claim—seems much diminished.” Id. , at
426.

															   That statement is true enough,
although other rationales may animate the presumption in such
circumstances. See The Barbed Wire Patent , 143 U. S. 275 , 292 (1892) (explaining
that because the patentee “first published this device; put it upon
record; made use of it for a practical purpose; and gave it to the
public … . doubts … concerning the actual inventor … should be
resolved in favor of the patentee”); cf. Brief for United States as Amicus Curiae 33 (arguing that even when the
administrative cor-rectness rationale has no relevance, the
heightened standard of proof “serves to protect the patent holder’s
reliance interests” in disclosing an invention to the public in
exchange for patent protection). The question remains, however,
whether Congress has specified the applicable standard of proof. As
established, Congress did just that by codifying the common-law
presumption of patent validity and, implicitly, the heightened
standard of proof attached to it.

															   Our pre-1952 cases never adopted or endorsed
the kind of fluctuating standard of proof that Microsoft envisions.
And they do not indicate, even in dicta, that anything less than a
clear-and-convincing standard would ever apply to an invalidity
defense raised in an infringement action. To the contrary, the
Court spoke on this issue directly in RCA , stating that
because the heightened standard of proof applied where the evidence
before the court was “different” from that considered by the PTO,
it applied even more clearly where the evidence was identical. 293
U. S., at 8. Likewise, the Court’s statement that a “dubious
preponderance” will never suffice to sustain an invalidity defense, ibid. , admitted of no apparent exceptions. Finally, this
Court often applied the heightened standard of proof without any
mention of whether the relevant prior-art evidence had been before
the PTO examiner, in circumstances strongly suggesting it had not.
See, e.g. , Smith , 301 U. S., at 227,
233.[ Footnote 9 ]

															   Nothing in §282’s text suggests that Congress
meant to depart from that understanding to enact a standard of
proof that would rise and fall with the facts of each case. Indeed,
had Congress intended to drop the heightened standard of proof
where the evidence before the jury varied from that before the
PTO—and thus to take the unusual and impractical step of enacting a
variable standard of proof that must itself be adjudicated in each
case, cf. Santosky v. Kramer , 455 U. S. 745 , 757
(1982)[ Footnote 10 ]—we
assume it would have said so expressly.

															   To be sure, numerous courts of appeals in the
years preceding the 1952 Act observed that the presumption of
validity is “weakened” or “dissipated” in the circumstance that the
evidence in an infringement action was never considered by the PTO.
See Jacuzzi Bros. , Inc. v. Berkeley Pump
Co. , 191 F. 2d 632, 634 (CA9 1951) (“largely
dissipated”); H. Schindler & Co. v. C.
Saladino & Sons , 81 F. 2d 649, 651 (CA1
1936) (“weakened”); Gillette Safety Razor Co. v. Cliff
Weil Cigar Co. , 107 F. 2d 105, 107 (CA4 1939) (“greatly
weakened”); Butler Mfg. Co. v. Enterprise Cleaning
Co. , 81 F. 2d 711, 716 (CA8 1936) (“weakened”). But we
cannot read these cases to hold or even to suggest that a
preponderance standard would apply in such circumstances, and we
decline to impute such a reading to Congress. Instead, we
understand these cases to reflect the same commonsense principle
that the Federal Circuit has recognized throughout its
existence—namely, that new evidence supporting an invalidity
defense may “carry more weight” in an infringement action than
evidence previously considered by the PTO, American Hoist ,
725 F. 2d, at 1360. As Judge Rich explained:

															“When new evidence touching validity of the patent
not considered by the PTO is relied on, the tribunal considering it
is not faced with having to disagree with the PTO or with deferring
to its judgment or with taking its expertise into account. The
evidence may, therefore, carry more weight and go further toward
sustaining the attacker’s unchanging burden.” Ibid. (emphasis deleted)

															See also SIBIA Neurosciences, Inc. v. Cadus Pharmaceutical Corp. , 225 F. 3d 1349, 1355–1356
(CA Fed. 2000) (“[T]he alleged infringer’s burden may be more
easily car-ried because of th[e] additional [evidence]”); Group
One, Ltd. v. Hallmark Cards, Inc. , 407 F. 3d
1297, 1306 (CA Fed. 2005) (similar).

															   Simply put, if the PTO did not have all
material facts before it, its considered judgment may lose
significant force. Cf. KSR , 550 U. S., at 427. And,
concomitantly, the challenger’s burden to persuade the jury of its
invalidity defense by clear and convincing evidence may be easier
to sustain. In this respect, although we have no occasion to
endorse any particular formulation, we note that a jury instruction
on the effect of new evidence can, and when requested, most often
should be given. When warranted, the jury may be instructed to
consider that it has heard evidence that the PTO had no opportunity
to evaluate before granting the patent. When it is disputed whether
the evidence presented to the jury differs from that evaluated by
the PTO, the jury may be instructed to consider that question. In
either case, the jury may be instructed to evaluate whether the
evidence before it is materially new, and if so, to consider that
fact when determining whether an invalidity defense has been proved
by clear and convincing evidence. Cf., e.g. , Mendenhall v. Cedarapids, Inc. , 5 F. 3d
1557, 1563–1564 (CA Fed. 1993); see also Brief for International
Business Machines Corp. as Amicus Curiae 31–37. Although
Microsoft emphasized in its argument to the jury that S4 was never
considered by the PTO, it failed to request an instruction along
these lines from the District Court. Now, in its reply brief in
this Court, Microsoft insists that an instruction of this kind was
warranted. Reply Brief for Petitioner 22–23. That argument,
however, comes far too late, and we therefore refuse to consider
it. See Rent-A-Center, West, Inc. v. Jackson , 561
U. S. ___ , ___ (2010) (slip op., at 12); cf. Fed. Rule Civ. Proc.
51(d)(1)(B).

															III

															   The parties and their amici have presented opposing views as to the wisdom of
the clear-and-convincing-evidence standard that Congress adopted.
Microsoft and its amici contend that the heightened
standard of proof dampens innovation by unduly insulating “bad”
patents from invalidity challenges. They point to the high
invalidation rate as evidence that the PTO grants patent protection
to too many undeserving “inventions.” They claim that inter
partes reexamination proceedings before the PTO cannot fix the
problem, as some grounds for invalidation (like the on-sale bar at
issue here) cannot be raised in such proceedings. They question the
deference that the PTO’s expert determinations warrant, in light of
the agency’s resources and procedures, which they deem inadequate.
And, they insist that the heightened standard of proof essentially
causes juries to abdicate their role in reviewing invalidity claims
raised in infringement actions.

															   For their part, i4i and its amici , including the United States, contend that the
heightened standard of proof properly limits the circumstances in
which a lay jury overturns the considered judgment of an expert
agency. They claim that the heightened standard of proof is an
essential component of the patent “bargain,” see Bonito Boats,
Inc. v. Thunder Craft Boats, Inc. , 489 U. S. 141 , 150–151
(1989), and the incentives for inventors to disclose their
innovations to the public in exchange for patent protection. They
disagree with the notion that the patent issuance rate is above the
optimal level. They explain that limits on the reexamination
process reflect a judgment by Congress as to the appropriate degree
of interference with patentees’ reliance interests. Finally, they
maintain that juries that are properly instructed as to the
application of the clear-and-convincing-evidence standard can, and
often do, find an invalidity defense established.

															   We find ourselves in no position to judge the
comparative force of these policy arguments. For nearly 30 years,
the Federal Circuit has interpreted §282 as we do today. During
this period, Congress has often amended §282, see, e.g., Pub. L. 104–141, §2, 109 Stat. 352; Pub. L. 98–417, §203, 98 Stat.
1603; not once, so far as we (and Microsoft) are aware, has it even
considered a proposal to lower the standard of proof, see Tr. Oral
Arg. 10. Moreover, Congress has amended the patent laws to account
for concerns about “bad” patents, including by expanding the
reexamination process to provide for inter partes proceedings. See Optional Inter Partes Reexamination Procedure Act
of 1999, 113 Stat. 1501A–567, codified at 35 U. S. C. §311 et seq . Through it all, the evidentiary standard adopted
in §282 has gone untouched. Indeed, Congress has left the Federal
Circuit’s interpretation of §282 in place despite ongoing
criticism, both from within the Federal Government and
without.[ Footnote 11 ]

															   Congress specified the applicable standard of
proof in 1952 when it codified the common-law presumption of patent
validity. Since then, it has allowed the Federal Circuit’s correct
interpretation of §282 to stand. Any re-calibration of the standard
of proof remains in its hands.

															*  *  *

															   For the reasons stated, the
judgment of the Court of Appeals for the Federal Circuit is

															Affirmed.

															   The Chief Justice took no part in
the consideration or decision of this case. Footnote 1 As originally enacted in 1952, the first
paragraph of §282 read: “A patent shall be presumed valid. The
burden of establishing invalidity of a patent shall rest on a party
asserting it.” 66 Stat. 812. Congress has since amended §282,
inserting two sentences not relevant here and modifying the
language of the second sentence to that in the text. Footnote 2 Although not relevant here, the Court of
Appeals modified the effective date of the permanent injunction
that the District Court entered in favor of i4i. 598 F. 3d
831, 863–864 (CA Fed. 2010). Footnote 3 i4i contends that Microsoft forfeited the
first argument by failing to raise it until its merits brief in
this Court. The argument, however, is within the scope of the
question presented, and because we reject it on its merits, we need
not decide whether it has been preserved. Footnote 4 A preliminary word on terminology is in
order. As we have said, “[t]he term ‘burden of proof’ is one of the
‘the slipperiest members of the family of legal terms.’ ” Schaffer v. Weast , 546 U. S. 49 , 56 (2005)
(quoting 2 J. Strong, McCormick on Evidence §342, p. 433 (5th ed.
1999) (alteration omitted)). Historically, the term has encompassed
two separate burdens: the “burden of persuasion” (specifying which
party loses if the evidence is balanced), as well as the “burden of
production” (specifying which party must come forward with evidence
at various stages in the litigation). Ibid. Adding more
confusion, the term “burden of proof” has occasionally been used as
a synonym for “standard of proof.” E.g. , Grogan v. Garner , 498 U. S. 279 , 286
(1991).

															Here we use “burden of proof” interchangeably with “burden of
persuasion” to identify the party who must persuade the jury in its
favor to prevail. We use the term “standard of proof” to refer to
the degree of certainty by which the factfinder must be persuaded
of a factual conclusion to find in favor of the party bearing the
burden of persuasion. See Addington v. Texas , 441 U. S. 418 ,
423 (1979). In other words, the term “standard of proof” specifies
how difficult it will be for the party bearing the burden of
persuasion to convince the jury of the facts in its favor. Various
standards of proof are familiar—beyond a reasonable doubt, by clear
and convincing evidence, and by a preponderance of the evidence.
See generally 21B C. Wright & K. Graham, Federal Practice &
Procedure §5122, pp. 405–411 (2d ed. 2005) (hereinafter Fed.
Practice) (describing these and other standards of proof). Footnote 5 Among other cases, Justice Cardozo cited Cantrell v. Wallick , 117 U. S. 689 , 695–696
(1886) (“Not only is the burden of proof to make good this defence
upon the party setting it up, but … every reasonable doubt should
be resolved against him” (internal quotation marks omitted)); Coffin v. Ogden , 18 Wall. 120, 124 (1874) (“The
burden of proof rests upon [the defendant], and every reasonable
doubt should be resolved against him”); The Barbed Wire
Patent , 143 U. S. 275 , 285 (1892) (“[This]
principle has been repeatedly acted upon in the different
circuits”); and Washburn v. Gould , 29
F. Cas. 312, 320 (No. 17,214) (CC Mass. 1844) (charging jury
that “[i]f it should so happen, that your minds are led to a
reasonable doubt on the question, inasmuch as it is incumbent on
the defendant to satisfy you beyond that doubt, you will find for
the plaintiff”). Footnote 6 Microsoft objects that this reading of §282
“conflicts with the usual understanding of presumptions.” Reply
Brief for Petitioner 4. In sup-port, it relies on the
“understanding” reflected in Federal Rule of Evidence 301, which
explains the ordinary effect of a presumption in federal civil
actions. That Rule, however, postdates the 1952 Act by nearly 30
years, and it is not dispositive of how Congress in 1952 understood
presumptions generally, much less the presumption of pat-ent
validity. In any event, the word “presumption” has often been used
when another term might be more accurate. See Thayer 335 (“Often …
maxims and ground principles get expressed in this form of a
presumption perversely and inaccurately”). And, to the extent
Congress used the words “presumed valid” in an imprecise way, we
cannot fault it for following our lead. Footnote 7 In a similar vein, Microsoft insists that
there simply was no settled presumption of validity for Congress to
codify in 1952. Microsoft points to a handful of district court
decisions, which “question[ed] whether any presumption of validity
was warranted,” or which “required the patentee to prove the
validity of his patent by a preponderance of the evidence.” Brief
for Petitioner 24 (emphasis deleted; brackets and internal
quotation marks omitted); see, e.g., Ginsberg v. Railway Express Agency, Inc. , 72 F. Supp. 43, 44
(SDNY 1947) (stating, in dicta, that “[i]t may now well be said
that no presumption whatever arises from the grant of patent”); see
also post, at 1 (Thomas, J., concurring in judgment). RCA makes clear, however, that the presumption of patent
validity had an established meaning traceable to the mid-19th
century, 293 U. S.
1 , 7–8 (1934); that some lower courts doubted its wisdom or
even pretended it did not exist is of no moment. Microsoft may be
correct that Congress enacted §282 to correct lower courts that
required the patentee to prove the validity of a patent. See American Hoist & Derrick Co. v. Sowa & Sons,
Inc. , 725 F. 2d 1350, 1359 (CA Fed. 1984). But the
language Congress selected reveals its intent not only to specify
that the defendant bears the burden of proving invalidity but also
that the evidence in support of the defense must be clear and
convincing. Footnote 8 For those of us for whom it is relevant, the
legislative history of §282 provides additional evidence that
Congress meant to codify the judge-made presumption of validity,
not to set forth a new presumption of its own making. The
accompanying House and Senate Reports both explain that §282
“introduces a declaration of the presumption of va-lidity of a
patent, which is now a statement made by courts in deci-sions, but
has had no expression in the statute.” H. R. Rep. No. 1923,
82d Cong., 2d Sess., 10 (1952) (hereinafter H. R. Rep.);
S. Rep. No. 1979, 82d Cong., 2d Sess., 9 (1952) (hereinafter
S. Rep.). To the same effect, the Reviser’s Note indicates
that §282’s “first paragraph declares the existing presumption of
validity of patents.” Note following 35 U. S. C. §282 (1952
ed.).

															Prior to 1952, the existing patent laws already incorporated the
sum and substance of the presumption as Microsoft would define
it—that is, they “assign[ed] the burden of proving invalidity to
the accused infringer,” Brief for Petitioner 14 (emphasis deleted).
See 35 U. S. C. §69 (1946 ed.) (providing that a defendant in
an infringement action “may plead” and “prove on trial” the
invalidity of the patent as a defense); see also Patent Act of
1870, ch. 230, §61, 16 Stat. 208 (same); Patent Act of 1836, ch.
357, §15, 5 Stat. 123 (similar); Patent Act of 1793, ch. II, §6, 1
Stat. 322 (similar); Coffin , 18 Wall., at 124 (explaining
that the Patent Act of 1836 “allowed a party sued for infringement
to prove, among other defences, that the patentee was not the
original and first inventor of the thing patented, or of a
substantial and material part thereof claimed to be new” (internal
quotation marks omitted)). The House and Senate Reports state,
however, that §282 established a principle that previously “had no
expression in the statute.” H. R. Rep., at 10; S. Rep.,
at 9. Thus, because the only thing missing from §282’s predecessor
was the heightened standard of proof itself, Congress must have
understood the presumption of patent validity to include the
heightened standard of proof attached to it. Footnote 9 Microsoft cites numerous court of appeals
decisions as support for its claim that a preponderance standard
must apply in the event that the evidence in the infringement
action varies from that considered by the PTO. We see no hint of
the hybrid standard of proof that Microsoft advocates in these
cases. Indeed, in some of these cases it appears that the court
even evaluated the evidence according to a heightened standard of
proof. See Jacuzzi Bros. , Inc. v. Berkeley
Pump Co. , 191 F. 2d 632, 634 (CA9 1951) (“Although it is
not expressly stated that th[e] conclusion [of invalidity] is based
upon evidence establishing the thesis beyond a reasonable doubt,
the Trial Court expressed no doubt. And the record shows that such
conclusion was supported by substantial evidence”); Western
Auto Supply Co. v. American-National Co. , 114
F. 2d 711, 713 (CA6 1940) (concluding that the patent was
invalid where the court “entertain[ed] no doubt” on the
question). Footnote 10 Not the least of the impracticalities of such
an approach arises from the fact that whether a PTO examiner
considered a particular reference will often be a question without
a clear answer. In granting a patent, an examiner is under no duty
to cite every reference he considers. 1 Dept. of Commerce, PTO,
Manual of Patent Examining Procedure §904.03, p. 900–51 (8th
rev. ed. 2010) (“The examiner is not called upon to cite all
references that may be available, but only the ‘best.’ Multiplying
references, any one of which is as good as, but no better than, the
others, adds to the burden and cost of prosecution and should
therefore be avoided” (emphasis deleted)); Manual of Patent
Examining Procedure §904.02, p. 129 (1st rev. ed. 1952)
(same), http://www.uspto.gov/ web/offices/pac/mpep/old/E1R3_900.pdf
(all Internet materials as visited June 6, 2011, and available in
Clerk of Court’s case file); see also Brief for Respondents 45–46
(describing additional impracticalities). We see no indication in
§282 that Congress meant to require collateral litigation on such
an inherently uncertain question. Footnote 11 See, e.g. , FTC, To Promote
Innovation: The Proper Balance of Competition and Patent Law and
Policy 28 (Oct. 2003), http://www.ftc.gov/
os/2003/10/innovationrpt.pdf (recommending that “legislation be
enacted specifying that challenges to the validity of a patent be
determined based on a preponderance of the evidence”); Alsup, Memo
to Congress: A District Judge’s Proposal for Patent Reform, 24
Berkeley Tech. L. J. 1647, 1655 (2009) (same); Lichtman &
Lemley, Rethinking Patent Law’s Presumption of Validity, 60 Stan.
L. Rev. 45, 60 (2007) (proposing “statutory amendment or …
judicial reinterpretation of the existing statute and its
associated case law” to lower the standard of proof to a
preponderance of the evidence (footnote omitted)). 564 U. S. ____ (2011) MICROSOFT CORP. V. I4I LTD. PARTNERSHIP 564 U. S. ____ (2011) SUPREME COURT OF THE UNITED STATES NO. 10-290 MICROSOFT CORPORATION, PETITIONER v. i4i
LIMITED PARTNERSHIP et al.

															on writ of certiorari to the united states court of
appeals for the federal circuit

															[June 9, 2011]

															   Justice Breyer, with whom Justice
Scalia and Justice Alito join, concurring.

															   I join the Court’s opinion in
full. I write separately be-cause, given the technical but
important nature of the invalidity question, I believe it worth
emphasizing that in this area of law as in others the evidentiary
standard of proof applies to questions of fact and not to questions
of law. See, e.g., Addington v. Texas , 441 U. S. 418 ,
423 (1979). Thus a factfinder must use the “clear and convincing”
standard where there are disputes about, say, when a product was
first sold or whether a prior art reference had been published.

															   Many claims of invalidity rest, however, not
upon factual disputes, but upon how the law applies to facts as
given. Do the given facts show that the product was previously “in
public use”? 35 U. S. C. §102(b). Do they show that the
invention was “nove[l]” and that it was “non-obvious”? §§102, 103.
Do they show that the patent ap-plicant described his claims
properly? §112. Where the ultimate question of patent validity
turns on the correct answer to legal questions—what these
subsidiary legal standards mean or how they apply to the facts as
given—today’s strict standard of proof has no application. See, e.g., Graham v. John Deere Co. of Kansas
City , 383 U. S.
1 , 17 (1966); Minnesota Mining & Mfg. Co. v. Chemque, Inc. , 303 F. 3d 1294, 1301 (CA Fed. 2002); Transocean Offshore Deepwater Drilling, Inc. v. Maersk
Contractors USA, Inc. , 617 F. 3d 1296, 1305 (CA Fed.
2010); cf. Markman v. Westview Instruments, Inc. , 517 U. S. 370 (1996).

															   Courts can help to keep the application of
today’s “clear and convincing” standard within its proper legal
bounds by separating factual and legal aspects of an invalidity
claim, say, by using instructions based on case-specific
circumstances that help the jury make the distinction or by using
interrogatories and special verdicts to make clear which specific
factual findings underlie the jury’s conclusions. See Fed. Rules
Civ. Proc. 49 and 51. By isolating the facts (determined with help
of the “clear and convincing” standard), courts can thereby assure
the proper interpretation or application of the correct legal
standard (without use of the “clear and convincing” standard). By
preventing the “clear and convincing” standard from roaming outside
its fact-related reservation, courts can increase the likelihood
that discoveries or inventions will not receive legal protection
where none is due. 564 U. S. ____ (2011) MICROSOFT CORP. V. I4I LTD. PARTNERSHIP 564 U. S. ____ (2011) SUPREME COURT OF THE UNITED STATES NO. 10-290 MICROSOFT CORPORATION, PETITIONER v. i4i
LIMITED PARTNERSHIP et al.

															on writ of certiorari to the united states court of
appeals for the federal circuit

															[June 9, 2011]

															   Justice Thomas, concurring in the
judgment.

															   I am not persuaded that Congress
codified a standard of proof when it stated in the Patent Act of
1952 that “[a] patent shall be presumed valid.” 35 U. S. C.
§282; see ante , at 7. “[W]here Congress borrows terms of
art,” this Court presumes that Congress “knows and adopts the
cluster of ideas that were attached to each borrowed word … and the
meaning its use will convey to the judicial mind.” Morissette v. United States , 342 U. S. 246 , 263
(1952). But I do not think that the words “[a] patent shall be
presumed valid” so clearly conveyed a particular standard of proof
to the judicial mind in 1952 as to constitute a term of art. See, e.g. , ante , at 12, n. 7 (“[S]ome lower
courts doubted [the presumption’s] wisdom or even pretended it did
not exist”); Philip A. Hunt Co. v. Mallinckrodt
Chemical Works , 72 F. Supp. 865, 869 (EDNY 1947) (“[T]he
impact upon the presumption of many late decisions seems to have
rendered it as attenuated … as the shadow of a wraith”); Myers v. Beall Pipe & Tank Corp. , 90
F. Supp. 265, 268 (D Ore. 1948) (“[T]he presumption of
[patent] validity … is treated by the appellate courts as
evanescent as a cloud”); American Hoist & Derrick Co. v. Sowa & Sons, Inc. , 725 F. 2d 1350, 1359 (CA
Fed. 1984) (“[I]n 1952, the case law was far from consistent—even
contradictory—about the presumption”); cf. Bruesewitz v. Wyeth LLC , 562 U. S. ___, ___–___ (2011) (slip op., at
9–10) (Congress’ use of a word that is similar to a term of art
does not codify the term of art). Therefore, I would not conclude
that Congress’ use of that phrase codified a standard of proof.

															   Nevertheless, I reach the same outcome as the
Court. Because §282 is silent as to the standard of proof, it did
not alter the common-law rule. See ante , at 6 (“[§282]
includes no express articulation of the standard of proof”). For
that reason, I agree with the Court that the heightened standard of
proof set forth in Radio Corp. of Amer- ica v. Radio
Engineering Laboratories, Inc. , 293 U. S. 1 (1934)—which
has never been overruled by this Court or modified by
Congress—applies.

Summary: In Microsoft Corp. v. i4i Ltd. Partnership, the Supreme Court held that a party challenging the validity of a patent must prove its invalidity by clear and convincing evidence. This presumption of validity applies to all issued patents, and the burden of proof rests on the party asserting invalidity. The Court's decision affirmed the longstanding precedent set by the Radio Corp. of America v. Radio Engineering Laboratories, Inc. case, which established the clear and convincing evidence standard for patent invalidity defenses.


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, Washington,
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. 12–398

															_________________

															ASSOCIATION FOR MOLECULAR PATHOLOGY,
et al., PETITIONERS v. MYRIAD GENETICS, INC.,
et al.

															on writ of certiorari to the united states
court of appeals for the federal circuit

															[June 13, 2013]

															Justice Thomas delivered the opinion of the
Court.

															Respondent Myriad Genetics, Inc. (Myriad),
discovered the precise location and sequence of two human genes,
mutations of which can substantially increase the risks of breast
and ovarian cancer. Myriad obtained a number of patents based upon
its discovery. This case involves claims from three of them and
requires us to resolve whether a naturally occurring segment of
deoxyribonucleic acid (DNA) is patent eligible under 35
U. S. C. §101 by virtue of its isolation from the rest of
the human genome. We also address the patent eligibility of
synthetically created DNA known as complementary DNA (cDNA), which
contains the same protein-coding information found in a segment of
natural DNA but omits portions within the DNA segment that do not
code for proteins. For the reasons that follow, we hold that a
naturally occurring DNA segment is a product of nature and not
patent eligible merely because it has been isolated, but that cDNA
is patent eligible because it is not naturally occurring. We,
therefore, affirm in part and reverse in part the decision of the
United States Court of Appeals for the Federal Circuit.

															I

															A

															Genes form the basis for hereditary traits in
living organisms. See generally Association for Molecular
Pathology v. United States Patent and Trademark Office ,
702 F. Supp. 2d 181, 192–211 (SDNY 2010). The human ge- nome
consists of approximately 22,000 genes packed into 23 pairs of
chromosomes. Each gene is encoded as DNA, which takes the shape of
the familiar “double helix” that Doctors James Watson and Francis
Crick first described in 1953. Each “cross-bar” in the DNA helix
consists of two chemically joined nucleotides. The possible
nucleotides are adenine (A), thymine (T), cytosine (C), and guanine
(G), each of which binds naturally with another nucleotide: A pairs
with T; C pairs with G. The nucleotide cross-bars are chemically
connected to a sugar-phosphate backbone that forms the outside
framework of the DNA helix. Sequences of DNA nucleotides contain
the information necessary to create strings of amino acids, which
in turn are used in the body to build proteins. Only some DNA
nucleotides, however, code for amino acids; these nucleotides are
known as “exons.” Nucleotides that do not code for amino acids, in
contrast, are known as “introns.”

															Creation of proteins from DNA involves two
principal steps, known as transcription and translation. In
transcription, the bonds between DNA nucleotides separate, and the
DNA helix unwinds into two single strands. A single strand is used
as a template to create a complementary ribonucleic acid (RNA)
strand. The nucleotides on the DNA strand pair naturally with their
counterparts, with the exception that RNA uses the nucleotide base
uracil (U) instead of thymine (T). Transcription results in a
single strand RNA molecule, known as pre-RNA, whose nucleotides
form an inverse image of the DNA strand from which it was created.
Pre-RNA still contains nucleotides corresponding to both the exons
and introns in the DNA molecule. The pre-RNA is then naturally
“spliced” by the physical removal of the introns. The resulting
product is a strand of RNA that contains nucleotides corresponding
only to the exons from the original DNA strand. The exons-only
strand is known as messenger RNA (mRNA), which creates amino acids
through translation. In translation, cellular structures known as
ribosomes read each set of three nucleotides, known as codons, in
the mRNA. Each codon either tells the ribosomes which of the 20
possible amino acids to synthesize or provides a stop signal that
ends amino acid production.

															DNA’s informational sequences and the processes
that create mRNA, amino acids, and proteins occur naturally within
cells. Scientists can, however, extract DNA from cells using well
known laboratory methods. These methods allow scientists to isolate
specific segments of DNA—for instance, a particular gene or part of
a gene—which can then be further studied, manipulated, or used. It
is also possible to create DNA synthetically through processes
similarly well known in the field of genetics. One such method
begins with an mRNA molecule and uses the natural bonding
properties of nucleotides to create a new, synthetic DNA molecule.
The result is the inverse of the mRNA’s inverse image of the
original DNA, with one important distinction: Because the natural
creation of mRNA involves splicing that removes introns, the
synthetic DNA created from mRNA also contains only the exon
sequences. This synthetic DNA created in the laboratory from mRNA
is known as complementary DNA (cDNA).

															Changes in the genetic sequence are called
mutations. Mutations can be as small as the alteration of a single
nucleotide—a change affecting only one letter in the genetic code.
Such small-scale changes can produce an entirely different amino
acid or can end protein production altogether. Large changes,
involving the deletion, rearrangement, or duplication of hundreds
or even millions of nu- cleotides, can result in the elimination,
misplacement, or duplication of entire genes. Some mutations are
harmless, but others can cause disease or increase the risk of
disease. As a result, the study of genetics can lead to valu- able
medical breakthroughs.

															B

															This case involves patents filed by Myriad
after it made one such medical breakthrough. Myriad discovered the
precise location and sequence of what are now known as the BRCA1
and BRCA2 genes. Mutations in these genes can dramatically increase
an individual’s risk of developing breast and ovarian cancer. The
average American woman has a 12- to 13-percent risk of developing
breast cancer, but for women with certain genetic mutations, the
risk can range between 50 and 80 percent for breast cancer and
between 20 and 50 percent for ovarian cancer. Before Myriad’s
discovery of the BRCA1 and BRCA2 genes, scientists knew that
heredity played a role in establishing a woman’s risk of developing
breast and ovarian cancer, but they did not know which genes were
associated with those cancers.

															Myriad identified the exact location of the
BRCA1 and BRCA2 genes on chromosomes 17 and 13. Chromosome 17 has
approximately 80 million nucleotides, and chro- mosome 13 has
approximately 114 million. Association for Molecular
Pathology v. United States Patent and Trademark Office ,
689 F.3d 1303, 1328 (CA Fed. 2012). Within those chromosomes, the
BRCA1 and BRCA2 genes are each about 80,000 nucleotides long. If
just exons are counted, the BRCA1 gene is only about 5,500
nucleotides long; for the BRCA2 gene, that number is about 10,200. Ibid. Knowledge of the location of the BRCA1 and BRCA2 genes
allowed Myriad to determine their typical nucleotide
sequence.[ 1 ] That information,
in turn, enabled Myriad to develop medical tests that are useful
for detecting mutations in a patient’s BRCA1 and BRCA2 genes and
thereby assessing whether the patient has an increased risk of
cancer.

															Once it found the location and sequence of the
BRCA1 and BRCA2 genes, Myriad sought and obtained a number of
patents. Nine composition claims from three of those patents are at
issue in this case.[ 2 ] See id. , at 1309, and n. 1 (noting composition claims).
Claims 1, 2, 5, and 6 from the ’282 patent are representative. The
first claim asserts a patent on “[a]n isolated DNA coding for a
BRCA1 polypeptide,” which has “the amino acid sequence set forth in
SEQ ID NO:2.” App. 822. SEQ ID NO:2 sets forth a list of 1,863
amino acids that the typical BRCA1 gene encodes. See id. , at
785–790. Put differently, claim 1 asserts a patent claim on the DNA
code that tells a cell to produce the string of BRCA1 amino acids
listed in SEQ ID NO:2.

															Claim 2 of the ’282 patent operates similarly.
It claims “[t]he isolated DNA of claim 1, wherein said DNA has the
nucleotide sequence set forth in SEQ ID NO:1.” Id., at 822.
Like SEQ ID NO:2, SEQ ID NO:1 sets forth a long list of data, in
this instance the sequence of cDNA that codes for the BRCA1 amino
acids listed in claim 1. Importantly, SEQ ID NO:1 lists only the
cDNA exons in the BRCA1 gene, rather than a full DNA sequence
contain- ing both exons and introns. See id., at 779
(stating that SEQ ID NO:1’s “MOLECULE TYPE:” is “cDNA”). As a re-
sult, the Federal Circuit recognized that claim 2 asserts a patent
on the cDNA nucleotide sequence listed in SEQ ID NO:1, which codes
for the typical BRCA1 gene. 689 F. 3d, at 1326, n. 9; id., at 1337 (Moore, J., concurring in part); id., at
1356 (Bryson, J., concurring in part and dissenting in part).

															Claim 5 of the ’282 patent claims a subset of
the data in claim 1. In particular, it claims “[a]n isolated DNA
having at least 15 nucleotides of the DNA of claim 1.” App. 822.
The practical effect of claim 5 is to assert a patent on any series
of 15 nucleotides that exist in the typical BRCA1 gene. Because the
BRCA1 gene is thousands of nucleotides long, even BRCA1 genes with
substantial mutations are likely to contain at least one segment of
15 nucleotides that correspond to the typical BRCA1 gene.
Similarly, claim 6 of the ’282 patent claims “[a]n isolated DNA
having at least 15 nucleotides of the DNA of claim 2.” Ibid. This claim operates similarly to claim 5, except that it references
the cDNA-based claim 2. The remaining claims at issue are similar,
though several list common mutations rather than typical BRCA1 and
BRCA2 sequences. See ibid. (claim 7 of the ’282 patent); id., at 930 (claim 1 of the ’473 patent); id., at
1028 (claims 1, 6, and 7 of the ’492 patent).

															C

															Myriad’s patents would, if valid, give it the
exclusive right to isolate an individual’s BRCA1 and BRCA2 genes
(or any strand of 15 or more nucleotides within the genes) by
breaking the covalent bonds that connect the DNA to the rest of the
individual’s genome. The patents would also give Myriad the
exclusive right to synthetically create BRCA cDNA. In Myriad’s
view, manipulating BRCA DNA in either of these fashions triggers
its “right to exclude others from making” its patented composition
of matter under the Patent Act. 35 U. S. C. §154(a)(1);
see also §271(a) (“[W]hoever without authority makes
. . . any patented invention . . . infringes
the patent”).

															But isolation is necessary to conduct genetic
testing, and Myriad was not the only entity to offer BRCA testing
after it discovered the genes. The University of Pennsylvania’s
Genetic Diagnostic Laboratory (GDL) and others provided genetic
testing services to women. Petitioner Dr. Harry Ostrer, then a
researcher at New York University School of Medicine, routinely
sent his patients’ DNA samples to GDL for testing. After learning
of GDL’s testing and Ostrer’s activities, Myriad sent letters to
them asserting that the genetic testing infringed Myriad’s patents.
App. 94–95 (Ostrer letter). In response, GDL agreed to stop testing
and informed Ostrer that it would no longer accept patient samples.
Myriad also filed patent infringement suits against other entities
that performed BRCA testing, resulting in settlements in which the
defendants agreed to cease all allegedly infringing activity. 689
F. 3d, at 1315. Myriad, thus, solidified its position as the
only entity providing BRCA testing.

															Some years later, petitioner Ostrer, along with
medical patients, advocacy groups, and other doctors, filed this
lawsuit seeking a declaration that Myriad’s patents are invalid
under 35 U. S. C. §101. 702 F. Supp. 2d, at 186.
Citing this Court’s decision in MedImmune, Inc. v. Genentech, Inc. , 549 U.S.
118 (2007), the District Court denied Myriad’s motion to
dismiss for lack of standing. Association for Molecular
Pathology v. United States Patent and Trademark Office ,
669 F. Supp. 2d 365, 385–392 (SDNY 2009). The District Court then
granted summary judgment to petitioners on the composition claims
at issue in this case based on its conclusion that Myriad’s claims,
including claims related to cDNA, were invalid because they covered
products of nature. 702 F. Supp. 2d, at 220–237. The Federal
Circuit reversed, Association for Molecular Pathology v. United States Patent and Trademark Office , 653 F.3d 1329
(2011), and this Court granted the petition for certiorari, vacated
the judgment, and re- manded the case in light of Mayo
Collaborative Services v. Prometheus Laboratories, Inc. ,
566 U. S. ___ (2012). See Association for Molecular
Pathology v. Myriad Genetics, Inc. , 566 U. S. ___
(2012).

															On remand, the Federal Circuit affirmed the
District Court in part and reversed in part, with each member of
the panel writing separately. All three judges agreed that only
petitioner Ostrer had standing. They reasoned that Myriad’s actions
against him and his stated ability and willingness to begin BRCA1
and BRCA2 testing if Myr- iad’s patents were invalidated were
sufficient for Article III standing. 689 F. 3d, at 1323; id., at 1337 (opinion of Moore, J.); id., at 1348
(opinion of Bryson, J.).

															With respect to the merits, the court held that
both isolated DNA and cDNA were patent eligible under §101. The
central dispute among the panel members was whether the act of isolating DNA—separating a specific gene or sequence of
nucleotides from the rest of the chromosome—is an inventive act
that entitles the individual who first isolates it to a patent.
Each of the judges on the panel had a different view on that
question. Judges Lourie and Moore agreed that Myriad’s claims were
patent eligible under §101 but disagreed on the rationale. Judge
Lourie relied on the fact that the entire DNA molecule is held
together by chemical bonds and that the covalent bonds at both ends
of the segment must be severed in order to isolate segments of DNA.
This process technically creates new molecules with unique chemical
compositions. See id. , at 1328 (“Isolated DNA
. . . is a free-standing portion of a larger, natural DNA
molecule. Isolated DNA has been cleaved ( i.e. , had covalent
bonds in its backbone chemically severed) or synthesized to consist
of just a fraction of a naturally occurring DNA molecule”). Judge
Lourie found this chemical alteration to be dispositive, because
isolating a particular strand of DNA creates a nonnaturally
occurring molecule, even though the chemical alteration does not
change the information-transmitting quality of the DNA. See id., at 1330 (“The claimed isolated DNA molecules are
distinct from their natural existence as portions of larger
entities, and their informational content is irrelevant to that
fact. We recognize that biologists may think of molecules in terms
of their uses, but genes are in fact materials having a chemical
nature”). Accordingly, he rejected petitioners’ argument that
isolated DNA was ineligible for patent protection as a product of
nature.

															Judge Moore concurred in part but did not rely
exclusively on Judge Lourie’s conclusion that chemically breaking
covalent bonds was sufficient to render isolated DNA patent
eligible. Id., at 1341 (“To the extent the majority rests
its conclusion on the chemical differences between [naturally
occurring] and isolated DNA (breaking the covalent bonds), I cannot
agree that this is sufficient to hold that the claims to human
genes are directed to patentable subject matter”). Instead, Judge
Moore also relied on the United States Patent and Trademark
Office’s (PTO) practice of granting such patents and on the
reliance interests of patent holders. Id., at 1343. However,
she acknowledged that her vote might have come out differently if
she “were deciding this case on a blank canvas.” Ibid. Finally, Judge Bryson concurred in part and
dissented in part, concluding that isolated DNA is not patent eli-
gible. As an initial matter, he emphasized that the breaking of
chemical bonds was not dispositive: “[T]here is no magic to a
chemical bond that requires us to recognize a new prod- uct when a
chemical bond is created or broken.” Id., at 1351. Instead,
he relied on the fact that “[t]he nucleotide sequences of the
claimed molecules are the same as the nucleotide sequences found in
naturally occurring human genes.” Id., at 1355. Judge Bryson
then concluded that genetic “structural similarity dwarfs the
significance of the structural differences between isolated DNA and
naturally occurring DNA, especially where the structural
differences are merely ancillary to the breaking of covalent bonds,
a process that is itself not inventive.” Ibid . More- over,
Judge Bryson gave no weight to the PTO’s position on patentability
because of the Federal Circuit’s position that “the PTO lacks
substantive rulemaking authority as to issues such as
patentability.” Id., at 1357.

															Although the judges expressed different views
concerning the patentability of isolated DNA, all three agreed that
patent claims relating to cDNA met the patent eligibility
requirements of §101. Id., at 1326, and n. 9
(recognizing that some patent claims are limited to cDNA and that
such claims are patent eligible under §101); id., at 1337
(Moore, J., concurring in part); id., at 1356 (Bryson, J.,
concurring in part and dissenting in part) (“cDNA cannot be
isolated from nature, but instead must be created in the laboratory
. . . because the introns that are found in the native
gene are removed from the cDNA segment”).[ 3 ] We granted certiorari. 568 U. S. ___
(2012).

															II

															A

															Section 101 of the Patent Act provides:

															“Whoever invents or discovers any new and
useful . . . composition of matter, or any new and useful
improvement thereof, may obtain a patent therefor, subject to the
conditions and requirements of this title.” 35 U. S. C.
§101.

															We have “long held that this provision contains
an important implicit exception[:] Laws of nature, natural
phenomena, and abstract ideas are not patentable.” Mayo , 566
U. S., at ___ (slip op., at 1) (internal quotation marks and
brackets omitted). Rather, “ ‘they are the basic tools of
scientific and technological work’ ” that lie beyond the
domain of patent protection. Id., at ___ (slip op., at 2).
As the Court has explained, without this exception, there would be
considerable danger that the grant of patents would “tie up” the
use of such tools and thereby “inhibit future innovation premised
upon them.” Id. , at ___ (slip op., at 17). This would be at
odds with the very point of patents, which exist to promote
creation. Diamond v. Chakrabarty , 447 U.S.
303 , 309 (1980) (Products of nature are not created, and
“ ‘manifestations . . . of nature [are] free to all
men and reserved exclusively to none’ ”).

															The rule against patents on naturally occurring
things is not without limits, however, for “all inventions at some
level embody, use, reflect, rest upon, or apply laws of nature,
natural phenomena, or abstract ideas,” and “too broad an
interpretation of this exclusionary principle could eviscerate
patent law.” 566 U. S., at ___ (slip op., at 2). As we have
recognized before, patent protection strikes a delicate balance
between creating “incentives that lead to creation, invention, and
discovery” and “imped[ing] the flow of information that might
permit, indeed spur, in- vention.” Id., at ___ (slip op., at
23). We must apply this well-established standard to determine
whether Myr- iad’s patents claim any “new and useful
. . . composition of matter,” §101, or instead claim
naturally occurring phenomena.

															B

															It is undisputed that Myriad did not create or
alter any of the genetic information encoded in the BRCA1 and BRCA2
genes. The location and order of the nucleotides existed in nature
before Myriad found them. Nor did Myr- iad create or alter the
genetic structure of DNA. In- stead, Myriad’s principal
contribution was uncovering the precise location and genetic
sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13.
The question is whether this renders the genes patentable.

															Myriad recognizes that our decision in Chakrabarty is central to this inquiry. Brief for
Respondents 14, 23–27. In Chakrabarty , scientists added four
plasmids to a bacterium, which enabled it to break down various
components of crude oil. 447 U. S., at 305, and n. 1. The
Court held that the modified bacterium was patentable. It explained
that the patent claim was “not to a hitherto unknown natural
phenomenon, but to a nonnaturally occurring manufacture or
composition of matter—a product of human ingenuity ‘having a
distinctive name, character [and] use.’ ” Id., at
309–310 (quoting Hartranft v. Wiegmann , 121 U.S.
609 , 615 (1887); alteration in original). The Chakrabarty bacterium was new “with markedly different
characteristics from any found in nature,” 447 U. S., at 310,
due to the additional plasmids and resultant “capac- ity for
degrading oil.” Id., at 305, n. 1. In this case, by
contrast, Myriad did not create anything. To be sure, it found an
important and useful gene, but separating that gene from its
surrounding genetic material is not an act of invention.

															Groundbreaking, innovative, or even brilliant
discovery does not by itself satisfy the §101 inquiry. In Funk
Brothers Seed Co. v. Kalo Inoculant Co. , 333 U.S.
127 (1948), this Court considered a composition patent that
claimed a mixture of naturally occurring strains of bacteria that
helped leguminous plants take nitrogen from the air and fix it in
the soil. Id., at 128–129. The ability of the bacteria to
fix nitrogen was well known, and farmers commonly “inoculated”
their crops with them to improve soil nitrogen levels. But farmers
could not use the same inoculant for all crops, both because plants
use different bacteria and because certain bacteria inhibit each
other. Id., at 129–130. Upon learning that several
nitrogen-fixing bacteria did not inhibit each other, however, the
patent applicant combined them into a single inoculant and obtained
a patent. Id., at 130. The Court held that the composition
was not patent eligible because the patent holder did not alter the
bacteria in any way. Id., at 132 (“There is no way in which
we could call [the bacteria mixture a product of invention] unless
we borrowed invention from the discovery of the natural principle
itself”). His patent claim thus fell squarely within the law of
nature exception. So do Myriad’s. Myriad found the location of the
BRCA1 and BRCA2 genes, but that discovery, by itself, does not
render the BRCA genes “new . . . composition[s] of
matter,” §101, that are patent eligible.

															Indeed, Myriad’s patent descriptions highlight
the problem with its claims. For example, a section of the ’282
patent’s Detailed Description of the Invention indicates that
Myriad found the location of a gene associated with increased risk
of breast cancer and identified mutations of that gene that
increase the risk. See App. 748–749.[ 4 ] In subsequent language Myriad explains that the
location of the gene was unknown until Myriad found it among the
approximately eight million nucleotide pairs contained in a subpart
of chromosome 17. See Ibid .[ 5 ] The ’473 and ’492 patents contain similar language as
well. See id ., at 854, 947. Many of Myriad’s patent
descriptions simply detail the “iterative process” of discovery by
which Myriad narrowed the possible locations for the gene sequences
that it sought.[ 6 ] See, e.g. , id ., at 750. Myriad seeks to import these
extensive research efforts into the §101 patent-eligibility
inquiry. Brief for Respondents 8–10, 34. But extensive effort alone
is insufficient to satisfy the demands of §101.

															Nor are Myriad’s claims saved by the fact that
isolating DNA from the human genome severs chemical bonds and
thereby creates a nonnaturally occurring molecule. Myr- iad’s
claims are simply not expressed in terms of chemical composition,
nor do they rely in any way on the chemi- cal changes that result
from the isolation of a particular section of DNA. Instead, the
claims understandably focus on the genetic information encoded in
the BRCA1 and BRCA2 genes. If the patents depended upon the
creation of a unique molecule, then a would-be infringer could
arguably avoid at least Myriad’s patent claims on entire genes
(such as claims 1 and 2 of the ’282 patent) by isolating a DNA
sequence that included both the BRCA1 or BRCA2 gene and one
additional nucleotide pair. Such a molecule would not be chemically
identical to the molecule “invented” by Myriad. But Myriad
obviously would resist that outcome because its claim is concerned
primarily with the information contained in the genetic sequence , not with the specific chemical composition of a
particular molecule.

															Finally, Myriad argues that the PTO’s past
practice of awarding gene patents is entitled to deference, citing J. E. M. Ag Supply, Inc. v. Pioneer
Hi-Bred Int’l, Inc. , 534 U.S.
124 (2001). See Brief for Respondents 35–39, 49–50. We
disagree. J. E. M. held that new plant breeds were eligible
for utility patents under §101 notwithstanding separate statutes
providing special protections for plants, see 7 U. S. C.
§2321 et seq. (Plant Variety Protection Act); 35
U. S. C. §§161–164 (Plant Patent Act of 1930). After
analyzing the text and structure of the relevant statutes, the
Court mentioned that the Board of Patent Appeals and Interferences
had determined that new plant breeds were patent eligible under
§101 and that Congress had recognized and endorsed that position in
a subsequent Patent Act amendment. 534 U. S., at 144–145
(citing In re Hibberd , 227 USPQ 443 (1985) and 35
U. S. C. §119(f)). In this case, however, Congress has
not endorsed the views of the PTO in subsequent legislation. While
Myriad relies on Judge Moore’s view that Congress endorsed the
PTO’s position in a single sentence in the Consolidated
Appropriations Act of 2004, see Brief for Respondents 31,
n. 8; 689 F. 3d, at 1346, that Act does not even mention
genes, much less isolated DNA. §634, 118Stat. 101 (“None of the
funds appropriated or otherwise made available under this Act may
be used to issue patents on claims directed to or encompassing a
human organism”).

															Further undercutting the PTO’s practice, the
United States argued in the Federal Circuit and in this Court that
isolated DNA was not patent eligible under §101, Brief for
United States as Amicus Curiae 20–33, and that the PTO’s
practice was not “a sufficient reason to hold that isolated DNA is
patent-eligible.” Id., at 26. See also id. , at 28–29.
These concessions weigh against deferring to the PTO’s
determination.[ 7 ]

															C

															cDNA does not present the same obstacles to
patentability as naturally occurring, isolated DNA segments. As
already explained, creation of a cDNA sequence from mRNA results in
an exons-only molecule that is not naturally occurring.[ 8 ] Petitioners concede that cDNA
differs from natural DNA in that “the non-coding regions have been
removed.” Brief for Petitioners 49. They nevertheless argue that
cDNA is not patent eligible because “[t]he nucleotide sequence of
cDNA is dictated by nature, not by the lab technician.” Id., at 51. That may be so, but the lab technician unquestionably
creates something new when cDNA is made. cDNA retains the naturally
occurring exons of DNA, but it is distinct from the DNA from which
it was derived. As a result, cDNA is not a “product of nature” and
is patent eligible under §101, except insofar as very short series
of DNA may have no intervening introns to remove when creating
cDNA. In that situation, a short strand of cDNA may be
indistinguishable from natural DNA.[ 9 ]

															III

															It is important to note what is not implicated by this decision. First, there are no method claims
before this Court. Had Myriad created an innovative method of
manipulating genes while searching for the BRCA1 and BRCA2 genes,
it could possibly have sought a method pat- ent. But the processes
used by Myriad to isolate DNA were well understood by geneticists
at the time of Myriad’s patents “were well understood, widely used,
and fairly uniform insofar as any scientist engaged in the search
for a gene would likely have utilized a similar approach,” 702
F. Supp. 2d, at 202–203, and are not at issue in this
case.

															Similarly, this case does not involve patents
on new applications of knowledge about the BRCA1 and BRCA2
genes. Judge Bryson aptly noted that, “[a]s the first party with
knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an
excellent position to claim applications of that knowledge. Many of
its unchallenged claims are limited to such applications.” 689
F. 3d, at 1349.

															Nor do we consider the patentability of DNA in
which the order of the naturally occurring nucleotides has been
altered. Scientific alteration of the genetic code presents a
different inquiry, and we express no opinion about the application
of §101 to such endeavors. We merely hold that genes and the
information they encode are not patent eligible under §101 simply
because they have been isolated from the surrounding genetic
material.

															*  *  *

															For the foregoing reasons, the judgment of the
Federal Circuit is affirmed in part and reversed in part.

															It is so ordered. Notes 1 Technically, there is no
“typical” gene because nucleotide sequences vary between
individuals, sometimes dramatically. Geneticists refer to the most
common variations of genes as “wild types.” 2 At issue are claims 1, 2,
5, 6, and 7 of U. S. Patent 5,747,282 (the ’282 patent), claim
1 of U. S. Patent 5,693,473 (the ’473 patent), and claims 1,
6, and 7 of U. S. Patent 5,837,492 (the ’492
patent). 3 Myriad continues to
challenge Dr. Ostrer’s Declaratory Judgment Act standing in this
Court. Brief for Respondents 17–22. But we find that, under the
Court’s decision in MedImmune, Inc. v. Genentech,
Inc. , Dr. Ostrer has alleged sufficient facts “under all the
circumstances, [to] show that there is a substantial controversy,
between parties having adverse legal interests, of sufficient
immediacy and reality to warrant the issuance of a declaratory
judgment.” 549 U.S.
118 , 127 (2007) (internal quotation marks
omitted). 4 The full relevant text of
the Detailed Description of the Patent is as follows: “It is a
discovery of the present invention that the BRCA1 locus which
predisposes individuals to breast cancer and ovarian cancer, is a
gene encoding a BRCA1 protein, which has been found to have no
significant homology with known protein or DNA sequences.
. . . It is a discovery of the present invention that
mutations in the BRCA1 locus in the germline are indicative of a
predisposition to breast cancer and ovarian cancer. Finally, it is
a discovery of the present invention that somatic mutations in the
BRCA1 locus are also associated with breast cancer, ovarian cancer
and other cancers, which represents an indicator of these cancers
or of the prognosis of these cancers. The mutational events of the
BRCA1 locus can involve deletions, insertions and point mutations.”
App. 749. Notwithstanding Myriad’s repeated use of the phrase
“present invention,” it is clear from the text of the patent that
the various discoveries are the “invention.” 5 “Starting from a region
on the long arm of human chromosome 17 of the human genome, 17q,
which has a size estimated at about 8 million base pairs, a region
which contains a genetic locus, BRCA1, which causes susceptibility
to cancer, including breast and ovarian cancer, has been
identified.” Ibid. 6 Myriad first identified
groups of relatives with a history of breast cancer (some of whom
also had developed ovarian cancer); because these individuals were
related, scientists knew that it was more likely that their
diseases were the result of genetic predisposition rather than
other factors. Myriad compared sections of their chromosomes,
looking for shared genetic abnormalities not found in the general
population. It was that process which eventually enabled Myriad to
determine where in the genetic sequence the BRCA1 and BRCA2 genes
reside. See, e.g. , id ., at 749, 763–775. 7 Myriad also argues that
we should uphold its patents so as not to disturb the reliance
interests of patent holders like itself. Brief for Respondents
38–39. Concerns about reliance interests arising from PTO
determinations, insofar as they are relevant, are better directed
to Congress. See Mayo Collaborative Services v. Prometheus Laboratories, Inc. , 566 U. S. ___, ___
(2012) (slip op., at 22–24). 8 Some viruses rely on an
enzyme called reverse transcriptase to reproduce by copying RNA
into cDNA. In rare instances, a side effect ofa viral infection of
a cell can be the random incorporation of fragments of the
resulting cDNA, known as a pseudogene, into the genome. Such
pseudogenes serve no purpose; they are not expressed in protein
creation because they lack genetic sequences to direct protein
expression. See J. Watson et al., Molecular Biology of the
Gene 142, 144, fig. 7–5 (6th ed. 2008). Perhaps not surprisingly,
given pseudogenes’ apparently random origins, petitioners “have
failed to demonstrate that the pseudogene consists of the same
sequence as the BRCA1 cDNA.” Association for Molecular
Pathology v. United States Patent and Trademark Office ,
689 F.3d 1303, 1356, n. 5 (CA Fed. 2012). The possibility that
an unusual and rare phenomenon might randomly create a
molecule similar to one created synthetically through human
ingenuity does not render a composition of matter
nonpatentable. 9 We express no opinion
whether cDNA satisfies the other statutory requirements of
patentability. See, e.g. , 35 U. S. C. §§102, 103,
and 112; Brief for United States as Amicus Curiae 19,
n. 5. SUPREME COURT OF THE UNITED STATES

															_________________

															No. 12–398

															_________________

															ASSOCIATION FOR MOLECULAR PATHOLOGY,
et al., PETITIONERS v. MYRIAD GENETICS, INC.,
et al.

															on writ of certiorari to the united states
court of appeals for the federal circuit

															[June 13, 2013]

															Justice Scalia, concurring in part and
concurring in the judgment.

															I join the judgment of the Court, and all of its
opinion except Part I–A and some portions of the rest of the
opinion going into fine details of molecular biology. I am un- able
to affirm those details on my own knowledge or even my own belief.
It suffices for me to affirm, having studied the opinions below and
the expert briefs presented here, that the portion of DNA isolated
from its natural state sought to be patented is identical to that
portion of the DNA in its natural state; and that complementary DNA
(cDNA) is a synthetic creation not normally present in nature.

Summary: The Supreme Court ruled that naturally occurring DNA segments are products of nature and cannot be patented, but synthetically created DNA (cDNA) can be patented as it is not naturally occurring. Justice Thomas delivered the opinion, with Justice Scalia concurring in part and concurring in the judgment.