Amicus Curiae Brief — Lilly v. Sun Pharmaceutical Industries, Ltd.

No. 10-972

IN THE

Supreme Court of the United States

ELI LILLY AND COMPANY,

Petitioner,

SUN PHARMACEUTICAL INDUSTRIES, LTD.,

Respondent.

On Petition For A Writ Of Certiorari

To The United States Court Of Appeals

For The Federal Circuit

BRIEF OF WASHINGTON LEGAL FOUNDATION

AS AMICUS CURIAE IN SUPPORT OF

PETITIONER

DANIEL J. POPEO MATTHEW D. MCGILL

RICHARD A. SAMP Counsel of Record

WASHINGTON LEGAL WILLIAM G. JENKS

FOUNDATION xIBSON, DUNN & CRUTCHER LLP

2009 Massachusetts 1050 Connecticut Avenue, N.W.

Avenue, N.W. Washington, D.C. 20036

Washington, D.C. 20036 (202) 955-8500

(202) 688-0302 mmegill@gibsondunn.com

Counsel for Amicus Curiae

WILSON-EPES PRINTING CO , INC (202) 789-0096 — WASHINGTON, D C 20002

QUESTION PRESENTED

After Eli Lilly and Company applied for a patent

claiming the pharmaceutical composition gemcit-

abine, Lilly’s scientists discovered a new use for it.

Lilly applied for a second patent claiming the new

use, and, on the same day, filed a continuation-in-

part describing the new use and claiming priority to

the original application. The Patent and Trademark

Office granted Lilly two patents—the first for the

composition and the second for its new use—but the

Federal Circuit. below declared the second patent in-

valid under the doctrine of double patenting because,

as a result of the simultaneously filed but earlier-

granted continuation-in-part application, the new

use had been described in the first patent. The ques-

tion presented is:

Whether the court of appeals erred by holding

that the mere description of an invention in a patent

renders a subsequently issued patent claiming that

invention invalid.

ll

TABLE OF CONTENTS

INTEREST OF AMICUS CURIAE.......

By RE IE TE casnenctsanpstrepacnasiotneciosane Pere anes

SUMMARY OF ARGUMENT. ...............

PADUA FEE ciecacis hte ncccndsncuiccecscotacins eae

I. THE FEDERAL CIRCUIT'S DECISION

BELOW CONFLICTS WITH DECISIONS OF

THIS COURT, DECISIONS OF THE

REGIONAL CIRCUITS, AND

LONGSTANDING RULES OF THE PATENT

AND TRADEMARK OP BIOER. o.cccocicacocscasccccacccocccee

A. THE DECISION BELOW CANNOT BE

RECONCILED WITH THIS COURT’S

DS oe Ce eee ere

B. THE DECISION BELOW CONFLICTS

WITH DECISIONS OF THE REGIONAL

Page

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isadtvecese )

COURTS OF APPEAL S.............0.000005- ee 10

C. THE DECISION BELOW CONTRADICTS

LONGSTANDING RULES OF THE

PATENT AND TRADEMARK OFFICE. ......... 16

Il. PROPER APPLICATION OF THE DOCTRINE

OF DOUBLE PATENTING IS A MATTER OF

SPECIAL IMPORTANCE WARRANTING

THIS COURT’S REVIEW. .............0.000000. peamtarrnge 18

CHEF a snocebecccicdsncccesiaccnn eal: 22

111

TABLE OF AUTHORITIES

CASES

Allergan, Inc. v. Alcon Labs., Inc.,

324 F.3d 1322 (Fed. Cir. 2003).....

Am. Comme’ns Co. v. Pierce,

208 F.2d 763 (1st Cir. 1953)........

Ansonia Brass & Copper Co. v. Elec.

Supply Co.,

144 U.S. 11 (1892)...

Bilski v. Kappos,

130 S. Ct. 3218 (2010).......

Bonito Boats, Inc. v. Thunder Craft Boats,

Inc.,

4B9 US. 141 CLOGS) ononicicscncsescss:. an

Cardinal Chem. Co. v. Morton Int, Inc..

508 U.S. 83 (19993) ................ rk ence en

Century Elec. Co. v. Westinghouse Elec. &

Mfg. Co.,

191 F. 350 (8th Cir. 1911)............

eBay Inc. v. MercExchange, L.L.C.,

547 U.S. 388 (2006) ..................

Fehr v. Activated Sludge, Inc.,

84 F.2d 948 (7th Cir. 1936)............

Festo Corp. v. Shoketsu Kinzoku Kogyo

Kabushiki Co.,

535 U.S. 722 (2002)...

Page(s)

at

peed

lv

Holmes Group, Inc. v. Vornado Air

Circulation Sys., Inc.,

ae GEIR, CP ND oreidecasinndvsonencanesanzamenaentian 10, 11

In re Fallaux,

564 F.3d 1313 (Ped. Cir. 20080). ........0.0260...0:.02:..... 21

Intricate Metal Prods., Inc. v. Schneider,

324 F.2d 556 (Sth Cir. 1963) .........2.00ccssessesscesesee. 15

KSR Int'l Co. v. Teleflex Inc.,

Ee BF. FI OD rs enconsiccciiviecteonevisccutceenassennens 21

Miller v. Eagle Mfg. Co.,

ee Ne IE oi vecsintces cecnianvannepsietzdcoaananon passim

Montgomery Ward & Co. v. Gibbs,

ZT FP .2e SS COG Car. UGB) on casecinsecicctenescncenessussenn 14

O’Reilly v. Morse,

ee OF, CED Re .) Ge CED cin csctesidcincniccrsnnnncenceie 6

Odtorne v. Amesbury Nail Factory,

18 F. Cas. 578 (C.C.D. Mass. 1819)................2..... 5

Pfaff v. Wells Elecs., Inc.,

Te OF OR LE vin nitticrndsinienssntianacisthaconvendmamennvamedad: 10

Pierce v. Allen B. Du Mont Labs., Inc.,

Se Be BAD Ce Cr, CD aa einlnvevgcesenctcnceeestcoviace 15

S.H. Kress & Co. v. Aghnides,

246 F.2d 718 (4th Cir. 1957) ....0..n0nccccceeeceoness 14,15

Smith v. Kingsland,

EPG Fe ee. CD. BO onccvisscic eens 15

Suffolk Co. v. Hayden,

70 U.S. (3 Wall.) 315 (1866).................. 8,9, 10, 19

V

Thomson-Houston Elec. Co. v. Elmira & H.

Ry. Co.,

FE Wx Ge Ce Gri. BO ei vc cexeccihceccccdacenscdccvacserucnae i3

Thomson-Houston Elec. Co. v. Ohto Brass

Co.,

ee, Fe Cee Ge, BT vvocsiiccnsecashscorsias 12. 13,19

Traitel Marble Co. v. U.T. Hungerford

Brass & Copper Co.,

ee Hk BOO CAS GF. 1927)... oc 0sscssncessscevensoscese 13, 14

WaAl v. Rexnord, Inc.,

G26 FBG LIGO a Cir. 1960).....0cccccscccssccsececoseee 15

Weatherhead Co. v. Drillmaster Supply Co.,

BE eee OO CIEE CEE. DBGG) 000. nc sccecveccecssrecsccsccsene 15

CONSTITUTIONAL PROVISIONS

ee I PN BG is icinsicccesincnssennccanarenceens 1,18

STATUTES

Be Be 0 EI E Pireisescesscencssonsnsvencnvesnssansenci 10, 18

Be Ps BD oniscscnvcssensacescssvesvensnosscsnnssseons 10, 18

is cpncinsenapanskavsdnceasaacewastounviveusaoanias 7

Be AM an paiac side sca evnnecsivennecakevnudsnensponususcuconaanvns 7

is ccicatitn su. enks eiesncbuwsuswatanabeesabanswh 21

ee ya svn cpascwvanvsnonapennvaceaneccastusecosvenctsanenenes 17

Rie I vances nencancnaccencnsransdennscuvesscasanvanes 21

ths FOIE ve ccgnncsncnenseccevacesnccsvecasnsnssssvenbasason 21

I ose ccc pupncadbiee bas auinoonamandasbuaacanare 21

Uruguay Round Agreements Act, Pub. L.

No. 103-465, 108 Stat. 4809 (1994)....00000.000000. 21

REGULATIONS

gtk ee BOR) b ) ena nnenreS 17

ee Na ie © BREE) CID a sisnisen cnn sccensvesosesacvoenssnnee 16

RE Cm ew © ERR) CFG vi cscesesavscncsecessesssesensensssnne 16

re ee i Fe CI iescsiccnicasnrnvics estoysenconanasnenene 17

OTHER AUTHORITIES

Br. of WLF as Amicus Curiae in Support of

Eli Lilly and Company and Supporting

En Banc Review, Sun Pharm. Indus.,

Ltd. v. Eli Lilly & Co., 611 F.3d 1381

(Fed. Cir. 2010) (No. 2010-1105)..................ccncce0e. 1

Donald S. Chisum, Chisum on Patents

I genta ns Vue e oa en ie umeadedt ta Diraa ecadeaataaeskcons 7,8

U.S. PTO, Manual of Patent Examining

Procedure (8th ed. rev. 5 2006).................0. 2c. cece 17

BRIEF OF WASHINGTON LEGAL

FOUNDATION AS AMICUS CURIAE

IN SUPPORT OF PETITIONER

INTEREST OF AMICUS CURIAE

Washington Legal Foundation (“WLF”) is a non-

profit public interest law and policy center that regu-

larly appears before federal and state courts to pro-

mote economic liberty, free enterprise, and a limited

and accountable government. WLF has participated

in numerous court proceedings raising important is-

sues regarding the patenting of pharmaceuticals and

the enforcement of pharmaceutical patents. See, e.g.,

Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322,

1330 n.6 (Fed. Cir. 2003) (citing WLF’s amicus brief);

Br. of WLF as Amicus Curtae in Support of Eli Lilly

and Company and Supporting En Banc Review, Sun

Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381

(Fed. Cir. 2010) (No. 2010-1105).

Correctly applied, the doctrine of double patent-

ing “promote[s] the Progress of . . . useful Arts,” U.S.

Const. art. I, § 8, cl. 8, by ensuring that the monopoly

granted to an invention persists only for a limited

time. The decision below enlarges the doctrine in a

manner that undermines the disclosure function of

1 Pursuant to this Court’s Rule 37.2(a), amicus timely noti-

fied the parties of its intent to file this brief. The parties have

consented to the filing of this brief in letters submitted here-

with. Pursuant to this Court’s Rule 37.6, amicus states that

this brief was not authored in whole or in part by counsel for

any party, and that no person or entity other than amicus or its

counsel made a monetary contribution intended to fund the

preparation or submission of this brief.

2

patents, which, no less than the patent monopoly it-

self, is an engine of progress. WLF thus has a sub-

stantial interest in this Court’s decision whether to

grant review of the opinion below.

STATEMENT

In 1982, Dr. Larry Hertel, an employee of Eli

Lilly and Company, invented a new and useful

pharmaceutical composition called gemcitabine, the

active ingredient in the drug Lilly now markets as

Gemzar®. Pet. App. 2a, 57a, 59a-60a. Lilly filed an

application to patent gemcitabine on March 10, 1983,

describing the composition and a method of using it

to treat viral infections. Jd. at 3a, 60a.

While the application was still pending, Dr.

Hertel and a collaborator at Lilly, Dr. Gerald

Grindey, discovered a new use for gemcitabine—as a

drug for treating cancer. See Pet. App. 4a, 6la-62a.

Accordingly, Lilly filed an application for a second

patent on December 4, 1984, claiming the new anti-

cancer use. Jd. at 4a. That same day, Lilly also filed

a continuation-in-part of its original application, de-

scribing the anticancer use in a short paragraph. See

id. at 3a-4a.

The Patent and Trademark Office (“PTO”) sub-

sequently granted Lilly two separate patents. The

first, U.S. Patent No. 4,808,614 (the “614 patent”),

issued on February 28, 1989, and claimed Dr.

Hertel’s original invention: the composition gemcit-

abine and its antiviral use. Pet. App. 2a, 2la, 23a.

The second, U.S. Patent No. 5,464,826 (the “826 pat-

ent”), issued on November 7, 1995, and claimed Drs.

Hertel and Grindey’s subsequent discovery of gem-

citabine’s anticancer use. Z/d. at 2a, 23a-25a. The

614 patent expired on May 15, 2010, id. at 3a, and

3

the ’826 patent is scheduled to expire on November 7,

2012, id. at 4a.

In 2007, Sun Pharmaceutical Industries, Ltd., a

generic drug manufacturer, filed suit against Lilly in

the U.S. District Court for the Eastern District of

Michigan. Pet. App. 5a, 19a-20a. Seeking to market

a generic version of Gemzar® for use as an antican-

cer medication before November 7, 2012, Sun re-

quested a declaratory judgment that Lilly’s ’826 pat-

ent is invalid. See id. at 20a.

The district court declared the 826 patent inva-

lid, Pet. App. 33a, and a three-judge panel of the

Federal Circuit affirmed, id. at 2a. The panel rested

its decision on the proposition that “a claim to a

method of using a composition is not patentably dis-

tinct from an earlier claim to the identical composi-

tion in a patent disclosing the identical use.” Jd. at

12a (internal quotation marks omitted). That propo-

sition, the panel held, “extends to any and all such

uses disclosed in the specification of the earlier pat-

ent.” Ibid. Thus, the panel concluded, although the

614 patent did not claim gemcitabine’s anticancer

use, the mere description of that use in the ’614 pat-

ent renders the ’826 patent invalid under the doc-

trine of double patenting. See id. at 18a. “In light of

the earlier 614 patent’s description of gemcitabine’s

use in treating cancer,” the panel explained, “the as-

serted claims of the later ’826 patent, which recite a

method of using gemcitabine to treat cancer, are not

patentably distinct from the ’614 patent’s claim to

gemcitabine,” because “[t]he asserted claims of the

later ’826 patent simply claim the anticancer use dis-

closed in the specification of the 614 patent.” Jbid.

(emphasis added).

4

By a five-to-four vote, the Federal Circuit denied

Lilly’s petition for rehearing en banc. See Pet. App.

131la-132a. Dissenting from that denial, Judge New-

man, joined by Chief Judge Rader and Judges Lourie

and Linn, argued that “[t}he law of double patenting

is contrary to the panel’s holding.” Jd. at 136a; see

also id. at 138a (“The panel opinion violates a vast

body of precedent.”). The law of double patenting,

Judge Newman explained, “is directed to whether

the invention claimed in a later patent is an obvious

variant of the invention claimed in an earlier pat-

ent”—not whether the invention claimed in a later

patent happened to be described in an earlier one.

Id. at 138a. After all, Judge Newman noted, “there

is no dispute that Lilly would be entitled to a sepa-

rate patent on the anticancer use if Lilly had not in-

cluded the disclosure of anticancer use in the specifi-

cation of the continuation-in-part filed the same day”

as Lilly’s 826 patent. Jd. at 140a. Judge Newman

therefore criticized the panel for failing to explain

how its holding advanced the purpose of the doctrine

of double patenting—a doctrine “intended to prevent

improper timewise extension of the patent right.” Jd.

at 139a-140a (internal quotation marks omitted).

SUMMARY OF ARGUMENT

It is a fundamental principle of patent law that

an inventor is entitled to as many patents as he has

inventions. The judicially created doctrine of double

patenting is not supposed to disturb this principle.

Instead, the doctrine is supposed to prevent an appli-

cant from receiving two patents for one invention and

thereby extending his monopoly on the single inven-

tion. Nevertheless, when Lilly obtained a patent for

one invention (the pharmaceutical composition gem-

citabine) and later obtained a second patent for a dis-

5

tinct invention (gemcitabine’s subsequently discov-

ered anticancer use), the Federal Circuit declared

the second patent invalid for double patenting,

thereby limiting Lilly to one patent for two inven-

tions. The court of appeals rested its decision on a

new inflexible and categorical rule—any description

of an invention in an earlier-issued patent renders a

later-issued patent claiming that invention invalid.

That rule conflicts not only with decisions of this

Court, but also with decisions of the regional courts

of appeals and longstanding rules of the PTO. What

is more, the practical effect of Federal Circuit’s deci-

sion to limit applicants to a single patent for two in-

ventions will be to discourage disclosure and innova-

tion, the twin pillars of a well-functioning patent sys-

tem. Certioran is warranted.

ARGUMENT

THE FEDERAL CIRCUIT’S DECISION BELOW

CONFLICTS WITH DECISIONS OF THIS

CouRT, DECISIONS OF THE REGIONAL

CIRCUITS, AND LONGSTANDING RULES OF

THE PATENT AND TRADEMARK OFFICE.

A. THE DECISION BELOW CANNOT BE

RECONCILED WITH THIS COURT’S

DECISIONS.

In Miller v. Eagle Manufacturing Co., 151 U.S.

186 (1894), which the decision below fails to cite, this

Court affirmed “the well-settled rule that two valid

patents for the same invention cannot be granted ei-

ther to the same or to a different party.” Jd. at 197.

Citing Odiorne v. Amesbury Nail Factory, 18 F. Cas.

578 (C.C.D. Mass. 1819) (No. 10,430) (Story, J.), the

Court stated that the reason for the rule is to prevent

what would otherwise amount to an improper

6

timewise extension of the term of a patent. See

Miller, 151 U.S. at 198. Once a patent issues for an

invention, the Court explained, “the power to create

a monopoly is exhausted”; “a new and later patent

for the same invention would operate to extend or

prolong the monopoly beyond the period allowed by

law.” Ibid. Thus, the Court held, “[iJf, upon a proper

construction of ... two patents, ... they should be

considered as covering the same invention, then the

later must be declared void” under the doctrine of

double patenting. Id. at 196-97.

At the same time, the Court in Miller stressed

that application of the doctrine of double patenting

should not come at the expense of another funda-

mental principle of patent law—“that a later patent

may be granted where the invention is clearly dis-

tinct from, and independent of, one previously pat-

ented.” 151 U.S. at 199. The Court noted, for ex-

ample, that “fa] single invention may include both

the machine and the manufacture it creates, and in

such cases, if the inventions are really separable, the

inventor may be entitled to a monopoly of each.”

Ibid. By the same token, “an inventor may make a

new improvement on his own invention of a pat-

entable character, for which he may obtain a sepa-

rate patent.” Jbid.; accord O’Reilly v. Morse, 56 U.S.

(15 How.) 62, 122 (1854). Thus, while acknowledging

that “no patent can issue for an invention actually

covered by a former patent,” the Court emphasized

that “where the second patent covers matter de-

scribed in the prior patent, essentially distinct and

separable from the invention covered thereby and

claims made thereunder, its validity may be sus-

tained.” Miller, 151 U.S. at 198.

7

The Federal Circuit’s decision below—-declaring

Lilly’s ’826 patent invalid because the invention

claimed therein was “disclosed in the specification of

the ’614 patent,” Pet. App. 18a (emphasis added)—

cannot be squared with Miller's pronouncement. that

the validity of a second patent that “covers matter

described in [a] prior patent ... may be sustained” if

the inventions at issue are “essentially distinct and

separable,” Miller, 151 U.S. at 198 (emphasis added).

Here, there is no question that the initial discovery

of a pharmaceutical composition and the subsequent

discovery of a new use for that composition are sepa-

rately patentable under the Patent Act. See 35

U.S.C. § 101 (“Whoever invents or discovers any new

and useful process ... or composition of matter, or

any new and useful improvement thereof, may ob-

tain a patent therefor ....”); rd. § 100(b) (defining

the term “process” to include “a new use of a known

... composition of matter”); Ansonia Brass & Copper

Co. v. Elec. Supply Co., 144 U.S. 11, 18 (1892) (“[f

an old device or process be put to a new use which is

not. analogous to the old one, and the adaptation of

such process to the new use is of such a character as

to require the exercise of inventive skill to produce it,

such new use will not be denied the ment of pat-

entability.”); 1 Donald S. Chisum, Chisum on Patents

§ 1.03[8][c] (2010) (confirming that courts “recognize

the availability of process claims for new and nonob-

vious uses” of old inventions).

And yet, despite the fact that Lilly’s ’614 patent

claimed only gemcitabine and its antiviral use, and

the fact that the subsequent discovery of gemcit-

abine’s anticancer use is separately patentable from

both, the Federal Circuit declared the ’826 patent in-

valid because the anticancer use claimed therein had

been described in the 614 patent. Pet. App. 18a.

8

That holding contradicts this Court’s decision in

Miller, which makes plain that the mere description

of an invention in an earlier-issued patent does not

render a later-issued patent claiming that invention

invalid. See 151 U.S. at 198; accord 3A Chisum, su-

pra, § 9.01 (“[The doctrine of double patenting] does

not preclude a second patent on subject matter that

is disclosed but not claimed in the first patent.”).

The per se rule for which the decision below stands—

that whenever a patent describes an invention, it

renders a subsequent patent claiming that invention

invalid—is inconsistent with the rule articulated in

Miller that the validity of the subsequent patent

“may be sustained,” so long as the invention claimed

therein is “essentially distinct and separable” from

any invention previously patented. 151 U.S. at 198.

The decision below also conflicts with this

Court’s decision in Suffolk Co. v. Hayden, 70 U.S. (3

Wall.) 315 (1866), a case predating Miller. The

plaintiff in Suffolk had sought to patent various im-

provements to a trunk used for cleaning cotton. The

plaintiffs initial application claimed improvements

to the interior arrangement of the trunk. 7Id. at 315.

While that application was still pending, the plaintiff

filed a second application, which claimed improve-

ments to the trunk’s form. Jd. at 316. That applica-

tion also described—but did not claim—the im-

provements covered by the plaintiffs initial applica-

tion. Ibid. Thereafter, in March 1857, the plaintiff

received a patent on his second application, for im-

provements to the trunk’s form. /bid. He then filed

a third application, once again claiming improve-

ments to the trunk’s interior arrangement, which re-

sulted in a patent in December 1857. Ibid. It was

not until September 1860, nearly three years leer,

that the plaintiff finally received a patent on his ini-

3

tial application, also for improvements to the interior

arrangement of the trunk. Jbid.

The plaintiff brought suit against the defendant

for infringing the patent granted in December 1857

for improvements to the interior arrangement. Suf-

folk, 70 U.S. at 316-17. As a defense to infringement,

the defendant argued a type of double patenting. See

id. at 317. According to the defendant, the December

1857 patent was void because the failure of the prior

March 1857 patent to claim improvements to the in-

terior arrangement “operated as an abandonment or

dedication of [those improvements] to the public.”

Id. at 318; see also Fehr v. Activated Sludge, Inc., 84

F.2d 948, 953 (7th Cir. 1936) (describing as a type of

double patenting the situation that arises “where the

inventor claims one form of his invention in one pat-

ent, and at a later time claims another form which

was disclosed in his earlier application,” but only

“where there has been such a delay as to amount toa

dedication”).

This Court disagreed. It held that the pendency

of the plaintiffs initial application, for the “same”

improvements to the interior arrangement of the

trunk, “repelled any inference of abandonment or

dedication from the omission to again claim [them]”

in the March 1857 patent. Suffolk, 70 U.S. at 318.

Thus, despite the fact that improvements to the inte-

rior arrangement had been previously described in

the March 1857 patent, the Court “d[id] not perceive

any objection” to the process resulting in the Decem-

ber 1857 patent actually claiming those improve-

ments. Jd. at 319.

This Court’s decision in Suffolk cannot be recon-

ciled with the Federal Circuit’s decision below. In re-

jecting the defendant’s double-patenting argument,

10

this Court perceived no objection to the validity of

the plaintiffs second patent, even though his first

patent had already described the same invention.

Suffolk, 70 U.S. at 319. But the Federal Circuit be-

low did object to the validity of Lilly’s second patent,

precisely because Lilly’s first patent had already de-

scribed gemcitabine’s anticancer use. Pet. App. 18a.

The holding below flatly contradicts the decision in

Suffolk.

This Court should grant certiorari to resolve the

conflict between the Federal Circuit’s decision below

and this Court’s decisions in Miller and Suffolk.

Without this Court’s intervention, a rule contrary to

the principles articulated in this Court’s cases will

continue to distort the patent law of this Nation.

B. THE DECISION BELOW CONFLICTS WITH

DECISIONS OF THE REGIONAL COURTS

OF APPEALS.

“Not all cases involving a patent-law claim fall

within the Federal Circuit’s jurisdiction.” Holmes

Group, Inc. v. Vornado Air Circulation Sys., Inc. , 535

U.S. 826, 834 (2002). To be sure, the Federal Circuit

has exclusive appellate jurisdiction over all actions

arising under federal patent law. See 28 U.S.C.

§§ 1295(a)(1), 1338(a). But the regional circuits con-

tinue to have appellate jurisdiction over actions in

which patent-law issues are presented only in the de-

fendant’s answer. See Holmes, 535 U.S. at 830-32.

Because the doctrine of double patenting could be

raised as a counterclaim in an action outside the

Federal Circuit’s exclusive jurisdiction, a_ conflict

with the regional circuits over the question pre-

sented would furnish a compelling reason for this

Court to grant certiorari. Pfaff v. Wells Elecs., Inc.,

525 U.S. 55, 60 (1998) (citing the conflict between the

11

Federal Circuit’s decision and the decisions of re-

gional circuits as a reason for granting certiorari); see

also Holmes, 535 U.S. at 839 (Stevens, J., concurring

in part and concurring in the judgment) (noting that

a conflict between the Federal Circuit and the re-

gional circuits “may be useful in identifying ques-

tions that ment this Court’s attention,” and that “oc-

casional decisions by courts with broader jurisdiction

will provide an antidote to the risk that the special-

ized court may develop an institutional bias”).

Such a conflict is present here. Each of the re-

gional courts of appeals to have addressed the ques-

tion presented has rejected the Federal Circuit’s per

se rule that a patent is invalid whenever the inven-

tion claimed therein was described in an earlier-

issued patent. In accordance with this Court’s deci-

sions in Miller and Suffolk, these other circuits have

recognized that the mere description of an invention

in an earlier-issued patent does not render a later-

issued patent claiming that invention invalid.

In Century Electric Co. v. Westinghouse Electric

& Manufacturing Co., 191 F. 350 (8th Cir. 1911), for

example, the Eighth Circuit, in an opinion authored

by Judge Walter Sanborn and joined by then-Judge

Van Devanter, affirmed that:

one who makes several patentable in-

ventions that result in a new and useful

machine or process, or both, may have

as Many separate valid patents as he

makes patentable inventions. His is the

option to secure all these inventions by

a single patent, or by many patents, and

the fact that he describes all of them in

his application or specification for an

earlier patent to secure one or more of

12

them, does not invalidate a subsequent

patent to him for those inventions there

described but not claimed.

Id. at 353 (emphasis added).

At issue in Century Electric were three inven-

tions of Nikola Tesla. In 1888, Tesla had applied for

two patents: one for a method of using a motor, and

the other for the motor itself. Jd. at 352-54. In 1889,

while his first two applications were still pending,

Tesla had filed a third application, for an improved

motor. Jd. at 353-54. His third application de-

scribed—but did not claim—the method and motor

that formed the basis of his first two applications.

Id. at 357. And though it was the last of his applica-

tions filed, his third was the first granted by the Pat-

ent Office in 1891. ZJd. at 352. A patent for the

method did not issue until 1894, and a patent for the

original motor, not until 1896. Jbid. As a defense to

infringement of Tesla’s patents, the defendant ar-

gued that the latter two patents were invalid for

double patenting over the 1891 patent, which had

described the method and the motor claimed by the

latter two. JIbid. Rejecting this argument, the

Eighth Circuit explained that the defendant had

“failled] to give due weight” to the rule that an in-

ventor “may describe in an application an invention

which he does not claim therein without waiving his

right to claim and secure a subsequent patent for it.”

Id. at 358 (emphases added).

The Sixth Circuit applied the same rule in Thom-

son-Houston Electric Co. v. Ohio Brass Co., 80 F. 712

(6th Cir. 1897) (Taft, J.). That case involved two

patent applications relevant here: the first, filed in

1887, for improvements in suspended switches for

electric railways, id. at 713, 715; the second, filed a

13

year later, for improvements relating to those

claimed in the first application, rd. at 717-18. The

patent resulting from the second application, which

was granted in 1889, described (but did not claim)

the improvements covered by the first application,

which was not granted until the following year. See

td. at 713, 717, 724. Sued for infringement, the de-

fendant claimed that the later-issued patent was in-

valid for double patenting over the earlier-issued

patent. Jd. at 714, 724. In an opinion by then-Judge

Taft, the Sixth Circuit quoted the passage in Miller

stating that “where the second patent covers matters

described in the prior patent, essentially distinct and

separable from the invention covered thereby and

claims made thereunder, its validity may be sus-

tained.” Jd. at 728 (quoting Miller, 151 U.S. at 198).

The court of appeals then rejected the defendant’s

double-patenting argument as contrary to Miller,

and held that the later-issued patent was “not ren-

dered void by” the earlier-issued patent. Jbid.

When the same question of double patenting

arose in a case involving the same patents, the Sec-

ond Circuit reached the same conclusion: The patent

issued later was valid, despite the fact that its

claimed invention had been described in the patent

issued earlier. See Thomson-Houston Elec. Co. v.

Elmira & H. Ry. Co., 71 F. 396, 407 (2d Cir. 1896).

Decades later, the Second Circuit expounded the

same principle in Traitel Marble Co. v. U.T. Hunger-

ford Brass & Copper Co., 22 F.2d 259 (2d Cir. 1927),

a case involving a patent for an apparatus and a sub-

sequent patent for improvements to it. Writing for

the Second Circuit in Traitel, Judge Learned Hand

stated that “it is never an objection to an improve-

ment patent that an earlier generic patent has cov-

ered the same structure, and each is valid, though

14

taken out by a single inventor.” /d. at 262. He then

concluded that the patents before him presented

“precisely the same situation, except that, because

the applications were copending, it is not necessary

that the improvement should be an invention over

the matters disclosed in the other application.” Jdid.

(emphasis added). Judge Hand’s opinion has been

properly understood to mean that “the claim of the

second application need not be a patentable advance

over the disclosures of the specifications (as distinct

from the claims) of the first application.” S.H. Kress

& Co. v. Aghnides, 246 F.2d 718, 726 (4th Cir. 1957)

(per curiam on motions for rehearing).

The Fourth Circuit’s decision in Montgomery

Ward & Co. v. Gibbs, 27 F.2d 466 (4th Cir. 1928),

stands for the identical proposition. The plaintiff

there brought suit alleging infringement of a patent

claiming “improvements in traps designed for the

capture of fur-bearing animals.” Jd. at 467. The de-

fendant contended that the patent in suit was void

for double patenting over a previously issued patent,

id. at 468, but the Fourth Circuit disagreed. The

court of appeals found that the “two patents . . . were

copending, and while a somewhat similar trap was

described in [the earlier-issued patent], it was not

there claimed as in [the patent in suit], although de-

scribed.” Jbid. Recognizing that “[i]t is not fatal if

the invention of the second patent is disclosed in the

earlier patent, provided it is not claimed there, and

the applications for the two patents were copending,”

the Fourth Circuit concluded that the defendant’s

claim of double patenting was “not well founded.” Id.

at 469 (emphases added).

Reiterating the same principle in a later case,

the Fourth Circuit stated that “where the applicant

15

files a second application while the earlier one is still

pending in the Patent Office, and the first patent

contains disclosures not embodied in the claims, he is

not barred from embodying the unclaimed disclo-

sures in the later application.” Aghnides, 246 F.2d at

726 (emphasis added). Agreeing with the Fourth

Circuit’s approach, the Ninth Circuit has quoted that

passage directly in an opinion of its own. Intricate

Metal Prods., Inc. v. Schneider, 324 F.2d 555, 560

(9th Cir. 1963). The Seventh Circuit has made clear

that it, too, recognizes the same principle. In setting

forth the “correct” test for double patenting in

Weatherhead Co. v. Drillmaster Supply Co., 227 F.2d

98 (7th Cir. 1955), the Seventh Circuit declared that

“(wlhen determining whether or not double patent-

ing exists only the claims are compared.” /d. at 102.

Accordingly, the Seventh Circuit explained, “when

[copending] applications were made by the same in-

ventor and the doctrine of double patenting applies,

the later patent need not show an inventive advance

over what was disclosed but not claimed in the ear-

lier patent.” Jbid. (emphases added).

In addition to the circuits discussed above, three

other regional courts of appeals in considering dou-

ble-patenting defenses have quoted the key passage

in Miller, 151 U.S. at 198, in which this Court stated:

“(Wjhere the second patent covers matter described

in the prior patent, essentially distinct and separable

from the invention covered thereby and claims made

thereunder, its validity may be sustained.” Am.

Comme’ns Co. v. Pierce, 208 F.2d 763, 766 (1st Cir.

1953); Wahl v. Rexnord, Inc., 624 F.2d 1169, 1178 (3d

Cir. 1980); Pierce v. Allen B. Du Mont Labs., Inc., 297

F.2d 323, 327 (3d Cir. 1961); Smith v. Kingsland, 178

F.2d 26, 30 (D.C. Cir. 1949). Unlike the Federal Cir-

cuit below, which did not cite Miller, these other cir-

16

cuits recognize that the validity of a patent “may be

sustained,” even if the invention claimed therein was

described previously in an earlier-issued patent.

As the foregoing demonstrates, the Federal Cir-

cuit’s decision below conflicts with the decisions of

every regional circuit to have addressed the question

presented. Following this Court’s decisions in Miller

and Suffolk, the First, Second, Third, Fourth, Sixth,

Seventh, Eighth, Ninth, and D.C. Circuits have made

clear that the mere description of an invention in a

patent does not render a subsequently issued patent

claiming that invention invalid. The Federal Cir-

cuit’s adoption of a directly contrary rule warrants

this Court’s review.

C. THE DECISION BELOW CONTRADICTS

LONGSTANDING RULES OF THE PATENT

AND TRADEMARK OFFICE.

In addition to contradicting the decisions of this

Court and the regional courts of appeals, the Federal

Circuit’s decision below conflicts with longstanding

rules of the PTO.

At the time the two applications at issue here

were filed, the PTO’s rules barred an applicant from

presenting, in a single application, claims to a com-

position and more than one method of using that

composition. See 37 C.F.R. § 1.141(a)-(b) (1984). The

rules thus required Lilly to present its claims to

gemcitabine and its antiviral use in one application,

and its claim to gemcitabine’s anticancer use in an-

other—which is precisely what Lilly did. If Lilly had

violated these rules by presenting its claims in only a

single application, the PTO would have simply forced

Lilly’s claims into separate patents by restricting the

17

application’s scope. See 35 U.S.C. § 121; 37 C.F.R.

§ 1.142(a).

Similariy, today, the PTO’s rules provide that

“[tlwo or more independent and distinct inventions

may not be claimed in one national application.” 37

C.F.R. § 1.141(a) (2011). And the Manual of Patent

Examining Procedure makes clear that gemcitabine’s

anticancer use would be regarded as an invention in-

dependent and distinct from gemcitabine and its an-

tiviral use. See U.S. PTO, Manual of Patent Examin-

ing Procedure § 806.05(h) (8th ed. rev. 5 2006) (“A

product and a process of using the product can be

shown to be distinct inventions if ... the product as

claimed can be used in a materially different proc-

ess.”). Thus, presented with Lilly’s claims today, the

PTO would still require that they be divided into two

separate applications, through imposing a restriction

requirement if necessary. See 35 U.S.C. § 121.

The Federal Circuit’s decision effectively nullifies

the PTO’s longstanding policy of prohibiting claims

like Lilly’s from being claimed in a single application.

In declaring Lilly's ’826 patent invalid for double

patenting, the court of appeals concluded that Lilly’s

claim to gemcitabine’s anticancer use is “not pat-

entably distinct from the ’614 patent’s claim to gem-

citabine.” Pet. App. 18a. That conclusion directly

conflicts with the PTO’s rules, which required that

Lilly obtain two distinct patents for its claims to

gemcitabine and its anticancer use. The decision be-

low will thus have the effect of binding claims to-

gether through the doctrine of double patenting that

the PTO has long required to be patented separately

under its own rules. Because the decision below es-

sentially negates the policies of the PTO, this Court

18

should not deny the petition without at least first

calling for the views of the Solicitor General.

II. PROPER APPLICATION OF THE DOCTRINE

OF DOUBLE PATENTING IS A MATTER OF

SPECIAL IMPORTANCE WARRANTING THIS

COURT’S REVIEW.

As noted above, the Federal Circuit has exclusive

appellate jurisdiction over all actions arising under

federal patent law. See 28 U.S.C. §§ 1295(a)()),

1338(a). That alone makes “the rule that it applied

in this case .. . a matter of special importance to the

entire Nation.” Cardinal Chem. Co. v. Morton Int'l,

Inc., 508 U.S. 83, 89 (1993). But even beyond that,

the decision below is of special importance because

its expansion of the judicially created doctrine of

double patenting threatens to undermine the consti-

tutionally defined purposes of our Nation’s patent

system.

Article I of the Constitution empowers Congress

“[tlo promote the Progress of Science and useful Arts,

by securing for limited Times to Authors and Inven-

tors the exclusive Right to their respective Writings

and Discoveries.” U.S. Const. art. I, § 8, cl. 8. A pat-

ent gives an inventor “the exclusive right to practice

[an] invention for a period of years.” Bonito Boats,

Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 151

(1989). But the granting of such rights is only a

means to “promot[ing] the Progress of ... useful

Arts.” “(T]he ultimate goal of the patent system is to

bring new designs and technologies into the public

domain through disclosure.” bid.

The Federal Circuit’s decision below seriously

undermines this goal. By giving preclusive effect to

disclosures of new inventions in an previously issued

19

patent, the Federal Circuit’s decision discourages

inventors from making such disclosures in the first

place. As the four judges who dissented from the

denial of rehearing below noted, “there is no dispute

that Lilly would be entitled to a separate patent on

the anticancer use if Lilly had not included the

disclosure of anticancer use in the specification of the

continuation-in-part filed the same day” as Lilly’s

826 patent application. Pet. App. 140a. By limiting

Lilly to one patent for two inventions, the decision

below effectively penalizes Lilly for having described

the anticancer use in a copending application. The

lesson for future patent applicants is simple: Always

disclose as little as possible.

That lesson rings especially true given that

inventors seeking to patent more than one invention

can never be sure about the order in which the PTO

will grant their applications. Not infrequently, an

inventor files an application for an_ invention

followed later by an application for improvements in

that invention, while the original application is still

pending. In many cases, “the course of an

application for a generic or broad invention may

legitimately take longer in its course through the

patent office than a comparatively unimportant

improvement on that invention.” Ohio Brass, 80 F.

at 727 (Taft, J.). As a result, the PTO grants the

applications out of order: The application for the

improvements issues first, and the application for

the basic invention issues second. See, e.g., Suffolk,

70 U.S. at 315-16 (involving similar facts); Century

Elec., 191 F. at 352 (same); Ohio Brass, 80 F. at 713,

717 (same).

Under the Federal Circuit’s per se rule, the later-

issued patent for the basic invention will be declared

20

invalid for double patenting because the earlier-

issued patent will invanably describe the basic

invention in the course of claiming improvements in

it. The inventor will thus be limited to one patent for

two inventions simply because the PTO granted his

applications out of order; had the PTO instead

granted his applications in the order in which they

were filed, the inventor would have received two

patents—one for each of his distinct inventions. The

Federal Circuit has therefore decided that in

circumstances involving copending applications, the

number of valid patents to which an inventor is

entitled will depend on the most arbitrary of factors:

which application the PTO grants first.

Seeking to avoid the risk of having patents for

their basic inventions declared invalid, inventors will

simply seek to patent their inventions one at a time,

thereby delaying “the Progress of ... useful Arts.”

Rather than seek to patent improvements in their

basic inventions while their original applications for

those inventions are still pending, inventors will

delay filing any improvement applications until their

original applications are granted, out of fear that the

mere description of the basic invention in a

copending improvement application could result in

an earlier-issued patent giving rise to double

patenting. In some cases, inventors may decide

never to reveal their later-discovered improvements.

The practical effect of the decision below will thus be

to discourage inventors from promptly filing

applications to patent new inventions and

discoveries. This delay in disclosure will, in turn,

harm innovation overall. For not only will inventors

be unwilling to practice their new inventions while

other of their applications are still pending before

the PTO, but they will be unable to learn from, and

9]

improve upon, the inventions of others that would

have otherwise been disclosed in the absence of the

Federal Circuit’s rule.2

The per se rule announced by the decision be-

low—that whenever a patent describes an invention,

it renders a later-issued patent claiming that inven-

tion invalid—will serve only to undermine disclosure

and innovation, the touchstones of a well-functioning

patent system. As this Court has noted, the adoption

of “categorical rules” carries the danger of “wide-

ranging and unforeseen impacts.” Bilski v. Kappos,

130 S. Ct. 3218, 3229 (2010); see also KSR Int'l Co. v.

Teleflex Inc., 550 U.S. 398, 415 (2007) (“rejecting the

rigid approach” of the Federal Circuit to the question

of obviousness under 35 U.S.C. § 103); eBay Inc. v.

MercExchange, L.L.C., 547 U.S. 388, 394 (2006)

(holding that the Federal Circuit “erred in its cate-

gorical grant” of permanent injunctive relief). But

that danger may be at its zenith where, as here, the

categorical rule threatens the careful balance of

competing interests secured by a judicially created

~ Although the terms of patents resulting from applications

filed today are measured from their application filing dates

rather than from their patent issue dates, see Uruguay Round

Agreements Act, Pub. L. No. 103-465, sec. 532, § 154(a)(2), 108

Stat. 4809, 4984 (1994) (codified at 35 U.S.C. § 154(a)(2)), the

decision below will still have the effect of causing inventors to

seek to patent their inventions one at a time. Because the

terms of patents for basic inventions are frequently increased,

see 35 U.S.C. §§ 154(b), 156, inventors will still be discouraged

from filing copending applications for new improvements, given

the risk under the Federal] Circuit’s rule that a shorter-termed

patent for new improvements will render a longer-termed pat-

ent for the basic invention invalid. See In re Fallaux, 564 F.3d

1313, 1319 (Fed. Cir. 2009).

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