Opposition Brief — Vanderbilt University v. ICOS Corp.

37

ZF

No. 10-412

IN THE

Siyneme Court of the United States

VANDERBILT UNIVERSITY,

Petitioner,

Vv.

ICOS CORPORATION,

Respondent.

ON PETITION FOR A WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

BRIEF IN OPPOSITION

THOMAS I. ROSS

Counsel of Record

KEVIN M. FLOWERS

MATTHEW C. NIELSEN

MARSHALL GERSTEIN

BORUN LLP

233 South Wacker Drive

6300 Willis Tower

Chicago, IL 60606

(312) 474-6300

tross@marshallip.com

AL EA AERTS LEN TLE AE IE IGS SI ey He

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

QUESTIONS PRESENTED

|. Whether the lower courts were correct in re

jecting Petitioner’s request to add its scientists as co-

inventors on patents under 385 U.S.C. § 256, where the

district court found that Petitioner’s theory regarding

its scientists’ alleged contribution to the inventions,

when compared to the contrary account established by

the patent owner, was at best only “equally plausible.”

2. Whether a court of appeals may affirm a dis-

trict court’s judgment on an alternative ground sup-

ported by the record.

(i)

CORPORATE DISCLOSURE STATEMENT

[COS Corporation is a wholly-owned subsidiary of

[eli Lilly & Company, which is publicly traded.

(11)

TABLE OF CONTENTS

Page

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CORPORATE DISCLOSURE STATEMENT............. ii

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A. Dr. Daugan’s Invention Of The Pat-

ented Compounds.....................+. ‘caueesuiecsheaaetien ean 4

B. Proceedings in the District Court .........0............ 7

C. Proceedings in the Court of Appeals ............... 11

REASONS FOR DENYING THE PETITION .......... 13

I. THE STANDARD OF PROOF IS Nor QOur-

COME-DETERMINATIVE AND DOES NOT

I 13

A. This Case Is An Unsuitable Vehicle

Because Reversal On The Question

Presented Cannot Alter The Outcome ............ 14

B. Even If This Case Were A Suitable Vehi-

cle, The Clear-And-Convincing-Evidence

Standard For Correction-Of-Inventorship

Claims Would Not Merit Review ...................... 21

Il. AN APPELLATE COURT’S AUTHORITY TO

AFFIRM ON AN ALTERNATIVE GROUND

SUPPORTED By THE RECORD IS SETTLED,

PARTICULARLY WHERE THE DISTRICT

CouRT HAS MADE THE NECESSARY SUP-

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TABLE OF AUTHORITIES

CASES

Page(s)

ACEquip Ltd. v. American Engineering Corp.,

SEG Ol BBE Ca i inccicielocscisoess ects 26

Abuelhawa v. Uniied States, 129 S. Ct. 2102

Acme Highway Products Corp. v. D.S. Brown

Co., 431 F.2d 1074 (6th Cir. 1970), cert. de-

webanel, GPR TF Te. Te CRB hiccsccccecvisscrscenesecommsssesatsnns 21, 23

Amax Fly Ash Corp. v. United States, 514 F.2d

SOGT TEA. Ce Fe inivititicnittinasenttheauncsee

Barth v. Gelb, 2 F.3d 1180 (D.C. Cir. 1998).................... 21

Beall v. Ormsby, 154 F.2d 663 (C.C.P.A. 1946)... 19

Beck v. Praupis, 529 U.S. 494 (QOD) cesccssvscnessesscessstsenecsass 22

Berenyt v. District Director, INS, 385 U.S. 630

CIEE D wisd:covcesepce'counevincipuceneeismcaceccemienausnababiaanmanacant 17

Berquist v. Washington Mutual Bank, 500

© ee BR CAR FED viticcnctcinissinaiiscncsiniiceiaets 26

Bowoto v. Chevron Corp., 621 F.3d 1116 (9th

RA iirc cesknncondicccuip comuiineccnatnctlcegvadsinae dunia deuntasaieccpoas 21

Brooks v. Ross, 578 F.3d 574 (7th Cir. 2009) ..............0 26

Cannon v. University of Chicago, 441 U.S. 677

Carreras v. Sajo, Garcia & Partners, 596 F.3d

Ee Ee Be tna acebhccasines cs shlciaendintapiacncniens 26

Cates v. Morgan Portable Building Corp., 780

Fee ee Rey EE pecssicsssaceoleraceascrenin 21

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TABLE OF AUTHORITIES—Continued

Concrete Pipe & Products of California, Inc. v.

Construction Laborers Pension Trust for

Southern Calrfornia, 508 U.S. 602 (1993)......

Cook Brotech Inc. v. ACell, Inc., 460 F.3d 13865

i Gs SIs oietectcvccutsincscacsieasccuann aera.

Davis v. Roberts, 425 F.3d 830 (10th Cir. 2005) ...

Deering v. Winona Harvester Works, 155 U.S.

RS ays oicttescniinn vansnan sa teivkca raves nda tancameainnees

Director, Office of Workers’ Compensation

Programs v. Greenwich Collieries, 512 US.

Be CE iatisicciseinnndonssuemeimanesaene

Eli Lilly & Co. v. Aradigm Corp., 376 F.3d

DE 0 Sra, BE sesaitbinsisstecccactsssteasstrsncevacias

Ethicon, Inc. v. U.S. Surgical Corp., 185 F.8d

Re Oe Ok Cah. RE satcsessnnkiancaceovtsnasasmnseniinn

Festo Corp. v. Shoketsu Kinzoku Kogyo Kabu-

SCE EO. SA UB. Te Ct cs ccesesissesscenencsccees

Friends of Tims Ford v. TVA, 585 F.8d 955

Gee es ts ee

Garrett Corp. v. United States, 422 F.2d 874

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Gonzales v. O Centro Espirita Beneficente

Uniao do Vegetal, 546 U.S. 418 (2006) ...........

Goodyear Atomic Corp. v. Miller, 486 U.S. 174

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Graver Tank & Manufacturing Co. v. Linde

Aw Products Co., 36 US. 271 C194) siccscscss:

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TABLE OF AUTHORITIES— “Continued

Page(s)

Green v. CSX Transportation, Inc., 414 F.3d

FCT Ci Be cicsisrisitieaesmariaticnsiucioon 26

Hess v. Advanced Cardiovascular Systems,

Inc., 106 F.3d 976 (Fed. Cir. 1997)............... 17, 23, 25

Impax Laboratories, Inc. v. Aventis Pharma-

ceuticals Inc., 468 F.3d 1366 (Fed. Cir.

BT sacik ccs tksniscepsiscilideasenaan a ee 27

Jaffke v. Dunham, 352 U.S. 280 (1957) weecceecccseessseeeee 3, 25

Kimberly-Clark Corp. v. Procter & Gamble

Instributing Co., 973 F.2d 911 (Fed. Cir.

BUF ssn caxstsesediacssesdsguetasscaciotia nen tae 19

Koziara v. City of Casselberry, 392 F.8d 1302

CRE, Be iieitesiccsciuenccceponnnainztuicnen 26

Levin v. Septodont Inc., 34 F. App’x 65 (4th

Oe, BE isiscxisactscnisiceeatccmsieclassnuntadeauens nee 23

Merck & Co. v. Reynolds, 130 8. Ct. 1784 (2010)......3, 22

Miles v. Apex Marine Corp., 498 U.S. 19 (1990)........... 22

Monsanto Co. v. Kamp, 269 F. Supp. 818

Sa ED csncccaterascatinehsarciiedisiesatesrenenraeeiane 23

Morgan Stanley Capital Group Inc. v. Public

Utility District No. 1 of Snohomish

County, 128 S. Ct. 2733 (2008) ...c.scccceccssesecssseeeesseeeee 26

North Star Steel Co. v. Thomas, 515 U.S. 29

5 SLIT A IEE CII ARTA RMIO Re RID Chto Ps 22

Pointer v. Six Wheel Corp., 177 F.2d 153 (9th

es I isicdssaiissaiecsncdsicstuderincrsiuee saa a2

Price v. Symsek, 988 F.2d 1187 (Fed. Cir. 1998)........... 16

Vii

TABLE OF AUTHORITIES—Continued

Pullman-Standard v. Swint, 456 U.S. 2738

el oe sbsananscportentinnensey

Schaffer ex rel. Schaffer v. Weast, 546 U.S. 49

artnet oars Cuda end ass uadtiaasaagieaienecatnnss

Serrano v. Francis, 345 F.3d 1071 (9th Cir.

EEE ea RE EE ol ne

Shelton v. Kennedy Funding, Inc., 622 F.3d

Be CURE CAE, oss sscssdiceessssscaseesacnsiensceneasocennss

Shepard v. United States, 544 U.S. 13 (2005).......

Shum v. Intel Corp., 499 F.3d 1272 (Fed. Cir.

SF RRS ORS ORF ROS OM Re RT PO Pe er

Siegert v. Gilley, 500 U.S. 226 (1991).................

Sommerville v. United States, 376 U.S. 909

(_. SRPRANERPRERS aeaster SoS EN NOOR PS RE AAC Aa nO

Stern v. Trustees of Columbia University in

City of New York, 434 F.3d 13875 (Fed. Cir.

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T.I.M.E. Inc. v. United States, 359 U.S. 464

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The Barbed Wire Patent, 143 U.S. 275 (1892)......

Thigpen v. Roberts, 468 U.S. 27 (1984)...........0..2..

Tourscher v. McCullough, 184 F.3d 236 (3d Cir.

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Trovan, Ltd. v. Sokymat SA, 299 F.3d 1292

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United States v. Hasan, 609 F.3d 1121 (10th

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TABLE OF AUTHORITIES—Continued

Page(s)

United States v. Johnston, 268 U.S. 220 (1925)....0.00..... 17

United States v. Smith, 395 F.2d 516 (4th Cir.

ESET RnR BOE IO aL OE eR IN FOREN E RNE 26

United States v. Sommerville, 324 F.2d 712 (8d

a os amamaadiianaeiaesmeatcneasacsetens 15

W.L. Gore & Associates, Inc. v. Garlock, Inc.,

TS ete Be Ci EE, Cee, BID wtenececesstnnciasensésneceeesnasss 27

Watson v. United States, 552 U.S. 74 (2007) .............3, 23

DOCKETED CASES

D.S. Brown Co. v. Acme Highway Products

Gee, FE, Fil EE CU) oo Pecenicsrsersincocssnsissecsssnsasrnnscsscns 21

Microsoft Corp. v. 141 Ltd. Partnership, No. 10-

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STATUTES AND RULES

35 U.S.C.

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OTHER AUTHORITIES

1 Chisum on Patents (Nov. 2007) ..........ccccccccscccscscccscecees 24

Gressman, Eugene, et al., Supreme Court

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Lutz, Karl B., The New 1952 Patent Statute, 35

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TABLE OF AUTHORITIES—Continued

Page(s)

2 McCormick on Evidence (6th ed. 2006) ........ ee. 24

1 Mueller, Christopher B., & Laird Kirkpatrick,

Federal Evidence (8d ed. 2007) .............ccccccceeeeceeeeees 14

IN THE

Supreme Court of the United States

No. 10-412

VANDERBILT UNIVERSITY,

Petitioner,

LCOS CORPORATION,

Respondent.

ON PETITION FOR A WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

BRIEF IN OPPOSITION

INTRODUCTION

Neither of the questions presented by Petitioner

Vanderbilt University merits this Court’s attention.

Vanderbilt lost this case not because it faced a “clear

and convincing” standard of proof, but because it failed

to convince the district court that its theory based on

speculation was any more than “equally plausible”

when compared to ICOS’s contrary account based on

evidence. Pet. App. 82a. There is no need for this

Court to review a case where, as here, the question

presented will have no effect on the outcome. Vander-

bilt’s petition should be denied.

2

1. Although the question this Court will review in

Microsoft Corp. v. 141 Ltd. Partnership (No. 10-290)—

the appropriate standard of proof for claims of patent

invalidity over prior art references not submitted to

the Patent Office—bears some resemblance to Vander-

bilt’s first question presented, this Court’s review of 747

does not warrant granting or even holding Vanderbilt’s

petition, for at least two reasons.

First, and critically, the Federal Circuit’s disposi-

tion of this case was manifestly correct regardless of

what standard of proof is applied. As the district court

found, and Vanderbilt does not deny, the record con-

tains a complete “lack of evidence” supporting Vander-

bilt’s argument on several essential points. Pet. App.

79a-80a n.50. The district court accordingly held that,

at the very most, Vanderbilt’s speculative theory of

events was “equally plausible” when compared to

[COS’s contrary account based on the evidence. /d.

82a. That finding is dispositive, because it confirms

that Vanderbilt failed to prove even by a preponder-

ance of the evidence that its scientists should be added

as co-inventors. Where, as here, the resolution of the

question presented “is irrelevant to the ultimate out-

come of the case before the Court, certiorari may be

denied.” Gressman et al., Supreme Court Practice

§ 4.4(f), at 248 (9th ed. 2007).

Second, even were this Court to conclude in 747 that

a preponderance-of-the-evidence standard applies to

invalidity challenges based on prior art references not

submitted to the Patent Office, that would not compel

application of a similar standard in the correction-of-

inventorship context of this case. Judicial decisions re-

quiring clear and convincing evidence in order to cor-

rect inventorship date back decades, including prior to

the 1952 enactment of the current Patent Act. Con-

-*

~~

gress’s enactment of 35 U.S.C. § 256 did not purport to

alter that common law standard, and Congress’s con-

tinued failure to disturb it demonstrates legislative ac

quiescence. See, e.g., Merck & Co. v. Reynolds, 130 S.

Ct. 1784, 1795 (2010) (“We normally assume that, when

Congress enacts statutes, it is aware of relevant judi-

cial precedent.”); Watson v. United States, 552 U.S. 74,

82-83 (2007) (prolonged congressional inaction following

judicial construction of a statute ““enhance[s| even the

usual precedential force” accorded statutory interpre-

tations (quoting Shepard v. United States, 544 U.S. 13,

23 (2005))). Congress’s approval of the clear-and-

convincing-evidence standard is confirmed by its con-

tinued refusal to revise the proof requirements in cor-

rection-of-inventorship cases. Notably, not one of the

amici supporting Microsoft’s petition in 247 has sup

ported Vanderbilt’s petition here.

2. Vanderbilt’s second question presented is also

unworthy of review. It is settled law that “[a] success-

ful party in the District Court may sustain its judgment

on any ground that finds support in the record.” Jaffke

v. Dunham, 352 U.S. 280, 281 (1957) (per curiam).

Every court of appeals has applied this rule repeatedly,

including in cases in which the district court has com-

mitted harmless legal error. Nothing in this Court’s

decision in Pullman-Standard v. Swint, 456 U.S. 273

(1982), alters that established principle of appellate re-

view, particularly where—as here—the court of ap-

peals affirms on a basis that the district court itself

adopted as an alternative ruling.

4

STATEMENT

A. Dr. Daugan’s Invention Of The Patented

Compounds

This case turns on research conducted by Dr. Alain

Daugan, a medicinal chemist at a Glaxo Wellcome Inc.

research facility in Les Ulis, France. Pet. App. 33a-36a.

In the early 1990s, Dr. Daugan invented certain chemi-

cal compounds that, along with compositions compris-

ing them and methods for using them, are claimed in

U.S. Patents Nos. 5,859,006 (the '006 patent) and

6,140,329 (the ’829 patent), both of which were assigned

to Respondent ICOS Corporation. The parties “agree

that Dr. Daugan was the first to conceive” the claimed

compounds. /d. 23a.

The specific compounds Dr. Daugan invented pro-

vide for increased relaxation of smooth muscle tissue,

resulting in the widening of blood vessels (vasodilation)

and increased blood flow. Pet. App. 34a. The com-

pounds, known as “PDE5 inhibitors,” inhibit the func-

tion of an enzyme called phosphodiesterase V

(“PDE5”), which would otherwise break down a cyclic

nucleotide called cyclic guanosine monophosphate

(“cGMP”). When not broken down, cGMP activates an-

other protein called cGMP kinase, which causes smooth

muscle tissue to relax. /d.

The net effect of PDES inhibitors is srnooth-muscle

relaxation and increased blood flow. Pet. App. 34a. As

a result, PDE5 inhibitors can be effective in treating

erectile dysfunction (“ED”). Jd. 3a. One of the com-

pounds Dr. Daugan invented, tadalafil, became the ac-

tive ingredient in Cialis®, one of the world’s best-

selling drugs for the treatment of ED.

Tadalafil and the other claimed compounds that Dr.

Daugan invented are tetracyclic (2.e., four-ringed)

3)

molecules that comprise a particular three-ringed sub-

structure known as a “beta-carboline.” Pet. App. 59a.

Dr. Daugan’s invention of tadalafil resulted from a

comprehensive chemical study between 1992 and 1994

that began with a “lead” compound that Glaxo desig-

nated GR380040x, which also had a beta-carboline sub-

structure. Jd. 60a. Dr. Richard Labaudiniére, the head

of chemistry and leader of Glaxo’s PDE5 project in

I'rance, asked Dr. Daugan to modify GR380040x, which

(along with other beta-carboline lead compounds) had

been identified at Glaxo as a potent PDE5 inhibitor. /d.

62a. Dr. Daugan then worked independently to make

structural modifications to the beta-carboline backbone

(the “seaffold”) of GR30040x.

Dr. Daugan conducted an extensive series of ex-

periments as he sought, through “trial and error,” to

create a more potent, selective, and orally effective

PDE5 inhibitor. Ct. App. J.-A. 453:19-455:17. As part of

that search, he made a series of analogs of GR30040x,

creating “several hundred[]” compounds as he strove

“to identify the best compound.” /d. 674:12-20. For

example, from June to December 1992, Dr. Daugan fo-

cused on compounds with a four-ring backbone com-

prising a three-ring beta-carboline structure linked to a

five-membered “hydantoin” ring, but these proved inef-

fective when taken orally. /d. 693:23-700:3. Dr. Daugan

then tried replacing the five-membered hydantoin ring

found in the GR30040x analogs with a six-membered

piperazinedione ring, a substitution that led to his dis-

covery of a group of compounds that he later desig-

nated “Formula (L)” in the patents-in-suit. Jd. 699:22

701:19, 2650, 7553-7562, 7517. Dr. Daugan continued

studying and altering this new family of compounds,

creating and testing scores of compounds with dispa-

6

rate chemical substituents, and by June 1993, he had

invented tadalafil. /d. 662:6-664:4, 701:7-708:22.

Dr. Labaudiniére explained his initia] identification

of GR30040x as a “lead” compound, testifying without

contradiction that his attention was drawn to two other

beta-carbolines, designated CC128002 and GR35273,

because scientific literature and a separate Glaxo pro-

ject had described them as inhibiting PDE5. Ct. App.

J.A. 470:7-471:4. Dr. Labaudiniére searched Glaxo’s

chemical-compound database for compounds with simi-

lar substructures and discovered potential candidates

for further research, including GR30040x. Jd. 470:7-25,

967. This unchallenged account was confirmed by tes-

timony from Dr. Daugan and two experts, as well as by

minutes from Glaxo meetings and Glaxo France’s con-

temporaneous 1992-1993 Annual Report. Pet. App.

65a-69a; Ct. App. J.A. 2639-2699.

Dr. Daugan and Glaxo first sought patent protec-

tion for tadalafil and the other claimed compounds in

1994, when Glaxc filed a U.K. patent applieation. A

U.S. patent application was filed under the Patent Co-

operation Treaty in 1995, issuing as the ’006 patent in

1999. A second U.S. patent application directed specifi-

cally to the use of tadalafil to treat ED was filed in 1996

and issued as the ’329 patent in 2000. The relevant pat-

ent claims are directed to particular chemical com-

pounds, pharmaceutical compositions comprising those

compounds, and methods for using those compounds.

Pet. App. 34a-36a. The rights in these inventions had

previously been assigned to ICOS. Id. 7a, 34a.

In 2002, [COS obtained approval to market tadala-

fil as the active ingredient in Cialis®, a commercial ED

drug. In 2007, ICOS was acquired by Eli Lilly & Com-

pany.

7

B. Proceedings in the District Court

On July 20, 2005, years after Dr. Daugan obtained

his patents and well after Cialis® became a commercial

success, Petitioner Vanderbilt University sued [COS

under 35 U.S.C. § 256, alleging that three of its profes-

sors—Dr. Jackie D. Corbin, Dr. Sharron H. Francis,

and Dr. Sekhar R. Konjeti—should be added to the

patents-in-suit as joint inventors with Dr. Daugan. Pet.

App. 2a.

The district court held a bench trial on Vanderbilt’s

correction-of-inventorship claim. Vanderbilt did not

contend that its professors had conceived tadalafil; the

parties agreed that Dr. Daugan alone had done so. Pet.

App. 28a. The Vanderbilt professors acknowledged

that they had never had any contact with Dr. Daugan:

Dr. Corbin admitted that he “never met Dr. Daugan,”

had no “direct connection with Dr. Daugan,” had “never

worked together with Dr. Daugan to solve any kind of a

problem,” and was “working independently” from Dr.

Daugan. Ct. App. J.A. 386:4-387:5. Dr. Konjeti simi-

larly admitted that he “didn’t know that Dr. Daugan

existed” and “never had any collaboration” with him.

Id. 595:16-28. The record contains no evidence or sug-

gestion that either the professors or Vanderbilt ever

filed any application claiming inventorship of any com.

pounds comprising a beta-carboline substructure, and

certainly not tadalafil or any of the other compounds

claimed in the ’006 patent.

The evidence also showed that the Vanderbilt pro

fessors had no inkling that the beta-carboline com-

pounds Dr. Daugan was studying could even be used as

PDE5 inhibitors. Pet. App. 79a (citing Vanderbilt’s

written responses to ICOS’s Requests for Admission).

Dr. Corbin admitted that he “didn’t know that anyone

8

in the world was working on beta-carboline compounds

to make PDE-5 inhibitors” in 1992 or 1993, and he

“didn’t think of using beta-carboline compounds” at

that time. Ct. App. J.A. 383:3-14. Dr. Konjeti similarly

admitted that he “didn’t know that beta-carboline com-

pounds could inhibit PDE,” was not aware of the struc-

ture of the compounds claimed in the patents, and

“hadn’t thought of any methods for making the ... com-

pounds claimed in the patents.” Jd. 592:5-593:20,

594:16-595:2. Accordingly, Vanderbilt likewise filed no

patent applications directed to the uses of such com-

pounds claimed in the 329 patent.

Instead of allegations as to conception of the com-

pounds and uses at issue, Vanderbilt rested its claim to

joint inventorship on a highly attenuated “theory” or

“hypothesis.” Pet. App. 72a, 73a, 82a. Specifically,

Vanderbilt ventured that a non-beta-carboline PDE5

inhibitor its professors identified—a compound known

as 8-(4-hydroxy phenylthio)-isobutylmethylxanthine,

designated an “IBMX analog”—led to Dr. Daugan’s in-

vention of the beta-carboline compounds claimed in the

patents. /d. 36a. Vanderbilt’s theory involved a com-

plex chain of hypothetical events, none of which was

supported by evidence. Indeed, Vanderbilt admitted

that it had “no direct evidence to support its view of the

facts,” but took the position that it “‘need not prove

specifically how [its version of events] occurred, but

simply how it logically could have occurred.” Pet. App.

17a; see also id. 73a.

Vanderbilt’s theory was that Dr. Daugan’s discov-

ery of tadalafil resulted from the Vanderbilt professors’

recognition of potent PDE5 inhibition by the IBMX

analog (which was not a beta-carboline). The profes-

sors had included their finding regarding the IBMX

analog in a January 3, 1992 research funding proposal

9

sent to Dr. Barry Ross, a scientist at Glaxo U.K. Pet.

App. 5a. On April 8, 1992, Dr. Ross forwarded the pro-

posal to a group including Dr. Labaudiniére. /d. 6a. At

that point, Vanderbilt’s theory departed the realm of

evidence and rested entirely on speculation. Vander

bilt contended, without evidentiary support, that (1)

Dr. Labaudiniére immediately read the proposal; (2) he

somehow recognized four unidentified “structural fea

tures” of Vanderbilt’s [BMX analog that were purport-

edly central to its inhibition of PDE5; and (8) he used

some of those “features” to inform the database search

that led him to identify GR30040x, which he then di-

rected Dr. Daugan to research. /d. 73a-75a. Alterna-

tively, Vanderbilt argued (4) that Dr. Daugan himself

learned of the Vanderbilt professors’ disclosure of the

IBMX analog, and (5) used some of that IBMX analog’s

features to guide his modification of GR30040x, which

eventually led to his invention of the patented com-

pounds. /d. 75a-76a.

As mentioned, Vanderbilt had no direct evidence

for its speculative chain of events. Indeed, the features

that it argued Dr. Labaudiniére utilized and conveyed

to Dr. Daugan--which it now refers to as “Vanderbilt

Structural Features’”—were not identified as being

necessary or sufficient for improving the potency of any

PDE5 inhibitor in any contemporaneous document, in-

cluding the January 1992 proposal or any other internal

Vanderbilt documents. Ct. App. J.A. 423:11-425:3,

756:5-12, 763:13-765:19, 843:14-847:3, 1881-1836. Indeed,

prior to an expert report and testimony in this case (2d.

418:6-24), Vanderbilt had never referred to these ele-

ments as a related set of features in any communication

to Glaxo. Nor did Vanderbilt name these elements the

“Vanderbilt Structural Features” until after the trial

had finished—the first such mention appeared in Van-

10

derbilt’s post-trial brief. Dkt. No. 149 at 22 (D. Del.

Feb. 25, 2008).

ICOS countered Vanderbilt’s speculation with ex-

tensive evidence, including contemporaneous docu-

ments and undisputed testimony from fact and expert

witnesses, all of which showed that the Vanderbilt pro-

fessors’ research had no influence on either Dr. La-

baudiniére or Dr. Daugan. As for Vanderbilt’s first

theory, unrebutted testimony showed that Dr. La-

baudiniére (1) did not conduct his search for beta-

carboline compounds based on the supposed “Vander-

bilt Structural Features”; (2) would not have conducted

such a search because it would have been scientifically

unsound and impractical; and (3) would not have dis-

covered GR30040x by performing the search as Van-

derbilt conjectured. Ct. App. J.A. 488:21-489:12, 470:7-

471:4, 942:16-24. Indeed, Dr. Labaudiniére’s unrebut-

ted testimony showed that he did not know about Van-

derbilt’s research until June 1998--months after Dr.

Daugan conceived the claimed compounds. /d. 438:21

439:12, 7369.

Regarding Vanderbilt’s alternative theory that Dr.

Daugan himself knew of and was influenced by the

Vanderbilt professors’ IBMX analog, Dr. Daugan pro-

vided direct and unchallenged testimony that, before

the lawsuit, he had never (1) seen any document writ-

ten by the Vanderbilt professors, (2) seen the results of

any experiment they conducted, (8) discussed their

work with anyone, (4) known anything about their re-

search, or (5) been influenced by any theory based on

the “structural features” of an IBMX analog. Ct. App.

J.A. 668:17-669:4. Rather, Dr. Daugan explained that

his effort was an independent, extensive empirical re-

search study based on trial and error, explicitly stating

that “no information and no one influenced [him] in the

1]

design and conception of the [claimed] compounds.” /d.

674:6-7; see also id. 658:17-659:3, 660:5-9, 660:22-661:21,

674:3-20, 677:13-684:6, 693:19-708:17. Finally, Dr. Dau-

gan testified that, even if he had known that the IBMX

analog was a potent PDE5 inhibitor, that would not

have helped him design the claimed beta-carboline

compounds, because the two different kinds of com-

pounds had no relevant structural similarity. /d. 673:1-

11; see also id. 7516-7542.

The district court ruled that Vanderbilt failed to

prove that Drs. Corbin, Francis, or Konjeti were inven-

tors of either the ’006 or ’329 patents. Pet. App. 3la-

83a. The court articulated two reasons for rejecting

Vanderbilt’s correction-of-inventorship claim. F rst,

the court ruled that there was “no evidence that [tne

Vanderbilt professors] ever conceived the ‘specific

chemical structure of the compound’ claimed,” a matter

the court deemed dispositive under binding precedent.

Id. 7T9a-80a n.50. Second, the court noted the “lack of

evidence” supporting Vanderbilt’s theory that Dr. La-

baudiniére communicated any of Vanderbilt’s “struc-

tural features” to Dr. Daugan. /d. 79a n.50. As for how

Dr. Labaudiniére identified GR30040x, while the court

criticized [COS’s position in some respects (7d. 80a-81a),

its ultimate conclusion was that both parties’ accounts

were “equally plausible with respect to the identifica-

tion of GR380040x.”: Id. 82a.

C. Proceedings in the Court of Appeals

The Federal Circuit affirmed on the second basis

articulated by the district court. As to the first basis,

the court of appeals accepted Vanderbilt’s argument

that a co-inventor need not have “an independent men-

tal picture of the complete compound claimed”; it suf-

ficed that “a group of co-inventors must collaborate and

12

work together to collectively have a definite and per-

manent idea of the complete invention.” Pet. App. 22a.

However, the court of appeals affirmed based on

the district court’s finding that the parties’ accounts of

the identification of the GR30040x compound—which,

though not claimed in the patents, was the linchpin of

Vanderbilt’s theory of co-inventorship—-were “‘equally

plausible” and that “Vanderbilt failed to produce any

evidence of joint invention of tadalafil.” Pet. App. 23a.

Accordingly, the court ruled that, “under the correct

legal test, Vanderbilt did not carry its burden. Thus,

any erroneous interpretations of our case law were

harmless error.” J/d.; see also id. 19a (“These errors,

however, do not affect the outcome of this appeal and

are therefore harmless in context. When tested by the

correct law, the facts of the case still require affir-

mance.”).

Judge Dyk concurred in part and dissented in part.

Judge Dyk agreed that the evidence supported the dis

trict court’s ruling that Dr. Daugan “did not himself di-

rectly utilize the Vanderbilt scientists’ contributions.”

Pet. App. 26a. Judge Dyk maintained, however, that

the court “could not have properly found that the Van-

derbilt scientists made a contribution to the identifica-

tion of GR380040x if it were ‘equally plausible’ that they

did not make a contribution.” /d. 28a. Alternatively,

Judge Dyk believed that the district court’s opinion

could be read as irretrievably “tainted” by its legal er-

ror that a joint inventor was required to conceive the

entire claimed invention. /d. 28a-29a.

The Federal Circuit denied Vanderbilt’s petition

for rehearing and rehearing en banc. Pet. App. 86a-87a.

13

REASONS FOR DENYING THE PETITION

I. THE STANDARD OF PROOF IS NOT OUTCOME-

DETERMINATIVE AND DOES NOT MERIT REVIEW

Vanderbilt’s attempt to hitch its wagon to this

Court’s grant of certiorari in 247 depends on ignoring

Vanderbilt’s failure to convince either the district court

or the court of appeals that its theory of events based

on speculation was any more plausible than [COS’s ac-

count of the invention based on evidence. Even if this

Court were to grant certiorari, receive merits briefs,

hear oral argument, and reverse the Federal Circuit’s

application of a “clear and convincing” standard of

proof, the outcome would be exactly the same: a judg-

ment that Vanderbilt failed to carry its burden, because

the district court found that Vanderbilt’s theory was no

more than “equally plausible” compared to ICOS’s ac-

count. Pet. App. 82a. The Court is rightly disinclined

to review cases in which reversal will not affect the ac-

tual controversy between the parties, and it should not

make an exception here.

Additionally, the Federal Circuit’s settled require-

ment that a putative co-inventor must adduce clear and

convincing evidence of inventorship in order to prevail

under 35 U.S.C. § 256 is correct. The statute simply

codified preexisting common law on the matter, which

Congress has never abrogated. Regardless of the out-

come in 742, there is no reason to reconsider the stan-

dard of proof in correction-of-inventorship cases—an

issue on which the Court has previously denied certio-

rari.

14

A. This Case Is An Unsuitable Vehicle Because

Reversal On The Question Presented Cannot

Alter The Outcome

Although the clear-and-convincing-evidence stan-

dard was invoked below to reinforce Vanderbilt’s fail-

ure to support its theory with evidence, the courts be-

low could and—based on their express statements—

would have reached the very same result under a pre-

ponderance standard. As the district court and the

court of appeals majority recognized, Vanderbilt’s the-

ory was at most “equally plausible” when compared to

the account [COS supported with evidence. Pet. App.

23a, 82a. It is settled—-and Vanderbilt does not dis-

pute—that “when the evidence is evenly balanced, the

[burdened party] must lose.” Dnrector, Office of Work-

ers’ Compensation Programs v. Greenwich Collieries,

512 U.S. 267, 281 (1994); see also Gonzales v. O Centro

Espirita Beneficente Uniao do Vegetal, 546 U.S. 418,

428 (2006) (government failed to carry its burden where

the evidence was “in equipoise”’); Concrete Pipe &

Prods. of Cal., Inc. v. Construction Laborers Pension

Trust for S. Cal., 508 U.S. 602, 622 (1993) (preponder-

ance-of-the-evidence standard requires “the trier of

fact to believe that the existence of a fact is more prob-

able than its nonexistence before [it] may find in favor

of the party who has the burden” (emphasis added; in-

ternal quotation marks omitted)).'

' Vanderbilt does not dispute the proposition that, even under

a preponderance standard, it would still bear the burden of proof

as the party seeking to change the status quo. See, e.g., Schaffer

ex rel. Schaffer v. Weast, 546 U.S. 49, 57-58 (2005) (“Absent some

reason to believe that Congress intended otherwise, ... the burden

of persuasion les where it usually falls, upon the party seeking

relief.”); 1 Mueller & Kirkpatrick, Federal Evidence § 3.1, at 104

15

This Court generally does not grant certiorari to

resolve legal issues that will not affect the outcome of

the case in which they arise. See, e.g., Gressman et al.,

Supreme Court Practice § 4.4(f), at 248 (9th ed. 2007)

(citing Sommerville v. United States, 376 U.S. 909

(1964)).* That practice is sound, as the fact that the de-

cision below ultimately did not turn on the issue pre-

sented raises the question whether the issue is disposi-

tive in any case, or at least arises sufficiently fre-

quently to merit this Court’s intervention.

Although Vanderbilt cites the number of amicus

briefs supporting the petition in 747 (Supp. Br. 2), it is

notable that not one amicus supported Vanderbilt’s pe-

tition here, nor did any of the 747 briefs suggest that the

Court should alter the longstanding requirement of

clear and convincing evidence in correction-of-

inventorship cases. Indeed, a Section 256 plaintiff must

corroborate his or her own testimony with objective

evidence—a common-law requirement of proof that

Vanderbilt accepts as proper under the statute, while

recognizing that it is “unique[]” to the correction-of-

inventorship context. Pet. 20. Yet the independent

corroboration requirement in correction-of

inventorship cases is closely linked to the requirement

(3d ed. 2007) (“Perhaps the broadest and most accepted idea is that

the person who seeks court action should justify the request,

which means that the plaintiffs bear the burdens on the elements

in their claims.”).

In Sommerville, the circuit panel was divided as to whether

liability was governed by state or federal law, and the courts of

appeals were similarly divided, but the disagreement was theo-

retical because the defendant would have been liable under either

approach. United States v. Sommerville, 324 F.2d 712, 714, 717

n.16 (3d Cir. 1963); see also id. at 720 (Steel, J., concurring).

16

of clear and convincing evidence. See, e.g., The Barbed

Wire Patent, 143 U.S. 275, 284 (1892) (holding that tes-

timony in patent cases is often “unsatisfactory” and re-

quiring proof that is “clear, satisfactory, and beyond a

reasonable doubt”); Deering v. Winona Harvester

Works, 155 U.S. 286, 300, 301 (1894) (“grave suspicion”

regarding testimony requires “evidence so cogent as to

leave no reasonable doubt in the mind of the court that

the transaction occurred substantially as stated”); T’ro-

van, Ltd. v. Sokymat SA, 299 F.3d 1292, 1802 (Fed. Cir.

2002) (“To meet the clear and convincing burden of

proof, alleged co-inventors must prove their contribu

tion to the conception with more than their own testi-

mony|[.]”); Price v. Symsek, 988 F.2d 1187, 1194 (Fed.

Cir. 1993) (claims to priority or derivation are “re

garded with skepticism,” so that “without some type of

corroborating evidence, an alleged inventor’s testimony

cannot satisfy the ‘clear and convincing evidence’ stan-

dard”). Here, of course, Vanderbilt provided no evi-

dence, let alone corroboration, of its theory that Dr.

Daugan’s invention of tadalafil was somehow influenced

by the Vanderbilt professors’ work with the IBMX ana-

log.

’ Vanderbilt states in a footnote that documentary evidence

corroborated the Vanderbilt professors’ discovery of the 1IBMX

analog. Pet. 21 n.5. But the patents at issue do not claim the

IBMX analog; rather, they claim tadalafil and other beta-carboline

compounds. As the courts below held, no direct evidence corrobo-

rates Vanderbilt’s speculation that its professors had any role

whatsoever in Dr. Daugan’s conception of the claimed beta-

carboline compounds. Pet. App. 17a. Vanderbilt’s failure to pro-

vide corroboration for its claims of co-inventorship provides an

independent basis for affirmance, further counseling against a

grant of review.

17

To be sure, the opinions below framed Vanderbilt’s

failure of proof in terms of a lack of “clear and convince

ing evidence” (Pet. App. 23a, 82a n.53), but that is un

derstandable in light of the precedent that bound both

courts. E.g., Hess v. Advanced Cardiovascular Sys.,

Inc., 106 F.3d 976, 979-980 (Fed. Cir. 1997). Neverthe

less, the finding that the evidence regarding the identi-

fication of GR30040x was in equipoise would manifestly

compel the same conclusion under a preponderance

standard.

Vanderbilt has precious little to say about the ef-

fect of the finding that its theory was only “equally

plausible” compared to ICOS’s account (Pet. App.

82a)—other than to contend that the district court’s

finding was error, supposedly because the court failed

to consider certain evidence (Pet. 10). But the court of

appeals implicitly rejected that argument when it com-

plimented the district court for its “thorough review of

all of the evidence.” Jd. 18a; see also id. 23a (citing the

district court’s “careful review of the evidence”).

Whether the district court did or did not consider par

ticular evidence—and whether the court of appeals cor

rectly found no error—is a case-specific factual deter

mination that does not warrant this Court’s review.

See S. Ct. R. 10 (certiorari is “rarely granted” when the

petition asserts “erroneous factual findings”); United

States v. Johnston, 268 U.S. 220, 227 (1925) (Holmes, J.)

(“We do not grant a certiorari to review evidence and

discuss specific facts.”). Certiorari is particularly un-

warranted where, as here, “the findings of fact made by

the district court receive the concurrence of the court

of appeals.” Gressman, § 4.14, at 271; see also Berenyt

v. strict Dir., INS, 385 U.S. 680, 635 (1967) (following

the “Court’s repeated pronouncements” against re-

viewing factual findings that were “reached by the Dis-

1s

trict Judge and accepted by the Court of Appeals”);

Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 336

U.S. 271, 275 (1949) (“A court of law, such as this Court

is, rather than a court for correction of errors in fact

finding, cannot undertake to review concurrent findings

of fact by two courts below in the absence of a very ob-

vious and exceptional showing of error.”).

Vanderbilt also claims that the district court “found

that Vanderbilt’s scientists contributed to the process

through which Dr. Daugan invented the compounds.”

Pet. 11 (emphasis added) (citing Pet. App. 80a). But a

contribution to the “inventive process” (Pet. App. 80a)

is not the same as a contribution to the conception of

the invention itself. See, e.g., Ethicon, Inc. v. U.S. Sur-

gical Corp., 135 F.3d 1456, 1460 (Fed. Cir. 1998) (“Be-

cause conception is the touchstone of inventorship, each

joint inventor must generally contribute to the concep-

tion of the invention.” (alteration and internal quotation

marks omitted)). The district court accordingly cited a

case that expressly distinguished between significant

“contributions to conception” on the one hand and “pro-

saic contributions to the inventive process that do not

render the contributor a co-inventor” on the other. Ali

Lilly & Co. v. Aradigm Corp., 376 F.3d 1352, 1359 (Fed.

Cir. 2004) (emphasis added) (cited at Pet. App. 80a).

The court specifically ruled that the Vanderbilt scien

tists’ contributions to Dr. Daugan’s “inventive process,”

if any, were of the second “prosaic” kind. Pet. App.

80a. Indeed, the parties agreed that Dr. Daugan, and

Dr. Daugan alone, conceived tadalafil and the other

claimed compounds. /d. 23a.

Moreover, as the court of appeals correctly ruled,

the district court’s ultimate finding, reviewing the evi-

dence in full, was that even Vanderbilt’s theory as to

the identification of GR30040x—which was at most a

19

“prosaic” step in Dr. Daugan’s “inventive process,” not

itself an inventive contribution—was itself no more

than “equally plausible.” Pet. App. 23a, 82a. The panel

majority ruled that the principal finding that the par-

ties’ accounts were “equally plausible” compelled a find-

ing that Vanderbilt failed to carry its burden—a de-

termination that would stand under a preponderance

test as well. Vanderbilt may well disagree with that

view, but the interpretation of a particular trial court

opinion in a particular case does not warrant this

Court’s intervention.

Vanderbilt has no other path to relief in this case.

The panel was unanimous—and Vanderbilt does not

seriously dispute—that there was no evidence (let

alone a preponderance) that the Vanderbilt professors

collaborated with Dr. Daugan himself, which would

have required an “open line of communication during ...

[the named inventor’s] inventive efforts,” Cook Biotech

Inc. v. ACell, Inc., 460 F.3d 1365, 1373 (Fed. Cir. 2006)

(internal quotation marks omitted), as well as “some

element of joint behavior.” Kimberly-Clark Corp. v.

Procter & Gamble Distrib. Co., 973 F.2d 911, 917 (Fed.

Cir. 1992) (“Individuals cannot be joint inventors if they

are completely ignorant of what each other has

done[.]”). As the court of appeals noted, there was no

evidence of any collaboration here. Pet. App. 16a-19a;

see also id. 26a (Dyk, J., concurring in part and dissent-

ing in part) (agreeing with panel majority in upholding

the district court’s finding that Dr. Daugan “did not

himself directly utilize” the Vanderbilt professors’

work). And Vanderbilt does not dispute that disclosure

to a company like Glaxo is insufficient to establish dis-

closure to an individual inventor. See Beall v. Ormsby,

154 F.2d 663, 665-666 (C.C.P.A. 1946).

20

Thus, Vanderbilt’s only route to success was to

prove (1) that Dr. Labaudiniére searched for and found

GR30040x based on his knowledge of Vanderbilt’s

IBMX analog and (2) that the identification of

GR30040x was in fact an inventive (and not a “prosaic’’)

contribution to the conception of tadalafil. But as the

court of appeals found, Vanderbilt’s case failed on the

first point. There was “no clear error in the district

court’s factual findings underpinning its determination

regarding Glaxo’s identification of GR380040x” (Pet.

App. 18a), given Vanderbilt’s failure to offer anything

more than attorney argument to support its claim in

the face of “direct evidence supporting Dr. La-

baudiniere’s claim to sole identification of GR30040x”

(id. 17a). Even viewing ICOS’s evidence with skepti-

cism, the district court found that Vanderbilt’s case did

not surpass “equall]” plausibility. Jd. 82a. And on the

key question whether the Vanderbilt scientists “com-

municated to Glaxo a compound of the general struc-

ture of [the compounds! of the patents at issue,” Van-

derbilt’s presentation was “devoid of evidence.” 7d.

79a. Thus, Vanderbilt’s claim was properly rejected no

matter what standard of proof applied.

As is discussed in the following section, the Court

should not reassess the settled standard of proof appli-

cable in correction-of-inventorship cases under Section

256. But even if the Court were interested in embark-

ing on such a venture, this case is not a suitable vehicle

for it. Merits review in this case would be a moot court

that would unnecessarily squander Court and party re-

sources. If the issue is as important as Vanderbilt in-

21

sists it is, the Court can await a case in which it might

6 4

actually make a difference.

B. Even If This Case Were A Suitable Vehicle,

The Clear-And-Convincing-Evidence Standard

For Correction-Of-Inventorship Claims Would

Not Merit Review

Even if Vanderbilt’s Section 256 claim could suc

ceed under a preponderance standard—and it cannot—

the Federal Circuit’s decades-long jurisprudence that

such claims require clear and convincing evidence is

correct and should not be upset. The Court should

therefore decline to review the issue, just as it has be-

fore. Pet. for Cert. 12, D.S. Brown Co. v. Acme High-

way Prods. Corp., No. 70-1140 (U.S. Dec. 21, 1970) (con-

tending that the court of appeals “erred ... in its ruling

that joint inventorship must be proven by clear and

convincing evidence”), cert. denied, 401 U.S. 956 (1971).

Vanderbilt’s primary argument for certiorari in

this case is that claims under Section 256 are exactly

the same as all other civil claims. Pet. 21. But Section

256 was not enacted in a vacuum. Rather, it was part of

* Vanderbilt is wrong to suggest (Pet. 22-23) that an error re-

garding the standard of proof can never be harmless. See, e.g.,

Bowoto v. Chevron Corp., 621 F.3d 1116, 1124 (9th Cir. 2010) (af-

firming where “any difference in the burden of proof’ would be

“immaterial under the circumstances of this case”). Indeed, courts

of appeals have affirmed even where the district court has placed

the burden on the wrong party. E.g., Barth v. Gelb, 2 F.3d 1180,

1189 (D.C. Cir. 1993) (“Viewing the evidence through the lens of

those findings, we conclude that it was not so closely balanced that

the court’s error in assigning the burden of persuasion to Mr.

Barth would have affected the outcome.”); Cates v. Morgan Port-

able Bldg. Corp., 780 F.2d 683, 688 (7th Cir. 1985) (“The judge’s

error about who had the burden of proof was harmless.”).

99

rs

the 1952 Patent Act, which-—among other things—-

codified several preexisting patent law doctrines. F.g.,

Lutz, The New 1952 Patent Statute, 35 J. Pat. Off. Soc’y

155, 156 (1953) (“Congress ... codified some doctrines of

patent law that were developed in the courts by ‘com-

mon law’ processes.”). The requirement of clear and

convincing evidence predated the 1952 Act by at least

three years. See Pointer v. Six Wheel Corp., 177 F.2d

1538, 157 (9th Cir. 1949) (“{I]t must appear by clear and

convincing proof that the two inventors collaborated in

evolving the patented device.”). Congress is presumed

to legislate on the background of that doctrine—a prin-

ciple Vanderbilt does not appear to contest with re-

spect to the requirement of independent corroboration

of inventorship evidence. Pet. 20-21; see Abwelhawa v.

United States, 129 S. Ct. 2102, 2106 (2009) (“legislatures

act with case law in mind,” so that Congress is pre-

sumed to be familiar with “traditional judicial” ap-

proaches); Beck v. Prupis, 529 U.S. 494, 501 (2000)

(Congress “presumably knows and adopts the cluster of

ideas that were attached” to statutory terms, so that

the “absence of contrary direction may be taken as sat-

isfaction with widely accepted definitions, not as a de-

parture from them” (internal quotation marks omit-

ted)); North Star Steel Co. v. Thomas, 515 U.S. 29, 34

(1995) (“[I]t is not only appropriate but also realistic to

presume that Congress was thoroughly familiar with

[our] precedents ... and that it expect[s] its enactments

to be interpreted in conformity with them.” (quoting

Cannon v. University of Chi., 441 U.S. 677, 699

(1979)).°

> Accord, e.g., Merck & Co. v. Reynolds, 130 8. Ct. 1784, 1795

(2010) (citing cases); Miles v. Apex Marine Corp., 498 U.S. 19, 32

23

Decisions in several circuits have articulated the

clear-and-convincing standard under the 1952 Act,° yet

Congress has never sought to alter that settled re-

quirement, despite remaining “free to alter what

[courts] have done.’”” Watson v. United States, 552 U.S.

74, 82 (2007). In 1984, Congress amended the definition

of a joint inventor in Section 116, expressly referencing

lower court decisions. Pet. App. 10a (noting that the

1984 amendments codified the principles of Monsanto

Co. v. Kamp, 269 F. Supp. 818 (D.D.C. 1967)). Those

amendments made it easier to become a joint inventor,

by recognizing for example joint inventors who did not

physically work together, but Congress elected not to

relax the uniformly-applied standard of proof in correc-

tion-of-inventorship cases. “The responsibility for

changing [settled law] rests with Congress,” Festo

Corp. v. Shoketsu. Kinzoku Kogyo Kabushiki Co., 5385

(1990) (Congress “must have intended to incorporate” the estab-

lished judicial “gloss” because “Congress is aware of existing law

when it passes legislation”); Goodyear Atomic Corp. v. Miller, 486

U.S. 174, 184-185 (1988) (“We generally presume that Congress is

knowledgeable about existing law pertinent to the legislation it

enacts.”); T.1.M.E. Inc. v. United States, 359 U.S. 464, 474 (1959)

(Supreme Court “cannot assume [Congress] was unaware” of a

common law decision relevant to its establishment of a statutory

scheme).

E..g., Hess, 106 F.3d at 980; Acme Highway Prods. Corp. v.

D.S. Brown Co., 431 F.2d 1074, 1083 (6th Cir. 1970) (“[I]t has been

well established that joint inventorship must be proven by clear

and convincing evidence.”); Garrett Corp. v. United States, 422

F.2d 874, 880 (Ct. Cl. 1970) (“The burden of showing misjoinder or

nonjoinder of inventors is a heavy one and must be proved by clear

and convincing evidence”); see also Levin v. Septodont Inc., 34 F.

App’x 65, 70 (4th Cir. 2002) (party seeking to correct patent’s list

of inventors “must prove that claim by clear and convincing evi-

dence”).

U.S. 722, 739 (2002), and Congress has declined to make

the change that Vanderbilt seeks.’

In its supplemental brief, Vanderbilt belatedly at-

tempts to liken its case te 242, which involves the appli

cability of a clear-and-convincing-evidence standard in

invalidity challenges based on prior art not placed be-

fore the Patent Office. See Pet. for Cert. i, Microsoft

Corp. v. 741 Ltd. P’ship, No. 10-290 (U.S. Aug. 27, 2016).

But as Vanderbilt recognizes, eleven amicus briefs

supported Microsoft’s petition for certiorari, emphasiz-

ing the claimed frequency with which the standard of

proof may be dispositive in invalidity cases. By con-

trast, not one amicus has supported Vanderbilt’s peti-

tion in this case or even suggested that it raises a ques-

tion of significant importance. As shown in the preced-

ing section, even this case does not turn on the issue."

’ Clear and convincing evidence is additionally appropriate

because claims under 35 U.S.C. § 256 are equitable in nature,

Shum v. Intel Corp., 499 F.3d 1272, 1277 (Fed. Cir. 2007), and

plaintiffs seeking equitable relief have historically had to prove

factual contentions by clear and convincing evidence. See 2

McCormick on Evidence § 340 & n.15, at 488 (6th ed. 2006) (citing

cases). In fact, one authoritative commentator has questioned

whether Section 256 creates an independent cause of action at all,

given that the statutory language does not purport to do so. See 1

Chisum on Patents § 2.04(7], at 2-142 (Nov. 2007) (finding the exis-

tence of federal jurisdiction under Section 256 “highly question-

able, both in terms of the statutory language of Section 256 and of

policy”).

; Although the use of a clear-and-convincing standard to

prove co-inventorship has been linked to the presumption of valid-

ity, see, e.g., Stern v. Trustees of Columbia Univ. in City of N.Y.,

434 F.3d 1375, 1877 (Fed. Cir. 2006), the standard is supported by

other “important policy considerations”—most notably countering

the temptation for aspiring co-inventors to reconstruct their prior

No matter how 242 is resolved, the outcome in this

case will be the same, because Vanderbilt failed to

prove that its professors are entitled to be named co-

inventors by even a preponderance, and clear and con-

vincing evidence is 4 longstanding common law stan-

dard that Congress has implicitly approved and never

disturbed. There is no need, and certainly no pressing

need, for this Court to review Vanderbilt’s first ques-

tion presented.

Il. AN APPELLATE COURT’S AUTHORITY TO AFFIRM ON

AN ALTERNATIVE GROUND SUPPORTED BY THE RE-

CORD IS SETTLED, PARTICULARLY WHERE THE DISs-

TRICT COURT HAS MADE THE NECESSARY SUPPORT-

ING FINDINGS

Vanderbilt’s second question presented is almost

an afterthought, and understandably so: it attempts to

discard a settled doctrine that this Court and every cir-

cuit have articulated countless times, namely that an

appellate court “may affirm on any ground that the law

and the record permit.” Thigpen v. Roberts, 468 U.S.

27, 30 (1984); see also, e.g., Jaffke v. Dunham, 352 U.S.

280, 281 (1957) (per curiam) (“A successful party in the

state of mind and inflate their contributions, “particularly where,

as here, the patent has been outstanding for a considerable time

and the patented device has been successful.” Hess, 106 F.3d at

980 (citing Amax Fly Ash Corp. v. United States, 514 F.2d 1041,

1047 (Ct. Cl. 1975)). These considerations have particular force in

this case, where scientists came forward years after the patents

issued to assert—without evidence—joint inventorship of a highly

successful cornmercial product.

26

District Court may sustain its judgment on any ground

. "9 -

that finds support in the record.”).

Here, the Federal Circuit’s affirmance was all the

more justified because it rested on a basis that the dis-

trict court itself accepted. As the panel majority ex

plained, the district court “did not rest its opinion

solely” on the interpretation of the law of inventorship

that the Federal Circuit held erroneous. Pet. App. 23a.

Rather, the district court—-like the Federal Circuit—-

separately ruled that Vanderbilt failed to carry its bur-

den to show that its professors contributed to the con-

ception of the claimed compounds, because its specula-

tive theory of events regarding the identification of the

unclaimed GR30040x compound was only “equally plau-

sible” when compared to ICOS’s evidence. /d. 23a, 82a.

That finding sufficed to support the judgment, and the

Federal Circuit was fully entitled to affirm on that ba-

sis notwithstanding disagreeing with the district

court’s alternative ground of decision. See, e.g., Morgan

Stanley Capital Group Inc. v. Public Util. Dist. No. 1

of Snohomish County, 128 S. Ct. 2733, 2749 (2008) (af-

firming “on alternative grounds,” despite “significant

disagreement” with the lower court); Sregert v. Gilley,

” Accord Carreras Vv. Sajo, Garcia & Partners, 596 F.3d 25, 36

(Ist Cir. 2010); Shelton v. Kennedy Funding, Inc., 622 F.3d 943,

952 (8th Cir. 2010); Friends of Tims Ford v. TVA, 585 F.3d 955, 964

n.2 (6th Cir. 2009); Brooks v. Ross, 578 F.3d 574, 578 (7th Cir.

2009); Berquist v. Washington Mut. Bank, 500 F.3d 344, 349 (5th

Cir. 2007); United States v. Smith, 395 F.2d 516, 519 (4th Cir.

2005); Davis v. Roberts, 425 F.3d 830, 834 (10th Cir. 2005); Green v.

CSX Transp., Inc., 414 F.3d 758, 765 (7th Cir. 2005); Koziara v.

City of Casselberry, 392 F.3d 13802, 1306 n.2 (11th Cir. 2004);

ACEquip Ltd. v. American Eng’g Corp., 315 F.3d 151, 155 (2d Cir.

2003); Serrano v. Francis, 345 F.3d 1071, 1076-1077 (9th Cir. 2003);

Tourscher v. McCullough, 184 F.3d 236, 240 (8d Cir. 1999).

27

500 U.S. 226, 234-235 (1991) (affirming even though the

court of appeals misread precedent, because “[b]y a dif-

ferent line of reasoning, we reach the same conclu-

sion’).

The alternative ground of decision, which is sup-

ported by the evidence and findings of record, amply

distinguishes this case from Pullman-Standard v.

Swint, 456 U.S. 273 (1982). As Vanderbilt acknow]-

edges, the district court in Pullman-Standard had

failed to make findings on a matter that the Fifth Cir-

cuit held was legally relevant (a union’s intent in an

employment discrimination suit). Rather than remand

to allow the district court “to make the missing find-

ings,” the Fifth Circuit made those findings itself, set

aside the district court’s factual finding of no discrimi-

natory intent, and reversed the district court’s decision.

Id. at 275, 282-284, 291. This Court disapproved that

practice because Federal Rule of Civil Procedure 52(a)

“requires that findings of fact not be set aside unless

clearly erroneous.” /d. at 287; see also id. at 293. While

a remand is indeed preferable where, as in Pullman-

Swint and the other cases Vanderbilt cites, the court of

appeals’ reversal on a legal issue implicates factual mat-

ters on which no finding was made," those rulings do

10 “~ °O eT

See Impax Labs., Inc. v. Aventis Pharms. Inc., 468 F.3d

1366, 1383 (Fed. Cir. 2006) (remanding for a determination that

had “not yet been done,” because “the district court stopped its

analysis”); 7'rovan, 299 F.3d at 1310 (remanding because the dis-

trict court “did not completely address” claim construction issues);

W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1547

(Fed. Cir. 1983) (“the invention set forth in each claim was not in

each instance considered as a whole,” and “the references were not

assessed in their entireties”); see also United States v. Hasan, 609

F.3d 1121, 1129 (10th Cir. 2010) (remanding where district court

28

not speak to this case, where the court of appeals af-

firmed on an alternative ground that remains unaf-

fected by the legal ruling.

Here, the Federal Circuit did not make any new

findings, set aside findings made by the district court,

or reverse the district court’s judgment. Rather, it af-

firmed on a ground that the trial court itself articulated

and supported with its finding that Vanderbilt failed to

carry its burden of proof (even by a preponderance).

Thus, this is not a case in which the court of appeals

“attempt{ed] to reach its own factual findings” or

“usurpled] ... a trial court’s role in weighing evidence

against the appropriate legal standard.” Pet. 25. Ra-

ther, the district court’s finding of evidentiary equi-

poise was independent of its approach to inventorship

law, and the panel majority affirmed that finding as

based on “a careful review of the evidence.” Pet. App.

23a. That finding compelled affirmance, even under

Vanderbilt’s desired standard of proof."

failed to undertake the first step in a “two-step, sequential in-

quiry’”).

Notably, three of the four cases Vanderbilt cites as applying

the correct rule are from the Federal Circuit, which suggests ei-

ther that Vanderbilt’s supposed conflict does not exist or that it

may be resolved by further percolation within the Federal Circuit.

'' Since Vanderbilt’s second question is presented independ-

ently of its first, it is properly considered on the basis that the

Federal Circuit and district court correctly applied the clear-and-

convincing-evidence standard. But even if a preponderance stan-

dard applied, the district court’s findings still compel the same re-

sult. See supra Part I.A.

2

CONCLUSION

The petition for a writ of certiorari should be de

nied.

Respectfully submitted

‘THOMAS IL. ROSS

Counsel of Record

KEVIN M. FLOWERS

MATTHEW C. NIELSEN

MARSHALL GERSTEIN

30RUN LLP

233 South Wacker Drive

6300 Willis Tower

Chicago, IL 60606

(312) 474-6300

tross@marshallip.com

DECEMBER 2010