Amicus Curiae Brief — Duke University v. Madey

‘Supreme Court, U.S.

(3) FILED

No. 02-1007 JAN 29 2003

Supreme Court of the Bnited States

DUKE UNIVERSITY,

Petitioner,

V.

JOHN M.J. MADEY,

Respondent.

On Petition for a Writ of Certiorari to the

United States Court of Appeals

for the Federal Circuit

BRIEF FOR ASSOCIATION OF AMERICAN

MEDICAL COLLEGES, ET AL., AS AMICI CURIAE

IN SUPPORT OF PETITIONER

JOSEPH A. KEYES, JR. KEITH A. JONES

ASSOCIATION OF AMERICAN Counsel of Record

MEDICAL COLLEGES BECK, REDDEN & SECREST

2540 N Street, N.W. 1221 McKinney Street

Washingto :, D.C. 20037 Houston, TX 77010

(202) 828-0555 (713) 951-3700

WILSON-EPES PRINTING Co., INC. — (202) 789-0096 — WASHINGTON, D.C. 20001

QUESTION PRESENTED

Whether universities are precluded from asserting the

federal common law experimental use exemption from

liability for patent infringement merely because their

scientific research programs serve legitimate educational

purposes.

* The thiry-one amici curiae are listed in the Appendix, infra.

(i)

rr enees

TABLE OF CONTENTS E

Page

EPRI ESe FAME MREOUREY ESD) sissies casesvsnsssusvessscicandovosvoons i

DEE FOE 8 TIRE TTIED insewsnecvesnsevessasensiacovonevsenics iv

INTEREST OF THE AMICI CURIAE ......c.cccccccsccseseeees l

IEE UNNI ssh] sos cbuaniedeshnigeiinieansonsnvnaeesicis rience 3

SUMMARY OF ARGUMENT ...........cccccscsccsscssescseeees 4

IT alin dcctssihntniissasernsstasenbiciniecesnaieaniciessunsns 5

A. The Experimental Use — Exemption

Historically Has Protected Noncommercial

Research From Claims Of Patent

eg ER EL TATE EAE 5

B. The Decision Of The Federal Circuit In This

Case Radically Departs From Prior Law By

Denying The Experimental Use Exemption

To All Academic Scientific Research, Even

When That Research Is Manifestly

III cai soincnctkiisissseisiecnicivenduvaisacectinennks 8

C. The Decision Below Will Have A Significant

Chilling Effect On Academic Scientific

Research, Especially In Biotechnology And

oii ss lenis cernanneniibannohonos 1]

D. This Court Should Grant Review To Restore

The Federal Common Law Experimental Use

Exemption To Its Traditional Role As A Safe

Haven For Noncommercial Scientific Inquiry. 16

I iiledicia teeihuenichs cdincetepiinnssiditinsiesanasdoninn 18

APPENDIX: LIST OF AMICI CURIAE.........c..cccc00000 la

(iii)

iV

TABLE OF AUTHORITIES

CASES Page

Chesterfield v. United States, 159 F. Supp. 371

a SOI stissnniotiniinisanchaadebciaisinnlelieieapabapeitategl 6

Eli Lilly & Co. v. Medtronic, Inc., 872 F.2d 402

(Fed. Cir. 1989), aff'd, 496 U.S. 661 (1990) ..... 7

Embrex, Inc. v. Service Engineering Corp., 216

Fe ADS CEE, FA, Bee iinticseiesnreinnssnvecieennness 7

Holmes Group, Inc. v. Vornado Air Circulation

Systems, Inc., 122 S.Ct. 1889 (2002)................. 17

Madey v. Duke University, 307 F.3d 1351 (Fed.

Gi SIU 0 scchinitinctaninenesncchiasiaanataieeignamitionalensiniibiees 9,17

Pitcairn v. United States, 547 F.2d 1106 (Ct. Cl.

1976), cert. denied, 434 U.S. 1051 (1978)......... 10

Roche Products, Inc. v. Bolar Pharmaceutical

Co., 733 F.2d 858 (Fed. Cir. 1984)... ee 6, 7,.43

Ruth v. Stearns-Roger Mfg. Co., 13 F. Supp. 697

(D. Colo. 1935), rev’d on other grounds, 87

Pe Oo CEG CP DED titivcenscvsnvtionseeicibintealan 6

Whittemore v. Cutter, 29 F. Cas. 1120 (C.C.D.

NG, SUPE Paciseivessenttcddiceressceeveventllith 0 CSM SS: x C 5, 9

UNITED STATES CONSTITUTION |

FE TIN © citi ince nsceicciniisevtncsincinbiins» 6, 18

STATUTES

Drug Price Competition and Patent Term

Restoration Act of 1984, 35 U.S.C. § 271 (e)..... 7

FEDERAL REGISTER

G4 Fed. Reg, TZ0F0 CISG9) ..ncssccocesssersesssonsitancsoneee 13, 14

Vv

TABLE OF AUTHORITIES—Continued

MISCELLANEOUS Page

E. Barash, “Experimental Uses, Patents, and

Scientific Progress,” 91 Nw. U. L. Rev. 667

CUD Ui iniuctiniiincdshcnsancieigntbeaicdlahdeasibeiainliasensanca das 11, 13

L. Bruzzone, “The Research Exemption: A

Proposal,” 21 AIPLA Q. J. 52 (1993)............00. 9,13

R. Eisenberg, “Patents and the Progress of

Science: Exclusive Rights and Experimental

Use,” 56 U. Chi. L. Rev. 1017 (1989)............... 3, 13

R. Eisenberg, “Proprietary Rights and the Norms

of Science in Biotechnology Research,” 97

POR BiB ETF CE Piteecereisesetacenntbenmnsaacicines 9,13

I. Feit, “Biotechnology Research and _ the

Experimental Use Exception to Patent

Infringement,” 71 J. Pat. & Trademark Off.

SOS yy BED CT asc civisivisdscicaicBascisiacdeivccscentet 6, 12, 14

R.. Hantman, “Experimental Use as an Exception

to Patent Infringement,” 67 J. Pat. &

Trademark Off. Soc’y 617 (1985). ....... eee 7

M. Heller & R. Eisenberg, “Can Patents Deter

Invention? The Anticommons in Biomedical

Research,” 280 Science 698 (1998)......... 11, 12, 14, 15

S. Michel, “The Experimental Use Exception to

Infringement Applied to Federally Funded

Inventions,” 7 High Tech. L. J. 369 (1992)....... yA

J. Mueller, “No ‘Dilettante Affair’: Rethinking

the Experimental Use Exception to Patent

Infringement for Biomedical Research Tools,”

76 Wash. L. Rev. 1 (2001)................. 5-6, 7, 14, 15-16

National Science Foundation, Science and

Engineering Indicators 2002 (2002).............+0+ 2

vi

TABLE OF AUTHORITIES—Continued

Note, “Universities Ask Supreme Court to

Reverse Patent Ruling,” 299 Science 26

CORRIIREY 2, AEE vvsinavacsusnttengurneiappiancthuatiiiliiies

M. O’Rourke, “Toward a Doctrine of Fair Use

in Patent Law,” 100 Colum. L. Rev. 1177

CR i nsienslivsctisimtsvseinnessinveilasaiiiintlilinleliainiilatiandilihliint

M. Thayer & R. De Liberty, “The Research

Exemption to Patent Infringement: The Time

Has Come for Legislation,” 4 J. Biolaw &

SG. FC cc esntiolacenvisensiendiaencipiaveeniaiitiatin

J. Walsh, A. Arora, and W. Cohen, “The

Patenting and Licensing of Research Tools and

Biomedical Innovation,” in National Academy

of Sciences, Patents in the Knowledge-Based

BOORGHES CE covtnvnssensenricnncipitanaliliniaiedaliaes

Page

6,9

IN THE

Supreme Court of the Gnited States

No. 02-1007

DUKE UNIVERSITY,

Petitioner,

Ve

JOHN M.J. MADEY

Respondent.

On Petition for a Writ of Certiorari to the

United States Court of Appeals

for the Federal Circuit

BRIEF FOR ASSOCIATION OF AMERICAN

MEDICAL COLLEGES, ET AL., AS AMICI CURIAE

IN SUPPORT OF PETITIONER

INTEREST OF AMICI CURIAE '

Amici curiae represent universities whose faculties engage

in scientific research. They consist of the Association of

American Medical Colleges, whose membership includes

125 medical schools, nearly 400 teaching hospitals and health

systems, and 92 academic societies with an aggregate indi-

' The following representations are made pursuant to Sup. Ct. R. 37:

The parties have consented to the filing of this brief; no counsel for either

party authored any portion of this brief; no persons other than amici

curiae made any monetary contribution to the preparation or submission

of this brief.

2

vidual membership of approximately 100,000; the American

Council on Education, representing approximately 1800

colleges and universities and serving as a forum for consid-

eration of higher education issues of national importance; the

Association of American Universities, whose 62 members

include most of the nation’s leading public and private

research universities; the National Association of State

Universities and Land Grant Colleges, representing public

universities from all 50 states; the Council on Governmental

Relations, an association of 150 research-intensive univer-

sities devoted to maximizing the scientific benefit from

federal investment in academic research; the Association of

University Technology Managers, a non-profit organization

of approximately 3300 professionals dedicated to issues

related to technology transfer; Public Citizen, Inc., a public

interest advocacy group; the Howard Hughes Medical

Institute, which supports research conducted by faculty with

joint appointments at universities and the Institute; and the

following individual colleges, universities, and medical

schools: Baylor College of Medicine; The Regents of the

University of California; Carnegie Mellon University;

Emory University; University of Florida; Georgetown

University; The George Washington University; Iowa

State University of Science and Technology; Johns

Hopkins University; University of Kentucky; University

of Maryland; Massachusetts Institute of Technology;

Mount Sinai School of Medicine; New York University;

The University of North Carolina at Chapel Hill;

University of Pittsburgh; Rutgers, the State University of

New Jersey; University of Texas at Austin; Texas A&M

University; Vanderbilt University; University of

Washington; Washington State University; and Yale

University.

Universities spent more than $30 billion on scientific

research and development in calendar year 2000. National

Science Foundation, Science and Engineering Indicators

nn ree earner rereeti

3

2002, App. Table 5-2 (2002). The amici curiae all directly

engage in or actively support such university-based scientific

research. The decision by the Federal Circuit in this case,

however, poses a serious threat not only to the viability of

many individual academic research projects but also to the

vitality of academic scientific research generally. The amici

curiae have an obvious and very strong interest in this case

and in the reversal of the decision below.

INTRODUCTION

The Federal Circuit’s decision limiting the scope of the

common law experimental use exemption from liability for

patent infringement is of immense importance to all uni-

versities whose faculties engage in scientific research. By

effectively eliminating the exemption for even noncommer-

cial academic scientific research, the decision erects a

significant roadblock to the advancement of science. The

amici curiae are deeply disturbed by this ruling. See Note,

“Universities Ask Supreme Court to Reverse Patent Ruling,”

299 Science 26 (January 3, 2003). In the past, university-

based research has been crucial to scientific progress on

almost every front. The decision below threatens to stifle that

research and thereby endanger this nation’s continued

leadership in science and technology. The question presented

by this case is vital to the nation’s scientific wellbeing.

Universities will be forced to bear substantial adminis-

trative and financial costs to cover patent searches, infringe-

ment opinions, licensing agreements, and the inevitable

litigation that will be engendered by the Federal Circuit’s new

rule of patent law. The money diverted into such uses will no

longer be available for actual research. As a result of these

additional costs and also the associated delays occasioned by

patent searches and the negotiation of licenses, university-

based research programs will be curtailed and research

projects abandoned. In many situations patent holders are

likely to use the court’s ruling as a basis for imposing onerous

4

financial or nonfinancial licensing terms or even as a means

of barring entire lines of what they may view as potentially

competing scientific research. These developments place in

jeopardy the research plans and activities of thousands of

science graduate students and faculty researchers.

There is a serious risk that the Federal Circuit’s decision

will significantly impede this nation’s scientific progress. In

the end, the burden will be borne by the general public in its

capacity as consumer and beneficiary of the scientific

advances the patent system is intended to foster. The amici

curiae ask this Court to grant review and reverse in order to

avert the drastic consequences that otherwise can be expected

to flow from the decision below.

SUMMARY OF ARGUMENT

The experimental use exemption historically has protected

noncommercial research from claims of patent infringement;

although prior to this case there had been virtually no

litigation with respect to academic scientific research per se,

the scientific community had every reason to believe that the

exemption would protect noncommercial academic research

just as it protected other noncommercial research.

The decision below radically departs from prior law. With-

out inquiring into the commercial or noncommercial nature of

the research at issue, the Federal Circuit announced that

universities are ineligible to claim the experimental use

exemption for the paradoxical reason that the scientific

research in which they are engaged serves legitimate edu-

cational purposes. The obvious result of this ruling is to deny

the experimental use exemption with respect to all scientific

research conducted at universities and other nonprofit

research institutions, even when that research is manifestly

noncommercial.

The Federal Circuit’s holding in this case will have a

significant chilling effect on all academic scientific research,

5

and especially that in biotechnology and biomedicine.

Depriving university scientists of the experimental use

exemption will directly and significantly increase the cost of

basic research, the great majority of which is supported by

competitively awarded federal funds. In many situations, the

unanticipated need to negotiate licenses before initiating or

while in the midst of research projects may forestall or

seriously disrupt ongoing research. In some circumstances,

patent holders may refuse licenses and thus bar research from

going forward at all. The amici curiae are gravely concerned

that, if the experimental use exemption is no longer available,

the proliferation of patents on upstream tools for biotech-

nological, biomedical, and advanced electronic research

will have a very adverse effect on basic and applied down-

stream research activity at universities and other nonprofit

research institutions.

This Court should grant review to restore the federal com-

mon law experimental use exemption to its traditional role as

a safe haven for noncommercial scientific inquiry.

ARGUMENT

A. The Experimental Use Exemption Historically Has

Protected Noncommercial Research From Claims

Of Patent Infringement

“(T]he courts have long recognized . . . that a purely

‘experimental use’ of a patented invention, with no com-

mercial purpose, should be exempt from infringement lia-

bility.” R. Eisenberg, “Patents and the Progress of Science:

Exclusive Rights and Experimental Use,” 56 U. Chi. L. Rev.

1017, 1018-19 (1989). This experimental use exemption,

which was first articulated by Justice Story in Whittemore v.

Cutter, 29 F. Cas. 1120 (C.C.D: Mass. 1813), serves a pur-

pose somewhat analogous to that of the fair use doctrine of

copyright law. J. Mueller, “No ‘Dilettante Affair’: Rethink-

ing the Experimental Use Exception to Patent Infringement

6

for Biomedical Research Tools,” 76 Wash. L. Rev. 1, 42-43

(2001); M. O’Rourke, “Toward a Doctrine of Fair Use in

Patent Law,” 100 Colum. L. Rev. 1177, 1192-94 (2000). The

exemption ultimately is grounded in the same constitutional

rationale as the patent system itself: scholarly freedom to use

and build upon patented advances in the course of

noncommercial scientific inquiry is of critical importance to

“the Progress of Science and useful Arts.” U.S. Const., Art 1,

Sec. 8. See I. Feit, “Biotechnology Research and the Experi-

mental Use Exception to Patent Infringement,” 71 J. Pat. &

Trademark Off. Soc’y 819, 839 (1989).

In determining the type of “experimental use” entitled to

exemption, courts historically drew the line between com-

mercial and noncommercial research. Noncommercial re-

search was protected. For example, the exemption covered

the federal government’s use of a patented alloy “for

experimental purposes.” Chesterfield v. United States, 159 F.

Supp. 371, 375 (Ct. Cl. 1958). In the only reported case

involving an academic institution (the Colorado School of

Mines) the cuurt explained that the “making or using of a

patented invention merely for experimental purposes, without

any intent to derive profits or practical advantage therefrom,

is not infringement.” Ruth v. Stearns-Roger Mfg. Co., 13 F.

Supp. 697, 713 (D. Colo. 1935), rev’d on other grounds, 87

F.2d 35 (10th Cir. 1936).

In contrast, commercial research was not protected. A

major landmark in this regard was Roche Products, Inc. v.

Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. Cir. 1984),

where the Federal Circuit held that the experimental use

exemption does not cover one pharmaceutical company’s use

of another’s patented drug for the purpose of performing tests

necessary to obtain regulatory approval of its own competing

version of the drug. The court explained, “[w]e cannot

construe the experimental use rule so broadly as to allow a

violation of the patent laws in the guise of ‘scientific inquiry,’

7

when that inquiry has definite, cognizable, and not insub-

stantial commercial purposes.” Jd. at 863. See also Embrex,

Inc. v. Service Engineering Corp., 216 F.3d 1343, 1349 (Fed.

Cir. 2000) (holding, in a patent dispute between two

commercial competitors, that the experimental use exemption

does not protect research performed “expressly for com-

mercial purposes”).

“[A]fter Roche, scientists engaged in research and devel-

opment having more than negligible commercial purpose

could no longer rely on the experimental use doctrine.” J.

Mueller, supra, 76 Wash. L. Rev. at 24. Yet with its em-

phasis on the distinction between commercial and noncom-

mercial purposes, Roche appeared to confirm that genuinely

noncommercial scientific research undertaken by university

scientists or government researchers remained protected by

the experimental use exemption. As one writer put it shortly

after Roche, “[fjew would deny the experimental use ex-

ception for research on patented technology performed at a

university in furtherance of its educational function.” R.

Hantman, “Experimental Use as an Exception to Patent

Infringement,” 67 J. Pat. & Trademark Off. Soc’y 617,

633 (1985).

Subsequent developments provided further support for the

view that traditional noncommercial scientific research falls

well within the protective scope of the experimental use

exemption. Congress, believing that Roche had improperly

narrowed the exemption, enacted the Drug Price Competition

and Patent Term Resioration Act of 1984, 35 U.S.C. § 271(e),

reversing the result in that case and thereby extending

protection even to certain specified commercial research

activities. The Federal Circuit seemingly took this to heart,

giving the new statute a broad reading in Eli Lilly & Co. v.

Medtronic, Inc., 872 F.2d 402, 405-06 (Fed. Cir. 1989), aff'd,

496 U.S. 661 (1990).

8

This history afforded university communities and patent

holders alike strong reason to believe that Justice Story’s

experimental use exemption continued to protect noncom-

mercial academic research from claims of patent infringe-

ment. A recent study, based upon “70 interviews with

personnel at biotechnology and pharmaceutical firms and

universities,” confirms that “university researchers, to the

extent that they are doing noncommercial work, are largely

left alone” and that in those rare instances when universities

received letters alleging infringement “the typical response

was effectively to ignore such letters and inform the [patent]

holder that the university was engaged in research, did not

intend to threaten the firm’s commercial interests, and would

not cease its research.” J. Walsh, A. Arora, and W. Cohen,

“The Patenting and Licensing of Research Tools and

Biomedical Innovation,” 2, 35, in National Academy of

Sciences, Patents in the Knowledge-Based Economy (2003).

B. The Decision Of The Federal Circuit In This Case

Radically Departs From Prior Law By Denying

The Experimental Use Exemption To All Academic

Scientific Research, Even When That Research Is

Manifestly Noncommercial

The Federal Circuit in this case eschewed any inquiry into

whether the research at issue was genuinely noncommercial.

Instead, the court issued a broad ruling effectively deny-

ing the experimental use exemption to all university-based

research in all circumstances.

In an opinion frankly hostile to the experimental use

exemption, the Federal Circuit essentially disavowed prior

law with its clearly drawn distinction between commercial

and noncommercial research. The court held, instead, that the

exemption is not available to nonprofit universities because

scientific research at those universities serves legitimate

educational purposes:

9

[M]ajor research universities, such as Duke, often

sanction and fund research projects with arguably no

commercial application whatsoever. However, these

projects unmistakably further the institution’s legitimate

business objectives, including educating and

enlightening students and faculty participating in these

projects. ...

In short, regardless of whether a particular institution

or entity is engaged in an endeavor for commercial gain,

so long as the act is in furtherance of the alleged in-

fringer’s legitimate business and is not solely for amuse-

ment, to satisfy idle curiosity, or for strictly philo-

sophical inquiry, the act does not qualify for the very

narrow and strictly limited experimental use defense.

Madey v. Duke University, 307 F.3d 1351, 1362 (Fed.

Cir. 2002).

This decision is both bad law and bad policy. The dis-

tinction between commercial and noncommercial research

always has been the touchstone of the experimental use

exemption. Indeed, when he first articulated the doctrine

in Whittemore Justice Story was specifically contrasting

“philosophical experiments” with “use [of the patented inven-

tion] for profit.” 29 F. Cas. at 1121. Scientific research

directed toward “educating and enlightening students and

faculty,” Madey, 307 F.3d at 1362, is exactly the sort of

activity embraced by the early nineteenth-century expression

“philosophical experiments.” L. Bruzzone, “The Research

Exemption: A Proposal,” 21 AIPLA Q. J. 52, 60 (1993).

Noncommercial academic scientific research logically lies

at the very core of the experimental use exemption. R.

Eisenberg, “Proprietary Rights and the Norms of Science in

Biotechnology Research,” 97 Yale L.J. 177, 223 (1987). Yet

the Federal Circuit appears now to have made the exemption

inapplicable to virtually all truly serious scientific research.

This creates a substantial likelihood that “the patent system

10

[will] function to thwart the very innovation that it is intended

to foster.” M. O’Rourke, supra, 100 Colum. L. Rev. at 1180.

The Federal Circuit was led astray by language in Pitcairn

v. United States, 547 F.2d 1106 (Ct. Cl. 1976), cert. denied,

434 U.S. 1051 (1978), holding that the experimental use

exemption did not apply when the government was merely

engaged in testing newly purchased helicopters to make sure

that they worked properly. There can be no quarrel with the

result in Pitcairn: routine testing of equipment is not truly

scientific research and need not be protected as “experimental

use.” In justifying that unexceptionable result, however, the

Pitcairn court explained, somewhat infelicitously, only that

the government’s use of the helicopters had been “in keeping

with the legitimate business of the using agency.” Id.

at 1125-26.

The expression “legitimate business” was seized upon by

the Federal Circuit in this case without paying due attention

to context. The Pitcairn court had employed that expression

offhandedly, as a way of indicating that the government was

not actually engaged in scientific research but rather was

simply ascertaining, before placing its helicopters in regular

use, that they were capable of being operated in the manner

intended. The Federal Circuit here misread Pitcairn, making

the inquiry focus on the relationship of the patented in-

vention’s use to the defendant’s “business” rather than on

whether that use genuinely constitutes noncommercial scien-

tific research. The court lost sight of the values furthered by

the experimental use exemption and, in doing so, constructed

an apparently absolute barrier to a claim of exemption by any

modern research university (or by any government agency or

other nonprofit organization, for that matter) engaged in the

“business” of noncommercial scientific research.

11

C. The Decision Below Will Have A _ Significant

Chilling Effect On Academic Scientific Research,

Especially In Biotechnology And Biomedicine

“{A] significant portion of scientific innovation occurs in

university, government, and private non-profit environments

” E. Barash, “Experimental Uses, Patents, and Scientific

Progress, ” 91 Nw. U. L. Rev. 667, 696 (1997). Much of

this scientific innovation results from basic research that is

directed toward the general acquisition and dissemination

of scientific knowledge and has no explicit commercial

objective.

Universities and university scientists—to the extent they

consider the issue at all—assume that their noncommercial

research is exempt. See M. Thayer & R. De Liberty, “The

Research Exemption to Patent Infringement: The Time Has

Come for Legislation,” 4 J. Biolaw & Bus. 1, 2 (2000). They

“rarely check the patent literature to determine whether their

proposed research will infringe on any patents.” E. Barash,

supra, 91 Nw. U. L. Rev. at 698. Nor are they in a position to

do so. “While corporations have legal departments geared

towards answering potential legal quagmires, universities do

not have the infrastructure to render routine opinion work to

researchers.” Jd. Universities are “ill equipped to handle

multiple transactions for acquiring licenses to use research

tools.” M. Heller & R. Eisenberg, “Can Patents Deter

Invention? The Anticommons in Biomedical Research,” 280

Science 698, 700 (1998).

The decision below works a drastic change in the legal

environment. Depriving university scientists of the experi-

mental use exemption will directly and significantly increase

the cost of basic research even when patent holders are

willing to make licenses available:

{L]icensing patented inventions used in basic research

poses special problems. The need to obtain licenses

would add significant administrative and financial bur-

12

dens to researchers in fields where patent protection is

widespread. Most research builds on prior discoveries.

If a significant number of these are patented, obtaining

licenses on each would generate mounting royalty and

transaction costs.

S. Michel, “The Experimental Use Exception to Infringement

Applied to Federally Funded Inventions,” 7 High Tech. L. J.

369, 398 (1992). The need to allocate scarce university

resources to the processing of scientifically unproductive

administrative and legal paperwork will involve a significant

diversion of funds away from educationally more important

activities, including actual scientific research.

There will be not only greater costs but longer delays in

getting research started if, indeed, patent holders permit it to

be undertaken at all. The need to obtain licenses will

constitute an initial and major hurdle in the path of many

projects. “Delays in negotiating multiple agreements to use

patented processes, reagents, and gene fragments could stifle

the creative give-and-take of academic research.” M. Heller

& R. Eisenberg, supra, 280 Science at 700.

The added cost of conducting patent searches and paying

for licenses, and the concomitant delays in launching research

projects, are not the only, and may not be the worst, problems

facing universities and their researchers in the wake of the

decision below. The unanticipated need to acquire licenses in

the midst of a project can seriously disrupt if not entirely

derail ongoing research. It simply “is not practical for

researchers to wait for a patent infringement evaluation each

time they perform a basic laboratory technique.” I. Feit,

supra, 71 J. Pat. & Trademark Off. Soc’y at 822. Research

does not follow in a straight line. One line of inquiry will

often open up an entirely new line of inquiry not con-

templated at the outset. To halt research in mid-stream for

months or years in the face of an unanticipated need to obtain

a license—or even worse, to be required to abandon the

13

research altogether upon the denial of a license—will have a

very serious deleterious effect on the competitive advantage

American universities’ research programs currently have

in the world. See R. Eisenberg, supra, 56 U. Chi. L. Rev.

at 1056.

In some circumstances, the absence of an experimental use

exemption may make it altogether impossible to undertake a

planned research project. As the National Institutes of Health

has observed, “[p]rogess in science depends upon prompt

access to the unique research resources that arise from

biomedical research laboratories throughout the government,

academia, and industry.” 64 Fed. Reg. 72090, 72093 (1999).

It follows that “intellectual property restrictions can stifle the

broad dissemination of new discoveries and limit future

avenues of research... .” Jd. at 72092. The problem is that

“some patent holders will undoubtedly object to the use of

their inventions in subsequent research and, in the absence of

an experimental use exemption, might use their exclu-

sive rights to stop valuable research from proceeding.” R.

Eisenberg, supra, 56 U. Chi. L. Rev. at 1072. This “could

undermine a critical mechanism of the scientific community

for facilitating the progress of science.” R. Eisenberg, supra,

97 Yale L.J. at 225.

Even before the decision below, many commentators were

concerned that the Federal Circuit’s emphasis in Roche on the

narrowness of the experimental use exemption “could have

significant chilling effects on research efforts.” L. Bruzzone,

supra, 21 AIPLA Q. J. at 65; see also, e.g., S. Michel, supra,

7 High Tech. L.J. at 389-90; E. Barash, supra, 91 Nw. U. L.

Rev. at 698. By effectively abolishing the experimental use

exemption for all academic scientific research, the decision

below magnifies the problem enormously. The Federal

Circuit’s opinion in this case will have a very damaging

chilling effect on all university-based scientific research.

14

This chilling effect will be felt in all scientific areas where

patent protection has been granted to intellectual advances

that may form part of the foundation for further research,

including chemistry, physics, and advanced electronics. The

problem may be at its most severe, however, in biotechnology

and biomedicine: ,

The explosion of biotechnological and biomedical

research and development in the United States in the

past twenty years, with a corresponding increase in

patenting activity, particularly in the area of genomics,

has concomitantly heightened difficulties of access to

and dissemination of patented research tools. Bur-

geoning research and development will require ever-

greater numbers of proprietary tools, giving rise to

transaction costs associated with acquiring the right

to use each tool. In some cases, the patentee may refuse

to license the research tool altogether.

J. Mueller, supra, 76 Wash. L. Rev. at 5-7. The amici curiae

are gravely concerned that the decision below will encourage

patent holders to assert claims in a manner that will impede

or altogether frustrate university scientists’ ability to make

further basic advances in critical areas of biotechnology and

biomedicine.

The past two decades have seen “a spiral of overlapping

patent claims in the hands of different owners, reaching ever

further upstream in the course of biomedical research.”

M. Heller & R. Eisenberg, supra, 280 Science at 698.

“Patented research tools” now include such things. as “cell

lines, monoclonal antibodies, reagents, animal models,

growth factors, combinatorial chemistry and DNA libraries,

clones and cloning tools.” 64 Fed. Reg., supra, at 72092 n.1.

For example, “[m]jany of the pioneering developments in

basic laboratory methods necessary for recombinant DNA

experiments have been patented.” I. Feit, supra, 71 J. Pat. &

Trademark Off. Soc’y at 820.

15

Many patents in the field of biotechnology do not cover

products or even methods but are essentially informational in

nature, covering such matters as anonymous gene fragments

and protein crystalline coordinates. See, e.g., M. Heller & R.

Eisenberg, supra, 280 Science at 699. For example, patents

have been granted on the identification of “small segments of

complimentary DNA [that] have no presently known utility

[but] are believed to be useful as probes in searching for

corresponding full-length genes.” J. Mueller, supra, 76

Wash. L. Rev. at 13-14. The inability to work with such

information could blunt the promise of the remarkable

achievement of the Human Genome Project by crippling

follow-on basic research in fields such as genomics and

proteomics (the study of proteins and their functions within

the cell) and significantly impair academic research-

ers’ ability to achieve important new breakthroughs in bio-

medical science.

The magnitude of the problem is suggested by recent

action taken by Hoffman-La Roche Corporation (“Roche”)

with respect to its patents over the thermostable enzyme

Thermus aquaticus YT1 DNA polymerase (“Taq”) and poly-

merase chain reaction (“PCR”). Taq is a basic biotechnology

tool “widely used in DNA sequencing.” J. Mueller, supra, 76

Wash. L. Rev. at 2. PCR is “the revolutionary DNA

amplification process that utilizes Taq.” /d. at 3. In 1995,

Roche accused more than forty U.S. universities and

research institutes (including Harvard, Stanford, Massa-

chusetts Institute of Technology, the Salk Institute, the

Scripps Research Institute, and the National Cancer

Institute) and more than 200 individual scientists of

infringing these patents. . . . Roche officials professed no

concern about the use of Taq for ‘pure research’

purposes, but stated that they felt compelled to take

16

action against those scientists engaged in what Roche

termed ‘highly practical’ research with potential profit-

making potential. —

Id. Roche and other similarly situated patentees may be

emboldened by the decision below to extend their aggressive

patent enforcement to noncommercial “pure research” as

well. See id. (“a Roche spokesperson . . . warned that she

‘wouldn’t want to predict what action Roche would take

relative to any patent . . . in the future’”). This poses a major

threat to the continued vitality of noncommercial academic

biotechnological and biomedical research programs.

This nation has benefited enormously in the past from

noncommercial academic scientific research, as more dis-

coveries and greater understanding of the unknown have

pointed toward and facilitated commercial research leading to

new and socially beneficial products and applications. The

Federal Circuit’s decision threatens to retard this process

significantly. Even before the decision below, there was

grave concern in the scientific and public policy communities

that “the proliferation of patents on ‘upstream’ basic tools of

biotechnological and biomedical research will stymie the

development of . . . downstream application{s].” J. Mueller,

supra, 76 Wash. L. Rev. at 7. The denial of experimental use

protection for noncommercial academic scientific research

will make a difficult situation much worse.

D. This Court Should Grant Review To Restore The

Federal Common Law _ Experimental Use

Exemption To Its Traditional Role As A Safe

Haven For Noncommercial Scientific Inquiry

This Court should grant the petition for certiorari and hold

that universities are not precluded from asserting the experi-

mental use exemption merely because their research pro-

grams serve legitimate educational purposes.

17

The issue clearly is important. Respondent may argue,

however, that certiorari should be denied because there is no

conflict among the circuits and the matter is interlocutory. In

the circumstances of this case, those factors do not genuinely

militate against review.

The Federal Circuit has exclusive appellate jurisdiction

over cases arising under federal patent law. 28 U.S.C.

§ 1295(a)(1). Thus there is and will be no conflict among the

circuits on the reach of the experimental use exemption. But

this does not mean that this Court should defer to the Federal

Circuit’s presumed expertise and leave standing the harmful

and misguided ruling below. As Justice Stevens recently

noted, “decisions by courts with broader jurisdiction will

provide an antidote to the risk that the specialized court

may develop an institutional bias.” Holmes Group, Inc. v.

Vornado Air Circulation Systems, Inc., 122 S.Ct. 1889, 1898

(2002) (concurring). This case presents an issue of federal

common law that is too important to be left to a specialized

patent court; this Court, with its broader perspective, should

intervene to resolve the issue.

Although the case nominally is interlocutory, there is

nothing further to be done on remand with respect to the

experimental use exemption. The Federal Circuit has noted

that Duke University’s scientific research projects “unmis-

takably further the institution’s legitimate business objectives,

including educating and enlightening students and faculty”

and has held that any act “in furtherance of the alleged

infringer’s legitimate business . . . does not qualify for the

very narrow and strictly limited experimental use defense.”

Madey, 307 F.3d at 1362. As a practical matter, that fore-

closes Duke from asserting the experimental use defense on

remand. Moreover, even if on remand Duke were to prevaii

on other grounds, the Federal Circuit’s ruling with respect to

experimental use still would stand as the radically new and

disruptive law of the land.

18

As long as it does remain standing, the Federal Circuit’s

ruling will raise serious concerns and cause serious harm to

American universities, to the academic scientific research

community, and to “the Progress of Science and useful Arts.”

U.S. Const., Art 1, Sec. 8. The case warrants immediate

plenary review.

CONCLUSION

The petition for a writ of certiorari should be granted.

Respectfully submitted,

JOSEPH A. KEYES, JR. KEITH A. JONES

ASSOCIATION OF AMERICAN Counsel of Record

MEDICAL COLLEGES BECK, REDDEN & SECREST

2540 N Street, N.W. 1221 McKinney Street

Washington, D.C. 20037 Houston, TX 77010

(202) 828-0555 (713) 951-3700

January 2003