# Amicus Curiae Brief — Duke University v. Madey

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URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386015_0969%3A08

## Record

- **Collection:** Supreme Court brief
- **Document type:** Amicus Curiae Brief
- **Published:** January 1, 2003
- **Citation:** 538 U.S. 959

## Text

‘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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386015_0969%3A08. Public record. Not legal advice.