Amicus Curiae Brief — eBay Inc. v. MERCEXCHANGE, LLC

j ] Supreme Court, U.S.

iss i riLeo

¥2/ war 1 0 2006

No. 05-130 | ormor: OF THE CLERK

IN THE

Supreme Court of the United States

EBAY AND HALF.CoM, INC.,

Petitioners,

Vv.

MERCEXCHANGE, L.L.C.

Respondent.

On Writ of Certiorari to the

United States Court of Appeals

for the Federal Circuit

BRIEF OF BIOTECHNOLOGY INDUSTRY

ORGANIZATION AS AMICUS CURIAE. -

IN SUPPORT OF RESPONDENT

BRIAN P. BARRETT NANCY J. LINCK

Chair, Counsel of Record

BIOTECHNOLOGY INDUSTRY BIOTECHNOLOGY INDUSTRY

ORGANIZATION ORGANIZATION

Amicus Committee 1225 Eye Street, NW

EL! LILLY AND COMPANY Washington, DC 20005

Lilly Corporate Center (202) 962-6668

Indianapolis, Indiana 46285

(317) 276-7243

ES AT

WIiLSON-EPES PRINTING CO., INC. — (202) 789-0096 - WaSHINGTON,D.C.20001 ~

TABLE OF CONTENTS

FORT ET sigs stiicistniiariinbicininicctmninnanmvipinindsinnies

THE RIGHT TO INJUNCTIVE RELIEF 1S

VITAL IN ENSURING INNOVATION IN

THE BIOTECHNOLOGY INDUSTRY ...........

A. The Risks of the Biotechnology Industry

Require a Patent System that Adequately

Protects the Investment Necessary to Bring

IE Oy IO ersieciccsvnsiinicinsiiescctennnmeiiion

B. The Patent System Represents a Careful

Balance Between Providing Incentives

for Investment and Protecting the Public

OU scitsciihdincnesntincsceptiiicividnntirabiohasjicishistnsionininian

THE PATENT HOLDERS HAVE LONG

HAD THE GENERAL RIGHT TO OB-

TAIN AN INJUNCTION FOR PATENT

SITY © sttenceiessetiniennimataniuiabebenicninicinis

A. The Historical Basis for Injunctive Relief

Confirms is General Applicability in

PE TE ccciscodinsnnntinintertinmnntianiniennninets

B. This Court and the Federal Circuit Have

Correctly and Consistently Protected a

Patentee’s Exclusive Rights Through In-

junctive Relief, Absent Exceptional

REID aa See PURER SETS TOOT

(i)

10

10

14

il

TABLE OF CONTENTS—Continued

Page

C. Exclusive Patent Rights Are Enforceable

Via the General Right to Injunctive Relief

Even When A Valid Patent Covers A

Single Cotaponent of A Multi-Component

I cceviiehdtisociiniiaspeseeenineniedanmmensneiabtaniianinds 15

Ill. BIOTECH INNOVATION WOULD BE

FRUSTRATED IF THIS COURT CREATED

AN EXCEPTION TO THE RIGHT TO

INJUNCTIVE RELIEF WHEN THE

PATENT HOLDER DOES NOT USE THE

SIE aT sccvacesasnnisssbiinieiiiconsianntiientennaiiniehtinin 17

PP IUITY cccticncaciinscsnnssecdpnndtisnttasisiebeiinuiaieeiiiiainnien 22

TABLE OF AUTHORITIES

FEDERAL CASES Page

Bement v. National Harrow Co., 186 U.S. 70

[ra scdintinhinsseiohinennssidiabitihiateinipnatilanishinibiniianasdibiiepsititate 18

Bonito Boats, Inc. v. Thunder Craft Boats, Inc.,

a ls: OS COE hiierapltiincniisitnitiieiiidsdeniteniinnine 10

Continental Paper Bag Co. v. E. Paper Bag Co..,

ee CID eichscriisscnientiiniiinimnchabiininnsiiaiiies 17

Crown Die & Tool Co. v. Nye Tool & Machine

a, APE. Se AO LEED cacitticinietrtncinnaieciientiin 14, 15

Dawson Chemical Co. v. Rohm & Haas Co., 448

Sipe Fa UIT chictindendcneniiensiunuiiiandininabindaibimaiens 15

Ethicon Endo-Surgery v. U.S. Surgical Corp.,

855 F. Supp. 1500 (S.D. Ohio 1994)... 13

Festo Corp. v. Shoketsu Kinzoku Kogyo Kabu-

SHIRA CO... SIS US. 122 CADIZ) nnccccsecccscosscesesesene 8.9

foster v. America Machine & Foundry Co., 492

oe CARS GAUe Cle SPD cciecscithinitinidenticsinssnimeinss 18

Hartford-Empire Co. v. United States, 323 U.S.

Pe ae uisiiihissscuineceistsitiisbaltelaieidthiniainisinkehiieinsoe 20 |

Heaton-Peninsular Co. v. Eureka Specialty Co..,

OF Co RE ale CMD sedttrvcccesiniactnttinteninininnees 18

Johns Hopkins Univ. v. CellPro, 978 F. Supp.

Pe Ge We PF Pictnnionissieindnidiniiabiodsaplistindeiein 13

Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470

Eye ciichdinnelctiiosiatitidanpesnisaiaabiniiiianbdiaibeniseiiiaadbdsens 8

Schneider (Europe) AG vy. SciMed Life System

Inc., 852 F. Supp. 813 (D. Minn. 1994), aff'd,

60 F.3d 839 (Fed. Cir. 1995), cert. denied, 516 ;

Se RT PD ccsesiecieninlnisctcinananstndunivndsiiinageiasie 13

Shiley, Inc. v. Bentley Laboratories, Inc., 601 F.

Supp. 964 (C.D. Cal. 1985), aff'd, 794 F.2d

Ee CP i. REID sciccnctdieiniiatoncitenniniccicsiisiniiotes 14

Special Equip. Co. v. Coe, 324 U.S. 370

SFTP aincibaisestanitiniiesiinttlaniiuanpiniabaianiinetediiein 15. 17, 18, 19

1V

TABLE OF AUTHORITIES—Continued

Page

Ex parte Wood, 22 U.S. (9 Wheat.) 603 (1824)... 14

Zenith Radio Corp. v. Hazeltine Research, Inc.,

FOe GO Bie FR CIPO ccwinccscensinbintsinninliciesatiaiiin 15

In re Zletz, 893 F.2d 319 (Fed. Cir. 1989)............. 7

STATE CASES

Livingston v. Van Ingen, 9 Johns. Cas. 507

(PC ntntnccacivstcscasinscipeionanicipipicastieaiaséeniadmabigii 12

FEDERAL STATUTES

F Dire 1h POE satesitcactiinsiiaannseaissdiinplliaigebiiaadiel 19

Be Cia Fern FHI snctiscencestnniuegeticsinitcadiaplieaieninniaiivins 19

FP cs Ge PPO sccnccicnsinicisinabessininiiaaieieiin 7

Bee Pen BOER cneniinoniensbesnisiinpatiteiiasniiaesiidabininndel 7

Be rs B TEe Ga) ctccecssninitnrctecnsintictiantadaba 16

FD UBL. § 15 ccccrcsasosoonssseoenisopescenovosensentepsvaniniaee 7,15

Be Wiese BPO ciscisecsimnistniiunameniiiapieiiiiaptinaibaals 19

Be See Ee inition cciiaohaindihdiiiieiantinsseete 7

SP ailies OTD ctvtntencccivinnsvicidnaipnmapliadabamamaniie 7,19

SO UA. GETS vecstiesenivmietimmamsinuiiintiia 20

FF RR Aice DP scctdivniecacciininceotiibilidsdiabiuaaiianliidddeatin 10

FO Wels OBE ‘sncciicncscesniicinnsiemicapeiiiniiamaiiaiilintiansial 19

Be Gils OE AEE vcvsiwiccsiovtiinsedsensiaiiipiepiitiguaitamaiaiianias 19

42 VBL. FD secseccssinnninscsinniiiienibicgapbtanunbicnie 19

SS DAK. Gp PG Fe wtterecnentnieiienicitspeittiiiiani 19

eee 1]

> Bike See ee 1}

16 Stat. 198, Ch. 230, § 55 (1870)... ee eeseeeeees 11

29 Stat. 694, Ch. 391, § 6 (1897)... saaeeuianie 11

42 Stat. S92, Che. SB, § BS (9922). .ccrcccsrcccorosocceceesones 12

60 Stat. 778, Ch. 726, § 1 (1946)........c0cerccseeeee e 12

66 Stat. 792, Ch. 29, § 283 (1952)...........cccceccceeees 12

ST CPR. § 1.20 0 (SIGS) .nncccscccconccecseccassesssoascnsoers 16

V

TABLE OF AUTHORITIES—Continued

Page

American Inventors Protection Act of 1999, P.L.

106-113, 113 Stat. ISO} (1999) 16

ik & ee FT). | eee 15

MISCELLANEOUS

The Affordable Prescription Drugs Act, H.R.

2927, 106th Cong., Ist Sess. (1999) ee 20

The Affordable Prescription Drugs and Medical

Inventions Act, H.R. 1708, 107th Cong.. Ist

IED diitechctlldbistieapanidnsicietinsensttinnainsinnenenieinases 20

John V. Duca & Mine K. Yucel, An Overview of

Science and Cents: Exploring the Economics

of Biotechnology, Federal Reserve Bank of

Dallas Economic and Financial Policy Review

Soe iacenatesiitinicisaitideretcanencniniameanettsensetduntetinesscnsen 4

Federal Trade Comm'n, To Promote Innovation:

The Proper Balance of Competition and

Patent Law and Policy (2003) ...cccccccccccesseeeeeeeees 20

Hart Bill of 1973, 8. Rep. No. 1321, 93d Cong..,

Se nL TET) sciutirtiaseatsasibdinicsainscansdadinsinenentiionssntnate 20

H.R. Rep. No. 1923, 82d Cong., 2d Sess. 29

IU iiatiielehieliidiibdinsiaapenaitiananicmnebiceniadntaghtnanapdananunens 12

Ross Kerber, Spread the Wealth Biotech Group

Says States Need to Fund All Areas, Not Just

Stem Cells, Boston Globe, at Fl (Jan. 15,

ES a ae 4.5

National Acad. Of Sciences A Patent System for

the 21st Century, (Stephen A. Merrill et al.

an iinacictisdccanentitedndsiettbdiimeenuientencnmiiengiatiaintios 21

NII; Moving Research from the Bench to the

Bedside: Hearings Before the Subcomm. on

Health of the House Comm. on Energy and

Commerce, lO8th Cong., Ist Sess. 47 (2003)... 3,4

vi

TABLE OF AUTHORITIES—Continued

Patent Reform Act of 2005: Hearing on an

Amendment in the Nature of a Substitute to H.

R. 2795 Before the Subcomm. on the Courts,

Internet, and Intellectual Property of the

House Comm. on the Judiciary, 109th Cong.,

Page

ee eee 6, 16, 21

Patent Act of 2005: Hearing on H. R. 2795

Before the Subcomm. on the Courts, Internet,

and Intellectual Property of the House Cgmm.

on Judiciary, 109th Cong., 2d Sess. (2004).......

Patent Law Reform: Injunction and Damages:

Hearing Before the Senate Subcomm. on the

Judiciary, 109th Cong., 2d Sess. (2005)............

Patent Quality Improvement: Post-Grant Oppo-

sition: Hearing Before the Subcomm. on the

Courts, Internet, and Intellectual Property of

the House Comm. on Judiciary, \O8th Cong.,

2s SOE. GED cccnctttenchadiitenapiairnnmaniennmnes

Perspectives on Patent Harmonization and Other

Matters: Hearing Before the Subcomm. on

Intellectual Property of the Senate Comm. of

the Judiciary, 109th Cong., 2d Sess. 109-182

Ge encersenesccstintincameiiticinepetnciiignniimmmdenn

Perspectives on Patents: The Patent System

Today and Tomorrow: Hearing Before the

Subcomm. on Intellectual Property of the

Senate Comm. of the Judiciary, \O9th Cong..,

SE ER, CIEE chiarincnennitiincmnunpilaninnnts

William C. Robinson, Treatise on the Law of

Patent for Inventions (1890) ............ccceeeeeeeeeeeeees

Tommy G. Thompson, Remarks at the Milken

Institute’s Global Cont. (Apr. 26, 2004),

available at) www.hhs.gov/niews/speech/2004/

PED ccencnasnscenncccnstiiiifmscinatiiominantennanapersattn

Vii

TABLE OF AUTHORITIES—Continued

Tufts Center for the Study of Drug Development -

Pegs Cost of New Prescription Medicine at

$802 Million, News Release (Tufts Center for

the Study of Drug Development) Nov. 30,

2001, available at http: //csdd.tufts.edu/News

Events/RecentNews.asp?newsid=6 ..............000

Jim Wasserman, Cancer Drugs Fuel Biotech

Expansion, Sacramento Bee, at DI (June 15,

ee ec tovciiendMinsencnvinevinntinanimencncetacitinienstianianiannane

Harold C. Wegner, /njunctive Relief: A Charm-

ing Betsy Boomerang, \st Annual North-

western Journal of Technology and ‘Intellectual!

Property Symposium: IP Litigation in the 21st

Century, Northwestern Univ. (Feb. 2006).

available at http://www.foley.com/files/tb]_s3}

Publications/File Upload | 37/323 | /Injunctive%

20Relief%20% 20A % 20Charming% 20Betsy %

eT Te

Page

STATEMENT OF INTEREST

The Biotechnology Industry Organization (“BIO”) is a

trade association representing more than eleven hundred

member-companies, academic institutions and biotechnology

centers.' Its members range from the largest Fortune 500

companies to the smallest start-ups. BIO members expand

the boundaries of science on a daily basis. They are involved

in the research and development of healthcare, agricultural

and environmental products. In fiscal year 2003 alone, the

biotech sector filed over 40,000 new U.S. patent applications.

The promise of exclusionary rights in validly patented subject

matter provides the investment incentive for the research and

development of innovative products used to improve the

quality of millions of lives worldwide. BIO members, there-

fore, have great interest in this case. Increased uncertainty

about the availability of exclusive rights in validly patented

subject matter will negatively impact the amount of research

and development resources available to member-companices

and, most importantly, negatively impact public health and

welfare.

SUMMARY OF ARGUMENT oa

The last century has seen unprecedented improvements in

public health, much of which has resulted from technological

advances in the field of medicine.- The continued im-

provement of public health, however, depends on the ongoing

development of new and more effective treatments. The

United States Congress has repeatedly recognized the critical

need for robust medical research. Accordingly. and con-

' Pursuant to Supreme Court Rule 37.3(a), all parties have filed with

the Court general written consents. Pursuant to Rule 37.6, amicus curiae

States that no person or entity other than BIO or its members has made

any monetary contribution to the preparation or submission of this brief.

Further, no counsel for Petitioner or Respondent authored this brief in

whole or in part.

2

sistent with the Patent Clause of the United States Con-

stitution, art. I, § 8, cl. 8, Congress has enacted and refined a

national policy that creates incentives for investment in this

area—specifically, an intellectual property regime to reward

innovators by granting a general right to exclude in exchange

for disclosure of new and useful ideas.

New inventions and discoveries drive the biotechnology

industry. Millions of people worldwide benefit daily from

biotechnology-derived medicines and products. The right to

exclude others from practicing a validly patented invention

provides the investment incentive that is essential for high-risk,

high-cost biotechnology research and development. Increased

unpredictability with respect to the availability of exclusive

rights will greatly diminish the value of patent rights, weaken

the hand of patent owners in negotiations to determine the

value of a patent, shift such value determinations to the courts,

reduce inventors’ desire to promptly disclose inventions to the

public, and discourage the investment required to research and

discover innovative technologies.

This Court in its prior opinions and the Federal Circuit in

the case at bar have correctly determined that Congress

guaranteed patent Owners an exclusive right to their patented

inventions. This consistent statutory interpretation has

promoted the progress of the useful arts, including the

biotechnology arts, far better than any other system in the

world by providing a strong incentive to invent, disseminate

information, and discover alternatives and improvements to

patented inventions. It has also provided the necessary

certainty for parties to determine the value of exclusive

property rights without prolonged litigation that simply is not

affordable by most biotechnology companies. The success of

the U.S. patent system and the biotechnology industry derives

from the careful balance Congress has established in the

patent laws. Congress has not disturbed the patentee’s

exclusive right in more than two centuries. This Court should

not do so now.

3

ARGUMENT

I. THE RIGHT TO INJUNCTIVE RELIEF IS

VITAL IN ENSURING INNOVATION IN THE

BIOTECHNOLOGY INDUSTRY

A. The Risks of the Biotechnology Industry Re-

quire a Patent System that Adequately Protects

the Investment Necessary to Bring a Product to

Market

1. Advances in medicine do not happen by themselves.

They require the ingenuity of scientists, the perseverance of

companies working in the medical field, and huge investment

by the private sector and others. Members of BIO and others

working in the biotech sector have made significant contribu-

tions to previously unimaginable research discoveries and

medical advances, including medicines to treat diseases such

as heart disease, cancer, AIDS, stroke, septic shock, diabetes,

anemia, cystic~ fibrosis, multiple sclerosis, lupus, kidney

disease and liver disease. Although millions of lives already

have been saved and improved, the biotechnology revolution

is in its infancy. Literally every day, biotechnology compa-

nies invent and discover new tests, new drugs, new cures, or

new products. oy ee

Biotechnology companies must rely on investments (both

from private investors and from inside the company) to fund

development of risky and expensive new products. Bio-

technology is still an emerging field, despite remarkable

breakthroughs. Its further growth depends entirely on a

commitment to invest in research and development. See N/H:

Moving Research from the Bench to the Bedside: Hearings

Befere the Subcomm. on Health of the House Comm. on

Energy and Commerce, 108th Cong., Jst Sess. 47 (2003) (tes-

timony of Phylliss Gardner, M.D). (“The biotechnology

industry is the mow research and development-intensive and

capiial-focused industry an the world.”). Most biotechnology

4

companies are small ventures with little or no operating

income to meet these costs. These small, emerging com-

‘panies must turn to private investors for capital to fund their

labor-intensive research. Currently, a full 98% of research

and development investment in biotechnology comes from

the private sector. N/JH: Moving Research from the Bench

to the Bedside, supra, at 49. The continued support of

the private sector, however, is far from guaranteed, due to

the highly speculative nature of biopharmaceutical product

development.

The journey companies take from idea to marketable prod-

uct is neither simple, safe, nor short. The investment that a

company makes to develop even a single therapy is aston-

ishing. The average cost of developing a therapy exceeds

$800 million, and development can take up to fourteen years.

Tufts Center for the Study of Drug Development Pegs Cost of

New Prescription Medicine at $802 Million, News Release

(Tufts Center for the Study of Drug Development), Nov. 30,

2001, available at http: //csdd.tufts.edu/NewsEvents/Recent

News.asp?newsid=6. The chances that a biopharmaceutical

product will achieve FDA approval are approximately one in

5,000. See Tommy G. Thompson, Remarks at the Milken

Institute’s Global Conference (Apr. 26, 2004), available at

www.hhs.gov/news/speech/2004/040426.html. Of the prod-

ucts that are approved as therapies for patients, a mere one-

third cover their cost of development, much less turn a sig-

nificant profit. John V. Duca & Mine K. Yucel, An Overview

of Science and Cents: Exploring the Economics of Bio-

technology, Federal Reserve Bank of Dallas Economic and

Financial Policy Review (2002). In 2004, the industry

suffered a net loss of more than $5.3 billion. Jim Wasserman,

Cancer Drugs Fuel Biotech Expansion, Sacramento Bee.

June 15, 2005 at DI: see also Ross Kerber, Spread The

Wealth Biotech Group Says States Need To Fund All Areas,

Not Just Stem Cells, Boston Globe. Jan. 15, 2005 at FI.

(“|Bliotechnology’s complicated drugs can take a decade or

5

longer to reach the market, leading to billions of dollars of

annual losses for the industry.”).

The majority of biotechnology companies are small,

emerging companies with few employees, no therapies on the

market, and no operating income. They must find investors

willing to risk hundreds of millions of doilars on a very slim

chance of the therapy reaching market and turning a profit.

The company must not only convince investors that its long-

shot invention will pay off, but that investing in the company

is a better investment than countless, less risky, alternatives.

And larger BIO member companies make their own in-

vestment in R&D. In effect, they are “investors” who must

be willing to take risks and therefore also need certainty.

2. The primary asset of biotechnology companies is

intellectual property, and specifically patents. The sole right

granted by the patent—the right to exclude others from

practicing a validly patented invention for a limited time—

provides the incentive for B1O members’ high-risk, high-cost

research and development aimed at high rewards in pro-

moting improved health, longevity, and well-being. Without

the ability to enjoin infringers as the general rule, the right to

exclude would be meaningless and many, if not most, of

BIO’s members would be unable to attract the capital neces-

sary to fund research and development of new medicines.

Three examples from BIO members demonstrate the im-

portance of investment in their product candidates to the

health and welfare of the public. Robert Chess, Executive

Chairman of Nektar Therapeutics. recently testified about his

company's reliance on patents to attract investment capital for

developing the world’s first inhaled insulin for diabetic

patients. He explained that his company is not profitable

despite being in existence since 1991 and raising $1.2 billion

through seventeen rounds of financing. The issuance of a

single U.S. patent covering a form of inhaled insulin made it

possible to attract the investment required for critical research

6

and development. In 2006 his company and its partner

received FDA approval for their inhaled insulin product, the

first insulin not administered to patients by injection. See

Patent Reform Act of 2005: Hearings on an Amendment in

the Nature of a Substitute to H.R. 2795 Before the Subcomm.

on the Courts, Internet, and Intellectual Property of the

House Comm. on Judiciary, 109th Cong., Ist Sess. (2005)

(testimony of Robert Chess).

Another small biotechnology company, AlphaVax, has

patented a technology that has the potential to deliver

millions of doses of seasonal flu vaccine, as well as a

pandemic flu vaccine. This company does not anticipate any

of its vaccines will be approved for use by patients until 2011,

and, therefore, must attract investors willing to forego other

investment alternatives and risk millions of dollars on the

chance this therapy will ultimately reach the market and make

a profit. AlphaVax and its investors must have confidence

that their patents will provide a predictable right to exclude

others who did not make these discoveries or undertake

comparable risk.

A third BIO member, Guilford Pharmaceuticals (now MGI

Pharma). licensed patent rights to enable critical private

investment that ultimately led to regulatory approval of a

product to treat malignant brain tumors that extends the

expected average life span of treated patients by almost 20%.

Nevertheless, prior to its purchase, Guilford had not become

profitable, even though its product had been on the market for

several years.

These stories are commonplace among BIO members.

Biotechnology companies and their investors rely on patent

protection to provide the company its value. And without a

general right to injunctive relicf to enforce the right to

exclude, these and other companies might never have been

able to receive the investment needed to fund their ideas.

J

B. The Patent System Represents a Careful

Balance Between Providing Incentives for

Investment and Protecting the Public Interest

1. The Patent Act is clear: A patent grants the patentee

“the right to exclude others from making, using, offering for

sale, or selling the invention...” 35 U.S.C. § 154; and pro-

vides that the patentee “may .. . grant and convey an

exclusive right” under the patent. 35 U.S.C. § 261. Further-

more, under the Act “no patent owner . . . shall be denied

relief or deemed guilty of misuse or illegal extension of the

patent right by reason of his having . . . refused to license or

use any rights to the patent...” 35 U.S.C. § 271(d)(4). The

statutory right to exclude, the sete right granted by a patent,

cannot exist without the right to iniunctive relief.

Yet in order to obtain this right and receive a patent, the

prospective inventor must pass a gauntlet of hurdles. The

exclusive right to injunctive relief arises only after a court has

found a patent is valid. Both the Patent and Trademark

Office (“PTO”) and then a court upon review, must find that

the paient is limited to subject matter found to be entirely (1)

novel, (2) useful, and (3) non-obvious under stringent criteria

Congress has placed into the patent laws. 35 U.S.C. §§ 101-

103 (2002). A patent is subject to challenge for any of these

reasons. Defendants accused of patent infringement often

introduce reams of evidence at trial trying to invalidate a

patent on these grounds. Thus, as was the case here, a

patentee must withstand extensive challenges to his or her

patent prior to seeking a permanent injunction.

In addition to the requirements above, Congress has im-

posed an additional barrier before a patent is issued. The

patented subject matter must be sufficiently definite and have

a completeness and exactness such that the patented invention

can be put into practice. 35 U.S.C. § 112. See alse. e.g., In

re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989). The bargain

between the inventor and the government requires detinite-

8

ness because the driving force of the patent system is

disclosure. See, e.g., Kewanee Oil Co. v. Bicron Corp., 416

U.S. 470, 480-81 (1974). In exchange for disclosing to others

a new invention, the government grants the right to exclude

others from practicing the invention for a limited time period,

i.¢., typically 20 years from the patent application’s filing

date.

=

2. Therefore, only when the inventor has adequately

disclosed to the public something entirely novel, useful, and

non-obvious—and set out with definiteness the “metes and

bounds” of such an invention—does a court address the issue

of whether an ongoing infringement of such a patented

invention should be halted via an injunction.

For validly patented subject matter, an injunction allows the

patent holder to prevent a person from using the invention —

an invention that did not exist before the inventor created it.

Stopping such infringement of valid patents serves as the

economic incentive to create the new and non-obvious subject

matter that, in turn, promotes technological advances through

public disclosure via the patent. Changing the availability of

exclusionary rights would diminish this strong economic in-

centive. The inability to enjoin the infringement of a valid

patent would produce an unavoidable diminishment of the eco-

nomic power—and economic value—of rights in valid patents.

Further, for validly patented subject matter, an injunction

takes nothing from the public that existed before the in-

vention was made and nothing that was merely an obvious

alteration of known technology. A general rule enjoining in-

fringement of valid patents promotes the public interest.

Stopping such infringement of valid patents serves as the

economic incentive to create the new and non-obvious subject

matter that, once publicly disclosed via the patent, permits

that advance in technology to be further refined, extended

and improved. Cf. Festo Corp. v. Shoketsu Kinzoku Kogyo

Kabushiki Co., 535 U.S. 722, 736 (2002) (“[E]xclusive patent

9

rights are given in exchange for disclosing the invention to

the public.”) (emphasis added).

Diluting the general right to injunctive relief, in contrast,

would diminish a patent's value. In negotiations among pri-

vale parties, any increased uncertainty that infringement of a

valid patent would be stopped by the courts would demon-

strably weaken the hand of the patent owner. Investors: in

BIO member-companies would be less willing to invest in

high-risk research and development and less investment could

result in creating less new technology.

In addition, if the role of the courts changes from enjoining

infringement of validly issued patents, absent exceptional

circumstances, to deciding the terms on which courts will

sanction the ongoing infringement of valid patents, the estab-

lished system of patent ticensing will change dramatically.

Instead of private parties negotiating to determine the value

of validly patented inventions, the courts will find themselves

in the judicial licensing business—deciding the remuneration

paid to the patent owner when the court sanctions ongoing

infringement. Indeed, if an infringer can knowingly avoid an

injunction, some potential licensees and partners might relish

the prospect of—or at least the threat to a patent owner of—

having a jury set the terms for a judicial license. Given the

increased uncertainty of being able to enforce their exclusive

rights, many biotech companies, particularly those which are

resource-constrained, would have difficulty pursuing their

uncertain rights through costly litigation. Thus, they likely

would be forced to settle for much less than necessary to

recoup their investment, to continue research and to discover

innovative technologies.

Indeed, to reduce the risk of having their inventions copied,

the expense of prolonged litigation, and the threat of judicial

licenses, some inventors may choose not to participate in the

patent system at all. Instead, they could withhold filing of a

patent application, thereby maintaining their inventions as

10

trade secrets. Alternatively, they could detay the filing of

patent applications and the public disclosure of their

inventions until after negotiating and securing licensing terms

under conditions of strict confidentiality. -Either of these

approaches would deny other scientists timely and valuable

scientific information, normally available through published

patent applications. Moreover, any withholding of scientific

information by inventors would negatively impact the discov-

ery of alternatives and improvements to published inventions.

And it would completely defeat the patent system's fun-

damental purpose of bringing new ideas into the public

domain. See Bonito Boats, Inc. v. Thunder Craft Boats, Inc.,

489 U.S. 141, 151 (1989) (stating that “the ultimate goal of

the patent system is to bring new designs and technologies

into the public domain through disclosure’).

Biotechnology innovation depends on and has prospered

because of the long-held consensus that the essence of a

patent is the right to exclude This Court should not now

change these settled expectations.

Il. THE PATENT HOLDERS HAVE LONG HAD

THE GENERAL RIGHT TO OBTAIN AN

INJUNCTION FOR PATENT INFRINGEMENT

A. The Historical Basis for Injunctive Relief Con-

firms its General Applicability in Patent Cases

- 35 U.S.C. § 283 provides: “The several courts having juris-

diction of cases under this tithe may grant injunctions in

accordance with the principles of equity to prevent the

violation of any right secured by patent, on such terms as the

court deems reasonable.” Injunctive relief is clearly equitable

and thus will not be granted in a// cases. However, peti-

tioners’ heavy reliance on the language of § 283 is misplaced.

The history of this injunctive relief provision confirms the

general principle that after a valid patent has been adjudged

infringed, continuing or future infringement generally should

result in the grant of injunctive relief. In fact, its enactment

was to make certain al] federal courts had the power to grant

such relief in all patent cases.

When the first predecessor to Section 283 was enacted on

February 15, 1819, it stated:

That the circuit courts of the United States shall have

original cognizance, as well in equity as at law, of all

actions, suits, controversies, and cases, arising under any

law of the United States, granting- or confirming to

authors or inventors the exclusive right to their re-

spective writings, inventions, and discoveries: and upon

any bill an equity, filed by any party aggrieved in any

such cases, shall have authority to grant injunctions,

according to the course and principles of courts of

equity, to prevent the violation of the rights of any

authors or inventors, secured to them by any laws of the

United States, on such terms and conditions as the siid

courts may deem fit and reasonable . . . .

3 Stat. 481, Ch. 19 (1819) (emphasis added). Thus, its enact-

ment was not intended to limit injunctive relief, but rather

was intended to authorize the circuit courts to act both in

equity and at law.

The statute authorizing the court to act in equity for patent

cases was revised in 1836 (5 Stat. 117, Ch. 357, § 17) and

again in 1870 (16 Stat. 198, Ch. 230 § 55). Then, on March

3, 1897, the language was amended and simplified to read:

The several courts vested with jurisdiction of cases

arising under the patent laws shall have power to grant

injunctions according to the course and principle of

courts of equity, to prevent the violation of any right

secured by patent, on such terms as the court may deem

reasonable ....

R.S. 4921, 29 Stat. 694, Ch. 391, § 6 (1897) (emphasis

added).

12

The 1897 language was twice-reenacted without change

until 1952. See R.S. 4921, 42 Stat. 392, Ch. 58, § 8 (1922);

and 60 Stat. 778, Ch. 726, § 1 (1946). The 1952 statute read:

The several courts having jurisdiction of cases arising

under this title may grant injunctions in accordance with

the principles of equity to prevent the violation of any

right secured by patent, on such terms as the court deems

reasonable. .

66 Stat. 792, Ch. 29, § 283 (1952) (emphasis added).

In the comments to the final bill regarding Section 283, the

editors note that “this section is the same as the provision

which opens R.S. § 4921 with minor changes in language.”

H.R. Rep. No. 1923, 82d Cong., 2d Sess. 29 (1952).

Since well before the Constitution, the general rule was

that injunctions issued once the patent was adjudged valid

and infringed. See, e.g., Livingston v. Van Ingen, 9 Johns.

Cas. 507, 585 (1812). (Injunctions are always granted [sic]

to secure the enjoyment of statute privileges . . . . This is the

uniform course of the precedents. | believe there is no case to

the contrary; and the decisions in the English Chancery, on

this point, were the same before as since the American

Revolution.”). '

This general injunctive right did not change with the

enactment of the 1819 Patent Act. As Professor Robinson

explained in his classic 1890 treatise, The Law of Patents: “A

perpetual injunction issues, as a matter of course, at the

conclusion of a suit in equity, whenever the plaintiff has

. sustained the allegations of his bill, provided the patent has

not then expired.” 3 William C. Robinson, Treatise on the

Law of Patents for Inventions, § 1220, at 657 (1890).° See

’ Permanent injunctions granted after a patent had been determined to

be valid and infringed are distinct from preliminary injunctions: “A pre-

liminary injunction is not, like a perpetual injunction, a matter of course,

nor can its issue be governed by any formulated and established rules.” 3

13

also id. § 1088, at 400 (citation omitted). (“An adequate rem-

edy at law does not exist in any case where future infringe-

ments are to be prevented .... Future infringements can be

prevented only by an injunction issuing out of chancery, and

to this relief the plaintiff is entitled whenever he has reason to

apprehend a violation of his rights by the defendant.”).

Professor Robinson identified five different areas where an

injunction was not appropriate: Whenever (1) the sole relief

being sought is compensation for past infringement; (2) the

patentee is seeking a license fee from the infringer and the

infringing acts raise an implied acceptance of the patentee’s

offer; (3) the infringement has ceased; (4) the patent has

expired; or (5) the infringement is a breach of contract, by

whose provisions the compensation of the plaintiff for the

injury is determined. See id. § 1087, at 398-99. None of

these apply here, although they explain why an injunction

should not be automatic.

Exceptional circumstances also have properly led courts to

deny or temporarily stay a permanent injunction whtn an

important public need for the invention exists. See Jo/ms

Hopkins Univ. v. CellPro, 978 F. Supp. 184, 189 (D. Del.

1997); Schneider (Europe) AG v. SciMed Life Sys. Inc., 852

F. Supp. 813, 850-51, 861-62 (D. Minn. 1994), aff'd, 60 F.3d

839 (Fed. Cir. 1995), cert. denied, 516 U.S. 990 (1995)

(granting permanent injunction with a one-year transition “to

allow an efficient and non-disruptive changeover for those

institutions and physicians who now employ the [infringer’s

product} exclusively”); Ethicon Endo-Surgery v. U.S. Sur-

gical Corp., 855 F. Supp. 1500, 1517 (S.D. Ohio 1994)

(noting that to suddenly withdraw the infringing devices with

which a large number of surgeons are “unquestionably”

familiar and have been trained to use “could have a serious

Willham C. Robinson, Treatise on the Law of Patent for Inventions,

§ 1170, at 557 (1890).

14

disruptive effect on surgical practice”); Shiley, Inc. v. Bentley

Labs., Inc., 601 F. Supp. 964, 971 (C.D. Cal. 1985), aff'd.

794 F.2d 1561 (Fed. Cir. 1986) (granting an injunction

against the sale of an infringing blood oxygenatot, but

delaying the injunction for six months to minimize negative

impacts on hospitals and surgery candidates).

B. This Court and the Federal Circuit Have Cor-

rectly and Consistently Protected a Patentee’s

Exclusive Rights Through Injunctive Relief,

F Absent Exceptional Circumstances

This Court and the Federal Circuit have correctly and

consistently protected a patentee’s exclusive rights through

injunctive relief, absent exceptional circumstances. This

Court repeatedly has determined that Congress acted within .

its authority when it chose to promote the progress of science

and the useful arts by expressly granting patentees an exclu-

sive property right in their inventions. More than a century

ago, this Court stated:

The securing to inventors of an exclusive right to their

inventions, was deemed of so much importance, as a

means of promoting the progress of science and the

useful arts, that the constitution has expressly delegated

to Congress the power to secure such rights to them for a

‘limited period. The inventor has, during this period, a

property in his inventions; a property which is often of

very great value, and of which the law intended to give

him the absolute enjoyment and possession.

Ex parte Wood, 22 U.S. (9 Wheat.) 603, 608 (1824) (Story,

J.) (emphasis added). The “exclusive right” would not pro-

vide “absolute enjoyment” if it were forfeitable based on any

number of unpredictable circumstances. See also Crown Die

& Tool Co. v. Nye Tool & Mach. Works, 261 U.S. 24, 36

(1923) ("lt is the fact that the patentee has invented or

discovered something useful and thus has the common law

right to make, use and vend it himself which induces the

1S

Government to clothe him with power to exclude everyone

else from making, using, or vending it.”).

More recent decisions from this Court confirm this long-

standing principle of a patentee’s right to exclude: “By the

very terms of the statute the grant is nothing more than a

means of preventing others, except under license from the

patentee, from appropriating his invention.” Special Equip.

Co. v. Coe, 324 U.S. 370, 378 (1945) (interpreting the prede-

cessor of 35 U.S.C. § 154, U.S. Rev. Stat. § 4884). See also

Zenith Radio Corp. v. Hazeltine Research, Inc., 395 U.S. 100,

135 (1969) (“The heart of his legal monopoly is the right to

invoke the State’s power to prevent others from utilizing his

discovery without consent.”); Dawson Chem. Co. v. Rohm &

Haas Co., 448 U.S. 176, 215 (1980) (“Petitioners’ argument

runs contrary to the long-settled view that the essence of a

patent grant is the right to exclude others from profiting by

the patented invention.”).

C. Exclusive Patent Rights Are Enforceable Via

the General Right to Injunctive Relief Even

When A Valid Patent Covers A Single Com-

ponent of A Multi-Component Product

Exclusive patent rights are enforceable via injunction even

when a valid patent covers a single component of a multi-

component product. Although the biotechnology industry

typically relies on one or only a few patents to adequately

protect an entire marketed product, BIO’s members regularly

make inventions that are incorporated into and used in

conjunction with more complex products. There is no need

to alter the longstanding general right to injunctive relief

because sometimes one valid and infringed patent protects

only a single component of a multi-component product. Tes-

tumony during a recent patent reform hearing referred to this

situation as “a case of someone wanting to enjoin the sale of

pick-up trucks because they contain a built in beer cooler that

16

is claimed to be infringing.” Patent Reform Act of 2008:

Hearing on an Amendment in the Nature of a Substitute to H.

R. 2795 Before the Subcomm. on the Courts, Internet, and

Intellectual Property of the House Comm. on the Judiciary,

109th Cong., Ist Sess. (2005) (testimony of David Simon).

Such a situation does not justify a change in this Court's

precedent. First, the issuance of a permanent injunction is

based on a final determination that a presumptively valid

patent—meeting all statutory requirements—is infringed.

Second, seldom is the issuance of the patent a surprise. As a

result of the American Inventors Protection Act of 1999,

Public Law 106-113, 113 Stat. 1501, substantially all patent

applications publish 18 months after filing. 35 U.S.C. § 122

(b)(1)(A); 37 C.F.R. § 1.211 (2005). Prudent companies

regularly monitor and analyze the patent literature in areas

where they research and develop products, and continue to

assess their risk during the several years usually required to

complete patent litigation. Third, an injunction can and

should be tailored to prevent the infringement of the “claimed

invention,” for example, the cooler in the case of Mr. Simon’s

hypothetical. Fourth, the infringer has choices—remove the

cooler from the truck, design a cooler that doesn’t infringe the

valid patent, wait for the patent to expire, or seek a license

from the patent owner.

In the vast majority of cases in which a party is found

guilty of infringement, permanent injunctions are not issued

because the parties negotiate a settlement or the accused

infringer redesigns iis product to avoid infringement. If a

product cannot be redesigned to avoid a patent, it is likely that

the patent is protecting an important invention and an

injunction is warranted, absent exceptional circumstances.

17

Hil. BIOTECH INNOVATION WOULD BE FRUS-

TRATED IF THIS COURT CREATED AN

EXCEPTION TO THE RIGHT TO INJUNCTIVE

RELIEF WHEN THE PATENT HOLDER DOES

NOT USE THE INVENTION

BIO members, particularly small companies and univers-

ities, make valuable, patentable discoveries but frequently do

not practice or develop (“use’’) them for a variety of reasons.

They may lack scientific expertise, financing, or development

and manufacturing capacity. Likewise, they simply may be

unable to currently license other essential know-how. And

licensing immediately may not make economic sense, or they

may try and be unable to do so. In some cases, it may take

years before commercialization is feasible, or even possible.

These patent owners should not be deprived of their exclusive

rights, as they would be if this Court created a new basis to

avoid an injunction whenever a patent owner does not use its

patented invention.

Such a change in the law would run counter to this Court's

jurisprudence and to Congress's command.’ Moreover, it

begs the question of what “use” means. Licensing the patent

so that others might use it benefits the public, and is a “use.”

Continental Paper Bag Co. v. E. Paper Bag Co., 210 US.

405 (1908).

Regardless of what “use” means, however, “[t}his Court

has consistently held that failure of the patentee to make use

of a patented invention does not affect the validity of the

patent.” Special Equip. 324 U.S. at 78-79. This Court's

‘ Of course, under present jurisprudence, if lack of use negatively

impacts the public interest, as it could in the case of a life-saving drug,

sufficiently to outweigh the public interest in a strong patent system, then

that interest should be considered in deciding whether to issue an

Injunction.

-

18

decision in Continental Paper Bag was not an outlier.

Rather, it relied on traditional principles of patent law:

It is manifest as is said in Walker on Patents, § 106, that

Congress has not ‘overlooked the subject of non-use of

patented inventions’ .... In some foreign countries the

right granted to an inventor is affected by non-use. - This

policy, we must assume, Congress has not been ignorant

of nor of its effects. It has, nevertheless, selected

another policy; it has continued that policy through

many years. We may assume that experience has

demonstrated its wisdom and beneficial effect upon the

arts and sciences,

Id. at 429-30, As explained by this Court, use of patented

inventions is not required:

A suppression can endure but for the life of the patent,

and the disclosure he has made will enable all to enjoy

the fruit of his genius. His title is exclusive, and so

clearly within the constitutional provisions in respect of

private property that he is neither bound to use his

discovery himself nor permit others to use it.

Bement v. National Harrow Co., 186 U.S. 70, 90 (1902)

(quoting Heaton-Peninsular Co. v. Eureka Specialty Co., 77

FF. 288, 294-95 (6th Cir. 1896)).

A rule distinguishing patents by whether the patent holder

“uses” the invention is directly contrary to Congress's

command, Not only would such a rule diminish the value of

the patent, it will inexorably result’ in court-imposed

compulsory licensing—something acknowledged forthrightly

by the one case relied upon so heavily by petitioners and their

amici, Foster v. Am. Mach. & Foundry Co., 492 F.2d 4317

(2d Cir. 1974). Yet Congress consistently has rejected all

attempts to create compulsory licensing, except in certain

19

limited situations necessary to the public welfare.” These

exceptions show not only that Congress does not want

compulsory licensing as a general rule, but that not having an

injunctive right is appropriate only where the public interest

is involved. Indeed, this Court stated over 60 years ago that

“Congress has frequently been asked to change the policy of

the statutes as interpreted by this Court by imposing forfeiture

or providing for compulsory licensing if the patent is not

used within a specified time, but has not done so.” Special

Equip. 324 U.S. at 379 (footnotes omitted). The same is

equally true today.” Likewise, Congress has consistently re-

* Congress has, for example: (1) limited a patentee’s remedies against

the government to reasonable compensation (28 U.S.C. § 1498); (2) ex-

empted from infringement practicing an invention “solely for uses

reasonably related to the development and submission of information

under a Federal law which regulates the manufacture, use, or sale of

drugs” (35 U.S.C. § 271(e(1)): (3) provided the government authority to

grant licenses to government-funded inventions, under certain circum-

stances (35 U.S.C. § 204); (4) mandated a compulsory license if necessary

to ensure an adequate supply of food (7 U.S.C. § 2404); (5) required

licensing under reasonable terms of technology to prevent and control air

pollution (42 U.S.C. §§ 7401-7626). (6) provided licensing of certain

patented inventions related to nuclear material and atomic energy (42

U.S.C. § 2183(c)); (7) mandated licensing of patented inventions as neces-

sary to comply with the Clean Air Act (42 U.S.C. § 7608): and (8) limited

the enforceability of certain medical procedures patents (35 U.S.C. § 287).

* Granting compulsory licenses, unless narrowly and carefully tailored,

may well “run afoul” of the United States’ TRIPS obligations. See,

Harold C. Wegner, /njunctive Relief? A Charming Betsy Boomerang, \st

Annual Northwestern Journal of Technology and Intellectual Property

Symposium: IP Litigation in the 21st Century, Northwesterm University

(Feb. 2006), available at http://www.toley.com/files/ tbl_s31Publications/

FileUpload | 37/3231 /Injunctive% 20Relhiet™% 20% 20A% 20Charming™ 20B

etsyc 20Boomerang.pdt. The practice would certainly frustrate the United

States’ efforts to halt the grant of such licenses in other countries, At the

very least, this Court should consider what would-be required in order to

sufficiently address these and other international issues. See Wegener,

yupra.

20

jected any attempt to distinguish among patent owners based

upon whether the claimed invention is being “worked”

or “used.”

In addition, Congress has amended the patent laws on

numerous occasions without altering the right to exclude

infringement of valid patents.’ And Congress will certainly

continue to consider proposals to amend the patent laws to

promote the progress of the useful arts. In fact, the Federal

Trade Commission (FTC) and the National Academy of

Sciences (NAS) each recently conducted multi-year studies of

the U.S. patent system resulting in detailed reports and

extensive recommendations on how to improve the patent

system.” These two reports spurred the 109th Congress to

® See Hartford-Empire Co. v. United States, 323 U.S. 386, 416 (1943)

(citing rejected attempts by Congress). More recent proposals to limit the

right to exclude include: the Hart Bill of 1973, S. Rep. No. 1321, 93d

Cong.. 2d Sess. (1973): The Affordable Prescription Drugs Act, H.R.

2927. 106th Cong., Ist Sess. (1999); and The Affordable Prescription

Drugs and Medical Inventions Act, H.R. 708, 107th Cong., Ist Sess.

(2001) (proposal to allow compulsory licensing under certain conditions

related to health care costs).

’ For example, in 1999 Congress amended the patent law such that

nearly 95% of all patent applications now publish eighteen months from

filing to allow the public to benefit from the early disclosure of the

invention and to prevent unfair surprise to competitors from late-issuing

patents. A recent change in term from seventeen years from patent issu-

ance to twenty years from the filing. of the application has also harmo-

nized U.S. patent practice with the rest of the world and has prevented

patentee velay in the patent office from extending patent exclusivity:

Congress has also provided a “first-inventor defense” to certain in-

fringement actions in the area of business methods patents. 35 U.S.C.

§ 27% bx 1).

* The FTC conducted a multi-year study of the U.S. patent system and

issued a report in October 2003. Federal Trade Comm'n, To Promote

Innovation: The Proper Balance of Competition and Patent Law and

Policy (2003). While the FP'C determined that the patent system works

well, ten recommendations were made, in large part, to improve the

21

_

actively consider a number of patent reform proposals.”

Although neither report recommended changing the paten-

tee’s right to injunctive relief, Congress nevertheless con-

sidered and rejected legislation urged by select industry

groups that would have required courts to weigh any and

every fact in deciding whether to enjoin an adjudicated

infringer—exactly what Petitioners are asking this Court to

balance between patent owner's rights to exclusivity in valid patents and

the public's right not to be burdened by invalid patents.

The National Academies of Sciences’ Committee on Intellectual Prop-

erty Rights in the Knowledge-Based Economy also commissioned a

multi-year study of the patent system. The report from this study was

published in April 2004. Nat'l Acad. of Sciences, A Patent System for the

2/st Century (Stephen A. Merrill et al. eds., 2004). The NAS report

found that the U.S. patent system played an important role in stimulating

technical innovation by providing legal protection to inventions and by

disseminating useful technical information. It concluded with seven prin-

cipal recommendations to improve the U.S. patent system, several of

which overlap with those made by the FTC.

” Patent Quality Improvement: Post-Grant Opposition: Hearing Before

the Subcomm. on Courts, the Internet and the Intellectual Property of

the House Comm. on the Judiciary, \O8th Cong., 2d Sess. (2004); Per-

spectives on Patents: The Patent System.Today and Tomorrow: Hearing

Before the Subcomm. on Intellectual Property of the Senate Comm. on the

Judiciary, \O9h Cong., 2d Sess. (2005); Patent Act of 2008S: Hearing on

H.R. 2798 Before the Subcomm. on Courts, the Internet, and Intellectual

Property of the House Comm. on the Judiciary, \O9th Cong., 2d. Sess.

109-24 (2005), Patent Reform Act of 2008S: Hearing on an Amendment in

the Nature of a Substitute to H.R. 2798 Before the Subcomm. on Courts,

the Internet, and Intellectual Property of the House Comm. on the Judici-

ary, LO9th Cong., Ist Sess.~ 2005): Patent Law Reform: Injunctions and

Damages: Hearing Before the Senate Subcomm. on Intellectual Property

of the Senate Comm. on the Judiciary, \O9th, 2d Sess. (2005), Perspec

tives on Patent Harmonization and Other Matters: Hearing Before the

Subcomm. on Intellectual Property of the Senate Comm. of the Judiciary,

109th Cong.. 2d Sess. 109-182 (2005).

22

do without legislation."" Congress, not this Court, is the

proper branch to address any policy arguments about altering

the long-standing right to exclude. This Court should reject

petitioners’ attempt to limit the injunctive remedy by court

decision when Congress repeatedly has rejected these at-

tempts to do so.

CONCLUSION

For the foregoing reasons, the judgment of the Federal

Circuit should be affirmed.

Respectfully submitted,

BRIAN P. BARRETT NANCY J. LINCK

Chair, Counsel of Record

BIOTECHNOLOGY INDUSTRY BIOTECHNOLOGY INDUSTRY

ORGANIZATION ORGANIZATION

Amicus Committee 1225 Eye Street, NW

ELI LILLY AND COMPANY Washington, DC 20005

Lilly Corporate Center (202) 962-6668

Indianapolis, Indiana 46285

(317) 276-7243

March LO, 2006

Patent Act of 2008: Hearine on H.R. 2798 Before the Subcomm. on

Courts, the Internet, and Intellectual Property of the House Comm. on the

Judiciary, \O8th Cong., 2d Sess. 109-24 (2005) (legislation remains in

subcommittee without the injunction provision).