Amicus Curiae Brief — Life Techs. Corp. v. Promega Corp., 136 S. Ct. 290 (2015) (No. 14-1538)

RECORD No. 14-1538

AND :

BruEFs - IN THE

Supreme Court of the United States

LIFE TECHNOLOGIES CORPORATION; INVITROGEN IP

HOLDINGS, INC.; APPLIED BIOSYSTEMS, LLC,

Petitioners,

v.

PROMEGA CORPORATION,

Respondent.

On Writ Of Certiorari To The United States

Court Of Appeals For The Federal Circuit

BRIEF OF AMICUS CURIAE WISCONSIN

ALUMNI RESEARCH FOUNDATION IN

SUPPORT OF RESPONDENT

JENNIFER L. GREGOR* SHANE DELSMAN

GODFREY & KAHN, S.C. GODFREY & KAHN, S.C.

One East Main Street 833 East Michigan Street

Suite 500 Suite 1800

Madison, WI 53703 Milwaukee, WI 56202

jgregor@gklaw.com sdelsman@gklaw.com

(608) 257-3911 (414) 273-3500

*Counsel of Record

Counsel for Amicus Curiae Wisconsin Alumni

Research Foundation

Table of Authorities

Statement of Interest

Il. Argument

-i1-

TABLE OF CONTENTS

II. Introduction and Summary of _ the

Argument

A. Strong U.S. patents _incentivize

I ga Eas cata ek pa taunilenebannains

1. The 1980 Bayh-Dole Act granted

patent ownership and license rights

to universities to encourage

innovation in this country....................

. In 1984, Congress enacted 35 U.S.C.

§ 271(f) to further strong patent

IEG inddpsnctoad claanciescibviiaaharensseAonleniones

. Patent law would be weakened, and

innovation would be negatively

affected, if § 271(f)(1) is construed

RE EERE: Hla ca APE A ie

B. The Federal Circuit’s ruling should

stand because the safeguards against

overreach already in place for

§ 271(f)(1) are sufficient. ...........:ccecceeceeees

1. The facts of this case do not

illuminate the safeguards....................

2. Inducement is a crucial safeguard on

the scope of infringement under

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3. The requirement that the supplied

component be a “substantial portion”

protects against § 271(f)(1) having

CVOTURDONE BONING. o0nsseiessstacsemsesticeteen 16

C. Numerous recent changes in patent law

have provided additional protection

°°

TABLE OF AUTHORITIES

Page

CASES

Akamai Techs., Inc. v. Limelight

Networks, Inc.,

602 F.3d 1301 (Fed. Cir. 2012) ..............00000000000000 13

Alice Corp. Pty. Ltd. v. CLS Bank Inti,

BE, OR, ND CRD cccccecccccccccocseee 18

Arris Grp., Inc. v. British Telecomms.

PLC.

639 F.3d 1368 (Fed. Cir. 2011) ....................c0.0000-. 13

Bonito Boats, Inc. v. Thunder Craft

Boats, Inc.,

Te. censscsencouceee 18

Deepsouth Packing Co. v. Laitram

Corp.,

a casenenitvens 7

DSU Med. Corp. v. JMS Co.,

471 F.3d 1293 (Fed. Cir. 2006) ...........0.0000.cccc cece 14

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

Cee sis sccsssseosesstsssessscoecsenses 17

Fujt Photo Film Co. v. Jazz Photo Corp.,

394 F.3d 1368 (Fed. Cir. 2005) .............0.ccceceecceeee 14

Liquid Dynamics Corp. v. Vaughan Co.,

449 F.3d 1209 (Fed. Cir. 2006) ................. 13, 14, 15

Mayo Collaborative Servs. v.

Prometheus Labs., Inc.,

eee ee ee, Oe, AOD GIOID).......0.00000000000-. 18

-iv-

WesternGeco L.L.C. v. ION Geophysical

Corp.,

791 F.3d 1340 (Fed. Cir. 2015) ..........0.00...

STATUTES

Or ne Fe

Oe Wo einciccs cress

BO rn a a a Ed oe

Patent Law Amendment Act of 1984,

Pub. L. No. 98-622, § 101, 98 Stat.

OTHER AUTHORITIES

130 Cong. Rec. 28,069 (1984)...........0ccceee

Ashley J. Stevens,

The Enactment of Bayh-Dole, 29 J.

Tech. Transfer 93 (2004) ...........cccccceeeceeeees

Ass’n of Univ. Tech. Managers (AUTM),

U.S. Licensing Activity Survey: FY

EE wictiniietittgsnteictaeslvncsinisiaaciasswhens

Daniel E. Koshland, Jr.,

The Molecule of the Year, 246 Science

acs srntenssenicnestncctaabeicnintactaessddone

David Roessner et al.,

The Economic Impact of Licensed

Commercialized Inventions

Originating in University Research,

4B Thaw. FeR y BB GBI G. .nccneccccnticccessesecccses

Global Intellectual Property Center,

U.S. Chamber of Commerce,

Unlimited Potential (3d ed. 2015)............

-y-

The Golden Goose Award, 2013:

Thermus Aquaticus,

http://www.goldengooseaward.org/aw

ardees/c7vafs3ntt7jzovlxo68997rq5rx

ok (last visited Oct. 25, 2016)...........0000..00000..

The Nobel Prize in Chemistry 1993,

http://www.nobelprize.org/nobel_prize

s/chemistry/laureates/1993/ (last

| Raa ee ee

Valerie Landrio McDevitt et al.,

More than Money: The Exponential

Impact of Academic Technology

Transfer, 16 Tech. Innov. 75 (2014)..............

REGULATIONS

Be Gees cee taciniencnidianecnnbinicnnenneasnmanesas

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I. STATEMENT OF INTEREST!

Amicus Curiae Wisconsin Alumni Research

Foundation (“WARF”) was founded in 1925 as a

nonprofit entity to promote, encourage, and aid

scientific investigation and research at _ the

University of Wisconsin-Madison (“UW-Madison”).

One of WARF’s earliest accomplishments was to

patent a Vitamin D discovery that eventually

eliminated the childhood disease of rickets

worldwide. Other significant advancements from

UW-Madison and WARF include lifesaving organ

transplant technology, faster computer processors,

and Coumadin, the revolutionary treatment for

cardiovascular disease.

WARF’s portfolio includes more than 1,600

patented technologies covering a wide range of

categories including pharmaceuticals, agriculture,

food products, medical devices, pluripotent stem

cells, clean technology, information technology and

semiconductors. WARF has returned more than $ 2.3

billion in licensing revenue, adjusted for inflation, to

UW-Madison and the Morgridge Institute of

Research to fund research programs and initiatives.

In recognition of WARF’s contributions to science

and technology, WARF was awarded the National

! The parties have consented to the filing of this brief in global

consents to the filing of amicus briefs in support of any party.

In accordance with Rule 37.6, no counsel for a party authored

this brief in whole or in part, and no person or entity, other

than WARF or its counsel, has made any monetary

contributions to the preparation or submission of this brief.

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Medal of Technology in 2005—the nation’s highest

honor for technology innovation.

Il. INTRODUCTION AND SUMMARY OF THE

ARGUMENT

The Court should preserve the strength of the

U.S. patent system. University research is critical to

innovation in this country. And strong U.S. patents

are critical to incentivizing investments in research.

Any change in patent law that reduces the perceived

ability to protect investments in _ intellectual

property, including any change in the Federal

Cireuit’s interpretation of 35 U.S.C. § 271()(1), will

negatively affect university research and the

technology transfer sector.

At the time that Congress enacted § 271(f),

Congress was attempting to stimulate innovation

and strengthen patent law. This is apparent from the

1980 enactment of the Bayh-Dole Act, the highly

successful legislation that gave rise to the technology

transfer sector in American universities. Only a

short time later, in 1984, Congress amended the

Bayh-Dole Act and enacted § 271(f).

The cause of action in § 271(f) is already narrow.

The perceived negative effects of the Federal

Circuit’s ruling posited by others are unlikely to

occur because there are adequate safeguards in place

to ensure that the provision does not exceed its

intended scope.

The Court should affirm the Federal Circuit

decision; reversal is not appropriate or necessary at

this time, and the Federal Circuit and the jury were

both correct that Zag polymerase is a qualitatively

substantial component in the invention at issue.

It. ARGUMENT

A. Strong U.S. patents incentivize innovation.

A correlation exists between robust intellectual

property protection and positive economic benefits,

such as increased investment in research and

development, high-value job growth, and increased

innovative output. See Global Intellectual Property

Center, U.S. Chamber of Commerce, Uniimited

Potential 9-10 (8d ed. 2015). University and other

federally funded research play an important role in

innovation in this country, often providing the

groundwork for start-up businesses and significant

technological advances. Successful commercializa-

tion and application of the work resulting from this

research is bolstered by protecting the intellectual

property involved. Strong patent law helps American

businesses prosper.

1. The 1980 Bayh-Dole Act granted patent

ownership and license rights to

universities to encourage innovation in

this country.

University research plays a major role in the

advancement of technology in the United States

(“U.S.”). Universities are the birthplace of new

knowledge, discoveries, and technical know-how.

Beyond basic research, new products, equipment,

and instrumentation are also designed and tested in

academic settings. Human capital embodied in

students trained by American universities also

directly benefits the business sector when those

individuals become employees and business owners.

In 1980, Congress itself confirmed the importance

of university research when it enacted the federal

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Bayh-Dole Act. See 35 U.S.C. § 200°212; 37 C.E.R.

Part 401. This landmark legislation gave universities

the right to own and license patents resulting from

federally funded research. The Act thus spurred

significant transfer of technology and _ scientific

knowledge from universities to businesses.

The reason that Congress enacted the Bayh-Dole

Act was not to enrich universities, but to attempt to

stimulate the pace of innovation and the American

economy, which had slowed over the 1960s and 70s.

Ashley J. Stevens, The Enactment of Bayh-Dole, 29

J. Tech. Transfer 93 (2004).

The Bayh-Dole Act has been a _ resounding

success. Prior to the Bayh-Dole Act, when the federal

government owned inventions resulting from

federally funded research, fewer than 5% of the

28,000 federally owned patents were licensed to

industry. Valerie Landrio McDevitt et al., More than

Money: The Exponential Impact of Academic

Technology Transfer, 16 Tech. Innov. 75 (2014).

According to the 2014 AUTM Licensing Survey,

conducted by the Association of University

Technology Managers (“AUTM”), technology transfer

activities from institutions including universities,

hospitals and research institutes generated $28

billion in net product sales, 914 new start-up

companies, and 965 new commercial products in that

year. Ass’n of Univ. Tech. Managers (AUTM), U.S.

Licensing Activity Survey: FY 2014 8, 10 (2014).

Respondents to the AUTM survey also reported

6,363 new U.S. patents issued and 5,435 new

licenses executed in 2014. /d. at 8. The survey

concludes that “[clompanies spun out of research

universities have a far greater success rate than

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other companies, creating good jobs and spurring

economic activity.” Jd at 10. Indeed, 4,688 of

companies born of technology transfer activities were

still in business at the end of 2014. /d.

WARF is a leader in technology transfer and

itself manages more than 700 pending and 1,850

issued U.S. patents on UW-Madison technologies, as

well as over 2,000 foreign equivalents. WARF offers

more than 2,000 technologies for licensing, and

maintains more than 560 active commercial license

agreements. WARF’s most important patents include

the blood anticoagulant Warfarin, a coating process

making pills easier to swallow, treatments for

osteoporosis and cancer, magnetic resonance

techniques, and a discovery known as the “Wisconsin

Solution” that prolongs the use of transplant organs.

WARF’s investment in research and technology has

led to the creation of over 80 start-up companies.

The many benefits of university research are

significant and quantifiable. It has been estimated

that, assuming a 2% royalty and no _ product

substitution effects, over a 15-year period from 1996-

2010, university licensing agreements based on

product sales contributed at least $70.5 billion and

as much as $277.6 billion (2005 dollars) to the U.S.

gross domestic product. David Roessner et al., Zhe

Economic Impact of Licensed Commercialized

Inventions Originating In University Research, 42

Res. Pol’y 23, 23 (2013). Assuming moderately

conservative royalties of 5%, such agreements would

have contributed more than $122.2 billion to the

gross domestic product. /d.

-6-

It follows that patents are critical for securing

investments in university research and _ for

developing and licensing university inventions.

Private companies investing in and sponsoring

research at universities want to protect the results of

those research and development activities. Similarly,

licensees of federally funded research rely on the

patent system for stability in their rights. Strong

U.S. patents are essential to the efforts of

universities and institutions to transfer technology

and launch start-up companies. Indeed, the success

of the Bayh-Dole Act depends on a strong patent

system. Any change in law that reduces the

perceived ability of a patent owner or licensee to

protect the results of research and development

sponsored in universities will erode the willingness

of private companies to seek a patent license or to

sponsor research at a university.

2. In 1984, Congress enacted 35 U.S.C.

§ 271(f) to further strong patent rights.

The timing of the enactment of 35 U.S.C. § 271(f)

is significant. In the 1980s, Congress intended to

strengthen patent rights. In 1984, the year in which

Congress enacted § 271(f(1), (see Patent Law

Amendment Act of 1984, Pub. L. No. 98-622, § 101,

98 Stat. 3383), Congress also amended the Bayh-

Dole Act. During this time when Congress was

strengthening patent rights, it could not have

intended § 271(f) to be a trivial provision.

The specific reason that Congress enacted

§ 271(f) was to “prevent copiers from avoiding U.S.

patents by supplying components of a patented

product in this country so that the assembly of the

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components may be completed abroad.” 130 Cong.

Rec. 28,069 (1984) (statement of Rep. Kastenmeier).

The provision was, in part, a response to this Court’s

decision in Deepsouth Packing Co. v. Laitram Corp.,

406 U.S. 518 (1972), Ja.

The legislative history makes clear that the 1984

Congress sought strong patent law. The specific goal

of the subcommittee sponsoring new § 271(f) was to

“secure for the owners of intellectual property,

including patent holders, a workable, efficient, and

vigorous set of laws to protect their creations.” 130

Cong. Rec. 28,069. Strong patent law is the way to

implement that goal:

It is only through implementation of the

constitutional mandate of encouraging

the sciences and the useful arts that we

will be able to spur the inventive spirit

that has made our country a world

leader. Indeed, our ability to foster

innovation is a central element to our

national security, for without

technological and scientific

developments, we could not maintain

our current standard of living or hope

for the diminution of unemployment

caused by foreign competition.

ld.

While the 1984 bill resulting in § 271 was

“likely to be seen by most observers as mundane or

technical in nature,” those types of amendments are

still important. /d. For “without enactment of these

housekeeping-oriented measures, the patent system

would not be responsive to the challenges of a

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changing world and the public would not benefit

from the release of creative genius.” /d.

The petitioners (hereinafter “LifeTech”), as well

as other amici curiae, argue that § 271(f) cannot

cover the supply of a single component because

Congress was only trying to address the loophole at

issue in Deepsouth Packing Co. However, Congress’s

intent was clear, to allow “the patent system [to] be

responsive to the challenges of a changing world.” Jd.

(emphasis added). Therefore, Congress was not only

attempting to close the loophole directly at issue in

Deepsouth Packing Co., but also to address other

similar loopholes that may be raised in the future.

Permitting liability where a party only supplies a

single component furthers that goal.

In 1984, Congress also made amendments to the

Bayh-Dole Act. See Pub. L. No. 98-620, § 501, 98

Stat. 3335, 3364-68 (1984). While these amendments

were relatively minor, they did, among other things,

eliminate prior restrictions on the terms of exclusive

patent licenses. /d.

Based on these Congressional Acts, it is clear

that, in the 1980s, Congress intended to promote

strong patent law, including when it enacted § 271(f).

The legislative history of § 271(f)(1) is entirely

consistent with the textual statutory language and

the Federal] Circuit’s decision. The 35 years since the

passage of the Bayh-Dole Act have demonstrated

that the goals addressed by these 1980s actions are

still sound. And, the statistics discussed above

demonstrate that the legislation has worked to

encourage the transfer of technology from

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universities to the business sector. There is,

therefore, no need to reverse.

3. Patent law would be weakened, and

innovation would be negatively affected, if

§ 271(f(1) is construed narrowly.

Strong patent laws promote innovation, which

facilitates economic growth. It is a virtuous circle

with positive results. Strong patents incentivize

companies to take licenses from patent owners,

instead of taking the risks of infringement. Licenses

result in royalty revenue to patent owners. Greater

potential royalty revenue incentivizes inventors to

invent and publicly disclose their inventions through

the patent process.

When universities own patents, the revenue

generated from licenses is directly reinvested in

more research, improved facilities, and attracting

talent to American universities. This leads to

additional technological advancement and more

technology available for licensing to the business

sector.

Even specific statutory sub-parts, such as

§ 271(f)(1), are important to a regime of strong

patent laws. Patent law would be weakened if

§ 271(f)(1) is construed to necessarily exclude parties

that supply a single component from the U.S. and

actively induce the combination of the component

outside of the U.S. in a manner that would infringe if

done within the country. For example, parties who

supply those components would no longer take a

license.

The perception of a weakened patent system may

also encourage infringers. This would lead to less

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licensing and less revenue for scientific investigation

and research. An overly narrow interpretation of

§ 271(£(1) would be inconsistent with the clear

legislative intent of the 1984 Congress that enacted

the provision.

B. The Federal Circuit’s ruling should stand

because the safeguards against overreach

already in place for § 271(f)(1) are sufficient.

The Court should affirm the Federal Circuit's

interpretation of § 271(f)(1) because there are

already safeguards in place that prevent § 271(f)(1)

from having an overbroad scope.

1. The facts of this case do not illuminate the

safeguards.

Liability under § 271(f(1) is relatively

uncommon. And the _ provision already has

meaningful safeguards against the provision having

too broad a scope. But as explained below, the case at

hand has unique facts that cause the discussion of

these safeguards to fade to the background.

Promega Corporation is the exclusive licensee of

the Tautz patent at issue, U.S. Patent No. RE

37,984. Pet. App. 5a. Claim 42 of the Tautz patent is

the only one at issue now, and it covers a kit for

analyzing DNA samples, where the kit comprises

five components: a primer mix, a polymerizing

enzyme, nucleotides, a buffer solution, and control

DNA. Jd. at 7a-8a. The polymerizing enzyme that

LifeTech used was 7ag polymerase. Id.

Promega asserted the Tautz patent against

LifeTech. Jd. at 9a. LifeTech manufactured the Zag

polymerase required by claim 42 in the U.S., and

we 8 Ge

then shipped the component to its facility in the

United Kingdom (“UK”). Jd. at 8a. The UK facility

then assembled the domestic component with four

other components to make the kit which would

infringe the Tautz patent if the kit were assembled

in the U.S. /d. at 22a.

One unique aspect of this case relates to the

inducement aspect of § 271(f)(1). The district court

held that Promega waived its argument that the

LifeTech entity shipping the component from the

U.S. was a separate entity from the LifeTech facility

in the UK that assembled the patented product.

Opp’n Br. 15 n.5. This created a situation where

LifeTech was deemed to be inducing itself under

§ 271(f)(1). Pet. App. 24a. This is unusual because

the vast majority of businesses with international

scope have different operating entities in different

countries or regions. But in this case, “whether

LifeTech exhibited the necessary knowledge and

intent to combine the Tag polymerase with the

remaining components of its genetic testing kit ‘in a

manner that would infringe’ the Tautz patent if that

combination occurred within the U.S. is not

contested and presumed.” /d. at 34a. (emphasis

added). In most cases, there would be separate

entities involved, and inducement would not be

uncontested or presumed.

LifeTech, as well as other amici curiae, argue that

under the Federal Circuit’s decision, innocent

domestic manufacturers shipping a component

abroad are at a heightened risk for infringement.

Pet. Br. 5, 38. This is not so; nor is it an accurate

extrapolation of the Federal Circuit’s holding.

LifeTech was not an_ innocent domestic

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manufacturer. LifeTech intended to and succeeded in

inducing itself to combine the supplied component

with other components in a manner that would

infringe a patent if combined in the U.S.

Section 271(f)(1) is not intended to—and did not

in this case—subject an innocent domestic

component supplier to liability. To protect innocent

domestic manufacturers shipping a component

abroad, § 271(f)(1) contains an adequate safeguard

because no liability attaches unless the requisite

intent is found.

An additional safeguard on the scope of

§ 271(f)(1) is that the component or component

supplied must constitute “a substantial portion of

the components of the patented invention.” This is a

highly fact-specific inquiry; in this case, it was

essentially admitted because “LifeTech’s own witness

testified that the 7ag polymerase is one of the ‘main’

and ‘major’ components of the accused kits.” Pet.

App. 34a. The Federal Circuit even emphasized the

fact-specific nature of its conclusion explaining that

it was “based on the facts of this particular case.” /d.

at 28a.

2. Inducement is a crucial safeguard on the

scope of infringement under § 271(f)(1).

The cause of action under § 271(f)(1) is already

narrow. Unlike § 271(a) concerning traditional direct

infringement, § 271(f)(1) is not a strict liability tort.

Section 271(f)(1) requires active inducement:

Whoever without authority supplies or

causes to be supplied in or from the

United States all or a_ substantial

portion of the components of a patented

°-13-

invention, where such components are

uncombined in whole or in part, in such

manner as to actively induce the

combination of such components outside

of the United States in a manner that

would infringe the patent if such

combination occurred within the United

States, shall be liable as an infringer.

35 U.S.C. § 271(£)(1) (emphasis added).

Under § 271()(1), “lal finding of inducement

requires both an underlying instance of direct

infringement and a requisite showing of intent.”

Liquid Dynamics Corp. v. Vaughan Co., 449 F.3d

1209, 1222 (Fed. Cir. 2006) (citation omitted).

Like § 271(f)(1), § 271(b) requires inducement.

Section 271(f)(1) differs from 271(b) in what conduct

must be induced. Section 271(f)(1) requires that the

conduct being induced is “the combination of such

components,” while §271(b) requires that the

conduct being induced is “infringement of a patent.”

35 U.S.C. §§ 271((1), 2710b).

In the context of § 271(b), inducement has been

described as that which “causelsl, urgelsl,

encouragels|, or aid[s]’ the infringing conduct.”

Akamai Techs., Inc. v. Limelight Networks, Inc., 692

F.3d 1301, 1308 (Fed. Cir. 2012), revd on other

grounds, 572 U.S. __, 134 S. Ct. 2111 (2014), quoting

Arris Grp., Inc. v. British Telecomms. PLC, 639 F.3d

1368, 1379 n.13 (Fed. Cir. 2011). “Accordingly,

inducement requires evidence of culpable conduct,

directed to encouraging another’s infringement, not

merely that the inducer had knowledge of the direct

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infringer’s activities.” DSU Med. Corp. v. JMS Co.,

471 F.3d 1293, 1306 (Fed. Cir. 2006).

In the context of § 271(f)(1), a plaintiff would

need to prove that the accused domestic

manufacturer actively induced the combination of

such components. Supplying a component to a third

party abroad, without more, is not inducement under

§ 271()(1). In such a case, the domestic

manufacturer would be the inducee, not the inducer,

and no liability would attach.

The petitioners suggest that the domestic

manufacturer would be liable if it were put on notice

of the patent. Pet. Reply Br. 10. Putting aside

whether a knowledge requirement even exists under

§ 271(f)(1)2, it is certainly true that “la] patentee

may prove intent through circumstantial evidence,”

which can include knowledge of the patent. Liquid

Dynamics Corp., 449 F.3d at 1222 (quoting Fuji

Photo Film Co. v. Jazz Photo Corp., 394 F.3d 1368,

1377 (Fed. Cir. 2005)).

However, even if a domestic manufacturer was

put on notice of a _ patent, for example by

correspondence from the patent owner, and supplied

a component that was combined abroad in a manner

2 “We need not reach the question whether the district court

applied the correct standard under § 271(f)(1),” namely that the

defendant knew the intended combination would be infringing

if done domestically, because “[t]he verdict was clear that the

jury found liability under § 271(f(2) for all asserted claims.”

WesternGeco L.L.C. v. LON Geophysical Corp., 791 F.3d 1340,

1348 (Fed. Cir. 2015), judgment vacated on other grounds, 136

S. Ct. 2486 (2016).

-15-

that would infringe the patent if combined in the

U.S., this would still be insufficient to raise to the

level of intent necessary to prove infringement under

§ 271(f)(1). See id. The accused manufacturer would

have had to induce the combination abroad for

liability to attach.

If the domestic manufacturer went further, for

example, by providing instructions with the

component identifying the other components needed

and how to combine them, then the domestic

manufacturer would come closer to having the

requisite intent and may be liable under § 271(f)(1).

Even under’ these’ circumstances, further

information would be needed to determine whether

liability would attach based on the specific facts—

including, whether the component at issue was a

“substantial portion of the components” of the

invention.

In the instant case, the domestic manufacturer

and the foreign party combining the components

were deemed to be the same. And it is undisputed

that LifeTech had both knowledge of the patent and

the requisite intent to combine the supplied

component with other components in a manner that

would infringe the asserted patent if combined in the

U.S. Pet. App. 34a. In most cases, however,

inducement would not be “presumed,” and would

serve as an important limitation on the scope of

§ 271(0(1).

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3. The requirement that the supplied

component be a “substantial portion”

protects against § 271(f)(1) having

overbroad scope.

The second safeguard on the scope of § 271(f)(1) is

that a patent owner must prove that the component

or components supplied abroad constitute a

“substantial portion of a patented invention.” 35

U.S.C. § 271(f)(1). In some cases, a single component

may not be enough, but in this case, it is. The

Wisconsin jury concluded that there was liability

under § 271(f)(1), and the Federal Circuit held that

there was sufficient record evidence to support a

finding that 7’q polymerase is a “substantial

portion” of the invention. See Pet. App. 28a. These

findings were appropriate.

Taq polymerase is profoundly important, both in

the context of this case and in the field in general.

Taq polymerase is the key ingredient in the

polymerase chain reaction (PCR) method used to

amplify DNA segments for further use and study.

PCR is widely used in molecular biology. Indeed, 7aq

polymerase made _ possible many important

discoveries and_ technological advancements

including, sequencing the human genome, life saving

vaccines and sophisticated forensic science. The 1993

Nobel Prize in Chemistry was awarded to Kary B.

Mullis and Michael Smith for the invention of the

PCR method. The Nobel Prize in Chemistry 1998,

http://www.nobelprize.org/nobel_prizes/chemistry/lau

reates/1993/ (last visited Oct. 25, 2016). In 1989,

Science Magazine named 7Zaq polymerase its first

“Molecule of the Year.” Daniel E. Koshland, Jr., The

Molecule of the Year, 246 Science 1541 (1989). And,

-i7-

in 2013, the U.S. government gave the Golden Goose

award to Thomas Brock and Hudson Freeze who

discovered the Thermus aquaticus bacteria from

which 7aq polymerase originates. The Golden Goose

Award, 2013: Thermus Aquaticus,

http://www. goldengooseaward.org/awardees/c7vafs3n

tt7jzovlxo68997rq5rxok (last visited Oct. 25, 2016).

The Court should affirm the Federal Circuit’s

conclusion that 7aq polymerase was a substantial

portion of the invention in the Tautz patent. There is

no reason why a single component cannot be an

important or essential part of a whole, as it is in

other contexts. This is particularly true for a

molecule as significant as 7ag polymerase.

C. Numerous recent changes in patent law have

provided additional protection against patents

and claims of dubious merit.

An independent reason that the Court should not

disturb the Federal Circuit’s ruling is that recent

changes to patent law have adjusted existing

safeguards in the U.S. patent system. The patent

system contains numerous delicate balances. While

adjustments are necessary in a dynamic society, they

should be made with care. It is too soon to know how

these recent changes have affected the complex

equilibrium of patent law.

For example, in 2006, this Court held that the

traditional four-factor test that governs the award of

permanent injunctive relief must be equally applied

in patent cases. eBay Inc. v. MercExchange, L.L.C.,

547 U.S. 388 (2006). No longer are patent owners

awarded injunctions based solely on a finding of

infringement; injunctions are harder to obtain.

-18-

Post grant review procedures became available in

2012 with the enactment of the America Invents Act.

Pub. L. No. 112-29, 125 Stat. 284 (2011). Parties

defending against patents of dubious merit now have

more expedient and cost effective alternatives to

litigation to dispose of such threats.

That same year, in Mayo Collaborative Servs. v.

Prometheus Labs., Inc., 566 U.S. __, 1382 8S. Ct. 1289

(2012), this Court set a two part test for

distinguishing patents that claim laws of nature,

natural phenomena, and abstract ideas from those

that claim patent-eligible applications of those

concepts. Two years later, this Court provided

further guidance to that two part test in Alice Corp.

Pty. Ltd. v. CLS Bank Inti, 573 U.S. __, 134 S. Ct.

2347 (2014). The United States Patent and

Trademark Office and courts now are _ better

equipped to dispose of over-broad patents covering

abstract ideas.

Accused infringers are well equipped to protect

themselves from claims and patents of dubious

merit. But all of these changes have affected the

delicate balance between encouraging innovation

and stifling competition. See Bonito Boats, Inc. v.

Thunder Craft Boats, Inc., 489 U.S. 141, 146 (1989).

It is too soon to tell whether the scales are balanced

or have been overcorrected. There is nothing

presented in LifeTech’s arguments or the facts of this

case that warrant further adjustment of this

balance.

IV. CONCLUSION

WARF respectfully submits that the Federal

Circuit’s decision should remain undisturbed. 35

U.S.C. § 271(f)(1)

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already includes adequate

safeguards and no alteration in the law construing

the provision is necessary at this time of significant

change in American patent law.

October 31, 2016

Respectfully submitted,

JENNIFER L. GREGOR

Counsel of Record

GODFREY & KAHN, S.C.

One East Main Street, Suite 500

Madison, WI 53703

(608) 257-3911

jgregor@gklaw.com

SHANE DELSMAN

GODFREY & KARN, S.C.

833 East Michigan Street,

Suite 1800

Milwaukee, WI 53202

(414) 287-9653

sdelsman@gklaw.com

Counsel for Amicus Curiae

Wisconsin Alumni Research

Foundation