Petition for Writ of Certiorari — Willowood, LLC, et al., Petitioners v. Syngenta Crop Protection, LLC

Supreme Court briefMar 17, 2020

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No. _______

In The

Supreme Court of the United States

-------------------------- ♦ ---------------------------

WILLOWOOD, LLC, WILLOWOOD USA, LLC,

WILLOWOOD AZOXYSTROBIN, LLC,

WILLOWOOD LIMITED,

Petitioners,

SYNGENTA CROP PROTECTION, LLC,

Respondent.

-------------------------- ♦ --------------------------

On Petition for a Writ of Certiorari to the United

States Court of Appeals for the Federal Circuit

-------------------------- ♦ --------------------------

PETITION FOR WRIT OF CERTIORARI

AND APPENDIX VOLUME I OF II

-------------------------- ♦ --------------------------

Steven E. Tiller

Counsel of Record

WHITEFORD TAYLOR PRESTON LLP

Seven Saint Paul Street, Suite 1300

Baltimore, Maryland 21202

(410) 347-9425

stiller@wtplaw.com

Barry S. Neuman

WHITEFORD TAYLOR PRESTON LLP

1800 M Street, NW, Suite 450N

Washington, DC 20036

(202) 659-6761

bneuman@wtplaw.com

Barry E. Bretschneider

WHITEFORD TAYLOR PRESTON LLP

3190 Fairview Park Drive, Suite 800

Falls Church, Virginia 22042

(703) 280-9086

bretschneider@wtplaw.com

Counsel for Petitioners

Dated: March 17, 2020

THE LEX GROUPDC i 1050 Connecticut Avenue, N.W. i Suite 500, #5190 i Washington, D.C.

(202) 955-0001 i (800) 856-4419 i www.thelexgroup.com

20036

QUESTIONS PRESENTED

This Petition presents two questions for

review:

Whether

liability

for

patent

infringement under 35 U.S.C. §271(g) requires that

all steps of a patented process must be practiced by,

or at least attributable to, a single entity, a

requirement that this Court previously recognized is

a prerequisite for infringement under 35 U.S.C.

§§271(a) and (b) in Limelight Networks, Inc. v.

Akamai Technologies, Inc., 572 U.S. 915 (2014).

Whether, by requiring EPA to grant

expedited review and approval of labels for generic

pesticides that are “identical or substantially similar”

to the previously approved labels for the same

product, Congress intended to preclude claims of

pesticide labels.

PARTIES TO THE PROCEEDING

Petitioners, who were defendants in the

district court and respondents/cross-appellants in the

court of appeals, are Willowood USA, LLC (“WWUSA”), Willowood, LLC (“WW-LLC”), Willowood

Azoxystrobin, LLC (“WW-Azoxy”), and Willowood

Limited (“WW-China”)(collectively, “Willowood”).

Respondent, Syngenta Crop Protection, LLC

(“Syngenta”), was the plaintiff and appellant/crossappellee below.

CORPORATE DISCLOSURE STATEMENT

WW-USA is not a publicly-traded entity. WWUSA’s parent is Willowood USA Holdings, LLC,

which is owned by Dream Acquisition, LLC, which is

owned by Lariat Partners, LP. No publicly-held

entity owns any WW-USA stock.

Neither WW-LLC nor WW-Azoxy are publiclytraded entities. WW-LLC and WW-Azoxy are wholly

owned subsidiaries of WW-USA. No publicly-held

entity owns any WW-LLC or WW-Azoxy stock.

WW-China is not a publicly-traded entity and

has no parent entity. No publicly-held entity owns

any WW-China stock.

iii

RELATED CASES

Syngenta Crop Protection, LLC v. Willowood, LLC et

al, No. 1:15-cv-274, U.S. District Court for the Middle

District of North Carolina. Judgements on appeal

entered March 24 and April 10, 2017.

Syngenta Crop Protection, LLC v. Willowood, LLC et

al, Nos. 2018-1614 and 2018-2044, U.S. Court of

Appeals for Federal Circuit. Judgement entered

December 18, 2019.

TABLE OF CONTENTS

Page

QUESTIONS PRESENTED ........................................ i

PARTIES TO THE PROCEEDING ........................... ii

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

RELATED CASES .....................................................iii

TABLE OF CONTENTS............................................ iv

TABLE OF AUTHORITIES ...................................... xi

OPINIONS BELOW ................................................... 1

JURISDICTION ......................................................... 1

STATUTORY

AND

REGULATORY

PROVISIONS INVOLVED......................................... 1

STATEMENT OF CASE ............................................ 2

A. Factual and Procedural Background ......... 2

B. Pre-Trial Rulings ........................................ 3

1. Patent Infringement ............................. 3

2. Copyright Claims .................................. 4

C. Proceedings in the Federal Circuit ............ 6

1. Patent Infringement ............................. 7

2. Copyright Infringement ........................ 9

REASONS FOR GRANTING PETITION ................ 10

A. Patent Infringement ................................. 10

B. Copyright Infringement ........................... 11

ARGUMENT ............................................................. 12

THIS COURT SHOULD REVERSE

THE

APPELLATE

COURT’S

HOLDING THAT THE SINGLE

ENTITY RULE DOES NOT APPLY TO

SECTION 271(g) OF THE PATENT

ACT ................................................................. 12

A. Failing to Apply the Single Entity

Rule to §271(g) Would Impermissibly

Expand the Scope of §271(g) Beyond

Congress’ Intent ........................................ 13

B. The Federal Circuit’s Holding

Impermissibly Extends the Patent

Owner’s Monopoly Beyond the

Expiration of the Patents Covering

the Product at Issue ................................. 19

C. The Federal Circuit’s Decision

Applies Different Interpretations of

the Same Statutory Provision Within

§271 ........................................................... 21

D. The Federal Circuit’s Reliance on

Other Provisions of the U.S. Patent

Act to Support its Holding is

Misplaced .................................................. 22

II. THIS COURT SHOULD REVERSE

THE FEDERAL CIRCUIT’S HOLDING

THAT FIFRA DOES NOT PRECLUDE

CLAIMS

PESTICIDE LABELS .................................... 25

A. The FIFRA Statutory Scheme.................. 25

B. The Federal Circuit’s Holding that

FIFRA

Does

Not

Necessarily

Preclude Copyright Protection for

Pesticide Labels Effectively Repeals

the Statute’s Explicit Authorization

of Labels that are “Identical or

Substantially Similar” to Registered

Labels ........................................................ 29

C. Allowing Copyright Infringement

Claims Against Pesticide Labels

Would be Contrary to FIFRA’s

Fundamental Goals of Promoting

Generic Competition and Would

Upend

Decades

EPA’s

Implementation of the Statute................. 31

D. This Court’s Review is Warranted

Because the Federal Circuit’s

Decision Cannot be Reconciled With

the Second Circuit’s Decision in

SmithKline ................................................ 35

APPENDIX, Volume I:

Opinion of

The United States Court of Appeals

For the Federal Circuit

entered December 18, 2019 ........................... 1a

Order of

The United States District Court

For the Middle District of North Carolina

Re: Granting in Part Defendants’ Motion for

Summary Judgment and Denying Plaintiff’s

Motion to Exclude Mr. Schatzow’s Report

entered April 10, 2017 ................................. 40a

vii

Memorandum Opinion and Order of

The United States District Court

For the Middle District of North Carolina

Re: Granting in Part and Denying in Part

Plaintiff’s Motion for Summary Judgment,

Denying in Part Defendants’ Motion for

Summary Judgment, and Granting in

Part and Denying in Part Plaintiff’s

Motion to Exclude Certain Expert Opinions

entered March 24, 2017 ............................... 42a

7 U.S.C. § 136 .................................................... 72a

7 U.S.C. § 136a .................................................. 92a

17 U.S.C. § 102 ................................................ 143a

17 U.S.C. § 105 ................................................ 144a

17 U.S.C. § 501 ................................................ 146a

21 U.S.C. § 355 ................................................ 149a

35 U.S.C. § 271 ................................................ 192a

35 U.S.C. § 287 ................................................ 200a

40 C.F.R. § 152.42 ........................................... 209a

40 C.F.R. § 152.50 ........................................... 209a

40 C.F.R. § 152.80............................................ 213a

40 C.F.R. § 152.81............................................ 214a

40 C.F.R. § 152.82............................................ 216a

40 C.F.R. § 152.83 ........................................... 217a

40 C.F.R. § 152.84............................................ 219a

viii

40 C.F.R. § 152.85............................................ 219a

40 C.F.R. § 152.86 ........................................... 222a

40 C.F.R. § 152.90 ........................................... 225a

40 C.F.R. § 152.91 ........................................... 226a

40 C.F.R. § 152.92 ........................................... 227a

40 C.F.R. § 152.93 ........................................... 228a

40 C.F.R. § 152.94 ........................................... 230a

40 C.F.R. § 152.95 ........................................... 231a

40 C.F.R. § 152.96 ........................................... 232a

40 C.F.R. § 152.97 ........................................... 234a

40 C.F.R. § 152.98 ........................................... 235a

40 C.F.R. § 152.99 ........................................... 237a

40 C.F.R. § 152.107 ......................................... 241a

40 C.F.R. § 152.108 ......................................... 241a

40 C.F.R. § 152.113 ......................................... 243a

40 C.F.R. § 156.3 ............................................. 246a

40 C.F.R. § 156.10 ........................................... 246a

40 C.F.R. § 156.60 ........................................... 263a

40 C.F.R. § 156.62 ........................................... 265a

40 C.F.R. § 156.64 ........................................... 267a

40 C.F.R. § 156.66 ........................................... 268a

40 C.F.R. § 156.68 ........................................... 269a

40 C.F.R. § 156.70 ........................................... 270a

40 C.F.R. § 156.78 ........................................... 273a

40 C.F.R. § 156.80 ........................................... 277a

40 C.F.R. § 156.85 ........................................... 277a

40 C.F.R. § 156.140 ......................................... 279a

40 C.F.R. § 156.144 ......................................... 283a

40 C.F.R. § 156.146 ......................................... 284a

40 C.F.R. § 156.156 ......................................... 288a

40 C.F.R. § 156.159 ......................................... 290a

40 C.F.R. § 156.200 ......................................... 290a

40 C.F.R. § 156.203 ......................................... 291a

40 C.F.R. § 156.204 ......................................... 292a

40 C.F.R. § 156.206 ......................................... 293a

40 C.F.R. § 156.208 ......................................... 295a

40 C.F.R. § 156.210 ......................................... 299a

40 C.F.R. § 156.212 ......................................... 301a

S. Rep. 100-83, Process Patents Amendments

Act of 1987 (June 23, 1987) ............................. 312a

APPENDIX, Volume II: (Separately Bound)

H. R. Conf. Rep. 100-576 (1988)...................... 441a

Letter to Warren Stickle, President of Chemical

Producers & Distributors Association, from

Susan B. Hazen, Principal Deputy Assistant

Administrator of the U.S. Environmental

Protection Agency

dated August 3, 2005 ................................. 480a

Declaration of Lois Rossi

undated....................................................... 483a

Declaration of Debra Edwards,

With Attached Declaration of Lois Rossi,

dated June 17, 2009 ................................... 491a

Willowood Azoxy 2C Label Submitted to EPA

dated August 15, 2013 ............................... 501a

TABLE OF AUTHORITIES

Page(s)

CASES

Ajinomoto Co. v. Archer-Daniels-Midland Co.,

228 F.3d 1338 (Fed. Cir. 2000)....................... 14-15

Brulotte v. Thys Co.,

379 U.S. 29 (1964) ............................................... 19

Cardiac Pacemakers, Inc. v. St. Judge Medical, Inc.,

576 F.3d 1348 (Fed. Cir. 2009)............................ 22

Corley v. United States,

556 U.S. 303 (2009) ............................................. 29

Deepsouth Packing Co. v. Laitram Corp.,

406 U.S. 518 (1972) ........................................ 16-17

Eli Lilly & Co. v. Am. Cyanamid Co.,

82 F.3d 1568 (Fed. Cir. 1996) ............................. 15

FMC Corp. v. Control Solutions, Inc.,

369 F. Supp. 2d 539 (E.D. Pa. 2005) ............... 6, 32

Kimble v. Marvel Entertainment,

135 S. Ct. 2401 (2015) ................................... 19, 20

Limelight Networks, Inc. v.

Akamai Technologies, Inc.,

572 U.S. 915 (2014) ..................................... passim

Muniacution, Inc. v. Thomson Corp.,

532 F.3d 1318 (2008) ..................................... 12, 13

Mycogen Plant Sci., Inc. v. Monsanto Co.,

252 F.3d 1306 (Fed. Cir. 2001),

vacated on other grounds,

535 U.S. 1109 (2002) ........................................... 15

xii

NTP, Inc. v. Research in Motion,

418 F.3d 1282 (Fed. Cir. 2005)............................ 15

Ratzlaf v. United States,

510 U.S. 135 (1994) ....................................... 21, 24

Ruckelshaus v. Monsanto Co.,

467 U.S. 986 (1984) ............................ 25-26, 28, 31

SmithKline Beecham Consumer

Healthcare, L.P. v. Watson Pharm., Inc.,

211 F.3d 21 (2d Cir. 2000) ........................... passim

Synaptic Pharm. Corp. v. MDS Panlabs, Inc.,

265 F. Supp. 2d 452 (D. N.J. 2002) ..................... 16

Thomas v. Union Carbide Agric. Prods. Co.,

473 U.S. 568 (1985) ............................................. 31

STATUTES

7 U.S.C. § 136(a)(c)(3)(B)(i)(I)................................... 28

7 U.S.C. § 136(p) ....................................................... 26

7 U.S.C. § 136(q)(1)(E) .............................................. 26

7 U.S.C. § 136(q)(1)(F) .............................................. 26

7 U.S.C. § 136(q)(1)(G) .............................................. 26

7 U.S.C. § 136(q)(2)(A)-(D) ....................................... 26

7 U.S.C. § 136a(a) ..................................................... 25

7 U.S.C. § 136a(c)(1) ................................................. 25

7 U.S.C. § 136a(c)(1)(C) ............................................ 26

7 U.S.C. § 136a(c)(1)(F)(i) ......................................... 25

7 U.S.C. § 136a(c)(2) ................................................. 25

xiii

7 U.S.C. § 136a(c)(3)(B) ............................................ 27

7 U.S.C. § 136a(c)(3)(B)(i)(I) ............................. passim

7 U.S.C. § 136a(c)(3)(B)(ii)(II) .................................. 28

7 U.S.C. § 136a(c)(5) ..................................... 25, 27, 28

7 U.S.C. § 136a(c)(7) ................................................. 28

7 U.S.C. § 136a(c)(F)(iii) ........................................... 25

7 U.S.C. § 136a(t) ...................................................... 25

7 U.S.C. § 136a(u) ..................................................... 25

7 U.S.C. § 136j(a)(2)(G)............................................. 26

7 U.S.C. § 136w-8(b)(3)(tbl.1) ................................... 27

17 U.S.C. § 102............................................................ 1

17 U.S.C. § 105............................................................ 1

17 U.S.C. § 501............................................................ 2

17 U.S.C. § 501(a) ....................................................... 1

28 U.S.C. § 1254(1) ..................................................... 1

28 U.S.C. § 1331.......................................................... 2

28 U.S.C. § 1338.......................................................... 2

35 U.S.C. § 271...................................................... 2, 21

35 U.S.C. § 271(a) ............................................. passim

35 U.S.C. § 271(b) ............................................. passim

35 U.S.C. § 271(f) ................................................ 22, 23

35 U.S.C. § 271(g) ............................................. passim

35 U.S.C. § 287(b) ............................................... 23, 24

xiv

35 U.S.C. § 287(b)(1)(A) ............................................ 24

35 U.S.C. § 287(b)(1)(C) ............................................ 23

REGULATIONS

40 C.F.R. Part 152 ................................................ 1, 25

40 C.F.R. § 152.42 ..................................................... 25

40 C.F.R. § 152.50 ..................................................... 25

40 C.F.R. § 152.50(e)................................................. 26

40 C.F.R. § 152.80-99................................................ 25

40 C.F.R. § 152.107 ................................................... 27

40 C.F.R. § 152.108 ................................................... 27

40 C.F.R. § 152.109 ................................................... 27

40 C.F.R. § 152.110 ................................................... 27

40 C.F.R. § 152.111 ................................................... 27

40 C.F.R. § 152.112 ............................................. 27, 29

40 C.F.R. § 152.113 ................................................... 29

40 C.F.R. Part 156 ................................................ 1, 26

40 C.F.R. § 156.10 ..................................................... 27

40 C.F.R. § 156.10(i)(1)(i) ......................................... 26

OTHER AUTHORITIES

H.R. Conf. Rep. No. 576, 100th Cong.,

2d Sess. 1085–86 (1988),

reprinted in 1988 U.S.C.C.A.N. 2118-19.................. 16

H.R. Rep. No. 100-939 (1988) ................................... 28

Office of Pesticide Programs, U.S. Envt. Prot.

Agency, Label Review Manual (rev. 2016)

(https://www.epa.gov/pesticideregistration/pesticide-registration-manual ....... 27, 29

S. Rep. No. 100-83 (1987) ......................................... 16

S. Rep. No. 100-346 (1988) ....................................... 28

PETITION FOR A WRIT OF CERTIORARI

________________________

Petitioners respectfully petition for a writ of

certiorari to review the judgment of the United States

Court of Appeals for the Federal Circuit.

OPINIONS BELOW

The opinion of the Federal Circuit (App. 1a) is

reported at 994 F.3d 1344 (Fed. Cir. 2019). The

district court decisions at issue are unreported. (App.

40a; 42a).

JURISDICTION

The judgment of the Federal Circuit was

entered on December 18, 2019. (App. 1a). This

Court’s jurisdiction is invoked under 28 U.S.C.

§1254(1).

STATUTORY AND REGULATORY

PROVISIONS INVOLVED

The relevant

provisions are:

statutory

and

regulatory

Section 271(g) of the Patent Act, 35 U.S.C.

§271(g);

Section 136a(c)(3)(B)(i)(I) of the Federal

Insecticide, Fungicide and Rodenticide

Act, 7 U.S.C. §136a(c)(3)(B)(i)(I);

Sections 102, 105 and 501(a) of the

501(a); and

40 C.F.R. Parts 152 and 156.

STATEMENT OF CASE

This case presents questions of fundamental

importance to the proper interpretation of the United

States Patent Act and, more specifically, of this

Court’s construction of that statute in Limelight

Networks. It also presents questions of fundamental

importance to the proper interpretation and

implementation of the Federal Insecticide, Fungicide

and Rodenticide Act (“FIFRA”) which governs the

registration, sale, and use of pesticide products in the

United States.

A. Factual and Procedural Background

On March 27, 2015, Syngenta sued Willowood1

in the United States District Court for the Middle

District of North Carolina, for infringement of four

patents concerning the fungicide compound known as

azoxystrobin. Two of the asserted patents claimed the

azoxystrobin compound and expired in 2014, while

the other two were directed to processes for

manufacturing azoxystrobin. Syngenta also asserted

pertaining to the labels accompanying the defendants’

generic azoxystrobin products. The district court’s

jurisdiction was predicated on 28 U.S.C. §§1331 and

1338, 17 U.S.C. §271 and 35 U.S.C. §501. Of the

myriad of issues addressed by the courts below, this

Petition seeks review of the Federal Circuit’s holdings

concerning (1) alleged infringement of one of the

process patents, U.S. Patent No. 5,847,138 (“the ‘138

On February 15, 2019, WW-USA, WW-LLC, and WW-Azoxy

filed for protection under the United States Bankruptcy Act in

the United States Bankruptcy Court for the District of Colorado,

Case No. 19-11079-KHT. On March 3, 2020, that court approved

a plan of reorganization.

patent”) and (2)

infringement.

Petitioners’ alleged copyright

Syngenta uses azoxystrobin as an active

ingredient in formulating a number of end-use

fungicide products under various brand names,

including QUADRIS® and QUILT EXCEL®. As

required by FIFRA, both products are sold with

detailed labels that provide directions for use, storage

and disposal, as well as first-aid instructions and

environmental physical and chemical hazard

warnings. The QUADRIS label is comprised of more

than fifty, pages of small-type texts and charts, while

the QUILT EXCEL label includes twenty-nine pages.

(App. 5a-6a, 501a).

WW-China is a Hong Kong company that

contracts for the manufacture of azoxystrobin in

China and sells the fungicide to WW-USA, a separate

company based in Oregon. WW-USA and its wholly

owned subsidiary WW-LLC contracted with third

parties in the United States to formulate the

azoxystrobin compound into generic end-use

fungicide products, which they then marketed and

sold in this country pursuant to registrations

approved by the Environmental Protection Agency

(“EPA”), under the names Azoxy 2SC and AzoxysProp

Xtra, which correspond in composition and labeling to

Syngenta’s QUADRIS® and QUILT XCEL®,

respectively. (App. 5a-6a).

B. Pre-Trial Rulings

1. Patent Infringement

Syngenta moved for summary judgment that

Willowood infringed all four patents, including the

‘138 patent. The district court denied that motion

with respect to the ‘138 patent. (App. 51a-53a). The

court found it to be undisputed that WW-Ltd

purchased azoxystrobin from its Chinese supplier,

Yangcheng Tai He Chemicals Corp (“Tai He”), and

sold it to WW-USA, which then imported the

azoxystrobin into the United States. (App. 51a-53a).

The court found that it was also undisputed that the

azoxystrobin was manufactured in China by

performing both steps of the process claimed in the

‘138 patent. (App. 51a-53a). However, relying on this

Court’s opinion in Limelight Networks, the district

court held that 35 U.S.C. §271(g) requires that all

steps of the claimed process be performed by, or at

least be attributable to, a single entity. (App. 51a53a). The district court found genuine issues of

material facts as to whether Tai He performed both

steps of the process claimed by the ‘138 patent or

whether Willowood directed Tai He and others to

practice the claimed process. (App. 51a-53a). At trial,

both sides presented evidence on this issue. The jury

returned a verdict in favor of Willowood, finding that

Syngenta did not prove that both steps of the claimed

process were performed by, or were attributable to,

Willowood or any other single entity. (App.15a).

2. Copyright Claims

Willowood filed a motion for summary

judgment with respect to the copyright claims on the

grounds that FIFRA precludes copyright protection

for Syngenta’s pesticide labels. (App. 9a). Willowood

asserted that by directing EPA to “expeditiously”

review and approve generic pesticide labels that are

“identical or substantially similar” to brand-name

labels (7 U.S.C. §136a(c)(3)(B)(i)(I) (App. 110a)),

Congress intended to preclude copyright protection

for pesticide labels. (App. 9a). Willowood also argued

that because much of the labels’ text comprises

instructions and warnings mandated by FIFRA and

EPA regulations, and only limited means of

expressing such information exist, extending

substantially constrain a generic company’s ability to

devise original label language and thus conflict with

FIFRA’s goals of encouraging and facilitating generic

competition. (App. 10a).

Willowood also relied on SmithKline Beecham

Consumer Healthcare, L.P. v. Watson Pharm., Inc.,

211 F.3d 21, 23 (2d Cir. 2000), in which the Second

Circuit held that very similar provisions in the HatchWaxman Act governing generic drug labeling

preclude assertion of copyright claims by drug

manufacturers. (App. 10a). Alternatively, Willowood

argued that its use of Syngenta’s label language was

protected by the copyright doctrines of merger and

fair use because any language not specifically

authored or required by the EPA is so “basic” and

“commonplace in the industry” that it could not be

protected by copyrights. (App. 10a).

The United States filed a Statement of Interest

supporting Willowood’s positions with regard to the

in light of the plain language of 7 U.S.C.

§136a(c)(3)(B)(i)(I), EPA has long encouraged generic

labels to be identical to approved labels and has

consistently interpreted FIFRA as precluding the

application of copyright law to pesticide labels. (App.

11a). As the government has noted in this and other

cases, EPA has registered thousands of generic

products and most of their labels largely use language

that is identical or substantially similar to labels used

by the original registrants. Therefore, as a practical

matter, requiring every label of similar products to

differ from previously approved labels could

significantly limit the number of generic products

that could be approved, since it would be difficult,

especially for commonly used pesticides, for every

individual label to avoid copyright infringement.

(App. 488a).

In opposition, Syngenta argued that neither

FIFRA nor EPA’s regulations required Willowood to

copy Syngenta’s labels. Syngenta relied on FMC

Corp. v. Control Solutions, Inc., 369 F. Supp. 2d 539,

553-60 (E.D. Pa. 2005), which held that FIFRA does

not preclude copyright protection for pesticide labels.

(App. 10a).

The district court granted summary judgment

in favor of Willowood and dismissed the copyright

claims. (App. 40a). The court found the analysis in

FMC to be “unconvincing,” determining that “[e]ven

with some changes, use of the original pesticide label

as a ‘go by’ for the new label will result in copyright

infringement.” (App.41a). The court concluded that

because FIFRA contemplates copying by a generic

applicant “in ways that would otherwise infringe a

fungicide labels. (App. 40a-41a).

C. Proceedings in the Federal Circuit

Syngenta appealed (among other issues) the

district court’s judgments entered in favor of

Willowood with respect to the ‘138 patent and

trial court’s ruling that §271(g) of the Patent Act

requires all steps of patented processes be practiced

by, or attributable to, a single entity. The Federal

Circuit also reversed the district court’s holding that

FIFRA precludes copyright protection for pesticide

labels.

1. Patent Infringement

The Federal Circuit recognized that §271(g)

provides that “[w]hoever without authority imports

into the United States or offers to sell, sells, or uses

within the United States a product which is made by

a process patented in the United States shall be liable

as an infringer.” 35 U.S.C §271(g). (App. 26a).

According to the Federal Circuit, it was “an issue of

first impression” whether the single entity rule

applies to §271(g) as it does to §§271(a) and (b). (App.

26a).

The Federal Circuit noted that, as with any

statutory construction case, it must “begin with the

language of the statute.” (App. 26a). Because the

language of §271(g) makes clear that the acts that

give rise to liability are the importation, offer for sale,

sale, or use within the United States of a product that

was made by a process patented in the United States,

the Federal Circuit held that “nothing in the statutory

language suggests that liability arises from practicing

the patented process….” (App. 27a)(emphasis in

original). Rather, the court held, the focus is “only on

acts with respect to products resulting from the

patented process.” (App. 27a)(emphasis in original).

According to the appellate court, because the

statutory language is clear that practicing a patented

process abroad cannot create liability under §271(g),

“whether that process is practiced by a single entity

is immaterial to the infringement analysis under that

section.” (App. 27a).

The Federal Circuit rejected Willowood’s

argument that this Court’s decision in Limelight

Networks required application of the single entity

rule. (App. 28a). While the Federal Circuit agreed

with Willowood that §271(g) involved a form of direct

liability similar to §271(a), it concluded that liability

does not arise from practicing the patented process,

but rather from importing or selling the product

resulting from that patented process. (App. 29a).

Limelight Networks, the Federal Circuit held, was

inapposite because the statute at issue – §271(b) –

predicates induced infringement liability on the

existence of direct infringement. (App. 29a). Because

direct infringement under §271(a) requires a single

entity to perform all of the claimed steps, this Court

explained where “performance of all the patent’s steps

is not attributable to any one person….there has been

no direct infringement,” and consequently “no

inducement of infringement under §271(b).” (App.

29a). By contrast, the Federal Circuit held that

because liability under §271(g) is not predicated on

direct infringement of the patented process, it would

“not read into the patent laws limitations and

conditions which the legislature has not expressed.”

(App. 29a). The Federal Circuit therefore reversed the

district court’s judgment that Willowood USA did not

infringe the ‘138 patent under §271(g). (App. 35a).2

The Federal Circuit affirmed the jury’s finding that WWChina did not import into the United States, or sell or offer for

sale in the United States, the azoxystrobin at issue and therefore

affirmed the trial court’s judgment that WW-China did not

infringe the ‘138 patent. (App. 35a).

2. Copyright Infringement

On appeal,3 the Federal Circuit held that

FIFRA does not necessarily preclude copyright

protection for portions of Syngenta’s azoxystrobin

product labels, and therefore, the district court’s

holding that FIFRA precluded claims of copyright

infringement was “premature.” (App. 19a). The court

relied heavily on the fact that FIFRA allows EPA to

grant expedited approval for generic pesticide labels

not only where the generic label is “identical or

substantially similar” to the approved label, but

alternatively, where the generic’s label differs “only in

ways that would not significantly increase the risk of

unreasonable adverse effects on the environment.” 7

U.S.C. § 136a(c)(3)(B)(i)(I). According to the court, the

alternative pathway for obtaining expedited approval

for a generic label signifies that FIFRA does not

require generic labels to be identical or substantially

similar. (App. 21a).

On this basis, the court sought to distinguish

the Second Circuit’s decision in SmithKline.

According to the Federal Circuit, the Copyright Act

protects only against actual copying of protected

elements of a protected work, whereas FIFRA’s

similarity requirement does not foreclose expedited

review of an independently composed generic label

that happens to address the same facts, concepts, and

methods derived from the previously approved label.

(App. 21a-22a). The court instructed that on remand,

the district court should “first discern whether the

On appeal, the United States again weighed in on behalf of

Willowood, this time as amicus curiae. See App. 2a.

and fair use], would prohibit Willowood’s use of any

portion of Syngenta’s label.” “Only if the District

Court concludes that the Copyright Act would in fact

prohibit Willowood’s conduct in a manner

inconsistent with the purposes of FIFRA should it

revisit the question of whether and to what extent

FIFRA precludes Syngenta’s copyright claims for any

part of its pesticide labels.” (App. 24a-25a).

REASONS FOR GRANTING PETITION

A. Patent Infringement

This Court recently took it as a given that a

process patent may not be infringed under §271(a)

unless each element of the patented process is

practiced by, or attributable to, a single entity.

Limelight Networks, 572 U.S. at 921-22. This Court

then broadened that well-established principle by

holding that the single entity rule applied to claims

based on a party’s alleged inducement to infringe a

process patent under §271(b). Id. The Federal Circuit,

however, rejected these fundamental propositions by

finding Willowood liable for importing into, and

selling, azoxystrobin products in the United States

despite the fact that these products had been

manufactured by multiple parties each practicing less

than all steps of the ‘138 patent.

The Federal Circuit’s ruling turns patent law

on its head by imposing liability on a distributor of a

product that is made by a non-infringing method.

This broadening of protections for owners of process

patents flies in the face of Congress’ intent to simply

close a loophole in the Patent Act where infringers

could simply perform some or all of the steps of a

patented process outside of the United States to avoid

infringement liability notwithstanding that the

products manufactured by that patented process were

later sold in the United States. While §271(g) closed

this loophole, Congress did not intend to broaden the

scope of process patents to cover the practice of less

than all of the claimed steps of the patent. This,

however, is exactly what the result will be if the

Federal Circuit’s decision is permitted to stand.

B. Copyright Infringement

The Federal Circuit’s holding that FIFRA does

not preclude copyright protection for pesticide labels

effectively deletes FIFRA’s express requirement that

EPA “expeditiously” approve generic pesticide labels

that are identical or substantially similar to

previously approved labels. Given the length and

complexity of pesticide labels, Congress could not

possibly have permitted generic applicants to submit

“identical or substantially similar” labels – and

required EPA to approve such labels – without

understanding that the only practical way to devise

an identical or substantially similar label would be to

copy the prior label. The Federal Circuit’s decision

thus violates one of the most basic tenets of statutory

construction enunciated by this Court – that every

provision of a statute should be construed in a way

that gives it meaning.

As the government has repeatedly made clear

(in this case and elsewhere), applying copyright

protection to pesticide labels would thwart FIFRA’s

goals of encouraging and facilitating generic

competition in the pesticide market and would

upend EPA’s longstanding interpretation and

implementation of the statute, under which the

agency has approved thousands of pesticide labels

that are identical or substantially similar to

previously approved labels. The Federal Circuit

decision also cannot be reconciled with the Second

Circuit’s decision in SmithKline, which construed an

analogous statute governing drug labels to preclude

applicants. This Court should review the decision

below in order to correct an elemental error of

statutory construction committed by the Federal

Circuit, thus giving full effect to FIFRA’s language; to

remove the uncertainty hanging over generic

pesticide companies and EPA concerning a matter of

fundamental importance; and address the conflict

between the Federal and Second Circuits.

ARGUMENT

THIS COURT SHOULD REVERSE THE

APPELLATE COURT’S HOLDING THAT

THE SINGLE ENTITY RULE DOES NOT

APPLY TO SECTION 271(g) OF THE

PATENT ACT

This Court recently took it as a given that a

process patent may not be infringed unless each

element of the patented process is practiced by, or

attributable to, a single entity.

See Limelight

Networks, 572 U.S. at 921-22. That is, if multiple

steps are necessary to infringe a patented process,

practicing less than all of those required steps does

not constitute infringement. See, e.g., Muniacution,

Inc. v. Thomson Corp., 532 F.3d 1318 (2008). Yet, the

Federal Circuit’s decision imposes liability for these

very acts by finding Willowood liable for importing

into, and selling, azoxystrobin products in the United

States despite the fact that patents claiming the

azoxystrobin compound had expired and the specific

compound at issue had been manufactured by

multiple parties practicing less than all of the

patented steps. Such an inconsistent ruling should

not be permitted to stand.

A. Failing to Apply the Single Entity

Rule to §271(g) Would Impermissibly

Expand the Scope of §271(g) Beyond

Congress’ Intent.

Direct infringement of a process patent

requires a single party to practice every step of a

claimed method. Muniauction, 532 F.3d at 1328. For

if a single party practices less than all the steps of the

patented process that party would simply be

performing individual non-patented steps, and

therefore, could not be liable for infringement.

Parties cannot, however, avoid liability for

patent infringement simply by having third parties

carry out one or more of the claimed steps on its

behalf. Accordingly, where the actions of multiple

parties combine to perform every step of a patented

process, the patent is infringed if one party exercises

“control or direction” over the entire process such that

every step is attributable to that single entity. Id. at

1329. Consequently, in order to infringe on a multistep process claim under §271(a), a single party must

perform each step, or must control or direct other

parties involved in practicing each step, of the

patented process. Id. at 1330. This proposition has

become known as the “single entity” rule.

In Limelight Networks, this Court expanded

this principle by holding that liability for inducement

to infringe under §271(b) must similarly be predicated

on the actions of a single entity. 572 U.S. at 921-22.

To hold otherwise, this Court found, would deprive

§271(b) of ascertainable standards and require courts

to develop two parallel bodies of infringement law:

The Federal Circuit’s [decision to not

apply the single entity rule deprives]

§ 271(b) of ascertainable standards. If a

defendant can be held liable under

§271(b) for inducing conduct that does

not constitute infringement, then how

can a court assess when a patent

holder’s rights have been invaded? What

if a defendant pays another to perform

just one step of a 12-step process, and no

one performs the other steps, but that

one step can be viewed as the most

important step in the process? In that

case the defendant has not encouraged

infringement, but no principled reason

prevents him from being held liable for

inducement under the Federal Circuit’s

reasoning, which permits inducement

liability when fewer than all of a

method’s steps have been performed

within the meaning of the patent.

Id. at 922.

Notwithstanding this Court’s application of the

single entity rule to allegations of both direct and

indirect infringement under §§271(a) and (b), the

Federal Circuit held below that §271(g) does not

require application of the single entity rule. As this

Court is aware, however, §271(g) is simply another

form of direct infringement enacted to close a loophole

in the statutory scheme for the protection of process

patent owners. Ajinomoto Co. v. Archer-Daniels-

Midland Co., 228 F.3d 1338, 1347 (Fed. Cir. 2000); Eli

Lilly & Co. v. Am. Cyanamid Co., 82 F.3d 1568, 157172 (Fed. Cir. 1996).

Prior to enactment of §271(g), the owner of a

process patent had a remedy only if the unauthorized

use of its patented process occurred entirely within

the United States. See, e.g., NTP, Inc. v. Research in

Motion, 418 F.3d 1282, 1317-18 (Fed. Cir. 2005). That

same patent owner had no remedy, however, if those

same individuals practiced some or all of the patented

process abroad to manufacture products later

imported into the United States for sale or use. Id.

To close this loophole, §271(g) was enacted to “grant

patent owners the same protection against oversees

infringers as they already enjoyed against domestic

entities” under §271(a). Mycogen Plant Sci., Inc. v.

Monsanto Co., 252 F.3d 1306, 1318 (Fed. Cir. 2001),

vacated on other grounds, 535 U.S. 1109 (2002). The

legislative history of §271(g) confirms this analysis:

…[T]he process patent bill [ultimately

codified, in part, as 35 U.S.C. §271(g)]

was crafted to apply equally to the use or

sale of a product made by a process

patented in this country whether the

product (and the process) was used in

this country or a foreign country. The

bill is prompted by the use of patented

processes in other countries followed by

the importation of the resulting products

into this country. The use of the process

in this country is already an act of

infringement under existing patent law,

and such an infringing party would be

subject to the jurisdiction of the U.S.

courts. Thus, the inclusion of a domestic

process patent infringement in the scope

of a bill to extend protection to the

products is regarded by the [Judiciary

Committee] as a formality…, with little

or no practical consequences in patent

enforcement….

[35 U.S.C. §217(g)] will prevent

circumvention of a U.S. process

patentee’s rights through manufacture

abroad and subsequent importation into

the United States of products made by

the patented process.

S. REP. NO. 100-83, at 46–48 (1987)(emphasis added).

As the legislative history makes clear,

although its emphasis is on the importation of

products, the primary purpose of §271(g) is to

preserve the force of the patented processes that

create those products. Synaptic Pharm. Corp. v. MDS

Panlabs, Inc., 265 F. Supp. 2d 452, 460 (D. N.J.

2002).4 Nothing in the legislative history, however,

suggests that Congress intended to provide patent

owners with broader protections for the unauthorized

use of their patented processes outside the United

States than within the United States. Deepsouth

Packing Co. v. Laitram Corp., 406 U.S. 518, 531

The Conference Report which accompanied H.R. 3, the bill

that included the process patent provision when it was enacted,

characterizes both the House and Senate versions of the bill as

providing “that using, selling or importing a product made in

violation of a U.S. process patent is an act of patent

infringement.” H.R. Conf. Rep. No. 576, 100th Cong., 2d Sess.

1085–86 (1988), reprinted in 1988 U.S.C.C.A.N. 2118–19

(emphasis added).

“We…require a clear and certain signal from

Congress before approving the position of a litigant

who…argues that the beachhead of [patent

protection] is wider, and the area of public use is

narrower, than courts had previously thought. “).

As Congress has not evidenced any intent to

broaden the effect of the Patent Act, this Court should

not permit expansion of the protections afforded by

§271(g) to activities that are clearly not infringing

under any other set of circumstances. But that is

precisely what the Federal Circuit’s interpretation of

the statute does. Under §271(a), if multiple parties

combine to perform every step of a patented process

but those actions are not attributable to a single

entity, their actions would not give rise to

infringement liability. The same can be said for

indirect infringement under §271(b). Under the

Federal Circuit’s interpretation of §271(g), however, if

those same parties engaged in those same actions,

liability will nonetheless be imposed on the

distributor offering that product for sale in the United

States notwithstanding the fact that the patented

process had not been infringed. This result would be

in clear contravention of §271(g)’s purpose to grant

process patent holders a remedy (not a broader

remedy) against oversees infringement of their

patented processes where the resulting product is

imported into the United States.

The Federal Circuit supported its expansion of

the scope of §271(g) by focusing primarily on its

language:

[The language of §271(g)] makes clear

that the acts that give rise to liability

under §271(g) are the importation, offer

for sale, sale, or use within this country

of a product that was made by a process

patented in the United States. Nothing

in this statutory language suggests that

liability arises from practicing the

patent process abroad. Rather, the focus

is only on acts with respect to products

resulting from the patented process.

Thus, because the statutory language as

a whole is clear that practicing a

patented process abroad cannot create

liability under §271(g), whether that

process is practiced by a single entity is

immaterial to the infringement analysis

under that section.

(App. 26a-27a) (emphasis in original) (internal

citations omitted).

While the Federal Circuit

correctly noted that §271(g) targets the importers and

distributors of products made by a patented process,

it failed to recognize that it was expanding the scope

of process patents by imposing liability on parties

where the patented process was not infringed. The

dramatic effect of this decision can be seen here where

the process claimed by the patent at issue is

comprised of two steps, both of which were well

known in the industry prior to issuance of the patent,

yet, their practice by two separate entities acting

independently of each other, is held to be infringing.

The ‘138 patent claims a process for the

manufacture of azoxystrobin comprised of two steps –

an etherification step followed by a condensation step.

Both of these steps were well known in the industry

and had been practiced for many years prior to

issuance of the ‘138 patent. The jury found that two

separate entities performed each of these steps and

that their performance could not be attributed to

either Willowood or any other party. (App. 15a).

Accordingly, Willowood was held to not infringe

because the product that it imported into, and sold in,

the United States was not made by a patented

process, but rather, was manufactured by two

separate entities each performing non-patented steps.

The Federal Circuit’s decision to impose liability on

Willowood as a result of these actions turns patent

law on its head by imposing liability on the distributor

of a product that is made in a non-infringing manner.

B. The

Federal

Circuit’s

Holding

Impermissibly Extends the Patent

Owner’s

Monopoly

Beyond

the

Expiration of the Patents Covering the

Product at Issue.

In addition to the impermissible extension of

§271(g)’s affect noted above, the Federal Circuit’s

decision violates Kimble v. Marvel Entertainment, 135

S. Ct. 2401 (2015), by impermissibly extending

Syngenta’s patent protection beyond the expiration

date of the compound patents claiming azoxystrobin.

In Kimble, this Court affirmed the over fifty-year old

proposition first identified in Brulotte v. Thys Co., 379

U.S. 29 (1964), that a patent license agreement

requiring the payment of royalties for some period

beyond the life of the licensed patent was

unenforceable as a misuse of patent rights. In so

holding, the Court noted that the United States

patent system reflects a balance between fostering

innovation and ensuring public access to discoveries.

Consequently, once the statutory term of a patent

monopoly ends, “the right to make or use the article,

free from restriction, passes to the public.” Kimble,

135 S. Ct. at 2407. This Court elaborated on this

point:

In case after case, the Court has

construed … laws [which] preclude

measures that restrict free access to

formerly patented … inventions. In one

line of cases, we have struck down state

statutes with that consequence. By

virtue of federal law, we reasoned, “an

article on which the patent has expired,”

like an unpatentable article, “is in the

public domain and may be made and

sold by whoever chooses to do so.” In

a related line of decisions, we have

deemed unenforceable private contract

provisions limiting free use of such

inventions. ... Allowing even a single

company to restrict its use of an expired

or invalid patent, we explained, “would

deprive ... the consuming public of the

advantage to be derived” from free

exploitation of the discovery. And to

permit such a result, whether or not

authorized “by express contract,” would

impermissibly undermine the patent

laws.

Id.

Here, the products at issue had been protected

by two separate patents claiming the azoxystrobin

compound. Those patents expired, thus passing to the

public, free from restriction, the right to import,

make, use, sell, and offer for sale azoxystrobin in the

United States. By imposing liability on Willowood for

importing and selling azoxystrobin in the United

States notwithstanding that its manufacture did not

result from infringement of any patent, the Federal

Circuit has impermissibly extended Syngenta’s

patent monopoly beyond the term of the compound

patents.

C. The Federal Circuit’s Decision Applies

Different Interpretations of the Same

Statutory Provision Within §271.

The Federal Circuit’s decision also leads to the

impermissible application of different interpretations

of the same term within §271. See Ratzlaf v. United

States, 510 U.S. 135, 143 (1994)(“A term appearing in

several places in a statutory text is generally read the

same way each time it appears.”). In this regard,

§271(a) refers to direct infringement as making,

using, or selling “any patented invention” within the

United States. As this Court has made clear, multiple

parties who independently practice separate steps of

a multi-step process are not making, using, or selling

the “patented invention.” Thus, if the term “patented”

in §§271(a) and 271(g) is to be construed consistently,

a process which would not be a direct infringement

under §271(a) is not a “patented” process under

§271(g). To hold otherwise would lead to the term

“patented” having different meanings in §§271(a) and

271(g).

D. The Federal Circuit’s Reliance on

Other Provisions of the U.S. Patent Act

to Support its Holding is Misplaced.

The Federal Circuit also improperly relied on

Section 271(f)

§271(f) to support its holding.5

provides that the supply of components made in the

United States for assembly outside the country

constitutes infringement if “such combination

occurred within the United States.” The Federal

Circuit pointed to this provision as evidence that if

Congress intended to limit liability under §271(g) to

instances where the patented process was practiced

in a manner that would infringe the patent if

practiced within the United States – such as by

requiring a single entity to perform the entire process

– it knew how to do so. (App. 29a-31a). A virtually

identical argument, however, was rejected in

Limelight Networks.

As noted above, by failing to require

application of the single entity rule to §271(g), the

Federal Circuit gave a process patent broader

application than what was intended by Congress. As

this Court held in Limelight Networks, “courts should

not create liability for … non-infringing conduct

where Congress has elected not to extend that

concept.” Limelight Networks, 572 U.S. at 923.

Inclusion of certain language in §271(f) (“…if such

combination occurred within the United States…”)

instead illustrates that “when Congress wishes to

impose liability for [certain] activity that does not

Reliance on §271(f) to interpret §271(g) is fundamentally

questionable in the first place as §271(f) is not applicable to

method claims. Cardiac Pacemakers, Inc. v. St. Judge Medical,

Inc., 576 F.3d 1348 (Fed. Cir. 2009).

constitute direct infringement, it knows precisely how

to do so.” Id. As Congress has not indicated a clear

and certain signal that §271(g) was enacted to impose

liability for what is otherwise non-infringing activity,

the Federal Circuit’s reliance on §271(f) is improper.

As set forth above, the legislative history

makes clear that Congress simply intended to close a

loophole in the Patent Act with the adoption of

§271(g) so as to provide process patent owners with a

means to prevent the use of their patented processes

outside of the United States with the resulting

products being distributed inside the United States.

Congress did not set forth a clear and certain signal

that it intended to broaden the scope of those process

patents to preclude the non-infringing practice of

certain steps of the claimed process by separate and

independent parties. Yet, this is the exact result of

the Federal Circuit’s decision.

The Federal Circuit’s additional reliance on

§287(b) is also misplaced. The Federal Circuit,

relying on §287(b)(1)(C), held that because the act of

infringement under §271(g) occurs after a patented

process has already been used (i.e., the product has

been imported or sold), it is “immaterial” whether

that process is infringed. (App. 31a-32a). Willowood

does not dispute that the actions giving rise to

liability under §271(g) (i.e., the importation or sale of

the product made by the patented process) must occur

after the product has been made. This does not

change the fact that the Federal Circuit’s decision

broadens the scope of any process patent to provide

protection to processes that do not infringe the patent,

e.g., where practicing the claimed process cannot be

attributed to a single entity.

Moreover, the Federal Circuit failed to take

stock of another clause of the same provision –

§287(b)(1)(A) – which provides that modifications of

remedies provided by §287(b) are not available to “any

person who … practiced the patented process….” The

fact that §287(b)(1)(A) limits the modifications of

remedies provided in §287(b) to any “person who

practiced the patented process” as opposed to any

“persons who practiced the patented process” implies

Congress’ recognition that single entities practice

patented processes, not multiple entities. Furthermore,

Congress’ use of the term “patented process” in

§287(b)(1)(A) actually supports Willowood’s position.

As set forth above, §271(a) provides that any

person who, without authority, makes, uses, offers for

sale, or sells a “patented” invention, infringes that

patent. 35 U.S.C. §271(a). To hold that practicing a

“patented” invention means one thing – application of

the single entity rule – when construed in the context

of §271(a), but that it means something different –

single entity rule should not be applied – when

construing §271(g) and/or §287(b)(1)(A) violates basic

principles of statutory construction and turns patent

law on its head by imposing liability where the patent

has not been infringed. Ratzlaf, supra.

Here, the jury found that manufacture of the

azoxystrobin imported and sold by Willowood was not

attributable to any single entity.

Accordingly,

Willowood should not be held liable for patent

infringement under §271(g) as the process claimed by

the ‘138 patent was not infringed.

II. THIS

COURT

SHOULD

REVERSE

THE FEDERAL CIRCUIT’S HOLDING

THAT FIFRA DOES NOT PRECLUDE

LABELS.

A. The FIFRA Statutory Scheme

FIFRA prohibits the distribution or sale of “any

pesticide that is not registered” by EPA. 7 U.S.C.

§136a(a) (App. 92a).6 EPA shall register a pesticide

when, among other things, “its labeling and other

material required to be submitted comply with the

requirements of this subchapter” and “it will not …

cause unreasonable adverse effects on the

environment.” §136a(c)(5).

To facilitate EPA’s determination of whether

the substantive criteria are met, applicants must

submit or cite to data supporting the environmental

safety and efficacy of the pesticide.

7 U.S.C.

§136a(c)(1)-(2); 40 C.F.R. 152.42, 152.50, 152.80-99.7

FIFRA establishes an exclusivity period under which

the applicant maintains the sole right to use any data

it develops and submits for at least ten years

following registration and requires payment of

compensation for a generic applicant’s reliance on

such data. 7 U.S.C. §136a(c)(1)(F)(i) (App. 94a)

(requiring written permission of original submitter

for ten years following registration); §136a(c)(F)(iii)

(requiring compensation).

See Ruckelshaus v.

The term “pesticide” includes fungicides,

azoxystrobin. Id. §136(t), (u) (App. 81a).

such

Relevant sections of 40 C.F.R. Part 152 are reprinted at App.

209a et seq.

Monsanto Co., 467 U.S. 986, 994-95 (1984) (describing

these provisions).

The EPA-approved labeling is an integral part

of the registration. It is the primary means by which

EPA establishes and enforces the terms of the

registration and regulates the use of the pesticide.

FIFRA makes it unlawful to “use any registered

pesticide in a manner inconsistent with its labeling.”

§136j(a)(2)(G).

Each applicant must submit “a

complete copy of the labeling of the pesticide, a

statement of all claims to be made for it, and any

directions for use.” §136a(c)(1)(C) (App. 93a); 40

C.F.R. §152.50(e) (App. 211a); see 7 U.S.C. §136(p)

(App. 76a) (defining “labeling”). The information on

the label must be “placed thereon in such terms as to

render it likely to be read and understood by the

ordinary individual under customary conditions of

purchase and use.” §136(q)(1)(E). The label must

contain the necessary “directions for use,”

§136(q)(1)(F), which likewise must “be stated in terms

which can be easily read and understood by the

average person likely to use or to supervise the use of

the pesticide.” 40 C.F.R. §156.10(i)(1)(i) (App. 256a).8

The label also must include, among other things,

any necessary “warning or caution statement” for

the protection of health and the environment,

§136(q)(1)(G);

“an ingredient

statement,”

“statement of use classification,” and, for highly toxic

pesticides, “the skull and crossbones;…the word

“poison’ prominently in red on a background of

distinctly contrasting color; and a statement of a

practical treatment (first aid or otherwise) in case of

poisoning. §136(q)(2)(A)-(D).

A copy of 40 C.F.R. Part 156 is reprinted at App. 246a et seq.

EPA regulations prescribe in detail the required

contents and formatting of the label, including

specific language that must be used depending on

toxicity and use patterns. 40 C.F.R. §156.10.9 EPA

has published a manual with extensive guidance on

FIFRA’s labeling requirements. Office of Pesticide

Programs, U.S. Envt. Prot. Agency, Label Review

Manual (rev. 2016) (https://www.epa.gov/pesticideregistration/pesticide-registration-manual (the “EPA

Manual”)). The EPA Manual states that a “critical

function of the label is to translate the results of the

science evaluations into a set of conditions, directions,

precautions, and restrictions that define who may use

a pesticide, as well as where, how, how much and how

often it may be used.” Id. at 1-2.

EPA reviews all of the relevant data and the

proposed labeling for a completed application, assesses

the potential risks and benefits, and decides whether

to approve the application. §§152.107 – 152.112

(App. 241a-242a); see also 7 U.S.C. §136a(c)(5) (App.

113a). This process requires significant time and

resources. 7 U.S.C. §136w-8(b)(3)(tbl.1) (providing

review periods of fourteen to twenty-four months for

pesticides containing new active ingredients).

In 1988, Congress amended FIFRA to provide

a simpler path for expedited registration of generic

pesticides. Codified at §136a(c)(3)(B), FIFRA requires

EPA “as expeditiously as possible” to review and act

on any application for an end-use product that

Much of the label language and formatting is expressly

required by EPA regulations (see App. 246a et seq.) or otherwise

authored by EPA in documents such as the EPA Manual.

if registered as proposed, would be

identical or substantially similar in

composition and labeling to a currentlyregistered pesticide identified in the

application, or that would differ in

composition and labeling from such

currently-registered pesticide only in

ways that would not significantly

increase the risk of unreasonable

adverse effects on the environment.

7 U.S.C. §136(a)(c)(3)(B)(i)(I) (App. 110a). Congress

intended that these expedited procedures would

“hasten” and provide “for ‘fast track’ consideration” of

registration applications for end-use pesticide

products that are identical or substantially similar to

an already registered product. H.R. Rep. No. 100-939,

at 31 (1988); S. Rep. No. 100-346, at 20 (1988).

Applications for generic products and labeling that

meet the criteria of this provision must be reviewed

and approved within ninety days after receipt of a

complete application (7 U.S.C. §136a(c)(3)(B)(ii)(II))

(App. 110a-111a), thus drastically reducing the twoyear review time which the statute specifies for new

active ingredients. These provisions are in keeping

with one of the primary goals of Congress in enacting

FIFRA – to encourage, promote, and facilitate generic

competition in the pesticide market. Ruckelshaus,

467 U.S. at 1014.

Generic applicants (also known as “me-too”

applicants) can take advantage of the expedited

review process, but also must satisfy the

requirements for pesticide registration in §136a(c)(5),

including that the pesticide’s labeling complies

with FIFRA’s requirements. 7 U.S.C. §136a(c)(7); see

40 C.F.R. §§152.112 and 152.113. As the labeling for

the me-too pesticide (as well as the compound itself)

must be identical or substantially similar to the

currently registered pesticide or differ only in limited

ways, EPA can decide whether the application meets

the applicable requirements on an expedited basis.

For these pesticides, the EPA directs the label

reviewer to “ensure that the new product’s use

patterns, including any public health claims, are the

same as those of the cited product.” EPA Manual at

4-8. Further, in reviewing the directions of use on a

me-too label, the reviewer must make only “a side-byside comparison of the proposed set of use directions

to the use directions on the label for the registered

product(s).” Id.

B. The Federal Circuit’s Holding that

FIFRA Does Not Necessarily Preclude

Labels

Effectively

Repeals

the

Statute’s Explicit Authorization of

Labels

that

are

“Identical

Substantially Similar” to Registered

Labels.

One of this Court’s most fundamental

principles of statutory construction is that a statute

should be construed so that effect is given to all its

provisions, so that no part will be inoperative or

superfluous, void, or insignificant. Corley v. United

States, 556 U.S. 303, 314 (2009). The Federal

Circuit’s holding that FIFRA does not preclude

application of copyright protection for pesticide labels

violates this principle by effectively striking from the

statute Congress’ directive that EPA approve

“identical or substantially similar” labels and its

commensurate grant of permission for generic

applicants to submit such labels for approval.

The Federal Circuit thought it dispositive that

FIFRA §136a(c)(3)(B)(i)(I) requires expedited EPA

review not just if the product’s composition and

labeling is “identical or substantially similar” but also

if they would differ “only in ways that would not

significantly increase the risk of unreasonable

adverse effects on the environment.” (App 21a). The

Federal Circuit reasoned that in light of this second

pathway for expedited review, the statute does not

require me-too labels to be copied. By the Court’s

reasoning, however, the second pathway for expedited

approval is not just one alternative; it effectively

eliminates the first pathway, which specifically

directs EPA to expeditiously approve generic labels

that are “identical or substantially similar,” and

therefore necessarily contemplates copying of

previously approved labels.

In the Federal Circuit’s view, “FIFRA’s

similarity requirement does not foreclose expedited

review for an independently composed label that relies

solely on unprotected facts, concepts, and methods

derived from the registered label.”

(App. 21a)

(emphasis in original). This reasoning is untethered

to reality, however, because Willowood could not

reasonably be expected to “independently compose” a

generic label that would be identical to Syngenta’s

label. Even a cursory review of the azoxystrobin

labels at issue here shows why there is no realistic

way for a me-too applicant to devise a label that is

“identical” to an already approved label without

copying. Syngenta’s label for Azoxy 2.08SC, for

example, is over 50 pages long and contains primarily

technical and scientific information and instructions.

(App. 501a). Absent purposeful copying, the likelihood

that Willowood could come up with an “identical

label” is vanishingly small.

Rather than giving effect to both pathways for

expedited label approval that FIFRA authorizes, the

Federal Circuit effectively construed the second

pathway as nullifying, rather than supplementing,

the first. This violation of basic tenets of statutory

construction as applied to an important environmental

regulatory statute warrants reversal.

C. Allowing

Infringement

Claims Against Pesticide Labels

Would be Contrary to FIFRA’s

Fundamental Goals of Promoting

Generic Competition and Would Upend

Decades of EPA’s Implementation of

the Statute.

This Court has twice found that in enacting

FIFRA, Congress intended to encourage competition,

reduce barriers to entry for generic products, and

streamline EPA’s review process for me-too

applications. Ruckelshaus, at 1015; Thomas v. Union

Carbide Agric. Prods. Co., 473 U.S. 568, 571 (1985).

FIFRA §136a(c)(3)(B)(i)(I) is a linchpin in furthering

those goals by allowing me-too applicants to submit,

and directing EPA to approve, generic product labels

that are “identical or substantially similar” to

registered labels. (App. 110a). Consequently, as the

government has noted in this and other cases, EPA

has long encouraged me-too applicants to submit

product labels that are in fact identical to registered

labels, and interpreted FIFRA as permitting label

copying. Fifteen years ago, a district court held that

FIFRA does not preclude copyright protection for metoo labels. FMC, 369 F. Supp. 2d at 569. That court,

however, was significantly influenced by the fact that

the EPA failed to appear in support of the generic

applicant’s position. Id. at 570. But on many

occasions thereafter – including in this case – the EPA

has made plain that it interprets FIFRA as precluding

FMC was decided, EPA informed a trade association

why “[i]t has been the practice of [EPA] since…1978

to strongly encourage ‘me-too’ product labels to be

identical or substantially similar to the labels of the

products on which their registrations are based.”

(App. 480a). As me-too applicants continued to

submit proposed labels that were copied from

previously approved labels, brand-name companies

continued to threaten and initiate copyright

infringement actions. In cases brought in 2006 and

2009, senior EPA officials submitted detailed

declarations explaining why the agency views

application of copyright law to pesticide labels to be

antithetical to FIFRA’s statutory scheme and in

direct conflict with EPA’s interpretation and

implementation of the statute. (App. 483a; 491a).

In this case, the EPA again weighed in before

the district court and the Federal Circuit, explaining

why the FIFRA ‘me too’ standard, which is intended

to streamline review and registration of me too

products, “endorses label copying….” (App. 10a). As

the EPA has stated in this case and elsewhere,

allowing copyright infringement claims conflict not

just with the plain language of FIFRA

§136a(c)(3)(i)(I), and its’ pro-competitive goals; it

would also vitiate FIFRA’s bedrock purpose of

protecting human health and the environment

because variability in label language for substantially

identical products significantly increases the risk of

confusion among users, and hence the risk of pesticide

misuse. (App. 490a).

The United States also has pointed out that in

many cases there may be hundreds of EPA-approved

generic versions of a particular product. For example,

EPA has registered more than 650 generic versions of

the pesticide 2,4-D alone. (App. 489a). Even if there

were numerous ways to express the technical

information and instructions contained in a pesticide

label, application of copyright laws to every label

would mean that numerous generic labels must

convey the same basic information while avoiding

infringement not only of the original registrant’s

label, but of every previously approved generic label.

Not only would this serve no purpose, but as the

government has noted, it would severely increase the

risk of confusion on the part of end-users, thus

increasing the risk of environmental harm and

personal injury – completely contrary to FIFRA’s

purpose.

The Federal Circuit concluded that these

practical concerns do not necessarily create a conflict

between FIFRA and the Copyright Act because metoo applicants can invoke traditional copyright

defenses like merger (which can defeat copyright

claims when an underlying fact, procedure, or idea

can be expressed in so few ways that ‘protection of the

expression would effectively accord protection to the

idea itself”) or the fair use doctrine. (App. 21a). But

subjecting me-too applicants to the threat of copyright

infringement litigation in which they would have the

burden to prove various defenses does not comport

with FIFRA’s pro-competitive and pro-environmental

goals. The success of these defenses would be highly

fact-dependent in each case. The uncertainty of

success and substantial cost associated with

defending copyright claims would act as significant

deterrents to copy a registered label. The generic

would be faced with the Hobson’s choice of either

taking the risk that its copied label will be invalidated

under copyright law – and thus its ability to sell the

pesticide product derailed until it rewrites the label to

EPA’s satisfaction – or attempt to write an original

product label and thus defer its entry into the market

even though FIFRA does not require it to do so. In

short, the potential availability of affirmative

defenses to copyright infringement does not resolve

the conflict between copyright protection on the one

hand and FIFRA’s plain statutory language and

fundamental goals on the other.

The facts of this case bear this out. After

Syngenta filed suit, Willowood attempted to revise

the language and formatting of its azoxystrobin labels

in an effort to avoid Syngenta’s copyright claims.

Although EPA eventually approved revised labels,

the process was neither quick nor easy. In fact, EPA

rejected many proposed revisions submitted by

Willowood to ensure compliance with FIFRA’s

substantive requirements. (App. 23a-24a). Most

significantly, even after EPA approved revised label

language, Syngenta persisted in alleging that the

EPA-approved revised language infringed its

copyrights.

EPA plainly lacks the expertise to review metoo labels in relation to copyright law. Consequently,

no generic could be confident that any label approved

by EPA is non-infringing unless and until a copyright

claim is adjudicated. It is nonsensical to believe that

Congress would require EPA to spend the time and

effort to “expeditiously” approve an identical label

that might subsequently be nullified under copyright

law.

D. This Court’s Review is Warranted

Because the Federal Circuit’s Decision

Cannot be Reconciled With the Second

Circuit’s Decision in SmithKline.

In SmithKline, the Second Circuit held that the

Hatch-Waxman Amendments to the Federal Food,

Drug, and Cosmetic Act, which direct copying of drug

labels by generic producers in order to facilitate

generic drug competition, preclude copyright

infringement claims with respect to such labels.

SmithKline, 211 F.3d at 25. The Second Circuit

recognized that Congress could not have required

generic drug labels be to be identical to registered

labels “without requiring labels that will often violate

copyrights.” Id. at 28-29. It concluded: “Certainly, a

legislative drafter would believe that a sameness

requirement would lead to the creation of works that

would easily fall within the copyright law’s

infringement of ‘substantial similarity.’” Id. at 27.

The Second Circuit also explained in the generic drug

context that “[i]f labels that were ‘substantially

similar’ to copyrighted labels on pioneer drugs had to

be avoided, the administrative process of approving a

new label would…drain the resources of the FDA and

generic producer – not to mention the problem of

successive generic producers avoiding infringement of

multiple copyrighted labels.” Id. “Avoiding such

infringement would also delay the introduction of the

generic product without advancing public health and

safety ….” Id.

The Second Circuit’s reasoning in the drug

context applies with equal force to pesticide labels.

The Federal Circuit sought to distinguish SmithKline

on the grounds that the Hatch Waxman Act requires

generic drug labels to be identical. (App. 22a). But

the Second Circuit’s reasoning is equally applicable

here because FIFRA permits me-too applicants to

submit identical labels and requires EPA to approve

such labels. Consequently, the drafters of FIFRA, no

less than the drafters of the Hatch-Waxman Act,

would have understood that identical or substantially

similar pesticide labels might otherwise be subject to

labels, would delay the process of approving generic

products, drain the resources of the EPA, create

enormous problems for successive generic producers

who would have to avoid infringing copyrighted

labels, and would conflict with FIFRA’s primary goals

of environmental protection by creating potential

confusion among end users as a result of numerous

labels conveying the same information in varying

language and formats.

For the foregoing reasons, the Petition should

be granted so that this Court can resolve the conflict

between the Federal Circuit’s decision in this and the

Second Circuit’s decision in SmithKline.

Respectfully submitted,

Steven E. Tiller

Counsel of Record

WHITEFORD TAYLOR PRESTON LLP

Seven Saint Paul Street, Suite 1300

Baltimore, Maryland 21202-1626

Telephone: (410) 347-9425

Facsimile: (410) 223-4325

stiller@wtplaw.com

Barry S. Neuman

WHITEFORD TAYLOR PRESTON LLP

1800 M Street, NW, Suite 450N

Washington, DC 20036

Telephone: (202) 659-6761

Facsimile: (202) 327-6151

bneuman@wtplaw.com

Barry E. Bretschneider

WHITEFORD TAYLOR PRESTON LLP

3190 Fairview Park Drive, Suite 800

Falls Church, Virginia 22042-4510

Telephone: (703) 280-9086

Facsimile: (703) 280-9130

bretschneider@wtplaw.com

Attorneys for Petitioners

APPENDIX

APPENDIX TABLE OF CONTENTS

VOLUME I OF II

Page

Opinion of

The United States Court of Appeals

For the Federal Circuit

entered December 18, 2019 ........................... 1a

Order of

The United States District Court

For the Middle District of North Carolina

Re: Granting in Part Defendants’ Motion for

Summary Judgment and Denying Plaintiff’s

Motion to Exclude Mr. Schatzow’s Report

entered April 10, 2017 ................................. 40a

Memorandum Opinion and Order of

The United States District Court

For the Middle District of North Carolina

Re: Granting in Part and Denying in Part

Plaintiff’s Motion for Summary Judgment,

Denying in Part Defendants’ Motion for

Summary Judgment, and Granting in

Part and Denying in Part Plaintiff’s

Motion to Exclude Certain Expert Opinions

entered March 24, 2017 ............................... 42a

7 U.S.C. § 136.......................................................... 72a

7 U.S.C. § 136a........................................................ 92a

17 U.S.C. § 102...................................................... 143a

17 U.S.C. § 105...................................................... 144a

iia

17 U.S.C. § 501...................................................... 146a

21 U.S.C. § 355...................................................... 149a

35 U.S.C. § 271...................................................... 192a

35 U.S.C. § 287...................................................... 200a

40 C.F.R. § 152.42 ................................................. 209a

40 C.F.R. § 152.50 ................................................. 209a

40 C.F.R. § 152.80 ................................................. 213a

40 C.F.R. § 152.81 ................................................. 214a

40 C.F.R. § 152.82 ................................................. 216a

40 C.F.R. § 152.83 ................................................. 217a

40 C.F.R. § 152.84 ................................................. 219a

40 C.F.R. § 152.85 ................................................. 219a

40 C.F.R. § 152.86 ................................................. 222a

40 C.F.R. § 152.90 ................................................. 225a

40 C.F.R. § 152.91 ................................................. 226a

40 C.F.R. § 152.92 ................................................. 227a

40 C.F.R. § 152.93 ................................................. 228a

40 C.F.R. § 152.94 ................................................. 230a

40 C.F.R. § 152.95 ................................................. 231a

40 C.F.R. § 152.96 ................................................. 232a

iiia

40 C.F.R. § 152.97 ................................................. 234a

40 C.F.R. § 152.98 ................................................. 235a

40 C.F.R. § 152.99 ................................................. 237a

40 C.F.R. § 152.107 ............................................... 241a

40 C.F.R. § 152.108 ............................................... 241a

40 C.F.R. § 152.113 ............................................... 243a

40 C.F.R. § 156.3 ................................................... 246a

40 C.F.R. § 156.10 ................................................. 246a

40 C.F.R. § 156.60 ................................................. 263a

40 C.F.R. § 156.62 ................................................. 265a

40 C.F.R. § 156.64 ................................................. 267a

40 C.F.R. § 156.66 ................................................. 268a

40 C.F.R. § 156.68 ................................................. 269a

40 C.F.R. § 156.70 ................................................. 270a

40 C.F.R. § 156.78 ................................................. 273a

40 C.F.R. § 156.80 ................................................. 277a

40 C.F.R. § 156.85 ................................................. 277a

40 C.F.R. § 156.140 ............................................... 279a

40 C.F.R. § 156.144 ............................................... 283a

40 C.F.R. § 156.146 ............................................... 284a

iva

40 C.F.R. § 156.156 ............................................... 288a

40 C.F.R. § 156.159 ............................................... 290a

40 C.F.R. § 156.200 ............................................... 290a

40 C.F.R. § 156.203 ............................................... 291a

40 C.F.R. § 156.204 ............................................... 292a

40 C.F.R. § 156.206 ............................................... 293a

40 C.F.R. § 156.208 ............................................... 295a

40 C.F.R. § 156.210 ............................................... 299a

40 C.F.R. § 156.212 ............................................... 301a

S. Rep. 100-83, Process Patents Amendments

Act of 1987 (June 23, 1987) .................................. 312a

APPENDIX TABLE OF CONTENTS

VOLUME II OF II

Page

H. R. Conf. Rep. 100-576 (1988) ........................... 441a

Letter to Warren Stickle, President of Chemical

Producers & Distributors Association, from

Susan B. Hazen, Principal Deputy Assistant

Administrator of the U.S. Environmental

Protection Agency

dated August 3, 2005 ................................. 480a

Declaration of Lois Rossi

undated....................................................... 483a

Declaration of Debra Edwards,

With Attached Declaration of Lois Rossi,

dated June 17, 2009 ................................... 491a

Willowood Azoxy 2C Label Submitted to EPA

dated August 15, 2013 ............................... 501a

[ENTERED: December 18, 2019]

United States Court of Appeals

for the Federal Circuit

______________________

SYNGENTA CROP PROTECTION, LLC,

Plaintiff-Appellant

WILLOWOOD, LLC, WILLOWOOD USA, LLC,

WILLOWOOD AZOXYSTROBIN, LLC,

WILLOWOOD LIMITED,

Defendants-Cross-Appellants

______________________

2018-1614, 2018-2044

______________________

Appeals from the United States District Court

for the Middle District of North Carolina in No. 1:15cv-00274-CCE-JEP, Judge Catherine C. Eagles.

______________________

Decided: December 18, 2019

______________________

RUSSELL EVAN LEVINE, Kirkland & Ellis LLP,

Chicago, IL, argued for plaintiff-appellant. Also

represented by HARI SANTHANAM, MEREDITH ZINANNI.

STEVEN EDWARD TILLER, Whiteford, Taylor &

Preston LLP, Baltimore, MD, argued for defendantscross-appellants. Also represented by PETER JAMES

DAVIS; BARRY S. NEUMAN, Washington, DC; ALAN

DUNCAN, LESLIE COOPER HARRELL, Mullins Duncan

Harrell & Russell PLLC, Greensboro, NC.

MEGAN BARBERO, Appellate Staff, Civil

Division, United States Department of Justice,

Washington, DC, argued for amicus curiae United

States. Also represented by MARK R. FREEMAN,

JOSEPH H. HUNT; MATTHEW G.T. MARTIN, The United

States Attorney’s Office, Middle District of North

Carolina, United States Department of Justice,

Greensboro, NC.

MELVIN C. GARNER, Leason Ellis LLP, White

Plains, NY, for amicus curiae New York Intellectual

Property Law Association. Also represented by

LAUREN BETH EMERSON, ROBERT M. ISACKSON,

MARTIN SCHWIMMER.

JAMES PETER RATHVON, Paley Rothman,

Bethesda, MD, for amici curiae Aceto Agricultural

Chemicals Corp., Aceto Corporation, AgLogic

Chemical, LLC, Agro-Gor Corp., Albaugh, LLC,

Argite, LLC, Atticus, LLC, Axss Technical Holdings,

LLC, Chemstarr, LLC, Consus Chemicals, Inc., Decco

US Post-Harvest, Inc., Drexel Chemical Company,

Ensystex, Inc., Ensystex II, Inc., Ensystex III, Inc.,

Ensystex IV, Inc., Extremis, LLC, GeneraTec, LLC,

Gharda Chemicals International, Inc., Helm Agro US,

Inc., LG Chem, Ltd., MEY Corporation, PBI Gordon

Corp., Promika, LLC, Raymat Crop Science, Inc.,

Raymat Materials, Inc., RedEagle International,

LLC, RiceCo, LLC, Rotam Agrochemical Company,

Ltd., Rotam Ltd., Rotam North America Inc., Sharda

CropChem Ltd., Sharda USA, LLC, Summit Agro US,

LLC, Summit Agro North America Holding

Corporation, Tacoma AG, LLC, Tide International

USA, Inc., Troy Corporation, United Phosphorus,

Inc., UPL Delaware Inc., Woodstream Corporation.

JEFFREY PAUL KUSHAN, Sidley Austin LLP, for

amici curiae Biotechnology Innovation Organization,

CropLife International. Also represented by KATHI A.

COVER, iBiquity Digital Corporation, Columbia, MD.

______________________

Before REYNA, TARANTO, and STOLL, Circuit

Judges.

REYNA, Circuit Judge.

Syngenta Crop Protection, LLC, sued

Willowood, LLC, Willowood USA, LLC, Willowood

Azoxystrobin, LLC, and Willowood Limited in the

U.S. District Court for the Middle District of North

Carolina for copyright infringement and patent

infringement, asserting four patents directed to a

fungicide compound and its manufacturing processes.

Prior to trial, the district court dismissed the

be precluded by the Federal Insecticide Fungicide and

Rodenticide Act. The district court granted-in-part

and denied-in-part Syngenta Crop Protection, LLC’s

summary judgment motion with respect to patent

infringement. The district court also denied-in-part

the defendants’ motion to exclude expert testimony on

damages.

After a jury trial, the district court entered

judgment in favor of Willowood Limited on all patent

infringement claims; in favor of all defendants on

infringement of one patent at issue; and against

Willowood, LLC, and Willowood USA, LLC, on

infringement of the remaining three patents. The

district court denied Syngenta Crop Protection, LLC’s

motions for judgment as a matter of law. Syngenta

Crop Protection, LLC, appeals the district court’s

denials of its motions for judgment as a matter of law

and its final judgment. Defendants conditionally

cross-appeal the district court’s partial denial of their

motion to exclude expert testimony on damages. For

the reasons explained below, we affirm-in-part,

reverse-in-part, vacate-in-part, and remand for

further proceedings consistent with this opinion.

BACKGROUND

I. The Asserted Patents

Syngenta Crop Protection, LLC, (“Syngenta”)

is the assignee of U.S. Patent Nos. 5,602,076 (“the

’076 patent”), 5,633,256 (“the ’256 patent”), 5,847,138

(“the ’138 patent”), and 8,124,761 (“the ’761 patent”).

The ’076 patent is entitled “Certain Fungicides,

Pesticides and Plant Growth Regulants.” The ’256

patent is entitled “Certain Pyrimidinyloxy-phenyl

Acrylates, Derivatives Thereof and Their Fungicidal

Use.” The ’076 and ’256 patents (collectively, “the

Compound Patents”) expired on February 11, 2014.

The Compound Patents are directed to a group of

chemical compounds, including azoxystrobin, a

fungicide commonly used in agriculture to control

fungal growth on crops. J.A. 7; Appellant’s Br. 9.

The ’138 patent is entitled “Chemical Process”

and expired on December 8, 2015. The ’138 patent is

directed to a two-step process for manufacturing

azoxystrobin that includes an etherification step

followed by a condensation step. Appellant’s Br. 12;

J.A. 6672. The etherification step produces an

intermediate compound that is then used in the

condensation step to produce azoxystrobin. J.A. 6672.

The ’761 patent is entitled “Processes for the

Preparation of Azoxystrobin Using DABCO as a

Catalyst and Novel Intermediates Used in the

Processes” and does not expire until April 15, 2029.

The ’761 patent is directed to a process of using

the chemical catalyst 1,4-diazabicyclo[2.2.2]octane

(“DABCO”) during the condensation step to

manufacture azoxystrobin. ’761 patent col. 1 ll. 20–25;

J.A. 6682–83. Each claim of the ’761 patent requires

at least “the presence of between 0.1 and 2 mol % of

[DABCO].” ’761 patent col. 20 ll. 1–2, 25–26.

II. The Asserted Copyrights

Syngenta uses azoxystrobin as an active

ingredient in formulating its fungicide end-use

products. Appellant’s Br. 7. Syngenta markets and

sells these end-use products under several brand

names, including QUADRIS® and QUILT XCEL®.

Id. Both products are sold with detailed labels that

provide directions for use, storage, and disposal, as

well as first-aid instructions and environmental,

physical, and chemical hazard warnings. Id. at 19.

The QUADRIS® label comprises fifty-four pages of

small-type text and charts. J.A. 276; 424–77. The

QUILT XCEL® label comprises twenty-nine pages of

small-type text and charts. J.A. 276; 481–509.

Syngenta registered these two labels with the U.S.

19; J.A. 276–77, 479.

III. District Court Proceedings

On March 27, 2015, Syngenta brought suit

against Willowood, LLC (“Willowood LLC”),

Willowood USA, LLC (“Willowood USA”), and

Willowood Limited (“Willowood China”) (collectively,

“Willowood”)1 for patent and copyright infringement.

Willowood China is a Hong Kong company that

contracts for the manufacture of azoxystrobin in China

and sells the fungicide to Willowood USA, its Oregonbased affiliate. Willowood USA and Willowood LLC

contract with third parties to formulate azoxystrobin

into Willowood’s generic end-use fungicide products,

and market and sell azoxystrobin and those end-use

products in the United States. Shortly before the

expiration of the Compound Patents, Willowood filed

applications with the Environmental Protection

Agency (“EPA”) to register its Azoxy 2SC and

AzoxyProp Xtra generic products, which correspond

in composition and labeling to Syngenta’s

QUADRIS® and QUILT XCEL® fungicides,

respectively. J.A. 278, 714; Appellant’s Br. 19.

Syngenta asserted in its suit that Willowood’s

Azoxy 2SC and AzoxyProp Xtra products infringed

claims 1–4 and 12–14 of the ’076 patent, claims 1–3,

5, and 7 of the ’256 patent, claims 6 and 12–14 of the

’138 patent, and claims 1, 3–5, and 9–10 of the ’761

patent. J.A. 1617–1619, 1627. Syngenta also asserted

that Willowood infringed Syngenta’s registered

copyrights in its QUADRIS® and QUILT XCEL®

labels by copying those labels for Willowood’s Azoxy

2SC and AzoxyProp Xtra product labels. J.A. 289–91.

A. Pre-Trial Motions

On October 31, 2016, both parties filed motions

for summary judgment. Syngenta moved for

summary judgment that all asserted claims of the

Syngenta also sued Willowood Azoxystrobin,

LLC, but does not appeal the district court’s rulings concerning

this entity. Appellant’s Br. 6 n.1.

four patents were infringed by Willowood. Willowood

cross-moved for summary judgment, seeking

dismissal of Syngenta’s copyright claims and its claim

of infringement of the ’761 patent.

1. Patent Infringement Claims

The district court granted summary judgment

against Willowood USA for direct infringement of the

Compound Patents on the basis of Willowood’s

concession that Willowood USA imported five

kilograms of azoxystrobin into the United States in

2013, prior to the Compound Patents’ expiration.

Syngenta Crop Prot., LLC v. Willowood, LLC, No.

1:15-CV-274, 2017 WL 1133378, at *2 (M.D.N.C. Mar.

24, 2017) (“Summary Judgment Order”); see also J.A.

1617–18. The district court also granted summary

judgment against Willowood LLC for induced

infringement of the Compound Patents on the basis of

Willowood’s concession that Willowood LLC

contributed to and induced the formulation and

testing of Willowood’s Azoxy 2SC and AzoxyProp Xtra

products by third parties using the same imported

five kilograms of azoxystrobin. Summary Judgment

Order, 2017 WL 1133378, at *2–3; see also J.A. 1618.

The district court, however, denied summary

judgment against Willowood China for direct

infringement of the Compound Patents. Summary

Judgment Order, 2017 WL 1133378, at *2. The

district court found a genuine dispute of material fact

as to whether Willowood China’s sale of five

kilograms of azoxystrobin to Willowood USA took

place in China or within the United States as required

under 35 U.S.C. § 271(a). Id.

The district court next denied summary

judgment as to infringement of the ’138 patent. Id. at

*5. The district court found that it was undisputed

that Willowood China purchases azoxystrobin from

its Chinese supplier, Yangcheng Tai He Chemicals

Corp. (“Tai He”), and sells it to Willowood USA, which

then imports the azoxystrobin into the United States.

Id. at *4; see also J.A. 1619. The district court found

that it was also undisputed that the azoxystrobin in

question was manufactured in China by performing

both steps of the process claimed in the ’138 patent.

Summary Judgment Order, 2017 WL 1133378, at *4.

Relying on our decision in Akamai Technologies., Inc.

v. Limelight Networks, Inc., the district court

determined that 35 U.S.C. § 271(g) requires that all

steps of a claimed process be performed by or

attributable to a single entity. Id. at *5 (citing 797

F.3d 1020, 1022 (Fed. Cir. 2015)). On this basis, the

district court found a genuine dispute of material fact

as to whether Tai He performed both steps of the

process claimed by the ’138 patent during its

manufacture of azoxystrobin or whether Willowood

directed Tai He and others to practice the claimed

process. Id. at *4–5.

With respect to the ’761 patent, both parties

agreed that the issue of infringement turned on

whether the azoxystrobin that Willowood China

purchases and Willowood USA imports was

manufactured using DABCO at concentrations within

the claimed range of 0.1 and 2 mol %. Summary

Judgment Order, 2017 WL 1133378, at *6; J.A. 1627.

The district court denied summary judgment on this

issue, finding a genuine dispute of material fact as to

whether Willowood’s suppliers used DABCO within

the claimed range in the manufacturing process. See

Summary Judgment Order, 2017 WL 1133378, at *7.

The district court next granted Syngenta’s

motion to shift the burden of proof to Willowood

under 35 U.S.C. § 295 on the claim of infringement

of the ’761 patent. The district court found that

Syngenta demonstrated a substantial likelihood of

infringement, rejecting Willowood’s argument that

neither Tai He nor any of its intermediaries

manufacture azoxystrobin using DABCO within the

claimed range. Id. at *7–8. The district court credited

the testimony of Syngenta’s expert, who testified that

it would not be commercially reasonable to

manufacture azoxystrobin using DABCO outside the

claimed range. Id. at *8. The district court noted that

Willowood’s expert did not rebut this testimony, and

Willowood’s only rebuttal witness, the president of

Tai He, had “credibility issues.” Id. The district court

also determined that Willowood did not produce any

manufacturing records demonstrating that DABCO

was not used or describing what process was used

instead. Id. at *8, *10. The district court further

found that Syngenta made reasonable efforts to

discover Tai He’s actual manufacturing process, but

was unsuccessful because of Willowood’s failure to

cooperate. Id. at *9–10. Finding both elements of

§ 295 satisfied, the district court shifted the burden to

Willowood to prove non-infringement of the ’761

patent. Id. at *11.

2. Copyright Infringement Claims

In its cross-motion for summary judgment,

Willowood argued that Syngenta’s copyright claims

should be dismissed because the Federal Insecticide,

Fungicide, and Rodenticide Act (“FIFRA”) precludes

37. Willowood asserted that FIFRA requires generic

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fungicide products to have labels that are “identical

or substantially similar” to brand-name labels. J.A.

730–31. Willowood further contended that because

much of its labels’ text comprises instructions and

warnings mandated by FIFRA and EPA regulations,

and only limited means of expressing such

information exist, extending copyright protection to

Syngenta’s labels “would make subsequent labeling

practically impossible.” J.A. 731 & n.14, 733–35 (citing

SmithKline Beecham Consumer Healthcare, L.P. v.

Watson Pharm. Inc., 211 F.3d 21, 23 (2d Cir. 2000)).

Willowood also argued that any language that

is not required by the EPA is nonetheless

uncopyrightable because it is so “basic” and

“commonplace in the industry,” that it merges with

the ideas the language is meant to convey. J.A. 732.

In the alternative, Willowood argued that its use of

some of the language from Syngenta labels

constituted permissible fair use. J.A. 737–40.

In response, Syngenta argued that nothing in

FIFRA or EPA regulations authorizes or requires

Willowood to copy verbatim Syngenta’s labels. J.A.

2806. Syngenta asserted that pursuant to FIFRA’s

legislative scheme, the EPA requires only generic

products—not label language—to be identical or

substantially

similar

their

brand-name

counterparts, and then only to the extent that a

generic applicant seeks expedited review by the EPA.

Id. In support of its arguments, Syngenta relied

heavily on FMC Corp. v. Control Solutions., Inc., a

decision from the Eastern District of Pennsylvania,

which held that FIFRA does not preclude copyright

protection for pesticide labels because “verbatim or

nearly wholesale copying of another registrant’s label

11a

is unnecessary to obtain expedited review by the EPA

of a label.” 369 F. Supp. 2d 539, 553–60 (E.D. Pa.

2005); see J.A. 2806.

The United States filed a statement of interest

on this issue, presenting four arguments in support of

Willowood’s position. J.A. 2969–3005. First, according

to the government, FIFRA “endorses” copying by

generic applicants and furthers Congress’s intent of

expediting market access for generic fungicide

manufacturers. J.A. 2970, 2983–91. Second, the

government asserted that Syngenta granted

Willowood an implied license to copy its labels by

participating in FIFRA’s labeling scheme. J.A. 2970,

2991–94. Third, the government argued that

Willowood’s labels are protected under the doctrine of

merger, which permits copying of material that can

only be expressed in a limited number of ways. J.A.

2971, 2994–98. Lastly, the government argued that

Willowood’s labels are also protected under the

doctrine of fair use. J.A. 2971, 2998–3005.

The district court agreed with Willowood and

the United States, and issued a short order granting

summary judgment against Syngenta and dismissing

its copyright infringement claims. J.A. 33–34. The

district court stated that it found the analysis in FMC

“unconvincing,” and determined that “[e]ven with some

changes, use of the original pesticide label as a ‘go by’

for the new label will result in copyright infringement.”

Id. The district court concluded that because FIFRA

contemplates copying by a generic applicant “in ways

that would otherwise infringe a copyright, . . .

Congress intended a narrow exception to copyright

protection for the required elements” of fungicide

12a

labels. Id. The district court did not otherwise address

the arguments presented on this issue.

3. Willowood’s Motion to Exclude

On April 10, 2017, Willowood filed a motion to

exclude the testimony of Syngenta’s damages expert.

J.A. 3838–67; see also J.A. 37. Willowood did not

object to the expert’s methodology; rather, Willowood

contended that the expert’s choice of benchmarks was

based on unreliable facts or data. J.A. 44. Willowood

argued that the expert’s damages calculation was

speculative and unreliable because he based his

analysis on products unrelated to azoxystrobin and

Syngenta’s “wildly inaccurate” budgets. J.A. 48; see

also J.A. 3851–3861. Willowood also argued that

Syngenta’s expert did not properly apportion

damages for infringement of the ’761 patent because

the expert relied on the same methodology that he

used to calculate damages for infringement of the ’138

patent, even though the ’138 patent claims two steps

of the manufacturing process (etherification and

condensation) while the ’761 patent claims only one

step (condensation). J.A. 3861–3865.

The district court denied Willowood’s motion to

exclude with respect to the Compound Patents,

determining that Syngenta’s expert relied on

“sufficient facts and data applied using a reasonable

method in a justifiable manner” based on a

hypothetical non-infringing market with a similar

product as a benchmark. J.A. 35. The district court

approved the expert’s choice of using an herbicide

product as a benchmark, explaining that both

products created similar barriers to generic access to

the markets, were sold in similar markets, protected

the same crops, had comparable life cycles, and were

13a

both leading products for Syngenta. J.A. 47, 50. With

respect to using Syngenta’s budgets as benchmarks,

the district court found that the expert accounted for

any errors in budgeting, and explained that any

inaccuracies went to the weight of the evidence

instead of its admissibility. J.A. 49.

The

district

court,

however,

granted

Willowood’s motion to exclude Syngenta’s expert’s

testimony with respect to the ’138 and ’761 patents,

finding that the expert did not provide an adequate

explanation for his choice of bench-marks. The

district court found that in contrast to the

benchmarks chosen for the Compound Patents, the

expert provided “scant analysis for why nonazoxystrobin fungicides” were a proper benchmark

and no evidence of similarities between the products

and their markets. J.A. 53–54. The district court also

excluded testimony on lost profits with respect to the

’761 patent, explaining that the expert failed to

address but-for causation or account for existing noninfringing alternatives in his calculations. J.A. 55–58.

B. Trial and Post-Trial Motions

The district court held a seven-day trial

beginning on September 5, 2017. With respect to the

Compound Patents, the only issues at trial were

whether Willowood China imported into the United

States or sold to Willowood USA within the United

States the five-kilogram sample of azoxystrobin.

Syngenta argued that Willowood China imported

azoxystrobin into the United States by arranging for

its entry into the country. J.A. 6961. Syngenta also

argued that Willowood China’s sale of the

azoxystrobin necessarily occurred within the United

States because Willowood USA is located within the

14a

United States. Id. Willowood argued in response that

Willowood China did not infringe the Compound

Patents because the shipment of five-kilogram

sample of azoxystrobin was marked “f.o.b. China,”2

meaning that title to the azoxystrobin passed from

Willowood China to Willowood USA overseas. J.A.

6961. After presenting its case, Syngenta moved for a

judgment as a matter of law (“JMOL”) on this issue.

The district court denied Syngenta’s JMOL

motion, and the jury returned a specific verdict in

favor of Willowood China, finding that Syngenta did

not prove that Willowood China imported

azoxystrobin into the United States or sold

azoxystrobin within the United States. J.A. 266. The

jury awarded Syngenta $75,600 in damages for

infringement of the Compound Patents by Willowood

USA and Willowood LLC. Syngenta renewed its

motion for JMOL after the verdict, which the district

court again denied. J.A. 6523; Appellant’s Br. 12.

With respect to the ’138 patent, the only issue

at trial was whether both steps of the claimed process

were performed by a single entity or attributable to

Willowood as the directing or controlling entity. J.A.

240–241; 266; Appellant’s Br. 13. Syngenta presented

evidence that Willowood directed or controlled Tai

He’s manufacturing process, and that Tai He

performed both claimed steps. Appellant’s Br. 13–15.

In rebuttal, Willowood presented evidence that Tai

He did not perform the etherification step when

“F.o.b” stands for “free on board” and designates

a method of shipment whereby legal title passes from the seller

to the buyer once goods are delivered at a designated location.

Litecubes, LLC v. N. Light Prod., Inc., 523 F.3d 1353, 1358 n.1

(Fed. Cir. 2008).

15a

manufacturing Willowood’s azoxystrobin. See J.A.

8232–8241; J.A. 7682 at 63:22–64:11; Appellant’s Br.

15. The jury returned a specific verdict in favor of

Willowood with respect to the ’138 patent, finding

that Syngenta did not prove that both steps of the

claimed process were performed by or attributable to

a single entity. J.A. 266.

With respect to the ’761 patent, the only issue

at trial was whether during manufacture of

Willowood’s azoxystrobin, the condensation step was

performed using the DABCO catalyst within the

range claimed by the ’761 patent. J.A. 248–50;

Appellant’s Br. 17. The burden of proof was on

Willowood pursuant to the district court’s order under

35 U.S.C. § 295. Summary Judgment Order, 2017 WL

1133378, at *11. After presenting its case, Syngenta

moved for JMOL on this issue, which the district court

denied. J.A. 7045; Appellant’s Br. 18. After trial, the

jury returned a specific verdict in favor of Syngenta

that “the Defendants” did not prove that DABCO was

not used as claimed. J.A. 267. The jury awarded

$900,000 in damages to Syngenta for infringement of

the ’761 patent “by the Defendants.” Id.

After trial, the parties submitted proposed

final judgments to the district court. J.A. 6489. At

that point, a dispute arose between the parties as to

whether the jury found that Willowood China

infringed the ’761 patent. In resolving the dispute, the

district court noted that the jury found with respect

to the Compound Patents that Willowood China did

not import azoxystrobin into the United States or sell

azoxystrobin within the United States. Id. The

district court explained that “[n]either party asked

the court to submit a separate issue as to Willowood

16a

China’s infringement of the ’138 patent or the ’761

patent,” and concluded that “the parties implicitly

agreed to resolve Willowood China’s liability for the

[’138 and ’761 patents] based on the answer to the

importation question which was first on the verdict

sheet.” Id. The district court concluded that “[t]here is

no evidentiary basis” for finding that Willowood

China infringed the ’761 patent. Id.

On November 20, 2017, the district court

entered final judgment. The district court entered

judgment in favor of Willowood China on “all claims”

and in favor of all Willowood defendants on the claim

of infringement of the ’138 patent. J.A. 3. The district

court entered judgment against Willowood USA and

Willowood LLC on the claims of infringement of the

Compound Patents and the ’761 patent. Id. After the

district court entered final judgment, Syngenta

renewed its JMOL motion with respect to Willowood

China’s infringement. J.A. 6522–6523; Appellant’s

Br. 18. Syngenta contended that Willowood waived its

argument that Willowood China did not infringe the

’761 patent by not objecting to the wording of the jury

verdict form. J.A. 6522. The district court denied

Syngenta’s renewed JMOL motion. J.A. 91.

Syngenta appeals the district court’s dismissal

of its copyright claims, the district court’s conclusion

that § 271(g) requires every step of a claimed process

to be performed by or attributable to a single entity,

the jury’s verdict that Willowood did not infringe

the ’138 patent even with the single entity

requirement imposed on § 271(g), and the district

court’s judgment that Willowood China did not

infringe any of the asserted patents. Willowood

conditionally cross-appeals the district court’s partial

17a

denial of its motion to exclude the testimony of

Syngenta’s damages expert. We have jurisdiction

under 28 U.S.C. § 1295(a)(1).

DISCUSSION

I. Standard of Review

We review a district court’s decisions on

motions for summary judgment and JMOL under the

law of the regional circuit, in this case the Fourth

Circuit. Supernus Pharm., Inc. v. Iancu, 913 F.3d

1351, 1356 (Fed. Cir. 2019); Mohsenzadeh v. Lee, 790

F.3d 1377, 1381 (Fed. Cir. 2015). The Fourth Circuit

reviews the grant of a motion for summary judgment

de novo, viewing all evidence in the light most

favorable to the non-moving party. Amdocs (Israel)

Ltd. v. Openet Telecom, Inc., 761 F.3d 1329, 1337–38

(Fed. Cir. 2014) (citing Ramos v. S. Maryland Elec.

Co–op., Inc., 996 F.2d 52, 53 (4th Cir. 1993)). The

Fourth Circuit reviews a district court’s post-verdict

JMOL decisions de novo, determining whether the

jury’s verdict is supported by substantial evidence.

LifeNet Health v. LifeCell Corp., 837 F.3d 1316, 1322

(Fed. Cir. 2016) (citing Carolina Trucks & Equip., Inc.

v. Volvo Trucks of N. Am., 492 F.3d 484, 488 (4th Cir.

2007)). The Fourth Circuit reviews a district court’s

pre-verdict grant of JMOL de novo, viewing all

evidence in light most favorable to the non-moving

party and considering whether a reasonable jury

could find for the non-moving party. ActiveVideo, 694

F.3d at 1319 (citing Brown v. CSX Transp., 18 F.3d

245, 248 (4th Cir. 1994)).

We review questions of patent law under

Federal Circuit law. Ericsson, Inc. v. D-Link Sys.,

Inc., 773 F.3d 1201, 1214 (Fed. Cir. 2014). We review

18a

a jury’s findings on questions of fact, such as

infringement and damages, for substantial evidence.

Power Integrations, Inc. v. Fairchild Semiconductor

Int’l, Inc., 711 F.3d 1348, 1377 (Fed. Cir. 2013). We

review a district court’s decisions concerning damages

methodologies for abuse of discretion. ActiveVideo

Networks, Inc. v. Verizon Commc’ns, Inc., 694 F.3d

1312, 1332 (Fed. Cir. 2012) (citing Lucent Techs., Inc.

v. Gateway, Inc., 580 F.3d 1301, 1310 (Fed. Cir.

2009)).

We apply copyright law as interpreted by the

regional circuit. Amini Innovation Corp. v. Anthony

Cal., Inc., 439 F.3d 1365, 1368 (Fed. Cir. 2006).

Interpretation of the rights granted by the Copyright

Act is a question of law that the Fourth Circuit

reviews de novo. See Rosciszewski v. Arete Assocs.,

Inc., 1 F.3d 225, 229 (4th Cir. 1993).

We also review a district court’s rulings on

admission of expert testimony under the law of the

regional circuit. ePlus, Inc. v. Lawson Software, Inc.,

700 F.3d 509, 516 (Fed. Cir. 2012). The Fourth Circuit

reviews such evidentiary rulings for abuse of

discretion. Id. (citing Kopf v. Skyrm, 993 F.2d 374, 378

(4th Cir. 1993)).

review

questions

statutory

interpretation de novo. Mohsenzadeh, 790 F.3d at

1381 (citing AD Global Fund, LLC v. United States,

481 F.3d 1351, 1353 (Fed. Cir. 2007)). If two statutory

provisions are “capable of co-existence, it is the duty

of the courts, absent a clearly expressed congressional

intention to the contrary, to regard each as effective.”

Ruckelshaus v. Monsanto Co., 467 U.S. 986, 1018

(1984) (quoting Regional Rail Reorganization Act

19a

Cases, 419 U.S. 102, 133-34 (1974)) (internal

quotation marks omitted).

II. Syngenta’s Copyright Claims

Syngenta challenges the district court’s

summary judgment order dismissing its copyright

claims in their entirety. The dismissal was based on

the court’s holding that FIFRA “precludes copyright

protection for the required elements of pesticide

labels as against the labels of me-too [i.e. generic3]

registrants.” J.A. 33. We conclude that this

determination was premature. Because the text of

FIFRA does not, on its face, require a me-too

registrant to copy the label of a registered product, the

statute only conflicts with the Copyright Act to the

extent that some particular element of Syngenta’s

label is both protected under existing copyright

doctrines and necessary for the expedited approval

of Willowood’s generic pesticide product. This

determination requires this court to review the merits

of Syngenta’s copyright claims, which the district

court did not reach. Thus, we remand for the court to

do so in the first instance.

When evaluating the “alleged preclusion of a

cause of action under one federal statute by the

provisions of another federal statute,” we rely on

traditional rules of statutory interpretation. POM

Wonderful LLC v. Coca-Cola Co., 573 U.S. 102, 111

(2014). Among these principles is the presumption

Consistent with terminology used by the EPA,

the parties and the district court use the term “me-too” to refer

to applications requesting registration of generic pesticide

products pursuant to FIFRA’s criteria for expedited review.

See EPA, PRIA Glossary, https://www.epa.gov/pria-fees/priaglossary (last visited December 9, 2019).

20a

that a later-enacted statute does not impliedly repeal,

even in part, an earlier one. Id. (citing Carcieri v.

Salazar, 555 U.S. 379, 395 (2009)). Thus, where the

later-enacted statute does not cover the whole subject

of the earlier one and is not “clearly intended as a

substitute,” an implied repeal will only be found

where provisions in the two statutes are in

“irreconcilable conflict”—a stringent standard that

renders implicit repeals a “rarity.” Nat’l Ass’n of Home

Builders v. Defs. of Wildlife, 551 U.S. 644, 662-63

(2007); J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred

Int’l, Inc., 534 U.S. 124, 142 (2001). In the absence of

such conflict, statutory provisions acting upon the

same subject should be interpreted and applied in a

way that “gives effect to each” and “preserves the

purposes of both.” United States v. Borden Co., 308

U.S. 188, 198 (1939); Zenith Elecs. Corp. v. Exzec, Inc.,

182 F.3d 1340, 1347 (Fed. Cir. 1999).

Here, the Copyright Act prohibits parties from

reproducing the protected elements of a valid

actions would constitute fair use. See Harper & Row

Publishers, Inc. v. Nation Enterprises, 471 U.S. 539,

547 (1985); Lyons P’ship, L.P. v. Morris Costumes,

Inc., 243 F.3d 789, 801 (4th Cir. 2001); Ale House

Mgmt., Inc. v. Raleigh Ale House, Inc., 205 F.3d 137,

143 (4th Cir. 2000). At the same time, FIFRA provides

for expedited EPA review of applications for generic

pesticide products when the proposed “me-too”

product, as compared to the currently registered

product, (1) “would be identical or substantially

similar in composition and labeling” or (2) would

“differ in composition and labeling” “only in ways that

would not significantly increase the risk of

21a

unreasonable adverse effects on the environment.” 7

U.S.C. § 136a(c)(3)(B)(i)(I) (emphasis added).

In finding that FIFRA precluded copyright

claims against me-too applicants, the district court

relied on its understanding that “FIFRA

contemplates that a ‘me-too’ applicant will copy from

the original pesticide label in ways that would

otherwise infringe a copyright.” J.A. 33. But while use

of FIFRA’s expedited generic pathway is premised on

similarity to a registered product, the text of § 136

does not require a me-too applicant to ensure that its

product label is identical to a registered label; nor

does it require applicants to otherwise derive the

elements of its label from that of the registered label.

Rather, the statute provides for expedited review so

long as any differences between the proposed and

registered products “would not significantly increase

the risk of unreasonable adverse effects on the

environment”—a substantive criterion evaluated by

the EPA under its technical expertise. 7 U.S.C.

§ 136a(c)(3)(B)(i)(I).

This is significant because copyright

infringement requires, at a minimum, some copying

of protected elements from the copyrighted work,

which does not include “any idea, procedure, process,

system, method of operation, concept, principle, or

discovery” embodied by the work. 17 U.S.C. § 102(b);

Lyons P’ship, 243 F.3d at 801. FIFRA’s similarity

requirement does not foreclose expedited review for

an independently composed label that relies solely on

unprotected facts, concepts, and methods derived from

the registered label.

In this respect, the asserted conflict between

the Copyright Act and FIFRA differs from the conflict

22a

between the Copyright Act and the Hatch-Waxman

Act that was addressed in SmithKline, a decision

cited by the district court and Willowood. SmithKline

Beecham Consumer Healthcare, L.P. v. Watson

Pharms., Inc., 211 F.3d 21 (2d Cir. 2000). There, the

Second Circuit found that the Hatch-Waxman Act

“not only permit[s] but require[s] producers of generic

drugs to use the same labeling as was approved for,

and is used in, the sale of the pioneer drug.”4 Id. at 25

(emphasis added). In these circumstances, the court

concluded that generic applicants faced a doublebind: “if [the plaintiff’s] copyright claim has merit,

then [the defendant] cannot realistically use the

ANDA process to sell its [generic product] because it

will either have to change the label and lose FDA

approval or be enjoined from using a label that

infringes [the plaintiff’s] copyright.” Id. at 27. Thus,

the court found it “obvious” that Congress intended

for the Hatch-Waxman Act to “trump the copyright

laws.” Id. at 29. Here, in contrast, FIFRA’s express

allowance for differences between the proposed and

registered labels allows me-too applicants to avoid

this conflict by using an independently created label.

Willowood and 41 Companies Holding Generic

EPA Pesticide Registrations (“Generics Amici”)

counter that there are nonetheless practical and

regulatory constraints that frustrate their reasonable

attempts to comply with the requirements of both the

The Hatch-Waxman Act requires that, except for

changes related to the manufacturer name or approved

difference in the drug, “[a]n abbreviated application for a new

drug shall contain . . . (v) information to show that the labeling

proposed for the new drug is the same as the labeling approved

for the listed drug . . . .” 21 U.S.C. § 355(j)(2)(A) (emphases

added).

23a

We disagree that these concerns alone warrant

preclusion. To begin with, Generics Amici contend

there are “only so many ways to express the same

instructions and warnings” contained in many

portions of these pesticide labels, such that any

attempt to capture the pertinent information will

inevitably require using substantially the same

expressions. Generics Amici Br. at 8 (emphasis in

original); see also Appellee’s Br. at 23-25. But this is

precisely the type of problem addressed by the

traditional copyright doctrine of merger, under which

courts have declined to protect against copying when

an underlying fact, procedure, or idea can be

expressed in so few ways that “protection of the

expression would effectively accord protection to the

idea itself.” Kregos v. Associated Press, 937 F.2d 700,

705 (2d Cir. 1991); see also Morrissey v. Procter &

Gamble Co., 379 F.2d 675, 678 (1st Cir. 1967) (“When

the uncopyrightable subject matter is very narrow, so

that the topic necessarily requires, if not only one

form of expression, at best only a limited number, to

permit copyrighting would mean that a party or

parties, by copyrighting a mere handful of forms,

could exhaust all possibilities of future use of the

substance.” (internal citations and quotation marks

omitted)). Thus, copyright law has its own solution for

the constraints inherent in the expression of certain

information contained in pesticide labels.

Willowood raises a more difficult problem with

respect to portions of a registered label for which

the EPA has allegedly required me-too applicants to

copy otherwise protectable elements from the

registered label on the grounds that any differences

may adversely affect the environment by confusing

24a

users.5 For example, Willowood contends that when it

sought to revise the directions for use in its own label

from the four-column table format used by Syngenta

to a narrative form, the EPA required Willowood to

reinstate the information in a table, essentially

requiring Willowood to copy Syngenta’s format.

Appellee’s Br. at 24 (citing J.A. 3129-3200 (Azoxy 2.08

SC Label); J.A. 3201-3339 (AzoxProp Xtra label)). But

this is a predicament appropriately addressed, at

least in the first instance, under copyright law’s own

“equitable rule of reason”: the fair use doctrine. Sony

Corp. of Am. v. Universal City Studios, Inc., 464 U.S.

417, 448 (1984) (quoting H. Rep. No. 94–1476, at 65–

66, reprinted in 1976 U.S.C.C.A.N. 5659, 5679).

Under that established framework, the district court

can assess, based on factors such as the character of

the allegedly creative elements, their substantiality

in the context of the labels as a whole, and the nature

and effect of their use by Willowood, whether the

presence of those elements in Willowood’s generic

labels would fairly constitute infringement in

violation of the Copyright Act.6

Thus, we vacate the district court’s grant of

summary judgment on Syngenta’s copyright claims

and remand for further consideration. On remand,

This is distinct from portions of the registered

label where the language was originally mandated or suggested

by the EPA. Syngenta has disclaimed any copyright protection

over those label elements. Appellant’s Reply Br. at 11.

The Copyright Act expressly identifies the

following non-exhaustive factors to be considered in assessing

fair use: “(1) the purpose and character of the use . . . ; (2) the

nature of the copyrighted work; (3) the amount and

substantiality of the portion used in relation to the copyrighted

work as a whole; and (4) the effect of the use upon the potential

market for or value of the copyrighted work.” 17 U.S.C. § 107.

25a

the district court should first discern whether the

any portion of Syngenta’s label. The district court

should, for instance, consider whether the fair-use

doctrine or limits on copyrightable subject matter,

such as the merger doctrine, would eliminate

infringement. Only if the district court concludes that

the Copyright Act would in fact prohibit Willowood’s

conduct in a manner inconsistent with the purposes

of FIFRA should it revisit the question of whether and

to what extent FIFRA precludes Syngenta’s copyright

claims for any part of its pesticide labels. It is possible

that after a full assessment of the requirements of

there may come to light a truly irreconcilable conflict

between Copyright Act liability and implementation

of FIFRA. In the absence of a clear facial conflict,

however, we decline to wield the blunt tool of

preclusion before the full factual and legal contours of

any latent problem have been examined.

III. Infringement Under 35 U.S.C. § 271(g)

Syngenta next challenges the district court’s

interpretation of 35 U.S.C. § 271(g). The district court

interpreted § 271(g) to require that all steps of a

patented process be performed by or at the direction

or control of a single entity before infringement

liability under that section can attach. Summary

Judgment Order, 2017 WL 1133378, at *5. Syngenta

contends that the district court’s interpretation of

§ 271(g) is contrary to the plain language of the

statute and Congress’s intent expressed in the

legislative history. Appellant’s Br. 41–46. The amici

add to this argument by asserting that the district

26a

court’s interpretation is inconsistent with the

broader context of the statute as a whole and the

purpose behind § 271(g), and creates an impossible

evidentiary burden on the patent owner. See Amicus

NYPLA Br. 10–14; Amici Biotechnology & CropLife

Br. 8–14; 17–23. This is an issue of first impression.

We conclude that the district court erred by imposing

a single-entity requirement under § 271(g).

“As in all statutory construction cases, we

begin with the language of the statute.” Barnhart v.

Sigmon Coal Co., 534 U.S. 438, 450 (2002). The

meaning of statutory language “is determined by

reference to the language itself, the specific context in

which that language is used, and the broader context

of the statute as a whole.” Robinson v. Shell Oil Co.,

519 U.S. 337, 340 (1997). If the statutory language

does not clearly resolve the disputed issue, we also

consider the legislative history to determine

Congressional intent. Burlington N. R. Co. v.

Oklahoma Tax Comm’n, 481 U.S. 454, 461 (1987); In

re Swanson, 540 F.3d 1368, 1376 (Fed. Cir. 2008)

(citing Timex V.I. v. United States, 157 F.3d 879, 882

(Fed. Cir. 1998), and Deluxe Corp. v. United States,

885 F.2d 848, 850 (Fed. Cir. 1989)).

The resolution of this issue turns on the nature

of the infringing acts covered by § 271(g). Section

271(g) provides in relevant part that “[w]hoever

without authority imports into the United States or

offers to sell, sells, or uses within the United States a

product which is made by a process patented in the

United States shall be liable as an infringer.” 35

U.S.C. § 271(g) (2012). This language makes clear

that the acts that give rise to liability under § 271(g)

are the importation, offer for sale, sale, or use within

27a

this country of a product that was made by a process

patented in the United States. Id. Nothing in this

statutory language suggests that liability arises from

practicing the patented process abroad. Rather, the

focus is only on acts with respect to products resulting

from the patented process. Thus, because the

statutory language as a whole is clear that practicing

a patented process abroad cannot create liability

under § 271(g), whether that process is practiced by a

single entity is immaterial to the infringement

analysis under that section.

The context of the statute as a whole also

supports our conclusion. Section 271(a) states that

“whoever without authority makes, uses, offers to sell,

or sells any patented invention, within the United

States or imports into the United States any patented

invention during the term of the patent therefor,

infringes the patent.” 35 U.S.C. § 271(a). Derived from

this statutory language is the single-entity

requirement under § 271(a), which limits direct

infringement liability only to circumstances “where

all steps of a claimed method are performed by or

attributable to a single entity.” Akamai Techs., 797

F.3d at 1022; BMC Res., Inc. v. Paymentech, L.P., 498

F.3d 1373, 1379–81 (Fed. Cir. 2007).

On the basis of this court’s § 271(a)

jurisprudence, the district court concluded that §

271(g) similarly imposes a single-entity requirement

on the performance of a patented process. Summary

Judgment Order, 2017 WL 1133378, at *5 (citing

Akamai, 797 F.3d at 1022). This conclusion was

erroneous because infringement liability under the

two sections is distinct. In contrast to § 271(g), the act

that gives rise to liability under § 271(a) occurs when

28a

“a party . . . make[s], use[s], sell[s], or offer[s] to sell

the patented invention, meaning the entire patented

invention.” BMC, 498 F.3d at 1380. Under this

precedent, direct infringement under § 271(a) of a

process patent occurs only when a single party

practices every step of the claimed process. Id.; see

also 35 U.S.C. § 271(a) (infringement occurs when

“whoever without authority makes, uses, offers to sell,

or sells . . . or imports . . . any patented invention”

(emphasis added)). As discussed above, however,

liability under § 271(g) is not predicated on practicing

the claimed process, but rather on importing, offering

for sale, selling, or using a product. See 35 U.S.C.

§ 271(g) (infringement occurs when “whoever without

authority imports . . . or offers to sell, sells, or uses . . .

a product” (emphasis added)). Thus, the single-entity

requirement, which is necessary for direct

infringement liability under § 271(a), has no

application to acts that do not constitute infringement

under § 271(g).

On the same basis we reject Willowood’s

argument that the Supreme Court’s Limelight

decision requires us to apply the single-entity rule to

§ 271(g). Willowood asserts that the Court in that case

applied “the single entity rule to allegations of both

direct and indirect infringement under [§] 271(a) and

(b).” Appellee’s Br. 29 (citing Limelight Networks, Inc.

v. Akamai Techs., Inc., 572 U.S. 915, 921–22 (2014)).

Willowood argues that because “§ 271(g) is simply

another form of direct infringement,” we are bound by

the Limelight decision to apply the single-entity rule

to § 271(g). Id. We disagree.

Willowood fundamentally misunderstands the

nature of the act that gives rise to liability under

29a

§ 271(g). Although § 271(g) may involve a form of

direct liability, that liability does not arise from

practicing a patented process abroad. Limelight is

further inapposite because the statute at issue in

Limelight—§ 271(b)—predicates induced infringement

liability on the existence of direct infringement.

35 U.S.C. § 271(b) (“Whoever actively induces

infringement of a patent shall be liable as an

infringer.” (emphasis added)); Limelight, 572 U.S. at

921. Because direct infringement under § 271(a)

requires a single entity to perform all of the claimed

steps, the Supreme Court explained that where

“performance of all the patent’s steps is not

attributable to any one person[,] . . . . there has been

no direct infringement,” and consequently “no

inducement of infringement under § 271(b).” Id. at

922. By contrast, infringement liability under § 271(g)

is not predicated on direct infringement of the

patented process, and we will “not read into the

patent laws limitations and conditions which the

legislature has not expressed.” Diamond v. Diehr, 450

U.S. 175, 182 (1981) (quoting Diamond v.

Chakrabarty, 447 U.S. 303, 308 (1980)).

Section 271(f) reinforces our conclusion.

Section 271(f) creates liability for induced

infringement when a party “supplies or causes to be

supplied in or from the United States all or a

substantial portion of the components of a patented

invention . . . 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.”

35 U.S.C. § 271(f)(1) (2012) (emphasis added). If

Congress intended to limit liability under § 271(g) to

instances where the patented process was practiced

30a

in a manner that would infringe the patent if such

practice occurred within the United States—such as

it did by requiring a single entity to perform the entire

process under § 271(a)—it “kn[ew] precisely how to do

so.” Limelight, 572 U.S. at 923. Congress, however,

did not do so, even though § 271(g) was enacted four

years after § 271(f). See Microsoft Corp. v. AT & T

Corp., 550 U.S. 437, 441 (2007); Kinik Co. v. Int’l

Trade Comm’n, 362 F.3d 1359, 1362 (Fed. Cir. 2004).

“Where Congress includes particular language in one

section of a statute but omits it in another section of

the same Act, it is generally presumed that Congress

acts intentionally and purposely in the disparate

inclusion or exclusion.” Rodriguez v. United States,

480 U.S. 522, 525 (1987) (quoting Russello v. United

States, 464 U.S. 16, 23 (1983)) (internal alterations

and quotation marks omitted). The Supreme Court

has warned that “courts should not create liability

for . . . non-infringing conduct where Congress has

elected not to extend that concept.” Limelight, 572

U.S. 923. We heed this warning.

Willowood asserts that the inclusion of the

phrase “if such combination occurred within the

United States” in § 271(f) but not in § 271(g)

demonstrates that Congress did not intend for

§ 271(g) to extend the scope of patent protection

outside the United States to include conduct that

would

not

constitute

direct

infringement

domestically—such as the divided practice of a

patented process by more than one entity. Appellee’s

Br. 41–42. We agree with this proposition but reject

Willowood’s conclusion that the absence of that

phrase necessitates the application of the singleentity requirement to § 271(g). As explained above,

practicing a patented process abroad does not give

31a

rise to infringement liability under § 271(g). Thus, our

conclusion that a single entity need not perform every

step of a patented process abroad under § 271(g) does

not extend patent protection to cover extraterritorial

conduct that would not otherwise trigger liability

within the United States. Rather, it is Willowood who

asks us to impermissibly apply § 271(g) to

extraterritorial conduct by attempting to shift the

focus of the statute from domestic acts of importation,

offer for sale, sale, or use of a product to cover a

foreign act of practicing a patented process. See

WesternGeco LLC v. ION Geophysical Corp., 138 S.

Ct. 2129, 2137 (2018) (“If the conduct relevant to the

statute’s focus . . . . occurred in another country, ‘then

the case involves an impermissible extraterritorial

application regardless of any other conduct that

occurred in U.S. territory.’” (quoting RJR Nabisco,

Inc. v. European Cmty., 136 S. Ct. 2090, 2094 (2016))).

We are not inclined to do so.

Other sections of Title 35 add support to our

conclusion that infringement under § 271(g) is not

predicated on a single entity practicing a patented

process abroad. For example, § 287(b), which limits

available damages under § 271(g), states that “[t]he

modifications of remedies provided in this subsection

shall not be available to any [infringer under § 271(g)]

who . . . had knowledge before the infringement that a

patented process was used to make the product the

importation, use, offer for sale, or sale of which

constitutes the infringement.” 35 U.S.C. § 287(b)(1)(C)

(2012) (emphasis added). This language makes clear

that the act of infringement under § 271(g) occurs

after a patented process has already been used.

Thus, because practicing a patented process does not

trigger liability under § 271(g), it is immaterial

32a

whether that process is practiced by more than a

single entity. Additionally, § 287(b) limits available

remedies under § 271(g) in certain circumstances

where the manufacturer of a product made by a

patented process “is not known.” See 35 U.S.C.

§§ 287(b)(3)(B)(iii); 287(b)(4)(A)(iii); 287(b)(5)(C)(i)

(2012). It would not have made sense for Congress to

make infringement liability under § 271(g) contingent

on a single entity practicing a patented process while

expressly providing limitations on that liability where

it is unknown which manufacturer—or how many—

practiced the process.

The legislative history is instructive. A Senate

Report

accompanying

the

Process

Patents

Amendments Act of 1987, the bill that enacted

§ 271(g), states that the purpose of the statute is to

provide a remedy “when someone, without

authorization, uses or sells in the United States, or

imports into the United States a product made by

their patented process.” S. Rep. 100-83, at 29 (1987).

The Report makes clear that § 271(g) was enacted to

“extend protection to the products” resulting from

practicing a patented process and to “prevent

circumvention of a U.S. process patentee’s rights

through manufacture abroad and subsequent

importation into the United States of products made

by the patented process.” Id. at 46, 48 (emphasis

added); see also id. at 30 (stating that § 271(g) would

“protect against the entry into the U.S. marketplace

of goods made abroad without authorization from the

inventor”). Even Willowood concedes that the

legislative history’s clear “focus is on the importation

of products,” rather than on the use of a patented

process. Appellee’s Br. 31 The Report also clarifies

that § 271(g) “does not attempt to prevent the use of

33a

the process in another country.” S. Rep. 100-83, at 30

(emphasis added); see also id. at 48. The Report

explains that a “U.S. process patentholder [that] has

not obtained a similar patent in the other country . . .

has no right by virtue of his U.S. patent to prevent

anyone from using the process in that country.” S.

Rep. 100-83, at 30. Thus, because simply practicing a

patented process abroad does not come within the

ambit of § 271(g), that there may be several entities

involved in practicing the process is immaterial to the

infringement analysis under § 271(g).

Willowood argues that in enacting § 271(g),

Congress intended to provide patentees with “the

same protection against overse[a]s infringers as they

already enjoyed against domestic entities.” Appellee’s

Br. 30 (quoting Mycogen Plant Sci., Inc. v. Monsanto

Co., 252 F.3d 1306, 1318 (Fed. Cir. 2001), judgment

vacated on other grounds, 535 U.S. 1109 (2002))

(emphasis removed). On this basis, Willowood

contends that because direct infringement of a

process patent under § 271(a) requires the same

entity to perform all of the claimed steps, the same

must be true under § 271(g). Id. at 30–31. We

disagree.

The statutory language and legislative history

described above make clear that practicing a patented

process abroad does not trigger liability under

§ 271(g) in the same manner that practicing a

patented process domestically does under § 271(a).

Section 271(a) covers all patented processes, whether

or not they result in a product. Infringement under

§ 271(g) instead requires importation, sale, offer for

sale, or use within the United States of a product

made by a patented process. The different scope of

34a

protection offered under § 271(a) and § 271(g)

demonstrates that there is no inconsistency between

the two sections. The legislative history further

demonstrates that Congress did not enact § 271(g) to

provide for identical rights to those enjoyed by

patentees under § 271(a) with respect to process

patents. Rather, Congress made clear that § 271(g) “is

prompted by the use of patented processes in other

countries followed by the importation of the resulting

products into this country,” and simply “extend[s]

protection to the products” made by such processes. S.

Rep. 100-83 at 46.

Lastly, applying a single-entity requirement to

the practice of a patented process under § 271(g)

would impose an undue evidentiary burden on

patentees that is contrary to the intent of Congress.

Congress recognized “the great difficulties a patentee

may have in proving that the patented process was

used in the manufacture of the product in question”

where the manufacture occurred abroad. Id. at 57. As

a solution, Congress provided for a rebuttable

presumption in § 295 that shifted the burden to the

accused infringer to prove that the patented process

was not used in manufacturing the accused products.

See 35 U.S.C. § 295. Congress would not have on the

one hand recognized the difficulty in determining how

a product was manufactured, and on the other hand

concluded that determining who manufactured the

product would be an easy exercise so as to require

patentees to prove that a single manufacturer

practiced the claimed process.

We hold that in light of the plain language of

the statute, the broader context of the statutory

scheme as a whole, and the legislative history,

35a

§ 271(g) does not require a single entity to perform all

of the steps of a patented process for infringement

liability to arise from the importation into the United

States or offer to sell, sale, or use within the United

States of a product made by a process patented in the

United States.

It is undisputed that Willowood USA imported

into the United States an azoxystrobin compound

that was manufactured abroad using the process

patented by the ’138 patent. Summary Judgment

Order, 2017 WL 1133378, at *5. We therefore reverse

the district court’s judgment that Willowood USA did

not infringe the ’138 patent under § 271(g). The jury

found, however, that Willowood China did not import

into the United States or sell or offer for sale in the

United States the azoxystrobin compound at issue,

and as discussed below, substantial evidence supports

this finding. We therefore affirm the district court’s

judgment that Willowood China did not infringe the

’138 patent under § 271(g). Because neither the jury

nor the district court made any findings concerning

Willowood LLC’s role, if any, with respect to the

azoxystrobin compound made using the process

claimed in the ’138 patent, we vacate the district

court’s judgement that Willowood LLC did not

infringe the ’138 patent under § 271(g) and remand

for further proceedings.

IV. Infringement by Willowood China

Syngenta argues that the district court erred as

a matter of law by denying its JMOL motion and

entering judgment in favor of Willowood China on the

issues of infringement of the Compound Patents and

36a

the ’761 patent.7 Syngenta contends that substantial

evidence does not support the jury’s verdict that

Willowood China did not sell or import azoxystrobin

within the United States. Syngenta points to evidence

it presented that Willowood China “agreed to be ‘the

exclusive seller’” of Tai He’s azoxystrobin within the

United States and continued to sell azoxystrobin to

Willowood USA after 2013. Appellant’s Br. 63.

Syngenta argues that the fact that Willowood China’s

sale of azoxystrobin to Willowood USA was made

“f.o.b. China” is not determinative, because “a sale can

take place in more than one location.” Appellant’s

Reply Br. 36. Syngenta also contends that Willowood

China imported azoxystrobin into the United States,

pointing to evidence in the record that Willowood

China coordinates the shipping from China to the

United States, pays freight charges, and makes delivery

arrangements. Appellant’s Br. 63; Appellant’s Reply Br.

34–35. We are not persuaded by Syngenta’s arguments.

The question before us is not whether

substantial evidence supports Syngenta’s position but

whether substantial evidence supports the jury’s

verdict. See Regents of Univ. of California v. Broad

Inst., Inc., 903 F.3d 1286, 1294 (Fed. Cir. 2018) (“We

do not reweigh the evidence. It is not our role to ask

whether substantial evidence supports fact-findings

not made . . . , but instead whether such evidence

On the issue of Willowood China’s alleged

infringement of the Compound Patents, Syngenta appeals both

the district court’s denial of its motion for summary judgment

and its post-verdict motion for JMOL. See Appellant’s Br. 58–68.

A district court’s denial of summary judgment is not appealable

after a trial on the merits. Ortiz v. Jordan, 562 U.S. 180, 183–84

(2011); Function Media, L.L.C. v. Google, Inc., 708 F.3d 1310,

1322 (Fed. Cir. 2013). We therefore limit our review to

Syngenta’s appeal of the district court’s denial of JMOL.

37a

supports the findings that were in fact made.”). Here,

the jury heard evidence that because the shipment of

azoxystrobin was marked “f.o.b. China,” legal title

passed from Willowood China to Willowood USA in

Hong Kong. See J.A. 6794. The jury also heard

evidence that Willowood USA is responsible for

clearing the shipments of azoxystrobin through

customs in United States and for registering the

fungicide with the EPA. J.A. 6795. In addition,

Willowood presented testimony that Willowood USA

reimburses Willowood China for the freight charges,

and the jury saw Willowood’s invoices stating that

Willowood USA assumes the entire liability for the

shipment of azoxystrobin from China to the United

States. See id.; J.A. 8225–27.8 We conclude that this is

substantial evidence that supports the jury’s findings

that Willowood China did not infringe the Compound

Patents because it sold azoxystrobin in China and did

not import azoxystrobin into the United States.

Syngenta also contends that even if Willowood

China did not infringe the Compound Patents, the

jury found that Willowood China infringed the ’761

patent. Syngenta points to the jury’s finding that “the

Defendants” did not prove that Willowood’s

azoxystrobin was not manufactured using DABCO

within the range claimed by the ’761 patent and the

jury’s award of damages for infringement of the ’761

patent by “the Defendants.” Appellant’s Br. 68 (citing

J.A. 267). Syngenta asserts that “the Defendants”

Willowood’s counsel confirmed at Oral

Argument that Willowood USA is the importer of record and

assumes the risk of shipment. Oral Arg. at 22:29–22:31,

http://oralarguments.cafc.uscourts.gov/de-fault.aspx?fl=20181614.mp3 (“The importer of record is Willowood USA.”); id. at

23:16–23:19 (“Willowood USA assumes liability.”).

38a

referred to all Willowood entities collectively, including

Willowood China, and contends that Willowood waived

any argument to the contrary by failing to object to

the wording of the jury verdict form. Id. at 68, 71–72;

see also Appellant’s Reply Br. 39–42. Syngenta argues

that the question on the jury verdict form regarding

Willowood China’s importation or sale of azoxystrobin

applied only to the issue of infringement of the

Compound Patents, not the ’761 patent, and the

district court erred by linking the two issues.

Appellant’s Br. 69–72; Appellant’s Reply Br. 39–42.

We disagree.9 As we discussed above,

substantial evidence supports the jury’s finding that

Willowood China did not import azoxystrobin into the

United States or sell or offer for sale azoxystrobin

within the United States. The district court was thus

correct to find that Willowood China did not infringe

the ’761 patent. J.A. 6489. To the extent there was

any ambiguity in the jury verdict form, we have held

that district courts enjoy “broad discretion to

interpret an ambiguous verdict form, because district

courts witness and participate directly in the jury

trial process.” Telcordia Techs., Inc. v. Cisco Sys., Inc.,

612 F.3d 1365, 1378 (Fed. Cir. 2010); see also Prism

Techs. LLC v. Sprint Spectrum L.P., 849 F.3d 1360,

1377 (Fed. Cir. 2017).

In light of the foregoing, we conclude that the

district court did not err by denying Syngenta’s JMOL

motion with respect to infringement of the Compound

We reject Syngenta’s waiver argument because

we “have the discretion to consider issues not raised below ‘as

justice may require.’” Ninestar Tech. Co. v. Int’l Trade Comm’n,

667 F.3d 1373, 1382 (Fed. Cir. 2012) (quoting Hormel v.

Helvering, 312 U.S. 552, 555–59 (1941)).

39a

Patents and the ’761 patent and entering judgment in

favor of Willowood China on these issues.

V. Willowood’s Cross-Appeal

Willowood conditionally cross-appeals the

district court’s denial of its motion to exclude the

testimony of Syngenta’s expert concerning damages

for infringement of the Compound Patents. CrossAppellant’s Br. 56–66. Syngenta responds that

Willowood’s cross-appeal is procedurally improper

because it does not seek to expand the scope of the

judgment below. Appellant’s Resp. Br. 49–51. We

need not decide these issues because Willowood’s

cross-appeal is conditional on our reversal of the

judgment concerning the Compound Patents, and we

affirm the district court in that respect.

CONCLUSION

We have considered the parties’ remaining

arguments and find them unpersuasive. We conclude

that the district court did not provide an adequate

analysis of the potential conflict between FIFRA and

the Copyright Act for us to determine whether such a

conflict truly exists. We also conclude that the district

court erred by imposing a single-entity requirement

on the performance of a patented process under

§ 271(g). We agree with the district court in all other

respects. We therefore affirm-in-part, reverse-in-part,

vacate-in-part, and remand for further proceedings

consistent with this opinion.

AFFIRMED-IN-PART, REVERSED-IN-PART,

VACATED-IN-PART, AND REMANDED

COSTS

Each party shall bear its own costs.

40a

[ENTERED: April 10, 2017]

IN THE UNITED STATES DISTRICT COURT FOR

THE MIDDLE DISTRICT OF NORTH CAROLINA

SYNGENTA CROP

PROTECTION, LLC,

)

Plaintiff,

)

WILLOWOOD, LLC, et al., )

)

Defendant.

)

1:15-CV-00274

ORDER

Syngenta Crop Protection, LLC has sued four

affiliated companies, denominated collectively here as

Willowood,

claiming

patent

and

infringement. Because the Federal Insecticide

Fungicide and Rodenticide Act (FIFRA) precludes

pesticide labels as against the labels of me-too

registrants, the Court will grant summary judgment

to Willowood on Syngenta’s copyright claims. Cf.

SmithKline Beecham Consumer Healthcare, LP.

v.Watson Pharm., Inc., 211 F.3d 21, 29 (2d Cir. 2000)

(holding that the Hatch-Waxman Act precludes

against generic drug manufacturers).

The Court appreciates the analysis of FMC

Corp. v. Control Solutions, Inc., 369 F. Supp. 2d 539,

555-71 (E.D. Pa. 2005), but finds it unconvincing.

FIFRA contemplates that a “me-too” applicant will

copy from the original pesticide label in ways that

41a

would otherwise infringe a copyright. 7 U.S.C.

§ 136a(c)(3)(B)(i)(I). Even with some changes, use of

the original pesticide label as a “go by” for the new

label will result in copyright infringement. See 17

U.S.C. § 106; Lyons P’ship, L.P. v. Morris Costumes,

Inc., 243 F.3d 789, 801 (4th Cir. 2001) (discussing

substantially similar standard for copyright

infringement). In enacting FIFRA, Congress intended

a narrow exception to copyright protection for the

required elements of pesticide labels as against metoo registrants.

Syngenta has moved to exclude an expert

report from Steven Schatzow and declarations from

Gerald Simmons, Lois Rossi, Debra Edwards, and

Janelle Kay, all offered by Willowood in its defense of

Syngenta’s copyright claims. Because the Court is

granting the summary judgment motion on legal

grounds unrelated to the proffered evidence, the

Court has not considered this evidence and concludes

that these evidentiary motions are moot.

It is ORDERED that the Willowood’s motion

for summary judgment, Doc. 87, is GRANTED in

part as to Counts V and VI and Syngenta’s copyright

claims are dismissed. It is further ORDERED that

Syngenta’s motions to exclude Mr. Schatzow’s report,

Doc. 90, and certain declarations, Doc. 106, are

DENIED as moot.

This the 10th day of April, 2017.

/s/

UNITED STATES DISTRICT JUDGE

42a

[ENTERED: March 24, 2017]

IN THE UNITED STATES DISTRICT COURT FOR

THE MIDDLE DISTRICT OF NORTH CAROLINA

SYNGENTA CROP

PROTECTION, LLC,

)

Plaintiff,

)

WILLOWOOD, LLC, et al., )

)

Defendants.

)

1:15-CV-274

MEMORANDUM OPINION AND ORDER

Catherine C. Eagles, District Judge.

Syngenta Crop Protection, LLC has sued four

affiliated companies denominated collectively here as

Willowood,1

alleging

patent

and

infringement. Syngenta contends Willowood has

infringed its patents in connection with the

manufacture and sale of Willowood’s Azoxy 2SC,

AzoxyProp Xtra, and Tebustrobin SC products and

has infringed its copyrights by verbatim copying of

Syngenta product labels. Syngenta seeks partial

summary judgment on Counts I through IV, asserting

that its 5,602,076 Patent, 5,633,256 Patent, 5,847,138

Patent, and 8,124,761 Patent are valid and that

Willowood infringed the patents. Syngenta makes

1 The defendants are Willowood, LLC; Willowood USA,

LLC; Willowood Azoxystrobin, LLC; and Willowood Limited.

Where it is necessary to distinguish between the defendants,

these companies are referenced individually as W-LLC, W-USA,

and W-Ltd.

43a

related evidentiary objections to opinion testimony by

the defendant’s expert Dr. Mark A. Lipton.2

Willowood seeks summary judgment on Count IV,

asserting that its products do not infringe the ‘761

Patent as a matter of law, and on Counts V and VI,

asserting that Syngenta does not have a valid

The Court will grant in part and deny in part

Syngenta’s motion for summary judgment and will

deny Willowood’s motion for summary judgment as to

Count IV. The Court retains under advisement

Willowood’s motion for summary judgment as to

Counts V and VI, which will be resolved by separate

order.

Facts

The following facts are undisputed. Syngenta

holds several patents protecting azoxystrobin, a

fungicidal compound used to protect various crops,

and the process for making it.3 The ‘076 and ‘256

Patents expired on February 11, 2014, and the ‘138

Patent expired on December 8, 2015. Doc. 96-1 ¶¶ 29,

30. The ‘761 Patent will expire in April 2029. Id. at ¶

31. Willowood sells generic versions of crop-protection

2 Syngenta has objected to other expert testimony and

related declarations, which the Court will address in separate

orders.

3 See Doc. 12 at ¶¶ 20-21; Doc. 96-1 at ¶¶ 29-31; Doc. 1-8

(the ‘076 Patent); Doc. 1-9 (the ‘256 Patent); Doc. 1-10 (the ‘138

Patent); Doc. 1-11 (the ‘761 Patent). All citations in this opinion

are to the ECF docket and page numbers, or where appropriate

internal paragraph designations, except for deposition

transcripts, where citations are to the ECF docket number and

the deposition page and line numbers provided by the court

reporter.

44a

products, including the generic azoxystrobin

fungicides Azoxy 2SC and AzoxyProp Xtra. Doc. 12 at

¶¶ 73, 75; Doc 16 at ¶¶ 4, 8. Willowood and Syngenta

use azoxystrobin technical, a relatively pure form of

the chemical compound azoxystrobin, as the active

ingredient in their azoxystrobin fungicides. Doc. 96-1

¶¶ 34-35; Doc. 12 at ¶ 37 (admitting allegation in Doc,

1 at ¶ 37).

II.

Count I (the ‘076 Patent) and Count II (the

‘256 Patent)

Syngenta moves for summary judgment on

these two counts, contending that the evidence shows

that the two patents are valid and that Willowood

infringed the patents. The Court views the evidence

in the light most favorable to Willowood, the nonmoving party, as is appropriate at summary

judgment.

Validity

Patents are “presumed valid,” 35 U.S.C.

§ 282(a), unless the defendant can show invalidity by

clear and convincing evidence. Microsoft Corp. v. i4i

Ltd. P’ship, 564 U.S. 91, 95 (2011); Insite Vision Inc.

v. Sandoz, Inc., 783 F.3d 853, 858 (Fed. Cir. 2015).

Willowood presents no evidence of invalidity for

either the '076 or ‘256 Patents. Doc. 137 at 17:1318:15. The Court will grant summary judgment for

Syngenta on this issue.

Infringement

Relevant Facts

The ‘076 and ‘256 Patents claim a group of

chemical compounds, which include azoxystrobin.

Docs. 1-8, 1-9; Doc. 96-1 at ¶¶ 74, 87. In 2013, W-Ltd

45a

bought five kilograms of azoxystrobin technical from

its Chinese supplier, Yangcheng Tai He Chemicals

Corp., (“Tai He”), and sold it to W-USA. See Doc. 137

at 41:12-:15; Doc. 105 at 6-7 n.3; Doc. 15 at ¶ 6. WUSA imported the five kilograms of azoxystrobin

technical into the United States before the expiration

of the two patents. Doc. 96-7 at 3; Doc. 96-9 at 5, 6. WLLC commissioned Adjuvants Unlimited, Inc. to

formulate fungicides using azoxystrobin technical

and to create product samples. See Doc. 137 at 26:3:7. W-LLC then commissioned Analytical &

Regulatory Chemistry, Inc. (ARC) to analyze the

product samples for its EPA applications. Doc. 96-7 at

3; Doc. 96-10 at 41:21-42:10. Before performing these

studies, and before importing the azoxystrobin

technical, Willowood knew of the ‘076 and ‘256

Patents and knew that these activities would likely

infringe the patents. See Doc. 96-7 at 3; Doc. 96-10 at

305:11-:18.

ii.

Direct Infringement by WUSA and W-Ltd

Anyone who “makes, uses, offers to sell, or sells

any patented invention, within the United States or

imports into the United States any patented

invention” without the patent holder’s permission has

infringed the patent. 35 U.S.C. § 271(a).

Willowood concedes that in 2013. W-USA

infringed the ‘076 and ‘256 Patents by importing five

kilograms of azoxystrobin technical into the United

States. Doc. 96-9 at 5, 6. The Court will grant

summary judgment against W-USA on these two

counts.

46a

Willowood also concedes that W-Ltd sold

azoxystrobin technical to W-USA, which is located in

Roseburg, Oregon. See Doc. 15 at ¶ 6; Doc. 16 at ¶ 3.

Willowood asserts that the sale did not infringe

because the shipment of azoxystrobin technical “FOB

China” by W-Ltd, a Hong Kong company, was not a

sale “within the United States” under § 271(a). See

Doc. 15 at ¶ 3, 6; Doc. 137 at 18:16-:19.

Free on board or “FOB” is a shipping term that

indicates when in the delivery process title transfers

from the buyer to the seller. Litecubes, LLC v. N.

Light Prods., Inc., 523 F.3d 1353, 1.358 n. 1 (Fed. Cir.

2008). “FOB China” means that title transferred to

the buyer, W-USA, when the seller, W-Ltd, conveyed

the goods to the shipper in China. See id. at 1358 n.1,

1369.

In analyzing where a sale took place, the Court

should not “exalt form over substance. Id. at 1370

(quoting N. Am. Philips Corp. v. Am. Vending Sales,

Inc., 35 F.3d 1576, 1579 (Fed. Cir. 1994)). When other

factors indicate an intention to sell infringing

products to customers in the United States, shipment

FOB a location abroad neither limits the place of sale

to the location from which the goods were shipped nor

precludes liability under § 271. SEB S.A. v.

Montgomery Ward & Co., Inc., 594 F.3d 1360, 1375

(Fed. Cir. 2010), aff’d sub nom. Glob.-Tech

Appliances, Inc. v. SEB S.A., 563 U.S. 754 (2011); see

also Transocean Offshore Deepwater Drilling, Inc., v.

Maersk Contractors USA, Inc., 617 F.3d 1296, 131011 (Fed. Cir. 2010). To determine the location of the

sale, the fact-finder can consider the location, of the

buyer and seller, N. Am. Philips, 35 F.3d at 1579,

“where the products were shipped from and where the

47a

products were shipped to.” SEB, 594 F.3d at 1375,

“the transfer of tangible property,” Transocean, 617

F.3d at 1311, and “the agreement by which such a

transfer t[ook] place.” Id.; see also Litecubes, 523 F.3d

at 1369.

Here, the seller, W-Ltd, was in Hong Kong,

Doc. 15 at ¶ 3, while the buyer, W-USA, was in the

United States. Doc. 16 at ¶ 3. W-Ltd shipped the

azoxystrobin technical FOB China to W-USA, for

delivery in the United States. See id. at ¶ 8; Doc. 15

at ¶ 6. There is a genuine issue of material fact on

whether the sale took place in the United States, See

SEB, 594 F.3d at 1375 (approving instructions to the

jury to consider evidence including FOB terms,

invoices with U.S. companies, and delivery to the

United States to determine the location of the sale).

Summary judgment will be denied as to whether WLtd infringed.

iii.

Indirect Infringement by WLLC

“Whoever actively induces infringement of a

patent shall be liable as an infringer.” 35 U.S.C.

§ 271(b). Induced infringement requires (1) “active

steps taken to encourage direct infringement,”

Takeda Pharm. U.S.A., Inc. v. W.-Ward Pharm. Corp.,

785 F.3d 625, 630 (Fed. Cir. 2015) (quotation

omitted), and (2) knowledge or willful blindness that

the induced acts constitute patent infringement.

Glob.-Tech Appliances, 563 U.S. at 766, 768. An active

step sufficient for induced infringement includes

causing, urging, encouraging, or aiding another to

infringe the patent. Takeda Pharm., 785 F.3d at 631

48a

n.3 (citing Tegal Corp. v. Tokyo Electron Co., Ltd., 248

F.3d 1376, 1379 (Fed. Cir. 2001)).

W-LLC commissioned Adjuvants to formulate

azoxystrobin

fungicides

from

the

imported

azoxystrobin technical and commissioned ARC to

analyze samples of the resulting end products. Doc.

137 at 20:9-: 19, 26:3-:7; Doc. 96-10 at 41:21-42:10. WLLC knew that this use of azoxystrobin technical by

Adjuvants and ARC would infringe Syngenta’s

patents. Doc. 96-10 at 305:5-:18. By commissioning

Adjuvants and ARC to undertake formulation and

analysis that required using azoxystrobin technical,

W-LLC actively induced infringement of the ‘076 and

‘256 Patents. The Court will grant summary

judgment in favor of Syngenta against W-LLC.

III.

Count III (the '138 Patent)

Validity

Syngenta moves for summary judgment as to

the validity of the ‘138 Patent, which protects a

chemical process used to produce azoxystrobin

technical. Willowood proffers Dr. Lipton’s expert

opinion as evidence that the ‘138 Patent is invalid due

to obviousness, see 35 U.S.C. § 103, and asserts that

summary judgment should be denied, Syngenta

contends that Willowood’s evidence of obviousness is

insufficient to raise a disputed question of material

fact and moves to exclude Dr. Lipton’s analysis. As

noted supra, the burden to show invalidity is on the

challenger, and therefore Willowood must show by

clear and convincing evidence that at the time of the

invention, the patent’s claimed subject matter was

obvious to a person of ordinary skill in the art.

49a

Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343, 1353

(Fed. Cir. 2013). To prove obviousness, the defendant

must explicitly provide “[a] reason for combining

disparate prior art references.” InTouch Techs., Inc. v.

VGO Commc’ns, Inc., 751 F.3d 1327, 1351 (Fed. Cir.

2014); KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418

(2007) (requiring that arguments explicitly provide

an “articulated reasoning with some rational

underpinning” to make the asserted combinations

(quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir.

2006))).

In evaluating obviousness, an expert should

take steps “to guard against slipping into use of

hindsight and to resist the temptation to read into the

prior art the teachings of the invention in issue.”

Graham v. John Deere Co. of Kan. City, 383 U.S. 1, 36

(1966) (quotation omitted); see KSR Int’l, 550 U.S. at

421 (noting a factfinder “must be cautious of

arguments reliant upon ex post reasoning”); Insite

Vision, 783 F.3d at 859. In this case, Dr. Lipton stated

several times that “the substance of claim 6” was the

“starting point” of his obviousness analysis. Doc. 9615 at 142:8-:21, 144:5-:6. He explicitly admitted that

he started with Claim Six and worked backwards.

Doc. 96-15 at 140:7-:19.

Relying on Interactive Gift Express, Inc. v.

CompuServe Inc., 256 F.3d 1323, 1331 (Fed. Cir.

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