Amicus Curiae Brief — Helsinn Healtcare S.A. v. Teva Pharm. USA, Inc., 139 S. Ct. 358 (2018) (No. 17-1229)

No. 17-1229

IN THE

Supreme Court of the United States

HELSINN HEALTHCARE S.A.,

Petiti

v.

TEVA PHARMACEUTICALS USA INC., TEVA

PHARMACEUTICAL INDUSTRIES, LTD.,

Respondents.

On Warr or CERTIORARI TO THE UNrrep STaTES

Court or APPEALS FoR THE FEDERAL Cracurr

BRIEF OF AMICUS CURIAE

THE NAPLES ROUNDTABLE

IN SUPPORT OF NEITHER PARTY

ANDREW BALUCH MatruEw J. Dowp

Suir BaLuce LLP Counsel of Record

700 Pennsylvania Avenue, Rosert J. SCHEFFEL

Suite 2060 Dowpb ScHEFFEL PLLC

Washington, DC 20003 1717 Pennsylvania Avenue N W,

Suite 1025

Washington, DC 20006

(202) 559-9175

mdowd@dowdscheffel.com

Counsel for Amicus Curiae

30, 2018

COUNSEL PRESS

(800) 274-3321 + (B00) 369-6859

i

TABLE OF CONTENTS

Page

,_ + 5 4 SRS IER eS i

TABLE OF CITED AUTHORITIES .............. iii

INTEREST OF AMICUS CURIAE ..............+: 1

SUMMARY OF THE ARGUMENT................ 1

Scakdonctacccdictconsavaveeseaceseceed 4

I. The Correct Statutory Analysis Must

Consider The Statute’s Two “Sense

Of Congress” Provisions ..................+. 4

Il. The Federal Circuit Incorrectly Overlooked

The Explicit Legislative Purpose Of The

America Invents Act... .... 2.2... 60sec eee ees )

A. Abrogating Non-Disclosing Sales and

Uses as Prior Art is Consistent with

— Stated “Harmonization”

pueeesedeedh ccebekene ss UUeeneeees 10

BSI cw vcvccecesccnccoscesecces 12

Bi. Wa cedcnccsccdéuccccevoncteeses 15

3. Republic of Korea.................-- 17

it

Table of Contents

B. Abrogating Non-Disclosing Sales and

Uses as Prior Art is Consistent with

Congress’s Stated Goal of Achieving

Greater Certainty Regarding the

iit

TABLE OF CITED AUTHORITIES

Cases

Accardi v. Pennsylvania Railroad Co.,

SEB U.S. 225 (1966)... cece cece cccccees

Burrage v. United States,

Deal v. United States,

508 U.S. 129 (1998)... 2... cece e cece ences

Eli Lilly & Co. v. Medtronic, Inc.,

496 U.S. G61 (1990)... 2... cece cccccccccees

Exaon Mobil Corp. v. Allapattah Services, Inc.,

545 U.S. 546 (2005) ... 2... ee eee ee eee

Gibbons v. Ogden,

22 U.S. (9 Wheat.) 1 (1824) ..............4.-.

Hanson v. Espy,

8 F.3d 469 (7th Cir. 1993)... ........---2-65-

Page

w

Cited Authorities

Hoffman Plastic Compounds, Inc. v. NLRB,

Monahan v. Dorchester Counseling Center, Inc.,

961 F.2d 987 (ist. Cir. 1992) .................

National Cable Television Association, Inc. v.

United States,

Sp PO cc cccccccccccccccsccesees

Park ‘N Fly, Inc. v. Dollar Park & Fly, Inc.,

GID Ty BG cc ccc cccccccccsccccccccs

Richards v. United States,

PP WEE cece ccceccessccccovceocces

State Highway Commission v. Volpe,

479 F.2d 1099 (8th Cir. 1973)................-

Sturgeon v. Frost,

196 S. Ct. 1061 (OIG)... cece cece eenne

Utility Air Regulatory Group v. EPA,

134 S. Ct. 2427 (2014)... 2... ccc cee e cee eeee

v

Cited Authorities

Page

United States v. Ellis,

714 F-2d 953 (9th Cir. 1983).............00000000- 6

Yang v. California Department of Social

Services,

183 F.3d 953 (9th Cir. 1999) ...............222-5- 7

U.S. STATUTES

nS SL 8 DO 6

IE aE AP ENE ir Bae Aer Ree 6

oc. acesuaseareacenn 6

a 6

RE Ree RARE SR re RR IP NE 9

REE NE AN pe Ra PE ge ER 13, 15

ESS Se BR oni pana eee passim

RR OE CORE OT 13, 15

no cone pmeideadan 13, 15

Leahy-Smith America Invents Act of 2011,

Pub. L. No. 112-29, 125 Stat. 284........... passim

vt

Cited Authorities

Page

FOREIGN AUTHORITIES

European Patent Convention Art. 54(2)............. 13

European Patent Office, Guidelines for

Examination in the EPO (2015) ................ 15

Japanese Patent Office, Examination Guidelines

for Patent and Utility Model in Japan (2018)... . 22

Korean Intellectual Property Office, Patent

Examination Guidelines (July 2013) ............ 19

Korean Intellectual Property Office,

Understanding the Patent Act of the Republic

SR bhb dacdnssendacudeneesencessns 19

Patent Act (Act No. 121 of April 13,

1959, as amended up to Act No. 36

of May 14, 2014), art. 29(1) (1959) (Japan) ........ 20

Patent Act (Act No. 950, as amended up to

Act. No. 14112), art. 29(1) (2016) (S. Kor.) ......... 18

Patent Law of the People’s Republic

SE cutscucensocéecatbendueceoes 15

Patent Law of the People’s Republic of China,

SEY bias 64500560 4a00d0ES pbs dansecedeaues 15

vit

Cited Authorities

State Intellectual Property Office of the

People’s Republic of China, Guidelines for

Patent Examination (2010) ................-

OTHER SOURCES

157 Cong. Rec. 85319 Gaily ed. Sept. 6, 2011)... ..

157 Cong. Rec. $1360 (Mar. 8, 2011) .............

Jay Erstling & Ryan Strom, Korea’s Patent Policy

and Its Impact on Economic Development:

A Model for Emerging Countries?,

11 San Diego Int’! L.J. 441 (2010) ............

1A Norman Singer & J.D. Shambie Singer, Statutes

and Statutory Construction (7th ed. 2008) . . . .

The Interpretation of Legal Texts (2012)... . . ;

Mark Schafer, Note, How the Leahy-Smith America

Invents Act Sought To Harmonize United States

Patent Priority with the World, a Comparison

with the European Patent Convention, 12

Wash. U. Global Stud. L. Rev. 807 (2013) ......

Page

1

INTEREST OF AMICUS CURIAE'

Amicus curiae The Naples Roundtable, Inc. is a

501(c)(3) non-profit organization whose primary mission

is the exploration of ways to improve and strengthen

the U.S. patent system. To achieve this goal, the Naples

Roundtable supports the advanced study of both national

and international intellectual property law and policy.

The Naples Roundtable fosters the exchange of ideas

and viewpoints among the leading intellectual property

experts and scholars. It also organizes conferences and

other public events to promote the development and

exchange of ideas that improve and strengthen the U.S.

patent system.

More information about the Naples Roundtable

can be found on the organization’s website: http://www.

thenaplesroundtable.org. None of the Naples Roundtable,

the individuals on its Board of Directors, or its counsel

have any personal interest in the outcome of this case.

SUMMARY OF THE ARGUMENT

Amicus curiae submits this brief to focus on certain

erroneous aspects of the Federal Circuit’s methodology

of statutory construction.

1. No counsel for a party authored this brief in whole or in

part, and no such counsel or party made a monetary contribution

intended to fund the preparation or submission of this brief.

No person other than the amicus curiae, or its counsel, made

a monetary contribution to its preparation or submission. The

parties have consented to the filing of this brief.

2

The Federal Circuit’s approach to statutory

construction in this case illustrates the appeals court’s

failure to properly consider the explicit statutory

purpose when construing the statute. Statutory text

remains paramount, of course, but a statute’s purpose

cannot be overlooked when a court also examines other

interpretative evidence in order to construe the statute.

In certain instances, Congress memorializes the

purpose of legislation by including one or more “Sense

of Congress” provisions. When Congress includes such

a Sense of Congress provision, and when that Sense of

Congress speaks directly to the interpretative question,

then a court should consider this evidence of legislative

purpose when construing the statute. This Court ard

other courts have av..e so in the past, recognizing that a

Sense of Congress provision is highly probative evidence of

the statute’s legislative purpose. Indeed, because a Sense

of Congress provision is part of the enacted legislation,

it can be the strongest evidence of legislative purpose, as

it is here.

Here, the Federal Circuit erroneously overlooked two

explicit statutory Sense of Congress provisions, setting

forth the purpose of the statute. By overlooking these

explicit statements—that are part of the statutory text—

the Federal Circuit’s statutory analysis was incomplete

and failed to account for the statutory objectives Congress

sought to achieve when it passed the Leahy-Smith

America Invents Act of 2011 (“ALA”), Pub. L. No. 112-29,

125 Stat. 284.

Within § 3 of the AIA are two Sense of Congress

provisions that expressly state the objectives and

3

policies of the legislation. Behind the first-inventor-to-

file regime, as embodied in revised 35 U.S.C. § 102, were

Congress's expressly stated objectives of achieving both

(1) “harmonization of the United States patent system”

with those commonly used throughout the world and (2)

“greater certainty regarding the scope of protection”

provided by U.S. patents. AIA §§ 3(0), 3(p). Regarding

the first objective, because the vast majority of patent

applications filed outside the United States are filed

in jurisdictions where secret commercialization is not

regarded as prior art, the elimination of this category of

prior art brings the U.S. patent system in line with the

rest of the world. As for the second objective, Congress

intended to create greater certainty in the patent system

by making it easier to determine what is or is not prior

art without resorting to expensive discovery. This second

objective fits logically within the policy framework of

a first-inventor-to-file system. Limiting prior art to

information that is publicly known increases certainty

about the validity of issued patents. Both legislative

objectives are furthered by restricting the scope of prior

art under § 102 to that which makes the claimed invention

itself “available to the public.”

Both congressional objectives were thwarted, however,

by the Federal Circuit’s incomplete statutory analysis. The

appeals court did not cite, much less analyze, the Sense of

Congress provisions, yet the court seemingly considered

select arguments relating to legislative history. The

court’s incomplete analysis rests, in part, on its failure to

consider the highly relevant Sense of Congress provisions.

4

ARGUMENT

Il. The Correct Statutory Analysis Must Consider The

Statute’s Two “Sense Of Congress” Provisions

Congress’s “authoritative statement is the statutory

text, not the legislative history.” Exxon Mobil Corp. v.

Allapattah Servs., Inc., 545 U.S. 546, 568 (2005); see also

Hoffman Plastic Compounds, Inc. v. NLRB, 535 U.S. 137,

149—-50 n.4 (2002); Park ‘N Fly, Inc. v. Dollar Park & Fly,

Inc., 469 U.S. 189, 194 (1985) (“Statutory construction must

begin with the language employed by Congress and the

assumption that the ordinary meaning of that language

accurately expresses the legislative purpose.”). For this

reason, “the words of a governing text are of paramount

concern, and what they convey in their context is what the

text means.” Antonin Scalia & Bryan A. Garner, Reading

Law: The Interpretation of Legal Texts 441 (2012). The

obligation of the courts is thus to interpret the statute as

written. See Burrage v. United States, 134 S. Ct. 881, 892

(2014) (“The role of this Court is to apply the statute as it

is written—even if we think some other approach might

accord with good policy.”).

Even so, it is a “fundamental canon of statutory

construction that the words of a statute must be read in

their context and with a view to their place in the overall

statutory scheme.” F'DA v. Brown & Williamson Tobacco

Corp., 529 U.S. 120, 133 (2000); accord Sturgeon v. Frost,

136 S. Ct. 1061, 1070 (2016). A word’s meaning exists

only in the context in which the word is used. See Deal

v. United States, 508 U.S. 129, 132 (1993) (explaining the

“fundamental principle of statutory construction (and,

indeed, of language itself)” is that “the meaning of a word

5

cannot be determined in isolation, but must be drawn from

the context in which it is used”).

Legislative text is not always clear. See, e.g., Utility

Air Regulatory Group v. EPA, 134 S. Ct. 2427, 2441 (2014)

(noting that the Clean Air Act “is far from a chef doeuvre of

legislative draftsmanship”); Eli Lilly & Co. v. Medtronic,

Inc., 496 U.S. 661, 679 (1990) (“No interpretation we have

been able to imagine can transform § 271(e)(1) into an

elegant piece of statutory draftsmanship.”). When the text

is unclear or subject to multiple interpretations, courts

will and should routinely consider other evidence, such

as the legislative purpose of the statute.

This Court and others have regularly turned to

statutory purpose to ensure that the correct interpretation

is reached.

We believe it fundamental that a section of a

statute should not be read in isolation from the

context of the whole Act, and that in fulfilling

our responsibility in interpreting legislation,

“we must not be guided by a single sentence or

member of that sentence, but [should] look to

the provisions of the whole law, and to its object

and policy.”

Richards v. United States, 369 U.S. 1, 11 (1962) quoting

Mastro Plastics Corp. v. NLRB, 350 U.S. 270, 285 (1956);

see also 1A Norman Singer & J.D. Shambie Singer,

Statutes and Statutory Construction § 25:3 (7th ed. 2008)

(“The statute should be construed according to its subject

matter and the purpose for which it was enacted.”).

6

On occasion, the objective and policy behind a statute

are readily discernible because Congress explicitly stated

as much in provisions titled the “Sense of Congress.” A

Sense of Congress provision will frequently state what

Congress wanted to accomplish with the particular

legislation. The current U.S. Code is replete with Sense of

Congress provisions. See, e.g., 2 U.S.C. § 1511(a); 5 U.S.C.

§ 9701(f)(1); 15 U.S.C. § 2221(1)(1); 21 U.S.C. § 1961(a).

This Court and other courts have turned to and

relied on Sense of Congress provisions when interpreting

statutes. In Accardi v. Pennsylvania Railroad Co., 383

U.S. 225 (1966), the Court addressed whether a former

employer had improperly denied World War II veterans

their seniority rights guaranteed by the Selective Training

and Service Act of 1940. The Court looked to the statute’s

language, noting that it “clearly manifests a purpose

and desire on the part of Congress to provide as nearly

as possible that persons called to serve their country

in the armed forces should, upon returning to work in

because of their service to their country.” /d. at 228. This

“continuing purpose of Congress,” as the Court observed,

was further established by a Sense of Congress provision

that spoke directly to the protection of employment rights

to veterans returning to civilian life. Jd. at 229.

Courts of appeals have similarly relied on Sense of

Congress provisions when interpreting statutes. See

Hanson v. Espy, 8 F.3d 469, 476 (7th Cir. 1993) (relying on

a Sense of Congress provision to support the interpretation

of the Disaster Assistance Act of 1988); United States v.

Ellis, 714 F.2d 953, 955—56 (9th Cir. 1983) (relying on

a Sense of Congress provision when interpreting the

7

Consolidated Farm and Rural Development Act of 1961).

While a Sense of Congress provision may not always be

controlling, it “can be useful in resolving ambiguities in

statutory construction” and in reinforcing the meaning, of

the law. State Highway Comm'n v. Volpe, 479 F.2d 1099,

1116 (8th Cir. 1973).

Of course, a Sense of Congress provision does not

generally create legal rights. The plain text of the

Sense of Congress statement may use non-mandatory

language, such as the word “should.” See, e.g., Monahan

v. Dorchester Counseling Ctr., Inc., 961 F.2d 987, 994—

95 (ist. Cir. 1992) (holding as non-binding a Sense of

Congress that each state “should” review and revise its

laws to ensure services for mental health patients); Yang

v. Cal. Dep't of Social Servs., 183 F.3d 953, 958-61 (9th

Cir. 1999) (noting the Sense of Congress that Hmong and

other Lao refugees who fought in Vietnam war “should”

be considered veterans for purposes of receiving certain

welfare benefits). Or the Sense of Congress provision is

issued in a non-binding House or Senate Resolution. Even

so, a sense of Congress provision is almost always a direct

statement of legislative intent, having bicameral approval.

In some cases, such as with the AIA, a Sense of

Congress provision is the best evidence of what the

statutory text was intended to achieve. This Court has

long examined the Sense of Congress when understanding

the purpose of legislation and construing the terms of

the legislation—even in the absence of a formal Sense of

Congress provision. See, e.g., Nat'l Cable Television Ass'n,

Inc. v. United States, 415 U.S. 336, 337 (1974) (relying on

a Sense of Congress provision in the Independent Offices

Appropriation Act of 1952); see also Cameron Septic Tank

8

Co. v. Knoxville, 227 U.S. 39, 50 (1913) (holding that it

was “certainly the sense of Congress” that the Treaty of

Brussels of December 14, 1900 did not affect the expiration

of a U.S. patent); McClurg v. Kingsland, 42 U.S. 202,

207 (1843); Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1, 218

(1824). These examples and others confirm that the goal

of statutory interpretation—understanding the meaning

of the statute in the context of the statutory scheme and

legislative purpose—can often be achieved by reference

to a Sense of Congress provision.

In short, a Sense of Congress provision is a highly

probative interpretative guidepost, which a court tasked

with construing a statute should consider. Yet, the Federal

Circuit entirely overlooked the Sense of Congress sections

included in the ALA. Two Sense of Congress provisions in

AIA § 3 speak directly to the issue of Congress’s intent

in adopting a first-inventor-to-file regime, as embodied

in revised 35 U.S.C. § 102. As Petitioner explains, the

Federal Circuit incorrectly limited its inquiry to select

floor statements, to the exclusion of other statements,

and at the same time diminished the importance of the

statute’s text. Pet. Br. 28-29.

Here, the two Sense of Congress provisions are

perhaps the strongest evidence—beyond the text of

§ 102(a)(1)—about what Congress intended when it

enacted the AIA. Instead of considering the Sense of

Congress provisions, the Federal Circuit looked to—

and dismissed the value of—certain floor statements by

several members of Congress. The court’s error was to

look to only these floor statements and ignore the explicit

objectives embodied in the Sense of Congress provisions.

9

The Federal Circuit’s incomplete consideration of

the interpretative evidence is an incorrect method of

construing statutes. It leads to a misinformed view of

legislative purpose. If this Court’s interpretation of

§ 102(a)(1) considers interpretative evidence beyond that

section itself, then this Court must reject the Federal

Circuit’s incomplete approach and must account for

Congress’s stated purposes for amending § 102, as set

forth in the Sense of Congress provisions in the AIA.

II. The Federal Circuit Incorrectly Overlooked The

Explicit Legislative Purpose Of The America

Invents Act

In the present case, the Federal Circuit’s interpretation

of 35 U.S.C. § 102(a)(1), as enacted by the AIA, did not

account for Congress’s stated purpose for enacting the

AIA. The purpose of the legislation is set forth in two

Sense of Congress provisions. In the first, Congress

stated its intent was to harmonize U.S. patent law with

“the patent systems commonly used in nearly all other

countries” by converting the U.S. patent system from

a first-to-invent system to a first-to-file system. In the

second provision, Congress stated its intent was to provide

“greater certainty regarding the scope of protection.”

Both provisions underscore Congress’s affirmative

decision to eliminate the category of so-called “secret

prior art,” that is, any sales and uses that do not make

available to the public “the subject matter defined by a

claim in a patent or an application for a patent,” as the

term “claimed invention” is defined in 35 U.S.C. § 100()).

10

A. Abrogating Non-Disclosing Sales and Uses as

Prior Art is Consistent with Congress’s Stated

“Harmonization” Goal

One purpose of the ALA was to harmonize U.S. patent

law with the patent systems of other major countries. This

purpose is expressly stated in the AIA:

SENSE OF CONGRESS. —lIt is the sense

of the Congress that converting the United

States patent system from “first to invent” to

a system of “first inventor to file” will improve

the United States patent system and promote

harmonization of the United States patent

system with the patent systems commonly

used in nearly all other countries throughout

the world with whom the United States

conducts trade and thereby promote greater

international uniformity and certainty in the

procedures used for securing the exclusive

rights of inventors to their discoveries.

AIA § 3(p).

Because Congress amended 35 U.S.C. § 102 with the

express intention of harmonizing U.S. law with foreign

patent systems, the Federal Circuit should have considered

what the other major patent systems in the world require

for prior art in order to determine which interpretation

of amended § 102 best accords with Congress’s intent in

enacting the AIA.

To be clear, looking to non-U.S. patent jurisdictions

to understand what Congress intended is not the type

11

of reliance on foreign law that is sometimes viewed

skeptically. Compare Atkins v. Virginia, 536 U.S. 304,

316-17, n.21 (2002) (relying, in part, on an amicus brief

by the European Union in a case about whether certain

executions are prohibited by the Eighth Amendment),

with id. at 322 (Rehnquist, C.J., dissenting) (writing

separately “to call attention to the defects in the Court’s

decision to place weight on foreign laws . . . in reaching

its conclusion”).

Instead, examining non-U.S. patent systems is doing

exactly what Congress did when it passed the AIA. It

looked to what constituted prior art in the patent systems

of the other major industrialized nations. It observed

that most, if not all, nations require that prior art—and

thus a prior art sale—must be known to the public. If

the information is not known to the public, it is not prior

art in the major non-U.S. patent systems. Knowing this,

Congress included in the AIA its Sense of Congress

provision indicating that its goal was to improve the

U.S. patent system to be more like “the patent systems

commonly used in nearly all other countries throughout

the world with whom the United States conducts trade.”

AIA § 3(p). Accordingly, once the interpretative analysis

of the AIA proceeds to the stage of considering statutory

purpose and legislative history, it is entirely proper—and

indeed necessary—to examine non-U.S. patent systems,

as instructed by the Sense of Congress statement.

The top five national intellectual property offices are

the European Patent Office, the Japan Patent Office, the

Korean Intellectual! Property Office, the State Intellectual

Property Office of the People’s Republic of China, and the

United States Patent and Trademark Office. These five

12

intellectual property offices collaborate as the “IP5,” which

is “a forum of the five largest intellectual property offices

in the world that was set up to improve the efficiency of the

examination process for patents worldwide.” The national

patent offices of the IP5 “handle about 80 per cent of the

world’s patent applications, and 95 per cent of all work

carried out under the Patent Cooperation Treaty (PCT).’”*

Examining the foreign patent systems would have

revealed that in all major jurisdictions in the world, a sale

or use of an invention does not constitute prior art unless

the invention itself was available to the public. In none of

these jurisdictions is it sufficient that the mere fact of the

sale was public when the details of the claimed invention

were not publicly available. If the Federal Circuit’s

decision is allowed to stand, the United States will be the

outlier among the IP5, despite the AIA’s stated objective

of harmonizing this country’s patent laws with the rest of

the world. See Mark Schafer, Note, How the Leahy-Smith

America Invents Act Sought To Harmonize United States

Patent Priority with the World, a Comparison with the

European Patent Convention, 12 Wash. U. Global Stud.

L. Rev. 807 (2013).

1. Europe

Examination of patent applications in Europe is

generally governed by the European Patent Convention,

formerly known as Convention on the Grant of European

Patents (“EPC”). The EPC is a multilateral treaty

2. See About IP5 Co-Operation, http://www.fiveipoffices.

org/about.htm1.

3. Id.

13

instituting the European Patent Organisation. The EPC

established an autonomous legal system under which

European patents are granted.‘

The EPC requires that inventions claimed in

European patents satisfy similar requirements as those

in U.S. patents. Under the EPC, an invention must

be novel, must involve an inventive step, and must be

“susceptible to industrial application.” EPC Art. 54, 56,

57. These three requirements are analogous to the novelty,

nonobviousness, and utility requirements encoded in 35

U.S.C. § 102, § 103, and §§ 101 and 112, respectively.

Similar to U.S. law, Article 54(2) of the EPC defines

what information constitutes “prior art” for purposes of

novelty:

The state of the art shall be held to comprise

everything made available to the public by

means of a written or oral description, by use,

or in any other way, before the date of filing of

the European patent application.

EPC 54(2) (emphasis added). Thus, the EPC expressly

includes a requirement that information be “made

available to the public” in order to be considered as state

of the art, i.e., “prior art.”

The European Patent Office has issued examination

guidelines that further state that non-public use or sale of

4. The complete, regularly updated text of the EPC is

available on the European Patent Office’s website. https://tinyurl.

com/EuropeanPatentConvention.

14

the invention does not constitute prior art. One section of

the guidelines, reproduced below, highlights the European

rule that the use of an invention must be public in order

to qualify as a bar to patenting.

7.2.2 Agreement on secrecy

The basic principle to be adopted is that subject-

matter has not been made available to the public

by use or in any other way if there is an express

or tacit agreement on secrecy which has not

been broken.

In order to establish whether there is a tacit

agreement, the division must consider the

particular circumstances of the case, especially

whether one or more parties had an objectively

recognisable interest in maintaining secrecy.

Important aspects in this regard are, inter

alia, the commercial relationship between the

parties (e.g. parent company and subsidiary,

good faith and trust, joint venture or ordinary

of the purported secrecy agreement (e.g. test

specimens or parts for serial production).

A party alleging that subject-matter was not

made publicly available due to an express or

tacit agreement on secrecy must substantiate

and, if contested, prove this allegation. A party

alleging that an undisputed or proven agreement

on secrecy was broken must substantiate and,

if contested, prove this allegation.

15

European Patent Office, Guidelines for Examination in

the European Patent Office, Part G IV-7.2.2 (Nov. 2017).°

Thus, both the EPC and the European patent guidelines

limit prior art to information that is known to the public.

2. China

The patent laws of China similarly require public use

or sale of the invention in order for that activity to qualify

as a bar to patenting.

Article 22.1 of the Patent Law of the People’s Republic

of China establishes that patents can issue only for those

inventions that “are novel, creative and of practical use.”*

These requirements track the U.S. requirements of

novelty, nonobviousness, and utility encoded in 35 U.S.C.

§ 102, § 103, and §§ 101 and 112, respectively. Article 22.2

defines “novelty” to “mean|] that the invention or utility

model concerned is not an existing technology.”

Article 22.5 then states: “For the purposes of this

Law, existing technologies mean the technologies known

to the public both domestically and abroad before the

date of application.” This provision thus establishes that

an invention lacks “novelty” only if it was “known to the

public.”

5. The EPO's Guidelines for Examination in the Kuropean

Patent Office is available on its website. https://tinyurl.com/

EPOGuidelines.

6. An English translation of the Patent Law of the People’s

Republic of China is available on the website of the State

Intellectual Property Office of the People’s Republic of China.

See https-//tinyurl.com/ChinesePatent Law.

16

The examination guidelines for patent applications

under Chinese law confirm this view. Section 2.1 of the

Chinese guidelines, titled “Prior Art,” provide:

According to Article 22.5, the prior art means

any technology known to the public before the

date of filing in China or abroad. The prior

art includes any technology which has been

disclosed in publications in China or abroad, or

has been publicly used or made known to the

public by any other means in China or abroad,

before the date of filing (or the priority date

where priority is claimed).

The prior art shall be the technical contents

that are available to the public before the date

of filing. In other words, the prior art shall be

in such a state that it is available to the public

before the date of filing and shall contain such

contents from which the public can obtain

substantial technical knowledge.

It should be noted that technical contents in

the state of secrecy are not part of the prior

art. The state of secrecy includes not only

the situation where the obligation to keep

secret arises from regulations or agreements

regarding confidences but also the situation

where the obligation to keep secret arises from

social customs or commercial practices, that is,

from implicit agreements or understandings.

However, if a person having the obligation to

keep secret breaches the regulation, agreement,

17

or implicit understanding, rendering the

technical contents disclosed and making the

technologies available to the public, these

technologies shall form part of the prior art.

State Intellectual Property Office of the People’s Republic

of China, Guidelines for Patent Examination 171-72

(2010).”

The Chinese guidelines also explain that a

“[djisclosure by use means that by use the technical

solution is disclosed or placed in the state of being

available to the public.” /d. at 173. The disclosure must

be one through which “the relevant technical content is

placed in such a state that the public can know it if they

wish, disclosure by use can be established, and it is of

no relevance whether the public had actually known it.”

Id. If “at an exhibition or demonstration of a product no

explanation of the technical contents thereof is provided

so that the structure and function or compositions of

the product is not known to person skilled in the art,

the exhibition or demonstration does not constitute a

disclosure by use.” /d.

3. Republic of Korea

Along the same lines, the patent laws of the Republic of

Korea, «.e., South Korea, require public disclosure in order

to rise to the level of a patent-barring event. A non-public

use or sale will not foreclose patenting of a novel invention

in South Korea. See Jay Erstling & Ryan Strom, Korea's

Patent Policy and Its Impact on Economic Development:

7. httpa://tinyurl.com/Chinese Patent Rules.

18

A Model for Emerging Countries?, 11 San Diego Int’!

L.J. 441, 450-51 (2010) (describing the Korean Patent

Act as “provid{ing] that an invention has novelty unless

it is publicly known, used, or described in a ‘distributed

publication’ or published through ‘telecommunication

means”).

Article 29 of the South Korea Patent Act sets forth

the requirements of patentability. Article 29(1).1 prohibits

patents on “|i}nventions publicly known or worked in the

epublic of Korea or in a foreign country prior to the filing

of the patent application.” Patent Act (Act No. 950, as

amended up to Act. No. 14112), art. 29(1) (2016) (S. Kor.).*

The guidelines applying South Korean patent law

expand upon what is meant by “publicly known”:

A “publicly known” invention means an

invention the contents of which have been known

to an unspecified person without obligation of

secrecy in the Republic of Korea or a foreign

country prior to the filing of the application. The

time of filing in the “prior to the filing of the

application” refers to the exact point of time of

filing, even to the hour and minute of the filing

(if the invention is publicly known, the time is

converted into Korean time). It does not mean

the concept of the date of filing. “Unspecified

persons” refers to the general public who does

need to abide by secret observance duty.

8. An English translation of the Korean Patent Act is

available on the website of the Korean Intellectual Property Office.

https-//tinyurl.com/KoreanPatentAct.

19

Korean Intellectual Property Office, Patent Examination

Guidelines 208-09 (July 2013)*; see also Korean

Intellectual Property Office, Understanding the Patent

Act of the Republic of Korea 49 (2017) (“If an invention

is disclosed to a person who is obligated to keep it

confidential, it is not public knowledge.”)."°

Similarly, the Korean patent guidelines describe what

is meant by “publicly worked” and when an invention

cannot be patented because it has been “publicly worked.”

A “publicly worked” invention means an

invention which has been worked under the

conditions where the contents of the invention

are to be publicly known or can potentially

be publicly known in the Republic of Korea

or a foreign country (Definition of “working”

refers to the Patent Act Article 2). Also, “being

public” means a situation where it is no longer

kept in secret. So, even when a small fraction of

inner part of an invention is kept in secret with

regard to working of the invention, it shall not

be considered as a publicly worked invention.

Korean Intellectual Property Office, Patent Examination

Guidelines, supra, at 209. The thrust of the Korean

patent law is the same as the other major jurisdictions—

information must be publicly known in order to qualify

as prior art.

9. An English translation of the Korean Examination

Guidelines is available on the website of the Korean Intellectual!

Property Office. https-//tinyurl.com/KoreanPatentGuidelines.

10. https-//tinyurl.com/UnderstandingKoreaPatentAct.

4. Japan

Finally, Japanese patent law applies the same approach

to public use and sale as the other IP5 countries. Article

———

for patentability:

An inventor of an invention that is industrially

applicable may be entitled to obtain a patent

(i) inventions that were publicly known in Japan

or a foreign country prior to the filing of the

patent application;

(ii) inventions that were publicly worked in

Japan or a foreign country prior to the filing of

the patent application; or

(iii) inventions that were described in a

distributed publication, or inventions that

were made publicly available through an

electric telecommunication line in Japan or a

foreign country prior to the filing of the patent

application. 5

Patent Act (Act No. 121 of April 13, 1959, as amended up

to Act No. 36 of May 14, 2014), art. 29(1) (1959) (Japan)."’

Japanese law uses the same phrases “publiciy known” and

“publicly worked” as South Korean patent law.

* 11. An English translation of the Japanese Patent Act

is available on website of the World International Patent

21

The guidelines for patent examination under Japanese

law expand upon the meanings of “publicly known” and

“publicly worked”:

3.1.3 Publicly known prior art (Article 29(1)(i))

“Publicly known prior art” means prior art

which has become known to anyone as an art

without an obligation of secrecy (Note).

(Note) Prior art disclosed by a person on whom

obligation of secrecy is imposed to another

person who [is] not aware of its secrecy is

“publicly known prior art” irrespective of the

inventor’s or applicant’s intent to keep it secret.

Generally, an article of academic journal would

not be put in public view even if it was just

received. Therefore, prior art described in the

article is not “publicly known prior art” until

the article is published.

“Publicly known prior art” often become

known in lecture, briefing session and so on

generally. In this case, the examiner specifies

the prior art on the basis of the matters

explained in the lecture, briefing session and

so on. In interpreting the explained matters,

the examiner may use the matters derived by a

person skilled in the art as a base for specifying

“publicly known prior art” by considering the

common general knowledge at the time of the

lecture, briefing session and so on.

Japanese Patent Office, Examination Guidelines for

Patent and Utility Model in Japan, Part III, ch. 2,

22

§ 3-3.1.3 (2018). Again, the guidance of the Japanese

Patent Office is no different than the guidance under the

patent laws of Europe, China, and South Korea.

B. Abrogating Non-Disclosing Sales and Uses

as Prior Art is Consistent with Congress’s

Stated Goal of Achieving Greater Certainty

Regarding the Scope of Patent Protection

Another goal of the AIA was to increase certainty

with respect to the scope of legal protection provided by

issued patents. Congress stated its objective in a Sense

of Congress provision in the AIA.

SENSE OF CONGRESS.—It is the sense

of the Congress that converting the United

States patent system from “first to invent” to

a system of “first inventor to file” will promote

the progress of science and the useful arts by

securing for limited times to inventors the

exclusive rights to their discoveries and provide

inventors with greater certainty regarding the

scope of protection provided by the grant of

exclusive rights to their discoveries.

AIA § 3(0).

With § 3(0) of the AIA, Congress sought to eliminate

“secret” prior art that has, for decades, caused problems

12. An English translation of the Ezamination

Guidelines for Patent and Utility Model in Japan is available

on the Japanese Patent Office’s website. https://tinyurl.com/

Japanese PatentGuidelines.

23

in the U.S. patent system. The Sense of Congress

provision in § 3(0) embodies Congress’s deliberate decision

to eliminate an entire area of contention and inquiry

regarding the scope of confidential sales and uses as prior

art. As Senator Ky] stated before passage of the AIA, this

change will have particular benefit in increasing certainty

and reducing litigation discovery costs:

Public uses and sales of an invention will remain

prior art, but only if they make the invention

available to the public. An inventor’s confidential

sale of his invention, his demonstration of

its use to a private group, or a third party’s

unrestricted but private use of the invention

will no longer constitute private [sic, prior] art.

Only the sale or offer for sale of the invention to

the relevant public or its use in a way that makes

it publicly accessible will constitute prior art.

The main benefit of the AIA public availability

standard of prior art is that it is relatively

inexpensive to establish the existence of events

that make an invention available to the public.

Under current law, depositions and litigation

discovery are required in order to identify all

of the inventor’s private dealings with third

parties and determine whether those dealings

constitute a secret offer for sale or third party

use that invalidates the patent under the

current law’s forfeiture doctrines. The need for

such discovery is eliminated once the definition

of “prior art” is limited to those activities that

make the [invention] accessible to the public.

This will greatly reduce the time and cost of

24

patent litigation and allow the courts and the

[USPTO] to operate much more efficiently.

157 Cong. Ree. S5319, S5319-—21 (daily ed. Sept. 6, 2011)

(statement of Sen. Kyl). This statement thus directly links

Congress’s stated objective in AIA § 3(0) of achieving

greater certainty, with Congress’s redrafting of 35 U.S.C.

§ 102(a)(1), limiting prior art to those sales and uses that

make the invention itself available and known to the public.

Notably, the above statement of Senator Kyl refers

to both categories of prior art—‘“offer for sale or third

party use.” 157 Cong. Rec. at S5320 (“Public uses and

sales of an invention will remain prior art, but only if they

make the invention available to the public.”). The Federal

Circuit’s opinion below, however, dismissed Senator Ky]’s

floor statements because the specific examples of judicial

decisions that the senator mentioned would be abrogated

upon enactment of § 102(a)(1) were, according to the

Federal Circuit, “public use” cases, not “sale” cases. App.

38a (“The floor statements do not identify any sale cases

that would be overturned by the amendments.” (emphasis

in original)). It seems trivial to quibble about the specific

cases cited by the Senator on the Senate floor when the

statements explicitly and unambiguously referred to

both categories of prior art—“[p]ublic uses and sales.”

157 Cong. Rec. at S5320; accord 157 Cong. Rec. S1360,

$1371 (Mar. 8, 2011) (statement of Sen. Kyl) (“A contrary

construction of section 102(a)(1), which allowed private and

non-disclosing uses and sales to constitute invalidating

prior art, would be fairly disastrous for the U.S. patent

system.” (emphasis added)).

25

Thus, the AILA’s abrogation of non-disclosing uses and

sales as prior art in § 102(a)(1) was an intentional policy

decision, one that achieves greater certainty in the scope

of prior art and decreases litigation costs.

CONCLUSION

For these reasons, the Naples Roundtable respectfully

submits that, to the extent the legislative purpose and

legislative history are considered in construing post-

AIA § 102(a), the Court must also consider the AIA’s two

Sense of Congress provisions as part of the statutory

Respectfully submitted,

ANDREW BaLucu MatTHEw J. Dowp

Surrx Batucn LLP Counsel of Record

700 Pennsylvania Avenue, Rosert J. SCHEFFEL

Suite 2060 Dowpb ScHEeFFreL PLLC

Washington, DC 20003 1717 Pennsylvania Avenue

NW, Suite 1025

Washington, DC 20006

(202) 559-9175

mdowd@dowdscheffel.com

Counsel for Amicus Curiae

August 30, 2018