Amicus Curiae Brief — Helsinn Healthcare S.A., Petitioner v. Teva Pharmaceuticals USA, Inc., et al.

No. 17-1229

In the

Supreme Court of the United States

HELSINN HEALTHCARE S.A.,

Petitioner,

v.

TEVA PHARMACEUTICALS USA INC., TEVA

PHARMACEUTICAL INDUSTRIES, LTD.

Respondents.

On Petition for a Writ of Certiorari to the United

States Court of A ppeals for the Federal Circuit

BRIEF OF AMICUS CURIAE THE

NAPLES ROUNDTABLE IN SUPPORT

OF PETITIONER

A ndrew S. Baluch

Smith Baluch LLP

100 M Street SE, Suite 600

Washington, D.C. 20003

(847) 863-1645

Matthew J. Dowd

Counsel of Record

Dowd PLLC

1717 Pennsylvania Avenue NW

Suite 1025

Washington, D.C. 20006

(202) 573-3853

mjdowd@dowdpllc.com

Counsel for Amicus Curiae

April 2, 2018

279966

A

(800) 274-3321 • (800) 359-6859

i

TABLE OF CONTENTS

Page

TABLE OF CONTENTS . . . . . . . . . . . . . . . . . . . . . . . . . . i

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

INTEREST OF AMICUS CURIAE . . . . . . . . . . . . . . . . 1

REASONS FOR GRANTING THE PETITION . . . . . 1

I.

The Correct Statutory Interpretation Must

Consider The Legislative Purpose And

The “Sense Of Congress” Provisions . . . . . . . . . 3

II. The Federal Circuit’s Ruling Incorrectly

Overlooked The Explicit Leg islative

Purpose Of The America Invents Act . . . . . . . . . 8

A. A b r o g a t i n g N o n - D i s c l o s i n g

Sa les and Uses as P r ior A r t is

Consistent with Congress’s Stated

“Harmonization” Goal . . . . . . . . . . . . . . . . . . 9

1.

Europe . . . . . . . . . . . . . . . . . . . . . . . . . . 11

2. China . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

3.

Republic of Korea . . . . . . . . . . . . . . . . . 15

4. Japan . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

ii

Table of Contents

Page

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 . . . . . . . . . . . . . 19

CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

iii

TABLE OF CITED AUTHORITIES

Page

Cases

Accardi v. Pennsylvania Railroad Co.,

383 U.S. 225 (1966) . . . . . . . . . . . . . . . . . . . . . . . . . . 5, 6

Burrage v. United States,

134 S. Ct. 881 (2014) . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Cameron Septic Tank Co. v. Knoxville,

227 U.S. 39 (1913) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Deal v. United States,

508 U.S. 129 (1993) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

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

496 U.S. 661 (1990) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

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

545 U.S. 546 (2005) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

FDA v. Brown & Williamson Tobacco Corp.,

529 U.S. 120 (2000) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Gibbons v. Ogden,

22 U.S. (9 Wheat.) 1 (1824) . . . . . . . . . . . . . . . . . . . . . . 7

Hanson v. Espy,

8 F.3d 469 (7th Cir. 1993) . . . . . . . . . . . . . . . . . . . . . . . 6

Hoffman Plastic Compounds, Inc. v. NLRB,

535 U.S. 137 (2002) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

iv

Cited Authorities

Page

Mastro Plastics Corp. v. NLRB,

350 U.S. 270 (1956) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

McClurg v. Kingsland,

42 U.S. 202 (1843) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Monahan v. Dorchester Counseling Center, Inc.,

961 F.2d 987 (1st. Cir. 1992) . . . . . . . . . . . . . . . . . . . . . 6

National Cable Television Association, Inc. v.

United States,

415 U.S. 336 (1974) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

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

469 U.S. 189 (1985) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Richards v. United States,

369 U.S. 1 (1962) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

State Highway Commission v. Volpe,

479 F.2d 1099 (8th Cir. 1973) . . . . . . . . . . . . . . . . . . . . 6

Sturgeon v. Frost,

136 S. Ct. 1061 (2016) . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Utility Air Regulatory Group v. EPA,

134 S. Ct. 2427 (2014) . . . . . . . . . . . . . . . . . . . . . . . . . . 4

United States v. Ellis,

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

v

Cited Authorities

Page

Yang v. California Department of Social

Services,

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

U.S. STATUTES

2 U.S.C. § 1511(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

5 U.S.C. § 9701(f)(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

15 U.S.C. § 2221(l)(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

21 U.S.C. § 1961(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

35 U.S.C. § 100(j) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

35 U.S.C. § 102 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . passim

35 U.S.C. § 103 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

35 U.S.C. § 112 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Leahy-Smith America Invents Act of 2011,

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

FOREIGN STATUTES AND RULES

European Patent Convention Art. 54(2) . . . . . . . . . . . . 11

Eu r op e a n Pat ent O f f ic e , Gu idel i ne s for

Examination in the EPO (Nov. 2017) . . . . . . . . . . . . 12

vi

Cited Authorities

Page

Japanese Patent Office, Examination Guidelines

for Patent and Utility Model in Japan (2015) . . . . . . 19

Korean Intellectual Property Office, Patent

Examination Guidelines (July 2013) . . . . . . . . . . 16, 17

Korean Intellectual Property Office, Understanding

the Patent Act of the Republic of Korea . . . . . . . . . 16

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) . . . . . . . . . . . . . . . . . . . . . . . 18

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

No. 14112), art. 29(1) (2016) (S. Kor.). . . . . . . . . . . . . 15

Pat ent Law of t he People’s R epubl ic of

China, Art. 22.1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Pat ent Law of t he People’s R epubl ic of

China, Art. 22.5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

State Intellectual Proper ty Off ice of the

People’s Republic of China, Guidelines for

Patent Examination (2010) . . . . . . . . . . . . . . . . . . . . . 14

vii

Cited Authorities

Page

OTHER SOURCES

157 Cong. Rec. S1360 (Mar. 8, 2011) . . . . . . . . . . . . . . . 22

157 Cong. Rec. S5319 (daily ed. Sept. 6, 2011) . . . . . . . 21

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

and Statutory Construction (7th ed. 2008) . . . . . . . . 5

Antonin Scalia & Bryan A. Garner, Reading Law:

he Interpretation of Legal Texts (2012). . . . . . . . . . . 4

Jay Erstling & Ryan Strom, Korea’s Patent Policy

and Its Impact on Economic Development:

A Mo d e l f o r E m e r g i n g C o u n t r i e s?,

11 San Diego Int’l L.J. 441 (2010) . . . . . . . . . . . . . . . 15

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) . . . . . . . . . 11

1

INTEREST OF AMICUS CURIAE1

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.

REASONS FOR GRANTING THE PETITION

The petition for certiorari establishes by itself the

reasons the petition should be granted. Amicus curiae

submits this brief to expand on two particular points that

warrant expanded attention.

1. All parties have consented to the filing of this brief in

letters on file with the Clerk of Court, and the parties were notified

of amicus curiae’s intention to file this brief at least 10 days prior

to the filing of this brief. See Sup. Ct. R. 37.2(a). No counsel for a

party has authored this brief in whole or in part, and no person

other than amici curiae, their members, and their counsel has

made a monetary contribution to the preparation or submission

of this brief. See Sup. Ct. R. 37.6.

2

First, 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, as here, 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 and

other courts have done so in the past, recognizing that a

“sense of Congress” provision is strong evidence of the

legislative purpose of the statute.

Second, the Federal Circuit’s erroneous construction

overlooked two explicit statutory “sense of Congress”

provisions, setting forth the purpose of the statute. By

overlooking these explicit statements, the Federal Circuit

adopted an incorrect interpretation of the statute—one

that impedes the statutory objectives Congress sought to

achieve when it passed the Leahy-Smith America Invents

Act of 2011 (“AIA”), Pub. L. No. 112–29, 125 Stat. 284.

Within the A IA are two “sense of Cong ress”

provisions that expressly state the objectives and

policies of the legislation. Behind the first-inventor-tofile 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”

3

with those commonly used throughout the world and (2)

“greater certainty regarding the scope of protection”

provided by U.S. patents. AIA §§ 3(o), 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, the AIA’s creation

of greater patent certainty was intended by Congress to

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

prior art without resorting to expensive discovery, and fits

logically within the policy framework of a first-inventorto-file system. Both of these legislative objectives are

furthered by limiting the scope of prior art under § 102 to

that which makes the claimed invention itself “available to

the public.” Both objectives are thwarted, however, by the

Federal Circuit’s erroneous interpretation of that section

of the Patent Act.

I.

The Correct Statutor y Interpretation Must

Consider The Legislative Purpose And The “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

4

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, a “ f undamental canon of statutor y

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.” FDA 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

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 d’oeuvre 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.

5

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.”).

On occasion, the objective and policy behind a statute

are readily discernible because Congress explicitly stated

as much in provisions describing 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(l)(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

6

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 civilian life, resume their old employment without

any loss because of their service to their country.” Id.

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. Id. 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 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

always 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 (1st. Cir.

1992) (holding as non-binding a “sense of Congress” that

7

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)

(explaining that 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.

But in other cases, such as here, the “sense of

Congress” provision is very likely 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 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 the objective of statutory interpretation—

understanding the meaning of the statute in the context

of the statutory scheme and legislative purpose.

In short, a “sense of Congress” provision is often a

highly probative interpretative guidepost, which a court

tasked with construing a statute should consider. Yet,

the Federal Circuit expressed no consideration of the

two “sense of Congress” sections included in the AIA.

8

The two “sense of Congress” provisions in the AIA 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 focused on certain floor statements instead of

the statute’s text.

This error was compounded when the Federal Circuit

overlooked the two “sense of Congress” provisions in the

AIA. The two provisions are the strongest evidence—

beyond the text of § 102(a)(1) and the accompanying

House Committee Report No. 112-98 (2011)—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 not consider the “sense of Congress” provisions. The

incomplete consideration of the interpretative evidence

is not a correct method of construing statutes. It leads to

a misinformed view of legislative purpose. As explained

below, in the present case, the Federal Circuit adopted a

construction of the AIA that is directly undermined by

the “sense of Congress” provisions.

II. The Federal Circuit’s Ruling 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, is directly

in tension with 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

9

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

the subject matter defined by a claim in a patent or an

application for patent available to the public, as the term

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

A.

Abrogating Non-Disclosing Sales and Uses as

Prior Art is Consistent with Congress’s Stated

“Harmonization” Goal

One purpose of the AIA 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. —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 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 w ith 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.

10

AIA § 3(p).

Because Congress enacted 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 § 102 best accords with Congress’s intent

in enacting that section.

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

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.”2 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).” 3

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

2. See http://www.fiveipoffices.org/about.html.

3. Id.

11

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

governed by the European Patent Convention, formerly

known as Convention on the Grant of European Patents

(“EPC”). Article 54(2) of the EPC recites:

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.

(emphasis added).

The European Patent Office has issued examination

guidelines that further establish that non-public use or

sale of 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 subjectmatter 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.

12

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

commercial transaction) and the exact object

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.

European Patent Office, Guidelines for Examination in

the EPO, Part G IV-7.2.2 (Nov. 2017).4

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 the patents can issue only for those

4. https://w w w.epo.org/ law-practice/ legal-texts/html/

guidelines/e/g_iv_7_2_2.htm

13

inventions that “are novel, creative and of practical use.”5

These requirements are similar to the U.S. requirements

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

§§ 102, 103, 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.”

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

5. An English-version 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

http://english.sipo.gov.cn/lawpolicy/patentlawsregulations/915574.

htm.

14

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,

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).6

T he Ch i nese g u idel i nes a lso ex pla i n t hat a

“[d]isclosure by use means that by use the technical

solution is disclosed or placed in the state of being

available to the public.” Id. 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

6. http://www.sipo.gov.cn/zlsqzn/sczn2010eng.pdf

15

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.” Id.

3.

Republic of Korea

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

Korea, i.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:

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

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

Republic 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.).7

The guidelines applying South Korean patent law

expand on what is meant by “publicly known”:

7. http://www.kipo.go.kr/upload/en/download/PATENT_

ACT_2016.pdf.

16

A “publicly know n” 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 filling. “Unspecified

persons” refers to the general public who does

need to abide by secret observance duty.

Korean Intellectual Property Office, Patent Examination

Guidelines 208–09 (July 2013)8; 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.”)9.

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

8. http://w w w.kipo.go.kr/upload/en/download/patent_

examination_guidelines_2013_07.pdf

9. https://tinyurl.com/UnderstandingKoreaPatentAct

17

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.

4.

Japan

Finally, Japanese patent law applies the same

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

Article 29(1) of the Japanese Patent Act establishes the

requirements for patentability:

An inventor of an invention that is industrially

applicable may be entitled to obtain a patent

for the said invention, except for the following

cases:

(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

18

electric telecommunication line in Japan or a

foreign country prior to the filing of the patent

application.

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).10

Japanese law uses the same phrases “publicly known” and

“publicly worked” as South Korean patent law.

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 are 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.

10. http://www.wipo.int/edocs/lexdocs/laws/en/jp/jp198en.

pdf).

19

“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, § 3, at

6 (2015).11 This guidance is similar to 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 in

the scope of legal protection provided by issued patents.

Congress’s objective was set forth in one of the two “sense

of Congress” provisions included 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

11. https://www.jpo.go.jp/tetuzuki_e/t_tokkyo_e/ files_

guidelines_e/03_0203_e.pdf

20

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(o).

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

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

in the U.S. patent system. The “sense of Congress”

provision in § 3(o) 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 Kyl 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.

21

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

patent litigation and allow the courts and the

[USPTO] to operate much more efficiently.

157 Cong. Rec. S5319, S5319–21 (daily ed. Sept. 6, 2011)

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

Congress’s stated objective in AIA § 3(o) 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 Kyl’s

floor statements because the specific examples of judicial

decisions 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

22

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,

S1371 (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)).

Thus, the AIA’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 the above reasons and those stated in the petition,

this Court should grant a writ of certiorari.

Respectfully submitted,

A ndrew S. Baluch

Smith Baluch LLP

100 M Street SE, Suite 600

Washington, D.C. 20003

(847) 863-1645

Matthew J. Dowd

Counsel of Record

Dowd PLLC

1717 Pennsylvania Avenue

NW

Suite 1025

Washington, D.C. 20006

(202) 573-3853

mjdowd@dowdpllc.com

Counsel for Amicus Curiae

April 2, 2018