Amicus Curiae Brief — Teva Pharmaceuticals USA, Inc., Petitioner v. GlaxoSmithKline LLC, et al.

No. 22-37

IN THE

Supreme Court of the United States

TEVA PHARMACEUTICALS USA, INC.,

Petitioner,

v.

GLAXOSMITHKLINE LLC AND

SMITHKLINE BEECHAM (CORK) LIMITED,

Respondents.

ON PETITION FOR WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

BRIEF OF 42 PROFESSORS OF LAW, ECONOMICS,

BUSINESS, AND MEDICINE AS AMICI CURIAE IN

SUPPORT OF THE PETITION

MICHAEL A. CARRIER

RUTGERS LAW SCHOOL

217 North 5th Street

Camden, NJ 08102

S. SEAN TU

WEST VIRGINIA UNIVERSITY

COLLEGE OF LAW

101 Law School Drive

Morgantown, WV 26506

CHARLES DUAN

Counsel of Record

2701 Calvert Street NW, Apt. 623

Washington, DC 20008

(202) 713-5799

supremecourt.gov@cduan.com

Counsel for Amici Curiae

TABLE OF CONTENTS

TABLE OF AUTHORITIES . . . . . . . . . . . . . . . . . ii

INTEREST OF AMICI CURIAE . . . . . . . . . . . . . . 1

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

ARGUMENT . . . . . . . . . . . . . . . . . . . . . . . . . . 2

I.

The Federal Circuit Decision Creates a Statutory

Conflict . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

A. The Decision Undermines Key Balance Provisions of the Hatch–Waxman Act . . . . . . . . . . 3

B. The Decision Holds Patent Law to Prohibit

what Hatch–Waxman Requires . . . . . . . . . . . 6

II. Resolving the Conflict Is Important . . . . . . . . . . . 8

CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . 11

APPENDIX A: List of Academic Signatories . . . . . . . . 12

(i)

TABLE OF AUTHORITIES

CASES

AstraZeneca Pharmaceuticals LP v. Apotex Corp.,

669 F.3d 1370 (Fed. Cir. 2012) . . . . . . . . . . . . . . . 4

Caraco Pharmaceutical Laboratories, Ltd.

v. Novo Nordisk A/S,

566 U.S. 399 (2012) . . . . . . . . . . . . . . . . . . . . . 4–5

Purepac Pharmaceutical Co. v. Thompson,

354 F.3d 877 (D.C. Cir. 2004) . . . . . . . . . . . . . . . . 5

SmithKline Beecham Consumer Healthcare, LP

v. Watson Pharmaceuticals, Inc.,

211 F.3d 21 (2d Cir. 2000) . . . . . . . . . . . . . . . . . 7–8

Syngenta Crop Protection, LLC v. Willowood, LLC,

944 F.3d 1344 (Fed. Cir. 2019) . . . . . . . . . . . . . . . 8

Teva Pharmaceuticals USA, Inc. v. Sebelius,

595 F.3d 1303 (D.C. Cir. 2010) . . . . . . . . . . . . . . . . 4

Vornado Air Systems v. Duracraft Corp.,

58 F.3d 1498 (10th Cir. 1995) . . . . . . . . . . . . . . . . 7

Warner-Lambert Co. v. Apotex Corp.,

316 F.3d 1348 (Fed. Cir. 2003) . . . . . . . . . . . . . . . 4

Zenith Electronics Corp. v. Exzec, Inc.,

182 F.3d 1340 (Fed. Cir. 1999) . . . . . . . . . . . . . . . 7

STATUTES AND REGULATION

21 C.F.R. § 314.127(a)(7) . . . . . . . . . . . . . . . . . . . . 6

(ii)

(iii)

35 U.S.C. § 156(c), (g)(6) . . . . . . . . . . . . . . . . . . . . . 3

——— § 271 . . . . . . . . . . . . . . . . . . . . . . . . . . 8

——— § 271(b) . . . . . . . . . . . . . . . . . . . . 2, 6–8, 10

——— § 271(e)(5) . . . . . . . . . . . . . . . . . . . . . . . 4

Federal Food, Drug, and Cosmetics Act (FFDCA)

§ 505(b)(1)(viii),

21 U.S.C. § 355 . . . . . . . . . . . . . . . . . . . . . . . . 3

——— § 505(j)(2), (5)(B)(iv) . . . . . . . . . . . . . . . 3

——— § 505(j)(2)(A)(v) . . . . . . . . . . . . . . . . . 6

——— § 505(j)(2)(A)(viii) . . . . . . . . . . . . . . . . 4

——— § 505(j)(2)(B) . . . . . . . . . . . . . . . . . . . 4

——— § 505(j)(5)(B)(iii) . . . . . . . . . . . . . . . . . 4

——— § 505(j)(5)(B)(iv) . . . . . . . . . . . . . . . . . 4

——— § 505(j)(5)(F)(ii), (B)(iii) . . . . . . . . . . . . . 3

Hatch–Waxman Act, Pub. L. No. 98-417, 98 Stat. 1585

(1984) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2–8

OTHER SOURCES

Michael A. Carrier, Unsettling Drug Patent Settlements:

A Framework for Presumptive Illegality, 108 Mich.

L. Rev. 37 (2009) . . . . . . . . . . . . . . . . . . . . . . . 3

(iv)

Congressional Record . . . . . . . . . . . . . . . . . . . . . . 3

Ctr. for Drug Evaluation & Research, FDA, ANDA

Submissions—Refuse-to-Receive Standards (2d

rev. Dec. 2016), https://www.fda.gov/media/86660/

download . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Food & Drug Admin., Approved Drug Products with

Therapeutic Equivalence Evaluations (the Orange

Book) (42d ed. 2022), https://www.fda.gov/media/

71474/download . . . . . . . . . . . . . . . . . . . . . . . 9

Gov’t Accountability Office, Report GAO-12-371R, Drug

Pricing: Research on Savings from Generic Drug

Use (Jan. 31, 2012), https://www.gao.gov/assets/files.

gao.gov/assets/gao-12-371r.pdf . . . . . . . . . . . . . . 8

Shashank Upadhye, Generic Pharmaceutical Patent

and FDA Law (2020) . . . . . . . . . . . . . . . . . . . . 5

Lisa Urquhart, Top Companies and Drugs by Sales

in 2021, 21 Nature Reviews: Drug Discovery 251

(2022) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Bryan S. Walsh et al., Frequency of First Generic Drug

Approvals With “Skinny Labels” in the United

States, 181 JAMA Internal Med. 995 (2021) . . . . . . . 10

Xcenda AmersourceBergen, Modeling the Population

Outcomes of Cost-Related Nonadherence: Model

Report (2020), https://www.cidsa.org/publications/

xcenda-summary . . . . . . . . . . . . . . . . . . . . . . 10

INTEREST OF AMICI CURIAE

Amici curiae1 are 42 professors of law, economics,

business, and medicine. A list of signatories is attached in

Appendix A. Their sole interest in this case is to ensure

that patent law develops in a way that serves the public

interest and public health by promoting competition.

SUMMARY OF ARGUMENT

The Federal Circuit’s construction of inducement of

patent infringement creates two serious conflicts with the

federal statute on generic drug entry, in a way that is

likely to be exploited widely in years to come to the detriment of United States health care, competition, and the

federal government. Certiorari is warranted.

1. By permitting inducement of patent infringement

to be premised on the content of a generic drug’s approved labeling text, the Federal Circuit’s decision creates two conflicts with the Hatch–Waxman statutory

scheme on generic drug entry. First, Hatch–Waxman

carefully balances the interests of drug patent holders,

generic entrants, and the public. Key to that balance are

the two distinct pathways for generic entrants to deal

with drug patents during the regulatory approval process. The Federal Circuit’s decision renders all but unusable one of those two pathways, the “skinny-label carve1

Pursuant to Supreme Court Rule 37.2(a), all parties received appropriate notice of and consented to the filing of this brief. Pursuant

to Rule 37.6, no counsel for a party authored this brief in whole or

in part, and no counsel or party made a monetary contribution intended to fund the preparation or submission of the brief. No person

or entity, other than amici, their members, or their counsel, made a

monetary contribution to the preparation or submission of this brief.

1

2

out” procedure at the heart of this case, upsetting the legislatively designed balance.

Second, the Federal Circuit decision creates the untenable situation where Hatch–Waxman requires what

patent law now prohibits. Under Hatch–Waxman, a

generic drug is required to use the same labeling text as

its patented counterpart product with only limited exceptions. But the Federal Circuit requires intricate, detailed

editing of generic drug labels to avoid inducement—edits

that the Food and Drug Administration (“FDA”) likely

and rightly would deem statutorily noncompliant. This

bizarre double-bind cannot be correct as a matter of law.

2. Resolving these conflicts is not just necessary

for the proper functioning of the law—it is a matter of

tremendous national importance. As we find based on

review of the FDA drug patent records, the number of

method-of-use patents has exploded in recent decades.

Under the Federal Circuit’s decision, this mass of patents

could be leveraged to stymie generic competition for

years to come, greatly raising costs for American patients

and the federal government. Certiorari is required to resolve the unnecessary statutory conflicts that the Federal

Circuit has created, conflicts with major consequences for

the American public.

ARGUMENT

I.

THE FEDERAL CIRCUIT DECISION CREATES A

STATUTORY CONFLICT

In holding FDA-approved language in a generic drug

label to be the basis for inducement under 35 U.S.C.

§ 271(b), the Federal Circuit created two distinct conflicts

with the statutory regime for generic drug entry. See

Hatch–Waxman Act, Pub. L. No. 98-417, 98 Stat. 1585

3

(1984). It rendered unusable half of the intricate twopronged pathway for addressing patents in labels, and it

made compliance with both the statute and patent law potentially impossible. This Court’s review is required to

resolve these conflicts.

A.

THE DECISION UNDERMINES KEY BALANCE

PROVISIONS OF THE HATCH–WAXMAN ACT

The decision conflicts with the balanced statutory

scheme that Congress constructed in Hatch–Waxman.

By design, the landmark statute of 1984 struck a balance between drug patent holders and generic manufacturers, in order to promote the entry of “low-cost, generic

drugs for millions of Americans” and save American patients, states, and the federal government millions of dollars every year. 130 Cong. Rec. 24427 (1984) (statement

of Rep. Henry Waxman); see also Michael A. Carrier, Unsettling Drug Patent Settlements: A Framework for Presumptive Illegality, 108 Mich. L. Rev. 37, 42 (2009). That

balance is apparent throughout the legislation. For example, patent-holding drug innovators enjoy extensions

of patent term and additional market exclusivity, see 35

U.S.C. § 156(c), (g)(6); Federal Food, Drug, and Cosmetics Act (FFDCA) § 505(j)(5)(F)(ii), (B)(iii), 21 U.S.C. § 355,

while generic firms are granted incentives for challenging

questionable patents and a simplified approval process at

the FDA known as an Abbreviated New Drug Application (“ANDA”), see FFDCA § 505(j)(2), (5)(B)(iv).

Key to this balance is Hatch–Waxman’s intricate, twopronged procedure for early resolution of patent issues

during the generic approval process. Innovator firms

must notify the FDA of patents relevant to their products. See FFDCA § 505(b)(1)(viii). If a generic firm seeks

4

approval of a drug having an in-force patent, the generic’s

ANDA must choose one of two options.

Under the first, called the “paragraph IV certification,” the ANDA includes a certification alleging that the

patent is invalid or not infringed. Paragraph IV is considered a “risk” to the generic applicant, due to “the hazard of sparking costly litigation.” Teva Pharm. USA,

Inc. v. Sebelius, 595 F.3d 1303, 1305 (D.C. Cir. 2010).

The generic applicant must notify the patent holder of

its application for approval, FFDCA § 505(j)(2)(B), the

application is deemed a constructive act of infringement

triggering immediate cause for a patent lawsuit, see

35 U.S.C. § 271(e)(5), and if litigation ensues, approval

of the generic is stayed for up to 30 months, FFDCA

§ 505(j)(5)(B)(iii). To encourage generics to use this option despite the cost, Hatch–Waxman offers the first

ANDA applicant a 180-day exclusivity period over other

generics. See FFDCA § 505(j)(5)(B)(iv).

The alternative, called the “section viii carve-out” or

colloquially the “skinny label,” is reserved for patents

on methods of using a drug. See id. § 505(j)(2)(A)(viii).

Under this option, the generic drug’s proposed labeling

omits, to the FDA’s satisfaction, uses of the drug that

would infringe the method-of-use patent. See id.; Caraco

Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 406

(2012). Section viii does not trigger the immediate consequences of paragraph IV: The ANDA applicant need not

notify the patent holder, the 30-month stay does not apply, and a carve-out application does not give rise to constructive infringement and cause for immediate suit. See

AstraZeneca Pharm. LP v. Apotex Corp., 669 F.3d 1370,

1377–78 (Fed. Cir. 2012) (citing Warner-Lambert Co. v.

Apotex Corp., 316 F.3d 1348, 1356–60 (Fed. Cir. 2003)).

5

These features of the section viii carve-out evince a

legislative intent to provide certainty: a well-defined procedure for generics to obtain approval on an otherwise offpatent drug covered by method-of-use patents, “so that a

product . . . can quickly come to market.” Caraco, 566 U.S.

at 415. The immediate litigation consequences of paragraph IV are not needed for section viii because a carveout of a method of use, double-checked in the approval

process, provides certainty to the generic applicant and

the FDA that the drug and its labeling do not infringe.

See id. at 405 (“[T]he FDA cannot authorize a generic

drug that would infringe a patent.”). It is this certainty

that makes section viii “an attractive route for generic

manufacturers.” Purepac Pharm. Co. v. Thompson, 354

F.3d 877, 880 (D.C. Cir. 2004); see Shashank Upadhye,

Generic Pharmaceutical Patent and FDA Law § 26:11

(2020).

The Federal Circuit’s decision eviscerates half of this

balanced scheme. By allowing an inducement claim to

proceed to damages here, the Federal Circuit puts every generic drug manufacturer using a carved-out label

at risk of similar claims. Even for unmeritorious inducement claims, the time and expense of litigating those

claims—combined with the risk of lost-profit damages exceeding the generic firm’s revenues, as happened in the

present case—render the certainty of section viii a nullity.

Hatch–Waxman’s drafters almost certainly did not intend for one of its two distinct pathways for patent resolution to be carved out of the statute, but the Federal

Circuit’s decision has done so. Certiorari is warranted

to resolve this conflict between patent law and Hatch–

Waxman.

6

B.

THE DECISION HOLDS PATENT LAW TO

PROHIBIT WHAT HATCH–WAXMAN REQUIRES

The Federal Circuit’s reading of inducement conflicts

with Hatch–Waxman in another way: It prohibits under patent law activity that the generic approval statute

mandates. Under that statute, an ANDA can only be

approved if the labeling for the generic drug under consideration is “the same as the labeling approved for”

the patent-holding innovator firm’s equivalent product.

FFDCA § 505(j)(2)(A)(v); accord 21 C.F.R. § 314.127(a)(7).

But the import of the Federal Circuit’s decision is that

generic applicants must revise their labels to avoid inducement liability. That decision thus creates a serious dilemma of satisfying both Hatch–Waxman’s samelabeling requirement and § 271(b)’s different-labeling requirement.

To be sure, the statute and the FDA make allowances

for labeling edits in view of section viii carve-outs, but

only to the extent that the FDA agrees that “such differences do not render the proposed drug product less safe

or effective.” 21 C.F.R. § 314.127(a)(7). This is straightforward when whole sections on drug indications are omitted, but the Federal Circuit seemingly required more: detailed, intricate, scattered line edits across the labeling,

including in sections on dosage and administration. Such

edits would almost certainly prompt the FDA to question safety and efficacy under the whittled-down label.

See Ctr. for Drug Evaluation & Research, FDA, ANDA

Submissions—Refuse-to-Receive Standards 13 (2d rev.

Dec. 2016), available online (describing dosing regimen

alterations as reason for the FDA to reject an ANDA).2

2

Locations of authorities available online are shown in the Table

of Authorities.

7

And given that the patent-holding drug manufacturer itself writes the text of the labeling that generics must

copy, it has every incentive to draft that text cleverly

such that edits to avoid inducement will prompt an FDA

rejection.

The conflict arises because the Federal Circuit failed

to interpret § 271(b) in the context of Hatch–Waxman

“in a way that preserves the purposes of both.” Zenith

Elecs. Corp. v. Exzec, Inc., 182 F.3d 1340, 1347 (Fed. Cir.

1999) (quoting Vornado Air Sys. v. Duracraft Corp., 58

F.3d 1498, 1507 (10th Cir. 1995)). SmithKline Beecham

Consumer Healthcare, LP v. Watson Pharmaceuticals,

Inc. presents an instructive contrast. There, the Second

Circuit considered whether a generic drug label, being

identical in text to that of the reference product, was

an infringement of copyright. See 211 F.3d 21, 23–24

(2d Cir. 2000). The generic manufacturer in fact had attempted to revise the label to avoid copyright concerns,

but the FDA rejected the proposed alterations, requiring

virtually identical label text in view of Hatch–Waxman’s

same-labeling requirement. See id. at 24. Determining that “[t]he purposes of the Hatch–Waxman Amendments would be severely undermined if copyright concerns were to shape the FDA’s application of the ‘same’ labeling requirement,” the Second Circuit declined to hold

the generic label an infringement of copyright. Id. at

29. Given that Hatch–Waxman was later in time, more

specific, and more likely to have its purposes frustrated,

the court concluded that the Copyright Act was required

to yield, such that copying of drug labels for ANDA approvals was noninfringing. See id. at 28 & n.3.

For analogous reasons, there is a serious question of

how the panel’s construction of § 271(b) interacts with

8

Hatch–Waxman. Scattered editing throughout a label

to avoid inducement, like editing of labels to avoid copyright infringement, does not simply create a risk of the

FDA rejecting the label but also frustrates the purposes

behind the same-labeling requirement itself, namely conserving FDA resources and enabling speedy introduction

of generic drugs. See SmithKline, 211 F.3d at 28.3 And

as with the Copyright Act, § 271(b) is older in time and

far broader in scope than Hatch–Waxman.

Despite this stark incompatibility between the Federal Circuit’s construction of § 271 and the same-labeling

requirement of Hatch–Waxman, despite the damaging

double-bind for generic drug entrants that it creates, and

despite nearly every Federal Circuit judge’s acknowledgment of the statutory discrepancy, the appellate court

failed to rectify or even address the conflict. This Court

should do so.

II.

RESOLVING THE CONFLICT IS IMPORTANT

Petitioner notes the many serious economic and individual harms that would result from letting the Federal

Circuit’s decision stand, for patients, individuals, competition, and the federal government. These harms are the

result of the decision’s potential to cut off the tremendous

economic, health, and welfare boon that generic drug competition has offered. See, e.g., Gov’t Accountability Office,

3

Syngenta Crop Protection, LLC v. Willowood, LLC is distinguishable because this Court found that the statute at issue there

“does not require a me-too applicant to ensure that its product label is

identical.” 944 F.3d 1344, 1357 (Fed. Cir. 2019). Importantly, the Syngenta court agreed that Hatch–Waxman differed from that statute

in that the former “requires” same-labeling, such that “generic applicants faced a double-bind.” Syngenta, 944 F.3d at 1357 & n.4 (quoting

SmithKline, 211 F.3d at 25).

9

Report GAO-12-371R, Drug Pricing: Research on Savings from Generic Drug Use 4 (Jan. 31, 2012), available

online (finding savings of over $1 trillion over 12 years

due to generic drugs). To provide insight into the breadth

of those harms, amici present empirical data on the potential volume of patent litigation to which the Federal

Circuit has opened the door.

We use data from the FDA’s annual listing of patents

on approved drugs, published in Approved Drug Products with Therapeutic Equivalence Evaluations, colloquially known as the “Orange Book.”4 The listing identifies,

for each drug product approved as of the year of publication, all patents that the product’s manufacturer has

identified as covering the product. For patents directed

to methods of using the product, the listing also identifies

a “use code,” which we use to distinguish method-of-use

patents from patents directed to the drug product as a

whole.

The 1988 Orange Book listed 340 unique patents and

61 distinct use codes. Method-of-use patents were generally rare: The average Orange Book patent in 1988

identified 0.18 use codes. By 2019, however, method-ofuse patents were prevalent. There were 7,919 distinct

codes listed in the Orange Book, for 4,790 unique patents.

The average patent in 2019 was associated with 1.65 use

codes—over a ninefold increase compared to 1988.

The number of use codes associated with an active ingredient also provides a useful metric for the effect of the

Federal Circuit’s decision. As of 2019, each active ingredient listed in the Orange Book was associated with 3.17 use

4

See Food & Drug Admin., Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) (42d ed. 2022),

available online.

10

codes on average. This is almost a fivefold increase from

2001, when the average active ingredient had 0.70 use

codes. Put another way, the average generic firm seeking

to enter the market will have to contend, on average, with

slightly over three potential allegations of inducement of

patent infringement. Each allegation could result in substantial litigation costs, delays, and damages.5

This substantial increase in method-of-use patents

suggests that a large number of generic drugs may be at

risk of accusations of violating § 271(b) in view of the Federal Circuit’s decision. More importantly, the large number of method-of-use patents in force today means that

drug patent holders have a tremendous arsenal for frustrating generic entry. The patented drugs that skinnylabel generics typically compete with reap millions of dollars in revenue per day,6 so those drugs’ patent holders

have every incentive to engage in costly, time-consuming

inducement litigation to the fullest extent. Saddling the

lion’s share of future generic entrants with this litigation,

indeed likely deterring them from entering markets at all,

will have costs measured not just in billions of dollars but

also in human lives.7

5

A single patent may have several associated use codes, but since

each of those use codes could give rise to a distinct theory of patent

infringement that the generic firm will have to litigate, it is more

appropriate to count the number of use codes rather than distinct

patents.

6

See Bryan S. Walsh et al., Frequency of First Generic Drug Approvals With “Skinny Labels” in the United States, 181 JAMA Internal Med. 995, 995 (2021); see also Lisa Urquhart, Top Companies and

Drugs by Sales in 2021, 21 Nature Reviews: Drug Discovery 251, 251

(2022) (noting multi-billion dollar annual revenues on multiple drugs).

7

See Xcenda AmersourceBergen, Modeling the Population Outcomes of Cost-Related Nonadherence: Model Report 13 tbl.6 (2020),

available online.

11

Such costs are the unnecessary result of a Federal Circuit decision that ignores conflicts with federal statutes

and stymies the generic drug entry scheme. Resolving

this case and these errors of statutory interpretation is a

matter of immediate national importance.

CONCLUSION

For the foregoing reasons, the petition for a writ of

certiorari should be granted.

Respectfully submitted,

CHARLES DUAN

Counsel of Record

2701 Calvert Street NW, Apt. 623

Washington, DC 20008

(202) 713-5799

supremecourt.gov@cduan.com

MICHAEL A. CARRIER

RUTGERS LAW SCHOOL

217 North 5th Street

Camden, NJ 08102

S. SEAN TU

WEST VIRGINIA UNIVERSITY

COLLEGE OF LAW

101 Law School Drive

Morgantown, WV 26506

Counsel for Amici Curiae

August 2022

APPENDIX A

LIST OF ACADEMIC SIGNATORIES8

Professor Emeritus Joseph Bauer

Notre Dame Law School

Professor Jeremy Bock

Tulane University School of Law

Professor Michael A. Carrier

Rutgers Law School

Professor Bernard Chao

Sturm College of Law

University of Denver

Professor Thomas Cheng

Faculty of Law

The University of Hong Kong

Professor Rena M. Conti

Questrom School of Business

Boston University

Professor Jorge L. Contreras

S.J. Quinney College of Law

University of Utah

Research Professor Joshua Davis

University of California, Hastings College of the Law

8

The brief presents the views of the individual signers. Institutions are listed for identification purposes only.

12

13

Charles Duan

Postdoctoral Fellow

Cornell University

Professor Stacie B. Dusetzina

Vanderbilt University School of Medicine

Professor Samuel F. Ernst

Golden Gate University School of Law

Dr. William B. Feldman

Instructor in Medicine

Harvard Medical School

Professor Ted Frech

Department of Economics

University of California, Santa Barbara

Professor Michal Gal

Faculty of Law

University of Haifa

Professor William Gallagher

Golden Gate University School of Law

Professor James Grimmelmann

Cornell Law School

Professor Emerita Bronwyn H. Hall

Department of Economics

University of California, Berkeley

14

Professor Yaniv Heled

Georgia State University College of Law

Professor Thomas J. Horton

Knudson School of Law

University of South Dakota

Professor Michael J. Hutter

Albany Law School

Professor Aaron S. Kesselheim

Harvard Medical School

Professor Mark A. Lemley

Stanford Law School

Professor Christopher R. Leslie

University of California, Irvine School of Law

Professor Yvette Joy Liebesman

Saint Louis University School of Law

Professor Lee Ann Wheelis Lockridge

Paul M. Herbert Law Center

Louisiana State University

Professor Stephen McJohn

Suffolk University Law School

Professor Michael J. Meurer

Boston University School of Law

15

Professor Emily Michiko Morris

University of Akron School of Law

Clinical Professor Christopher Morten

Columbia Law School

Professor Tyler T. Ochoa

Santa Clara University School of Law

Former Professor Luigi Palombi

University of Sydney

Professor Jordan Paradise

Loyola University Chicago School of Law

Dr. Benjamin Rome

Instructor in Medicine

Harvard Medical School

Professor Ana Santos Rutschman

Charles Widger School of Law

Villanova University

Professor Rachel E. Sachs

Washington University in St. Louis School of Law

Professor Joshua D. Sarnoff

DePaul University College of Law

Professor Ameet Sarpatwari

Harvard Medical School

16

Professor Steven Semeraro

Thomas Jefferson School of Law

Professor Michael S. Sinha

Saint Louis University School of Law

Visiting Professor Jennifer Sturiale

Delaware Law School

Widener University

Professor S. Sean Tu

West Virginia University College of Law

Professor Liza Vertinsky

Francis King Carey School of Law

University of Maryland

Rev. 9069f21c