IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN ... … · innovation of both new branded and generic drugs and further harm consumers and the public interest. Case 2:12-cv-03824-PD

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

__________________________________________

) MYLAN PHARMACEUTICALS, INC., et al., )

) Plaintiffs, ) Civil Action No. 12-3824

) CONSOLIDATED v. )

) WARNER CHILCOTT PUBLIC LIMITED ) COMPANY, et al., )

) Defendants. )

__________________________________________)

[PROPOSED] BRIEF OF INTELLECTUAL PROPERTY AND ANTITRUST LAW PROFESSORS

AS AMICI CURIAE PHILLIP R. MALONE* Juelsgaard Intellectual Property and Innovation Clinic Mills Legal Clinic at Stanford Law School 559 Nathan Abbott Way Stanford, CA 94305 Telephone: 650-725-6369 Facsimile: 650-723-4426 [email protected] *Admitted Pro Hac Vice Attorney for Amici Curiae

Case 2:12-cv-03824-PD Document 596-3 Filed 05/07/14 Page 1 of 27

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TABLE OF CONTENTS

STATEMENT OF INTEREST OF AMICI CURIAE......................................................................... 1 SUMMARY OF ARGUMENT......................................................................................................... 1

ARGUMENT..................................................................................................................................... 3

I. Product-Hopping Manipulates the Hatch-Waxman Regulatory Framework to Exclude the Generic Competition the Act Seeks to Encourage ....................................................................... 3

A. Congress Created the Hatch-Waxman Framework to Promote Generic Entry ................... 4

B. Branded-Drug Manufacturers Use Product-Hopping to Prevent Generic Entry ................. 6

C. “Piggy-Back” Generic Entry Is Central to the Hatch-Waxman Design .............................. 7

II. Product-Hopping May Constitute Exclusionary Conduct That Violates Section 2 of the Sherman Act .............................................................................................................................. 8

A. Section 2 of the Sherman Act Is Well Suited to Address Product-Hopping Through the Rule of Reason .............................................................................................................. 9

1. Antitrust Laws Apply in the Pharmaceutical Industry ................................................... 9 2. A Monopolist’s Product Changes May Be Anticompetitive ........................................ 11

B. Product-Hopping May Illegally Exclude Competition by Generic Manufacturers ........... 12

III. Product-Hopping Discourages Efficient Drug Development and Innovation ......................... 15

A. Product-Hopping Encourages Generic Manufacturers to Develop Products for Foreclosed Markets ........................................................................................................... 15

B. Product-Hopping Diverts Brand Firm Resources from Genuine Innovation to Insignificant Modifications .............................................................................................. 16

CONCLUSION................................................................................................................................ 17 APPENDIX .................................................................................................................................... A1


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TABLE OF AUTHORITIES

Page(s) Federal Cases

aaiPharma Inc. v. Thompson, 296 F.3d 227 (4th Cir. 2002) ...................................................................................................... 10

Abbott Labs v. Teva Pharms. U.S.A., Inc., 432 F. Supp. 2d 408 (D. Del. 2006) ............................................................................. 3, 6, 12, 13

Aspen Skiing Co. v. Aspen Highlands Corp., 472 U.S. 585 (1985) ..................................................................................................................... 9

C.R. Bard, Inc. v. M3 Sys., Inc., 157 F.3d 1340 (Fed. Cir. 1988) .................................................................................................. 11

FTC v. Actavis, Inc., 133 S.Ct. 2223 (2013)..................................................................................................... 4, 7, 8, 10

In re Gabapentin Patent Litig., 649 F. Supp. 2d 340 (D.N.J. 2009)…………................………………………………………..10

SmithKline Corp. v. Eli Lilly & Co., 575 F.2d 1056 (3d Cir. 1978) ....................................................................................................... 9

United States v. Dentsply Int’l, Inc., 399 F.3d 181 (3d Cir. 2005) ................................................................................................... 9, 12

United States v. Grinnell Corp., 384 U.S. 563 (1966) ..................................................................................................................... 9

United States v. Microsoft Corp., 253 F.3d 34 (D.C. Cir. 2001) (en banc) ............................................................................ 8, 11, 12

Verizon Communications, Inc. v. Law Offices of Curtis V. Trinko, LLP, 540 U.S. 398 (2004) .................................................................................................................... 9

Walgreen Co. v. AstraZeneca Pharmaceuticals L.P., 534 F. Supp. 2d 146 (D.D.C. 2008) ............................................................................................ 13

Walgreen Co. v. Organon, Inc. (In re Remeron Antitrust Litig.), 335 F. Supp. 2d 522 (D.N.J. 2004)……........…………………………………………………..10

Federal Statutes

21 U.S.C. § 355 ................................................................................................................................. 2

21 U.S.C. § 355(j) ............................................................................................................................... 5


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Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act), Pub. L. No. 98-417, 98 Stat. 1585 ....................................................................................... 2

State Statutes

35 Pa. Cons. Stat. § 960.1 ................................................................................................................... 8

Other Authorities

3 Phillip E. Areeda & Herbert Hovenkamp, Antitrust Law (4th ed. 2013)………………...………………………………………………………………9, 11

Br. for Fed’l Trade Comm’n as Amicus Curiae, Mylan Pharms., Inc. v. Warner Chilcott Pub. Co., (No. 12-3824), 2013 WL 5692880…………………………………….3, 8, 12

C. Scott Hemphill & Mark A. Lemley, Earning Exclusivity: Generic Drug Incentives and the Hatch-Waxman Act, 77 Antitrust L.J. 947 (2011)...................................................3, 4, 6

C. Scott Hemphill, Paying for Delay, Pharmaceutical Patent Settlement as a Regulatory Design Problem, 81 N.Y.U. L. Rev. 1553 (2006) ................................................... 10

Frank A. Sloan & Chee-Ruey Hseih, Pharmaceutical Innovation: Incentives, Competition, and Cost-Benefit Analysis in International Perspective 270 (2007) .................... 16

Generic Pharmaceutical Association, Generic Drug Savings in the U.S. (5th ed. 2013), available at http://www.gphaonline.org/media/cms/2013_Savings_Study_ 12.19.2013_FINAL.pdf ………………………………………………........................................3

H.R. Rep. No. 98-857(II), Pt. 1 (1984) ................................................................................... 3, 4, 5, 7

Herbert Hovenkamp, Antitrust and the Regulatory Enterprise, 2004 Colum. Bus. L. Rev. 335 (2004) ......................................................................................................................... 10

Herbert Hovenkamp, Mark D. Janis, Mark A. Lemley, & Christopher R. Leslie, IP & Antitrust: An Analysis of Antitrust Principles Applied to Intellectual Property Law § 15.3c (2d ed. Supp. 2013) ........................................................................ 5, 6, 7, 11, 12, 17

Iain M. Cockburn, Is the Pharmaceutical Industry in a Productivity Crisis?, 7 Innovation Pol’y and the Economy 1 (2006) ............................................................................. 16

Janice M. Reichert, Trends in Development and Approval Times for New Therapeutics in the United States, 2 Nature Reviews 695 (2003) ............................................. 16

Jayashree Dubey & Rajesh Dubey, Pharmaceutical Innovation and Generic Challenge: Recent Trends and Causal Factors, 4 Int’l J. of Pharm. & Healthcare Marketing 175 (2010) ................................................................................................................ 16

Joseph A. DiMasi, et al., The Price of Innovation: New Estimates of Drug Development Costs, 22 J. Health Econ. 151 (2003) ................................................................... 16

Michael A. Carrier, A Real World Analysis of Pharmaceutical Settlements: The Missing Dimension of Product Hopping, 62 Fla. L. Rev. 1010 (2010) .......................... 3, 6, 8, 11


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Michael A. Carrier, Unsettling Drug Patent Settlements: A Framework for Presumptive Illegality, 108 Mich. L. Rev. 37 (2009) ............................................................. 3, 10

Office of Inspector Gen., Dep’t of Health & Human Servs., The Food and Drug Administration’s Generic Drug Review Process 13 (2008), available at http://www.oig.hhs.gov/oei/reports/oei-04-07-00280.pdf…………………………………….....5

Ronald Reagan, President of the United States, Remarks on Signing S. 1538 into Law (Sep. 24, 1984)..................................................................................................................... 4 Stacey L. Dogan & Mark A. Lemley, Antitrust Law and Regulatory Gaming,

87 Tex. L. Rev. 685 (2009) .............................................................................................. 6, 10, 12

Summary of NDA Approvals & Receipts, 1938 to the Present, FDA, http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/ SummaryofNDAApprovalsReceipts1938tothepresent/default.htm…………………………....16


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STATEMENT OF INTEREST OF AMICI CURIAE

Amici are professors of intellectual property (IP) and antitrust law. Their sole

interest in this case is to ensure that patent and antitrust law develop in a way that serves the

public interest and public health by promoting both innovation and competition.1

Amici2 are among the leading scholarly experts on the application of IP and antitrust

law in regulated industries. They include co-authors of the seminal treatises on IP and antitrust

law and antitrust law generally, as well as authors of the primary academic articles analyzing

product-hopping and other anticompetitive conduct in the context of the Hatch-Waxman

Act. Amici have closely studied the underlying legal issues material to this litigation and

submit this brief to assist the court in its analysis of how antitrust law may apply in the context

of product-hopping. In particular, amici explain that antitrust law is an appropriate means to

protect Hatch-Waxman’s carefully crafted statutory scheme—designed to promote generic

competition—from predatory regulatory gaming behavior that can produce serious

anticompetitive harm and raise drug prices for consumers, the government and third-party

payers.3

SUMMARY OF ARGUMENT

Historically, the pharmaceutical industry suffered from a lack of competition due to

the enormous initial costs required to get new drugs through the development, approval, and

marketing phases. Congress sought to correct this market failure in 1984 by enacting the

Hatch-Waxman Act. Hatch-Waxman was intended to recalibrate the balance between

1 Amici certify that counsel for Plaintiffs consented to the filing of this brief; counsel for Defendants advised that they neither oppose nor consent to filing of the brief. Amici also certify that no party’s counsel authored this brief in whole or in part, and that no person, including any party or party’s counsel, contributed money that was intended to fund preparing or submitting this brief. 2 A list of the amici and brief biographies are included in the Appendix. 3 Amici thank Stanford Law School Juelsgaard Intellectual Property and Innovation Clinic certified law students Yale Fu, Vikram Iyengar, Matt Rietfors, Emily Warren and Rachel Yu for their valuable contributions to this brief.


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innovation and competition by crafting a compromise that facilitated generic entry into the

market while strengthening the enforceability of patents. States supplemented this effort by

liberalizing drug-substitution laws.

Nevertheless, Hatch-Waxman has not functioned precisely as anticipated. Because

the Food and Drug Administration (FDA) approval process examines only the safety of new

drugs and not their effects on competition (and because this process is lengthy), branded-drug

manufacturers can game the regulatory system and artificially prolong their monopoly power.

Last year, the Supreme Court ruled in FTC v. Actavis that it is appropriate to apply

antitrust law to address anticompetitive subversion of Hatch-Waxman’s intent. “Product-

hopping,” which prevents generic entry through non-substantial product changes that trigger

delays in generic substitution, constitutes a similar form of regulatory gaming. Because

product-hopping exploits the Hatch-Waxman framework to exclude generic competition and

cause anticompetitive effects with no countervailing procompetitive justification, it constitutes

illegal exclusionary conduct under Section 2 of the Sherman Act.

This brief first describes how product-hopping frustrates the goals and operation of

Hatch-Waxman and state drug substitution laws. It then analyzes how this exclusionary

conduct can violate Section 2. Finally, it explains how product-hopping may deter valuable

innovation of both new branded and generic drugs and further harm consumers and the public

interest.


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ARGUMENT

I. Product-Hopping Manipulates the Hatch-Waxman Regulatory Framework to Exclude the Generic Competition the Act Seeks to Encourage

In 1984, Congress passed the Drug Price Competition and Patent Term Restoration

Act of 1984, commonly known as the Hatch-Waxman Act,4 to facilitate market entry of low-

cost generic drugs while incentivizing pharmaceutical companies to invest in developing new

drugs.5 Around the same time, all 50 states passed laws that allow—and in many cases,

require—pharmacists to substitute a generic drug when presented with a prescription for its

branded equivalent, unless a physician directs or the patient requests otherwise.6 Together with

Hatch-Waxman, these state substitution laws “create a regulatory framework designed to

reduce costs to consumers by lowering generic costs.”7 These laws and the Hatch-Waxman

Act have been remarkably successful in facilitating generic competition and generating large

savings for patients, health care plans, and the government.8

However, branded-drug manufacturers have developed a strategy known as product-

hopping, through which they make non-substantial changes to their branded products to take

4 1984, Pub. L. No. 98-417, 98 Stat. 1585 (codified as amended at 21 U.S.C. § 355 (2006)). 5 The legislative history of the Hatch-Waxman Act confirms that the Act was intended to mitigate the “serious anti-competitive effects” of FDA rules on generic drug approval and prevent the “practical extension of the monopoly position of the patent holder beyond the expiration of the patent.” H.R. Rep. No. 98-857(II), Pt. 1, p. 4 (1984); see Michael A. Carrier, Unsettling Drug Patent Settlements: A Framework for Presumptive Illegality, 108 Mich. L. Rev. 37, 42-45 (2009) (explaining how Congress promoted generic competition through (1) an experimental use defense, (2) a new abbreviated process for obtaining FDA approval and (3) a 180-day period of marketing exclusivity for the first generic to challenge a brand firm’s patent; and how it fostered brand-firm innovation through (1) patent term extensions, (2) periods of market exclusivity not based on patents and (3) an automatic 30-month stay of FDA approval). 6 Michael A. Carrier, A Real World Analysis of Pharmaceutical Settlements: The Missing Dimension of Product Hopping, 62 Fla. L. Rev. 1010, 1017 (2010). 7 Br. for Fed’l Trade Comm’n as Amicus Curiae at 7, Mylan Pharms., Inc. v. Warner Chilcott Pub. Co., (No. 12-3824), 2013 WL 5692880 (hereinafter “FTC Amicus”). 8 In 2012 alone, the use of generic drugs saved consumers $217 billion. Generic Pharmaceutical Association, Generic Drug Savings in the U.S. (5th ed. 2013) at 2, available at http://www.gphaonline.org/media/cms/2013_Savings_Study_12.19.2013_FINAL.pdf. See also C. Scott Hemphill & Mark A. Lemley, Earning Exclusivity: Generic Drug Incentives and the Hatch-Waxman Act, 77 Antitrust L.J. 947, 952 (2011) (stating that “once multiple generic firms enter the market, prices fall, often dramatically” and providing supporting empirics to show that prices for a cholesterol-reducing drug dropped from $150 pre-generic entry to $7 post-entry).


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advantage of the regulatory framework to impede generic substitution and exclude

competition.9

A. Congress Created the Hatch-Waxman Framework to Promote Generic Entry

Congress enacted Hatch-Waxman in response to the high costs of pharmaceuticals

resulting from patent monopolies on branded drugs and delayed generic market entry.10

Previously, generics faced limited incentives to enter a market because of the need for

expensive duplicative testing.11 As a result, branded drugs continued to reap monopoly profits

long after patents expired because of the effective extension of their monopoly term. Congress

therefore sought to increase the availability of generic substitutes to reduce both healthcare

costs and the high percentage of individual income spent on pharmaceuticals.12 The Supreme

Court recently confirmed that Hatch-Waxman’s purpose was to “speed the introduction of low-

cost generic drugs to market, thereby furthering drug competition.” FTC v. Actavis, 133 S.Ct.

2223, 2228 (2013).

The proponents of the Hatch-Waxman legislation urged its adoption as the best

possible compromise between the competing economic interests of patentees and generic

9 See, e.g., Abbott Labs. v. Teva Pharms. U.S.A., Inc., 432 F. Supp. 2d 408, 409 (D. Del. 2006) (describing allegations that Abbott Laboratories changed the formulation of a drug to prevent a generic drug from entering the marketplace). 10 In 1983 alone, the Federal Government spent $2.4 billion for drugs through Medicaid and in veterans and military hospitals. Then-President Ronald Reagan stated that the Hatch-Waxman Act would enable “the Federal Government, the largest single consumer of drugs, [to] be able to purchase generic drugs at significantly lower cost.” Ronald Reagan, President of the United States, Remarks on Signing S. 1538 into Law (Sep. 24, 1984). Congress noted that prices of generic versions of ten popular drugs were “on average 50 [%] less than their brand name equivalent[s].” H.R. Rep. No. 98-857(II), Pt. 1, p. 32 (1984). 11 H.R. Rep. No. 98-857(II), Pt. 1, p. 5 (1984) (stating that “the inability of generics to obtain approval . . . without enormous expenditures of money for duplicative tests” resulted in a practical extension of the patent monopoly). Moreover, earlier the Carter administration had urged Congress to act because “the requirements of duplicative tests on humans unnecessarily endangered human health.” Id. 12 The legislative history notes that the reduction in drug prices would be “especially important to the poor, the under-insured, and the elderly. The government itself, as purchaser of prescription drugs, [would] also save money as a result.” Id. p. 29.


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manufacturers.13 On the one hand, Hatch-Waxman allowed generic manufacturers expedited

entry to the market.14 Rather than submitting full safety and efficacy data to the FDA, a

generic manufacturer can now obtain much faster and cheaper approval by filing an

Abbreviated New Drug Application (ANDA), which certifies the bioequivalence of its generic

to an existing branded drug.15 Hatch-Waxman requires that the FDA complete its ANDA

review within 180 days, but in practice that approval often takes much longer.16 On the other

hand, Hatch-Waxman extended the terms of certain drug patents, “creat[ing] incentives for

increased research expenditures” by patentees.17

This compromise was designed to facilitate the introduction of low-cost generic

drugs into the market for the benefit of consumers, health care plans, and the government.18

The very nature of the highly regulated market necessitated the compromise.19 In a different

industry, like automobiles for example, there would be no need for similar provisions

because—unlike the FDA—there is no governmental regulatory agency that would delay

marketing of a new product after patent expiry.20

13 Hemphill & Lemley, supra note 8, at 947 (“The Hatch-Waxman Act gave additional protection to the inventors of new drugs, both by lengthening patent terms and by providing guaranteed terms of data exclusivity. In exchange, Hatch-Waxman made it easier for generic drug manufacturers to enter the market with a copy of the drug.”). 14 H.R. Rep. No. 98-857(II), Pt. 1, p. 11 (1984); Herbert Hovenkamp, Mark D. Janis, Mark A. Lemley, & Christopher R. Leslie, IP & Antitrust: An Analysis of Antitrust Principles Applied to Intellectual Property Law § 15.3c, at 15-77 (2d ed. Supp. 2013) (hereinafter “IP & Antitrust”). 15 21 U.S.C. § 355(j). 16 See Office of Inspector Gen., Dep’t of Health & Human Servs., The Food and Drug Administration’s Generic Drug Review Process 13 (2008), available at http://www.oig.hhs.gov/oei/reports/oei-04-07-00280.pdf (noting that the FDA review process for ANDAs often exceeds the 180-day statutory maximum); IP & Antitrust, § 15.3, at 15-78. 17 H.R. Rep. No. 98-857(II), Pt. 1, p. 10 (1984) (Congress noted in the legislative history that “[i]n most cases the bill affords greater protection for patent holders than current law.”). 18 Id. at 9 (stating that the Hatch-Waxman Act was designed to “implement the policy objective of getting safe and effective generic substitutes on the market as quickly as possible after the expiration of the patent.”). 19 Id. at 30. 20 Id.


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B. Branded-Drug Manufacturers Use Product-Hopping to Prevent Generic Entry

Product-hopping deprives the public of the benefit of the Hatch-Waxman

compromise. It involves an effort by a branded-drug owner to manipulate the lag times

inherent in the FDA’s generic-approval process in a way that, when combined with state drug

substitution laws, excludes generic entry and the competition and lower prices that entry would

bring.21 Product-hopping delays generic competition in several ways. First, by making trivial

modifications to its branded product, the brand firm can require its generic rival to start the

ANDA process all over again, repeating the same 180-day (and usually longer) FDA review.22

Second, where the branded drug’s patent is still in force, the new ANDA can prompt a fresh

litigation-triggered thirty-month stay.23 Third, product-hopping prevents pharmacists from

substituting generic versions pursuant to state substitution laws until the generic’s new ANDA

is approved.24 If the branded-drug firm has pulled its old product from pharmacy shelves and

convinced doctors to write prescriptions for its new product, the market for generics

collapses.25 Thus, generics cannot compete because state substitution laws only allow

pharmacists to prescribe generic alternatives when the FDA certifies them as bioequivalent. If

doctors only prescribe the new version of the branded drug, generics must await completion of

the additional ANDA approval process to even be considered for substitution.26

21 Stacey L. Dogan & Mark A. Lemley, Antitrust Law and Regulatory Gaming, 87 Tex. L. Rev. 685, 709 (2009); IP & Antitrust § 15.3c, at 15-78.4 (trivial alterations to branded drugs can delay generic entry and trigger an entirely new round of patent litigation, thus keeping drug prices high). 22 Dogan & Lemley, supra note 21, at 712; IP & Antitrust § 15.3c, at 15-78. 23 Dogan & Lemley, supra note 21, at 711-12. 24 Carrier, supra note 6, at 1017-18 (discussing how product reformulations further delay generics’ attempts to achieve bioequivalence, sometimes by years); IP & Antitrust § 15.3c, at 15-78.4 (“until the ANDA for that new product is approved . . . state laws limit the ability of pharmacists to substitute the ‘old’ generic for the ‘new’ branded drug.”). 25 Dogan & Lemley, supra note 21, at 712; Hemphill & Lemley, supra note 8, at 960 (while the generic firm waits for its new ANDA approval it may still sell its version of the old drug, “but that is often small comfort because pharmacists cannot substitute the old drug for the new brand-name drug.”). 26 Carrier, supra note 6, at 1018. See also IP & Antitrust § 15.3c, at 15-78.2 (citing Abbott Labs, 432 F. Supp. 2d to show how product hopping creates anticompetitive effects by delaying generic substitution).


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Product-hopping “therefore presents a paradigmatic case of a regulatory game. . . .

[It] exploits the product-approval process precisely because of its exclusionary effects and

converts it into a tool for suppressing competition.”27 Without the FDA’s lengthy product-

approval process, generic firms could quickly go to market with competing versions of branded

drugs when branded-drug patents expire. But the regulatory framework prevents them from

doing so, and the ability of branded-drug firms to exploit Hatch-Waxman and force generics

into multiple ANDAs before they can reach the market powerfully excludes such

competition.28 As some of the amici describe this problem in their treatise, “product-hopping

seems clearly to be an effort to game the rather intricate FDA rules. . . . The patentee is making

a product change with no technological benefit solely in order to delay competition.”29

C. “Piggy-Back” Generic Entry Is Central to the Hatch-Waxman Design

What the defendants here seek to disparage as “free riding” by generics (Defs. Br.

Mot. Dismiss 23-24) is in fact the very mechanism for introducing faster and more effective

generic competition that Hatch-Waxman and state drug substitution laws have deliberately

created.30 As the Supreme Court recently recognized, Hatch-Waxman’s abbreviated approval

procedures allow generics to “obtain approval while avoiding ‘the costly and time-consuming

studies’” needed for a pioneer drug and to “piggy-back on the pioneer’s approval efforts,

‘speed[ing] the introduction of low-cost generic drugs to market’ . . . thereby furthering drug

competition.” FTC v. Actavis, Inc., 133 S.Ct. 2223, 2228 (2013) (internal citations omitted).

The same piggy-back principle applies to marketing efforts. The Hatch-Waxman framework

27 IP & Antitrust § 15.3c, at 15-78.4-79. 28 Id. 29 Id. at 15-78. 30 The Hatch-Waxman Act was intended to improve the system for approval of generic drugs by the FDA that the House Report described as “too cumbersome and expensive.” H.R. Rep. No. 98-857(II), Pt. 1, p. 5 (1984). The House Judiciary Committee estimated that there were 150 drug products approved after 1962 that were off-patent, but for which no generics existed. Generics for these branded drugs would become available using the ANDA procedure. Id. p. 11.


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thus positions generic drugs as low-cost alternatives that do not rely on promotional efforts by

generic firms.31 State drug substitution laws also eliminate the need for generics to undertake

financially crippling marketing costs that could prevent generic viability.32 This elimination of

the need for generics to incur huge marketing costs, an effect intended by the federal and state

regulatory framework, removes a large impediment to effective generic entry and facilitates the

ability of generic companies to offer the lower price benefits intended by that framework.

This combined mechanism for facilitated generic entry and substitution solves the

price disconnect between “prescribing doctors, who are not directly responsive to drug pricing,

and paying insurers and consumers, who do not directly select the prescribed drug.”33 As a

result, drugs are much cheaper and more widely available today.34 Without these laws,

generics could not compete cost-effectively. The ability of generics to succeed in the market

without equivalent approval processes and marketing expenses is precisely the sort of

procompetitive “piggy-backing” to lower prices for consumers that these laws carefully

facilitate.

II. Product-Hopping May Constitute Exclusionary Conduct That Violates Section 2 of the Sherman Act

Antitrust rule-of-reason analysis is well-suited to analyze product design changes for

effects on competition under Section 2 of the Sherman Act. United States v. Microsoft Corp.,

253 F.3d 34 (D.C. Cir. 2001) (en banc). The Supreme Court has specifically approved antitrust

31 See H.R. Rep. No. 98-857(II), Pt. 1, p. 4 (1984) (stating that Congress enacted Hatch-Waxman to allow generics to compete via “following on” branded drugs because other paths to get generics to market are not cost-effective). 32 For example, Pennsylvania’s drug substitution law states that its purpose is to “permit consumers to secure necessary drugs at the most economical costs.” 35 Pa. Cons. Stat. § 960.1 (2014). 33 Carrier, supra note 6, at 1017 (in particular, drug substitution laws “carve out a role for pharmacists, who are much more sensitive to prices than doctors.”). 34 The first generic to enter the market is typically 20% to 30% cheaper than the branded drug. Subsequent generic entry creates greater price competition, with discounts of 85% or more off the price of the branded drug. A recent study of 5.6 million prescriptions revealed that patients and their insurance plans respectively paid an average of $17.90 and $26.67 for generic drugs and an average of $49.50 and $158.25 for brand drugs where no generic existed. FTC Amicus at 7 (internal citations omitted).


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scrutiny in the pharmaceutical industry for reverse-payment settlements, another form of

Hatch-Waxman regulatory gaming. F.T.C. v. Actavis, Inc., 133 S.Ct. 2223 (2013). Product-

hopping similarly creates the danger of anticompetitive exclusion of generic competition and

should also be subject to antitrust scrutiny under Section 2.

A. Section 2 of the Sherman Act Is Well Suited to Address Product-Hopping Through the Rule of Reason

A firm with market power illegally monopolizes if it willfully acquires or maintains

that power through exclusionary conduct rather than “growth or development as a consequence

of a superior product, business acumen, or historical accident.” United States v. Grinnell Corp.,

384 U.S. 563, 570-71 (1966); see United States v. Dentsply Int’l, Inc., 399 F.3d 181, 186 (3d

Cir. 2005). Exclusionary conduct by a monopolist impairs opportunities for rivals to compete

and “does not further competition on the merits or does so in an unnecessarily restrictive

way.” Aspen Skiing Co. v. Aspen Highlands Corp., 472 U.S. 585, 605 n.32 (1985). Put another

way, it is conduct “which prevents actual or potential rivals from competing or impairs their

opportunities to do so effectively.”35

1. Antitrust Laws Apply in the Pharmaceutical Industry

The mere fact that an industry is regulated does not immunize industry behavior

from antitrust scrutiny. Antitrust analysis “must always be attuned to the particular structure

and circumstances of the industry at issue” and it may be considerably more important in

industries where “nothing built into the regulatory scheme . . . performs the antitrust

function.” Verizon Communications, Inc. v. Law Offices of Curtis V. Trinko, LLP, 540 U.S.

398, 411-12 (2004) (internal citations omitted); see Dentsply, 399 F.3d at 189 (antitrust analysis

35 3 Phillip E. Areeda & Herbert Hovenkamp, Antitrust Law ¶ 651 (4th ed. 2013).


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must be guided by the economic realities of the industry at issue).36 Scholars, including some

of the amici here, have described Trinko as advocating an inverse relationship between the

regulatory scheme’s effectiveness at protecting competition and the need for antitrust

intervention.37 Further, regulatory tolerance of potentially anticompetitive behavior does not

compel antitrust to “get out of the way to avoid interference in the regulatory scheme.”38

The Supreme Court’s most recent pronouncement in this area specifically upheld

antitrust applicability to the pharmaceutical industry, even where the alleged “anticompetitive

effects fall within the scope of the exclusionary potential of the patent.” Actavis, 133 S.Ct. at

2230 (holding that reverse-payment settlements under the Hatch-Waxman “drug-regulatory

framework” engineered to delay generic entry may violate the Sherman Act).39 Product-

hopping, like the reverse-payment settlements at issue in Actavis, manipulates the provisions of

the regulatory framework to exclude generic entry in a way not anticipated by that framework.

See id. at 2234 (relying on the “general procompetitive thrust” and specific entry-promoting

provisions of the Hatch-Waxman Act as reasons to recognize antitrust liability for reverse-

payment settlements). Moreover, the FDA is not able to prevent this regulatory gaming

because it explicitly avoids consideration of competition effects when approving

36 The Third Circuit, in a pharmaceutical bundling case, held that antitrust analysis must be specifically attuned to the special circumstances of the pharmaceutical industry. See SmithKline Corp. v. Eli Lilly & Co., 575 F.2d 1056 (3d Cir. 1978). 37 See, e.g., Herbert Hovenkamp, Antitrust and the Regulatory Enterprise, 2004 Colum. Bus. L. Rev. 335, 353 (2004); Carrier, supra note 5, at 68-71. 38 Dogan & Lemley, supra note 21, at 717; see C. Scott Hemphill, Paying for Delay, Pharmaceutical Patent Settlement as a Regulatory Design Problem, 81 N.Y.U. L. Rev. 1553, 1557 (2006) (“A particular regulatory regime sets the boundaries of feasible anticompetitive conduct.”). 39 Antitrust scrutiny of regulatory gaming of Hatch-Waxman is hardly novel. See, e.g., In re Gabapentin Patent Litig., 649 F. Supp. 2d 340, 351 n.14 (D.N.J. 2009) (“Antitrust claims are, moreover, frequently based on allegations of manipulation of the Hatch-Waxman regulatory framework.”); Walgreen Co. v. Organon, Inc. (In re Remeron Antitrust Litigation), 335 F. Supp. 2d 522, 532 (D.N.J. 2004) (“Within the maze of Hatch-Waxman, if a patent-holder’s actions unlawfully maintain otherwise lawful monopoly power or use a lawful patent to manipulate the ANDA process, such actions could lead to anticompetitive effects in the relevant market.”).


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pharmaceutical products. aaiPharma Inc. v. Thompson, 296 F.3d 227, 241 (4th Cir. 2002)

(describing the FDA’s approach to Hatch-Waxman as “focus[ing] on its primary task of

ensuring that drugs are safe and effective” while letting private parties sort out their respective

rights).40 Under Trinko, antitrust analysis is particularly important in the pharmaceutical

context because the regulatory scheme fails to perform an antitrust function on its own.

2. A Monopolist’s Product Changes May Be Anticompetitive

Although courts generally “are properly very skeptical” that product design changes

harm competition, it is well established that a monopolist’s product change can do precisely

that. Microsoft, 253 F.3d at 65 (holding unanimously that Microsoft’s software-design changes

violated the Sherman Act because they had no procompetitive justification).41 Deference to

product innovation “does not mean that a monopolist’s product design decisions are per se

lawful.” Id.; see also C.R. Bard, Inc. v. M3 Sys., Inc., 157 F.3d 1340, 1382 (Fed. Cir. 1988).

Changes are anticompetitive where they have no purpose “other than protecting [the] monopoly”

and where they “unfairly tend[] to destroy competition itself.” Microsoft, 253 F.3d at 67; Id. at

58 (quoting Spectrum Sports, Inc. v. McQuillan, 506 U.S. 447, 458 (1993)).

Although some product changes in the pharmaceutical industry may represent

genuine innovation that furthers competition on the merits, modest or trivial reformulations or

other modifications with insubstantial medical benefits can be anticompetitive when they

exploit the regulatory barriers of Hatch-Waxman and state substitution laws to protect the

firm’s monopoly position by excluding competition from generic rivals. This can be especially

40 See also IP & Antitrust § 15.3c, at 15-79 (“Making matters worse, the [FDA] regulators can do nothing to thwart this obvious abuse of their administrative function.”). 41 See Areeda & Hovenkamp, supra note 35 at ¶ 776a (Although “product improvement without more is protected and beyond antitrust challenge[,] . . . strategic creation of incompatibility can have serious anticompetitive consequences, particularly in ‘network’ industries where compatibility itself is often an essential ingredient to product success.”) Given the regulatory framework for pharmaceuticals, incompatibility arises when branded drugs are modified to avoid bioequivalence with generics.


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true where, as alleged in this case, the branded firm makes changes and switches the market to

its reformulated drug before generic entry to eliminate generic competition.42

Such pharmaceutical product changes should not be afforded any special deference

in the antitrust analysis because regulatory barriers entirely restrict consumer choice between

products and eliminate market competition when a product hop occurs.43 In pharmaceutical

markets, “the success of a product switching scheme does not depend on whether consumers

prefer the reformulated version of the product over the original, or whether the reformulated

version provides any medical benefit.”44 In particular, product reformulations accompanied, as

is alleged in this case, by withdrawal of the previous versions prevent “consumers from

weighing the relative merits of competing products.”45 As a result, these product redesigns

present acute anticompetitive concerns.

B. Product-Hopping May Illegally Exclude Competition by Generic Manufacturers

To determine whether product design changes result in illegal monopolization, courts

employ a rule-of-reason analysis that involves weighing the changes’ anticompetitive effects

against their procompetitive justifications. Microsoft, 253 F.3d at 58-59. Product-hopping may

be illegal under rule-of-reason scrutiny. Abbott Labs v. Teva Pharms. U.S.A., Inc., 432 F. Supp.

2d 408, 422 (D. Del. 2006).46 Anticompetitive conduct does not require total foreclosure of

competitors from the market; it only requires barring them “from their cost-efficient means of

competing.” Id. at 423 (D. Del. 2006) (citing Microsoft, 253 F.3d at 64); see Dentsply, 399

F.3d at 191 (“it is not necessary that all competition be removed from the market. The test is

42 See Carrier, supra note 6, at 1020. 43 IP & Antitrust § 15.3c, at 15-79. 44 FTC Amicus at 12-13. 45 Id. at 13. 46 IP & Antitrust § 15.3c, at 15-78.1 (suggesting that under rule of reason analysis, plaintiffs can establish antitrust liability by demonstrating that anticompetitive harm of the conduct outweighs procompetitive benefit even when defendants can establish a valid business reason for their behavior); Dogan & Lemley, supra note 21, at 716-17.


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not total foreclosure but whether the challenged practices bar a substantial number of rivals or

severely restrict the market’s ambit.”).

Whether product-hopping violates the Sherman Act will depend on the specific

conduct at issue and its anticompetitive nature and effect. In the two primary cases that have

previously addressed product-hopping, the particular effects of the relevant conduct on

consumer choice in the market were determinative.

In Abbott Labs, then-District-Court-Judge Jordan held that the plaintiffs properly

alleged that product-hopping defendants illegally excluded generic competition by introducing

new drug formulations, withdrawing prior drug versions and changing prior versions’ National

Drug Data File codes to ‘obsolete.’ Abbott Labs, 432 F. Supp. 2d at 424. These actions

prevented pharmacists from using the generic to fill prescriptions for the old branded

version. Id. at 415-16. Meanwhile, pharmacists were also unable to substitute the generic

version of the old product for the new product. There was no “open market where the merits of

any new product [could] be tested by unfettered choice.” Id. at 422. In effect, the brand firm

functionally excluded generics from the market since they could not compete cost-effectively

on either version of the drug.

The other court to address a product-hopping case found that, under the facts at issue,

there was no illegal exclusion of competition. Walgreen Co. v. AstraZeneca Pharmaceuticals

L.P., 534 F. Supp. 2d 146, 151 (D.D.C. 2008). It distinguished Abbott Labs by noting that the

defendant in Abbott Labs sought to “deliberately limit rather than expand consumers’ choices

by merely changing the formulation of the drug.” Id. In contrast, Walgreen emphasized that

defendants introduced and began vigorously marketing a newly patented drug but kept the

original drug on the market, adding rather than eliminating a choice. The court concluded that


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this new product introduction did not prevent generics from competing via substitution on the

defendant’s original drug. The court did not address the question of whether more aggressive

actions, like those in Abbott Labs or those alleged in this case, could constitute illegal predatory

conduct and give rise to antitrust liability.

Thus, a nuanced understanding of pharmaceutical markets, the Hatch-Waxman Act,

and drug substitution laws, as applied by the court in Abbott Labs, makes clear that product-

hopping can constitute anticompetitive conduct under Section 2 if it reduces consumer choice

by excluding generic competition in the market. Under Hatch-Waxman and state substitution

laws, generics can only compete cost-effectively through substitution on the new or old

branded-drug version. When branded-drug manufacturers implement minor or non-substantial

product changes that supplant a prior brand version, they prevent generics from substitution on

the prior version and eliminate competition during the lengthy approval process for the generic

version of the new drug. This exclusionary conduct deprives consumers of competitive choices

and thus violates Section 2. Consumers, insurers and the government all will pay higher prices

for drugs for a longer period of time. Moreover, withdrawing the original branded drug from

the market for non-substantial medical reasons may harm existing patients for whom the

reformulated product is less effective, causes compliance problems (e.g., patients doing well on

a twice-a-day original formulation might have problems switching to a once-a-day

reformulation), and so on. Harm to the quality of care for existing patients simply to prolong

monopoly profits through product reformulations can be further anticompetitive harm.

The anticompetitive effects of product-hopping are particularly pronounced when the

conduct includes multiple product reformulations, changes timed to occur before generic entry,

purported justifications for change that are lacking or weak, when there are “smoking gun”


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documents (such as references to “preserving franchise” or “multiple strategies” or the like), or

other evidence that reveal an exclusionary objective rather than a genuine, substantial

improvement.

III. Product-Hopping Discourages Efficient Drug Development and Innovation

While innovation may sometimes come in the form of incremental but genuine

improvements, product-hopping can slow the development and marketing of new drugs while

providing few if any substantial medical benefits. The product-hopping game causes both

generic and branded-drug manufacturers to misallocate research and development resources,

further frustrating Hatch-Waxman’s carefully crafted mechanism to promote pharmaceutical

innovation.

A. Product-Hopping Encourages Generic Manufacturers to Develop Products for Foreclosed Markets

Product-hopping can divert resources and reduce investment by manufacturers that

would otherwise undertake generic development relying on the assumption that the regulatory

scheme under Hatch-Waxman and state substitution laws will work as intended. The

expectation that the regulatory structure will reward a less expensive generic with a substantial

share of the corresponding branded-drug market gives generic manufacturers an incentive to

commit resources to bringing generics to market. Generic firms facing product-hopping are

excluded from the expected market and instead must repeatedly chase a moving target, only to

find that each time they close in on approval for a particular formulation’s generic equivalent,

the target has again moved. Each successive product hop wastes resources that the generic

manufacturer could have instead used developing a new drug or more cost-efficient drug

production methods. Allowing branded-drug manufacturers to engage in product-hopping


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without effective antitrust scrutiny risks chilling the likelihood of future generic development

and entry.

Without the ability to rely on the intended operation of generic substitution laws,

generic manufacturers would also face the need to incur marketing costs to cultivate a market

for their drugs. In addition to diverting resources from innovation, marketing costs would

create a substantial impediment to effective generic entry. The immense cost of marketing

undermines the ability of generic companies to offer the lower-price benefits intended by the

federal and state regulatory framework. Furthermore, marketing may ultimately fail to

incentivize doctors to prescribe generics in lieu of branded drugs. Because one generic

manufacturer must bear the marketing costs from which all generics would benefit, marketing

costs create a prisoners’ dilemma for drugs with multiple generic entrants. As a result, no

single manufacturer would find it profitable to undertake generic marketing, reducing the

penetration of the generic product.

B. Product-Hopping Diverts Brand Firm Resources from Genuine Innovation to Insignificant Modifications

Brand firms that seek to maintain their market share after their patent expires through

product-hopping may devote valuable resources to making insignificant modifications to their

blockbuster drugs and then marketing the new versions.47 Modest reformulations or other

changes that do not produce substantial medical benefits, pursued to game the regulatory

system and exclude competition from generic alternatives, misdirect resources that could

instead be applied toward the discovery and development of new drugs. Studies have shown

that in recent years, the rate of new drug development has decreased relative to the rate of drug

reformulation. Although legislative and FDA efforts to promote new drug development

47 Joseph A. DiMasi, et al., The Price of Innovation: New Estimates of Drug Development Costs, 22 J. Health Econ. 151, 173 (2003) (“[O]ut-of-pocket cost per approved drug for post-approval R&D is 25.8 % of total R&D cost.”).


17

showed promise in the 1990s, the number of original application submissions and approvals for

new drugs has declined since the turn of the century.48 On the other hand, spending on drug

redesign and incremental improvements has significantly increased.49 Efforts to maintain

market power for blockbuster drugs are at least partially responsible for this trend.50

CONCLUSION

Product-hopping thwarts Hatch-Waxman’s goal of promoting generic entry into the

marketplace. Just like Lucy’s lifting of the football prevents Charlie Brown from ever actually

kicking it, product-hopping prevents generic manufacturers from bringing generics to market

and effectively offering competition to branded drugs. Hatch-Waxman sought to promote

innovation through its bargain between prolonged patent protection and expedited generic entry,

and product-hopping upsets this bargain. Innovation is stifled, and consumers, insurers and the

government pay the substantial price. As an antitrust matter, engaging in product-hopping to

impede generic competition is precisely the sort of behavior that Section 2 condemns.51

48 Janice M. Reichert, Trends in Development and Approval Times for New Therapeutics in the United States, 2 Nature Reviews 695, 701 (2003); Iain M. Cockburn, Is the Pharmaceutical Industry in a Productivity Crisis?, 7 Innovation Pol’y and the Economy 1 (2006); Summary of NDA Approvals & Receipts, 1938 to the present, FDA, http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SummaryofNDAApprovalsReceipts1938tothepresent/default.htm. 49 Jayashree Dubey & Rajesh Dubey, Pharmaceutical Innovation and Generic Challenge: Recent Trends and Causal Factors, 4 Int’l J. of Pharm. & Healthcare Marketing 175 (2010). 50 Id. at 189 (noting that the threat of generic competition has caused pharmaceutical companies to “explor[e] the route of incremental innovation to increase market life of their existing blockbuster products”). 51 IP & Antitrust § 15.3c, at 15-79.


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Dated: May 7, 2014 Respectfully submitted,

/s/ Phillip R. Malone PHILLIP R. MALONE* Juelsgaard Intellectual Property and Innovation Clinic Mills Legal Clinic at Stanford Law School 559 Nathan Abbott Way Stanford, CA 94305 Telephone: 650-725-6369 Facsimile: 650-723-4426 [email protected] *Admitted Pro Hac Vice Attorney for Amici Curiae


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APPENDIX

Michael A. Carrier is Distinguished Professor and Co-Director of the Rutgers

Institute for Information Policy & Law at Rutgers University School of Law. He has written

extensively on the intersection of intellectual property and antitrust law, particularly in the

context of the pharmaceutical industry.1 His scholarship on pharmaceutical patents and their

effects on competition has been cited twice by the Supreme Court, including a 2013 amicus

brief in FTC v. Actavis, co-authored with other amici here.2

Stacey L. Dogan is Professor of Law at Boston University School of Law. She

is a leading scholar of intellectual property and competition law and coauthored the

authoritative article on regulatory gaming in the pharmaceutical industry.3 She is the Chair of

the Intellectual Property Section of the Association of American Law Schools.

Hillary Greene is Professor of Law at the University of Connecticut School of

Law and is currently a Senior Visiting Scholar at the University of California, Berkeley, School

of Law and a Visiting Scholar at the School of Engineering’s Fung Institute. She has extensive

experience with antitrust and patent law interface issues.4 Previously, she served as Project

Director for Intellectual Property at the Federal Trade Commission’s Office of the General

Counsel. She also serves on the editorial board of the Antitrust Law Journal.

1 Michael A. Carrier, Provigil: A Case Study of Anticompetitive Behavior, 3 Hastings Sci. & Tech. L.J. 441 (2011); Michael A. Carrier, A Real World Analysis of Pharmaceutical Settlements: The Missing Dimension of Product Hopping, 62 Fla. L. Rev. 1010 (2010); Michael A. Carrier, Unsettling Drug Patent Settlements: A Framework for Presumptive Illegality, 108 Mich. L. Rev. 37 (2009); Michael A. Carrier, Of Trinko, Tea Leaves, and Intellectual Property, 31 J. Corp. L. 357 (2005). 2 Br. Amici Curiae of 118 L., Econ., & Bus. Professors & the Am. Antitrust Inst., No. 12-416, FTC v. Actavis, 133 S. Ct. 2223 (2013). 3 Stacey L. Dogan & Mark A. Lemley, Antitrust Law and Regulatory Gaming, 87 Tex. L. Rev. 685 (2009) 4 Hillary Greene, Information Product Redesign as Commercial Expression: Antitrust Treatment of Speech and Innovation (B.U. L. Rev., forthcoming 2015) (examining the antitrust implications of incremental innovations ostensibly characterized by both pro and anticompetitive effects); Hillary Greene, Patent Pooling Behind the Veil of Uncertainty: Antitrust, Competition Policy, and the Vaccine Industry, 90 B.U. L. Rev. 1397 (2010).


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C. Scott Hemphill is Professor of Law at Columbia Law School. His

scholarship focuses on the balance between innovation and competition created by intellectual

property and antitrust law. He has written extensively about regulation in the pharmaceutical

industry and competition between generic and branded-drug manufacturers.5 He previously

served as Chief of the Antitrust Bureau in the Office of the New York State Attorney General.

Herbert Hovenkamp is the Ben and Dorothy Willie Chair at the University of

Iowa College of Law. He is co-author of the seminal treatises on antitrust law and on the

intersection of IP and antitrust law,6 and has written numerous books and articles on the topic

of antitrust law and its interaction with innovation.7 In 2008, he received the John Sherman

Award from the Antitrust Division of the Department of Justice, an award presented only once

every three years to an individual for their outstanding achievements in antitrust law.

Mark A. Lemley is the William H. Neukom Professor of Law at Stanford Law

School. He is the author of seven books and is among the world’s most-cited law review

authors.8 His scholarship focuses on intellectual property law, antitrust law and technology and

the law. He is a co-author of the seminal IP and antitrust law treatise and has written

extensively on the topic of regulatory gaming in the pharmaceutical context, including

5 C. Scott Hemphill & Bhaven N. Sampat, Evergreening, Patent Challenges, and Effective Market Life in Pharmaceuticals, 31 J. Health Econ. 327 (2012); C. Scott Hemphill & Mark A. Lemley, Earning Exclusivity: Generic Drug Incentives and the Hatch-Waxman Act, 77 Antitrust L.J. 947 (2011); C. Scott Hemphill, Paying for Delay: Pharmaceutical Patent Settlement as a Regulatory Design Problem, 81 N.Y.U. L. Rev. 1553 (2006); Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, & Carl Shapiro, Activating Actavis, Antitrust Magazine, Aug. 26, 2013, at 16. 6 3 Phillip E. Areeda & Herbert Hovenkamp, Antitrust Law (4th ed. 2013); Herbert Hovenkamp, Mark D. Janis, Mark A. Lemley, & Christopher R. Leslie, IP & Antitrust: An Analysis of Antitrust Principles Applied to Intellectual Property Law (2d ed. Supp. 2013). 7 See, e.g., Herbert Hovenkamp, Innovation and Competition Policy: Cases and Materials (2d ed. 2013); Christina Bohannon & Herbert Hovenkamp, Creation Without Restraint: Promoting Liberty and Rivalry in Innovation (2012); Herbert Hovenkamp, The Antitrust Enterprise: Principle and Execution (2006); Herbert Hovenkamp, Consumer Welfare in Competition and Intellectual Property Law, 9 Competition Policy Int’l J. 53 (2014); Herbert Hovenkamp, Markets in IP and Antitrust, 100 Geo. L.J. 2133 (2012); Herbert Hovenkamp, Antitrust and the Regulatory Enterprise, 2004 Colum. Bus. L. Rev. 335 (2004). 8 Fred R. Shapiro & Michelle Pearse, The Most-Cited Law Review Articles of All Time, 110 Mich. L. Rev. 1483 (2012) (finding that Lemley has authored or co-authored 9 of the 100 most-cited law review articles).


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specifically on the issue of product-hopping.9 His works have been cited over 140 times by

courts, including seven United States Supreme Court opinions, and over 9,500 times in books

and law review articles.

9 Herbert Hovenkamp, Mark D. Janis, Mark A. Lemley, & Christopher R. Leslie, IP & Antitrust: An Analysis of Antitrust Principles Applied to Intellectual Property Law (2d ed. Supp. 2013); Stacey L. Dogan & Mark A. Lemley, Antitrust Law and Regulatory Gaming, 87 Tex. L. Rev. 685 (2009); C. Scott Hemphill & Mark A. Lemley, Earning Exclusivity: Generic Drug Incentives and the Hatch-Waxman Act, 77 Antitrust L.J. 947 (2011); Mark. A. Lemley, Property, Intellectual Property, and Free Riding, 83 Tex. L. Rev. 1031 (2005).


CERTIFICATE OF SERVICE

I certify that on May 7, 2014, I electronically submitted the foregoing [Proposed] Brief of

Intellectual Property and Antitrust Lawyers as Amici Curiae to the Clerk of the Court

using the ECF system, which sent notification to all counsel of record.

Dated: May 7, 2014 /s/ Phillip R. Malone PHILLIP R. MALONE* Juelsgaard Intellectual Property and Innovation Clinic Mills Legal Clinic at Stanford Law School 559 Nathan Abbott Way Stanford, CA 94305 Telephone: 650-725-6369 Facsimile: 650-723-4426 [email protected] *Admitted Pro Hac Vice Attorney for Amici Curiae


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IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN ... … · innovation of both new branded and generic drugs and further harm consumers and the public interest. Case 2:12-cv-03824-PD