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
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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.”).
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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).
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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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