throbber
Case: 20-2402 Document: 64 Filed: 10/14/2020 Pages: 20
`
`No. 20-2402
`____________________________________________
`IN THE UNITED STATES COURT OF APPEALS FOR THE SEVENTH
`CIRCUIT
` _____________________________________________
`UFCW LOCAL 1500 WELFARE FUND, et al,
` Plaintiffs—Appellants,
` v.
`ABBVIE INC., et al,
` Defendants—Appellees
`____________________________________________
`Appeal from the Northern District of Illinois (Eastern Division)
`Case No. 19-cv-01873
`The Honorable Manish S. Shah
`____________________________________________
`BRIEF OF AMICI CURIAE CONSUMER ACTION AND U.S. PUBLIC
`INTEREST RESEARCH GROUP IN SUPPORT OF PLAINTIFFS-
`APPELLANTS
`____________________________________________
`
`James B. Zouras
`
`StephanZouras, LLP
`100 N Riverside Plaza
`Suite 2150
`
`Chicago, IL 60606
`
`David Balto
`Law Offices of David Balto
`8030 Ellingson Drive
`Chevy Chase, MD 20815
`
`Andre Barlow
`Doyle Barlow & Mazard
`1776 K Street, NW, #200
`Washington, D.C. 20004
`
`Counsel for Amici Curiae Consumer Action and U.S. Public Interest Research Group
`
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`Case: 20-2402 Document: 64 Filed: 10/14/2020 Pages: 20
`APPEARANCE & CIRCUIT RULE 26.1 DISCLOSURE STATEMENT
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`20-2402
`Appellate Court No: _______________
`
`UFCW Local 1500 Welfare Fund, et al. v. Abbvie Inc., et al.
`Short Caption: _________________________________________________________________________________________
`
` To enable the judges to determine whether recusal is necessary or appropriate, an attorney for a non-governmental party, amicus curiae,
`intervenor or a private attorney representing a government party, must furnish a disclosure statement providing the following information
`in compliance with Circuit Rule 26.1 and Fed. R. App. P. 26.1.
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` The Court prefers that the disclosure statements be filed immediately following docketing; but, the disclosure statement must be filed
`within 21 days of docketing or upon the filing of a motion, response, petition, or answer in this court, whichever occurs first. Attorneys are
`required to file an amended statement to reflect any material changes in the required information. The text of the statement must also be
`included in the front of the table of contents of the party’s main brief. Counsel is required to complete the entire statement and to use
`N/A for any information that is not applicable if this form is used.
`
`[ ]
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`PLEASE CHECK HERE IF ANY INFORMATION ON THIS FORM IS NEW OR REVISED AND
`INDICATE WHICH INFORMATION IS NEW OR REVISED.
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`(1)
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`(2)
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`The full name of every party that the attorney represents in the case (if the party is a corporation, you must provide the corporate disclosure
`information required by Fed. R. App. P. 26.1 by completing item #3):
`U.S. Public Interest Research Group, Amicus Curiae
`________________________________________________________________________________________________________
`
`Consumer Action, Amicus Curiae
`________________________________________________________________________________________________________
`
`The names of all law firms whose partners or associates have appeared for the party in the case (including proceedings in the district court or
`before an administrative agency) or are expected to appear for the party in this court:
`Stephan Zouras, LLP
`________________________________________________________________________________________________________
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`Law Offices of David A. Balto, Doyle Barlow & Mazard PLLC
`________________________________________________________________________________________________________
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`If the party, amicus or intervenor is a corporation:
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`i)
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`Identify all its parent corporations, if any; and
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`Provide information required by FRAP 26.1(b) – Organizational Victims in Criminal Cases:
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`(5)
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`Provide Debtor information required by FRAP 26.1 (c) 1 & 2:
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`N/A
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`10/14/2020
`s/ James B. Zouras
`Attorney’s Signature: ________________________________________ Date: ________________________________________
`
`James B. Zouras
`Attorney’s Printed Name: __________________________________________________________________________________
`
`✔
`Please indicate if you are Counsel of Record for the above listed parties pursuant to Circuit Rule 3(d). Yes _____ No _____
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`100 N. Riverside Plaza, Suite 2150
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`Save As
`Case: 20-2402 Document: 64 Filed: 10/14/2020 Pages: 20
`APPEARANCE & CIRCUIT RULE 26.1 DISCLOSURE STATEMENT
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`Clear Form
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`20-2402
`Appellate Court No: _______________
`
`UFCW Local 1500 Welfare Fund, et al. v. Abbvie Inc., et al.
`Short Caption: _________________________________________________________________________________________
`
` To enable the judges to determine whether recusal is necessary or appropriate, an attorney for a non-governmental party, amicus curiae,
`intervenor or a private attorney representing a government party, must furnish a disclosure statement providing the following information
`in compliance with Circuit Rule 26.1 and Fed. R. App. P. 26.1.
`
` The Court prefers that the disclosure statements be filed immediately following docketing; but, the disclosure statement must be filed
`within 21 days of docketing or upon the filing of a motion, response, petition, or answer in this court, whichever occurs first. Attorneys are
`required to file an amended statement to reflect any material changes in the required information. The text of the statement must also be
`included in the front of the table of contents of the party’s main brief. Counsel is required to complete the entire statement and to use
`N/A for any information that is not applicable if this form is used.
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`[ ]
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`PLEASE CHECK HERE IF ANY INFORMATION ON THIS FORM IS NEW OR REVISED AND
`INDICATE WHICH INFORMATION IS NEW OR REVISED.
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`(1)
`
`(2)
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`The full name of every party that the attorney represents in the case (if the party is a corporation, you must provide the corporate disclosure
`information required by Fed. R. App. P. 26.1 by completing item #3):
`U.S. Public Interest Research Group, Amicus Curiae
`________________________________________________________________________________________________________
`
`Consumer Action, Amicus Curiae
`________________________________________________________________________________________________________
`
`The names of all law firms whose partners or associates have appeared for the party in the case (including proceedings in the district court or
`before an administrative agency) or are expected to appear for the party in this court:
`StephanZouras, LLP, Law Offices of David Balto, Doyle Barlow & Mazard PLLC
`________________________________________________________________________________________________________
`
`________________________________________________________________________________________________________
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`(3)
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`If the party, amicus or intervenor is a corporation:
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`i)
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`Identify all its parent corporations, if any; and
`
`N/A
`________________________________________________________________________________________________
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`ii)
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`list any publicly held company that owns 10% or more of the party’s, amicus’ or intervenor’s stock:
`
`N/
`________________________________________________________________________________________________
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`(4)
`
`Provide information required by FRAP 26.1(b) – Organizational Victims in Criminal Cases:
`
`N/A
`________________________________________________________________________________________________________
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`(5)
`
`Provide Debtor information required by FRAP 26.1 (c) 1 & 2:
`
`N/A
`________________________________________________________________________________________________________
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`10/14/2020
`/s/ Andre Barlow
`Attorney’s Signature: ________________________________________ Date: ________________________________________
`
`Andre Barlow
`Attorney’s Printed Name: __________________________________________________________________________________
`
`✔
`Please indicate if you are Counsel of Record for the above listed parties pursuant to Circuit Rule 3(d). Yes _____ No _____
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`1776 K Street, Suite 200, NW, Washington, DC 20004
`Address: ______________________________________________________________________________________________
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`________________________________________________________________________________________________________
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`202-589-1838
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`abarlow@dbmlawgroup.com
`E-Mail Address: __________________________________________________________________________________________________
`rev. 12/19 AK
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`

`Save As
`Case: 20-2402 Document: 64 Filed: 10/14/2020 Pages: 20
`APPEARANCE & CIRCUIT RULE 26.1 DISCLOSURE STATEMENT
`
`Clear Form
`
`20-2402
`Appellate Court No: _______________
`
`UFCW Local 1500 Welfare Fund, et al. v. Abbvie Inc., et al.
`Short Caption: _________________________________________________________________________________________
`
` To enable the judges to determine whether recusal is necessary or appropriate, an attorney for a non-governmental party, amicus curiae,
`intervenor or a private attorney representing a government party, must furnish a disclosure statement providing the following information
`in compliance with Circuit Rule 26.1 and Fed. R. App. P. 26.1.
`
` The Court prefers that the disclosure statements be filed immediately following docketing; but, the disclosure statement must be filed
`within 21 days of docketing or upon the filing of a motion, response, petition, or answer in this court, whichever occurs first. Attorneys are
`required to file an amended statement to reflect any material changes in the required information. The text of the statement must also be
`included in the front of the table of contents of the party’s main brief. Counsel is required to complete the entire statement and to use
`N/A for any information that is not applicable if this form is used.
`
`[ ]
`
`PLEASE CHECK HERE IF ANY INFORMATION ON THIS FORM IS NEW OR REVISED AND
`INDICATE WHICH INFORMATION IS NEW OR REVISED.
`
`(1)
`
`(2)
`
`The full name of every party that the attorney represents in the case (if the party is a corporation, you must provide the corporate disclosure
`information required by Fed. R. App. P. 26.1 by completing item #3):
`U.S. Public Interest Research Group, Amicus Curiae
`________________________________________________________________________________________________________
`
`Consumer Action, Amicus Curiae
`________________________________________________________________________________________________________
`
`The names of all law firms whose partners or associates have appeared for the party in the case (including proceedings in the district court or
`before an administrative agency) or are expected to appear for the party in this court:
`StephanZouras, LLP, Law Offices of David A. Balto, Doyle Barlow & Mazard PLLC
`________________________________________________________________________________________________________
`
`________________________________________________________________________________________________________
`
`(3)
`
`If the party, amicus or intervenor is a corporation:
`
`i)
`
`Identify all its parent corporations, if any; and
`
`N/A
`________________________________________________________________________________________________
`
`ii)
`
`list any publicly held company that owns 10% or more of the party’s, amicus’ or intervenor’s stock:
`
`N/A
`________________________________________________________________________________________________
`
`(4)
`
`Provide information required by FRAP 26.1(b) – Organizational Victims in Criminal Cases:
`
`N/A
`________________________________________________________________________________________________________
`
`(5)
`
`Provide Debtor information required by FRAP 26.1 (c) 1 & 2:
`
`N/A
`________________________________________________________________________________________________________
`
`10/14/2020
`/s/ David A. Balto
`Attorney’s Signature: ________________________________________ Date: ________________________________________
`
`David A. Balto
`Attorney’s Printed Name: __________________________________________________________________________________
`
`✔
`Please indicate if you are Counsel of Record for the above listed parties pursuant to Circuit Rule 3(d). Yes _____ No _____
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`8030 Ellingson, Drive, Chevy Chase, MD 20815
`Address: ______________________________________________________________________________________________
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`202-577-5424
`Phone Number: ________________________________________ Fax Number: ______________________________________
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`david.balto@dcantitrustlaw.com
`E-Mail Address: __________________________________________________________________________________________________
`rev. 12/19 AK
`
`

`

`Case: 20-2402 Document: 64 Filed: 10/14/2020 Pages: 20
`
`TABLE OF CONTENTS
`
`PAGE NO.
`
`TABLE OF
`CONTENTS…………………………………………………...................…..............…...…ii
`TABLE OF
`AUTHORITIES………………………………………………….................................…. iii
`INTEREST OF AMICI CURIAE....………….......................................................……1
`INTRODUCTION AND SUMMARY OF ARGUMENTS …………………….......... 3
`ARGUMENT………………………………………………….........…....…............…….…. 4
`I.
`The District Court’s Decision Will Harm Competition and Lead to
`Higher Prescription Drug Prices…….............………...................................4
`CONCLUSION…………………………………………………........................................12
`
`ii
`
`

`

`Case: 20-2402 Document: 64 Filed: 10/14/2020 Pages: 20
`
`TABLE OF AUTHORITIES
`
` PAGE NO.
`
`MISCELLANEOUS
`AbbVie Inc., 2019 Annual Report…………....................................................................4
`AAM 2019 Generic Biosimilars Access and Savings Report……......................……7, 8
`Biosimilars Council, Failure to Launch White Paper Part 1........................................8
`C. Scott Hemphill & Bhaven Sampat, Drug Patents at the Supreme Court, 339
`Science 1386, 1387 (2013) ……………………….........................................…......6
`Christopher Rowland, Why Humira’s Price Keeps Rising Despite FDA Approval of
`Generic Competition, Washington Post (2020) ………………….........................9
`Eric Sagonowsky, AbbVie Offers Up 80% Humira Discount in EU Tender Market to
`Hold Off Biosimilars, Oct. 31, 2018...................................................................10
`FTC, Pay for Delay: How Drug Company Pay-Offs Cost
`Consumers Billions (2010). .................................... ............................................5
`Gregg Girvan and Avik Roy, The Growing Power of Biotech Monopolies Threatens
`Affordable Care, Foundation for Research on Equal Opportunity (September
`15, 2020)…………………...............................................................................5, 7, 8
`IQVIA Institute Report, Biosimilars in the United States 2020-2024: Competition,
`Savings, and Sustainability (September 29, 2020). ……………...........…….…..8
`Mana Mishra, Humira Biosimilars Available at up to 80% Discount in Europe,
`Reuters, November 2018……………...................................……………….........10
`Overpatented, Overpriced: How Excessive Pharmaceutical Patenting is Extending
`Monopolies and Driving Up Drug Prices, I-Mak Report (2018) ……….......9, 10
`Robert H. Bork, The Antitrust Paradox (New York: Free Press,
`1978)..…………………...........................................................................................6
`Scripta Insights, The Latest on Drug Patent Scams, July
`2019.....................................................................................................................10
`Sy Mukherjee, Protect at All Costs: How the Maker of the World’s Bestselling Drug
`Keeps Prices Sky- High, Fortune, July 18, 2019………....….............……........9
`
`iii
`
`

`

`Case: 20-2402 Document: 64 Filed: 10/14/2020 Pages: 20
`
`INTEREST OF AMICI CURIAE
`Amici Curiae Consumer Action and U.S. Public Interest Research Group
`
`(“U.S. PIRG”) (collectively “Amici”) are leading advocates for competitive markets,
`
`which benefit all consumers by maintaining lower prices and promoting innovation
`
`and developing efficiencies.1 Amici are public interest groups and advocates for
`
`competitive health care markets. Amici are leading advocates for consumers and
`
`patients who seek lower prescription drug prices. Amici respectfully submit this
`
`brief in support of Plaintiff-Appellants UFCW Local 1500 Welfare Fund’s, et al.,
`
`appeal of the District Court’s dismissal of their antitrust litigation opposing AbbVie’
`
`Inc.’s (“AbbVie”) anticompetitive conduct that delayed the entry of biosimilar
`
`competition and resulted in U.S. consumers paying higher prices for AbbVie’s
`
`biologic drug, Humira.
`
`Consumer Action is a national not forprofit organization that has worked to
`
`advance consumer literacy and protect consumer rights in many areas for over forty
`
`years. The organization achieves its mission through several channels, from direct
`
`consumer education to issue-focused advocacy. Consumer Action is particularly
`
`concerned with ever-growing healthcare costs including rising costs within the
`
`pharmaceutical industry and has been an Amici in pay for delay cases.
`
`U.S. PIRG is a not for profit organization that advocates for the public
`
`interest, working to win concrete results on real problems that affect millions of
`
`1 No counsel for a party has authored this brief in whole or in part, and no party or
`party’s counsel, or any other person has contributed money that was intended to
`fund the preparation or submission of this brief. All parties have consented to the
`filing of this brief.
`
`1
`
`

`

`Case: 20-2402 Document: 64 Filed: 10/14/2020 Pages: 20
`
`lives, and standing up for the public against powerful interests when they push the
`
`other way. It employs grassroots organizing and direct advocacy for the public on
`
`many different issues including healthcare, preserving competition, and protecting
`
`consumer welfare. U.S. PIRG has been directly involved in prescription drug policy
`
`and has been an Amici in pay for delay cases.
`
`These leading consumer organizations have a long history of advocating for
`
`access to affordable health care and controlling prescription drug costs without
`
`compromising quality. Amici have a strong interest in preserving competition in
`
`prescription drug markets and in protecting the ability of consumers to challenge
`
`anticompetitive conduct. Amici submit this brief because the anticompetitive
`
`conduct at issue led to demonstrably higher prescription drug prices in the United
`
`States.
`
`Amici have a strong interest in protecting their members and the public from
`
`market manipulation that increases the cost of prescription medication. Amici are
`
`concerned about the rapidly increasing costs of prescription drugs caused by the
`
`anticompetitive conduct of drug manufacturers such as AbbVie and are concerned
`
`that the decision below will undermine the critical role of private class action
`
`lawsuits in combating anticompetitive practices and deterring future
`
`anticompetitive conduct. Amici’s participation in this case will assist this Court to
`
`understand the importance of biosimilar medication and the consumer harm that
`
`would result if the District Court’s ruling is affirmed. Amici urge this Court to
`
`2
`
`

`

`Case: 20-2402 Document: 64 Filed: 10/14/2020 Pages: 20
`
`reverse the District Court’s ruling; otherwise, Amici are concerned that the ruling
`
`will open the floodgates to increased market manipulation.
`
`INTRODUCTION AND SUMMARY OF ARGUMENT
`Amici are concerned at the growing number of anti-biosimilar strategies
`
`employed in the pharmaceutical industry that increase costs to consumers. Generic
`
`and biosimilar entry increases competition and greatly decreases the cost of
`
`prescription drug medication. Amici offer this brief because branded manufacturers
`
`engaging in anticompetitive tactics that delay the entry of biosimilars cost
`
`American payors and consumers billions of dollars. Reverse payment settlements
`
`and the creation of patent thickets are two of the most harmful forms of
`
`anticompetitive business behavior in today’s economy. The former occurs when a
`
`brand manufacturer provides compensation to biosimilars to delay them from
`
`entering the U.S. prescription drug market. The latter results from a brand
`
`manufacturer abusing the patent process to build a patent estate that extends
`
`exclusivity of its monopoly beyond what Congress intended to deter biosimilar
`
`competition in the United States. These anticompetitive tactics employed by brand
`
`manufacturers cause enormous harm, as they require consumers including payors,
`
`the federal government, U.S. taxpayers and patients to overpay by billions of dollars
`
`and deprive patients’ access to affordable medications that they need. Consumers
`
`will continue to lose if these tactics are allowed unabated.
`
`Amici submit this brief in support of Plaintiffs/Appellants in their appeal of a
`
`decision from the District Court that dismissed its class action litigation. The
`
`decision in this case is critical to the overall efforts to control healthcare costs in the
`
`3
`
`

`

`Case: 20-2402 Document: 64 Filed: 10/14/2020 Pages: 20
`
`United States. This Court should reverse the District Court’s decision. That
`
`decision if it is affirmed will likely result in increased prescription drug prices as
`
`pharmaceutical drug manufacturers will be emboldened to follow AbbVie’s lead and
`
`engage in similar anticompetitive tactics using their own patent thicket strategies
`
`along with pay for delay settlement agreements to keep biosimilars out of the U.S.
`
`market. If the District Court’s decision is not reversed, other brand manufacturers
`
`will imitate AbbVie and thwart the entry of biosimilars in the United States while
`
`allowing them to enter Europe sooner. This outcome will increase drug prices for
`
`patients, employers, and taxpayers in the United States as more affordable
`
`medicines will be delayed from entering the U.S. prescription drug market. For
`
`these reasons, Amici seek for this Court to reverse the District Court's decision and
`
`remand for further consideration.
`
`I.
`
`ARGUMENT
`The District Court’s Decision Will Harm Competition and Lead to
`Higher Prescription Drug Prices
`AbbVie is the brand manufacturer of the biologic drug, Humira, the number
`
`one selling drug in the world. Humira was introduced in 2002 and has generated
`
`billions in revenue. In 2018 alone, the drug generated over $19 billion in global
`
`sales.2
`
`Humira's continued commercial success is attributable to AbbVie's
`
`anticompetitive conduct in which it engaged in the strategic accumulation of
`
`patents that resulted in costly patent litigation and reverse payment settlements
`
`2 AbbVie Inc., 2019 Annual Report.
`
`4
`
`

`

`Case: 20-2402 Document: 64 Filed: 10/14/2020 Pages: 20
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`effectively blocking them from the U.S. market. This tactic enabled AbbVie to
`
`artificially extend the life of its Humira monopoly and to foreclose the U.S. market
`
`to biosimilar drugs which are more affordable to consumers and payors. Indeed, as
`
`the record shows, AbbVie openly discussed their strategy in investor presentations
`
`by indicating that engaging in these costly patent litigation disputes could delay
`
`biosimilars from the market for 4 to 5 years.3
`
`The reverse payment settlements regarding Humira resulted in significantly
`
`higher prescription drug prices for payors and patients in the United States. In
`
`general, reverse payment settlements that have kept generics out of the U.S.
`
`prescription drug market cost patients and taxpayers billions of dollars per year.4 A
`
`recent analysis estimates the cost of such settlements before Actavis to be over $60
`
`billion.5
`
`The District Court’s dismissal will only embolden other drug manufacturers
`
`to use the patent process, along with the courts and reverse settlement payments,
`
`as tools to delay the entry of rivals.6 The District Court’s decision incentivizes drug
`
`3 See Gregg Girvan and Avik Roy, The Growing Power of Biotech Monopolies
`Threatens Affordable Care, Foundation for Research on Equal Opportunity,
`available at: https://freopp.org/the-growing-power-of-biotech-monopolies-threatens-
`affordable-care-e75e36fa1529 (September 15, 2020).
`
`4 FTC, Pay for Delay: How Drug Company Pay-Offs Cost Consumers Billions (2010).
`
`5 Michael Kades, Competitive Edge: Underestimating the Cost of Underenforcing
`U.S. Antitrust Laws, Wash. Center for Equitable Growth (Dec. 13, 2019).
`
`6 Removing Obstacles to Generic Drug Competition, Center for American Progress,
`David Balto, June 23, 2009 at 20.
`
`5
`
`

`

`Case: 20-2402 Document: 64 Filed: 10/14/2020 Pages: 20
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`manufacturers not to innovate but rather to focus on tweaking their patent estates
`
`to extend the life of their monopolies and then suing rivals for alleged patent
`
`infringement and seeking reverse payments.7
`
`Indeed, one of the most effective ways for a brand manufacturer to maintain
`
`market power is through the abuse of government processes.8 The cost to the brand
`
`manufacturer engaging in such abuse typically is minimal, while the
`
`anticompetitive effects resulting from such abuse often are significant.9
`
`Approximately 40 years ago, then-Circuit Court Judge Robert Bork observed that
`
`“[p]redation by abuse of governmental procedures, including administrative and
`
`judicial processes, presents an increasingly dangerous threat to competition.”10
`
`Anticompetitive conduct through regulatory and judicial abuse can be especially
`
`pernicious. In a healthy market, when a company obtains a dominant position
`
`through competition in the marketplace, we can expect other competitors to arise
`
`and possibly displace them. But no natural competitive force can displace
`
`dominance acquired through abuse of the regulatory and judicial processes. That is
`
`especially the case in the pharmaceutical industry where litigation and regulatory
`
`approval are necessities to market entry.
`
`7 See C. Scott Hemphill & Bhaven Sampat, Drug Patents at the Supreme Court, 339
`Science 1386, 1387 (2013).
`
`8 Supra, note 5.
`
`9 Id.
`
`10 Robert H. Bork, The Antitrust Paradox (New York: Free Press, 1978).
`6
`
`

`

`Case: 20-2402 Document: 64 Filed: 10/14/2020 Pages: 20
`
`Here, AbbVie’s successful extension of its Humira monopoly along with the
`
`reverse settlements kept biosimilars out of the U.S. market in exchange for an early
`
`entry in Europe. If this strategy is found to be legal under the antitrust laws, it will
`
`have serious ramifications for the cost of prescription drugs going forward.
`
`Biologics such as AbbVie’s Humira are essential for the treatment of serious
`
`debilitating and life-threatening diseases. While fewer than 2% of all U.S.
`
`prescriptions are for biologic drugs, they account for almost 40% of all U.S. drug
`
`spending.11 In other words, biologics are extremely expensive, and they are the
`
`fastest-growing segment of drug spending in the United States.
`
`When Congress passed the Biologics Price Competition and Innovation Act
`
`ten years ago, the expectation was that a robust biosimilar market would
`
`substantially lower the price of biologic drugs. Indeed, there were estimates
`
`indicating that the cost savings to the U.S. healthcare system from the use of
`
`biosimilars could have been up to hundreds of billions of dollars over a decade.12
`
`One study suggests that there may be a significant uptick in the rate of biosimilar
`
`approvals over the next few years which have the potential to generate nearly $100
`
`11 AAM 2019 Generic Biosimilars Access and Savings Report at p. 4, available at:
`https://accessiblemeds.org/sites/default/files/2019-09/AAM-2019-Generic-
`Biosimilars-Access-and-Savings-US-Report-WEB.pdf.
`
`12 See Gregg Girvan and Avik Roy, The Growing Power of Biotech Monopolies
`Threatens Affordable Care, Foundation for Research on Equal Opportunity,
`available at: https://freopp.org/the-growing-power-of-biotech-monopolies-threatens-
`affordable-care-e75e36fa1529 (September 15, 2020).
`7
`
`

`

`Case: 20-2402 Document: 64 Filed: 10/14/2020 Pages: 20
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`billion in cost savings.13 However, a number of obstacles including anticompetitive
`
`patent thicket strategies and reverse settlement agreements have delayed and may
`
`in the future delay many biosimilars from entering and competing in the United
`
`States. Unfortunately, from 2010 to 2019, biosimilars have only saved U.S. patients
`
`about $1.8 billion.14 If Americans could have bought FDA-approved biosimilars
`
`over the past four years, they could have saved over $9 billion.15 Thus, patients’
`
`access to biosimilar drugs is critically important to lowering overall drug spending
`
`and costs to patients in the United States.
`
`Disputes between branded biologics and biosimilars will continue as patent
`
`thickets prevent biosimilar entry after the expiration of the original patents on a
`
`drug. A recent report analyzing the twelve best selling drugs in the United States
`
`13 See IQVIA Institute Report, Biosimilars in the United States 2020-2024:
`Competition, Savings, and Sustainability, available at:
`https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-
`states-2020-2024 (September 29, 2020).
`
`14 See Gregg Girvan and Avik Roy, The Growing Power of Biotech Monopolies
`Threatens Affordable Care, Foundation for Research on Equal Opportunity,
`available at: https://freopp.org/the-growing-power-of-biotech-monopolies-threatens-
`affordable-care-e75e36fa1529 (September 15, 2020)..
`
`15 AAM 2019 Generic Biosimilars Access and Savings Report, p. 16 available at:
`https://accessiblemeds.org/sites/default/files/2019-09/AAM-2019-Generic-
`Biosimilars-Access-and-Savings-US-Report-WEB.pdf; see also Biosimilars Council,
`Failure to Launch White Paper: Part 1, June 2019, available at:
`https://biosimilarscouncil.org/wp-content/uploads/2019/10/Failure-to-Launch-Part-
`1.pdf. The White Paper concludes that delayed launch of biosimilars due to patent
`thickets cost the U.S. health care system an astounding $7.6 billion in lost savings
`since 2015 and that other anticompetitive tactics by brand drug manufacturers,
`along with inadequate incentives for their use and insufficient information for
`patients have slowed biosimilars adoption, adding upwards of $2.2 billion in
`potential lost savings since 2015 to the $7.6 billion.
`
`8
`
`

`

`Case: 20-2402 Document: 64 Filed: 10/14/2020 Pages: 20
`
`revealed that pharmaceutical manufacturers of the brand drugs filed on average
`
`125 patent applications to extend their monopolies “far beyond the twenty years of
`
`protection intended under U.S. patent law” in an effort to preserve their monopoly
`
`pricing.16 As if to add insult to injury, drug manufacturers are also increasing
`
`prescription drug prices even as they extend the life of their monopolies.17 Make no
`
`mistake the District Court’s decision with respect to AbbVie’s conduct will have
`
`huge ramifications going forward.
`
`AbbVie is the most egregious violator of the patent thicket strategy that
`
`resulted in a reverse settlement and the harm caused to U.S. payors and consumers
`
`is clear. AbbVie’s economic incentive is to prolong the life of Humira, the world’s
`
`number one selling drug for as long as it can. Humira’s list price in the Unite

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