IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________________
`
`COALITION FOR AFFORDABLE DRUGS VIII, LLC
`Petitioner
`v.
`TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
`Patent Owner, based on Electronic Records of PTO
`U.S. Patent No. 7,932,268 B2 to Rader
`Filing Date: March 7, 2005
`Issue Date: April 26, 2011
`TITLE: METHODS FOR TREATING DISORDERS OR DISEASES ASSOCIATED
`WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE
`MINIMIZING SIDE EFFECTS
`________________________________
`
`Inter Partes Review Trial No. TBD
`________________________________
`
`Declaration of Jeffery A. Marx in Support of
`Coalition for Affordable Drugs’ Petition for
`Inter Partes Review of U.S. Patent No. 7,932,268 B2
`
`

`
`Declaration of Jeffery A. Marx
`Petition for Inter Partes Review of U.S. Patent No. 7,932,268 B2
`
`I, Jeffery A. Marx, declare as follows:
`
`1.
`
`I am a partner with the law firm of Rakoczy Molino Mazzochi Siwik
`
`LLP, counsel for Petitioner Coalition for Affordable Drugs VIII (“Coalition”) in
`
`this matter.
`
`2.
`
`I am a practicing attorney and am a member in good standing of the
`
`Bars of the State of Illinois (2005) and the State of Wisconsin (2005), as well as
`
`the following courts: United States Court of Appeals for the Federal Circuit (2012),
`
`United States District Court for the Northern District of Illinois (2005) and United
`
`States District Court for the Western District of Wisconsin (2008). I am also
`
`admitted to practice before US PTO (Registration No. 56,977).
`
`3.
`
`I submit this Declaration in support of Coalition’s Petition for Inter
`
`Partes Review of U.S. Patent No. 7,932,268 B2, and, in particular, to authenticate
`
`and provide to the U.S.P.T.O. certain facts and exhibits cited and referenced in
`
`Coalition’s Petition. I understand that my declaration will be included in
`
`Petitioner’s Exhibit List as CFAD Ex. 1034.
`
`4.
`
`I have personal knowledge of the facts stated in this Declaration and,
`
`if called to testify, I could and would testify competently to the matters stated
`
`herein.
`
`5.
`
`Attached hereto as Exhibit A is a true and correct copy of a page from
`
`the website www.goodrx.com as it appeared on July 6, 2015 showing the monthly
`
`
`
`1
`
`

`
`Declaration of Jeffery A. Marx
`Petition for Inter Partes Review of U.S. Patent No. 7,932,268 B2
`
`price of Juxtapid 5mg, 10 mg, 20 mg, 30 mg, 40 mg, and 60 mg dosage strengths.
`
`This information can be found at http://www.goodrx.com/juxtapid. This exhibit is
`
`included in Petitioner’s Exhibit List as CFAD Ex. 1024.
`
`6.
`
`Attached hereto as Exhibit B is a true and correct copy of CNBC
`
`article “‘Fast Money’ faux pas: Firm draws FDA warning, DOJ subpoena” which
`
`discusses the pricing of Juxtapid as it appeared on July 9, 2015. This article can be
`
`found at http://www.cnbc.com/2014/01/13/fast-money-faux-pas-aegerion-draws-
`
`fda-warning-doj-subpoena.html. This exhibit is included in Petitioner’s Exhibit
`
`List as CFAD Ex. 1025.
`
`7.
`
`Attached hereto as Exhibit C is a true and correct copy of a Cigna
`
`press release as it was available on July 24, 2015. The press release, dated
`
`November 7, 2003, states that Cigna management is scheduled to appear at the
`
`CIBC World Markets’ 14th Annual Healthcare Conference held on November 11,
`
`2003.
`
`The
`
`press
`
`release
`
`can
`
`be
`
`found
`
`online
`
`at
`
`http://newsroom.cigna.com/article_display.cfm?article_id=236. This exhibit
`
`is
`
`included in Petitioner’s Exhibit List as CFAD Ex. 1035.
`
`8.
`
`Attached hereto as Exhibit D is a true and correct copy of a Gilead
`
`Sciences, Inc. press release as it was available on July 24, 2015. The press release,
`
`dated March 4, 2004, states that Gilead Sciences, Inc. will be making a corporate
`
`presentation from the 7th Annual Lehman Brothers Global Healthcare Conference
`
`
`
`2
`
`

`
`Declaration of Jeffery A. Marx
`Declaration of Jeffery A. Marx
`Petition for Inter Partes Review of U.S. Patent No. 7,932,268 B2
`Petition for Inter Partes Review of U.S. Patent No. 7,93 2,268 B2
`
`on March
`on March
`
`5. The
`5.
`The
`
`press
`press
`
`release
`release
`
`can
`can
`
`be
`be
`
`found
`found
`
`online
`online
`
`at
`at
`
`http:/ /investors. gilead.com/phoenix.zhtml ?c=69964&p=irol-
`http://inVestors.gilead.com/phoenix.zhtml‘?c=69964&p=irol-
`
`newsArticle Print&ID=501785 . This exhibit is included in Petitioner's Exhibit
`newsArticle_Print&]D=501785. This exhibit
`is included in Petitioner’s Exhibit
`
`List as CFAD Ex. 1036.
`List as CFAD Ex. 1036.
`
`9.
`
`9.
`
`Attached hereto as Exhibit E is a true and correct copy of a Dot Hill
`Attached hereto as Exhibit E is a true and correct copy of a Dot Hill
`
`Systems Corp. press release cataloged on PR Newswire as it was available on July
`Systems Corp. press release cataloged on PR Newswire as it was available on July
`
`24, 2015. The press release, dated May 4, states that Dot Hill’s president and CEO
`24, 2015. The press release, dated May 4, states that Dot Hill's president and CEO
`
`will be presenting at the Robert W. Baird 2004 Growth Stock Conference being
`will be presenting at the Robert W. Baird 2004 Growth Stock Conference being
`
`held on May
`6,
`2004. The press
`held on May 6, 2004. The press
`
`release
`can
`be
`release can be
`
`found
`online
`at
`found online at
`
`http://wwwprnewswire.com/news-releases/dot-hill—to-present-at-robert—w—baird-
`http://www.prnewswire.com/news-releases/dot-hill-to-present-at-robert-w-baird-
`
`is
`is
`
`included
`included
`
`in
`in
`
`2004-growth-stocleconference-73777807.html. This
`exhibit
`2004-growth-stock-conference-73777807.html. This exhibit
`Petitioner’s Exhibit List as CFAD Ex. 1037.
`Petitioner's Exhibit List as CF AD Ex. 1 03 7.
`10.
`I hereby declare that all statements made herein are true and correct;
`10.
`I hereby declare that all statements made herein are true and correct;
`and further that these statements were made With the knowledge that willful false
`and further that these statements were made with the knowledge that willful false
`statements and the like so made are punishable by fine or imprisonment, or both,
`statements and the like so made are punishable by fine or imprisonment, or both,
`under Section 1001 of Title 18 of the United States Code.
`under Section 1001 of Title 18 of the United States Code.
`RESPECTFULLY SUBMITTED,
`RESPECTFULLY SUBMITTED,
`féf
`/effery A. Marx
`
`Date: Aug \Q-; z_g~s-59;’
`
`3
`
`

`
`Exhibit A
`
`Exhibit A
`
`
`
`

`
`Goodfl<
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`<1. s,,.,,n Drug Prkes
`
`Hov. 0t,Oflf~x Wnrks
`
`Mohi!e App
`
`OtSCOUIII Ldrd
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`r.tme ..
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`Help
`
`R~grsler or Srgn In •
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`Award-winning
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`
`Juxtapid (lomitapide) ~rTP inhibilo"
`Juxtapid lloinitapiclel
`l'»|‘l’Pliilii!.i'ita'.r-.
`LDMITAPI DE is used in corritiiiiriliori with allot and other iiiedicines to lower blood cholesterol levels in patients with El genetic ttisoroortlial iosults in
`LOMITAPIDE is used 111 cornbma11on Willi diet and other mL'<llcines to lower blood cholesleml levels 1n pulienls with a genetic disorder lhal results in
`high blood izholostaml levels.
`high blood choleslerol levels.
`
`arr till . in nu».
`
`LaIes1Newsi1i
`Images
`5JuxtapioPrii:es W?IlllSJUl<l«3fl|J"
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`Juxtapid Prices Vo/hattS Jmnnpld? Side Effeds
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`Prices and coupons for 30 capsules of Juxtapid 5mg (brand)
`Prices and coupons for 30 capsules of Juxtapid 5mg (brand)
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`Specialty medication
`Specialty medication
`Thisdmg is considered a specially-medication, which means:
`This drug is considered a specially medication, which means·
`-
`it is very expensive. A typicl fill can cost $3.1.5T6 or rnorelor 30 capsules of Juxtapid 5mg.
`It Is very expensive. A lypical fill can cost $31 ,576 or more ·ror 30 capsules of Juxtapid 5mg.
`< Ealtems in need ollhis drug will usually find rnootol the cost paid by an insurance COn'|pEl1y;
`govornmanl-or non prol”il.organlzatiori. If you are uninsured or need help with your i:o-piay,.the
`Pat1enls 1n need of this drug will usually find most of lhe cost paid by an 1nsurance company,
`rnamifacttirer may also ofier asslstantge. Learn more »
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`governrnenl or non profit organization. If you are uninsured or need help with your co-pay, lhe
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`• Mosl relail pharmacies will not stock this medrcation. The manufacturer may offer more
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`Learn mom about specialty modicatioris,
`information on how to fill th1s prescription. Learn more •
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`
`• 5mg
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`CFAD Ex. 1024 (1 of 12)
`
`CFAD Ex. 1024 (1 of 12)
`
`

`
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`
`CFAD Ex. 1024 (2 of 12)
`
`CFAD Ex. 1024 {2 of 12)
`
`

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`Juxtapid (lomitapide) . nr tutubttarr.
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`Prices and coupons for 30 capsules of Juxiapid 10mg (brand)
`Prices and coupons for 30 capsules of Juxtapid 10mg (brand)
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`•
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`«.a- Juxtapld ilsrsnni
`• Ju><tapld (bland)
`'_ Farm
`Form
`v Dosage
`A:
`firrlg
`• Dosage
`
`v 5mg
`‘*5 mm!
`U Znmg
`• · 10mg
`t • 20mg
`mg
`‘--“ WW9
`0 30mg
`. , gun-.9
`0 40mg
`v Quantity
`t} 60mg
`..
`.
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`rm ‘ an _;apgulgg~'
`• Quantity
`
`• 30
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`capsules·
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`Add My Medicare Plan
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`~(§§D—
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`- @>(cid:173)
`&
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`DRIVE IT
`+ SALES EVENT—
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`-
`
`SALES EVENT- -
`
`Oown
`Paymt:nt
`
`First Month's
`Payment
`
`Specialty medication
`Specialty medication
`This drug is considered a specialty medication, which means?
`This drug is considered e spectalty medication, which means:
`-
`It to vary expena£ve.A typical till canrzost $3Z.fl9u or more for flflimpsules ot..IuxlP|d 101119.
`It Is very expensive. A lyptcal flit can cost $32,890 or more for 30 capsules of Juxlapld 10mg.
`- Patients In need at this drug will usually find most of the cost paldby an insurance company.
`govemrnontar non profit organization. It you are uninsured ornaacl help with -your copay. the
`Patients 111 need of I his drug will usually find most of the cost paid by an tnsuranc~ company,
`manufacturer may also ‘altar assistance. Learn more :-
`government or non profit organization. If you are uninsured or need help with your co-pay, the
`_
`_
`_
`manufacturer may also offer assistance. Learn more •
`- Most retail pharmacies will not stuck this medication The manufacturer may offer more
`Most retail pharmacies 1vill not stock ihis medtcation. The manufacturer may offer more
`information on howto fill lhisprewcnpiion. Learn more in
`Learn more about suacietty medications.
`information on how to fill this prescription. Leom more •
`Learn more about specialty moo1Coti0ns.
`
`C Kmart
`\.’1n\N itmu :l[':lFnl-.
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`Target
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`Rite-Aid
`Va::w'.t10feU13tdll"'
`Viva-x slczna detail,
`
`531,575.50
`$31,575.50
`with fl-99 mupnn
`with free coupon
`$31,575.50
`Wm-I flea coupon
`S3 1 ,575.50
`with free coupon
`
`mm fmetoupnn
`531 ,668.40
`with free coupon
`331,711.30
`with tree discount
`S31 1711.80
`with free discount
`$31,711.80
`with tree discount
`531,711.80
`.
`with free discount
`$32,888.70
`....,........,,.,,,
`532,888.70
`with free coupon
`$32,889.50
`with free coupon
`532,889.50
`$33,275 .60
`with free coupon
`Wllh tree discount
`
`533,275.60
`$33,472 .80
`wtlll Ilea discount
`with free Coupon
`
`$33,472.80
`533,661.46
`with free coupon
`with free cuupun
`
`533,661.46
`$33,357.14
`w1th Ires coupon
`with free wupgn
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`833,857.14
`Rite-Aid
`‘ can‘! find your local pharmacy?
`V1ev1 st...~re detotb
`wtth free coupon
`GoudRx adheres to quality standards establishad by a nationally-recognized
`prolossional organization that works to ensure the pubtic health and patient safety
`As such. GoodRir only displays ilie mamas rid locations oi pharmacies that have
`Can't find your local pharmacy?
`been approved by this organization.
`GoodRx adheres lo quality standards established by a nationally-recognized
`However. we can provide you with this coupon to pay 534,045.56 ~ 534,822.27 at
`professional organization lhot works to ensure lhe public health and patient setely
`most independent phonnacie-5'naar you.
`As sucll. GoodRx only dtsptsys lhe names and tocat1ons of pharmacies lhal have
`been approved by this organization.
`
`D Get Free Coupon
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`However, we con provida you w1th thiS coupon to pay <34.045.56 . ' 34.822.27 at
`most independent pharmacies near you.
`
`CFAD Ex. 1024 (3 of 12)
`
`CFAD Ex. 1024 (3 of 12)
`
`

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`in us, The pncna we xnnw am nuriseslez-.1hmam;whita we uarlava uur dale In he ganarally aacumte. Ma cannnlguamnlau mm the mine wu display wm easily
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`owners and fights Imlders and are used solely‘ la tc|HB'senl mu pmduds r.\Im-.-5er1g-hlsslnmcers Tm Inimnulwl is TI.1fiN()i'lTlilL7O[!a| pm poses only am: I:- not mean! to De: auuslntursfor
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`GFAD Ex. 1024 (4 of 12)
`
`CFAD Ex. 1024 (4 of 12)
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`Juxtapid (lomitapide) M Pl"'"b11o"
`Juxta (lornétaoidei
`F»l'lF‘ lliilttillol-u
`LOMITAPIDE is used in combination wrih that and minor ntadicinos to loweir hlood cholesterol levels in patients with a genetic disorder that results in
`LOMITAPIDE is 11sed in combination wrtll diG( and other med1crnos to lowor blood choioslerot levels in patients with a genetic drsordor that results in
`high blood cholesterol levels.
`high blood chOlesterol levels.
`
`i Jrmapld Prices ‘ Wnalls Jlimapltl?
`Si-:levEtraL1s
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`Juxtapld Prices Wllalts Juxtapld? Si·j e Errects
`tma9es Latest News (1)
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`Prices and coupons for 30 capsules of Juxtapid 20mg (brand)
`Prices and coupons for 30 capsules of Juxtapid 20mg {brand)
`5’ Get drug prices near you
`w.
`9 Get drug prices near you
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`;~, ~ f:J11t1r vour ~ttl rod!:'
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`COi1\|,'.|3l"t‘_‘5iT!lt|al"Dl‘U95
`Comp~re Sirnl:tr Drugs
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`1
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`c Share ~ !~e to My Presoripllons
`ca snare? =1 v sa;;._;it;ri;;t;g,t.:m;i
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`Specialty medication
`Specialty medication
`This drug is considered l-LI specially medication‘ which means:
`Tilts drug 1s considered a specialty medic alton, which means:
`- it is very axpamlva. A typical fiil can cost $33 .560 or more for 30 capsules otéultlapid 20mg.
`• It Is very expensive. A lypicol fill can cost $33,680 or more for 30 capsules of Juxtapid 20mg.
`- Faliants in [god of this Fiilis will usually find must of the cost paidhy an insurance company.
`govarnrnent or nonprofit organization liyou are uninsured or naarl help with your co-pay, the
`Patients In need of this drug will usually find most of the cost paid by an insurance company,
`manuiacturerrnay also oiferassistnce. Learn more I:
`government or non profit organization. If you are uninsured or need help with your co-pay, lhe
`manufacturer may also offer assistance. learn more •
`- Most ralail pharmacies will not stuck this medication. The manufacturer may oiiar mora
`information on how to fill this prescription. Learn more >1
`• Most retail pharmacies Will not stock thts medication. The manufacturer may offer more
`informotton on 11ow to filii his prescnption. Learn more •
`Loam more about specialty medications.
`Learn more about specialty medications
`
`Capsule
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`.3: Jumpll! ibrancl)
`•• Juxtapld (brand)
`v Form
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`• Form
`v Dosage
`• Dosage
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`· ~ 5mg
`-=-W119
`t > 10mg
`la‘ mm
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`'7‘ “mitt
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`' J 60mg
`V Gummy
`‘ll ; so Ycapsulas
`• Quantity
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`30 capsules
`Ad“ MY MEUKBT9 9'5"
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`$33,275.36
`$33,275.36
`with flag dismuni
`with free discount
`$33,275.35
`with [I-ea dis,-_-aunt
`$33,275.36
`wiU1 free discount
`$33l,66'D.2‘l
`with he mupen
`$33,660.21
`with free coupon
`$33,661.45
`with free goupgn
`$33,661.46
`with free coupon
`$33,661.46
`with free mung"
`$33,661.46
`with free coupon
`$33,661.46
`_
`mm {[93 mum"
`533,661.46
`with free coupon
`$33,661.46
`_
`_
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`$33,661.46
`with free discount
`$33,661 .46
`wm-.1.-ea mupgn
`$33,661.46
`with free coupon
`$33,651 .46
`with iree cpupnn
`$33,661 .46
`$33,857.14
`with free coupon
`with {reg coupon
`
`$33,857.14
`$34,050.06
`with free coupon
`with [[99 cuupgn
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`$34,050.06
`CVS Pharmacy
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`V1~w ~tore detmt"
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`t3oodR‘;: adheres to quality standards established bya nationally-recognized
`professional organization that works to ensure the public health and patiant safety.
`A Can't find your local pharmacy?
`As such. Goodfix only displays the namas and locations of pharrrlocles that hava
`been approved by this organization.
`GoodRx adheres to quality standards established by a nationally-recognized
`However, we can proyttie you with this coupon to pay $34,045 56 - 534,822 27 at
`prolessional organizatton that works to ensure the publtc health and patient safety.
`most independent pharmacies near you.
`As such, GoodRx only dtsplays the names ond locations of pllannoctos tllat have
`Deen approved by this organtzation.
`0 .’\.'I<IlJ|
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`However, we can provrde you willt tilts coupon to pay >34,045 SB - • 34,822 27 nt
`most independent pharmacies oeor you.
`
`0 Get Free DIScount
`
`0 Get Free Otscount
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`0 Get Fre