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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
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`COALITION FOR AFFORDABLE DRUGS VIII, LLC
`Petitioner,
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`v.
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`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
`Patent Owner
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`______________
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`Case: IPR2015-01836
`Patent No. 7,932,268
`______________
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`PATENT OWNER PRELIMINARY RESPONSE
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`TABLE OF CONTENTS
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`I.
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`INTRODUCTION ......................................................................................... 1
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`II. BACKGROUND FACTS .............................................................................. 4
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`A. Hypercholesterolemia and Hyperlipidemia ............................................... 4
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`B. Treatment of Hypercholesterolemia and Hyperlipidemia ......................... 5
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`C. The Development of Lomitapide ............................................................... 6
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`1. BMS Abandons Lomitapide ............................................................. 6
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`2. The Rader Study ............................................................................... 7
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`3. U.S. Provisional Application No. 60/550,915 ................................. 9
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`4. Prosecution of U.S. Appl. No. 10/591,923 and Issuance of
`the ʼ268 Patent ............................................................................ 9
`5. Juxtapid®. ........................................................................................ 11
`III. THE BOARD SHOULD DENY CFAD’S PETITION AS
`STATUTORILY DEFICIENT FOR FAILURE TO IDENTIFY
`ALL REAL PARTIES IN INTEREST ...................................................... 11
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`IV. THE BOARD SHOULD NOT INSTITUTE IPR BECAUSE
`CFAD HAS NOT CARRIED ITS BURDEN OF
`DEMONSTRATING A LIKELIHOOD THAT THE ʼ268
`PATENT CLAIMS ARE UNPATENTABLE .......................................... 13
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`A. The Provisional Application Fully Supports the ’268 Patent
`Claims, and Thus CFAD’s Stein 2004 and Pink Sheet 2004
`References Qualify as Prior Art (if At All) Under Only 35 U.S.C. §
`102(a) ............................................................................................................. 14
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`B. Neither the Stein Presentation Nor the Stein Slides Qualify As
`Prior Art Under Either 35 U.S.C. §§ 102(a) or 102(b) .................................. 20
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`1. The Stein Presentation Is Not a “Printed Publication” and is
`Thus Not Prior Art ............................................................................... 21
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`2. The Stein Slides Are Not a “Printed Publication” ......................... 28
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`C. To the Extent Stein 2004 and Pink Sheet 2004 Qualify As Prior
`Art Under Only 35 U.S.C. § 102(a), They Are Not Prior Art Because
`They Published After Dr. Rader’s Invention ................................................. 34
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`D. Ground 1 is Deficient Because the Combination of Pink Sheet
`2004 and Chang is Redundant of the Art Relied on in Ground 2, and
`Nevertheless Fails to Render the Claims Obvious ........................................ 35
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`1. Ground 1 (Pink Sheet 2004 plus Chang) Should be Rejected
`Because it Adds Nothing Over Ground 2 (Stein plus Chang) ............ 35
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`2. Pink Sheet 2004 and Chang Do Not Render the Claims
`Unpatentable ........................................................................................ 37
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`a. The References Fail to Teach or Suggest Both
`the Claimed Method of Step-Wise Administration
`of Increasing Doses of Lomitapide and the Specific
`Claimed Dosage Ranges……………….………………….….37
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`b. CFAD Fails to Articulate a Motivation to Substitute
`Lomitapide for Implitapide in Dr. Stein's Protocol…………. 39
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`c. CFAD Fails to Articulate a Reasonable Expectation
`of Success of Arriving at the Claimed Subject
`Matter…………………………………………………………42
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`E. Ground 2 is Deficient Because the Combination of Stein 2004 and
`Chang Fails to Render the Claims Obvious .................................................. 46
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`F. Secondary Considerations Support the Patentability of the ’268
`Patent Claims ................................................................................................. 50
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`1. Unexpected Results Support the Patentability of the ’268
`Patent’s Claims .................................................................................... 50
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`2. Commercial Success Supports the Patentability of the ’268
`Patent……… ....................................................................................... 51
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`3. The Claimed Invention Met a Long-Felt, Unmet Need ................. 53
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`V.
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`IF IPR IS INSTITUTED, IT SHOULD NOT BE INSTITUTED
`FOR ALL CLAIMS ..................................................................................... 54
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`VI. CONCLUSION ............................................................................................ 55 
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`TABLE OF AUTHORITIES
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`Cases
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` Page(s)
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`Allergan, Inc. v. Sandoz Inc.,
`796 F.3d 1293 (Fed. Cir. 2015) .......................................................................... 50
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`Air Liquide Large Indus. U.S. LP v. Praxair Tech., Inc.,
`IPR2015-01074 (P.T.A.B.) ................................................................................. 24
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`Atlanta Gas Light Co. v. Bennett Regulator Guards, Inc,
`IPR2013-00453 (P.T.A.B.) ................................................................................. 13
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`Bayer AG v. Carlsbad Tech., Inc.,
`2001 WL 34125673 (S.D. Cal. Oct. 24, 2001) ................................................... 40
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`Coalition for Affordable Drugs (ADROCA) v. Acorda Therapeutics,
`Inc., IPR2015-00720 (P.T.A.B.) ......................................................................... 12
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`Coalition for Affordable Drugs (ADROCA) v. Acorda Therapeutics,
`Inc., IPR2015-00817 (P.T.A.B.) ................................................................... 23, 28
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`Coalition for Affordable Drugs VI LLC v. Biogen MA Inc.,
`IPR2015-01993 (P.T.A.B.) ................................................................................. 12
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`Coalition for Affordable Drugs VI LLC v. Celgene Corp.,
`IPR2015-01169 (P.T.A.B.) ................................................................................. 12
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`Coalition for Affordable Drugs III LLC v. Jazz Pharmaceuticals, Inc.,
`IPR2015-01018 (P.T.A.B.) ..................................................................... 12, 20, 33
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`Coalition for Affordable Drugs IV LLC v. Pharmacyclics, Inc.,
`IPR2015-01076 (P.T.A.B.) ........................................................................... 12, 22
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`Corning Inc. v. DSM IP Assets B.V.,
` IPR2013-00053 (P.T.A.B.) ................................................................................ 14
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`Illumina, Inc. v. Trustees of Columbia Univ.,
`IPR2012-00006 (P.T.A.B.) ................................................................................. 35
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`In re Cronyn,
`890 F.2d 1158 (Fed. Cir. 1989) .......................................................................... 29
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`In re Hall,
`781 F.2d 897 (Fed. Cir. 1986) ..................................................................... .31, 32
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`In re Klopfenstein,
`380 F.3d 1345 (Fed. Cir. 2004) ...................................................................passim
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`In re McLaughlin,
`443 F.2d 1392 (C.C.P.A. 1971) .......................................................................... 52
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`Liberty Mut. Ins. Co. v. Progressive Casualty Ins. Co.,
`CBM2012-00003 (P.T.A.B.) ........................................................................ 35, 36
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`Mass. Inst. of Tech. v. Harman Int’l Indus.,
`584 F. Supp. 2d 297 (D. Mass. 2008) ................................................................. 20
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`Phigenix, Inc. v. Immunogen, Inc.,
`IPR2014-00676 (P.T.A.B.) ................................................................................. 53
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`Procter & Gamble Co. v. Teva Pharms. USA, Inc.,
`566 F.3d 989 (Fed. Cir. 2009) ............................................................................ 54
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`SRI Int’l Inc. v. Internet Sec. Sys., Inc. et al.,
`511 F.3d 1186 (Fed. Cir. 2008) .................................................................... 22, 30
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`Star Sci., Inc. v. R.J. Reynolds Tobacco Co.,
`655 F.3d 1364 (Fed. Cir. 2011) .................................................................... 15, 19
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`Syntex (U.S.A.) LLC v. Apotex Inc.,
`No. C 01-02214 MJJ, 2006 WL 1530101 (N.D. Cal. June 2, 2006) .................. 53
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`ZOLL Lifecor Corp. v. Philips Elec. N. Am. Corp.,
`Case IPR2013-00606 (P.T.A.B.) ............................................................ 11, 12, 13
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`Statutes
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`35 U.S.C. § 102 ........................................................................................................ 21
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`35 U.S.C. §§ 102(a) ..........................................................................................passim
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`35 U.S.C. § 102(b) ............................................................................................passim
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`35 U.S.C. § 103(a) ................................................................................................... 50
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`35 U.S.C. § 112 .................................................................................................. 15, 19
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`35 U.S.C. § 312(a)(2) ........................................................................................... 3, 11
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`35 U.S.C. § 312(a)(3) ............................................................................................... 54
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`Other Authorities
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`37 C.F.R. § 42.106(b) .............................................................................................. 13
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`37 C.F.R. § 1.131 ..................................................................................................... 34
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`37 C.F.R. § 42.22(a)(2) ............................................................................................ 50
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`PATENT OWNER’S LIST OF EXHIBITS
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`Ex. 2001
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`Ex. 2002
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`Ex. 2003
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`Ex. 2004
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`Ex. 2005
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`Ex. 2006
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`Ex. 2007
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`Ex. 2008
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`Ex. 2009
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`Ex. 2010
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`University of Pennsylvania Patent License Agreement (May 19,
`2006)
`NDA #203858, Sponsor’s Background Package For the
`Endocrinologic and Metabolic Drugs Advisory Committee
`Meeting, Advisory Committee Briefing Materials (Oct. 17, 2012)
`ClinicalTrials.gov: Safety, Tolerability, and Efficacy of
`Microsomal Triglyceride Protein (MTP) Inhibitor, available at
`https://clinicaltrials.gov/ct2/show/NCT01556906?term=NCT0155
`6906&rank=1
`Marina Cuchel et al., Inhibition of Microsomal Triglyceride
`Transfer Protein in Familial Hypercholesterolemia, 356 (2) N.
`ENG. J. MED. 148-56 (Jan. 11, 2007).
`U.S. Appl. No. 14/075,483, Amendment and Response to Final
`Office Action (Nov. 30, 2015)
`FDA News Release, FDA approves new orphan drug for rare
`cholesterol disorder, available at
`http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncement
`s/ucm333285.htm (Dec. 26, 2012)
`Marina Cuchel et al., Efficacy and safety of a microsomal
`triglyceride transfer protein inhibitor in patients with homozygous
`familial hypercholesterolemia: a single-arm, open-label, phase 3
`study, 381 THE LANCET 40-46 (Jan. 5, 2013)
`Joseph Walker et al., New Hedge Fund Strategy: Dispute the
`Patent, Short the Stock, THE WALL STREET JOURNAL (Apr. 7,
`2015), available at
`http://www.wsj.com/articles/hedgefundmanagerkylebasschallenge
`sjazzpharmaceuticalspatent1428417408
` Intentionally Left Blank
`Patentee’s Observations in reply to the Notice of Opposition by
`Dr. Evan Stein, European Patent No. 1 725 234
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`Ex. 2011
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`Ex. 2012
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`Ex. 2013
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`Ex. 2014
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`Ex. 2015
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`Ex. 2016
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`The Pink Sheet, MTP inhibitor research discontinued (July 31,
`2000)
`Aegerion Pharmaceuticals, Inc., U.S. Securities and Exchange
`Commission, Form 10-K (March 2, 2015)
`Aegerion Pharmaceuticals, Inc., U.S. Securities and Exchange
`Commission, Form 10-K (March 18, 2013)
`Aegerion Pharmaceuticals, Inc., Third Quarter 2015 Earnings
`Conference Call, available at
`http://files.shareholder.com/downloads/AEGR/0x0x860375/8F9C
`1576-D084-454D-BBCF-
`C656C341E238/AEGR_Q3_15_Slides_Final.pdf (Nov. 9, 2015)
`JUXTAPID label (2012)
`Center For Drug Evaluation And Research, Application Number
`203858Orig1s00, Summary Basis for Regulatory Action (Dec. 21,
`2012)
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`I.
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`INTRODUCTION
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`IPR2015-01836
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`Petitioner Coalition for Affordable Drugs VIII, LLC (“CFAD”) has not
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`shown a reasonable likelihood of demonstrating that at least one claim of U.S.
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`Patent 7,932,268 (“the ’268 Patent”) is unpatentable, and its petition should
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`therefore be denied.
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`The ’268 Patent claims a method of treating high levels of fats
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`(hyperlipidemia) and cholesterol (hypercholesterolemia) in the blood through the
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`step-wise administration of increasing doses of lomitapide, an inhibitor of
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`“microsomal triglyceride transfer protein” (“MTP”). This invention helped to
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`solve a problem regarding the safety and tolerability of lomitapide that had stymied
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`others in the pharmaceutical industry.
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`Starting in the late 1990’s, Bristol-Myers Squibb (“BMS”) was developing
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`compounds in the MTP inhibitor class, including BMS-201038 (lomitapide), for
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`treating hyperlipidemia and hypercholesterolemia. Ex. 1001 at 5:47-49. BMS
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`discontinued development of lomitapide when clinical trials with fixed doses of the
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`drug revealed liver and gastrointestinal adverse effects that limited the drug’s
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`usefulness for treating patients with hyperlipidemia. Ex. 1001 at 6:20-25; Ex. 2002
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`at 34. It subsequently donated rights to the drug to the University of Pennsylvania.
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`Ex. 2001 at 1.
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`Dr. Daniel Rader, a professor at the Perelman School of Medicine at the
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`University of Pennsylvania, and the inventor of the ’268 Patent, began pursuing
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`clinical development of lomitapide using a different approach. Whereas BMS had
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`attempted to develop a fixed dose of the drug, Dr. Rader sought to reduce the side
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`effects that had led to BMS discontinuing development of lomitapide by starting
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`with a low dose of the drug and using a step-wise administration of increasing
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`doses. Dr. Rader discovered that in many patients this administration regimen
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`surprisingly reduced the incidence and intensity of side effects that had impacted
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`the tolerability of the drug, while still allowing effective treatment of patients’
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`hyperlipidemia. Ex. 1010 at 2-3, ¶¶ 9-14; Ex. 1001 at 13:30-62.
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`The ’268 Patent claims embody Dr. Rader’s discovery that hyperlipidemia
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`and hypercholesterolemia can be treated through administration of lomitapide in
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`increasing step-wise dosages, wherein each dose level is administered for a number
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`of weeks. See e.g., Ex. 1001, claim 1. Dr. Rader’s discovery is particularly
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`significant to patients who suffer from homozygous familial hypercholesterolemia
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`(“HoFH”), a condition characterized by extremely high cholesterol levels, which
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`was generally not effectively treated with the therapeutic agents that were known
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`in the art.
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`CFAD’s Petition, which attempts to undermine Dr. Rader’s invention, is
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`deficient in a number of different ways. First, CFAD has failed to identify all of
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`the real parties in interest to this proceeding, as required by 35 U.S.C. § 312. 35
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`U.S.C. § 312(a)(2). CFAD’s other IPR petitions identify real parties in interest that
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`have not been identified here.
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`Second, CFAD relies on three purported prior art references, but fails to
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`meet its burden to prove that two of them—Stein 2004 and the Pink Sheet 2004—
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`are prior art under 35 U.S.C. §§ 102(a) or 102(b). CFAD does not present proof
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`that these references were publicly available prior to the priority date.
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`Third, CFAD’s references relate to a different drug, implitapide, and to a
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`study which sought to establish a fixed dose of that drug. None of the prior art
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`relied on by CFAD teaches or suggests a step-wise escalating dose treatment
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`regimen with lomitapide.
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`Because CFAD has failed to meet its burden of proving that a person of skill
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`would have been motivated by the prior art to develop the step-wise, escalating
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`dose regimen claimed in the ’268 Patent, and that they would have had a
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`reasonable expectation of success in doing so, the Board should deny CFAD’s
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`petition.
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`II. BACKGROUND FACTS
`A. Hypercholesterolemia and Hyperlipidemia
`Hypercholesterolemia, a condition characterized by very high levels of
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`cholesterol in the blood, is a well-known risk factor for atherosclerotic
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`cardiovascular disease (“ASCVD”), the major cause of mortality in the Western
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`world. Ex. 1001 at 1:23-24. Patients with ASCVD experience a build-up of
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`plaque inside their arteries, making it difficult for the arteries to carry oxygen-rich
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`blood to the heart, brain, and other parts of the body. It is well understood that
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`lowering total cholesterol (“TC”) and low-density lipoprotein (“LDL”) cholesterol
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`(“LDL-C”) is associated with a significant reduction in clinical cardiovascular
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`events. Ex. 1001 at 1:25-29.
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`Hypercholesterolemia is a form of hyperlipidemia, a condition in which
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`elevated levels of lipids are detected in blood. Triglycerides are one type of fat
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`(lipid) found in the blood. Although triglycerides store unused calories and
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`provide the body with energy, higher-than-normal triglyceride levels are often
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`associated with known risk factors for heart disease. Ex. 1001 at 1:48-51.
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`Elevated triglyceride levels may also contribute to thickening of artery walls, a
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`physical change that is believed to be a predictor of atherosclerosis. Id. at 1:51-53.
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`Treatment of Hypercholesterolemia and Hyperlipidemia
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`B.
`At the time of the invention, a number of drug treatments were available for
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`lowering serum cholesterol and triglycerides. The most well-known class of
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`agents was (and perhaps still is) statins. Ex. 1001 at 2:22-24; 30-31. Other well-
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`known treatments included niacin and fibric acid derivatives (“fibrates”). Id. at
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`2:49-51; 58-62.
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`However, prior to the invention of the ’268 Patent, treatment in patients with
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`a severe form of familial hypercholesterolemia known as homozygous familial
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`hypercholesterolemia (“HoFH”) was challenging because LDL levels remained
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`extremely elevated despite aggressive use of known combination therapy. Ex.
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`1001 at 1:32-37; 4:24-29. HoFH is a rare genetic condition in which the LDL
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`receptors are minimally (if at all) functional. Ex. 2002 at 11-12. Conventional
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`lipid-lowering therapies such as statins were generally not effective in HoFH
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`patients, because statins require a functioning LDL receptor to work. Id. at 13, 29.
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`Patients with HoFH develop early and severe ASCVD due to elevated LDL-C
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`levels, which may lead to early cardiac-related death. Id. at 12. Effective medical
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`therapy was therefore urgently needed for this group of high-risk patients.
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`Accordingly, although a number of treatments were available to the general
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`population for lowering serum cholesterol and triglycerides, “each [had] its own
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`drawbacks and limitations in terms of efficacy, side-effects and qualifying patient
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`population.” Ex. 1001 at 2:3-6. And in terms of the high-risk HoFH patients, there
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`was an extremely limited range of treatment options that were considered both safe
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`and efficacious. Id. at 3:55-57. Accordingly, there was a need in this field for
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`therapeutics which did not suffer from the limitations of the then-existing drug
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`treatments for hypercholesterolemia and hyperlipidemia.
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`C. The Development of Lomitapide
`In June 1996, BMS submitted an Investigational New Drug Application
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`(“IND”) for BMS-201038 (lomitapide), which is an MTP inhibitor. Ex. 2002 at
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`34. MTP is a protein responsible for shuttling lipid molecules between
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`membranes, as well as assembling lipoproteins that contain apolipoprotein B
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`(“apo-B”). It is thought that MTP mediates triglyceride absorption from the
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`intestine and lipoprotein secretions from the liver by linking lipids to apo-B.
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`Accordingly, inhibition of MTP typically leads to decreases in circulating levels of
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`apo-B-containing lipoproteins, including LDL-C. Ex. 2002 at 14.
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`BMS Abandons Lomitapide
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`1.
` The BMS development program included clinical studies designed to
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`assess the safety, pharmacokinetics, and pharmacodynamics of lomitapide as a
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`monotherapy at fixed doses in subjects with hypercholesterolemia. Ex. 2002 at 34.
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`Although substantial dose-related decreases in serum lipid parameters were
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`observed, the clinical trials revealed severe, dose-limiting adverse events. These
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`adverse events, occurring at fixed doses ranging from 25 mg/day to 100 mg/day,
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`included gastrointestinal events (e.g., diarrhea) and aminotransferase elevations (an
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`indicator of liver damage, most likely related to the known MTP side effect of
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`increased hepatic fat) that led to a high rate of treatment discontinuations. Ex.
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`1001 at 6:20-25; Ex. 2001 at 30, ¶ B. Ultimately, BMS abandoned the
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`development of lomitapide in 2000 due to the drug’s side effects. Ex. 2002 at 34.
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`The Rader Study
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`2.
`Specifically citing the “significant and serious hepatotoxicities in the
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`dosages used” in the BMS development program, and noting that lomitapide
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`“could not be developed as a pharmaceutical product of general or wide utility[,]”
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`in 2003 BMS transferred the IND for BMS-201038 to the University of
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`Pennsylvania. Exhibit 2001 at 30, ¶ B. Prior to this time, Dr. Daniel Rader, a
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`professor at the Perelman School of Medicine at the University of Pennsylvania,
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`began advancing the idea of the clinical development of lomitapide as a treatment
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`for HoFH, and requested the transfer of the IND from BMS.
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`At least as early as June 2003, Dr. Rader and his colleague, Dr. Marina
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`Cuchel, initiated a Phase II study designed to evaluate the efficacy and safety of
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`lomitapide in the treatment of subjects with HoFH (Clinical Trial Identifier
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`NCT01556906 (“the Rader Study”)). See Ex. 2002 at 34-35; Ex. 2003 at 2-3. This
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`was the first study to evaluate the administration of an MTP inhibitor using a dose-
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`titration strategy of step-wise, increasing dose levels in an attempt to improve
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`tolerability and render the drug useful for treating patients. Dr. Rader and his team
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`employed a dosing regimen of administering lomitapide at a low dose (0.03 mg/kg)
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`and progressively escalating to higher doses every 4 weeks (0.1 mg/kg, 0.3 mg/kg,
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`and 1.0 mg/kg, respectively). Ex. 2002 at 35; see also Ex. 2004 at 3-4.
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`The Rader Study showed a substantially improved tolerability profile and
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`significant lipid-lowering effects when lomitapide was administered using this
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`dose-titration strategy. Ex. 2004 at 8 (“. . . [W]e devised a dose-titration strategy
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`that might allow the intestine to accommodate the increasing inhibition of [MTP].
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`Under these conditions, all six patients tolerated the drug up to the highest dose . . .
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`with relatively minor gastrointestinal side effects.”); id. at 7-8 (“Plasma levels of
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`all other apolipoprotein B-containing lipoproteins were similarly reduced by
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`inhibition of the microsomal triglyceride transfer protein”). The study concluded
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`prior to February 4, 2004. Ex. 2005 at 8.
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`U.S. Provisional Application No. 60/550,915
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`3.
`On March 5, 2004, after the Rader Study was completed, Dr. Rader filed
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`U.S. Provisional Patent Appl. No. 60/550,915 with the United States Patent and
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`Trademark Office. This application, entitled “Methods For Treating
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`Hyperlipidemia And Hypercholesterolemia While Minimizing Side-Effects,”
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`disclosed and claimed a method of treating hyperlipidemia and
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`hypercholesterolemia by administering an effective amount of an MTP inhibitor
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`such as lomitapide in a series of escalating doses. See, e.g., Ex. 1006 at 31.
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`Subsequently, on March 7, 2005, Dr. Rader filed PCT/US2005/007435. A
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`national stage entry application, U.S. Appl. No. 10/591,923 (“the ’923
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`Application”), was filed on September 5, 2006. The ’923 Application issued as the
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`’268 Patent on April 26, 2011. On March 11, 2011, while the ’923 Application
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`was pending, Dr. Rader filed U.S. Pat. Appl. No. 13/046,118 (“the ’118
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`Application”) as a continuation application. The ’118 Application, which
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`eventually issued as U.S. Pat. No. 8,618,135, is also being challenged by the
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`Petitioner in a parallel proceeding (IPR2015-01835).
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`4.
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`Prosecution of U.S. Appl. No. 10/591,923 and Issuance of
`the ʼ268 Patent
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`The arguments advanced during prosecution of the ʼ923 Application
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`overcame rejections by Examiner under 35 U.S.C. §§ 102(b) and 103(a) based on
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`references that did not suggest how to overcome the difficulty inherent in
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`effectively dosing MTP inhibitors while minimizing side effects. Ex. 1009 at 6-7
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`(noting that the cited prior art failed to recognize that constant, high doses of MTP
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`inhibitor would cause GI-related disorders and increase hepatic fat). The
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`Applicant established that the cited prior art did not teach either a specific dosing
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`regimen with a step-wise increase in doses as set forth in the claims, or that a step-
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`wise dosing of an MTP inhibitor such as lomitapide would reduce adverse effects
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`while maintaining efficacy compared to a corresponding constant dosing level. Id.
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`at 7-8.
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`During prosecution the Applicant submitted the declaration of Dr. William
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`Sasiela, Ph.D. (“the Sasiela Declaration”), who was then Executive Vice President
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`and Chief Medical Officer of licensee Aegerion Pharmaceuticals, Inc.
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`(“Aegerion”). Dr. Sasiela explained the severity of side effects associated with
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`lomitapide and the fact that BMS had discontinued its study of the compound. Ex.
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`1010 at 1, ¶¶ 5, 7. The Sasiela Declaration reviewed data from the lomitapide
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`clinical trials, and described the dramatic decrease in adverse effects in patients
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`who received a treatment regimen of step-wise, increasing dose levels versus
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`patients who received a fixed dose of lomitapide. Ex. 1010 at 3, ¶ 14.
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`After a rigorous substantive examination, the ’268 Patent issued on April 26,
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`2011.
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`5.
`Juxtapid®
`In 2006, Aegerion and the Trustees of the University of Pennsylvania
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`entered into a license agreement for lomitapide under which Aegerion obtained
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`exclusive worldwide rights to lomitapide for the treatment of HoFH and certain
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`other therapeutic areas. Based on the favorable results of the Rader Study,
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`additional clinical studies were carried out,1 culminating in Aegerion’s submission
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`of a New Drug Application for Juxtapid® (lomitapide) to the FDA. The FDA
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`approved Juxtapid® in December 2012, as an adjunct to a low-fat diet and other
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`lipid-lowering therapies for the treatment of adult patients with HoFH. Ex. 2006.
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`III. THE BOARD SHOULD DENY CFAD’S PETITION AS
`STATUTORILY DEFICIENT FOR FAILURE TO IDENTIFY ALL
`REAL PARTIES IN INTEREST
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`An IPR petition “may be considered only if . . . the petition identifies all real
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`parties in interest.” 35 U.S.C. § 312(a)(2). This statutory requirement is a
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`“threshold issue.” ZOLL Lifecor Corp. v. Philips Elec. N. Am. Corp., Case
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`IPR2013-00606, Paper 13 at 8 (P.T.A.B. Mar. 20, 2014). A real party in interest is
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`a party that “desires review” of the patent, and “may be the petitioner itself, and/or
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`1 See, e.g., Ex. 2002 at 35-36; Ex. 2007.
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`it may be the party or parties at whose behest the petition has been filed.” Id. at 9.
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`CFAD’s petition here fails to meet this basic, threshold requirement.
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`The Board is very familiar with the petitioner here. CFAD has filed
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`numerous petitions requesting inter partes review of pharmaceutical patents. See,
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`e.g., IPR2015-00720 (Coalition for Affordable Drugs (ADROCA) LLC v. Acorda
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`Therapeutics, Inc.); IPR2015-01018 (Coalition for Affordable Drugs III LLC v.
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`Jazz Pharmaceuticals, Inc.); IPR2015-01076 (Coalition for Affordable Drugs IV
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`LLC et al. v. Pharmacyclics, Inc.); IPR2015-01169 (Coalition for Affordable
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`Drugs VI LLC et al. v. Celgene Corp.). As has been widely reported, CFAD is a
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`petitioner for high net worth investors who profit by bringing IPRs. Ex. 2008.
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`In its Petition, CFAD lists nine real parties in interest. CFAD, however, has
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`not named IP Navigation Group, LLC (“IP Nav”) and nXn Partners, LLC
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`(“nXnP”) as real parties in interest. Pet. at 1-2. These two firms are listed as real
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`parties in interest in a number of other CFAD petitions. See, e.g., Coalition for
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`Affordable Drugs (ADROCA) LLC v. Acorda Therapeutics, Inc., IPR2015-00720,
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`Paper 1 at 1-2 (naming IP Nav and nXnP as real parties in interest); Coalition for
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`Affordable Drugs III LLC v. Jazz Pharmaceuticals, Inc., IPR2015-01018, Paper 1
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`at 2-3 (same); Coalition for Affordable Drugs V LLC et al. v. Biogen MA Inc.,
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`IPR2015-01993, Paper 1 at 1-2 (same).
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`Patent Owner has no ability to determine, in CFAD’s intricate web of
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`subsidiary organizations, whether these two firms are real parties in interest to the
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`present matter. However, the fact that they appear as real parties in interest in
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`numerous petitions brought by CFAD, but are absent here, strongly suggests that
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`CFAD has failed to meet its burden to properly name the real parties in interest to
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`this case. Atlanta Gas Light Co. v. Bennett Regulator Guards, Inc., IPR2013-
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`00453, Paper 91 at 7 (P.T.A.B. Feb. 23, 2015) (“. . . [A]s evidenced by the
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`statutory requirement, the burden of persuasion or proof that the petitioner has
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`named all real parties-in-interest remains with the petitioner.”) (emphasis in
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`original). If the Board finds that CFAD has indeed failed to name all real parties in
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`interest, Patent Owner requests that the Board dismiss the petition as “incomplete.”
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`37 C.F.R. 42.106(b); ZOLL Lifecor Corp., Case IPR2013-00606, Paper 13 at 16.
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`IV. THE BOARD SHOULD NOT INSTITUTE IPR BECAUSE CFAD HAS
`NOT CARRIED ITS BURDEN OF DEMONSTRATING A
`LIKELIHOOD THAT THE ʼ268 PATENT CLAIMS ARE
`UNPATENTABLE
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`CFAD advances two obviousness grounds. In Ground 1, CFAD argues that
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`claims 1-10 are obvious over the Pink Sheet 2004 in view of Chang. In Ground 2,
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`CFAD argues that claims 1-10 are obvious over the Stein Presentation or the Stein
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`Slides (which CFAD collectively calls “Stein 2004”) in view of Chang.
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`Throughout an inter partes review, “the burden of persuasion to prove
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`unpatentability of the challenged claims remains with the petitioner.” Corning Inc.
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`v. DSM IP Assets B.V., IPR2013-00053, Paper 66 at 6-7 (P.T.A.B. May 1, 2014).
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`CFAD has failed to carry its burden of demonstrating that the alleged prior
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`art renders the claims of the ’268 Patent obvious. Patent Owner therefore
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`respectfully requests that the Board deny CFAD’s Petition for failing to show a
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`reasonable likelihood of success in proving that the claims of the ʼ268 Patent are
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`unpatentable.
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`A. The Provisional Appli