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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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`MYLAN PHARMACEUTICALS INC., and PFIZER INC.,
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`Petitioners,
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`v.
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`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`_____________________________
`
`IPR2018-01670: Patent 8,679,069
`IPR2018-01678: Patent 8,992,486
`IPR2018-01680: Patent 9,526,844
`IPR2018-01682: Patent 9,526,844
`IPR2018-01684: Patent 9,604,008
`IPR2019-00122: Patent 8,992,486
`_____________________________
`
`
`DECLARATION OF DEFOREST MCDUFF, PH.D.
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`Declaration of DeForest McDuff
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`Mylan Ex.1060
`Mylan v. Sanofi - IPR2018-01676
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`I, DeForest McDuff, Ph.D., declare as follows:
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`I.
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`Introduction
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` Qualifications
`A.
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`1.
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`I am a Partner at Insight Economics and an expert in applied business
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`economics with more than ten years of experience in consulting, finance, and
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`economic research. I provide expert witness testimony and consulting in a variety
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`of areas, including lost profits, reasonable royalties, unjust enrichment, commercial
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`success, irreparable harm, finance, statistics, valuation, and business optimization.
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`2. My expertise and experience span a variety of topics, including intellectual
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`property, competition, business, antitrust, finance, labor, employment, and class
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`action. My work spans the life sciences (including pharmaceuticals,
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`biotechnology, diagnostics, and medical devices), electronics (including consumer
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`electronics, semiconductors, computers, and telecommunications), and has
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`included projects on a diverse range of other industries.
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`3.
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`I have significant experience evaluating the economics of the
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`pharmaceuticals industry. I have provided expert analysis and consulting in over
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`50 cases involving pharmaceuticals and related products, including evaluations of
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`economic damages, competition, commercial success, irreparable harm, and other
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`issues. I have evaluated a number of pharmaceutical product launches, both in a
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`litigation setting and an advisory role, and have published articles and taught
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`continuing legal education on pharmaceutical topics as well.
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`4.
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`I earned my Ph.D. in economics from Princeton University. At Princeton, I
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`received a National Science Foundation Graduate Research Fellowship for
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`academic research studying financial economics and applied microeconomics. I
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`have published research in several peer-reviewed academic journals. I graduated
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`summa cum laude with undergraduate degrees in economics and mathematics from
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`the University of Maryland. My curriculum vitae, provided as Attachment A-1,
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`contains more details on my background, education, experience, and expert
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`testimony.
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` Scope of Work
`B.
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`5.
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`In connection with my work on this matter, Insight Economics has been
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`retained by Wilson Sonsini Goodrich & Rosati on behalf of Mylan
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`Pharmaceuticals Inc. (“Mylan”) and by Winston & Strawn on behalf of Pfizer Inc.
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`(“Pfizer”). Insight Economics is being compensated at a rate of $700 per hour for
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`my work and at lower rates for time spent by others on my team. The
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`compensation of Insight Economics is not dependent on the substance of my
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`testimony or the outcome of this matter.
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`6.
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`For this declaration, I was asked to review and respond to the Declaration of
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`Henry G. Grabowski, Ph.D. In Support of Patent Owner’s Response to Petition for
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`Declaration of DeForest McDuff
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`Mylan Ex.1060
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`Inter Partes Review of U.S. Patent No. 8,679,069 (“’069 Declaration”),
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`Declaration of Henry G. Grabowski, Ph.D. In Support of Patent Owner’s Response
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`to Petition for Inter Partes Review of U.S. Patent 8,992,486 (“’486 Declaration”),
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`Declaration of Henry G. Grabowski, Ph.D. In Support of Patent Owner’s Response
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`to Petition for Inter Partes Review of U.S. Patent 9,526,844 (“’844 Declaration”),
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`and Declaration of Henry G. Grabowski, Ph.D. In Support of Patent Owner’s
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`Response to Petition for Inter Partes Review of U.S. Patent 9,604,008 (“’008
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`Declaration”) (collectively, “Grabowski Declarations”), submitted in June 2019 in
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`their respective IPR cases: the ’069 Declaration submitted in IPR2018-01670, the
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`’486 Declaration submitted in IPR2018-01678 and IPR2019-00122, the ’844
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`Declaration submitted in IPR2018-01680 and IPR2018-01682, and the ’008
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`Declaration submitted in IPR2018-01684.1 The Grabowski Declarations pertain to
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`the alleged commercial success of Lantus SoloStar sold by Sanofi-Aventis
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`Deutschland GmbH (“Sanofi”) and the alleged nexus to U.S. Patent Nos.
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`8,679,069 (Ex 1001), 8,992,486 (Ex 1003), 9,526,844 (Ex 1004), and 9,604,008
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`(Ex 1005). The Grabowski Declarations are substantively identical except they
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`1
`I understand that Dr. Grabowski submitted “corrected” declarations in July
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`2019, which I have focused on for the purposes of this declaration.
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`each reference a different one of the four patents.2 This declaration addresses all of
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`the Grabowski Declarations collectively for their respective IPR cases. This
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`declaration is a statement of my current opinions in this matter and the basis and
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`reasons for these opinions, which are subject to change based upon additional
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`information, analysis, and/or opinions of other experts.
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` Sources
`C.
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`7.
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`In analyzing the Grabowski Declarations and the alleged commercial
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`success of Lantus SoloStar, I have evaluated the Grabowski Declarations and
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`documents cited therein, the Declaration of Dr. William C. Biggs in Support of
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`Mylan-Pfizer Reply (the “Biggs Declaration”),3 as well as the documents cited
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`throughout my declaration and Attachments. A list of the documents I have relied
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`upon are contained in Attachment A-2.
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`II. Background
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` Patents-at-issue
`A.
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`8.
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`I understand that the following patents (collectively, “the patents-at-issue”)
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`are at issue in their corresponding IPR proceedings (as noted above, I have been
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`2
`Ex 1055: Henry Grabowski, Dep. Tr., 9/5/2019, at 72:3-7.
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`3
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`Ex 1048: Expert Declaration of William Curtis Biggs, M.D., FACE, ECNU
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`in Support of Mylan-Pfizer Reply.
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`asked to respond to Dr. Grabowski’s opinions, which are limited to only the ’069
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`patent, ’486 patent, ’844 patent, and ’008 patent):
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` 8,679,069 (“the ’069 patent”)
` 8,992,486 (“the ’486 patent”)
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`IPR2018-01670
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`IPR2018-01678
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`IPR2019-00122
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` 9,526,844 (“the ’844 patent”)
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`IPR2018-01680
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` 9,604,008 (“the ’008 patent”)
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`IPR2018-01684
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`IPR2018-01682
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`The ’069 patent was filed on November 11, 2010 and issued on March 25,
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`9.
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`2014;4 the ’486 patent was filed on June 4, 2013 and issued on March 31, 2015;5
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`the ’844 patent was filed on May 17, 2016 and issued on December 27, 2016;6 and
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`the ’008 patent was filed on June 30, 2014 and issued on March 28, 2017.7 I
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`understand that claim 1 of the ’069 patent,8 claims 1-6, 12-18, 20, 23, 26-30, 32-
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`4
`Ex 1001: ’069 patent.
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`5
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`6
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`7
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`8
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`Ex 1003: ’486 patent.
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`Ex 1004: ’844 patent.
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`Ex 1005: ’008 patent.
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`Petition for Inter Partes Review for Patent No. 8,679,069, Case IPR2018-
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`01670, at 1.
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`33, 36, 38-40 of the ’486 patent,9 claims 21-30 of the ’844 patent,10 and claims 1,
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`3, 7-8, 11, and 17 of the ’008 patent are at issue in these IPR proceedings.11 The
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`’069 patent, and ’486 patent are titled “Pen-Type Injector” and share the following
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`abstract:
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`A housing for a dispensing apparatus. The housing comprising a main
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`housing and a dose dial sleeve. The dose dial sleeve comprising a helical
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`groove configured to engage a threading provided by the housing. A dose
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`knob is disposed near a proximal end of the dose dial sleeve and a piston rod
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`is provided within the housing. The piston rod is non-rotatable during a dose
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`setting step. A driver comprises an internal threading near a distal portion of
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`the driver and is adapted to engage an external thread of the piston rod. A
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`9
`Petition for Inter Partes Review for Patent No. 8,992,486, Case IPR2018-
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`10678, at 1;
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`Petition for Inter Partes Review for Patent No. 8,992,486, Case IPR2019-
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`00122, at 1.
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`10
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`Petition for Inter Partes Review for Patent No. 9,526,844, Case IPR2018-
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`01680, at 1;
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`Petition for Inter Partes Review for Patent No. 9,526,844, Case IPR2018-
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`01682, at 1.
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`11
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`Petition for Inter Partes Review for Patent No. 9,604,008, Case IPR2018-
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`01684, at 1.
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`tubular clutch is located adjacent a distal end of the dose knob and operatively
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`coupled to the dose knob. The dose dial sleeve may extend circumferentially
`around at least a portion of the tubular clutch.12
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`10. The ’844 patent is also titled “Pen-Type Injector” and has the following
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`abstract:
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`The present invention relates to injectors, such as pen-type injectors, that
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`provide for administration of medicinal products from a multidose-cartridge
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`and permit a user to set the delivery dose. The injector may include a housing,
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`a piston rod adapted to operate through the housing, a dose dial sleeve
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`located between the housing and the piston rod, and a drive sleeve located
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`between the dose dial sleeve and the piston rod. The dose dial sleeve may have
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`a helical thread of first lead and the drive sleeve may have a helical groove
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`of second lead. The first lead of the helical thread and the second lead of the
`helical groove may be the same.13
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`11. The ’008 patent is titled “Drive Mechanisms Suitable For Use In Drug
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`Delivery Devices” and has the following abstract:
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`A drive mechanism suitable for use in drug delivery devices is disclosed. The
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`drive mechanism may be used with injector-type drug delivery devices, such
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`as those permitting a user to set the delivery dose. The drive mechanism may
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`12
`Ex 1001: ’069 patent
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`Ex 1003: ’486 patent.
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`13
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`Ex 1004: ’844 patent.
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`include a housing, a dose dial sleeve, and a drive sleeve. A clutch is
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`configured to permit rotation of the drive sleeve and the dose dial sleeve with
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`respect to the housing when the dose dial sleeve and drive sleeve are coupled
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`through the clutch. Conversely, when the dose dial sleeve and drive sleeve are
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`in a de-coupled state, rotation of the dose dial sleeve with respect to the
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`housing is permitted and rotation of the drive sleeve with respect to the
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`housing is prevented. In the de-coupled state, axial movement of the drive
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`sleeve transfers force in a longitudinal direction for actuation of a drug
`delivery device.14
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` Diabetes
`B.
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`12. The Centers for Disease Control and Prevention (“CDC”) describes diabetes
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`as a chronic disease that affects how the human body turns food into energy.15
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`Specifically, food that is broken down into sugars (glucose) and released into the
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`bloodstream is utilized by the body’s cells as energy.16 Insulin is a hormone
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`14
`Ex 1005: ’008 patent.
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`15
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`Ex 1073: CDC, About Diabetes,
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`https://www.cdc.gov/diabetes/basics/diabetes.html (accessed 7/18/2019).
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`16
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`Ex 1073: CDC, About Diabetes,
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`https://www.cdc.gov/diabetes/basics/diabetes.html (accessed 7/18/2019).
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`produced by the pancreas that allows the blood sugar into the body’s cells.17
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`Diabetes is a condition in which the body either fails to produce enough insulin or
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`cannot use the insulin it makes as effectively as it should.18 Excess blood sugar
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`that accumulates and stays in the bloodstream over time can cause health problems,
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`including heart disease, vision loss, and kidney disease.19
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`13. Approximately 30.3 million adults in the U.S. have diabetes, which is the
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`seventh leading cause of death in the U.S. and the number one cause of kidney
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`failure, lower-limb amputations, and adult onset of blindness.20 There are three
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`main types of diabetes: type 1 (an autoimmune reaction that prevents the body
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`from making insulin), type 2 (the body becomes less efficient at using insulin to
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`17
`Ex 1073: CDC, About Diabetes,
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`https://www.cdc.gov/diabetes/basics/diabetes.html (accessed 7/18/2019).
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`18
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`Ex 1073: CDC, About Diabetes,
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`https://www.cdc.gov/diabetes/basics/diabetes.html (accessed 7/18/2019).
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`19
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`Ex 1073: CDC, About Diabetes,
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`https://www.cdc.gov/diabetes/basics/diabetes.html (accessed 7/18/2019).
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`20
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`Ex 1073: CDC, About Diabetes,
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`https://www.cdc.gov/diabetes/basics/diabetes.html (accessed 7/18/2019).
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`maintain normal blood sugar levels), and gestational diabetes (occurs during
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`pregnancy but usually disappears after childbirth).21
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` Treatment
`C.
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`14. There are several forms of treatment for diabetes, including the following
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`drug classes: Insulins, Glitazones, Sulfonylureas, Thyroid Drugs, and Other Oral
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`Agents.22 The most prevalent treatment class is insulin therapy, which can be
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`administered either through a subcutaneous injection or inhalation.23 Within the
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`injectable insulin group, there are five subclasses of treatments based on the length
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`of time it takes insulin to reach the bloodstream and begin to lower the body’s
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`blood sugar levels (“onset”), the time when the insulin maximizes its ability to
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`lower blood sugar (“peak”), and the length of time insulin continues to work within
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`the body (“duration”): Rapid Acting; Short-Acting; Intermediate-Acting; Long-
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`21
`Ex 1073: CDC, About Diabetes,
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`https://www.cdc.gov/diabetes/basics/diabetes.html (accessed 7/18/2019).
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`22
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`Ex 1087: SG Cowen, Pharmaceutical Therapeutic Categories Outlook, 2001-
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`10, at 137.
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`23
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`Ex 1087: SG Cowen, Pharmaceutical Therapeutic Categories Outlook, 2001-
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`10, at 137.
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`Acting; and Pre-Mixed (a mix of intermediate- and short-acting insulin).24 I
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`understand that there is a general lack of generic competition for insulin treatments
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`and that prices for insulin have “skyrocketed” in the last several decades.25 Indeed,
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`a study presented at the American Diabetes Association concluded that “the cost of
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`insulin results in nearly 25 percent of patients not taking insulin as they should”
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`(i.e., the patients are “self-rationing”).26 I understand that Lantus is a long-acting
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`24
`Ex 1094: WebMD, “Types of Insulin for Diabetes Treatment,”
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`https://www.webmd.com/diabetes/diabetes-types-insulin#1 (accessed
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`7/18/2019).
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`25
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`Ex 1090: U.S. News and World Report, “Insulin Costs are Skyrocketing.
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`This is Why.,” https://health.usnews.com/health-care/for-
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`better/articles/2018-06-29/whats-behind-the-rising-costs-of-insulin (accessed
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`7/18/2019).
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`26
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`Ex 1090: U.S. News and World Report, “Insulin Costs are Skyrocketing.
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`This is Why.,” https://health.usnews.com/health-care/for-
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`better/articles/2018-06-29/whats-behind-the-rising-costs-of-insulin (accessed
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`7/18/2019).
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`injectable insulin drug product, and is used to treat adults with type 2 diabetes and
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`pediatric patients with type 1 diabetes.27
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`III. Analysis of Commercial Success
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` Overview
`A.
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`15. The commercial success of a product that embodies a claimed invention of a
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`patent is a secondary consideration that may be set forth by a patent owner to argue
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`the claim is not obvious. I have been informed that commercial success may be
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`relevant to the determination of a patent’s obviousness based on the presumption
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`that an idea could have been brought to market sooner, in response to market
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`forces, had it been obvious to persons skilled in the art. I have been further
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`informed that evidence of commercial success may be relevant to obviousness if
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`there is a nexus between the alleged commercial success and the patentable
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`features of the asserted claims.
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`16. For this declaration, I was asked to review the Grabowski Declarations that
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`have been put forth by Sanofi in support of commercial success of Lantus SoloStar
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`27
`Ex 1081: Lantus Webpage, “Get to Know the Lantus SoloSTAR Insulin
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`Pen,” https://www.lantus.com/get-to-know-the-lantus-solostar-pen (accessed
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`7/19/2019).
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`as a secondary consideration in the current matters.28 Upon review, I find that the
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`Grabowski Declarations have not demonstrated the commercial success of Lantus
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`SoloStar nor have they shown a nexus to the claimed inventions, based upon the
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`following factors: (1) the Grabowski Declarations provide a limited and
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`incomplete analysis of Lantus SoloStar’s market performance, (Section III.B
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`below); (2) the Grabowski Declarations do not establish a nexus to the patents-at-
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`issue (Section III.C); (3) blocking patents reduce the relevance of the commercial
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`performance of Lantus SoloStar (Section III.D); (4) Dr. Grabowski has established
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`no nexus between the claims and non-SoloStar products (Section III.E); (5) Dr.
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`Grabowski provides an incomplete analysis of other SoloStar products (Section
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`III.F). For reasons discussed in Sections III.C on demand factors for Lantus
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`SoloStar, Section III.D on blocking patents, and other reasons described below, I
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`have concluded that no such nexus to the claimed inventions exists.
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` The Grabowski Declarations provide a limited and incomplete
`B.
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`analysis of Lantus SoloStar’s market performance
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`17. The Grabowski Declarations claim to show the commercial success of the
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`Lantus SoloStar product based upon the assertions that: (1) Lantus SoloStar’s sales
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`28
`Ex 2109: Grabowski Declarations, 6/22/2019.
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`“substantially outperformed” sales of Lantus OptiClik;29 (2) Lantus SoloStar “was
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`a driver of the commercial success of the Lantus Franchise as a whole;”30
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`(3) Lantus SoloStar’s market shares have shown “strong performance” among
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`insulin pen products;31 (4) the development of “follow-on products” such as the
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`Basaglar KwikPen and Mylan’s biologic pen device;32 and (5) Lantus SoloStar has
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`had “strong formulary placement.”33 However, the Grabowski Declarations’
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`analysis of Lantus SoloStar’s market performance is limited and incomplete,
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`including: (1) no benchmarks for evaluating success; (2) no evaluation of costs or
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`profits; (3) limiting to “pens only” is a faulty market definition; and (4) formulary
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`status does not separately demonstrate commercial success. These factors are
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`evaluated in the sections that follow.
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`29
`Ex 2109: Grabowski Declarations, 6/22/2019, ¶¶ 35-37.
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`30
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`31
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`32
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`33
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`Ex 2109: Grabowski Declarations, 6/22/2019, ¶ 34.
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`Ex 2109: Grabowski Declarations, 6/22/2019, ¶¶ 43-44.
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`Ex 2109: Grabowski Declarations, 6/22/2019, ¶ 38.
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`Ex 2109: Grabowski Declarations, 6/22/2019, ¶¶ 39-42;
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`Ex 2192: Formulary Placement: Medicare Plans;
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`Ex 2191: Formulary Placement: Commercial Plans.
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`(1) No benchmarks for evaluating success
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`18. The Grabowski Declarations provide very little guidance for what
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`constitutes a commercially successful pharmaceutical product, and provide
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`essentially no relevant benchmarks for concluding whether Lantus SoloStar has
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`been successful.
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`19. Dr. Grabowski reports only: (a) calculated values and growth rates for
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`Lantus SoloStar sales and prescriptions,34 (b) Lantus SoloStar’s share of the
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`“Lantus franchise,”35 (c) a comparison of Lantus SoloStar sales and prescriptions
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`to Lantus OptiClik,36 and (d) a summary of sales for two Lantus SoloStar “follow-
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`on products.”37 In doing so, Dr. Grabowski tabulates the sales figures yet fails to
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`provide meaningful comparisons from which to conclude whether or not they are
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`commercially successful.
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`20. For example, Dr. Grabowski reports the supposed growth rate for Lantus
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`SoloStar to be “8,526 percent.”38 However, reporting growth rates from product
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`34
`Ex 2109: Grabowski Declarations, 6/22/2019, ¶¶ 32-33.
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`35
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`36
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`37
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`38
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`Ex 2109: Grabowski Declarations, 6/22/2019, ¶ 34.
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`Ex 2109: Grabowski Declarations, 6/22/2019, ¶¶ 35-37.
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`Ex 2109: Grabowski Declarations, 6/22/2019, ¶ 38.
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`Ex 2109: Grabowski Declarations, 6/22/2019, ¶ 32.
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`launch is misleading and provides little indication of success. In fact, any amount
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`of growth starting from close-to-zero at launch can appear to be large in percentage
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`terms because the starting point is so small. By comparison, use of Lantus
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`OptiClik also grew over 8,000% in the first three years (from 14,000 prescriptions
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`in the 12 months ending March 2005 to 1.2 million prescriptions in the 12 months
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`ending March 2008 1.2 million / 14,000 – 1 = 8,471%), thus showing no unique
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`characteristics of the SoloStar pens compared to OptiClik. See Attachment B-10.
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`21. Similarly, Dr. Grabowski summarily concludes Lantus SoloStar’s increasing
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`share within the Lantus Franchise is evidence of commercial success.39 However,
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`Dr. Grabowski provides very little analysis for why Lantus SoloStar’s share of the
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`Lantus franchise is increasing. As discussed below, Sanofi sought to actively
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`switch patients among its Lantus products to extend its patent protection. If
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`anything, prescription data show that the growth rate of the Lantus franchise had
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`already stabilized before the launch of Lantus SoloStar, showing no incremental
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`increase from the new product. See Section III.C.(3) below. Again, this indicates
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`that Lantus SoloStar sales were not driven by any unique characteristics of the
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`SoloStar pen itself.
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`39
`Ex 2109: Grabowski Declarations, 6/22/2019, ¶ 34.
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`22. Dr. Grabowski’s single supposed “good benchmark,”40 the Lantus OptiClik,
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`is actually not an appropriate benchmark. Dr. Grabowski implies that Lantus
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`SoloStar competitively “displaced Lantus OptiClik as the preferred Lantus pen,”41
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`but this is not the case. As discussed, below, Sanofi actively migrated Lantus
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`patients from the OptiClik to the SoloStar, and even took OptiClik off the market
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`to benefit SoloStar. In contrast, Lantus SoloStar did not appear to impact the
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`overall sales trajectory of Lantus products.
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`(2) No evaluation of costs or profits
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`23. One consideration for commercial success analysis is whether the sales and
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`profits of a product are large enough to incentivize others to bring a particular
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`product to market sooner if the claimed subject matter were obvious. Consistent
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`with this, evaluation of success in the pharmaceutical context often involves a
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`comparison of sales and profits to the costs incurred during years of research,
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`40
`Ex 2109: Grabowski Declarations, 6/22/2019, ¶ 35.
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`41
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`Ex 2109: Grabowski Declarations, 6/22/2019, ¶ 37.
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`development, and clinical trials, which are often substantial.42 For example, Dr.
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`Grabowski’s own research shows how pharmaceutical products often lose money
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`for years before possibly earning any return on investment:43
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`42
`Ex 1076: DiMasi, Joseph, Henry Grabowski, and Ronald Hansen (2016),
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`"Innovation in the pharmaceutical industry: New estimates of R&D costs,"
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`Journal of Health Economics 47: 20–33.
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`Ex 1074: David, Jesse and Marion B. Stewart (2005), “Commercial Success:
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`Economic Principles Applied to Patent Litigation,” in Gregory K. Leonard
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`and Lauren J. Stiroh, ed., Economic Approaches to Intellectual Property
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`Policy, Litigation, and Management, White Plains, NY: National Economic
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`Research Associates, Inc., at 160.
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`Ex 1084: McDuff, Andrews, and Brundage (2017), “Thinking Economically
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`About Commercial Success,” Landslide 9(4): 37-40.
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`43
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`Ex 1077: Grabowski, Vernon, and DiMasi (2002), “Returns on Research and
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`Development for 1990s New Drug Introductions,” Pharmacoeconomics 20
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`Suppl. 3: 11-29.
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`Market Introduction
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`200 -
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`150
`
`100
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`50 -
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`0
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`-50 -
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`-100
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`$US millions (2000 values)
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`11 10 9 8 7 6 5 4 3 2
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` 1 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
`Year
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`Fig. 5. Cash flows over the product life cycle: baseline case.
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`
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`24. Dr. Grabowski testified before Congress in support of increasing FDA data
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`exclusivity for biologics (such as Lantus) as compared to exclusivity available
`
`under the Hatch-Waxman Act because he predicted biologic compounds would
`
`take even longer on average to make up for investments costs than small-molecule
`
`drugs.44 It certainly may not be assumed that Lantus SoloStar has been a
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`commercial success from the perspective of return on investment. Despite this, the
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`Grabowski Declaration provides no analysis whatsoever of Lantus SoloStar’s
`
`costs, profits, return on investment, or any other measure of profitability, and thus
`
`lacks sufficient basis to claim that Lantus SoloStar earned a return on investment
`
`and that it is a commercially successful pharmaceutical product.
`
`
`44
`Ex 1055: Henry Grabowski, Dep. Tr., 9/5/2019, at 140:11-141:17, 143:4-13.
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`(3) Limiting to “pens only” is a faulty market definition
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`25. Dr. Grabowski acknowledges that “a relevant set of products to analyze the
`
`performance of Lantus SoloSTAR is the set of prescription injectable insulin or
`
`insulin analog products.”45 Despite this, Dr. Grabowski limits his analysis to just
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`45
`Ex 2109: Grabowski Declarations, 6/22/2019, ¶ 21. During his deposition,
`
`Dr. Grabowski agreed that "all insulin injectable products, whether
`
`administered by pen or by vial and syringe” is “the data that is the
`
`appropriate data to do commercial success.” Ex 1055: Henry Grabowski,
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`Dep. Tr., 9/5/2019, at 22:10-19. When asked whether it was “inappropriate
`
`to look at the entire injectable insulin product market to perform a
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`commercial success analysis for the Lantus SoloSTAR pen,” Dr. Grabowski
`
`testified that this “can be one complementary measure,” that “one can
`
`always broaden an analysis to a broader field—broader markets, and I have
`
`done that in one case.” Ex 1055: Henry Grabowski, Dep. Tr., 9/5/2019, at
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`26:9-19. Dr. Grabowski also agreed that SoloStar is used to deliver short-
`
`acting and long-acting insulin, was not aware of any reason it can’t be used
`
`to deliver intermediate acting insulin, and that the pen operates the same way
`
`regardless of whether it’s delivering a short-acting or a long-acting insulin.
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`Ex 1055: Henry Grabowski, Dep. Tr., 9/5/2019, 27:16-29:7
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`injectable pen products, reporting: (a) Lantus SoloStar and several other long-
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`acting pen products’ sales and prescription as a share of all injectable pens,46 and
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`(b) Lantus SoloStar and several other long-acting pen products’ sales and
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`prescriptions as a share of just long-acting injectable pens.47 Such an analysis
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`misrepresents the market and provides inflated market share calculations.
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`26.
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`In actuality, Lantus SoloStar competes in the insulin market against the
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`many other fast-acting, short-acting, intermediate-acting, and long-acting insulin
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`and insulin analog products, as acknowledged by Sanofi48 itself and third-party
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`market analysis:
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`46
`Ex 2109: Grabowski Declarations, 6/22/2019, ¶ 43.
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`47
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`Ex 2109: Grabowski Declarations, 6/22/2019, ¶¶ 44-45.
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`48 Dr. Grabowski considered it appropriate to compare Lantus SoloStar to all
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`insulin pen products regardless of whether they are fast-acting or long-
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`acting. Ex 1055: Henry Grabowski, Dep. Tr., 9/5/2019, at 81:20-83:4. He
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`agreed that his Exhibit 2186 “provides a complete list of the relevant
`
`competitive products for the SoloStar pen” and that his list includes
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`“products that are sold as a vial and syringe administration method” as well
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`as “fast-acting, intermediate-acting, and long-acting insulin products.” Ex
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`1055: Henry Grabowski, Dep. Tr., 9/5/2019, at 90:18-91:9. Although he
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`a. Aventis 20-Fs (2002, 2003): Lantus is described as competing
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`within the “insulin market” (i.e., all insulin products) within the
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`United States and worldwide.49
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`b. Sanofi Lantus SoloStar Launch Book (2007): Within the “Patient
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`Targeting” section, Lantus SoloStar’s “Business Opportunities”
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`include “[u]ncontrolled and/or unsatisfied T2DM patients on
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`competitor insulin,” which include various fast-acting and long-
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`acting insulin products such as: “NPH,” “Premix,” and
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`“Levemir.”50
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`admitted pen sales for fast- and intermediate-acting insulins made up nearly
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`half of all insulin pen sales, Dr. Grabowski omitted these pen sales from
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`depiction on his graph, while including them in the total. Ex 1055: Henry
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`Grabowski, Dep. Tr., 9/5/2019, at 82:22-84:12. Dr. Grabowski left the vial
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`and syringe share of the insulin injectable market off his graph entirely. Ex
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`1055: Henry Grabowski, Dep. Tr., 9/5/2019, at 84:13-22.
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`49
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`Ex 1068: Aventis Form 20-F, 2002, at 60.
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`50
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`Ex 1069: Aventis Form 20-F, 2003, at 57.
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`Ex 2145: Lantus SoloStar Launch Book, 2007, at 11.
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`c. Therapeutic Categories Outlook (2015): Market shares are
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`presented for the “US insulin market,” including for
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`“Lantus/Solostar” and for fast-acting, intermediate-acting, and
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`long-acting products such as Humulin, Humalog, Novolin,
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`Levemir, and Apidra.51
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`d. Sanofi 20-F (2006): Sanofi describes Lantus as competing within
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`“the insulin market…”52 and further compares Lantus’ clinical
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`profile to neutral protamine hagedorn (NPH) insulin.53
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`e. UBS Large Cap Pharmaceuticals Handbook (2018): UBS reports
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`market shares and sales for the “Diabetes (Insulin)” market
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