UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`V.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`Case No. IPR2018-01675
`U.S. Patent No. 8,603,044
`
`DECLARATION OF DR. ROBIN S. GO LAND IN SUPPORT OF PA TENT
`OWNER'S RESPONSE TO PETITION FOR INTER PARTES REVIEW OF
`U.S. PA TENT NO. 8,603,044
`
`Sanofi Exhibit 2111.001
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`V.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`Case No. IPR2018-01675
`U.S. Patent No. 8,603,044
`
`DECLARATION OF DR. ROBIN S. GO LAND IN SUPPORT OF PA TENT
`OWNER'S RESPONSE TO PETITION FOR INTER PARTES REVIEW OF
`U.S. PA TENT NO. 8,603,044
`
`Sanofi Exhibit 2111.001
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`TABLE OF CONTENTS
`
`Background and Experience ........................................................................... . 1
`I.
`Fees and Prior Testimony ................................................................................ 3
`II.
`III. Materials Reviewed and Information Considered ........................................... 3
`IV.
`Summary of Opinions ..................................................................................... .4
`V.
`Background on Diabetes & Treatments .......................................................... 5
`VI.
`Sanofi's Lantus® SoloSTAR® Product .......................................................... 6
`VII. A Long-Felt but Unmet Need Existed for an Easy-to-Use, Disposable
`Pen ................................................................................................................... 7
`VIII. Pens Prior to SoloSTAR® did not Meet the Long-Felt Need for an
`Easy-to-Use, Disposable Pen ........................................................................... 9
`SoloSTAR® Met A Long-Felt but Unmet Need Existed for an Easy-
`to-U se, Disposable Pen ................................................................................. . 11
`Materials Considered ............................................................................................... 16
`
`IX.
`
`1
`
`Sanofi Exhibit 2111.002
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`I, Robin S. Goland, M.D., have been retained by Sanofi-Aventis
`
`Deutschland GmbH ("Patent Owner" or "Sanofi"), as an independent expert
`
`witness in the above-captioned inter partes review ("IPR") that has been instituted.
`
`I understand that Mylan Pharmaceuticals Inc. ("Mylan" or "Petitioner") has
`
`requested that the U.S. Patent and Trademark Office cancel as unpatentable certain
`
`claims of this patent.
`
`This declaration sets forth my analyses and opinions based on my experience
`
`and the materials I have considered. As I explain below, it is my opinion that
`
`Lantus® SoloStar® satisfied a long-felt but unmet need for a long-lasting insulin
`
`or insulin glargine drug in an easy-to-use disposable pen.
`
`I.
`
`Background and Experience
`
`1.
`
`Included as Exhibit 2112 to this declaration is my current curriculum
`
`vitae. I have summarized my educational and professional background below.
`
`2.
`
`I received a Bachelor of Arts in History from Harvard University in
`
`1976. After completing my undergraduate studies, I went on to obtain an M.D.
`
`degree from Columbia University in 1980.
`
`3.
`
`After completing my internship in 1981, I undertook a residency in
`
`internal medicine at New York-Presbyterian/Columbia University from 1980-
`
`1984. I completed a fellowship in endocrinology at Columbia University College
`
`1
`
`Sanofi Exhibit 2111.003
`Mylan v. Sanofi
`IPR2018-01675
`
`
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`of Physicians and Surgeons in 1987. I am board-certified in Internal Medicine and
`
`Endocrinology.
`
`4.
`
`Since completing my residency and fellowship, I've held a number of
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`academic positions at Columbia University College of Physicians and Surgeons,
`
`including Assistant Professor of Clinical Medicine (1987-1989), Assistant
`
`Professor of Medicine ( 1990-1996), Florence Irving Associate Professor of
`
`Medicine (1997-2008), Professor of Clinical Medicine (2008-present ), Professor of
`
`Clinical Medicine and Clinical Pediatrics (2010-present), and J. Merrill Eastman
`
`Professor of Clinical Diabetes (20 I I-present).
`
`5.
`
`Since 1987, I have been the Chief of the Diabetes Clinic at New York-
`
`Presbyterian Hospital/Columbia University. In 1997, I founded the Naomi Berrie
`
`Diabetes Center at Columbia University, and I have served the center as co(cid:173)
`
`director ever since. The Naomi Berrie Diabetes Center serves 14,000 patients each
`
`year, approximately 40% of which have Type I diabetes. In addition, the Center
`
`conducts clinical research on diabetes.
`
`6.
`
`During my career, I have authored or co-authored over 80 peer-
`
`reviewed articles. I am a member of the American Diabetes Association. I also
`
`served as a member of the Medical Advisory Board of the Juvenile Diabetes
`
`Foundation, New York Chapter, the Pharmacy and Therapeutics Committee of
`
`2
`
`Sanofi Exhibit 2111.004
`Mylan v. Sanofi
`IPR2018-01675
`
`
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`Merck Health Solutions, and the Medical Advisory Board of the NY Stem Cell
`
`Foundation.
`
`7.
`
`I am an experienced clinical investigator and principal investigator in
`
`diabetes trials. In 1996-1999, I received the Irving Scholar Award for Clinical
`
`Investigation from Columbia University.
`
`8. My other qualifications are set forth in my curriculum vitae.
`
`II.
`
`Fees and Prior Testimony
`
`9.
`
`In the past five years, I have testified as an expert in deposition and at
`
`trial in the Sanofi v. Merck litigation, Case No. 16-812-RGA, in the District of
`
`Delaware.
`
`10.
`
`I am being compensated for my time at my standard rate of $750 for
`
`each hour of service that I provide in connection with these proceedings. This
`
`compensation is not contingent upon my opinions or testimony, the outcome of
`
`these proceedings, or any issues involved in or related to this IPR.
`
`III. Materials Reviewed and Information Considered
`
`11.
`
`The declaration and opinions set forth herein are based on references
`
`and other documents cited in this declaration and/or identified in the list of
`
`materials at the end of this Declaration, and my personal education, professional
`
`experience, and other relevant knowledge.
`
`3
`
`Sanofi Exhibit 2111.005
`Mylan v. Sanofi
`IPR2018-01675
`
`
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`12. My opinions are based on the information available to me to date. I
`
`reserve the right to supplement my analyses and opinions in the event that
`
`additional information becomes available that is relevant to these proceedings.
`
`13.
`
`I may expand or modify my opinions as my investigation and study
`
`continue, and supplement my opinions in light of any relevant orders or in
`
`response to any additional information I review, any matters the Petitioner raises,
`
`or any opinions Petitioner's experts may provide.
`
`IV. Summary of Opinions
`
`14. As detailed below, it is my opinion that patients who require insulin or
`
`insulin analog therapy need an easy-to-use injection pen device. This need is
`
`especially pronounced in elderly patients, and in patients suffering from dexterity
`
`and other mobility problems. An easy to use device is important for patients to
`
`adhere to their treatment program.
`
`15. The injection pen devices available prior to the launch ofLantus®
`
`SoloStar® were more difficult to use than Lantus® SoloStar® and had a higher
`
`injection force, meaning the devices required significantly more force by the
`
`patient's thumb to depress the button to administer the medication. The higher
`
`injection force made the prior devices much more difficult to use.
`
`16. Lantus® SoloStar® was the first pen injection device for insulin or
`
`insulin glargine that satisfied the long-felt need for an easy-to-use device with low
`
`4
`
`Sanofi Exhibit 2111.006
`Mylan v. Sanofi
`IPR2018-01675
`
`
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`injection force. My patients overall prefer Lantus® SoloStar® over all other
`
`available pen injection devices.
`
`V.
`
`Background on Diabetes & Treatments
`
`17. Diabetes mellitus is a disease characterized by hyperglycemia, or high
`
`blood sugar. There are two types of diabetes: type 1 and type 2. Patients with type
`
`1 diabetes are insulin-deficient, meaning their pancreatic beta cells do not produce
`
`enough insulin and therefore blood glucose cannot enter the cells to be used for
`
`energy. In type 2 diabetes, the body is insulin-resistant, meaning that the pancreas
`
`must make extra insulin to compensate for the body's failure to use insulin
`
`properly. Over time, patients with type 2 diabetes can become insulin-deficient,
`
`meaning the body cannot make enough insulin to keep blood glucose at normal
`
`levels.
`
`18. Choosing the appropriate treatment option for a patient depends on
`
`multiple factors and must be individualized. Type 1 diabetes is treated with insulin.
`
`The treatment class of "insulins" includes both human insulin and insulin analogs,
`
`like insulin glargine. Insulins and insulin analogs are further broken down into
`
`three categories: (1) rapid-acting; (2) intermediate; and (3) long-acting. Type 2
`
`diabetes is treated with diet and exercise to start, but because it is a chronic
`
`progressive condition, changes in the patient's regimen over the lifetime are to be
`
`expected. All of my type 1 diabetes patients currently use rapid-acting insulin, and
`
`5
`
`Sanofi Exhibit 2111.007
`Mylan v. Sanofi
`IPR2018-01675
`
`
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`additionally approximately 5% of my type 1 diabetes patients use intermediate(cid:173)
`
`acting insulin, and 40% of my type 1 diabetes patients use long-acting insulin or
`
`insulin analog. Approximately 30% of my type 2 diabetes patients currently use
`
`long-acting insulin or insulin analog and 5% use rapid-acting insulin.
`
`19.
`
`Patient preference and adherence are important considerations when
`
`deciding on a diabetes treatment. Finding a treatment that adequately controls a
`
`patient's blood sugar levels could take weeks, months, or even longer depending
`
`on the patient.
`
`VI. Sanofi's Lantus® SoloSTAR® Product
`
`20.
`
`Insulins and insulin analogs can be delivered to the body in an
`
`injectable pen format or by using a vial and syringe. Lantus® is the first long(cid:173)
`
`acting basal insulin or insulin analog I am aware of with once-daily administration
`
`and a twenty-four duration. When the Lantus® insulin glargine formulation was
`
`first launched in May 2001, it was available only in a 10 mL vial. Therefore,
`
`patients using the Lantus® insulin glargine formulation had to use a syringe to
`
`draw out the formulation from the vial and then inject the formulation with the
`
`synnge.
`
`21.
`
`The Lantus® insulin glargine formulation can now be delivered using
`
`a disposable pen (Lantus® SoloSTAR®) and by using a vial and syringe. Sanofi's
`
`Lantus® SoloSTAR® is a disposable pen-type injection device that administers
`
`6
`
`Sanofi Exhibit 2111.008
`Mylan v. Sanofi
`IPR2018-01675
`
`
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`Lantus® for the treatment of diabetes. In 2007, the FDA approved Lantus®
`
`SoloS TAR®, 1 which is still on the market today. I was a practicing physician when
`
`the SoloSTAR® pen launched. In my clinical experience, Lantus® SoloSTAR® is
`
`widely used by patients taking Lantus®.
`
`VII. A Long-Felt but Unmet Need Existed for an Easy-to-Use, Disposable
`Pen
`
`22.
`
`For patients dealing with a lifelong condition like diabetes that
`
`requires daily medication/care, anything that can be done to reduce the burden of
`
`living with such a condition is a huge benefit. In particular, ease of use is key for
`
`the self-administration. My type 2 diabetes patients, for example, are typically
`
`middle aged or elderly, and have conditions that may cause a variety of physical
`
`and/or cognitive impairments.
`
`23.
`
`For example, a 2011 study explained that "people with insulin-treated
`
`diabetes have frequently been reported to suffer from a deterioration of fine motor
`
`skills" that impact "hand-eye coordination, balance, dexterity, tracking, and other
`
`skills."2 The study further reported that "[p ]atients with type 2 diabetes showed
`
`disturbed vibration perception. " 3 As I explained above, these problems are
`
`1 Lantus® SoloSTAR® Approval Ltr., available at
`https ://www. accessdata.f da. gov/ drugsatf da _ docs/ appletter/2 007 /021081 s024 ltr. pdf
`(last accessed June 19, 2019).
`2 Exhibit 2125 at 2.
`3 Exhibit 2125 at 1.
`
`7
`
`Sanofi Exhibit 2111.009
`Mylan v. Sanofi
`IPR2018-01675
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`
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`especially prevalent with older people. I agree with the study's concern that
`
`"[m]anual dexterity may have an enormous impact on occupational performance as
`
`well as on activities of daily living,"4 including on the ability to administer insulin
`
`glargine.
`
`24. Another study reported that diabetes "is associated with limitation of
`
`joint mobility of the fingers, which can be due to connective tissue changes,
`
`neuropathy, vasculopathy, or combinations of these problems."5 As the study
`
`states, problems associated with diabetes can include "Dupuytren disease, flexor
`
`tenosynovitis, carpal tunnel syndrome ( diabetic hand), stiff hand syndrome,
`
`shoulder-hand syndrome (reflex dystrophy) and limited joint mobility (LJM) ....
`
`LJM is of particular interest because it is common in young patients and associated
`
`with an increased risk for the serious complications of nephropathy and
`
`retinopathy. "6
`
`25. Other studies report that poorly controlled diabetes can also be
`
`"associated with blindness and end stage renal disease," and "coronary artery
`
`disease is more severe in patients with diabetes."7 In elderly patients, this is further
`
`4 Id. at 2.
`5 Exhibit 2134 at 1.
`6 Id.
`7 See Exhibit 2141 at 2.
`
`8
`
`Sanofi Exhibit 2111.010
`Mylan v. Sanofi
`IPR2018-01675
`
`
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`complicated with other co-morbidities that make it difficult to self-inject and
`
`increase dosing errors. 8
`
`26.
`
`Thus, the easier an injection device is to use, the more likely it is that
`
`patients will use the device in accordance with their doctor's instruction.
`
`VIII. Pens Prior to SoloSTAR® did not Meet the Long-Felt Need for an Easy(cid:173)
`to-Use, Disposable Pen
`
`27.
`
`Prior to the launch ofLantus® SoloSTAR® pen, there were two pens
`
`on the market in the United States administering a long-acting insulin or insulin
`
`analog, Lantus® OptiClik® and Levemir® FlexPen®. Neither of these pens,
`
`however, satisfied the long-felt need for an easy-to-use, disposable pen.
`
`28.
`
`The OptiClik® had a much higher injection force than SoloSTAR®
`
`and was thus more difficult to use. The OptiClik® further did not automatically
`
`reset after injection and thus required additional steps by the user prior to its next
`
`use. OptiClik® was also relatively large, making it less convenient to carry.
`
`Lantus® OptiClik® was thus a mechanically inferior design to Lantus®
`
`SoloSTAR® and did not satisfy the long-felt but unmet need for an easy to use
`
`device with a low injection force, as provided by Lantus® SoloSTAR®. I
`
`understand that Lantus® OptiClik® has been discontinued.
`
`8 See id.; see also Exhibit 2159; Exhibit 2200; Exhibit 2138.
`
`9
`
`Sanofi Exhibit 2111.011
`Mylan v. Sanofi
`IPR2018-01675
`
`
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`29.
`
`Levemir® FlexPen® likewise did not address the long-felt need for an
`
`easy to use device with a low injection force. In particular, the FlexPen® has a
`
`relatively high injection force, which requires patients to exert more effort to
`
`depress the button on the device to administer the medication. This makes the
`
`device more difficult to use, and more uncomfortable, and thus increases the risk of
`
`a patient not adhering to their prescribed routine. The FlexPen® also has
`
`suboptimal maximum-dose stop and last-dose stop features. These features are
`
`intended to ensure that the patient does not inject too much medication, and that
`
`the patient is prevented from selecting a larger dose than the medication that
`
`remains in the cartridge.
`
`30.
`
`I am also familiar with other disposable pen devices on the market in
`
`the United States prior to SoloSTAR® that delivered insulin in the rapid-acting and
`
`intermediate-acting insulin markets. These devices included Lilly
`
`Humalog/Humulin Pen, NovoPen 3, and AutoPen Classic. Although I would not
`
`consider these devices for my patients who require long-acting insulin or insulin
`
`analog due to their duration of action, these other devices suffered from the same
`
`shortcomings as the OptiClick® and FlexPen® and would not be appropriate for
`
`the long-acting insulin or insulin analog market were they made for such market.
`
`10
`
`Sanofi Exhibit 2111.012
`Mylan v. Sanofi
`IPR2018-01675
`
`
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`IX. SoloSTAR® Met A Long-Felt but Unmet Need Existed for an Easy-to(cid:173)
`Use, Disposable Pen
`
`31.
`
`The Lantus® SoloSTAR® pen fulfilled the long-felt, but unmet need
`
`for an easy-to-use, low injection force pen for administering a long-acting insulin
`
`glargine formulation.
`
`32.
`
`In my clinical experience, my patients who require long-acting insulin
`
`or insulin analog have found the Lantus® SoloS TAR® pen more convenient and
`
`easier to use than other pen devices delivering long-acting insulin or insulin
`
`analog. For example, individuals with dexterity issues, such as the elderly or
`
`patients with other coordination issues, have found the SoloSTAR® pen easier to
`
`use. 9
`
`33. A primary reason that the SoloSTAR® pen is so easy-to-use is
`
`because of the low injection force, or the amount of pressure a patient needs to
`
`apply to the injection button in order to inject the dose. 10 My elderly patients and
`
`9 See also Exhibit 2116 at 9 ( finding that, through design verification and
`validation, SoloSTAR® was "easy to use with a dose injection force lower than
`both [FlexPen® and Humalog/Humlin® pen] and, in a nonclinical environment, is
`preferred by more people than the [aforementioned pens]."); see also Exhibit 2143
`at 9; Exhibit 2144 at 9-11.
`10 See, e.g., Exhibit 2123 at 6 (finding that "the results of the injection force study
`show that the Lantus pens, [ClickStar and SoloSTAR®], require a significantly
`lower injection force compared with the reusable or prefilled insulin pens
`containing the insulin glargine copies. The lower injection force may be of great
`benefit for diabetes patients with reduced finger joint mobility or limited hand
`strength."); Exhibit 2116 at 9 (finding that SoloSTAR® had a lower injection force
`
`11
`
`Sanofi Exhibit 2111.013
`Mylan v. Sanofi
`IPR2018-01675
`
`
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`children in particular have found that with SoloSTAR®, it is quite easy to depress
`
`the button due to the low injection force.
`
`34.
`
`The SoloSTAR® device also features a short dial extension length
`
`that reduces the strain on the patient's thumb. This makes it easier for the patient's
`
`thumb to reach the button that must be depressed to administer the medication.
`
`35.
`
`The SoloSTAR® device is also easy to use because it includes the
`
`ability to dial up and dial back a desired dose, and provides tactile and audible
`
`feedback, portability, and ease of handling. They have also found that Lantus®
`
`SoloSTAR® pen requires less training or "steps" to administer.
`
`36.
`
`The SoloSTAR® pen also has audible dial clicks, which allow a
`
`patient to hear clicks as the dose is being dialed. Visual impairment, including
`
`diabetic retinopathy, is a common complication with poorly controlled diabetes.
`
`Audible dial clicks, therefore, help patients with any visual impairment to ensure
`
`they are injecting the correct dose, which in turn helps patients maintain stable
`
`blood glucose levels.
`
`3 7.
`
`The SoloS TAR® pen also offers the additional benefit of a last dose
`
`stop, which prevents a patient from dialing a dose that is higher than the remaining
`
`dose in the pen. 11 If the pen lacked this feature, patients could dial a higher dose
`
`than FlexPen and the Humalog®/Humulin® pen); Exhibit 2143 at 7; Exhibit 2144
`at 5.
`11 See Exhibit 2123 at 7.
`
`12
`
`Sanofi Exhibit 2111.014
`Mylan v. Sanofi
`IPR2018-01675
`
`
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`than what is actually available in the pen; therefore, patients may think they are
`
`injecting a higher dose than they actually are. The discrepancy between the
`
`intended dose and actual injected dose could cause the patient's blood glucose
`
`levels to become destabilized. My patients have found the above features to be
`
`highly convenient and contribute to the device being easy to use
`
`38.
`
`The SoloSTAR® pen was also the first SOU pen, offering an
`
`additional benefit of administering 80 units at once compared to other pens, which
`
`can only administer 60 units at once. 12 For patients who require higher units of
`
`insulin glargine, this may reduce the number of injections they need, thereby
`
`reducing burden and discomfort.
`
`39.
`
`The SoloSTAR® device also has the added benefit of being
`
`disposable. In my experience, patients prefer disposable pens because they are
`
`more convenient and require fewer steps to administer the medication. 13 Reusable
`
`devices require that the medicine cartridge be periodically replaced. For example,
`
`some patients find the process of replacing the cartridge to be challenging, and if
`
`done incorrectly, can lead to errors.
`
`12 See, e.g., Exhibit 2116 at 4 (noting that the SoloSTAR® pen was developed to
`include a maximum dose of 80 units to try to prevent patients from having to inject
`themselves multiple times to get their correct dose); Exhibit 2144 at 5.
`13 See also Exhibit 2143 at 2; Exhibit 2144 at 2.
`13
`
`Sanofi Exhibit 2111.015
`Mylan v. Sanofi
`IPR2018-01675
`
`
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`40.
`
`Studies have confirmed that Lantus® SoloS TAR® is a superior
`
`device and has a lower injection force than the previously available devices. A
`
`2007 study, for example, requested that respondents "rank the injection force of
`
`each pen by injecting 40 U into a receptacle; this task was completed for each pen
`
`in a random order." 14 The study found that 69% of surveyed patients preferred the
`
`injection force of SoloSTAR® over other injection pens.
`
`41. Multiple other studies confirm my opinion that patients prefer
`
`SoloSTAR® over other pen devices, in part, because it has a lower injection force.
`
`A 2013 injection force study, for example, found that SoloSTAR® requires "a
`
`significantly lower injection force compared with the reusable or prefilled insulin
`
`pens containing the insulin glargine copies. The lower injection force may be of
`
`great benefit for diabetes patients with reduced finger joint mobility or limited
`
`hand strength."15
`
`42.
`
`These studies confirm my opinion that LANIUS SoloSTAR satisfied
`
`a long-felt but unmet need for an injection device with low injection force. The
`
`other pen devices I describe above had too high of an injection force for my
`
`patients. With SoloSTAR, patient adherence to their prescribed treatment has
`
`14 See Exhibit 2143 at 3.
`15 See Exhibit 2123 at 6; see also Exhibit 2121 at 2, 9 (finding that 7 out of 10
`patients now prefer the lower injection force of SoloSTAR® to competitor
`products and in 2008 it accounted for "41 % of all growth in the global injectable
`insulin market").
`
`14
`
`Sanofi Exhibit 2111.016
`Mylan v. Sanofi
`IPR2018-01675
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`improved, and patients are able to administer their treatments with much greater
`
`ease and less discomfort.
`
`43. Numerous industry publications also confirm my experience with
`
`patient and healthcare provider preference for SoloST AR® over other devices
`
`because of its ease of use and low injection force. 16
`
`44. Based on all of the foregoing, the Lantus® SoloSTAR® pen met a
`
`long-felt but unmet need for an easy-to-use, safe, disposable pen that was
`
`particularly well suited to administering a long-acting insulin glargine formulation.
`
`I declare that all statements made herein are of my own lmowledge, are true,
`
`and that all statements made on info1mation and belief are believed to be true; and
`
`further that these statements are made with the lmowledge that willful false
`
`statements and the like so made are punishable by fine or imprisonment, or both,
`
`under Section 10001 of Title 18 of the United States Code.
`
`Dated: June 24, 2019
`
`Robin S. Goland, Mb
`
`16 See, e.g., Exhibit 2126 at 3; see also Exhibit 2128; Exhibit 2113; Exhibit 2140 at
`1; Exhibit 2121; Exhibit 2184; Exhibit 2185; Exhibit 2143; Exhibit 2100.
`
`15
`
`Sanofi Exhibit 2111.017
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`DECLARATION OF DR. ROBINS. GOLAND
`MATERIALS CONSIDERED
`
`Andreas Bode, Development of the SoloSTAR insulin pen device design
`verification and validation, 6 EXPERT OPINION ON DRUG DELIVERY 103 (2008)
`
`Alastair Clarke & Geralyn Spollett, Dose accuracy and injection force dynamics of
`a novel disposable insulin pen, 4 EXPERT OPINION ON DRUG DELIVERY 165 (2007)
`
`Arnd Friedrichs et al., Dose Accuracy and Injection Force of Different Insulin
`Glargine Pens, 7 J. DIABETES SCI. AND TECH. 1346 (2013)
`
`Arlan L. Rosenbloom, Limitation of Finger Joint Mobility in Diabetes Mellitus, 3
`J. DIABETIC COMPLICATIONS 77 (1989)
`
`DBA Design Effectiveness Awards 2009: SoloSTAR
`
`Document Bates stamped SANOFI _ 00006282 (Charles E. Buban, A pen that seeks
`to improve diabetes care, INQUIRER.NET (2008))
`
`Document Bates stamped SANOFI_00006299 (Sanofi-aventis' SoloSTAR(R)
`Insulin Pen for Lantus and Apidra Receives the Prestigious GOOD DESIGN
`Award, PR Newswire)
`
`Jerome S. Fischer et al., United States Patient Preference and Usability for the
`New Disposable Insulin Device Solostar® versus Other Disposable Pens, 2 J.
`DIABETES SCI. AND TECH.1157 (2008)
`
`Samita Garg et al., Insulin glargine and glulisine SoloSTARpensfor the treatment
`of diabetes, 5 EXPERT REV. MED. DEVICES 113 (2008)
`
`Thomas Haak et al., Comparison of Usability and Patient Preference for the New
`Disposable Insulin Device SoloStar Versus FlexPen, Lilly Disposable Pen, and a
`Prototype Pen: An Open-Label Study, 29 CLINICAL THERAPEUTICS, 650 (2007)
`
`Lantus® SoloSTAR® Approval Ltr., available at
`https://www.accessdata.fda.gov/drugsatfda _ docs/appletter/2007 /021081 s024ltr.pdf
`(last accessed June 19, 2019)
`
`Riccardo Perfetti, Reusable and Disposable Insulin Pens for the Treatment of
`Diabetes: Understanding the Global Differences in User Preference and an
`Evaluation of Inpatient Insulin Pen Use, 12 DIABETES TECH. & THERAPEUTICS 79
`(2010)
`
`16
`
`Sanofi Exhibit 2111.018
`Mylan v. Sanofi
`IPR2018-01675
`
`
`
`Julia Pfutzner et al., Evaluation of Dexterity in Insulin-Treated Patients with Type
`land Type 2 Diabetes Mellitus, 5 J. DIABETES SCI. AND TECH. 158 (2011)
`
`Yuzu Sato et al., Clinical Aspects of physical exercise for diabetes/metabolic
`syndrome, 77S DIABETES RESEARCH AND CLINICAL PRACTICE S87 (2007)
`
`Serpil Savas et al., The effects of the diabetes related soft tissue hand lesions and
`the reduced hand strength on functional disability of hand in type 2 diabetic
`patients, 77 DIABETES RESEARCH AND CLINICAL PRACTICE 77 (2007)
`
`W. Schady et al., Observations on Severe Ulnar Neuropathy in Diabetes, 12 J.
`DIABETES AND ITS COMPLICATIONS 128 (1998)
`
`John Shelmet et al., Preference and resource utilization in elderly patients:
`InnoLet versus vial/syringe, 63 DIABETES RESEARCH AND CLINICAL PRACTICE 27
`(2004)
`
`Thomas van der Burg, Injection Force of SoloSTAR® Compared with Other
`Disposable Insulin Pen Devices at Constant Volume Flow Rates, 5 J. DIABETES
`SCI. AND TECH. 150 (200 l)
`
`Bradley M. Wright et al., A Review Of Insulin Pen Devices And Use In The Elderly
`Diabetic Population, 3 CLINICAL MEDICINE INSIGHTS: ENDOCRINOLOGY &
`DIABETES 54 (2010)
`
`17
`
`Sanofi Exhibit 2111.019
`Mylan v. Sanofi
`IPR2018-01675
`
`
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