`
`
`BEFORE THE PATENT TRIAL AND APPEALS BOARD
`
`
`AMNEAL PHARMACEUTICALS LLC
`Petitioner
`
`v.
`
`HOSPIRA, INC
`Patent Owner
`
`
`Inter Partes Review No. IPR2016-01577
`Patent 8,242,158
`
`
`DECLARATION OF JAMES GORDON CAIN, MD, MBA, FAAP
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`
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`1
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1002
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`
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`TABLE OF CONTENTS
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`INTRODUCTION ........................................................................................... 1
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`
`I.
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`II. QUALIFICATIONS & BACKGROUND ...................................................... 2
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`III.
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`INFORMATION CONSIDERED ................................................................... 3
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`IV. THE ‘158 PATENT ......................................................................................... 3
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`A.
`
`B.
`
`State of the Art ...................................................................................... 3
`
`Scope of the ‘158 Patent ........................................................................ 6
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`V.
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`CLAIM CONSTRUCTION ............................................................................ 6
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`A. A Person of Ordinary Skill in the Art (POSA) ..................................... 6
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`B.
`
`C.
`
`Broadest Reasonable Interpretation ...................................................... 7
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`Claim Terms of the ‘158 Patent ............................................................ 8
`
`i.
`
`ii.
`
`“Ready To Use” .......................................................................... 8
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`“Dexmedetomidine” ................................................................... 9
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`VI. THE CLAIMED INVENTION IS WELL-KNOWN IN THE ART .............10
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`VII. CONCLUDING STATEMENTS ..................................................................16
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`i
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page i
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`I.
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`INTRODUCTION
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`I, James Gordon Cain, MD, MBA, FAAP, declare as follows:
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`1.
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`I am over 18 years of age. I have personal knowledge of the facts
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`stated in this declaration and could testify competently to them if asked to do so.
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`2.
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`In this proceeding before the U.S. Patent and Trademark Office
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`(“USPTO”), I have been retained by Amneal Pharmaceuticals LLC (“Amneal” or
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`“Petitioner”) as an independent expert consultant. Although I am receiving
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`compensation at my standard consulting rate for the time that I spend on this
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`proceeding, I have no other interest in its result. I also expect to be reimbursed for
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`reasonable expenses incurred in relation to my consulting. My compensation is
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`independent of the opinions rendered or the outcome of this proceeding.
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`3.
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`I understand that this proceeding involves U.S. Patent No. 8,242,158
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`(“the ‘158 patent”), Ex. 1001, issued on August 14, 2012, and that the ‘158 patent
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`issued from U.S. Patent Application Serial No. 13/343,672 (“the ‘672
`
`application”), Ex. 1008, filed on January 4, 2012.
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`4.
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`I have been asked by counsel for Amneal to explain the technical
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`subject matter of the ‘158 patent and its background. I have also been asked to
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`explain whether prior art discloses the compositions claimed in the ‘158 patent.
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`My opinions are set forth below.
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`1
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 1
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`II. QUALIFICATIONS & BACKGROUND
`5. My qualifications and credentials are fully set forth in my curriculum
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`vitae, attached hereto as Exhibit A. I am an expert in the fields of clinical
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`anesthesia and sedation, with significant experience with ready to use medications.
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`In particular, I am knowledgeable about the use of dexmedetomidine for sedation
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`purposes. For the past 24 years, I have accumulated significant training and
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`experience in these and related fields.
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`6.
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`In 1987, I received a B.S. in Biology from the University of Scranton.
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`In 1992, I received my M.D. from the School of Medicine at the University of
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`Pittsburgh. From 1992-1993, I attended Yale University as a Primary-Care
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`Internal Medicine intern. Through the Massachusetts General Hospital at Harvard
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`University, I completed my Anesthesiology Residency from 1993-1996 and
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`Critical Care Medicine Fellowship in 1997 as well as my Adult and Pediatric
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`Cardiac Anesthesiology Fellowship from 1995-1996 at the Massachusetts General
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`Hospital and Boston Children’s Hospital.
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`7.
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`Subsequent to my postgraduate work, I held the position of Instructor
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`at Harvard University in 1998 and as Assistant and Associate Professor at West
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`Virginia University from 1998-2005. From 2005 to the present, I have held the
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`position as Visiting Associate Professor at the University of Pittsburgh.
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`8.
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`In addition to my academic appointments, I am currently the Director
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`2
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 2
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`of Perioperative Medical Services, Transplant Anesthesiology and Trauma
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`Anesthesiology as well as the Chief Charge Anesthesiologist at the Children’s
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`Hospital of Pittsburgh of UPMC. I have been employed as an anesthesiologist
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`and/or intensivist since 1996 in a number of additional roles, as set forth in my CV,
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`Ex. A.
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`9.
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`Further, from 2000 to the present, I have gained a significant amount
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`of experience in the field of sedation by studying teaching the effect of
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`dexmedetomidine on patients. In particular, I am published in the field of
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`administration of dexmedetomidine and have given a multitude of invited lectures,
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`as enumerated in my CV, Ex. A.
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`10.
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` I am not an attorney or patent agent and I offer no legal opinions
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`herein. My opinions here are based on my professional experience, scientific
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`expertise, and the materials I have reviewed.
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`III.
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`INFORMATION CONSIDERED
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`11.
`
`In forming my opinions, I have reviewed the ‘158 patent, its
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`prosecution history, and other prior art references cited in this declaration. In
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`particular, I have reviewed the exhibits to Amneal’s petition listed in Exhibit B
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`attached hereto.
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`IV. THE ‘158 PATENT
`State of the Art
`A.
`12.
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`
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` The medical field has recognized dexmedetomidine as a general
`3
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 3
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`sedation/analgesic agent since 1988. Ex. 1005, U.S. Pat. No. 4,910,214 (“the ‘214
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`patent”), col. 3, ll. 55-59. Dexmedetomidine, (S)-4-[1-(2,3-dimethylphenyl)ethy]]-
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`1H-imidazole, which
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`is
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`the S-enantiomer of medetomidine,
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`4-[1-(2,3-
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`dimethylphenyl)ethy]]-7H-imidazole, has the following structure:
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`13.
`
`rw 6
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`Dexmedetomidine
`
`medetomidine
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`14. Medetomidine, a racemic mixture, was first disclosed in the prior art
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`in 1985, Ex. 1004, U.S. Pat. No. 4,544,664 (“the “664 patent’), col. 19, 1. 47 — col.
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`20, 1. 38, and separated into two enantiomers, one of which was dexmedetomidine,
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`in 1988, Ex. 1005, col. 1, ll. 8-43.
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`15. Additionally, no later than 1999 when dexmedetomidine entered the
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`US market, articles such as Venn, et al., Anaesthesia 54:1136-1142 (1999), Ex.
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`1024, established that the prior art disclosed methodsof sedating a patient while in
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`an intensive care unit by administering dexmedetomidine, or a pharmaceutically
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`acceptable salt thereof, to the patient.
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`16.
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`Thereafter, in 2004, U.S. Patent No. 6,716,867 likewise disclosed
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`methods of sedating a patient. Ex. 1006, U.S. Pat. No. 6,716,867 (“the “867
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`patent’). The ‘867 patent was issued on April 6, 2004, and therefore constitutes
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`4
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC — Exhibit 1002 — Page 4
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`prior art under the relevant section of the patent code as I have been informed by
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`counsel.
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`17. The ‘867 patent specifically relates to a method of sedating a patient
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`while in the intensive care unit by administering dexmedetomidine or a
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`pharmaceutically acceptable salt thereof to the patient. Ex. 1006, abstract. The ‘867
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`patent describes the use of dexmedetomidine that is diluted in 0.9% sodium
`
`chloride solution which is then ready for administration to patients. Id. at col. 7, ll.
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`60-65.
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`18. Administration of dexmedetomidine to a patient via parenteral
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`(including intravenous infusion and intramuscular, Ex. 1021, Dyck et al.,
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`Anesthesiology 78:813-820 (1993); Ex. 1022, Scheinin et al., Anesthesiology
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`78:1065-1075 (1993)), transmucosal (including buccal and intranasal, Ex. 1023,
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`Yuen et al., Anesth. Analg. 105:374-80 (2007)) and oral routes was within the
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`scope of the prior art. See also Ex. 1004 and Ex. 1005.
`
`19.
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`In the prior art, dexmedetomidine was provided as a concentrate that
`
`directed the user to dilute prior to administration to a patient. See, e.g., Ex. 1007,
`
`Sec. 2.4. Dexmedetomidine formulations for sedation were commercially available
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`in the U.S. as early as December 23, 1999, as PrecedexTM injection for intravenous
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`infusion following dilution (or alternatively “PrecedexTM Concentrate”).
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`20. The use of premix formulations of parental medications, particularly
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`5
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 5
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`those for use in an intensive care unit setting was also well known prior to the
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`filing date of the Patents-in-Suit. For example, Gerlach, Ex. 1020, proposes the use
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`of standardized drug preparations to improve medication safety in the ICU. See
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`also Giorgi, Ex. 1015 (most effective way to reduce microbial contamination in
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`ICU setting is use of ready to use solution). Thus, from at least these prior art
`
`references, one of ordinary skill in the art would have been well aware of the
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`properties of dexmedetomidine and the benefits of ready to use medications.
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`Scope of the ‘158 Patent
`
`B.
`21. The ‘158 patent generally relates to premixed pharmaceutical
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`compositions of dexmedetomidine for parenteral administration to patients. Ex.
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`1001, col. 2, ll. 61-66. In particular, the specification provides that suitable
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`containers include glass vials, ampoules, syringes, and plastic flexible containers,
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`such as polyvinyl chloride (PVC), VisIV™, polypropylene, and CR3 containers.
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`Id. at col. 9, ll. 17-23. The specification also provides numerous suitable
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`concentrations for the premixed concentrations, including 4 μg/mL. Id. at col. 7, l.
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`64 – col. 8, l. 16.
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`V. CLAIM CONSTRUCTION
`A. A Person of Ordinary Skill in the Art (POSA)
`I have been informed that construction of the terms of a patent claim
`22.
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`is to be done from the point of view of a POSA at the time of the invention. For
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`purposes of defining a POSA, I have assumed that the time of the invention is the
`6
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 6
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`date of filing of the ‘672 application, namely January 4, 2012.
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`23.
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`In formulating my opinions, I have relied upon my review of the
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`references cited, my experience in the relevant art, and also considered the
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`viewpoint of a POSA. In my opinion, the POSA at the time of invention would
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`have held an advanced degree, such as a Ph.D. or MD in the field of drug
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`development and formulation, or in the alternative would have significant clinical
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`experience in anesthesia or sedation and would have familiarity with the use of
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`parenteral injection and/or familiarity with ready to use medications, as of January
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`4, 2012.
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`B.
`24.
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`Broadest Reasonable Interpretation
`I have been advised by counsel that in an inter partes review
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`proceeding before the USPTO, like this one, a patent claim term is to receive the
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`“broadest reasonable interpretation” in light of the specification of the patent in
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`which it appears. I have also been advised that, at the same time, patent claim
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`terms are generally given their ordinary and customary meanings as would be
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`understood by a POSA.
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`25.
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`I have also been advised by counsel that patent claims are to be
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`construed first in the context of the specification, including the plain meaning of
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`the claims, of the patent. The prosecution history of the patent should also be
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`considered to the extent that it provides clarification.
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`7
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 7
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`26.
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`I have kept in mind these claim construction principles in the analysis
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`set forth below. In some cases, and where I have stated as such, my opinions have
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`also been informed by specific portions of the prosecution history of the ‘158
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`patent.
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`C. Claim Terms of the ‘158 Patent
`i. “Ready To Use”
`‘158 patent discloses an embodiment of
`27. The
`
`the claimed
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`pharmaceutical composition as being a “ready to use” liquid pharmaceutical
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`composition. I have set forth my understanding, as a person of ordinary skill in the
`
`art, of what the term “ready to use” means below.1
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`28. The claims of
`
`the ‘158 patent describe
`
`the claimed
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`liquid
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`pharmaceutical composition as being “ready to use” for parenteral administration.
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`For example, independent claim 1 of the ‘158 patent reads:
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`A ready to use liquid pharmaceutical composition for parenteral
`administration to a subject, comprising dexmedetomidine or a
`pharmaceutically acceptable salt thereof at a concentration of about 4
`μg/mL disposed within a sealed glass container.
`
`Ex. 1001, col. 26, ll. 4-8.
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`29. Also, the specification of the ‘158 patent discloses that the
`
`
`1 The dependent claims, in my opinion, do not introduce any terms that require
`
`construction.
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`8
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`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 8
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`formulation of dexmedetomidine can be “ready to use.” In particular, the
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`specification of the ’158 patent states:
`
`[i]n certain embodiments, the compositions of the present invention
`can be formulated as ‘ready to use’ compositions which refer to
`premixed compositions that are suitable for administration to a
`patient without dilution. For example, in certain embodiments, the
`compositions of the present invention are ‘ready to use’ upon
`removing the compositions from a sealed container or vessel.
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`Ex. 1001, at col. 3, ll. 56-63 (emphasis added).
`
`30. Additionally, the term “ready to use” is a well-known term of art in
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`the medical and pharmaceutical industry. See, e.g., Ex. 1044, “Injectable
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`medicines,” WHO Collaborating Centre
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`for Pharmaceutical Pricing and
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`Reimbursement Policies, http://whocc.goeg.at/Glossary/PreferredTerms
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`(last
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`visited August 9, 2016). It is my opinion that one of skill in the art would
`
`understand the term “ready to use” to mean “requiring no further dilution or
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`reconstitution before transfer to an administration device.” Id.
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`31. Based on these descriptions, and my understanding of how this term is
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`used by persons of ordinary skill in the art, it is my opinion that the broadest
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`reasonable interpretation of “ready to use” must include a liquid pharmaceutical
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`composition that requires no further dilution or reconstitution before administration
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`to a patient.
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`ii. “Dexmedetomidine”
`‘158 patent discloses an embodiment of
`32. The
`
`the claimed
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`
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`9
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 9
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`
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`pharmaceutical composition as comprising dexmedetomidine. The specification
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`further defines “dexmedetomidine” as “(S)-4-[1-(2,3-dimethylphenyl) ethyl]-1H-
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`imidazole,” and provides the following chemical formula:
`
`Ex. 1001, col. 3, ll. 21-45.
`
`
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`33. The specification of the ‘158 patent defines dexmedetomidine as a
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`“substantially pure, optically active dextrorotary stereoisomer of medetomidine, as
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`the free base or pharmaceutically acceptable salt.” Ex. 1001, col. 3, ll. 21-24.
`
`Therefore, it is my opinion that the broadest reasonable interpretation of
`
`“dexmedetomidine” means “substantially pure, optically active dextrorotary
`
`stereoisomer of medetomidine, as the free base or pharmaceutically acceptable
`
`salt.” Id.
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`VI. THE CLAIMED INVENTION IS WELL-KNOWN IN THE ART
`I understand that during prosecution of the ‘672 application,
`34.
`
`Applicants submitted arguments to overcome an obviousness rejection over the
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`Precedex Draft Label. Ex. 1012, Office Action Response, mailed Mar. 13, 2012,
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`U.S. Application No. 13/343,672.
`
`35. Specifically, Applicants argued that the Precedex™ draft label failed
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`10
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`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 10
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`to suggest or describe that the diluted 4 μg/mL dexmedetomidine composition is
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`disposed within a sealed glass container. Id. at p. 7.
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`36. The applicants argued
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`that “upon withdrawing
`
`the claimed
`
`composition from a sealed glass container, an artisan of ordinary skill can
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`administer the composition directly to a subject” whereas the Precedex™ draft
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`label composition would be “not suitable for administering to a patient upon
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`withdrawing the composition from a sealed container.” Id.
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`37. Applicants further argued
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`that
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`the ready
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`to use premixture
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`composition in a sealed glass container is more stable over a prolonged period
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`compared to, for example, the premixture composition in a plastic container. Id. at
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`p. 8.
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`38.
`
`In my opinion, one of skill in the art would have had a reasonable
`
`expectation of success of storing the diluted formulation for extended period of
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`time. In fact, my own institution has been utilizing a pharmacy made under sterile
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`conditions 4 mcg/cc (i.e., 4 μg/mL) dilution stored in acceptable syringes up to one
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`week with no apparent adverse events since at least 2007, Ex. 1035, Cain,
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`TraumaCare 13:3-5 (2007), and it appears from Anderson et al., Ex. 1038, Am. J.
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`Health Syst. Pharm. 69:595-7 (2012), that Utah pharmacy had similar findings
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`with minimal degradation in polyproylene syringes and references in document to
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`such considerations in direct communication with Hospira in 2011.
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`11
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 11
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`39.
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`In my review of the prosecution history of the ‘158 I note that
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`applicants relied upon an FDA Memorandum by Cynthia G. McCormick, M.D.,
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`dated November 30, 1999 (“the McCormick FDA Memorandum”) to support their
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`argument that the diluted 4 μg/mL dexmedetomidine composition was known in
`
`the art to be is stable for only 24 hours. Ex. 1013, p. 8.
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`40. Having reviewed Applicants’ arguments, I conclude that the results
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`achieved with the claimed invention would not have been unexpectedly superior
`
`over the results that would be obtained by products already known in the prior art.
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`41.
`
`In my opinion, the undiluted PrecedexTM solution disclosed in the
`
`2010 Label is ready to use for parenteral administration to a patient in some
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`circumstances.
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`42. Furthermore, and in contrast to some medications which require
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`central venous administration unless diluted (e.g. dopamine, potassium and
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`parenteral nutrition), insofar as I can ascertain there is no documented harm in
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`administration of intravenous dexmedetomidine at 100mcg/ml other than the
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`inconvenience of its relatively small volume.
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`43. Based on my experience, dexmedetomidine is routinely administered
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`parentally (primarily intramuscularly) and transmucosally to patients in the
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`undiluted concentration of 100 mcg/mL directly from the vial as described in the
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`2010 Precedex Label and demonstrates successful results. For example, undiluted
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`12
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`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 12
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`intranasal administration has become a prime method of sedation for pediatric
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`patients at the Children’s Hospital of Pittsburgh.
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`44.
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`In fact, as part of my usual practice, I, and our sedation team in
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`general, administer PrecedexTM to patients at the provided, undiluted concentration
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`of 100 μg/mL, directly from the glass vial. In my opinion, the undiluted
`
`concentration of PrecedexTM, without dilution, is ready to use, just as effective as
`
`the diluted formulation and the preferred concentration for intramuscular and
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`transmucosal administration. This 100mcg/cc concentration of ready to use
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`dexmedetomidine is typically used for preoperative premedication and procedural
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`sedation either as a solo agent or an adjunct with medications such as midazolam
`
`and ketamine. See also Ex. 1039, G. DiSilvio, M. Jacoby, D. Weiner, A.
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`Broussard, P. Callahan, and J. Cain, “Intranasal Dexmedetomidine & Midazolam:
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`A Novel Sedation Technique for Infant PFT,” Society for Pediatric Anesthesia,
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`Phoenix, Arizona (March 2015).
`
`45. The 2010 Precedex Label directed a POSA to prepare a 4 μg/mL
`
`solution of PrecedexTM for parenteral administration via intravenous infusion by
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`diluting 2 mL of PrecedexTM in 48 mL of 0.9% sodium chloride injection to a total
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`of 50 mL.
`
`46. Dexmedetomidine is also routinely administered in the diluted
`
`concentration of 4 mcg/mL by following the dilution instructions set forth by the
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`
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`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 13
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`1999 Precedex package insert and the 2010 Precedex Label.
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`47. Given the routine use and general acceptance of “ready to use” in the
`
`industry, and as shown in the prior art, a POSA would have been motivated to
`
`create an embodiment that falls within the scope of claims 1-4 based on available
`
`prior art.
`
`48.
`
`In my experience, dosages in “ready to use” form are commonly used
`
`and have been for a number of decades.
`
`49.
`
`In fact, differential dilution is routine and necessary in medical
`
`practice in order to tailor the appropriate amount and concentration of drug to be
`
`administered under particular sets of circumstances, such as for pediatric patients,
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`to maintain osmolality, to avoid phlebitis and/or to avoid fluid overload. See Ex.
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`1040, Neu et al., Crit. Care Med. 10:610-12 (1982); Ex. 1041, Potts et al.,
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`Pediatrics 113:59-62 (2004); Ex. 1042, Merry et al., Pediatric Anesthesia 21:743-
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`753 (2011); Ex. 1043, Rodriguez-Gonzalez et al., J. Am. Med. Info. Assoc. 1:72-
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`78 (2012). Additionally, many locations, including Children’s Hospital of
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`Pittsburgh, have discontinued nearly all ICU bedside differential dilutional
`
`preparations and moved them to sterile preparation by pharmacy. See Ex. 1038.
`
`50.
`
`In fact, prior to January 4, 2012, I asked our pharmacy to prepare 10
`
`mL premixed syringes of dexmedetomidine at a diluted concentration of 4 mcg/mL
`
`for use as an anesthetic. Ex. 1035.
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`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 14
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`51. Since 2005 our pharmacy has been preparing these syringes in a
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`sterile setting. They determined that per their review of literature and customary
`
`treatment of other medications they routinely dilute, that a shelf life of 7 days was
`
`acceptable. I am unaware of any adverse events attributable to this practice since it
`
`began.
`
`52. Additionally, Applicant’s reliance upon the FDA Memorandum by
`
`Cynthia G. McCormick, M.D. does not actually support their argument that the
`
`diluted 4 μg/mL dexmedetomidine composition was known in the art to be is stable
`
`for only 24 hours.
`
`53.
`
`Instead, it is clear that the 24-hour limit was merely based on the FDA
`
`approved indications for use.
`
`54.
`
`In fact, Hospira itself sponsored studies in which the medication was
`
`administered for more than 24 hours to pediatric patients. See, e.g., Ex. 1045,
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`Chrysostomou et al., Pediatric Crit. Care Med. 10:654-60 (2009). Indeed, there is
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`no mention of stability or instability in the documents relied upon by Applicants.
`
`55. A POSA would not understand stability of the dexmedetomidine to be
`
`limited to 24 hours.
`
`56. Therefore, it is my opinion that in view of the routine nature of
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`medical practice to choose the appropriate amount and concentration of drug to be
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`administered under particular sets of circumstances, it would have been obvious
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`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 15
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`for a POSA to prepare a ready to use solution of dexmedetomidine hydrochloride
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`within the scope of claims 1-4.
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`VII. CONCLUDING STATEMENTS
`In signing this declaration, I understand that the declaration will be
`57.
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`filed as evidence in a contested case before the Patent Trial and Appeal Board of
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`the United States Patent and Trademark Office. I acknowledge that I may be
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`subject to cross-examination in this case and that cross-examination will take place
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`within the United States. If cross-examination is required of me, I will appear for
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`cross-examination within the United States during the time allotted for cross-
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`examination.
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`58.
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`I declare that all statements made herein of my knowledge are true,
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`and that all statements made on information and belief are believed to be true, and
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`that these statements were made with the knowledge that willful false statements
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`and the like so made are punishable by fine or imprisonment, or both, under
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`Section 1001 of Title 18 of the United States Code.
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`16
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 16
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`17
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`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 17
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`EXHIBIT A
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`Curriculum Vitae – James Gordon Cain
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`
`
`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 18
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`
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`CURRICULUM VITAE
`
`June 2016
`
`James Gordon Cain, MD, MBA, FAAP
`Director, Perioperative Medical Services, Children’s Hospital of Pittsburgh of UPMC
`Director, Transplant Anesthesiology, Children’s Hospital of Pittsburgh of UPMC
`Director, Trauma Anesthesiology, Children’s Hospital of Pittsburgh of UPMC
`Visiting Associate Professor, Department of Anesthesiology, University of Pittsburgh
`Past President, International Trauma Anesthesiology and Critical Care Society
`Past President, West Virginia Society of Anesthesiologists
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`BIOGRAPHICAL
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`Birth Date
`February 25
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`Name
`James Gordon Cain, MD, MBA, FAA P
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`Home Address
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`107 Sherborne Drive
`McMurray, Pennsylvania 15317
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`Cell Phone
`724.506.3141
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`
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`Business Address
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`Department of Anesthesiology
`Children’s Hospital of Pittsburgh of UPMC
`4401 Penn Avenue
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`Pittsburgh, Pennsylvania 15224
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`Business Phone
`412.692.5260
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`Birth Place
`Towanda, Pennsylvania
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`Citizenship
`United States of America
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`Hospital: cainj@upmc.edu
`University: jgc13@pitt.edu
`Personal: jamesgcain@gmail.com
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`Business Fax
`412.692.8685
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`EDUCATION AND TRAINING
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`POSTGRADUATE
`1997
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`Massachusetts General Hospital
`Harvard University
`
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`
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`James Gordon Cain, MD, MBA, FAAP
`
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`Critical Care Medicine Fellowship
`William Hurford, MD
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`1
`
`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 19
`
`
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`CURRICULUM VITAE
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`Boston, Massachusetts
`
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`1995-1996 Massachusetts General Hospital
`Boston Children’s Hospital
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`Harvard University
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`Boston, Massachusetts
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`1993-1996 Massachusetts General Hospital
`Harvard University
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`
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`Yale University
`New Haven, Connecticut
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`1992-1993
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`PROFESSIONAL
`1987-1992
`University of Pittsburgh
`School of Medicine
`Pittsburgh, Pennsylvania
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`
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`GRADUATE
`Katz Graduate School of Business
`2014-2018
`Anticipated University of Pittsburgh
`
`Pittsburgh, Pennsylvania
`
`
`Katz Graduate School of Business
`University of Pittsburgh
`Pittsburgh, Pennsylvania
`
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`2011-2012
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`2001-2003
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`UNDERGRADUATE
`1983-1987
`University of Scranton:
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`Adult and Pediatric Cardiac
`Anesthesiology Fellowship
`Michael D’Ambra, MD
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`Anesthesiology Residency
`Warren Zapol, MD
`
`Primary-Care Internal Medicine
`Internship
`Stephen Huot, MD, PhD
`
`MD, 1992
`
`PhD, Organization Behavior and
`Human Resource Management
`Minor: Strategic Management
`
`MBA, International, 2012
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`Business Administration
`Courses
`
`Auburn University/Southern Medical
`Association
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`
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`
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`James Gordon Cain, MD, MBA, FAAP
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`BS, 1987, Biology
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`2
`
`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 20
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`CURRICULUM VITAE
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`
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`
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`A Jesuit Institution
`Scranton, Pennsylvania
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`Minor, History
`Cognate, Chemistry
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`APPOINTMENTS AND POSITIONS
`ACADEMIC APPOINTMENTS
`2005-present University of Pittsburgh
`School of Medicine
`Pittsburgh, Pennsylvania
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`Visiting Associate Professor
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`Harvard University
`School of Medicine
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`Harvard University
`School of Medicine
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`2004-2005 West Virginia University
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`School of Medicine
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`1998-2004 West Virginia University
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`School of Medicine
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`1998
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`1993-1997
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`NON-ACADEMIC APPOINTMENTS AND POSITIONS
`2014-present Children’s Hospital of Pittsburgh of UPMC Director
`Pittsburgh, Pennsylvania
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`Transplant Anesthesiology
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`2014-present Children’s Hospital of Pittsburgh of UPMC Founding Member
`Pittsburgh, Pennsylvania
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`Radiology Anesthesiology Team
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`Associate Professor
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`Assistant Professor
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`Instructor
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`Clinical Fellow
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`2012-present Children’s Hospital of Pittsburgh of UPMC Founding Member
`Pittsburgh, Pennsylvania
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`Transplant Anesthesiology Team
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`2008-present Children’s Hospital of Pittsburgh of UPMC Director
`Pittsburgh, Pennsylvania
`
`
`Perioperative Medical Services
`
`James Gordon Cain, MD, MBA, FAAP
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`
`
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`3
`
`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 21
`
`
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`CURRICULUM VITAE
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`2008-present Children’s Hospital of Pittsburgh of UPMC Chief Charge Anesthesiologist
`Pittsburgh, Pennsylvania
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`2005-present Children’s Hospital of Pittsburgh of UPMC Director
`Pittsburgh, Pennsylvania
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`Trauma Anesthesiology
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`2005-present Children’s Hospital of Pittsburgh of UPMC Pediatric Transplant
`Pittsburgh, Pennsylvania
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`Anesthesiologist
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`2005-present Children’s Hospital of Pittsburgh of UPMC Pediatric Anesthesiologist
`Pittsburgh, Pennsylvania
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`2005-2011
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`2007-2008
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`2008
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`2008
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`2005-2008
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`1998-2005
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`UPMC Presbyterian Hospital
`Pittsburgh, Pennsylvania
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`Anesthesiologist
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`Children’s Hospital of Pittsburgh of UPMC Charge Anesthesiologist
`Pittsburgh, Pennsylvania
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`Children’s Hospital of Pittsburgh of UPMC Pediatric Pain Physician
`Pittsburgh, Pennsylvania
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`Children’s Hospital of Pittsburgh of UPMC
`Pittsburgh, Pennsylvania
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`Children’s Hospital of Pittsburgh of UPMC Pediatric Cardiac Anesthesiologist
`Pittsburgh, Pennsylvania
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`Interim Associate Director
`Perioperative Medical Services
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`
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`Ruby Memorial Hospital
`Robert C. Byrd Health Sciences Center
`West Virginia University
`Morgantown, West Virginia
`
`Charge Anesthesiologist
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`James Gordon Cain, MD, MBA, FAAP
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`4
`
`Petition for Inter Partes Review of US 8,242,158
`Amneal Pharmaceuticals LLC – Exhibit 1002 – Page 22
`
`
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`CURRICULUM VITAE
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`1998-2005
`
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`1998-2005
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`
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`Ruby Memorial Hospital
`Robert C. Byrd Health Sciences Center
`West Virginia University
`Morgantown, West Virginia
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`
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`Ruby Memorial Hospital
`Robert C. Byrd Health Sciences Center
`West Virginia University
`Morgantown, West Virginia
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`Cardiac Anesthesiologist
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`Anesthesiologist
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`1998-2005
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`Anesthesiologist
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`Chestnut Ridge Hospital
`Robert C. Byrd Health Sciences Center
`West Virginia University
`Morgantown, West Virginia
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`1998-2005 West Virginia University Children’s Hospital Pediatric Anesthesiologist
`Robert C. Byrd Health Sciences Center
`West Virginia University
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`2003-2005
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`2003-2004
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`2003-2004
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`2003-2004
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`Ruby Memorial Hospital
`Robert C. Byrd Health Sciences Center
`West Virginia University
`Morgantown, West Virginia
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`Intensivist
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`Allegheny General Hospital
`Pittsburgh, Pennsylvania
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`Allegheny General Hospital
`Pittsburgh, Pennsylvania
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`Allegheny General Hospital
`Pittsburgh, Pennsylvania
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`Director
`Trauma Anesthesiology
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`Cardiac Anesthesiologist
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`Pediatric Anesthesiologist
`
`James Gordon Cain, MD, MBA, FAAP
`
`
`5
`
`Petition for In