UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.
`MYLAN LABORATORIES LIMITED
`Petitioner
`
`v.
`
`QUALICAPS CO. LTD.
`Patent Owner
`
`U.S. Patent No. 6,649,180
`Filing Date: April 13, 2000
`Issue Date: November 18, 2003
`Title: HARD CAPSULE FORMED OF CELLULOSE ETHER FILM WITH A
`SPECIFIC CONTENT OF METHOXYL AND HYDROXYPROPOXYL
`GROUPS
`
`Inter Partes Review No. Unassigned
`
`DECLARATION OF ARTHUR H. KIBBE IN SUPPORT OF PETITION
`
`FOR INTER PARTES REVIEW OF U.S. PATENT NO. 6,649,180
`
`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.100 ET SEQ.
`
`iPetitioner Mylan Pharmaceuticals Inc. - Exhibit 1011 - Page 1
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`TABLE OF CONTENTS
`I. INTRODUCTION ...................................................................................... - 1 - II.
`
`MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(B) ........................ -
`
`1 - A. REAL PARTY IN INTEREST ........................................................ - 1 -
`
`B. RELATED MATTERS ....................................................................
`- 1 -
`C. PAYMENT OF FEES ...................................................................... - 2 -
`
`D. DESIGNATION OF LEAD COUNSEL ......................................... - 3 -
`
`E. SERVICE INFORMATION ............................................................ - 3 -
`
`F.
`
`POWER OF ATTORNEY ............................................................... - 4 -
`
`III. REQUIREMENTS FOR INTER PARTES REVIEW................................. -
`
`4 - A. GROUND FOR STANDING........................................................... -
`
`4 - B. IDENTIFICATION OF CHALLENGE........................................... -
`
`5 - 1. Claims Challenged ................................................................. - 5 -
`
`2.
`
`3.
`
`Background of the Technology.............................................. - 5 -
`
`Prior Art ............................................................................... - 12 -
`
`I.
`
`II.
`
`III.
`
`IV.
`
`SCOPE OF THE REPORT ...................................................................1
`
`QUALIFICATIONS AND EXPERIENCE ..........................................3
`
`TECHNOLOGY BACKGROUND OF CLAIMED SUBJECT
`MATTER OF THE ’180 PATENT ..................................................... 7
`
`A.
`
`B.
`
`Thermal Gelling ..........................................................................8
`
`Additive Gelling........................................................................10
`
`C. STATEMENT OF THE PRECISE RELIEF REQUESTED ......... - 13 -
`IV.OVERVIEW OF THE ’180 PATENT .....................................................
`- 13 - A.PRIORITY DATE OF THE ’180 PATENT .................................. -
`i
`
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`13 -.......................................................................................................13
`SUMMARY OF THE ’180 PATENT............................................ - 14 -
`
`C. PERSON OF ORDINARY SKILL IN THE ART......................... - 15 -
`D. 15
`
`B.
`
`V.
`
`VI.
`
`IDENTIFICATION OF THE PRIOR ART ........................................15
`
`A.
`
`B.
`
`Yamamoto.................................................................................15
`
`The Japanese Pharmacopeia .....................................................16
`
`C.
`Greminger .................................................................................16
`VII. CLAIM CONSTRUCTION ........................................................... - 15 - 1.
`.............................................................................................................17
`
`A.
`
`B.
`
`“gelling agent” ..................................................................... - 17 -.
`...................................................................................................17
`
`2. “gelling aid” ......................................................................... - 18 -
`...................................................................................................18
`
`VIII. STATEMENT OF LEGAL PRINCIPLES .........................................18
`
`IX. UNPATENTABILITY OF THE ’180 PATENT CLAIMS................19
`
`A.
`
`Ground 1: Claims 1 and 4 are Unpatentable as Obvious
`in View of Yamamoto in Combination with Japanese
`Pharmacopeia
`19
`
`1.
`
`Claim 1............................................................................19
`
`i.
`
`Limitation [1.1] “A hard capsule formed of a
`film composition comprising a
`
`i
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`hydroxypropyl methyl cellulose as a base, a
`LEGAL STANDARDS ............................................................................ -
`
`V.
`19 -
`
`Obviousness.................................................................................... -
`
`A.
`19 -
`
`VI.FULL STATEMENT OF THE REASONS FOR THE RELIEF REQUESTED
`........................................................................................... - 21 -
`
`A.GROUND 1: CLAIMS 1 AND 4 ARE UNPATENTABLE AS
`OBVIOUS IN VIEW OF YAMAMOTO IN
`COMBINATION WITH JAPANESE PHARMACOPEIA
`........................................ - 21 -
`
`Brief Summary of Yamamoto.............................................. -
`
`1.
`21 -
`
`2.
`
`Brief Summary of Japanese Pharmacopeia ......................... -
`22 - 3. Claim 1 ................................................................................. -
`
`22 - 4. Claim 4 ................................................................................. -
`
`33 -
`
`ii.
`
`gelling agent, and a gelling aid.”..........................19
`
`Limitation [1.2] wherein said hydroxypropyl
`methyl cellulose has a content of
`hydroxypropoxyl groups of at least 4% by
`weight of the hydroxypropyl methyl
`cellulose and a content of methoxyl groups
`and hydroxypropoxyl groups combined of 23
`to 37.6% by weight of the hydroxypropyl
`methyl cellulose....................................................21
`
`2.
`
`Claim 4............................................................................30
`
`i.
`
`Limitation [4.1] The hard capsule formed of
`a film of claim1, wherein the content of
`methoxyl and hydroxypropoxyl groups
`combined is 29 to 37% by weight of the
`ii
`
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`hydroxypropyl methyl cellulose...........................30
`
`B.
`
`GROUND 2: CLAIMS 1 AND 4 ARE UNPATENTABLE AS
`OBVIOUS IN VIEW OF GREMINGER
`...................................... - 41 -Ground 2: Claims 1 and 4 are
`Unpatentable as Obvious in View of Greminger
`38
`
`Brief Summary of Greminger .............................................. -
`
`Claim 1 ................................................................................. -
`
`Claim 4 ................................................................................. -
`
`1.
`41 -
`
`2.
`41 -
`
`3.
`48 -
`
`1.
`
`Claim 1............................................................................38
`
`i.
`
`ii.
`
`Limitation [1.1] “A hard capsule formed of a
`film composition comprising a
`hydroxypropyl methyl cellulose as a base, a
`gelling agent, and a gelling aid.”..........................38
`
`Limitation [1.2] wherein said hydroxypropyl
`methyl cellulose has a content of
`hydroxypropoxyl groups of at least 4% by
`weight of the hydroxypropyl methyl
`cellulose and a content of methoxyl groups
`and hydroxypropoxyl groups combined of 23
`to 37.6% by weight of the hydroxypropyl
`methyl cellulose....................................................41
`
`2.
`
`Claim 4............................................................................44
`
`ii
`
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`i.
`
`Limitation [4.1] The hard capsule formed of
`a film of claim1, wherein the content of
`methoxyl and hydroxypropoxyl groups
`combined is 29 to 37% by weight of the
`hydroxypropyl methyl cellulose...........................44
`
`C.
`
`THE PROPOSED GROUNDS FOR REJECTION
`ADDRESS PATENTEE’S ASSERTED
`UNEXPECTED BENEFIT OF SHELL CLARITY AND
`STABILITY.......................................... - 51 -The
`Proposed Grounds for Rejection Address Patentee’s
`Asserted Unexpected Benefit of Shell Clarity and
`Stability............................................................................................47
`
`1.
`
`2.
`
`Yamamoto.......................................................................48
`
`Greminger.............................................................................49
`
`X.
`
`VII.
`CONCLUSION.........................................................................................
`- 55 - ...........................................................................................................51
`
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`EXHIBIT LIST
`
`Exhibit No. Description
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`United States Patent No. 6,649,180
`
`Complaint, Warner Chilcott (US), LLC et al. v. Mylan
`Pharmaceuticals, Inc., et al., Case No. 2:15-cv-01740-JRG-RSP
`(E.D. Texas)
`
`Proof of Service of Complaint, Case No. 2:15-cv-01740-JRG-
`RSP (E.D. Texas)
`
`United States Patent No. 5,756,123 (“Yamamoto”)
`
`The Japanese Pharmacopeia (The Society of Japanese
`Pharmacopeia, 13th ed. 1996) (“Japanese Pharmacopeia”)
`
`United States Patent No. 3,493,407 (“Greminger”)
`
`21 C.F.R. § 172.874 (1998)
`
`National Formulary (American Pharmaceutical Association,
`12th ed. 1965)
`
`Handbook of Pharmaceutical Excipients (1986)
`
`File History of United States Patent No. 6,649,180
`
`Expert Declaration of Arthur H. Kibbe
`
`Shin-Etsu Chemical Co., Ltd. PHARMACOAT Technical
`Information
`Shin-Etsu Chemical Co., Ltd. TC-5 Technical Information
`
`Chichester, C.O., E.M. Mrak, and G.F. Stewart, “Utilization of
`Synthetic Gums in the Food Industry,” Advances in Food
`Research, Volume 12, Technical Center, General Foods
`Corporation, Tarrytown, N.Y., 1963.
`
`Deposition Transcript of Jason T. McConville, Ph.D., Case No.
`2:15-cv-1471-JRG-RSP (E.D. Tex.), July 8, 2016
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`iii
`
`I, Arthur H. Kibbe, being over the age of 18 and competent to make the
`
`statements herein, hereby declare the following:
`
`I.
`
`INTRODUCTIONSCOPE OF THE REPORT
`
`Through counsel, real parties in interest
`
`1.
`
`I have been retained on behalf of Petitioner Mylan
`
`Pharmaceuticals Inc. (“Mylan” or “Petitioner”) hereby respectfully petitions
`
`for institution of inter partes review of U.S. Patent No. 6,649,180 (the “’180
`
`Patent”), titled “HARD CAPSULE FORMED OF CELLULOSE ETHER
`
`FILM WITH A SPECIFIC CONTENT OF METHOXYL AND
`
`HYDROXYPROPOXYL GROUPS.” Ex.
`
`1001. The ’180 Patent is currently asserted in a co-pending litigation, and this
`
`petition is being filed within one year of Petitioner being served with a complaint
`
`for infringement. See Ex. 1002. Thus, the ’180 Patent is eligible for inter partes
`
`review.
`
`II.MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(B)
`
`A.REAL PARTY IN INTEREST
`
`The following real parties-in-interest are identified: Mylan
`
`Pharmaceuticals Inc., which is the Petitioner in this matter, and Mylan
`
`Laboratories Limited, both of which are wholly owned subsidiaries of Mylan
`
`Inc.; Mylan Inc., which is an indirectly wholly owned subsidiary of Mylan N.V.;
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1011 - Page 6
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`and Mylan N.V.
`
`B.RELATED MATTERS
`
`The ‘180 Patent is the subject of a civil action filed by Warner Chilcott
`
`(US), LLC, Warner Chilcott Company, LLC, and Qualicaps Co., Ltd. against
`
`Mylan Pharmaceuticals, Inc., Mylan Laboratories Ltd., and Mylan, Inc. This
`
`lawsuit was
`
`filed in the United States District Court for the Eastern District of Texas on
`
`November 9, 2015. Warner Chilcott (US), LLC et al. v. Mylan Pharmaceuticals,
`
`Inc., et al., Case No. 2:15-cv-01740-JRG-RSP (consolidated for the purposes of
`
`claim construction and discovery with Case No.
`
`2:15-cv-01471-JRG-RSP).Petitioner” or “Mylan”) as an independent expert
`
`consultant to analyze and provide my opinions on the invalidity of U.S. Patent
`
`No. 6,649,180 (the “’180 Patent”), and such other topics as addressed in this
`
`report.
`
`2.
`
`As part of this work, I have been requested by counsel for
`
`Petitioner to study Claims 1 and 4 of the ’180 Patent and opine on their
`
`invalidity.
`
`3.
`
`Ex. 1002. Qualicaps is the owner of the ’180 Patent.I understand
`
`based on information and belief, including assignment information available
`
`in the United States Patent and Trademark Office Patent Assignment
`
`Database, the ’180 Patent was initially assigned to Shionogi Qualicaps Co.,
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1011 - Page 7
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`Ltd. and is currently assigned to Qualicaps Co., Ltd. Upon information and
`
`belief, Warner Chilcott Company, LLC has an exclusive license to
`
`manufacture a drug called DELZICOL® under the ’180 Patent. Rejection and
`
`cancellation of Claims 1 and 4 of the ’180 Patent will prevent Patent Owner
`
`from claiming technologies in the public domain as its own and prevent it
`
`from asserting these invalid claims to exclude others in commerce.
`
`The following pending actions also involve the ’180 Patent: Warner
`
`Chilcott (US), LLC et al. v. Teva Pharmaceuticals USA, Inc. et al., Case No.
`
`2:15- cv-01471-JRG-RSP (consolidated with Case No.
`
`2:15-cv-01740-JRG-RSP) (E.D. Tex.), Warner Chilcott (US), LLC et al. v.
`
`Zydus Pharmaceuticals (USA) Inc. et al., Case No. 2:16-cv-00323-JRG-RSP
`
`(E.D. Tex.), and Warner Chilcott (US), LLC et al. v. Teva Pharmaceuticals USA,
`
`Inc. et al., Case No. 1:15-cv-00761-GMS (D. Del.).
`
`C.PAYMENT OF FEES
`
`A payment of $23,000 may be charged against Deposit Account No. 20-
`
`1430. Thus, this Petition meets the fee requirements under 37 C.F.R. § 42.15 and
`
`35 U.S.C. § 312(a)(1).
`
`4.
`
`In this declaration, I will discuss the technology related to the
`
`’180 Patent, including an overview of that technology as it was known at the
`
`1 E
`
`TITIONER MYLAN EXHIBIT 1010
`
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`D.DESIGNATION OF LEAD COUNSEL
`
`Lead Counsel for Petitioner is Mitchell G. Stockwell (Reg. No. 39,389),
`
`of Kilpatrick Townsend & Stockton LLP. David C. Holloway (Reg. No.
`
`58,011), Miranda C. Rogers (Reg. No. 73,339), and Jonathan D. Olinger (pro
`
`hac vice to be filed) also of Kilpatrick Townsend & Stockton LLP are Backup
`
`Counsel for Petitioner.
`
`E.SERVICE INFORMATION
`
`As identified in the attached Certificate of Service, a copy of this
`
`Petition, in its entirety, is being served to the address of the attorney or agent of
`
`record in the Patent Office for the ’180 Patent, as well as counsel of record for
`
`the Patent Owner in the above-referenced litigation. Counsel for Petitioner
`
`may be contacted via the methods below:
`
`Mitchell G. Stockwell
`Registration No. 39,389
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, Suite 2800
`Atlanta, GA 30309-4528
`I.
`815-6500 (telephone)
`I.
`541-3403 (facsimile)
`
`David C. Holloway
`Registration No. 58,011
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, Suite 2800
`Atlanta, GA 30309-4528
`9.
`815-6500 (telephone)
`541-3403 (facsimile)
`B.
`
`Miranda C. Rogers
`Registration No. 73,339
`Kilpatrick Townsend & Stockton LLP
`1400 Wewatta Street, Suite 600
`Denver, CO 80202
`A.
`571-4000 (telephone)
`571-4321 (facsimile)
`B.
`
`-2
`
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`Jonathan D. Olinger (pro hac vice to be
`filed) Kilpatrick, Townsend & Stockton
`LLP 1100 Peachtree Street, Suite 2800
`Atlanta, GA 30309-4528
`A.
`815-6500 (telephone)
`541-3403 (facsimile)
`0
`
`The following email address may be used for service and all
`
`communications to both Lead and Backup Counsel:
`
`Mylan-WC-IPR@kilpatricktownsend.com
`
`F.POWER OF ATTORNEY
`
`Pursuant to 37 C.F.R. § 42.10(b), a Power of Attorney executed by
`
`Petitioner for appointing the above designated counsel is concurrently
`
`filed.
`
`III.REQUIREMENTS FOR INTER PARTES REVIEW
`
`This Petition meets and complies with all requirements under 37 C.F.R.
`
`§ 42.104 for inter partes review of Claims 1 and 4 of the ’180 Patent.
`
`A.GROUND FOR STANDING
`
`Pursuant to 37 C.F.R. § 42.104(a), Petitioner certifies that the ’180
`
`Patent is available for inter partes review, and further certifies that Petitioner
`
`is not barred or estopped from requesting an inter partes review challenging
`
`the ’180 Patent on the grounds identified herein. The ’180 Patent has not been
`
`subject to a previous estoppel-based proceeding of the AIA, and the Complaint
`
`-3
`
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`served on Petitioner was
`
`time of the earliest filing date of April 13, 2000. This overview of the relevant
`
`technology provides some of the bases for my opinions with respect to the
`
`’180 Patent.
`
`5.
`
`In forming my opinions, I have relied upon the ’180 Patent, the
`
`prosecution history of the ’180 Patent, the Exhibits to the Petition for Inter
`
`Partes Review of the ’180 Patent, and my own experience and expertise in
`
`the relevant technologies and systems that were already in use prior to, and
`
`within the timeframe of the earliest priority date of the claimed subject
`
`matter in the ’180 Patent – April 13, 2000.
`
`6.
`
`This declaration is based on the information currently available
`
`to me. To the extent that additional information becomes available, I reserve
`
`the right to continue my investigation and study, which may include a review
`
`of documents and information that may be produced, as well as testimony
`
`from depositions that may not yet be taken.
`
`7.
`
`My opinions and conclusions are set forth below. If called
`
`upon to testify, I am prepared to do so.
`
`8.
`
`I am being compensated at my standard rate of $750 per hour
`
`for the time I spend on this matter. No part of my compensation is
`
`dependent upon the outcome of this proceeding, and I have no financial or
`
`other economic interest in this matter.
`
`-4
`
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`served within the last twelve months, on November 9, 2015. See Exs. 1002 and
`
`1003.
`
`B.IDENTIFICATION OF CHALLENGE
`II. QUALIFICATIONS AND EXPERIENCE
`9.
`I am an emeritus Professor of Pharmaceutical Sciences at the
`
`Wilkes University School of Pharmacy, Wilkes University, as well as the
`
`former Chair of the Department of Pharmaceutical Sciences in the School of
`
`Pharmacy. I earned a Bachelor of Science degree in Pharmacy from
`
`Columbia University in 1966, a Master of Science degree in
`
`Pharmacy/Pharmaceutics from the University of Florida in 1968, and my
`
`Ph.D. in Pharmaceutics from that institution in 1973. My areas of
`
`concentration at that time were Pharmaceutics, Pharmacokinetics and
`
`Biopharmaceutics. My dissertation was on the stability of solid dosage
`
`forms. I joined the faculty of the Department of Pharmaceutical Sciences at
`
`Wilkes University as its Chair in 1994. In that capacity, I oversaw the
`
`construction of the laboratory and research space in the then new School of
`
`Pharmacy, and continue to direct the faculty and teach undergraduate and
`
`professional courses in pharmaceutics (dosage form design and manufacture)
`
`and pharmacokinetics.
`
`10.
`
`I have held a variety of positions in academia, industry, and the
`
`government over the course of my career. My work has been largely
`
`-3
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`concentrated in the fields of pharmaceutical formulation development;
`
`pharmacokinetics; and the pharmaceutical testing, regulatory and approval
`
`11.
`
`Pursuant to 37 C.F.R. § 42.104(b), the precise relief requested by
`
`Petitioner is that the Patent Trial and Appeal Board invalidate Claims 1 and 4 of
`
`the ’180 Patent.
`
`Claims Challenged
`
`-4
`
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`processes. I served as the Chief of Pharmaceutical Development Services for
`
`the National Institutes of Health (NIH) from 1984-1985. In that position, I
`
`directed a staff of 15 scientists, developed delivery systems for Phase I
`
`clinical trials, and supported the internal NIH clinical research program. As
`
`the Senior Director of Professional and Scientific Affairs for the American
`
`Pharmaceutical Association from 1987-1992, my responsibilities included
`
`the development of policy statements on relevant scientific issues; the
`
`representation of the Association before Congress and the Food and Drug
`
`Administration (FDA); the development and management of symposia on
`
`scientific issues; the management of various professional staff; and the
`
`management of the Journal of Pharmaceutical Science. My experience also
`
`extends to the pharmaceutical industry. I was the Director of Client Services
`
`for BioResearch Laboratories, Ltd. from 1985-87, where I negotiated the
`
`protocol design and contracts for hundreds of Phase I studies and
`
`bioequivalency studies. I was also the Director of Marketing for Pharmakon
`
`Research International, Inc. from 1992-94, where I negotiated the protocol
`
`design and contracts for numerous preclinical trials.
`
`12.
`
`From 1972 to 1984, I was an Assistant/Associate Professor of
`
`Pharmaceutics at the School of Pharmacy of the University of Mississippi.
`
`While at the University of Mississippi, I taught undergraduate and graduate
`
`4
`
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`13.
`
`Claims 1 and 4 of the ’180 are challenged in this Petition.
`
`5
`
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`Petition for Inter Partes Review of U.S. Patent No. 6,649,180
`
`level courses in the areas of formulation design and development,
`
`pharmacokinetics, and the physical chemistry of heterogenous systems;
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`conducted research in those areas, among others; and served as a thesis
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`advisor to Ph.D. candidates. I also taught continuing education courses to
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`licensed pharmacists while on faculty at the University of Mississippi, and
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`was Chair of the School of Pharmacy’s Curriculum Committee.
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`14.
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`I am a Fellow of the Academy of Pharmaceutical Research and
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`Science, and have served on various editorial boards. I presently serve on the
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`Editorial Review Panel of the Journal of Drug Development and Industrial
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`Pharmacy, and as a Reviewer for the Journal of Pharmaceutical Science and
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`the Journal of the American Pharmacists Association.
`
`15.
`
`I was the Chair of the Food and Drug Administration’s (FDA)
`
`Pharmaceutical Sciences Advisory Committee (2002 to 2004) and its
`
`subcommittee on cGMP and PAT. I continued as a member of this Advisory
`
`Committee and as a special employee of the FDA consulting on formulation
`
`issues that affect FDA policy. I have also serve as a scientific consultant to
`
`the Subcommittee on Oversight and Investigations of the Committee on
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`Energy and Commerce of the United States House of Representatives. I have
`
`also served as a member of the FDA’s Generic Drug Advisory Committee. I
`
`am the past chair of the PA Governor’s Advisory
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`5
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`16.
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`Background of the Technology
`
`6
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`Panel on Renal Disease having served for over ten years on the committee.
`
`While with the American Pharmaceutical Association, I served as the Chair of
`
`a special panel appointed by the Commissioner of FDA to investigate the
`
`generic drug approval process which produced a report entitled “Fairness in
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`the Generic Drug Approval Process,” sometimes referred to as “the Kibbe
`
`Report.”
`
`17.
`
`I have authored or co-authored numerous papers in refereed
`
`journals, have written a number of essays and articles published in the
`
`professional press, and have made a number of presentations before national
`
`and international professional societies.
`
`18.
`
`I co-authored the “Generic Drugs and Generic Equivalency”
`
`chapter in the Encyclopedia of Pharmaceutical Technology (1st Ed. 1993) and
`
`authored that chapter in the two subsequent editions of the Encyclopedia of
`
`Pharmaceutical Technology. As an invited guest speaker, I have lectured on
`
`the generic drug approval process.
`
`19.
`
`I served as the Editor-in-Chief of the Handbook of
`
`Pharmaceutica1 Excipients (3rd Ed. 2000), and authored a number of the
`
`monographs contained therein. I serve on the Steering Committee for all the
`
`subsequent editions of the Handbook of Pharmaceutical Excipients, and have
`
`authored a number of monographs for those editions. I have also
`
`6
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`authored a chapter entitled “Theory of Dissolution” in the book “Dissolution
`
`Theory, Technology & Methods” edited by Anthony Palmieri III. (ISBN 0-
`
`9761519-1-X)
`
`20. During the course of my career, I have received several awards
`
`and honors, including recognition for my contributions to the training of
`
`pharmacy students.
`
`21. My complete curriculum vitae is attached hereto as
`
`Attachment A.
`
`III. TECHNOLOGY BACKGROUND OF CLAIMED SUBJECT
`MATTER OF THE ’180 PATENT
`
`22. Medicinal capsules have been around for more than a century.
`
`Originally, the capsules were made out of gelatin, which is derived from
`
`collagen from animal by-products. It is essentially the same material used to
`
`make foods such as marshmallows and JELL-O. Ex. 1011 at ¶ 19.
`
`23.
`
`The manner in which gelatin was made into capsules is similar
`
`in many regards to processes used today, using other materials. Id. at ¶ 20.
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`First, one makes a mixture of approximately 30% gelatin and 70% hot water.
`
`Id. This forms a viscous hot mixture. Id. For opaque and/or colored capsules
`
`an opacifying agent, dye, pigment, and other addenda are added. Id. Room
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`temperature stainless steel pins then are dipped into the hot liquid. Id.
`
`Gelatin
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`adheres to the surface of the pins forming a film for use as the hard capsule. Id.
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`The film is dried to remove excess water and stripped off the pin, forming
`
`the cap and body of the capsule. Id. The body and cap of the capsule are
`
`filled with a pharmaceutical compound and joined together. Id.
`
`24. A temperature difference resulting from heating the mixture and
`
`then cooling the mixture by introducing the cooler, room temperature pins
`
`allows the gelatin molecules to cross-link and bind to one another. Id. at ¶ 21.
`
`25.
`
`There were several problems with the use of gelatin. One
`
`concern is that gelatin capsule were made from animal products. Id. at ¶ 22.
`
`The pharmaceutical industry identified cellulose ethers as one material that
`
`could replace gelatin capsules. Id. Cellulose ethers are derived from plant
`
`materials and can be manipulated into plastic films that make up capsule caps
`
`and bodies. Id. One such cellulose ether is hydroxypropylmethylcellulose
`
`(“HPMC”). Id. Two common, but vastly different, ways of creating HPMC
`
`capsules were developed: thermal gelling and additive gelling. Id.
`
`A. a.Thermal Gelling
`
`26.
`
`In this method, no additives are utilized to form capsule films.
`
`U.S. Patent No. 3,493,407 (“Greminger”), a prior art reference discussed in greater
`detail herein,relied upon in the petition, also discloses a method of thermal gelling
`in which pins are dipped into a warmed aqueous solution and transferred to an oven
`for several minutes until dry. Ex. 1006 at col. 3, line 60-col. 4, line 70.
`
`8
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`27.
`
`Likewise, in a method primarily utilized by Capsugel Belgium
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`NV, the stainless steel pins used to form and shape the HPMC capsule films
`
`are preheated above HPMC’s gelation temperature. Id. at ¶ 23. The pins are
`
`dipped into a cooler solution of HPMC dispersed in the solvent water. Id. The
`
`pins are removed from the aqueous solution, with an HPMC film having
`
`formed on the surface of the pins. Id. The gel capsule pieces are dried at a
`
`particular temperature and humidity to allow the HPMC to gel and dry on the
`
`pin. Id. The HPMC capsule shells are then removed. Id.
`
`28. HPMC-only capsules form gels that can be made into capsule
`
`films when HPMC is dissolved in water and then heated. Id. at ¶ 24. No
`
`other chemicals or reagents are added to the system.1 Id. Water is present in
`
`the system as the solvent to disperse the HPMC. Id. The heat needed to
`
`cause the HPMC to gel is added to the system by dipping pins that are
`
`heated above the gelling temperature of the HPMC dispersed in the water
`
`solvent. Id. The energy around the pins then leads to the HPMC molecules
`
`exposing their hydrophobic units. Id. The HPMC molecules then organize
`
`by aligning their hydrophobic units. Id. This organization leads to the
`
`gelling of HPMC. Id.
`
`29.
`
`The HPMC-only capsules formed from this thermal gelation
`
`
`1 Nonetheless, Patent Owner’s exclusive licensee has accused the capsules made from this
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`process possess many advantages over gelatin capsules. Id. at ¶ 25.
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`Because they are derived from vegetable sources, they may be more
`
`widely accepted by
`
`
`process as infringing in the underlying litigation.
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`customers, including those in cultures that rely primarily on vegetable sources
`
`for nutrition or that have strict regulations on materials from animal sources.
`
`Id.
`
`B.b.Additive Gelling
`
`30. As discussed above, capsule films made from gelatin include
`
`animal products and there was a desire to remove animal products from
`
`capsule films. Id. at ¶ 27. However, the thermal gelling process used