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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_____________________________
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`MYLAN TECHNOLOGIES INC.,
`Petitioner,
`
`v.
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`MONOSOL RX, LLC,
`Patent Owner.
`
`_____________________________
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`Patent No. 8,603,514
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`_____________________________
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`DECLARATION OF GRAHAM BUCKTON, PH.D.
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`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 001
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`Table of Contents
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`Page
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`I.QUALIFICATIONS ..................................................................................................... 3
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`II.SCOPE OF WORK .................................................................................................... 6
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`III.OVERVIEW OF THE ’514 PATENT .......................................................................... 7
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`IV.FILE HISTORY OF THE ’514 PATENT ................................................................... 10
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`V.LEGAL STANDARDS ............................................................................................... 16
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`VI.LEVEL OF ORDINARY SKILL AND RELEVANT TIME ............................................ 19
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`VII.CLAIM CONSTRUCTION ..................................................................................... 20
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`VIII.THE STATE OF THE ART ................................................................................... 21
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`IX.ASSERTED REFERENCES DISCLOSE OR SUGGEST EACH OF THE
`CLAIMED FEATURES OF THE ’514 PATENT ..................................................... 28
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`GROUND 1. THE TEACHINGS OF ILANGO AND CHEN MAKE CLAIMS 1-3, 9,
`15, 62-65, 69-73, AND 75 OBVIOUS.................................................................. 39
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`X.CONCLUDING STATEMENTS .................................................................................. 63
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`XI.APPENDIX – LIST OF EXHIBITS ........................................................................... 64
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`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 002
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`I, Graham Buckton, declare as follows:
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`I.
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`QUALIFICATIONS
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`1. My name is Graham Buckton. I am an Emeritus Professor of
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`Pharmaceutics in the UCL School of Pharmacy of the University of London. I was
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`employed at the School of Pharmacy of the University of London from 1988 to
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`2015, initially as Lecturer, then Senior Lecturer, Reader and Professor, during
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`which time I served as the Head of the Department of Pharmaceutics between
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`January 2001 and April 2007. I served as Chair of the Master of Sciences in
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`Pharmacy (MPharm) Exam Board between 2002 and 2012, and have been an
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`MPharm (or Bachelors in Pharmacy, BPharm) Examiner at Queens University of
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`Belfast, Cardiff University, University of Nottingham, Kings College, University
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`of Colombo, Sri Lanka, Robert Gordon University and the University of East
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`Anglia. I received my Ph.D. in Pharmaceutics from Kings College London in
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`1985.
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`2.
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`In 2000 I founded a contract services company called Pharmaterials
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`Ltd. I sold the majority stake to a U.S. company, Pharmaceutics International Inc.
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`(PII), in 2008 and the remaining stake in 2012, at which time I exited. I was Chief
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`Executive Officer from 2000-2012. Pharmaterials carries out materials
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`characterization, salt selection, polymorph screening, pre-formulation, formulation
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`development, assay development and clinical trial manufacture.
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`-3-
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`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 003
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`3.
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`I have served on the Committee on Safety of Medicines (CSM), which
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`is the body in the UK that grants (and revokes) marketing authorizations (the
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`equivalent of the FDA in the US), and I chaired its Chemistry, Pharmacy and
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`Standards (CPS) sub-committee. I remain a member of CPS of the Commission on
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`Human Medicines (a renamed version of CSM). I have been a member of the
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`British Pharmacopoeia Commission and have been a member of working parties
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`for the European and the United States Pharmacopoeias.
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`4.
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`I am the Managing Director of Buckton Consulting. I offer consulting
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`services in the following areas: (1) physical form, formulation development, GMP
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`manufacturing, and regulatory considerations, (2) company strategy review and
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`management, (3) due diligence, and (4) expert witness. As a consultant to
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`industrial companies, I advise on materials science, formulation (various products,
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`including inhalation and oral delivery), and regulatory standards.
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`5. My research has focused on investigating the behavior of
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`pharmaceutical materials, especially interfacial interactions between two or more
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`material surfaces, and their use in processing and drug delivery. Applications of
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`my research include studies of surface interactions, adaptation of physical
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`properties of powders by crystallization and physical manipulation such as milling,
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`and the preparation of drug dosage forms including solid oral dosage forms and
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`-4-
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`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 004
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`inhalation dosage forms, including film-coatings. I have published on my work in
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`this field, presenting data on film coating solutions.
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`6.
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` My research has been funded by such organizations as the
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`Engineering and Physical Sciences Research Council (EPSRC), Pfizer,
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`AstraZeneca, GSK, and Novartis, as well as other foundations and companies in
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`industry.
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`7.
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`I served a 10 year term as Editor of the International Journal of
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`Pharmaceutics and have been a member of the editorial boards of a number of
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`journals, including Pharmaceutical Research, the AAPS Journal and AAPS
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`Pharm SciTec.
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`8.
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`I have authored a book on Interfacial Phenomena in Drug Delivery
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`and Targeting. I have also authored or co-authored over 180 peer-reviewed
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`journal articles, of which numerous articles present original research related to
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`solid dosage forms, including film-forming materials and film-coatings. In
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`addition, I have authored or co-authored more than 100 abstracts and book
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`reviews. I am listed as an inventor on 6 patents or patent applications.
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`Additionally, I have lectured at over 130 conferences, seminars, and symposia
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`around the world and have served as a testifying expert witness on 18 cases.
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`9.
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`I have received numerous awards and honours, specifically, the
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`appointment in 2003 as the Science Chairman for the British Pharmaceutical
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`-5-
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`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 005
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`Conference, the first recipient of the Academy of Pharmaceutical Sciences Medal
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`in 2000, the 1998 Stig Sunner Award, the 1998 Foss Near Infrared European Users
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`Group Award, the 1993 British Pharmaceutical Conference Science Medal, and the
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`1992 Pfizer Award for “excellence in published research.”
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`10. A summary of my education, experience, publications, awards and
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`honours, patents, publications, and presentations is provided in my CV, a copy of
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`which is separately submitted. EX1003.
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`II.
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`SCOPE OF WORK
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`11.
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`I understand that a petition is being filed with the United States Patent
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`and Trademark Office for Inter Partes Review of U.S. Patent No. 8,603,514 (“the
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`’514 patent,” EX1001). I have been retained by the Petitioner as a technical expert
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`to provide analysis and opinions regarding the ’514 patent. I have reviewed the
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`’514 patent and relevant sections of its prosecution history in the United States
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`Patent and Trademark Office. EX1004. I have also reviewed and considered
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`various other documents in arriving at my opinions, and cite them in this
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`declaration. For convenience, documents cited in this declaration are listed in the
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`Appendix in Section XI.
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`12.
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`I am being compensated at the rate of ₤350/hour for my time in this
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`matter and I have no financial interest in the outcome.
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`-6-
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`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 006
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`III. OVERVIEW OF THE ’514 PATENT
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`13. The ’514 patent is entitled “Uniform Films For Rapid Dissolve [sic]
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`Dosage Form Incorporating Taste-Masking Compositions.” The first page of the
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`patent states that an application for the ’514 patent (U.S. Application No.
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`11/775,484, “the ’484 application”) was filed on July 10, 2007 and claims priority
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`to several applications. The patent states that the ’484 application is a continuation-
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`in-part of U.S. Application No. 10/768,809 (“the ’809 application). The ’809
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`application is itself a continuation-in-part application of PCT/US02/32594,
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`PCT/US02/32542, and PCT/US02/32575, which were all filed on October 11,
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`2002. The earliest claimed priority date of the ’484 application is October 12,
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`2001, the filing date of U.S. Provisional Application No. 60/328,868 (“the ’868
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`application”).
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`14.
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`I am informed that a federal judge has found that the’514 patent is
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`only entitled to the benefit of U.S. Provisional Application No. 60/414,276 (“the
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`’276 application”) filed on September 27, 2002. For the purposes of my declaration
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`and the prior art presented in the grounds herein, however, I have assumed that the
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`applicable date is the earliest priority date claimed in the ’514 patent, October 12,
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`2001. However, the outcome of my opinions does not depend on which of these
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`dates is used.
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`-7-
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`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 007
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`15. The claims of the ’514 patent are generally directed to drug delivery
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`film compositions made of water-soluble or water-swellable polymers.
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`Independent claim 62 of the ’514 patent recites the following:
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`62. A drug delivery composition comprising:
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`(i) a cast film comprising a flowable water-soluble or water
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`swellable
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`film-forming matrix comprising one or more
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`substantially water soluble or water swellable polymers; and a
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`desired amount of at least one active;
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`wherein said matrix has a viscosity sufficient to aid in substantially
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`maintaining non-self-aggregating uniformity of the active in the
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`matrix;
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`(ii) a particulate active substantially uniformly stationed in the
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`matrix; and
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`(iii) a taste-masking agent selected from the group consisting of
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`flavors, sweeteners, flavor enhancers, and combinations thereof to
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`provide taste-masking of the active;
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`wherein the particulate active has a particle size of 200 microns or
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`less and said flowable water-soluble or water swellable film-
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`forming matrix is capable of being dried without loss of substantial
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`uniformity in the stationing of said particulate active therein; and
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`wherein the uniformity subsequent to casting and drying of the
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`matrix is measured by substantially equally sized individual unit
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`doses which do not vary by more than 10% of said desired amount
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`of said at least one active.
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`EX1001, 73:48-74:9.
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`-8-
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`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 008
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`16. Claims 63-65 and 69-73 each depend directly from claim 62. Claims
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`63 and 64 respectively recite that the particle size of the active is 150 microns or
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`less and 100 microns or less. Id. at 74:10-13. Claim 65 recites that the variation in
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`drug content is less than 5% by weight between film dosage units. Id. at 74:14-16.
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`Claim 69 recites that the taste masking agent is present at 0.1-30% by weight of the
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`entire composition. Id. at 74:29-31. Claim 70 recites that the taste masking agent is
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`present at 0.01-10% by weight of the entire composition. Id. at 74:32-34. Claim 71
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`recites that the active is chosen from one of several drugs classes, including
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`narcotics, analgesics, erectile dysfunction therapies, and combinations thereof. Id.
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`at 35-45. Claim 72 recites that the viscosity of the film forming matrix is an
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`amount that prevents the active agent from settling out during mixing or coating.
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`Id. at 46-49. Claim 73 recites that the active is an opiate or opiate derivative. Id. at
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`50-51.
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`17.
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`Independent claim 1 of the ’514 patent is similar to independent claim
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`62, but requires that the taste masking agent be “coated or intimately associated
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`with said particulate to provide taste-masking of the active” instead of requiring
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`that the taste-masking agent be a flavour, sweetener, flavour enhancer. EX1001,
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`67:34-56. Claims 2, 3, 9, 15, and 75 depend directly from claim 1. Claims 2 and 3
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`respectively recite a combined particulate and taste-masking agent particle size of
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`150 microns and 100 microns. Id. at 67:57-62. Claim 9 recites that the variation in
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`-9-
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`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 009
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`drug content is less than 5% by weight between film dosage units. Id. at 68: 30-32.
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`Claim 15 recites that the active of the drug delivery composition is chosen from
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`one of several drugs classes, including narcotics, analgesics, erectile dysfunction
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`therapies, and combinations thereof. Id. at 68:50-59. Claim 75 recites that the
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`active is an opiate or opiate derivative and that the taste masking agent is one of
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`the following: flavours, sweeteners, flavour enhancers, and combinations thereof.
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`Id. at 74:53-56.
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`IV. FILE HISTORY OF THE ’514 PATENT
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`18. As noted above, the ’514 patent issued from the ’484 application and
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`claims the benefit of October 12, 2001 as its earliest effective filing date.
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`19. Applicants removed claim limitations directed to a “controlled release
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`agent” on July 7, 2010 in response to a Restriction Requirement. EX1004 at 949-
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`950 and 955-956. Despite the title of the ’514 patent, the specification and issued
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`claims of the ’514 patent are compatible with films with either a rapid or a slow
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`release rate. For example, the ’514 patent states:
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`“The term “controlled release” is intended to mean the release of
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`active at a pre-selected or desired rate…Desirable rates include fast
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`or immediate release profiles as well as delayed, sustained or
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`sequential release…The polymers that are chosen for the films of the
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`present invention may also be chosen to allow for controlled
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`disintegration of the active. This may be achieved by providing a
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`-10-
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`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 010
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`substantially water insoluble film that incorporates an active that will
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`be released from the film over time. This may be accomplished by
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`incorporating a variety of different soluble or insoluble polymers and
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`may also include biodegradable polymers in combination.”
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`EX1001 at 13:5-20
`20. The ’514 patent also identifies certain advantages of slow release
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`films:
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`“The convenience of administering a single dose of a medication
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`which releases active ingredients in a controlled fashion over an
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`extended period of time as opposed to the administration of a number
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`of single doses at regular intervals has long been recognized in the
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`pharmaceutical arts. The advantage to the patient and clinician in
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`having consistent and uniform blood levels of medication over an
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`extended period of time are likewise recognized. The advantages of a
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`variety of sustained release dosage forms are well known. However,
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`the preparation of a film that provides the controlled release of an
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`active has advantages in addition to those well-known for controlled-
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`release tablets. For example, thin films are difficult to inadvertently
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`aspirate and provide an increased patient compliance because they
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`need not be swallowed like a tablet. Moreover, certain embodiments
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`of the inventive films are designed to adhere to the buccal cavity and
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`tongue, where they controllably dissolve.”
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`Id. at 13:30-46.
`21. The challenged claims have no limitation with respect to dissolution
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`or drug release rates, either expressly or implicitly. Thus, the ’514 patent teaches
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`-11-
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`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 011
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`and claims films that are compatible with both rapidly dissolving and slowly
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`dissolving films.
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`22. The Examiner issued an Office Action on September 9, 2010 rejecting
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`all claims of the ’484 application as anticipated under 35 U.S.C. §102(e) by U.S.
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`Patent No. 7,067,116. (“Bess”). EX1004 at 963-973. The Examiner stated that
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`Bess disclosed orally dissolvable films with active agents and taste masking agents
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`and thus anticipated the claims. Id. at 966-969. The Examiner also rejected all
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`claims as obvious under §103, over WO2000/42992 (EX1006, “Chen”) in view of
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`U.S. Patent No. 5,653,993 (“Ghanta”). The Examiner stated that Chen disclosed
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`water-soluble films with an active agent and taste-masking agents, including
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`encapsulation of the active agent in a material other than the hydrocolloid of the
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`film-forming matrix to mask taste. Id. at 969-971. The Examiner relied on
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`Ghanta’s disclosure of taste-masked microcapsules that do not aggregate, and
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`stated that in combination, Chen in view of Ghanta taught all of the elements of the
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`claimed invention. Id. at 969-971. The Examiner also rejected the claims as
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`obvious under §103, over U.S. Patent No. 4,713,243 (“Schiraldi”) in view of U.S.
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`Patent No. 3,237,596 (“Grass”) and Schiraldi in view of U.S. Publication No.
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`2004/0156901 (“Thakur”). Id. at 971-973.
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`23. Applicants responded on December 9, 2010 by amending the claims
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`to require that “the uniformity is determined by the composition having a variation
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`-12-
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`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 012
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`of drug content of less than 10% per film unit. Id. at 999. Applicants primarily
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`argued that neither Bess nor Chen in view of Ghanta disclosed such uniformity,
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`which Applicants said that they had achieved using certain drying methods. Id. at
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`1009-1010.
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`24. The Examiner responded in a Final Office Action on February 2, 2011
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`maintaining all rejections and stating that the Applicants’ arguments were not
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`persuasive. Id. at 1162-1172. The Examiner stated that the prior art references do
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`in fact disclose obtaining uniform solutions for film casting. Id. at 1165 & 1169.
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`25. Applicants responded on April 4, 2011 by amending the claims to add
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`the limitation that the film-forming matrix comprised two or more substantially
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`water soluble or water swellable polymers (this limitation was later changed to
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`“one or more” Id. at 1298) and a viscosity sufficient to maintain in non-self-
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`aggregating uniformity of the active. Id. at 1180. Applicants argued that none of
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`the references taught the claim element of a viscosity for maintaining uniformity of
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`the active. Id. at 1191 & 1194. Applicants further stated that “uniformity is
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`determined by the composition having a variation of drug content of less than 10%
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`per film dosage unit, as claimed.” Id. at 1194. Applicants submitted a supplemental
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`amendment on April 15, 2011, amending several dependent claims to specify that
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`drug variance is less than 5%, 2%, or 0.5% “per film dosage unit” rather than “per
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`film unit.” Id. at 1207. Applicants also submitted a request for continued
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`-13-
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`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 013
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`examination (RCE) and a petition for extension of time on June 1, 2011. Id. at
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`1223-1227.
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`26. The Examiner issued an Office Action on June 19, 2012 maintaining
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`the rejections based on the same references and arguments used previously. Id. at
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`1241-1253. Applicants responded on December 19, 2012, amending the claims to
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`introduce the limitation that the films are cast film compositions, that uniformity
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`was directed to uniformity after casting and drying, and that uniformity was
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`measured in substantially equally sized individual unit doses. Id. at 1264.
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`27. The Examiner issued a Final Office Action on March 13, 2013
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`maintaining the rejections over Bess and Chen in view of Ghanta and stating that,
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`“Applicant appears to be arguing the claims as a process of making and not the
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`final composition. The method in which the composition is made does not hold
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`patentable weight in a composition claims [sic].” Id. at 1290. The Examiner further
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`stated that, “the skilled artisan would have understood the importance of providing
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`a homogenous film in order to ensure appropriate dosing of active agents to
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`provide correct efficacy of the drug to the patient.” Id. at 1293.
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`28. On May 10, 2013, Applicants submitted an amendment and response
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`after Final Office Action. Id. at 1297. Applicants stated that they had presented the
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`Examiner with the declaration of B. Arlie Bogue (“Bogue Declaration”) during a
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`May 1, 2013 interview to show uniformity of the claimed films. Id. at 1316.
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`-14-
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`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 014
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`Applicants further stated that Figure 5 of Chen had been discussed to demonstrate
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`that Chen’s films varied by greater than 10% of the active. Id. Applicants stated
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`that the Examiner agreed in this interview that the combination of the Chen and
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`Bess references had been overcome. Id. I have reviewed the Bogue Declaration
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`and note that although it describes assessing certain films for active uniformity, it
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`makes no mention of the use of taste-masking agents or the particle size of the
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`active. (Declaration of B. Arlie Bogue, March 13, 2013; Reexamination Control
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`No. 95/002,170) (EX1007) at 2-3.
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`29. The Examiner issued a Notice of Allowance on June 14, 2013. Id. at
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`1329. Applicants filed an Amendment after Notice of Allowance along with a
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`detailed interview summary on June 18, 2013. Id. at 1351. In the detailed interview
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`summary, Applicants stated that neither Chen nor Bess teach film dosage units
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`with less than 10% variation in the amount of active. Id. at 1368. The Examiner
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`issued an applicant-initiated interview summary on May 1, 2013 stating that the
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`Applicants presented a declaration and arguments regarding the teachings of Bess
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`and Chen. Id. at 1375. The Examiner stated that the pending claims were allowable
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`in light of the arguments made by the applicant and after review of Figure 5 of
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`Chen. The Examiner further stated that “neither Bess nor Chen inherently result in
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`a film having a uniformity in which the individual unit does not vary by more than
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`10% of the active.” Id.
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`
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`-15-
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`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 015
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`30.
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`I note, however, that Figure 5 of Chen does not necessarily establish
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`that the variation in drug content of each of Chen’s films was greater than 10%.
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`V. LEGAL STANDARDS
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`31.
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`I have been informed that a claimed invention is not patentable under
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`35 U.S.C. § 103, for obviousness, if the differences between the invention and the
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`prior art are such that the subject matter as a whole would have been obvious at the
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`time the invention was made to “a person having ordinary skill in the art” to which
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`the subject matter of the invention pertains. I understand that “a person of ordinary
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`skill in the art” is a hypothetical person who is presumed to have known the
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`relevant art at the time of the invention. As discussed above, I understand that prior
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`art for the purpose of this declaration includes references that were published
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`before October 12, 2001.
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`32.
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`I have been instructed that, a determination of obviousness requires
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`inquiries into (i) the scope and content of the art when the invention was made; (ii)
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`the differences between the art and the claims at issue; (iii) the level of ordinary
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`skill in the pertinent art when the invention was made; and, to the extent they exist,
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`any secondary considerations.
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`33.
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`I am informed that a claim can be found to be obvious if all the
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`claimed elements were known in the prior art and one skilled in the art could have
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`combined the elements as claimed by known methods with no change in their
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`-16-
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`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 016
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`respective functions, and the combination would have yielded nothing more than
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`predictable and expected results to one of ordinary skill in the art.
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`34.
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`I am informed that improper hindsight must not be used when
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`comparing the prior art to the invention for obviousness. Thus, a conclusion of
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`obviousness must be firmly based on the knowledge and skill of a person of
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`ordinary skill in the art at the time the invention was made.
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`35.
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`I have been informed that obviousness may also be shown by
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`demonstrating that it would have been obvious to modify what is taught in a single
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`piece of prior art to create the patented invention. I understand that obviousness
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`may be demonstrated by showing that it would have been obvious to combine the
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`teachings of more than one item of prior art. I understand that in order for a
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`combination of references or teachings to render the claimed invention obvious,
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`there must be some supporting rationale for combining the cited references or
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`teachings as proposed.
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`36.
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`I am informed that the following are examples of principles that may
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`indicate that it would have been obvious to combine multiple teachings, resulting
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`in the claimed combination, if the claimed combination involves: (i) the
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`combination of prior art elements according to known methods to yield predictable
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`results; (ii) the simple substitution of one known element for another to obtain
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`predictable results; (iii) the use of a known technique to improve similar methods
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`
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`-17-
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`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 017
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`or products in the same way; (iv) the application of a known technique to a known
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`method or product ready for improvement to yield predictable results; (v) the
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`application of a technique or approach that would have been “obvious to try” (e.g.,
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`choosing from a finite number of identified, predictable solutions, with a
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`reasonable expectation of success); (vi) predictable variations of a known work in
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`one field of endeavor prompted for use in either the same field or a different field
`
`based on design incentives or other market forces; or (vii) some teaching,
`
`suggestion, or motivation in the prior art that would have led one of ordinary skill
`
`to modify the prior art reference or to combine prior art reference teachings to
`
`arrive at the claimed invention.
`
`37.
`
`I have been instructed that “secondary considerations” may be
`
`weighed against evidence of obviousness where appropriate. I understand that such
`
`secondary considerations, where in evidence, may include: (i) commercial success
`
`of a product due to the merits of the claimed invention; (ii) a long-felt, but
`
`unsatisfied need for the invention; (iii) failure of others to find the solution
`
`provided by the claimed invention; (iv) deliberate copying of the invention by
`
`others; (v) unexpected results achieved by the invention; (vi) praise of the
`
`invention by others skilled in the art; (vii) lack of independent simultaneous
`
`invention within a comparatively short space of time; and (viii) teaching away
`
`
`
`-18-
`
`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 018
`
`
`
`from the invention in the prior art. I am informed that secondary considerations are
`
`relevant where there is a nexus between the evidence and the claimed invention.
`
`VI. LEVEL OF ORDINARY SKILL AND RELEVANT TIME
`
`38.
`
`I have been advised that “a person of ordinary skill in the relevant
`
`field” is a hypothetical person who is presumed to have known the relevant art at
`
`the time of the invention. I am informed that a person of ordinary skill in the art is
`
`also a person of ordinary creativity. I have assumed for the purposes of this
`
`declaration that the relevant timeframe for assessing the patentability of the claims
`
`of the ’514 patent for the purposes of this declaration is October 12, 2001, the
`
`earliest effective filing date of the application that led to the ’514 patent. Unless
`
`otherwise specifically noted, all of my opinions expressed herein regarding a
`
`person of ordinary skill in the art apply to a person of ordinary skill in the art as of
`
`October 12, 2001. However, the outcome of my opinions would not be different if
`
`a later date, such as September 27, 2002, was used.
`
`39. By virtue of my education, experience, and training, I am familiar
`
`with the level of skill in the art of the ’514 patent prior to October 12, 2001. In my
`
`opinion, a person of ordinary skill in the relevant field as of October 12, 2001
`
`would typically have a Ph.D. in pharmaceutics, or in a drug delivery relevant field
`
`of a related discipline such as physical or polymer chemistry, or could have a
`
`bachelor’s degree in pharmaceutics, or in a related field, plus two to five years of
`
`
`
`-19-
`
`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 019
`
`
`
`relevant experience in developing drug formulations. Additionally, a person of
`
`ordinary skill in the art would have been familiar with and able to understand the
`
`information known in the art relating to film formulations for mucosal applications
`
`and delivery of pharmaceutical drugs, including the publications discussed in this
`
`declaration.
`
`VII. CLAIM CONSTRUCTION
`
`40.
`
`I have been advised that, in the present proceeding, the ’514 patent
`
`claims are to be given their broadest reasonable interpretation in view of the
`
`specification. I also understand that, absent some reason to the contrary, claim
`
`terms are typically given their ordinary and accustomed meaning as would be
`
`understood by one of ordinary skill in the art. I have followed these principles in
`
`my analysis throughout this declaration. The ’514 patent provides certain
`
`definitions. In my opinion, these definitions are conventional. Certain claim terms
`
`are not defined in the ’514 patent. I discuss one term below.
`
`41. Under the broadest reasonable interpretation in light of the language
`
`of claims 1 and 62 and the specification of the ’514 patent, the phrase “flowable
`
`water-soluble or water swellable film-forming matrix” refers to the flowability of
`
`the film-forming matrix prior to casting and drying the film. After the casting and
`
`drying steps are completed, the matrix is no longer flowable. Indeed, that is the
`
`
`
`-20-
`
`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 020
`
`
`
`purpose of drying the film. Thus, the term “flowable” in claims 1 and 62 refers to
`
`the film-forming matrix, not the dried matrix in the final cast film.
`
`VIII. THE STATE OF THE ART
`
`42. Below I describe some of the relevant aspects of what was generally
`
`known in the art as of October 12, 2001.
`
`43. Film dosage formulations are well-known in the art and have been
`
`utilized for decades to deliver active pharmaceutical ingredients to mucosal
`
`surfaces. In the early 1970s, the contraceptive film (“C-film”) was developed to
`
`deliver spermicidal agents to the vaginal mucosa. Frankman et al., Clinical
`
`evaluation of C-Film, a vaginal contraceptive, 3 J. Int. Med. Res. 292-96, 292
`
`(1975) (“Frankman”) (EX1008); U.S. Patent No. 5,595,980 to Brode et al.
`
`(“Brode”) (EX1009) at 1:20-28 & 4:23-27. This drug delivery system involved
`
`formulation of spermicidal agents, such as cetylpyridine bromide or nonoxynol-9,
`
`in water-soluble polyvinyl alcohol films. EX1008 (Frankman), 292. C-films were
`
`provided as square dosage units (5 x 5 cm), which would rapidly dissolve after
`
`mucosal application to deliver efficacious levels of spermicide. Id.
`
`44. Films for vaginal delivery of agents were also used to test efficacy of
`
`active agents for the prevention of sexually transmitted infections. Roddy et al., A
`
`controlled trial of nonoxynol 9 film to reduce male-to-female transmission of
`
`sexually transmitted diseases, 339 N. Engl. J. Med. 504-10, 504 (1998) (“Roddy”)
`
`
`
`-21-
`
`Par Pharm., Inc., et al.
`Exhibit 1002
`Page 021
`
`
`
`(EX1010). Thus, the notion of utilizing polymer-based films for delivery of actives
`
`was well established in the field for nearly thirty years prior to the alleged priority
`
`date of the ’514 patent.
`
`45. Films for oral delivery of active agents were also known years before
`
`the earliest claimed priority date of the ’514 patent. For example, films for oral
`
`delivery were developed for the treatment of periodontal diseases. U.S. Patent No.
`
`4,569,837 to Suzuki et al. (“Suzuki”) (EX1011). Suzuki discloses compositions
`
`made from water-soluble film forming polymers with viscous solutions (e.g., 5-
`
`30,000 centipoise (which in various texts, quoted below is abbreviated to “cps,”
`
`“cp,” “CP,” and which I refer to as “cP”)), resulting in cast films measuring 260
`
`microns thick for the delivery of antibacterial agents, such as chlorhexidine, to the
`
`periodontal pocket using film. EX1011 (Suzuki), 2:51-59 & Example 1.
`
`46.
`
` As another example, films for the oral delivery of local numbing
`
`agents were known. U.S. Patent No. 6,159,498 to Tapolsky et al. (“Tapolsky”)
`
`(EX1012) at 7:43-51; Yamamura et al., Oral mucosal adhesive film containing
`
`local anesthetics: in vitro and clinical evaluation. 43 J Biomed Mater Res. 313-
`
`317, 313 (1998) (“Yamamura”) (EX1013). Tapolsky teaches formulations of
`
`precipitat
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