UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`DR. REDDY’S LABORATORIES, LTD. AND DR. REDDY’S
`LABORATORIES, INC.,
`Petitioners,
`
`v.
`
`MONOSOL RX, LTD.,
`Patent Owner.
`
`
`
`
`
`
`
`
`DECLARATION OF METIN ÇELIK, Ph.D. IN SUPPORT OF PETITION FOR
`INTER PARTES REVIEW OF U.S. PATENT NO. 8,603,514
`
`“UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM
`INCORPORATING TASTE-MASKING COMPOSITIONS”
`
`
`
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`
`
`Case No. IPR2016-XXXXX
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`DRL - EXHIBIT 1003
`DRL001
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`DR. REDDY’S LABORATORIES, LTD. AND DR. REDDY’S
`LABORATORIES, INC.,
`Petitioners,
`
`v.
`
`MONOSOL RX, LTD.,
`Patent Owner.
`
`
`
`
`
`
`
`
`DECLARATION OF METIN ÇELIK, Ph.D. IN SUPPORT OF PETITION FOR
`INTER PARTES REVIEW OF U.S. PATENT NO. 8,603,514
`
`“UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM
`INCORPORATING TASTE-MASKING COMPOSITIONS”
`
`
`
`
`
`
`Case No. IPR2016-XXXXX
`
`
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`DRL - EXHIBIT 1003
`DRL001
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`TABLE OF CONTENTS
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`
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`I.
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`INTRODUCTION ........................................................................................... 1
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`Page
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`II. QUALIFICATIONS ........................................................................................ 1
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`A. Education and Work Experience ............................................................ 3
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`B. Professional Affiliations, Activities, and Awards .................................. 4
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`C. Publications and Educational Involvement ............................................ 5
`
`D. Prior Testimonies ................................................................................... 6
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`III. SCOPE OF THE WORK AND COMPENSATION ...................................... 6
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`A. Bases for Opinion and Materials Considered......................................... 7
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`IV. SUMMARY OF OPINIONS .......................................................................... 7
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`V.
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`LEGAL STANDARDS ................................................................................. 13
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`VI. PERSON OF ORDINARY SKILL IN THE ART ........................................ 15
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`VII. THE ‘514 PATENT ....................................................................................... 15
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`A. Priority Date of the ‘514 Patent............................................................ 15
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`B. The Challenged Claims of the ‘514 Patent .......................................... 16
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`VIII. BACKGROUND AND TUTORIAL ............................................................ 21
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`A. Polymers ............................................................................................... 21
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`B. Particles ................................................................................................ 24
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`DRL - EXHIBIT 1003
`DRL002
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`TABLE OF CONTENTS
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`(Continued)
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`C. Role of Viscosity .................................................................................. 25
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`D. Drying of Suspensions ......................................................................... 29
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`E. Role of Uniformity in Drug Formulations ........................................... 31
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`Flavoring of Pharmaceutical Formulations .......................................... 33
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`F.
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`IX. SCOPE AND CONTENT OF THE PRIOR ART REFERENCES .............. 33
`
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`A. WO 200/42992 (Chen) (Ex. 1005) ...................................................... 33
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`B. U.S. Patent No. 7,067,116 (Bess) (Ex. 1004) .................................... 40
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`C.
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`CA 2274910 (Cremer) (Ex. 1006) ..................................................... 41
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`X.
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`INVALIDITY OF THE ‘514 PATENT ........................................................ 42
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`Claims 1 and 62 of the ‘514 Patent are Obvious over
`Bess in view of Chen .......................................................................... 42
`
`A.
`
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`B. A POSA would combine the Teaching of Bess and Chen
`
`along with the Knowledge in the Art .................................................. 46
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`C. Additional Limitations in Independent Claims 1 and 62
`
`do not render those claims Nonobvious over Bess and Chen ............. 47
`
`The Dependent Claim Limitations Do Not Render the ‘514x
`Asserted Claims Nonobvious over Bess and Chen.. ........................... 47
`
`Claims 1 and 62 of the ‘514 Patent are Obvious over
`Chen and Cremer ................................................................................ 49
`
`A POSA would combine the Teachings of Chen and Cremer
`along with the Knowledge in the Art .................................................. 54
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`D.
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`E.
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`F.
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`DRL - EXHIBIT 1003
`DRL003
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`TABLE OF CONTENTS
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`(Continued)
`
`
`G. Additional Limitations in Independent Claims 1 and 62
`do not render those claims Nonobvious over Chen and
`Cremer ................................................................................................. 55
`
`
`
`
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`H.
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`
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`The Dependent Claim Limitations do not render the
`those Claims Nonobvious over Chen and Cremer.. ............................ 55
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`XI. CONCLUSION ............................................................................................. 57
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`-iii-
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`DRL - EXHIBIT 1003
`DRL004
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`I.
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`I, Metin Çelik, Ph.D. declare as follows:
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`INTRODUCTION
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`1. My name is Metin Çelik. I have been retained by counsel for Petitioner
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`Dr. Reddy’s Laboratories, Inc. of 107 College Road East, Princeton, NJ 08540 and
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`Dr. Reddy’s Laboratories, Ltd. of 8-2-337, Road No. 3, Banjara Hills, Hyderabad,
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`India 500034) (collectively, “Dr. Reddy’s”) to provide opinions relating to U.S.
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`Patent 8,603,514 (“the ‘514 Patent”). I further understand that Dr. Reddy’s
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`requests that the United States Patent and Trademark Office (“USPTO”) cancel
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`certain claims of the ‘514 patent as unpatentable. I submit this expert declaration,
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`which addresses and supports the petition of Dr. Reddy’s.
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`II. QUALIFICATIONS
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`2. I am currently the President of Pharmaceutical Technologies
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`International, Inc. (“PTI”), a company that I founded in 1997. PTI develops
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`management tools, databases and expert systems for the pharmaceutical industry
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`worldwide and provides expert consultant services to various international
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`pharmaceutical, food, excipient and equipment companies and to law firms
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`throughout North America.
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`3. Since 2008, I am also a Research Professor of Pharmaceutical
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`Technology at the College of Pharmacy, Near East University in Cyprus where I
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`have established a tabletting research center.
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`DRL - EXHIBIT 1003
`DRL005
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`4. Over the past thirty years, working in industry, academia, and as a
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`consultant, I have been continuously involved in the development and formulation
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`of pharmaceutical products. I have also provided expert consultant services to the
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`Food and Drug Administration (“FDA”).
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`5. My involvement in the formulation and process of pharmaceutical
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`products has given me specialized expertise in the areas of solid dosage forms,
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`integrated compaction research systems, the theory and practice of pharmaceutical
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`compaction, excipient functionality testing, multiunit dosage form development,
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`artificial neural networks, design and development of pharmaceutical formulation
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`and processing expert systems, preformulation and compaction databases and the
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`development of Management Information Systems for FDA inspection
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`preparations and general project management purposes.
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`6. With respect to formulation and process of oral dosage forms, my
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`practical experience began at Novartis (formerly known as Sandoz) – Switzerland
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`in 1984. My knowledge in this area continued to develop during my time at
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`Novartis, in Switzerland and Turkey, and then as a professor in the College of
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`Pharmacy at Rutgers University in Piscataway, New Jersey. As a member of the
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`faculty at the latter institution, I lectured in this field (within and outside the
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`University) and conducted research both as an advisor to a Ph.D. project and as a
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`consultant to the pharmaceutical industry.
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`DRL - EXHIBIT 1003
`DRL006
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`A.
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`Education and Work Experience
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`7.
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`I earned my B.Sc. (Hons.) degree in Pharmacy from Hacettepe
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`University in Turkey in 1979.
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`8.
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`I was awarded a Ph.D. degree in Pharmaceutical Technology by the
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`Department of Pharmaceutical Technology, School of Pharmacy, De Montfort
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`University (formerly known as Leicester Polytechnic), the United Kingdom, in
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`1984.
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`9. After completing my Ph.D. in 1984, I took a position in the Galenical
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`R&D Department at Novartis in Switzerland, where I was involved in
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`pharmaceutical technology research and development. I was then promoted to
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`Development Co-ordinator, Galenical R&D at Novartis in Turkey, where I was
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`responsible for establishing a pharmaceutical research department.
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`10. In 1986, I joined Smith Kline & French Laboratories (presently known
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`as GlaxoSmithKline) in Swedeland, Pennsylvania, where I developed and
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`established the first state-of-the-art Compaction Simulator System in the Western
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`hemisphere.
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`11. In 1988, I joined the faculty at the College of Pharmacy, Rutgers
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`University, where I stayed until 1997. During my tenure at Rutgers, I taught
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`various courses to both undergraduate and graduate students that focused on the
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`theory and practice of pharmaceutical formulation and process development. Such
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`-3-
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`DRL - EXHIBIT 1003
`DRL007
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`courses included Drug Delivery, Problems in Pharmaceutics, and Pharmaceutical
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`Processes and Equipment.
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`12. At Rutgers, in my position as Director of Pharmaceutical Compaction
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`Research Laboratory & Information Center, I developed a second Compaction
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`Simulator System. The Compaction Simulator System at Rutgers was the first to
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`be developed in academia in the U.S.A., and consequently established Rutgers as
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`an internationally recognized pharmaceutical research centre.
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`13. Between 2004 and 2008, I was a Pharmaceutical Processing Research
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`Professor at the Department of Industrial Engineering (2004-2008) at Rutgers
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`where I was involved in the development of a Process Analytical Technology
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`(PAT) program at Rutgers.
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`B. Professional Affiliations, Activities, and Awards
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`14. I am or have been a member of the following professional
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`organizations: the American Association of Pharmaceutical Scientists (AAPS),
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`the New Jersey Pharmaceutical Association of Science and Technology
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`(NJPhAST), the American Association of Colleges of Pharmacy (AACP), and the
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`Ankara Chamber of Pharmacists (ACP).
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`15. I have been extensively involved with several groups in the AAPS. For
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`example, from 1995 to 1998, I held the position of chair of the AAPS Process
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`Development Focus Group. I am also a founder and the former chair of the AAPS
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`DRL - EXHIBIT 1003
`DRL008
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`Excipients Focus Group and a founder and the former chair of the AAPS Expert
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`Systems Focus Group. I have also served as a member of the Pharmaceutical
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`Technology Section Programming Committee.
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`16. In 1991, 1993, and 1994, I received the Faculty Academic Service
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`Increment Program Award in recognition of my service at Rutgers.
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`17. I am also listed in the Who’s Who in Science and Engineering (1995).
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`In 1996, I received the Commission of Science & Technology of New Jersey
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`Award.
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`18. While at Rutgers, I also received more than fifty grants from a wide
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`variety of pharmaceutical companies, including Glaxo and SmithKline Beecham,
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`totaling more than $1.1 million.
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`C. Publications and Educational Involvement
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`19. I have organized over thirty national and international symposia and
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`short courses. I have published a book, nine book chapters, and more than thirty
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`articles relating to pharmaceutical formulation and processing issues, along with
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`numerous abstracts and papers presented at scientific conferences.
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`20. I have also served as an editorial board member and/or reviewer for
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`journals such as Pharmaceutical Technology, Drug Development and Industrial
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`Pharmacy, the European Journal of Pharmaceutical Sciences, and the International
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`Journal of Pharmaceutics. In addition, I have made over 200 presentations at
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`DRL - EXHIBIT 1003
`DRL009
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`industry, academic, national and international meetings, and conferences, most of
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`which by invitation.
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`D. Prior Testimonies
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`21. Since 2000, the following are a list of matters in which I have
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`testified at trial or by deposition. (See Appendix A to Exhibit A, Curriculum
`
`Vitae).
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`22. Attached to this Declaration as Appendix A is a copy of my
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`Curriculum Vitae detailing my professional expertise in relation to the fields of
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`pharmaceutical formulation and process development.
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`III. SCOPE OF THE WORK AND COMPENSATION
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`23. I have been asked by counsel for Dr. Reddy’s to provide opinions
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`relating to U.S. Patent 8,603,514 (“the ‘514 Patent”)
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`24. I am being compensated for my time spent on this matter at my usual
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`consulting rate of $625.00 per hour. My compensation does not depend on the
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`outcome of this matter. No part of my compensation is dependent upon my
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`opinions given or the outcome of this case. I do not have any other current or past
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`affiliation as an expert witness or consultant with Dr. Reddy’s. I do not have any
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`current or past affiliation with Monosol RX, LLC, or any of the named inventors
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`on the ‘514 Patent.
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`-6-
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`DRL - EXHIBIT 1003
`DRL010
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`A. Bases for Opinion and Materials Considered
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`
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`25. Exhibit 1035 includes a list of the materials I considered, in addition to
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`my experience, education, and training, in providing the opinions contained herein.
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`IV. SUMMARY OF OPINIONS
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`26. As explained in detail in Section VIII, it is my opinion that all of the
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`challenged claims (1-3, 9, 15, 62-65, 69-73 and 75) of the ‘514 patent would have
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`been obvious in view of the prior art, including the references cited below, which
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`collectively teaches and motivates a person of ordinary skill in the art to make and
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`use the same film formulation compositions that are claimed by the ’514 patent.
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`27. It is my opinion that the challenged claims – claims 1-3, 9, 15, 62-65,
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`69-73, and 75 – are obvious under 35 U.S.C. § 103 in view of the prior art,
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`including the references cited below, which collectively teaches and motivates a
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`person of ordinary skill in the art to make and use the same film formulation
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`compositions that are claimed by the ‘514 patent.
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`28. I have reviewed the uniform thin film drug delivery prior art, and find
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`that one of ordinary skill in the art would have understood that the Bess1 and Chen2
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`references as well as the Chen and Cremer3 references render obvious the
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`challenged claims of the ’514 patent.
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`1 Bess, Ex. 1004
`2 Chen, Ex. 1005
`3 Cremer, Ex. 1006
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`DRL - EXHIBIT 1003
`DRL011
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`29. The allegedly inventive concepts of the ’514 patent were all well-
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`known in the prior art. It was known at the time of the alleged invention of the ‘514
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`patent that uniform suspensions are important for use in drug delivery. Dispersion
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`of pharmaceutical actives uniformly throughout a suspension was well known in
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`the art. Uniformity was known to be challenging for those compounds that were
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`not readily soluble, thereby forming suspensions. It would have thus been obvious
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`by the priority date to use uniform dispersion of pharmaceutical actives throughout
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`a suspension.
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`30. It was also known that uniform suspensions of particulate agents
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`(before or after casting) were highly dependent on viscosity. One of skill in the art
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`would have understood that uniformity in film formulations meant for human use
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`was expected and readily achieved. (See, e.g., Ex. 1013, The Theory and Practice
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`of Industrial Pharmacy, at 56-57, 358-359, 368-369.)4 The ’233 patent5 discloses
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`that homogeneous suspensions of various polymers, including vinyl acetate and
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`cellulose, were used for cast films. (Ex. 1022, ‘233 patent, at Abstract.) These films
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`were also dried and considered to be homogenous. (Id. at 4:59-5:3.) Further, it was
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`well known in the art that the uniformity of particulates in a suspension was
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`directly related to the suspension’s viscosity. (Ex. 1013, The Theory and Practice
`
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`4 Ex. 1013, The Theory and Practice of Industrial Pharmacy (Lachman et al., eds.,
`3d. ed. 1986).
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`DRL - EXHIBIT 1003
`DRL012
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`of Industrial Pharmacy, at 484.) The uniformity could also be affected by the
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`mixing time and speed used for making a suspension. (Id. at 491-492.) Stoke’s
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`law, well known in the art by 2001, taught that settling of particulates in a
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`suspension is directly related to, among other things, the density of the particles and
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`the viscosity of the solution (Ex. 1014, Theory of Pharmaceutical Systems,
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`Volume II: Heterogenous Systems, at 9.)5 Therefore, one of skill in the art would
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`understand that to achieve a desired uniformity, particularly for pharmaceutical
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`particles, one would necessarily consider the viscosity of the suspension.
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`31. It was well known that uniform particle distribution within a film,
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`whether cast or sprayed onto a drug dosage form, such as a tablet, was critical. (Ex.
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`1013, The Theory and Practice of Industrial Pharmacy, at 362-364.) One way to
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`achieve uniformity of particulates, such as in the case of colorants, was to “mill[]”
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`the colorant in the coating solution. (Id. at 369.) It was also well known that the
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`viscosity of the coating solution would affect the “uniform dispersion of the
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`colorants[’]” particle dispersion. (See id. at 369; Ex. 1014, Theory of
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`Pharmaceutical Systems, Volume II: Heterogeneous Systems, 1973, p. 9.)
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`32. It was well known that one could vary the viscosity of a suspension.
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`(Ex. 1013, The Theory and Practice of Industrial Pharmacy, at 484,491-492.)
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`5 Ex. 1014, Cartensen, Theory of Pharmaceutical Systems, Volume II:
`Homogenous Systems (1973).
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`-9-
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`DRL - EXHIBIT 1003
`DRL013
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`Lachman, for example, discloses that adding specific polymers, which have
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`different viscosities, could “cause loss of . . . the tendency to agglomerate.” (Id. at
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`654-55.) In other words, this could increase uniformity of the particles. Chen, too,
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`taught that “the viscosity of the hydrocolloid” is important to the properties of the
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`composition. (Chen, Ex. 1005, at 13:1-6, Tables 9a, 9b.) Multiple polymers with
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`various viscosities were available and could be used in films. (Ex. 1013, The
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`Theory and Practice of Industrial Pharmacy, at 365-368.)
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`33. A person of ordinary skill in the art would know by the priority date
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`that one of several methods to achieve rapid dissolution of pharmaceutical actives
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`is to employ mucoadhesive, uniform, oral films comprising polymers. Mucosally-
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`adhesive, oral dosage forms made of water- soluble polymers used to deliver
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`therapeutic agents have been known since at least 1997. (See Ex. 1023, Guo &
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`Zerbe, “Water soluble film for oral administration,” Proceedings of the 24th Int’l
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`Symposium on Controlled Release of Bioactive Materials, 227 (1997) (“Guo”), at
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`227; Ex. 1024, Cassidy et al., “Controlled buccal delivery of buprenorphine,” J.
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`Controlled Release, 25:21-29 (1993) (“Cassidy”) at 21-22; Ex. 1006, Cremer et al.,
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`Canad. Pat. No. CA2274910 (“Cremer”) at 10; Ex. 1027, U.S. Patent No.
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`5,948,430 to Zerbe et al., Abstract; and Ex. 1033, WO2001/70194 to Park et al.,
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`Abstract)
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`34. Some mucosally-adhesive films left an unpleasant residue in an user’s
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`-10-
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`DRL - EXHIBIT 1003
`DRL014
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`mouth after dissolution. (Ex. 1023, Guo at 227.) Rapidly dissolving films were
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`developed to alleviate this problem because they were manufactured without an
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`adhesive layer. These rapidly-dissolving films were used to deliver
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`pharmaceutically active agents and were typically made from water-soluble
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`polymers. (Id.; Ex. 1024, Cassidy at 21-22.) Rapidly dissolving films were
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`manufactured using conventional techniques, such as casting and drying. (Ex. 1013,
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`The Theory and Practice of Industrial Pharmacy, at 363.) The films were cut to
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`the desired size that satisfied appropriate requirements and then packaged. (Ex.
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`1023, Guo, at 227.) Chen discloses a cast film formulation formed from “a
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`substantially homogenous preparation” for oral delivery of a pharmaceutical active.
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`(Chen, Ex. 1005, at 4:24-32.) The components of the film were mixed to ensure
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`the components were “uniformly dispersed . . . in the hydrocolloid.” (Chen, Ex.
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`1005, at 17:6-11.)
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`35. Hydrogel films were also known in the art. According to dissolution
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`studies, hydrogel films were uniform when compared to one another. (Ex. 1024,
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`Cassidy, at 25, Fig. 3.) Hydrogel films were also cast and contained pharmaceutical
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`actives for oral delivery to achieve “rapid absorption.” (Ex. 1024, Cassidy, at 21-
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`22.) It was well-known in the art that dosage forms delivering pharmaceutical
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`agents to patients needed to be uniform with respect to the amount of drug found in
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`each individual film dose. (See, e.g., Ex. 1023, Guo, at 227-28.) Cassidy
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`DRL - EXHIBIT 1003
`DRL015
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`demonstrated, via dissolution studies, that the hydrogels exhibited uniform
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`dissolution of the measured components. (Ex. 1024, Cassidy, at 25, Fig. 3.)
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`36. A person of ordinary skill would have known to optimize uniformity
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`of pharmaceutical actives in drug dosage forms, including films. No later than 1989,
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`the Pharmakopoea Europae suggested that “uniformity of the weight of individually
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`dosed drugs” should differ by no more than 5% across the dosage forms. (See, e.g.,
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`Ex. 1025, U.S. Pat. No. 4,849,246 (“the ’246 patent”), at 1:63- 68.) And over the
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`years, uniform films complying with this standard were developed. (See Ex. 1026,
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`U.S. Pat. No. 5,393,528 (“the ’528 patent”), at 9:11-12 (the active agent “is evenly
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`dispersed throughout the film matrix.”); Ex. 1028, Zerbe et al., U.S. Pat. No.
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`5,629,003, at 1:54-57 (“homogeneous, water-soluble films intended for buccal
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`administration of hormones”) (citing prior art to Zerbe).) The ‘528 patent, like
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`others well-known in the art, included polymers. (Ex.1026,’528 patent, at Abstract,
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`10:66-11:3.) Uniform, cast films were also well known in the art. (See, e.g., Ex.
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`1028, U.S. Pat. No. 5,629,003, at 3:40, 5:51-53; Ex. 1029, Eur. Pat. No.
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`EP0090560, at 4:15.) For example, in 1997 Guo disclosed film formulations
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`containing pharmaceutical actives that could be manufactured using “conventional”
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`techniques that “meet the requirements of the specific application.” (Ex. 1023, Guo
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`at 227.)
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`37. A person of ordinary skill would have known to use taste-masking
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`DRL - EXHIBIT 1003
`DRL016
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`agents, particularly when the pharmaceutical active of interest was known to be
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`bitter or to have a bad taste. By 2001, many oral films included taste-masking
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`agents. (Ex. 1004, Bess at 6:8-7:40.) These were also used by Chen “to achieve
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`masking of taste for active agents that are bitter.” (Ex. 1005, Chen at 9:14-16.)
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`Chen further disclosed that “encapsulation of the active agents may also be utilized
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`to achieve masking of taste for active agents.” (Id. at 9:14-16.)
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`V.
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`LEGAL STANDARDS
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`38. I understand that a preponderance of evidence must be presented to
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`render a patent claim invalid in this proceeding.
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`39. I have been informed that the standard for obviousness is set out in
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`35 U.S.C. §103(a), the relevant version of which is quoted below:
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`“A patent may not be obtained though the invention is not identically
`disclosed or described as set forth in section 102 of this title, if the
`differences between the subject matter sought to be patented and the
`prior art are such that the subject matter as a whole would have been
`obvious at the time the invention was made to a person having ordinary
`skill in the art to which said subject matter pertains. Patentability shall
`not be negatived by the manner in which the invention was made.”
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`35 U.S.C. § 103(a).
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`40. I have been informed that in order for a patent claim to be considered
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`obvious, at the time the invention was made, each and every limitation of the claim
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`must be present within the prior art, or within the prior art in combination with the
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`general knowledge held by a person of ordinary skills in the art, and that such a
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`-13-
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`DRL - EXHIBIT 1003
`DRL017
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`
`
`person would have a reasonable expectation of success in combining these
`
`teachings to achieve the claimed invention. I also understand that the reason to
`
`select and combine features, the predictability of the results of doing so, and a
`
`reasonable expectation of success of doing so may be found in the teachings of the
`
`prior art themselves, in the nature of any need or problem in the field that was
`
`addressed by the patent, in the knowledge of persons of ordinary skill in the art at
`
`the time, as well as in common sense or the level of creativity exhibited by a POSA.
`
`There need not be an express or explicit suggestion to combine references. I
`
`understand the combination of familiar elements according to known methods is
`
`likely to be obvious when it does no more than yield predictable results.
`
`41. I understand that the obviousness of a claim is ultimately a legal
`
`conclusion based on underlying factual inquiries. I understand that the following
`
`factors are relevant to whether a claim is obvious: the scope and content of the
`
`prior art, the differences between the prior art and the claims at issue, the level of
`
`ordinary skill in the art, and whatever objective evidence may be present.
`
`42. I understand that a claim may be obvious where it is the result of
`
`combining familiar elements according to known methods to achieve predictable
`
`results. The claim is obvious where a POSA would have been motivated to combine
`
`the teachings of the prior art and would have had a reasonable expectation of
`
`success in doing so.
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`
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`-14-
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`DRL - EXHIBIT 1003
`DRL018
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`43. I understand that secondary considerations of non-obviousness must be
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`considered because such factors are probative of obviousness. These factors include
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`unexpected results, commercial success, long felt but unresolved need, teaching
`
`away, and failure of others.
`
`44. I have relied upon this understanding of the applicable legal standards in
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`reaching my opinions set forth in this declaration.
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`VI. PERSON OF ORDINARY SKILL IN THE ART
`
`
`45. It is my opinion that in the context of the ’514 patent, a person of
`
`ordinary skill in the art (“POSA”) would include a person who possesses a
`
`Master’s or Ph.D. in pharmaceutical sciences, formulation chemistry, or a related
`
`field, plus a number of years of relevant experience in developing drug
`
`formulations.
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`VII. THE ‘514 PATENT
`
`
`46. I have read the ’514 patent and the issued claims, entitled “Uniform
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`Films
`
`for Rapid Dissolve Dosage Form
`
`Incorporating Taste-Masking
`
`Compositions.” The ’514 patent claims priority to several applications, listed on
`
`the face of the patent, the earliest of which is October 12, 2001, which I understand
`
`to be a provisional application. The ’514 patent issued December 10, 2013, and
`
`names Robert K. Yang, Richard C. Fuisz, Garry L. Myers, and Joseph M. Fuisz as
`
`inventors.
`
`
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`-15-
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`DRL - EXHIBIT 1003
`DRL019
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`
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`A.
`
`Priority Date of the’514 Patent
`
`47. The ’514 patent was filed July 10, 2007, and is a continuation-in-part of
`
`application No. 10/768,809, filed on Jan. 30, 2004, now Pat. No. 7,357,891, and a
`
`continuation-in-part of application No. PCT/US02/32575, filed on Oct. 11, 2002,
`
`and a continuation-in-part of application No. 10/074,272, filed on Feb. 14, 2002,
`
`now Pat. No. 7,425,292; said application No. 10/768,809 is a continuation-in-part
`
`of application No. PCT/US02/32594, filed on Oct. 11, 2002, and a continuation-in-
`
`part of application No. 10/074,272; said application No. 10/768,809 is a
`
`continuation-in-part of application No. PCT/US02/32542, filed on Oct. 11, 2002,
`
`and a continuation-in-part of application No. 10/074,272, application
`
`No.11/775,484, which is a continuation-in-part of application No. 10/856,176, filed
`
`on May 28, 2004, now Pat. No. 7,666,337, and a continuation-in-part of application
`
`No. 10/768,809.
`
`B. Challenged Claims
`
`48. The challenged claims of the ‘514 patent include claims 1- 3, 9, 15, 62-
`
`65, 69-73, and 75 of the ’514 patent. The ’514 patent includes two illustrative
`
`independent claims, claims 1 and 62. Independent claim 1 recites:
`
`A drug delivery composition comprising:
`
`
`
`
`
`(i)
`
`a cast film comprising a flowable water-soluble or water
`
`swellable film-forming matrix comprising one or more substantially
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`-16-
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`DRL - EXHIBIT 1003
`DRL020
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`
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`water soluble or water swellable polymers; and a desired amount of at
`
`least one active; wherein said matrix has a viscosity sufficient to aid in
`
`substantially maintaining non-self- aggregating uniformity of the
`
`active in the matrix;
`
`(ii)
`
`a particulate active substantially uniformly stationed in the
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`matrix; and
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`(iii) a taste-masking agent coated or intimately associated with said
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`particulate to provide taste-masking of the active; wherein the
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`combined particulate and taste-masking agent have a particle size of
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`200 microns or less and said flowable water- soluble or water
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`swellable film-forming matrix is capable of being dried without loss of
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`substantial uniformity in the stationing of said particulate active
`
`therein; and wherein the uniformity subsequent to casting and drying
`
`of the matrix is measured by substantially equally sized individual unit
`
`doses which do not vary by more than 10% of said desired amount of
`
`said at least one active.
`
`49.
`
`Independent claim 62 recites:
`
` A
`
` drug delivery composition comprising:
`
`
`(i)
`
`a cast film comprising a flowable water-soluble or water
`
`swellable film-forming matrix comprising one or more substantially
`
`
`
`-17-
`
`DRL - EXHIBIT 1003
`DRL021
`
`
`
`water soluble or water swellable polymers; and a desired amount of at
`
`least one active; wherein said matrix has a viscosity sufficient to aid in
`
`substantially maintaining non-self- aggregating uniformity of the
`
`active in the matrix;
`
`(ii)
`
`a particulate active substantially uniformly stationed in the
`
`matrix; and
`
`(iii)
`
` a taste-masking agent selected from the group consisting of
`
`flavors, sweeteners, flavor enhancers, and combinations thereof to
`
`provide taste-masking of the active; wherein the particulate active has
`
`a particle size of 200 microns or less and said flowable water-soluble
`
`or water swellable film-forming matrix is capable of being dried
`
`without loss of substantial uniformity in the stationing of said
`
`particulate active therein; and wherein the uniformity subsequent to
`
`casting and drying of the matrix is measured by substantially equally
`
`sized individual unit doses which do not vary by more than 10% of
`
`said desired amount of said at least one active.
`
`50.
`
`I understand that the claim terms in the ’514 patent are interpreted
`
`according to their “broadest reasonable construction in light of the specification of
`
`the patent in which it appears.” In rendering my opinions, I applied only one
`
`specific construction:
`
`
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`-18-
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`DRL - EXHIBIT 1003
`DRL022
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`
`
`
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`“dried without the loss of substantial uniformity” (’514
`
`Patent, Ex. 1001, at claim 1 and 62) should be construed as “any
`
`method of drying.”
`
`51.
`
`I understand that in a co-pending litigation, Patent Owner’s expert
`
`witness on validity of the ‘514 patent, Dr. Langer, testified that the claims were not
`
`limited to any particular form of drying, or any particular drying parameters.
`
`
`
`52.
`
`I understand that during the prosecution of the ’514 patent, the
`
`pending claims were rejected as obvious over the Chen and Bess references.
`
`Applicants argued, in response to this rejection, that “‘the uniformity subsequent to
`
`casting and drying of the matrix is measured by substantially equally sized
`
`individual doses which do not vary by more than 10% of said desired amount of
`
`said at least one active’ in the claims overcomes the [Bess] and Chen references.”
`
`(Ex. 1002, ‘514 File History at 163 (May 10, 2013 Amendment and Response After
`
`Final Action).) Applicants also argued that Bess did not disclose the claimed
`
`uniformity because the purported invention required a particular drying technique
`
`that is not disclosed in Bess. (Ex. 1002, ‘514 File History, at 74 (April 4, 2011
`
`Amendment and Response).) Additionally, Applicants argued the specification of
`
`the ‘514 patent supported this position because it described an apparent deficiency
`
`in teaching drying methods that could accomplish the claimed uniformity. (Ex.
`
`1002, ‘514 File History at 74 (April 4, 2011 Amendment and Response); ‘514
`
`
`
`-19-
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`DRL - EXHIBIT 1003
`DRL023
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`
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`patent at 4:7-11.)
`
`
`
`53.
`
`I understand, though, that Patent Owner no
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