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, LLC,
`Patent Owner.
`
`
`
`
`
`
`
`
`DECLARATION OF RUSSELL J. MUMPER, Ph.D. IN SUPPORT OF
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,017,150
`
`“POLYETHYLENE OXIDE-BASED FILMS AND DRUG DELIVERY
`SYSTEMS MADE THEREFROM”
`
`
`
`
`
`
`Case No. IPR2016-XXXXX
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`DRL - EXHIBIT 1003
`DRL001
`
`

`
`
`
`TABLE OF CONTENTS
`
`I.
`
`Page
`QUALIFICATIONS AND BACKGROUND ................................................. 1
`Education and Experience; Prior Testimony ......................................... 1
`A.
`
`Basis for Opinion and Materials Considered ......................................... 9
`B.
`
`Scope of Work ....................................................................................... 9
`C.
`
`SUMMARY OF OPINIONS .........................................................................10
`II.
`III. LEGAL STANDARDS .................................................................................14
`IV. PERSON OF ORDINARY SKILL IN THE ART ........................................16
`V.
`THE ’150 PATENT .......................................................................................16
`Relevant Prosecution History of the ’150 Patent .................................20
`A.
`
`Priority Date of The ’150 Patent ..........................................................20
`B.
`
`VI. BACKGROUND AND TECHNOLOGY TUTORIAL ................................26
`
` Mucosally-Adhesive Drug Delivery Systems ......................................26 A.
`Polymers ..............................................................................................30
`B.
`
`
` Molecular Weight of Polymers ............................................................31 C.
`
` Oral Films as Delivery Systems...........................................................35 D.
`Common Components of Oral Films ........................................36
`1.
`2.
`Determining the Ratios of Polymer Film Components .............38
`VII. SCOPE AND CONTENT OF THE PRIOR ART REFERENCES ..............42
`Scope and Content Of The Prior Art As Of October 12, 2001 ............43
`A.
`
`1. WO2000/42992 (“Chen”) (Ex. 1021) ........................................43
`2.
`U.S. Application Pub. No. 2002/0147201 (“Chen II”)
`-i-
`
`
`
`DRL - EXHIBIT 1003
`DRL002
`
`

`
`B.
`
`
`C.
`
`
`B.
`
`
`
`C.
`
`
`(Ex. 1049) ..................................................................................47
`U.S. Patent No. 4,713,243 (“Schiraldi”) (Ex. 1004) .................48
`3.
`U.S. Patent No. 6,322,811 (“Verma”) (Ex. 1005) .....................50
`4.
`U.S. Patent No. 5,656,296 (“Khan”) .........................................51
`5.
`Summary of the Scope and Content of the Prior Art ..........................51
`1. Mucosally-adhesive water-soluble film products ......................51
`PEO in combination with cellulosic polymers6 ........................52
`2.
`Films containing PEOs of varying molecular weights ..............52
`3.
`Scope And Content of the Prior Art as of April 22, 2008 ....................53
`U.S. Patent App. No. 2005/0037055 (“Yang”) (Ex. 1006) .......53
`1.
`VIII. INVALIDITY OF THE ’150 PATENT ........................................................54
`Claims 1, 3-5, 7-10, 12-14, and 15-18 are Obvious over Chen in
`A.
`
`View of Schiraldi, Claims 6 and 14 are Obvious over Chen in
`View of Schiraldi and Additionally in View of Chen II .....................54
`Claims 1, 4-5, 8, 10, 13-14, and 17 Are Obvious Over Schiraldi
`in View of Verma ................................................................................59
`1.
`Claims 4 and 13 are Obvious Over Schiraldi in View of
`Verma ........................................................................................64
`Claims 5, 8, 14 and 17 are Obvious Over Schiraldi in
`View of Verma ..........................................................................64
`Claims 6-7, 9, 15-16, and 18 Are Obvious Over Schiraldi in
`View of Verma and Khan ....................................................................65
`1.
`Claims 6 and 15 are Obvious Over Schiraldi in View of
`Verma and Khan ........................................................................65
`Claims 7 and 16 are Obvious Over Schiraldi in View of
`Verma and Khan ........................................................................65
`
`2.
`
`2.
`
`
`
`-ii-
`
`DRL - EXHIBIT 1003
`DRL003
`
`

`
`3.
`
`D.
`
`
`Claims 9 and 18 are Obvious Over Schiraldi in View of
`Verma and Khan ........................................................................65
`The Challenged Claims Would Have Been Obvious As Of April
`22, 2008 Over Yang .............................................................................65
`1.
`Claims 4-9 and 13-18 Would Have Been Obvious as of
`April 22, 2008 Over Yang .........................................................66
`IX. CONCLUSION ..............................................................................................67
`
`
`
`
`-iii-
`
`DRL - EXHIBIT 1003
`DRL004
`
`

`
`1. My name is Russell J. Mumper. I have been retained by counsel for
`
`Petitioner Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd.
`
`(collectively – “Dr. Reddy’s”). I understand that Dr. Reddy’s is petitioning for
`
`inter partes review of U.S. Patent No. 8,017,150 (the “’150 patent”), which is
`
`owned by MonoSol RX, LLC. I further understand that Dr. Reddy’s will request
`
`that the United States Patent and Trademark Office (“USPTO”) cancel certain
`
`claims of the ’150 patent as unpatentable. I submit this expert declaration, which
`
`addresses and supports Dr. Reddy’s petition.
`
`I.
`
`QUALIFICATIONS AND BACKGROUND
`
`
`
` Education and Experience; Prior Testimony A.
`
`2.
`
`Currently, I am the Vice Provost for Academic Affairs for University
`
`of Georgia at Athens, with more than 25 years of combined research, product
`
`development and teaching experience in the pharmaceutical sciences. I have been
`
`on the faculty at University of Georgia in Athens, Georgia since 2014, where I hold
`
`full Professor positions (with tenure) in both the College of Pharmacy and the
`
`College of Engineering. Prior to my employment at the University of Georgia, I
`
`was the John A. McNeill Distinguished Professor in the Division of Molecular
`
`Pharmaceutics at the University of North Carolina’s (“UNC”) Eshelman School of
`
`Pharmacy in Chapel Hill, NC. At UNC, I was also the founding Director of the
`
`Center for Nanotechnology in Drug Delivery and Co-Director of UNC’s Institute
`
`
`
`-1-
`
`DRL - EXHIBIT 1003
`DRL005
`
`

`
`for Nanomedicine. Prior to that, I had been Vice Chair of the Department of
`
`Pharmaceutical Sciences at the University of Kentucky’s College of Pharmacy in
`
`Lexington, KY, where I also last served as an Associate Professor after receiving
`
`early tenure in 2003. For more than a decade at the University of Kentucky and
`
`the University of North Carolina at Chapel Hill, I taught a required first year
`
`course to pharmacy students pertaining to pharmaceutics and pharmaceutical
`
`dosage forms. This course covered a wide range of dosage forms by all different
`
`routes of administration including topical, injectable, oral, nasal, and buccal,
`
`among others. Prior to my time at University of Kentucky, I worked in industry,
`
`first at Burroughs Wellcome, Co. (now GlaxoSmithKline), then at Gene Medicine,
`
`Inc. (which became Valentis, Inc.), and at the ViroTex Corporation. I have also
`
`founded pharmaceutical start-up companies and served on the Board of Directors
`
`for angel investor and venture capital-backed companies. A copy of my
`
`curriculum vitae and list of publications is attached as Ex. A and filed as Ex. 1047.
`
`3. My business address is University of Georgia, 204 Administration
`
`Building, 220 South Jackson Street, Athens, GA 30602.
`
`4. My academic research programs have focused primarily in
`
`nanotechnology-based drug delivery and cell targeting, mucoadhesive gels and
`
`films for transmucosal drug delivery, and anti-cancer and anti-inflammatory
`
`properties of berries and berry extracts. From 1999 to the present, I received many
`
`
`
`-2-
`
`DRL - EXHIBIT 1003
`DRL006
`
`

`
`grants and contracts to support my research programs including from the National
`
`Institutes of Health and National Science Foundation, foundations, and many
`
`companies. In total, I received 42 grants or contracts from Federal funding
`
`agencies or foundations and 41 from pharmaceutical and biotechnologies
`
`companies.
`
`5.
`
`From 1992 until 1999, I worked in the pharmaceutical and
`
`biotechnology industries for three companies: Burroughs Wellcome Co.,
`
`GeneMedicine, and ViroTex Corporation. During these seven years, I was
`
`involved in various aspects of the creation of drug delivery systems including
`
`immediate and sustained oral solid dosage forms, gene delivery systems, and
`
`topical, vaginal and buccal dosage forms. I directed groups of scientists and efforts
`
`to transfer the discoveries into human clinical trials. While at ViroTex, I served as
`
`Director of Product Development and designed, optimized, and scaled-up drug
`
`delivery systems for topical (skin) and mucosal (buccal) delivery. Delivery
`
`systems were primarily polymer-based formulations applied as films, gels, pump
`
`sprays, or aerosols. At ViroTex, I led research effort on the application of
`
`ViroTex’s BEMA (BioErodible MucoAdhesive) delivery technology for buccal
`
`delivery and mucosal vaccines.
`
`6.
`
`I received a B.A. Chemistry from University of Kentucky, Lexington,
`
`Kentucky in 1988 with High Distinction and Departmental Honors.
`
`
`
`-3-
`
`DRL - EXHIBIT 1003
`DRL007
`
`

`
`7.
`
`I obtained a Ph.D. in Pharmaceutical Sciences (Pharmaceutics/Drug
`
`Delivery) from the University of Kentucky College of Pharmacy in 1991.
`
`8.
`
`After receiving my Ph.D., I performed postdoctoral research from
`
`1991-1992 under the direction of Professor Allan S. Hoffman and University of
`
`Washington, Seattle, Center for Bioengineering. My postdoctoral research was in
`
`the area of protein drug delivery.
`
`9.
`
`In addition to my industry experience in research and development, I
`
`have directly co-founded three companies that licensed technologies developed in
`
`my university laboratories. These companies worked to develop novel medical,
`
`drug and health products. NanoMed Pharmaceuticals Inc., which I co-founded in
`
`2000, developed nanoparticle-based advanced drug delivery systems to diagnose
`
`and treat disease. I was a co-inventor on all of the founding technology of
`
`NanoMed Pharmaceuticals which includes nanoparticle manufacturing processes,
`
`mucoadhesive thin-films, and topical film-forming gels. Then, in 2004, I co-
`
`founded Four Tigers, LLC. Four Tigers develops a pipeline of products utilizing
`
`disease-preventative and therapeutic properties of blackberries including chewing
`
`gums, topical products, and mucoadhesive thin-films. In 2009, I co-founded
`
`Capture Pharmaceuticals LLC, which develops prodrugs of chelating agents to
`
`treat people contaminated with radioisotopes in the event of a nuclear explosion or
`
`radioactive “dirty bomb,” or people suffering from toxicity due to the use of
`
`
`
`-4-
`
`DRL - EXHIBIT 1003
`DRL008
`
`

`
`gadolinium-based MRI contrast agents.
`
`10. While serving as the John A. McNeill Distinguished Professor at the
`
`University of North Carolina, Chapel Hill a major focus of my research was
`
`mucoadhesive gels, thin-films, and intravaginal rings for the transmucosal delivery
`
`of drugs, vaccines and microbicides.
`
`11.
`
`I have authored more than 300 scientific publications, including peer
`
`reviewed journal articles and abstracts on various aspects of pharmaceutics and
`
`advanced drug delivery systems for the delivery of small drugs, peptides and
`
`proteins, DNA, and vaccines. A complete list of my publications and other
`
`activities can be found in my curriculum vitae dated June 2016, attached as Ex. A
`
`and filed as Ex. 1047.
`
`12.
`
`I have published a number of peer reviewed papers on transmucosal
`
`delivery of drugs and mucoadhesive systems. For example, I co-authored a paper
`
`titled “Transmucosal Delivery of Testosterone in Rabbits using Novel Bi-Lay
`
`Mucoadhesive Wax-Film Composite Disks,” by Jay, S. et al. published in J.
`
`Pharm. Sci.(2002) 91(9): 2016-2025. I was also coauthor of the article
`
`“Formulation and In-Vitro and In-Vivo Evaluation of a Mucoadhesive Gel
`
`Containing Freeze Dried Black Raspberries: Implication for Oral Cancer
`
`Chemoprevention,” by Mallery, S.R. published in Pharm. Res. (2007) 24(4): 728-
`
`737.
`
`
`
`-5-
`
`DRL - EXHIBIT 1003
`DRL009
`
`

`
`13.
`
`I am the inventor or co-inventor of at least 49 U.S. and foreign patents
`
`and patent applications. I have prepared patent applications submitted to the
`
`United States Patent Office as well as patent offices overseas. I have also been
`
`active in responding to Office actions. These patents have included the invention
`
`of thin-film and film-forming gel technologies specifically designed for the
`
`trans(mucosal) delivery of drugs and vaccines.
`
`14.
`
`I am also co-inventor of patents for mucoadhesive drug delivery
`
`systems. For example, I am a co-inventor of two U.S. patents both titled “pH-
`
`Sensitive Mucoadhesive Film-form Gels and Wax-film Composites Suitable for
`
`Topical and Mucosal Delivery of Molecules,” U.S. Patent Nos. 8,865,150 and
`
`7,803,392.
`
`15. Since 1999, I have served on more than 25 scientific review panels for
`
`the National Institutes of Health, including serving as Chair of a Study Section.
`
`16. Over the past 15 years I have been routinely asked to review
`
`manuscripts submitted to almost thirty different scientific journals with most
`
`pertaining to advanced drug delivery systems. Some of these journals include:
`
`Advanced Drug Delivery Reviews, Biomaterials, Critical Reviews in Therapeutic
`
`Drug Carrier Systems, European Journal of Pharmaceutics and
`
`Biopharmaceutics, Expert Opinion in Drug Delivery, International Journal of
`
`Nanomedicine, International Journal of Pharmaceutics, Journal of Applied
`
`DRL - EXHIBIT 1003
`DRL010
`
`

`
`Polymer Science, Journal of Controlled Release, Journal of Dispersion Science
`
`and Technology, Journal of Drug Targeting, Journal of Pharmaceutical Sciences,
`
`and Molecular Pharmaceutics, among others.
`
`17.
`
`I have also served on the editorial advisory boards of four scientific
`
`journals including, HIV/AIDS – Research and Palliative Care, Journal of
`
`Biomedical Nanotechnology , Drug Development and Industrial Pharmacy, and
`
`TheScientificWorld Journal – Drug Delivery.
`
`18. From 1999 to 2006, I served as Assistant and Associate Director of
`
`the Center for Pharmaceutical Science and Technology (“CPST”). The CPST was
`
`the analytical, formulation development, and FDA-registered cGMP clinical trial
`
`manufacturing facility of the College of Pharmacy, University of Kentucky in
`
`Lexington, KY. From 1999 to 2006, working with seven different clients, I led the
`
`CPST’s efforts to complete seven full product development projects (analytical,
`
`formulation, manufacturing, quality control) leading to the successful submission
`
`of Investigational New Drug Applications and the commencement of human
`
`clinical trials. In 2007, the CPST became a for-profit company under the name of
`
`Coldstream Laboratories, Inc.
`
`19.
`
`I have previously served as an expert patent witness in the areas of
`
`oral sustained release drug delivery systems, and topical delivery systems for
`
`buccal, nasal, and skin application. In the last 6 years, I have been retained 6 times
`
`DRL - EXHIBIT 1003
`DRL011
`
`

`
`and prepared expert reports or declarations and was deposed in each of these cases.
`
`I testified in federal court twice, once at a Markman hearing and once at trial.
`
`20.
`
`In addition to teaching at the University, and advising and mentoring
`
`in science education, I am active in invited talks and seminars, particularly on
`
`nanotechnology-based drug delivery systems for cancer and vaccine applications,
`
`as well as oral (trans)mucosal delivery and mucosal immunization by the buccal
`
`and nasal routes of administration. In the past about 20 years, I have been invited
`
`to give more than 80 scientific talks at 15 different universities, 7 different national
`
`or international meeting venues in the United States, 12 different pharmaceutical
`
`companies, 12 different countries, and several other venues.
`
`21. My June 2016 CV also shows that I have published a number of peer-
`
`reviewed manuscripts on the creation, development, and testing of buccal and
`
`transbuccal drug, gene, and vaccine delivery systems, and the characterization of
`
`such delivery systems. The manuscripts have pertained to mucoadhesive thin-
`
`films, mucoadhesive film-forming gels, and the use of near-infra-red to determine
`
`the content and content uniformity of drug-containing thin-films. These peer-
`
`reviewed manuscripts pertaining to oral (buccal) delivery have been published in
`
`Pharmaceutical Research, Clinical Cancer Research, Journal of Pharmaceutical
`
`and Biomedical Analysis, Journal of Pharmaceutical Sciences, among others.
`
`22. Outside of the academia, I have been advisor and consultant to the
`
`DRL - EXHIBIT 1003
`DRL012
`
`

`
`United States government and leading chemical and pharmaceutical companies, as
`
`well as nascent biotechnology concerns. I have advised the Federal Trade
`
`Commission, GlaxoSmithKline (Parsippany, NJ), Merck & Co., Inc. (West Point,
`
`PA), and Isis Pharmaceuticals, Inc. (Carlsbad, CA), among others.
`
`23. Therefore, I believe I am well qualified to serve as a technical and
`
`scientific expert in this matter based on my educational background and research,
`
`industry, and teaching experience.
`
`
`
` B.
`
`Basis for Opinion and Materials Considered
`
`24. Exhibit 1048 includes a list of the materials I considered, in addition to
`
`my experience, education, and training, in providing the opinions contained herein.
`
`
`
` C.
`
`Scope of Work
`
`25.
`
`I have been retained by Dr. Reddy’s as a technical expert in this matter
`
`to provide various opinions regarding the ’150 patent. I receive $1,100 per hour for
`
`my services including for deposition testimony and $300 per hour for travel time.
`
`No part of my compensation is dependent upon my opinions given or the outcome
`
`of this case. I do not have any other current affiliation as an expert witness or
`
`consultant with Dr. Reddy’s. However, in 2003 I was retained by Dr. Reddy's
`
`Laboratories, Inc. in Upper Saddle River, New Jersey on a limited basis to serve on a
`
`panel of experts that met one time to advise the company on the future of medicine and
`
`the role of engineering and pharmaceutical sciences. I do not have any current or past
`
`DRL - EXHIBIT 1003
`DRL013
`
`

`
`affiliation with MonoSol RX, LLC, or any of the named inventors on the ’150
`
`patent.
`
`II.
`
`SUMMARY OF OPINIONS
`
`26.
`
`I understand that Dr. Reddy’s is challenging the validity of claims 1-18
`
`of the ’150 patent (“the Challenged Claims”).
`
`27.
`
`In reaching these opinions, I have reviewed the ’150 patent as well as
`
`portions of the file history of the ’150 patent. I have also reviewed references and
`
`articles, which I describe in greater detail below, and the materials listed in Exhibit
`
`1048 attached hereto. I have also relied upon my education, background, and
`
`experience in reaching the conclusions and in forming the opinions set forth herein.
`
`28. To summarize, for the reasons set forth below, it is my opinion that the
`
`Challenged Claims of the ’150 patent would be obvious to a person of ordinary skill
`
`in the art in view of the prior art, including art that discloses the use of hydrophilic
`
`cellulosic polymers and both low and high molecular weight polyethylene oxide
`
`(“PEO”) to form uniform film products containing active pharmaceutical
`
`ingredients.
`
`29. For the reasons set forth below, the Challenged Claims are entitled to a
`
`priority date no earlier than April 22, 2008. Alternatively, to the extent the Board
`
`determines that the specification of the ’150 patent contains a sufficient written
`
`description to support the claimed invention, the Challenged Claims are entitled to a
`
`DRL - EXHIBIT 1003
`DRL014
`
`

`
`priority date no earlier than May 23, 2003. It is my further opinion that the
`
`Challenged Claims would have been obvious to a person of ordinary skill in the art
`
`as of May 23, 2003 and April 22, 2008. The Challenged Claims of the ’150 patent
`
`represent no more than a combination of familiar elements assembled according to
`
`known methods to yield predictable results.
`
`30.
`
`It is my opinion that one of ordinary skill in the art would have
`
`considered the ‘150 patent obvious in view of the teachings of WO 2000/042992 to
`
`Chen in combination with US 4,713,243 to Schiraldi. Chen teaches hydrocolloid
`
`films for mucosal drug delivery, including films containing an opioid. The
`
`hydrocolloid can contain a hydrophilic cellulosic polymer, such as HPMC or HPC
`
`and can contain polyethylene oxide. Chen discloses Example 11, a mucoadhesive
`
`film containing 77.8% Polyox®WSR N-10, a polyethylene oxide having an
`
`average molecular weight of 100,000 Daltons (or Da), which meets the
`
`requirement of claim 1 of the ‘150 patent for “about 60% or more” of the low
`
`molecular weight PEO. Schiraldi teaches the use of a high molecular weight
`
`polyethylene oxide for mucoadhesive films. For example Schiraldi teaches a
`
`bioadhesive layer of a mucosal film having 60% w/w polyethylene oxide
`
`homopolymer (Polyox WSR N-301, molecular weight of 4,000,000 Da). Both
`
`Chen and Schiraldi teach varying the ratios of film polymers to control film
`
`properties. Importantly, Chen states “…the film may be formed using a mixture of
`
`DRL - EXHIBIT 1003
`DRL015
`
`

`
`two or more types of the same hydrocolloid that differ only in molecular weight
`
`and/ or degree of substitution.” Chen also states “The dosage unit may release the
`
`active agent over a period of time that is determined by a number of different
`
`factors.” Schiraldi teaches that “by varying the ratios of the above polymers both
`
`the solubility and adhesive properties of each layer of film may be controlled.”
`
`Thus, it is my opinion that one of ordinary skill reading Chen and Schiraldi would
`
`be highly motivated to vary the amounts of the low and high molecular weight
`
`polyethylene oxide to achieve the desired effects including, but not limited to drug
`
`solubility, mucoadhesion and drug release rate.
`
`31.
`
`It is also my opinion that one of ordinary skill in the art would have
`
`recognized that a mucosally-adhesive, water-soluble film product as claimed in the
`
`Challenged Claims of the ’150 patent was already disclosed in Yang. Yang
`
`disclosed various film compositions containing combinations of low molecular
`
`weight polyethylene oxide (PEO), higher molecular weight PEO and hydrophilic
`
`cellulosic polymers. A person of ordinary skill in the art would understand from
`
`Yang’s disclosures that the exact proportions of such film compositions could be
`
`readily and easily modified using the teachings of the prior art to obtain a film
`
`composition with the qualities described and claimed in the ’150 patent. One of
`
`ordinary skill in the art would also have recognized that combining small amounts
`
`of high molecular weight PEOs with low molecular weight PEOs improved the tear
`
`DRL - EXHIBIT 1003
`DRL016
`
`

`
`resistance of the final film. From Yang, one of ordinary skill in the art would have
`
`further recognized that films having 60% or greater amounts of low molecular
`
`weight PEO in such combinations resulted in faster dissolution of the films when in
`
`contact with mucosal membranes.
`
`32. Even before the publication of Yang, the properties of the claimed film
`
`compositions were well-described in the art and were well-known to a person of
`
`ordinary skill. The use of PEO in film compositions for use in delivering active
`
`pharmaceutical agents was disclosed in at least Schiraldi, including, in the use of
`
`analgesics. Schiraldi also teaches the use of cellulosic polymers in combination
`
`with PEO to produce a film with desirable structural characteristics. The
`
`combination of low molecular weight PEO and high molecular weight PEO in such
`
`compositions was a well-known means of further manipulating the structural
`
`properties of film compositions to attain desired thickness, uniformity, and tensile
`
`and shear strength. Such film compositions were routinely employed by those of
`
`ordinary skill in the art. As such, it would have been obvious to those of ordinary
`
`skill in the art to combine low molecular weight PEO, higher molecular weight
`
`PEO, and a hydrophilic cellulosic polymer, and modify the proportions of each
`
`component of the film composition to attain a film with the claimed structural
`
`properties and uniformity.
`
`
`
`DRL - EXHIBIT 1003
`DRL017
`
`

`
`III.
`
`LEGAL STANDARDS
`
`33.
`
`I understand that a preponderance of evidence must be presented to
`
`render a patent claim invalid in this proceeding.
`
`34.
`
`I have been informed that the standard for obviousness is set out in 35
`
`U.S.C. §103(a), the relevant version of which is quoted below:
`
`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.
`35 U.S.C. § 103(a) (2006).
`
`35.
`
`I have been informed that in order for a patent claim to be considered
`
`obvious, at the time the invention was made, each and every limitation of the claim
`
`must be present within the prior art, or within the prior art in combination with the
`
`general knowledge held by a person of ordinary skill in the art, and that such a
`
`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 in doing so may be found in the teachings of the
`
`DRL - EXHIBIT 1003
`DRL018
`
`

`
`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 person
`
`of ordinary skill in the art. 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.
`
`36.
`
`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.
`
`37.
`
`I understand that a claim may be obvious when it is the result of
`
`combining familiar elements according to known methods to achieve predictable
`
`results. The claim is obvious when a person of ordinary skill in the art would have
`
`been motivated to combine the teachings of the prior art and would have had a
`
`reasonable expectation of success in doing so.
`
`38.
`
`I understand that secondary considerations of non-obviousness must be
`
`considered because such factors are probative of obviousness. These factors
`
`include unexpected results, commercial success, long felt but unresolved
`
`DRL - EXHIBIT 1003
`DRL019
`
`

`
`need, teaching away, and failure of others.
`
`39.
`
`I have relied upon this understanding of the applicable legal standards
`
`in reaching my opinions set forth in this declaration.
`
`IV.
`
`PERSON OF ORDINARY SKILL IN THE ART
`
`40.
`
`It is my opinion that in the context of the ’150 patent, a person of
`
`ordinary skill in the art would include a person who possesses a Master’s or Ph.D.
`
`degree in pharmaceutical sciences, chemistry, or a related filed, and at least 5 years
`
`of experience with a Master’s degree or at least 2 years of experience with a Ph.D.
`
`degree.
`
`V.
`
`THE ’150 PATENT
`
`41.
`
`I have read the ’150 patent, entitled “Polyethylene Oxide-based Films
`
`and Drug Delivery Systems Made Therefrom.” The ’150 patent was filed on April
`
`22, 2008, as U.S. Patent Application No. 12/107,389, and is a divisional application
`
`of U.S. Patent Application No. 10/856,176, which was filed on May 28, 2004 and is
`
`now U.S. Patent No. 7,666,337, which is a continuation-in-part of application No.
`
`PCT/US02/032575, filed on Oct. 11, 2002, and a continuation-in-part of application
`
`No. PCT/US02/32594, filed on Oct. 11, 2002, and a continuation-in- part of
`
`application No. PCT/US02/32542, filed on Oct. 11, 2002. The ’150 patent was
`
`issued on Sep. 13, 2011. The ‘150 patent also claims priority of provisional
`
`application ser. nos. 60/473,902, filed May 28, 2003 and 60/371,940, filed April
`
`DRL - EXHIBIT 1003
`DRL020
`
`

`
`11, 2002.
`
`42.
`
`I understand that Dr. Reddy’s is challenging claims 1-18 of the ’150
`
`patent. Claims 1 and 10 are independent.
`
`43.
`
`Independent claim 1 recites:
`
`A mucosally-adhesive water-soluble film product comprising: an
`analgesic opiate pharmaceutical active; and at least one water-soluble
`polymer component consisting of polyethylene oxide in combination
`with a hydrophilic cellulosic polymer; wherein: the water-soluble
`polymer component comprises greater than 75% polyethylene oxide
`and up to 25% hydrophilic cellulosic polymer; the polyethylene
`oxide comprises one or more low molecular weight polyethylene
`oxides and one or more higher molecular weight polyethylene oxides,
`the molecular weight of the low molecular weight polyethylene oxide
`being in the range of 100,000 to 300,000 and the molecular weight of
`the higher molecular weight polyethylene oxide being in the range of
`600,000 to 900,000; and the polyethylene oxide of low molecular
`weight comprises about 60% or more in the polymer component.
`Independent claim 10 recites:
`44.
`
`A mucosally-adhesive water-soluble film product comprising: an
`analgesic opiate pharmaceutical active; and at least one water-soluble
`polymer component consisting of polyethylene oxide in combination
`with a hydrophilic cellulosic polymer; wherein: the water-soluble
`polymer component comprises the hydrophilic cellulosic polymer in a
`ratio of up to about 4:1 with the polyethylene oxide; the polyethylene
`oxide comprises one or more low molecular weight polyethylene
`
`DRL - EXHIBIT 1003
`DRL021
`
`

`
`oxides and one or more higher molecular weight polyethylene oxides,
`the molecular weight of the low molecular weight polyethylene oxide
`being in the range of 100,000 to 300,000 and the molecular weight of
`the higher molecular weight polyethylene oxide being in the range of
`600,000 to 900,000; and the polyethylene oxide of low molecular
`weight comprises about 60% or more in the polymer component.
`45. Dependent claims 2-3 and 11-12 of the ‘150 patent further limit the
`
`water soluble film of claim 1 to a film having a particular viscosity range and
`
`thickness. Claims 4-9 and 13-18 of the ’150 patent relate to the addition to the
`
`formulation of other pharmaceutical actives, sweeteners, flavors, and buffers.
`
`46.
`
`I understand that the claim terms in the ’150 patent are presumed to
`
`take on their ordinary and customary meaning based on the broadest reasonable
`
`construction in light of the specification of the patent in which it appears. It is also
`
`my understanding that Patent Owner has alleged in a co-pending litigation that
`
`claims 1 and 10 do not require a hydrophilic cellulosic polymer component.1 For
`
`the term:
`
`at least one water-soluble polymer component consisting of
`polyethylene oxide in combination with a hydrophilic cellulosic
`polymer; wherein the water-soluble polymer component comprises
`greater than 75% polyethylene oxide and up to 25% hydrophilic
`cellulosic polymer,
`
`1 See Ex. 1009, Joint Claim Construction Chart, Reckitt Benckiser Pharma