UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ALTAIRE PHARMACEUTICALS, INC.,
`Petitioner,
`
`V.
`
`PARAGON BIOTECK, INC.,
`Patent Owner.
`
`Case PGR20l 5-0001 1
`
`Patent 8,859,623 B1
`
`DECLARATION # 3 OF ASSAD SAWAYA
`
`I, Assad Sawaya, do hereby declare as follows:
`
`1.
`
`As shown in my curricula vitae, a true copy attached herein as Exhibit A,
`
`I have over 50 years of experience in the pharmaceutical industry.
`
`2.
`
`Since 1997, I have been the president of Altaire Pharmaceuticals, Inc.
`
`(“Altaire”). My responsibilities at Altaire include managing and directing a
`
`research and development laboratory including numerous chemist,
`
`Exhibit 1025, Page 1 of8
`
`Exhibit 1025, Page 1 of 8
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ALTAIRE PHARMACEUTICALS, INC.,
`Petitioner,
`
`V.
`
`PARAGON BIOTECK, INC.,
`Patent Owner.
`
`Case PGR20l 5-0001 1
`
`Patent 8,859,623 B1
`
`DECLARATION # 3 OF ASSAD SAWAYA
`
`I, Assad Sawaya, do hereby declare as follows:
`
`1.
`
`As shown in my curricula vitae, a true copy attached herein as Exhibit A,
`
`I have over 50 years of experience in the pharmaceutical industry.
`
`2.
`
`Since 1997, I have been the president of Altaire Pharmaceuticals, Inc.
`
`(“Altaire”). My responsibilities at Altaire include managing and directing a
`
`research and development laboratory including numerous chemist,
`
`Exhibit 1025, Page 1 of8
`
`Exhibit 1025, Page 1 of 8
`
`
`
`microbiologists, and pharmacists focusing in developing, among other
`
`things, ophthalmic, otic, dermatological and oral pharmaceutical products. I
`
`also manage employees having experience in analytical chemistry, method
`
`development, and method validation to meet the Food & Drug
`
`Administration’s requirements for “Quality Control and Quality Assurance.”
`
`The employees I manage employ state of the art methodologies, such as gas
`
`chromatography, high performance liquid chromatography, and ultra
`
`performance liquid chromatography. I am very familiar with and have
`
`personal knowledge of analyzing and interpreting the underlying testing
`
`methodologies and the results generated by such methodologies.
`
`Prior to founding Altaire, I was the president of Pharmafair Laboratories,
`
`Inc. (“Pharmafair”), which was later acquired by Bausch and Lomb
`
`Laboratories. At Pharmafair, I facilitated the development of formulations
`
`and processing controls for ophthalmic, otic, and dermatological products,
`
`and obtained more than 25 ANDA approvals. I additionally, directed and
`
`managed research and development laboratories, including analytical testing
`
`laboratories. I also oversaw chemical and microbiological testing conducted
`
`by a staff including a PhD chemist, a microbiologist, and a pharmacist.
`
`Exhibit 1025, P%S§‘3”§“c3’¥’%"
`
`Exhibit 1025, Page 2 of 8
`
`
`
`
`
`Prior to Pharmafair, I was the owner/operator of GMP Laboratories, a
`
`company that provided consulting services specifically directed to the
`
`pharmaceutical industry. In my role, I managed and trained the quality
`
`control laboratory staff that performed analytical and microbiological
`
`testing. Accordingly, in my role, I routinely analyzed quality control testing
`
`data relating to analytical and microbiological testing.
`
`Prior to GMP Laborites, I was a supervisor of microbiology for a quality
`
`control lab at Dome Laboratories and a manager of the same at Burroughs
`
`Wellcome Laboratory. As demonstrated in my resume, these roles
`
`intimately involved the active management of teams analyzing and testing
`
`pharmaceutical products, including developing a sterilization system for
`
`sterile pharmaceutical products. My role also required supervising and
`
`training microbiology analysts.
`
`In addition to my extensive work experience, I also attended Long Island
`
`University from 1957-1961 wherein I took courses for a Premed B.S.
`
`program.
`
`Explained herein is only a subset of my comprehensive work experience
`
`in the pharmaceutical industry. Please see my resume, Exhibit A, for a
`
`more complete recitation.
`
`DSMDB-34 l 0920 V1
`Exhibit 1025, Page 3 of 8
`
`Exhibit 1025, Page 3 of 8
`
`
`
`3.
`
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`sa1perx;§sing the tasting sf p§1a1*;nz«1s.:e:ut§ca.i canzpaaiticns since E35’? anci
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`have <ieve¥z*sped 5% g:1§fica::}i: i."3X§$€fI‘i€i'¥i3-6
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`in the §2§’2_armaateuiica§ industry.
`
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`Exhibit 1025, Page 4 o 8
`
`Exhibit 1025, Page 4 of 8
`
`
`
`
`
`EXHIBIT A
`
`DSMDB-341
`Exhibit 1025, Page 5
`
`V1
`8
`
`Exhibit 1025, Page 5 of 8
`
`
`
`
`
`ASSAD SAWAYA — CURRICULA VITAE
`
`1957 — 1958
`
`St. Vincent Hospital, NY, NY Bums Research Center
`Assistant Technician
`
`Responsibilities Included:
`
`1.
`2.
`3.
`
`Treat Patients for Hypothermia
`Wound treatment of burned patients
`Microbial isolation of infected burn wounds
`
`1957 — 1961 Long Island University
`Attended Premed B.S. Program
`Studied courses:
`
`0 Organic chemistry
`Inorganic chemistry
`
`Biology
`
`Microbiology
`Mathematics
`
`Geometry
`Calculus
`
`English Literature
`
`Geography
`Other prerequisite courses
`
`1961 — 1970 Dome Laboratories — Division of Miles Laboratog:
`Supervisor of Microbiology — Quality Control Lab.
`
`I
`
`Industrial Microbiology, Antibiotic Assays, Microbial Testing of
`Pharmaceutical products, Sterility testing, Endotoxin testing.
`I Toxicology testing using laboratory animals.
`I Pharmaceutical development of allergy products, topical skin products,
`ophthalmic and otic products, radio isotope pharmaceutical injectable
`diagnostic products.
`I Environmental control of sterile manufacturing operations —
`Development of sterilization system for sterile pharmaceutical products.
`Supervising and training of QC - microbiology analysts
`
`I
`
`1970 — 1976 Burro1_1gh§ Wellcome Labogtory
`I Manager of Microbiology Laboratory — Quality Control
`I Responsibilities Included:
`I
`Sterility Testing, Microbial Limits testing, Environmental monitoring,
`Endotoxin testing
`I Antimicrobial / Antibiotic analysis of pharmaceutical products
`I Design and control of purified water / water for injection systems
`
`Exhibit 1025, Page 6 of 8
`
`Exhibit 1025, Page 6 of 8
`
`
`
`Head of in-house committees for the control, production and design of
`pharmaceutical operations including sterile manufacturing, topical
`products, oral products.
`Managed and directed transfer of technology from pilot laboratory
`operation to full scale production operation
`Managed and trained QC — microbiology analysts
`
`1977 — 1978
`
`GMP Laboratories — Owner/Qmgtor
`Provided consulting services to emerging pharmaceutical companies.
`Managed and trained a fully stafi'ed QC laboratory, performing
`analytical and microbiological testing.
`
`1979 — 1987 President - Pharmafair Laboratories Inc.
`
`Developed formulations and processing controls for ophthalmic, otic,
`dermatological products.
`Obtained more than 25 ANDA approvals.
`Directed and managed research and development laboratories,
`analytical testing laboratories (chemical and microbiological testing -
`staffed with PHD chemist, microbiologist, pharmacist, etc.), and
`product development (formulation and process controls) staff.
`Designed class 100 cleanroom for sterile manufacturing ophthalmic,
`otic and diagnostic products.
`Managed and directed sterile manufacturing operations.
`
`1987 - 1990 Pharmafair Laboratories - as a subsidiary of Bausch and Lomb Laboratories —
`Owner/Qpgrator
`.
`Managed and directed technical transfer of technologies to Bausch and
`Lomb.
`
`Managed and directed development of ophthalmic products with
`Bausch & Lomb research group.
`
`1997 — 2016 Altaire Pharmaceuticals Inc. — President
`
`Responsibilities included:
`Managed and directed fully staffed research and development
`pharmaceutical development laboratory employing and
`managing more than twenty five chemists, microbiologists and
`pharmacists developing ophthalmic, otic, dermatological and
`oral pharmaceutical products; and developing / validating
`associated methods for active ingredients and drug products.
`Designed and developed sterile manufacturing operation,
`manufacturing over-the-counter ophthalmic products and NDA/ANDA
`ophthalmic solution/ointrnent products.
`
`Exhibit 1025, Page 7 of 8
`
`Exhibit 1025, Page 7 of 8
`
`
`
`Managing more than 120 employees with experience in analytical
`chemistry, method development and method validations to meet the
`FDA requirements “Quality Control and Qua.lity Assurance”
`management employing state of the art methodology, such as GC,
`HPLC, UV and UPLC.
`Developed formulations and process controls for ophthalmic, otic,
`demiatological and cough and cold products including NDA and
`ANDA products.
`Developed formulations for nano lipid ophthalmic products, awarded
`patents for such products (8530449; 9006214).
`Developed formulations for ophthalmic gel products, awarded patents
`for such products (5868493; 5516808).
`Developed formulations and process controls for preservative fiee
`ophthalmic products.
`Managed and directed stability analysis of active ingredients in finished
`drug products including ophthalmic, otic, demiatological and cough and
`cold products.
`Developed and designed class 100 clean room for sterile manufacturing
`of finished drug products.
`
`Exhibit 1025, Page 8 of 8
`
`Exhibit 1025, Page 8 of 8
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