INSITE VISION INCORPORATED, Inspire Pharmaceuticals,..., 2012 WL 8667473...
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`2012 WL 8667473 (D.N.J.) (Expert Report and Affidavit)
`United States District Court, D. New Jersey.
`
`INSITE VISION INCORPORATED, Inspire Pharmaceuticals, Inc. Pfizer Inc., Plaintiffs,
`v.
`SANDOZ INC., Sandoz GmbH, Sandoz Industrial Products S.A., Defendants.
`
`No. 11-cv-03080-MLC-LHG.
`April 12, 2012.
`
`Declaration of Uday B. Kompella, Ph.D. in Support of Plaintiffs' Proposed Claim Constructions
`
`Case Type: Intellectual Property >> Patent
`Jurisdiction: D.N.J.
`Name of Expert: Uday D. Kompella, Ph.D.
`Area of Expertise: Health Care-Physicians & Health Professionals >>Pharmacist/Pharmacologist
`
`Representing: Plaintiff
`
`Sheila F. McShane, Esq.
`Gibbons P.C.
`One Gateway Center
`Newark, New Jersey 07102
`(973) 594-4500
`Attorney for Plaintiffs, InSite Vision Incorporated, Inspire Pharmaceuticals Incorporated, and Pfizer Inc.
`
`Of Counsel: Dominick A. Conde, Esq.
`Lisa B. Pensabene, Esq.
`Joshua I. Rothman, Esq.
`Vishal C. Gupta, Esq.
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, New York 10104
`(212) 218-2100
`Attorneys for Inspire Pharmaceuticals, Inc. and Pfizer Inc.
`
`Rodger L. Tate, Esq.
`Robert M. Schulman, Esq.
`Jeff B. Vockrodt, Esq.
`Hunton & williams LLP
`2200 Pennsylvania Avenue, N.W.
`Washington, DC 20037
`(202) 955-1500
`(202) 828-3752 Fax
`Attorneys for InSite Vision Incorporated.
`
`I, Uday B. Kompella, declare as follows:
`
` © 2015 Thomson Reuters. No claim to original U.S. Government Works.
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`SENJU EXHIBIT 2037
`LUPIN v. SENJU
`IPR2015-01105
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`INSITE VISION INCORPORATED, Inspire Pharmaceuticals,..., 2012 WL 8667473...
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`I. EXPERIENCE AND QUALIFICATIONS
`
`1. I received my Ph.D. in 1994 from the University of Southern California, Los Angeles in the area of pharmaceutical sciences.
`I am currently a professor of pharmaceutics, ophthalmology, and bioengineering at University of Colorado Denver.
`
`2. I have extensive experience in ophthalmic pharmaceutical formulation development, including ocular drug delivery.
`
`3. My research includes the study of ocular drug delivery and the development of ophthalmic dosage forms, including sustained
`release formulations. I have directed the research of many graduate students, postdoctoral fellows, and technicians in the study
`of ocular drug delivery. I have co-edited three books on drug product development, one of which was specific to ophthalmic
`drugs. I have also been published in more than 130 scientific papers and presented over 150 abstracts at scientific meetings,
`and in many instances my publications and abstracts address ophthalmic drug formulations. I have also extensively lectured
`on drug delivery, including drug delivery to the eye.
`
`4. I am Editor-in-Chief of Expert Opinion on Drug Delivery. I was an editor of Clinical Research and Regulatory Affairs from
`2004 to 2008. I have been an editor of Pharmaceutical Research since 2004. I also currently serve on the editorial board of
`the following publications: International Journal of Pharmaceutical Sciences and Nanotechnology; Drug Delivery Technology;
`Journal of Ocular Pharmacology and Therapeutics; and Journal of Ocular Biology, Diseases and Informatics.
`
`5. I have received many honors and awards, specifically in ophthalmology, in recent years, such as the 2012 ARVO/AFER/
`Pfizer/Carl Camras Translational Research Award in Ophthamology; Keynote lecturer at Thadikonda Pharmaceutical Sciences
`Symposium, LV Prasad Eye Institute (LVPEI) in 2011; FARVO Designation, Silver Fellow, Association for Research in Vision
`and Ophthalmology in 2010; Keynote lecture, ASIA-ARVO, Association for Research in Vision and Ophthalmology in 2009;
`and an innovation award in recognition of successful commercialization of functionalized particles to treat eye disorders from
`the University of Nebraska Medical Center in 2008.
`
`6. I am a member of the American Association of Pharmaceutical Scientists and the Association for Research in Vision and
`Ophthalmology and have held several elected offices in both professional associations. From 2009 to 2012, I was a Physiology
`and Pharmacology section Representative on the Annual Meeting Program Committee for the Association for Research in
`Vision and Ophthalmology. From 2003 to 2004, I was the Chair of the Regulatory Sciences Section of the American Association
`of Pharmaceutical Scientists. From 2001 to 2003, I was the Chair of the Ocular Drug Delivery and Disposition Focus Group
`of the American Association of Pharmaceutical Scientists.
`
`7. I have served on the scientific advisory boards at Appian Laboratories and PCAsso Diagnostics since 2008. I have served
`on the scientific advisory board at The Glaucoma Foundation since 2009. I have also served on the Combination Products
`Advisory Committee at Vistakon (A Johnson & Johnson Co.) since 2009. From 2008-2010, I served on the scientific advisory
`board at Visionary Therapeutics Corporation.
`
`8. My curriculum vitae, including a list of my publications, is attached as Exhibit A. I am being compensated for my work at
`my customary rate of $650 per hour, in addition to being reimbursed for expenses. My compensation is not dependent upon
`the opinions rendered or the outcome of this litigation.
`
`II. MATERIALS REVIEWED
`
`9. I have been informed by Plaintiffs' counsel that the Plaintiffs InSite Vision Inc., Inspire Pharmaceuticals, Inc., and Pfizer Inc.
`(collectively “Plaintiffs”) have sued Sandoz Inc., Sandoz GmbH, and Sandoz Industrial Products S.A. (collectively “Sandoz”)
`for infringement of U.S. Patent Nos. 6,861,411 (“the '411 patent”), 6,159,458 (“the '458 patent”), 6,239,113 (“the '113 patent”),
`6,569,443 (“the '443 patent”), and 7,056,893 (“the '893 patent”) (collectively “the patents-in-suit”).
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`10. In connection with this suit, I have been asked by Plaintiffs' counsel to comment on the meaning of the following terms
`from the patents-in-suit, which were identified by the parties for claim construction. These claims and phrases are as follows:
`“administered once daily,” “one or two doses per day,” “ophthalmic composition,” and “ophthalmic medicament.”
`
`11. In connection with my declaration, I have reviewed the '411 patent, the '443 patent, the '893 patent, and the '458 patent,
`the Joint Claim Construction and Prehearing Statement, submitted to the court on February 27, 2012 (“Joint Statement”), and
`the references in Exhibit B of this declaration.
`
`12. The opinions set forth below are based on the education, knowledge, and experience that I have acquired over the past 20
`years in practicing, teaching, and consulting in the field of pharmaceutical sciences and ophthalmology, as well as information
`available to me as of the date of this declaration.
`
`III. THE PERSON OF ORDINARY SKILL IN THE ART
`
`13. I understand that the terms and phrases in patent claims must be interpreted as they would have been understood by a person
`having ordinary skill in the art (“POSA”) to which the invention related at the time of the invention.
`
`14. A person of ordinary skill with respect to the '411 patent, the '443 patent, the '893 patent, and the '458 patent is a person
`having a PharmD or bachelor's degree in pharmacy, pharmaceutical sciences, or related disciplines. This person would also
`have about three years of formulation experience.
`
`15. This declaration sets forth my opinions as to how a person of ordinary skill in the art would have understood the above-
`identified terms and phrases. This declaration also provides my opinions on Sandoz's proposed construction as reflected in the
`Joint Statement. I reserve the right to rebut any expert opinion or argument offered by Sandoz in support of its proposed claim
`constructions. I also reserve the right to modify or expand my opinions based on information not currently available to me.
`
`IV. ANALYSIS OF CLAIM TERMS RELATING TO DOSING REGIMENS
`
`16. Due to the nature of bacterial infections, a physician needs dosing flexibility of the antibiotic in order to provide the patient
`with effective therapeutic drug concentrations. Antibiotics are routinely administered in a regimen that requires more doses
`on one day than on subsequent days. For example, ophthalmic antibiotics are commonly administered more frequently on day
`one than subsequent days.
`
`17. Examples of topical ophthalmic antibiotics that were known to be dosed at a higher initial frequency followed by lower
`frequency include tobramycin, ofloxacin, and ciprofloxacin.
`
`A. “administered once daily”
`
`18. I have been asked to examine the term “administered once daily” in claim 3 of the '411 patent.
`
`19. Claim 3, which depends from claim 1, claims a method of treatment “comprising” a composition that is “administered once
`daily.” In the context of the claims and knowledge in the art, a person of ordinary skill in the art would understand that the
`“administered once daily” claim term means that the dosing regimen includes, but is not limited to once daily dosing.
`
`20. In the art, dosing regimens are not limited to fixed dosing regimens for the entire duration of treatment. Taking into
`consideration how antibiotics are administered, see supra ¶¶ 16-17, a person of ordinary skill in the art would understand that
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`the dosing of antibiotics could include days on which the antibiotic is administered once and days on which the antibiotic is
`administered more than once.
`
`21. It is my understanding that Sandoz's construction of “administered once daily” is “administered only once per day for
`the entire duration of treatment.” However, the claim language does not include limiting words of “for the entire duration of
`treatment.”
`
`22. The specification of the '411 patent states, “In a preferred embodiment, the concentration of azithromycin in the vehicle
`is such that a single dose (approx. 5 mg per eye) of said composition administered once daily for five days remediates the
`infection.” '411 patent, col. 1, 11. 58-62. A person of ordinary skill in the art would understand this description to be one type
`of dosing regimen that is preferred, but not the exclusive dosing regimen that could be used.
`
`B. “one or two doses per day”
`
`23. I have been asked to examine the term “one or two doses per day” in claim 40 of the '893 patent.
`
`24. Claim 40 claims, “The method of treating a patient of claim 23, wherein said administering is one or two doses of said
`composition per day for at least six days.” A person of ordinary skill in the art would understand “one or two doses per day”
`to mean “one or two doses per day.”
`
`25. A person of ordinary skill in the art, who would be knowledgeable about how antibiotics are administered and formulated,
`see supra ¶¶ 16-17, would understand that this claim term means that on some days of the treatment regimen, one dose is
`administered and on other days, two doses are administered. There are examples of antibiotics that are initially administered
`with more doses than on subsequent days.
`
`26. It is my understanding that Sandoz's construction of “one or two doses per day” is “either one dose per day for the entire
`duration of treatment or two doses per day for the entire duration of treatment.” However, the language of the claims does not
`limit the regimens of the invention to just those two possibilities.
`
`27. Additionally, nowhere in the specification is the dosing regimen of the invention limited to once a day for the entire period
`of treatment or twice a day for the entire period of treatment.
`
`V. ANALYSIS OF OPHTHALMIC CLAIM TERMS
`
`A. “ophthalmic composition”
`
`28. I have been asked to examine the term “ophthalmic composition” in claim 1 of the '458 patent, claims 16 and 44 of the
`'443 patent, and claim 2 of the '893 patent.
`
`29. A person of ordinary skill in the art would understand that an “ophthalmic composition” in the context of the '458, '443,
`and '893 patents is a composition that is instilled in the eye, as contrasted with, for example, an oral composition, which is
`for oral ingestion.
`
`30. The chapter on Ophthalmic Formulations in the 18 th Edition of Remington's Pharmaceutical Sciences (a reference
`commonly used by drug formulators) states that “ [o]phthalmic preparations are sterile products essentially free from foreign
`particles, suitably compounded and packaged for instillation into the eye.” Remington's Pharmaceutical Sciences, 1581,
`1581-1595 (18 th Ed. 1990) (Exhibit C).
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`31. The '458 patent specification states that the invention of this patent is “easily administered in liquid drop form to the eye”
`by “topically applying” the formulations to the eye. '458 patent, col. 2, 11. 1-16.
`
`32. Throughout the specification of the '443 patent, the composition that is the subject of the invention is described as being
`instilled into the eye. See, e.g., '443 patent, col. 5, 11. 49-54; col. 2,11. 37-40; col. 4,11. 14-29. The '443 patent also cites the
`'458 patent, which consistently defines “ophthalmic composition.” See supra ¶ 31.
`
`33. The '893 patent also describes “ophthalmic composition” as compositions that are instilled in the eye. See e.g., '893 patent,
`col. 3,11. 6-20.
`
`34. I understand that Sandoz's interpretation of “ophthalmic composition” is “composition of or relating to the eye.” It is my
`understanding that Sandoz relies on the Webster's II New Riverside University Dictionary definition of “ophthalmic.” (Exhibit
`D). A person of ordinary skill in the art would look to the context of the specifications to understand that “ophthalmic
`composition” means “a composition instilled into the eye.”
`
`B. “ophthalmic medicament”
`
`35. I have been asked to examine the term “ophthalmic medicament” in claim 1 of the '458 patent.
`
`36. For similar reasons that a person of ordinary skill in the art would understand that an “ophthalmic composition”, in the
`context of the '458 patent, requires “instillation in the eye,” a person of ordinary skill in the art would understand that “ophthalmic
`medicament,” described in the '458 patent, is intended for “instillation in the eye.” See supra ¶¶ 28-34.
`
`37. In fact, the objects of the '458 patent invention are described as “a novel ophthalmic composition that has a low viscosity
`and is easily administered in liquid drop form to the eye,” and “a novel method for treating diseases by topically applying to
`eyes a novel ophthalmic composition that exhibits sustained release of a medicament.” '458 patent, col. 2, 1-3; 12-15.
`
`38. “Medicament” is defined in the specification of the '458 patent as “any substance or drug that is useful in treating or
`ameliorating a disease or medical condition,” which is consistent with what a person of ordinary skill in the art would understand
`this term to mean. See '458 patent, col. 3, 11. 3-5.
`
`39. Consequently, a person of ordinary skill in the art would understand “ophthalmic medicament,” as it appears in claim 1 of the
`'458 patent, to mean “any substance or drug that is useful in treating a disease or medical condition that is instilled into the eye.”
`
`40. A person of ordinary skill in the art would find that this definition is consistent with the specification of the '458 patent, which
`states, “A medicament means any substance or drug that is useful in treating or ameliorating a disease or medical condition.
`The disease or medical condition can be in the eye or its surrounding tissue, but is not limited thereto; i.e. treating a condition
`remote from the eye via topical administration on the eye.” See '458 patent, col. 3,11. 3-8 (emphasis added).
`
`41. It is my understanding that Sandoz's proposed meaning for “ophthalmic medicament” is “any substance or drug that is useful
`in treating a disease or medical condition, which can be in the eye or its surrounding tissue or can be remote from the eye.”
`Sandoz's interpretation ignores the rest of the sentence in the '458 patent which makes clear that an “ophthalmic medicament”
`would be instilled in the eye (“via topical administration on the eye”). See supra ¶ 40.
`
`End of Document
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`© 2015 Thomson Reuters. No claim to original U.S. Government Works.
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` © 2015 Thomson Reuters. No claim to original U.S. Government Works.
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