`
`BEFORE THE PA TENT TRIAL AND APPEAL BOARD
`
`AMNEAL PHARMACEUTICALS LLC and AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioners
`
`V.
`
`ALMIRALL, LLC,
`Patent Owner
`
`Case IPR2019-00207
`Patent 9,517,219
`
`SUPPLEMENTAL DECLARATON OF DAVID W. OSBORNE, PH.D.
`
`1 of 4
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`Almirall EXHIBIT 2065
`
`Amneal v. Almirall
`IPR2019-00207
`
`
`
`IPR2019-00207
`Supplemental Declaration of David W. Osborne, Ph.D.
`
`I, David W. Osborne, do hereby declare as follows:
`
`1.
`
`I am over the age of 18 and otherwise competent to make this
`
`declaration. I have been retained as an expert on behalf of patent owner Almirall,
`
`LLC ("Almirall"). I understand this declaration is being submitted to supplement
`
`my first declaration, which was submitted in connection with Almirall's Patent
`
`Owner Response to the Petition for Inter Partes Review ("IPR") of claims 1-8 of
`
`U.S. Patent No. 9,517,219 ("the '219 patent") (Ex. 1001).
`
`2.
`
`I am being compensated for my time in connection with this IPR at
`
`my standard legal consultant rate of $500/hr. My compensation is not contingent
`
`on the outcome of this case.
`
`Exhibit 2049 (Poulsen)
`
`3.
`
`Exhibit 2049, Boyd Poulsen, Development Process in Topical Dosage
`
`Forms, AAPSIFDA Joint Workshop on Topical Product Development: Principles
`
`and Criteria! for the Development and Optimization of Topical Therapeutic
`
`Products, Arlington, VA (Mar. 26, 1990) ("Poulsen"), is a copy of the program for
`
`an AAPS/FDA Joint Workshop on Topical Product Development titled Principles
`
`and Criteria for the Development and Optimization of Topical Therapeutic
`
`Products, which took place March 26-28, 1990, at the Hyatt Regency Crystal City
`
`in Arlington, Virginia, and the printed presentation of Boyd J. Poulsen, Ph.D.,
`
`2
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`2 of 4
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`
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`IPR2019-00207
`Supplemental Declaration of David W. Osborne, Ph.D.
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`titled "Development Process in Topical Dosage Forms," presented at 10:50 a.m. on
`
`Monday, March 26, 1990, as part of that Joint Workshop.
`
`4.
`
`The program was printed and distributed in advance of the Joint
`
`Workshop. The Joint Workshop was put on jointly by the AAPS, which is the
`
`American Association of Pharmaceutical Scientists, a professional scientific
`
`organization with thousands of members, and the FDA. The Joint Workshop was
`
`open to the public, provided they paid a fee for attendance.
`
`5.
`
`Dr. Poulsen's presentation was printed and distributed to all attendees
`
`of the Joint Workshop.
`
`6.
`
`I personally attended the Joint Workshop and Dr. Poulsen's
`
`presentation. I estimate there were 300-500 people in attendance.
`
`7.
`
`In advance of the Joint Workshop, I, like other attendees, received in
`
`the mail a printed copy of the program for the Joint Workshop, setting forth the
`
`schedule of the workshop, topics of presentations to be given at the workshop, and
`
`various other items relating to the workshop.
`
`8.
`
`I confirm that Pages 1-4 of Exhibit 2049 are true and accurate copies
`
`of the printed program in advance of the Joint Workshop.
`
`9.
`
`At Dr. Poulsen's presentation at the Joint Workshop, I, like other
`
`attendees, received a printed copy of Dr. Poulsen's presentation.
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`3
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`3 of 4
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`
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`IPR2019-00207
`Supplemental Declaration of David W. Osborne, Ph.D.
`
`10.
`
`I confirm that Pages 5- 50 of Exhibit 2049 are true and accurate copies
`
`of the printed presentation of Dr. Poulsen distributed at the Joint Workshop, with
`
`my handwritten notes taken during the presentation. My handwritten notes appear
`
`on Pages 5 (my name), 8, 11, 16, 21- 24, 46 and 49.
`
`I hereby declare that all statements made herein of my own knowledge are
`
`true and that all statements made on information and belief are believed to be true;
`
`and further that these statements are made with the knowledge that willful false
`
`statements and the like are punishable by fine, imprisonment, or both, under
`
`Section 1001 of Title 18 of the United States Code.
`
`this .3Q_th day of August, 2019.
`
`~
`
`-----.:1;;.10,l
`David W. Osborne, Ph.D.
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`4
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`4 of 4
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