`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`REGENERON PHARMACEUTICALS, INC.
`
`Petitioner,
`
`Vv.
`
`NOVARTIS PHARMAAG,
`NOVARTIS TECHNOLOGYLLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`
`Patent Owners.
`
`
`
`Patent Number: 9,220,631
`
`
`
`DECLARATION OF HORST KOLLER
`
`Regeneron Exhibit 1092.001
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`Regeneron Exhibit 1092.001
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`
`
`1.
`
` Thave beenretained by Petitioner Regeneron Pharmaceuticals, Inc.
`
`(“Petitioner” or “Regeneron”), as an independent expert witness in the above-
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`captionedinter partes review (“IPR”), in which Regeneron has requested that the
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`U.S. Patent and Trademark Office cancel as unpatentable all claims of U.S. Patent
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`No. 9,220,631 (“the ’631 patent’).
`
`2.
`
`Myqualifications and compensation are set forth in myoriginal
`
`declaration submitted with Regeneron’s Petition for Inter Partes Review. See Ex.
`
`1003 (Koller Decl.) at {§ 5-17.
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`3.
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`I have providedthis supplementaldeclaration to authenticate five
`
`exhibits, Exhibits 1015, 1016, 1052, 1072 and 1074, which are cited in my original
`
`declaration, and for which I understand the Patent Owner has submitted objections.
`
`See Paper 17 (Patent Owner Objections).
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`4.
`
`Exhibit 1015 is the first volume of a book I reviewed in forming my
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`opinionsset forth in myoriginal declaration (Ex. 1003). The citation for Exhibit
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`1015 is Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage Forms:
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`Parenteral Medications, Volume 1: Formulation and Packaging (3rd ed. 2010).
`
`3:
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`Exhibit 1016 is the second volumeof the same book. The citation for
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`Exhibit 1016 is Sandeep Nema & John D. Ludwig, Pharmaceutical Dosage
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`Forms: Parenteral Medications, Volume 2: Facility Design, Sterilization and
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`Processing (3rd ed. 2010).
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`Regeneron Exhibit 1092.002
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`Regeneron Exhibit 1092.002
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`
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`6.
`
`Exhibits 1015 and 1016 are volumesofan authoritative handbook
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`frequently read, relied upon, and cited by packaging and drug product development
`
`experts such as myself. I have personally reviewed the exhibits and confirmed
`
`they are electronic copies of volumes 1 and 2 of the originally published book.
`
`Te
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`Exhibit 1052 is a book chapter that I reviewed in forming my opinions
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`set forth in my original declaration (Ex. 1003). The citation for the chapteris: John
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`R. Gillis & Gregg Mosley, Validation ofPharmaceutical Process, Chapter 16 —
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`Validation of Ethylene Oxide Sterilization Processes (2011), pp. 241-262.
`
`8.
`
`Exhibits 1052 is a chapter of an authoritative textbook frequently
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`read, relied upon, and cited by packaging and drug product development experts
`
`such as myself.
`
`I have personally reviewed the exhibit and confirmedthat it is an
`
`electronic copy ofthe originally published book chapter.
`
`9.
`
`Exhibit 1072 is an article that I reviewed in forming my opinionsset
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`forth in my original declaration (Ex. 1003). The citation for the article is: Lonny
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`Wolgemuth, Challenges with Prefilled Syringes: The Parylene Solution,
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`ONdrugDelivery (Oct. 2012), available at https://ondrugdelivery.com/wp-
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`content/uploads/201 8/1 1/Oct2012.pdf.
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`10.
`
`Exhibit 1072 was published in ONdrugDelivery, a medical magazine
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`that describes itself as being trusted throughout the pharma/biotech industry. The
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`magazineis frequently read, relied upon, and cited by packaging and drug product
`
`Regeneron Exhibit 1092.003
`
`Regeneron Exhibit 1092.003
`
`
`
`available at
`
`
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`development experts such as myself. I have personally reviewed the exhibit and
`
`
`
`
`
`
`
`
`
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`2012 of the October copy of an excerpt confirm that Exhibit 1072 is an electronic
`
`issue that is accessible via the above url.
`
`
`
`in forming my opinions 11. Exhibit 107 4 is another article that I reviewed
`
`
`
`
`
`set forth in my original declaration (Ex. 1003 ). The citation for the article is: SCS
`
`
`
`
`Coating Systems, SCS Parylene Properties (2007),
`https://www.physics.rutgers.edu/~podzorov/parylene%20properties.pdf.
`
`
`
`
`12. Exhibit 1074 was published by SCS Coating Systems, a company
`
`
`
`
`specialized in the development of Parylene. I am familiar with this company and
`
`
`
`
`has reviewed specifications and articles published by them in the past. I have
`
`
`
`
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`reviewed the exhibit and confirmed that it is an electronic copy of the article that is
`
`accessible via by the above url.
`13. I declare that all statements made herein of my own knowledge are
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`
`
`
`
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`
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`true and that all statements made on information and belief are believed to be true;
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`and further that these statements were made with the knowledge that willful false
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`
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`statements and the like so made are punishable by fine or imprisonment, or both,
`
`
`under Section 1001 of Title 18 of the United States Code.
`
`By: _���-� -�-?..-z./' ___ _
`Horst Koller
`
`3
`
`Regeneron Exhibit 1092.004
`
`
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