` Filed: March 17, 2016
`
`
`
`PETITIONERS PAR PHARMACEUTICAL, INC.’S
`AND AMNEAL PHARMACEUTICALS LLC’S RESPONSE
`TO PATENT OWNER’S NOTICE REGARDING NEW
`ARGUMENTS AND EVIDENCE IN PETITIONERS’ REPLY
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`1 Case IPR2015-01820 has also been joined with this proceeding.
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`
`AMNEAL PHARMACEUTICALS LLC,
`PAR PHARMACEUTICAL, INC., and WOCKHARDT BIO AG,
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`
`
`
`_____________________
`
`Case IPR2015-05471
`Patent 7,765,107
`_____________________
`
`
`
`Pursuant
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`to
`
`the Board’s March 3, 2016 e-mail, Petitioners Par
`
`IPR2015-00547
` Patent No. 7,765,107
`Certificate of Service
`
`
`
`Pharmaceutical, Inc. and Amneal Pharmaceuticals LLC identify the following
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`portions of Patent Owner’s Response (Paper No. 46) to which the arguments and
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`evidence that Patent Owner Jazz Pharmaceuticals, Inc. identified in its March 10,
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`2016 Notice (Paper No. 52) respond:
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`1. The arguments and evidence Jazz identified in Paragraph 1 of its Notice
`
`respond to the arguments in Patent Owner’s Response starting on page 9, after
`
`subheading (c), through page 11, line 9; including Jazz’s argument that: “the
`
`redactions in Ex. 1004 do not evidence public accessibility before the critical date”
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`(page 10); and “Petitioners ignore that the Briefing Booklet is addressed to a
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`limited Advisory Committee panel that was responsible for reviewing the Xyrem
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`drug application for FDA approval.” (page 10).
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`2. The arguments and evidence Jazz identified in Paragraph 2 of its notice
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`respond to arguments in Patent Owner’s response starting on page 10, line 8,
`
`through page 11, line 9; including Jazz’s argument that: “Petitioners ignore that the
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`Briefing Booklet is addressed to a limited Advisory Committee panel that was
`
`responsible for reviewing the Xyrem drug application for FDA approval.” (page
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`10). Further, the evidence to which Jazz refers was provided with the Petition. See
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`Paper No. 2.
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`1
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`IPR2015-00547
` Patent No. 7,765,107
`Certificate of Service
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`3. The arguments and evidence Jazz identified in Paragraph 3 of its notice
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`respond to arguments in Patent Owner’s response starting on page 5, line 1 (under
`
`subheading (a)) through line 13; including Jazz’s argument that: “[t]he dates on the
`
`documents do not establish public accessibility before the critical date” (page 5).
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`Further, the evidence Jazz refers to was provided with the Petition. See Paper No. 1
`
`at 15; see also Paper No. 2.
`
`Respectfully Submitted,
`
`
`
`
`
`
`
`Matthew C. Ruedy (Reg. No. 64,823)
`Maddox Edwards, P.L.L.C.
`1900 K Street NW – Suite 725
`Washington, D.C. 20006
`(202) 830-0779
`mruedy@meiplaw.com
`
`Attorney for Petitioners Amneal
`Pharmaceuticals LLC and Par
`Pharmaceutical, Inc.
`
`
`
`2
`
`
`Date: March 17, 2016
`
`
`
`
`
`
`
`IPR2015-00547
` Patent No. 7,765,107
`Certificate of Service
`
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e)
`
`The undersigned hereby certifies that the above-captioned “Petitioners Par
`
`Pharmaceutical, Inc.’s and Amneal Pharmaceuticals LLC’s Response to Patent
`
`Owner’s Notice Regarding New Arguments and Evidence in Petitioners’ Reply,”
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`was served in its entirety on March 17, 2016, upon the following parties via e-mail:
`
`John V. Biernacki
`jvbiernacki@jonesday.com
`JONES DAY
`North Point
`901 Lakeside Avenue
`Cleveland, OH 44114
`
`
`F. Dominic Cerrito
`nickcerrito@quinnemanuel.com
`Eric C. Stops
`ericstops@quinnemanuel.com
`Evangeline Shih
`evangelineshih@quinnemanuel.com
`Frank Calvosa
`frankcalvosa@quinnemanuel.com
`QUINN EMANUEL URQUHART &
`SULLIVAN LLP
`51 Madison Avenue
`22nd Floor
`New York, NY 10010
`Counsel for Patent Owner Jazz Pharmaceuticals, Inc.
`
`Jordana Garallek
`Patrick C. Gallagher
`JGarallek@duanemorris.com
`PCGallagher@duanemorris.com
`DUANE MORRIS LLP
`DUANE MORRIS LLP
`1540 Broadway
`190 South LaSalle Street, Suite 3700
`New York, NY 10036-4086
`Chicago, IL 60603-3433
`Counsel for Petitioner Wockhardt Bio AG
`
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`1
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`IPR2015-00547
` Patent No. 7,765,107
`Certificate of Service
`
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`
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`
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`Matthew C. Ruedy (Reg. No. 64,823)
`Maddox Edwards, P.L.L.C.
`1900 K Street NW – Suite 725
`Washington, D.C. 20006
`(202) 830-0779
`mruedy@meiplaw.com
`
`Attorney for Petitioners Amneal
`Pharmaceuticals LLC and Par
`Pharmaceutical, Inc.
`
`
`Date: March 17, 2016
`
`
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`2