`Filed: March 17, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`PAR PHARMACEUTICAL, INC., WOCKHARDT BIO AG, and
`AMNEAL PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`
`_____________________
`
`Case IPR2015-005541
`Patent 7,668,730 B2
`_____________________
`
`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 IPR2015-01818 has been joined with this proceeding.
`
`
`
`IPR2015-00554
`Patent No. 7,668,730
`Petitioners’ Response to Patent Owner’s March 10, 2016 Notice
`
`Pursuant
`
`to the Board’s March 3, 2016 e-mail, Petitioners Par
`
`Pharmaceutical, Inc. and Amneal Pharmaceuticals LLC identify the following
`
`portions of Patent Owner’s Response (Paper No. 39) to which the arguments and
`
`evidence that Patent Owner Jazz Pharmaceuticals, Inc. identified in its March 10,
`
`2016 Notice (Paper No. 50) respond:
`
`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 12, line 2; including Jazz’s argument that: “the
`
`redactions in Ex. 1004 do not evidence public accessibility before the critical date”
`
`(page 10); and “Petitioners ignore that the Briefing Booklet is addressed to a
`
`limited Advisory Committee panel that was responsible for reviewing the Xyrem
`
`drug application for FDA approval.” (page 11).
`
`2. The arguments and evidence Jazz identified in Paragraph 2 of its notice
`
`respond to arguments in Patent Owner’s response starting on page 11, line 1,
`
`through page 12, line 2; including Jazz’s argument that: “Petitioners ignore that the
`
`Briefing Booklet is addressed to a limited Advisory Committee panel that was
`
`responsible for reviewing the Xyrem drug application for FDA approval.” (page
`
`11). Further, the evidence to which Jazz refers was provided with the Petition. See
`
`Paper No. 2.
`
`1
`
`
`
`IPR2015-00554
`Patent No. 7,668,730
`Petitioners' Response to Patent Owner's March 10, 2016 Notice
`
`3. The arguments and evidence Jazz identified in Paragraph 3 of its notice
`
`respond to arguments in Patent Owner's response starting on page 5, line 7 (under
`
`subheading (a)) through line 17; including Jazz's argument that: "[t]he dates on the
`
`documents do not establish public accessibility before the critical date" (page 5).
`
`Further, the evidence Jazz refers to was provided with the Petition. See Paper No. 1
`
`at 15; see also Paper No. 2.
`
`Date: March 17, 2016 (cid:9)
`
`Respectfully Submitted,
`
`Janine A. Carlan
`Registration No. 42,387
`ARENT Fox LLP
`1717 K Street, NW
`Washington, DC 20006
`202.857.6000
`Attorney for Petitioners Par Pharmaceutical,
`Inc. and Amneal Pharmaceuticals LLC
`
`2
`
`
`
`IPR2015-00554
`Patent No. 7,668,730
`Certificate of Service
`
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))
`
`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,”
`
`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
`
`
`
`IPR2015-00554
`Patent No. 7,668,730
`Certificate of Service
`
`Respectfully Submitted,
`
`Bradford C. Frese
`Registration No. 69,772
`Attorney for Petitioner Par Pharmaceutical,
`Inc.
`
`Date: March 17, 2016
`ARENT FOX LLP
`1717 K Street, NW
`Washington, DC 20006
`202.857.6000
`
`2