IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`PAR PHARMACEUTICAL, INC.,
`Petitioner,
`
`v.
`
`HORIZON THERAPEUTICS, LLC,
`Patent Owner.
`
`_____________________
`
`Case No.: IPR2017-01767
`U.S. Patent No. 9,254,278
`_____________________
`
`PETITIONER’S OPPOSITION TO PATENT OWNER’S
`REQUEST FOR RECONSIDERATION UNDER 37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`PAR PHARMACEUTICAL, INC.,
`Petitioner,
`
`v.
`
`HORIZON THERAPEUTICS, LLC,
`Patent Owner.
`
`_____________________
`
`Case No.: IPR2017-01767
`U.S. Patent No. 9,254,278
`_____________________
`
`PETITIONER’S OPPOSITION TO PATENT OWNER’S
`REQUEST FOR RECONSIDERATION UNDER 37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`IPR2017-01767 ( U.S. Patent No. 9,254,278)
`Petitioner’s Opposition to Patent Owner’s
`Request for Reconsideration Under 37 C.F.R. § 42.71(d)
`TABLE OF CONTENTS
`
`
`
`
`
`Introduction ...................................................................................................... 1
`Argument ......................................................................................................... 1
` Horizon Has Not Met Its Burden to Show that the Board’s
`Decision Should be Modified. ............................................................... 1
`The ’197 Declaration Is Not Relevant and Is Not Inconsistent. ........... 2
` Conclusion ....................................................................................................... 3
`
`
`
`
`
`
`i
`
`
`
`IPR2017-01767 ( U.S. Patent No. 9,254,278)
`Petitioner’s Opposition to Patent Owner’s
`Request for Reconsideration Under 37 C.F.R. § 42.71(d)
`INTRODUCTION
`Per the Board’s Order (Paper 38), Petitioner Par Pharmaceutical, Inc.
`
`
`
`submits this opposition to Patent Owner Horizon Therapeutics, LLC’s request for
`
`reconsideration of the Board’s Order (Paper 37) denying Horizon’s request to
`
`submit the Declaration of Dr. Neal Sondheimer filed in IPR2018-01550 (“the
`
`’197 Declaration”) in this proceeding.
`
` ARGUMENT
` Horizon Has Not Met Its Burden to Show
`that the Board’s Decision Should be Modified.
`“The burden of showing a decision should be modified lies with the party
`
`challenging the decision. The request must specifically identify all matters the
`
`party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d).
`
`Horizon’s request for reconsideration appears to be based on the belief that
`
`the Board misapprehended or overlooked the relevance of the ’197 Declaration.
`
`The Board, however, did not deny Horizon’s request based on a determination that
`
`the ’197 Declaration was irrelevant to these proceedings. The Board instead relied
`
`on the fact that the discovery period for these proceedings was still open:
`
`Because Horizon will have an opportunity to cross-examine
`Dr. Sondheimer on the testimony Par presented in the instant
`proceedings, Horizon has an opportunity to elicit Dr. Sondheimer’s
`opinions on information relevant to these proceedings. There is no
`need for Horizon to present prepared testimony from a different
`proceeding.
`
`(Paper 37 at 2).
`
`1
`
`
`
`IPR2017-01767 ( U.S. Patent No. 9,254,278)
`Petitioner’s Opposition to Patent Owner’s
`Request for Reconsideration Under 37 C.F.R. § 42.71(d)
`Horizon’s citation to Ultratec, Inc. v. CaptionCall, LLC, 872 F.3d 1267
`
`(Fed. Cir. 2017) is inapposite. (Paper 39 at 2.) There, the patent owner sought to
`
`submit testimony from the petitioner’s expert that (1) “did not exist during the IPR
`
`discovery period” and (2) “address[ed] the same patents, references, and
`
`limitations at issue in the IPRs.” Ultratec, 872 F.3d at 1272-73 (emphases added).
`
`Unlike in Ultratec, the ’197 Declaration became available during Horizon’s
`
`discovery period for its sur-reply, being served the same day as Par’s Reply in this
`
`proceeding. The ’197 Declaration also addresses (1) a different patent that is not
`
`familially-related to the ’278 patent, (2) different prior art, and (3) completely
`
`different limitations than those at issue in this IPR. See Section II.B. Horizon,
`
`thus, has not met its burden to demonstrate that the Board should grant its request.
`
`
`The ’197 Declaration Is Not Relevant and Is Not Inconsistent.
`The ’197 Declaration also has no relevance to this proceeding. First, the
`
`patent at issue in IPR2018-01550 does not stem from any application in the
`
`’278 patent family. Second, the claims at issue in IPR2018-01550 relate to
`
`methods of adjusting the dosage of GPB based on the ratio of PAA to PAGN in
`
`view of the well-known dynamics of PAA-to-PAGN conversion. They are not
`
`based on using a patient’s fasting plasma ammonia levels, as they are here. Third,
`
`only one secondary reference used in the Grounds in this proceeding, Lee, is used
`
`in the ground demonstrating the unpatentability of the claims at issue in IPR2018-
`
`2
`
`
`
`IPR2017-01767 ( U.S. Patent No. 9,254,278)
`Petitioner’s Opposition to Patent Owner’s
`Request for Reconsideration Under 37 C.F.R. § 42.71(d)
`01550. And Par cites to different disclosures in Lee to demonstrate unpatentability
`
`of the challenged claims in this proceeding and in IPR2018-01550.
`
`Lastly, there are no inconsistencies in Dr. Sondheimer’s testimony. As his
`
`Reply Declaration states, the ’278 patent claims “encompass administering any
`
`amount of initial dosage or adjusted dosage” to lower a patient’s fasting plasma
`
`ammonia level, which could still remain within the range of safe and effective
`
`dosing. (EX1028, ¶18.) This would not give rise to the same concerns of PAA-
`
`dependent toxicity at issue in IPR2018-01550. There, the claims relate to
`
`determining the safe and effective dosing range for GPB. (See the ’197
`
`Declaration, e.g., ¶¶36-37, 55-58, 61-67.) The ’197 Declaration also states that a
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`POSA would have been aware of the possibility of PAA’s toxicity, which would
`
`have been “remote for practitioners using nitrogen scavenging medications within
`
`dosing guidelines.” (Id., ¶78.) This is entirely consistent with Dr. Sondheimer’s
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`testimony discussed above regarding lowering a patient’s fasting plasma ammonia
`
`level using safe and effective dosing.
`
` CONCLUSION
`Par requests that the Board deny Horizon’s request for reconsideration.1
`
`
`
`
`1 Should the Board grant Horizon’s request, Par requests the ability to submit a
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`paper limited to responding to Horizon’s discussion of the ’197 Declaration.
`
`3
`
`
`
`IPR2017-01767 ( U.S. Patent No. 9,254,278)
`Petitioner’s Opposition to Patent Owner’s
`Request for Reconsideration Under 37 C.F.R. § 42.71(d)
`Dated: September 17, 2018
`Respectfully submitted,
`
`
`David H. Silverstein (Reg. No. 61,948)
`AXINN, VELTROP & HARKRIDER LLP
`114 West 47th Street, 22nd Floor
`New York, NY 10036
`(212) 261-5651
`
`Counsel for Petitioner
`Par Pharmaceutical, Inc.
`
`4
`
`
`
`IPR2017-01767 ( U.S. Patent No. 9,254,278)
`Petitioner’s Opposition to Patent Owner’s
`Request for Reconsideration Under 37 C.F.R. § 42.71(d)
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e))
`The undersigned hereby certifies that the above-captioned “Petitioner’s
`
`Opposition to Patent Owner’s Request for Reconsideration Under 37 C.F.R.
`
`§ 42.71(d)” was served in its entirety on September 17, through the Patent Trial
`
`and Appeal Board End to End (PTAB E2E) system, and additionally upon the
`
`following parties via Electronic Mail, as agreed to by counsel:
`
`Robert Green: rgreen@greengriffith.com
`Matthew Phillips: mphillips@lpiplaw.com
`Emer Simic: esimic@greengriffith.com
`Dennis Bennett: dennisbennett@globalpatentgroup.com
`Ann Kotze: akotze@greengriffith.com
`
`
`Dated: September 17, 2018
`
`
`David H. Silverstein (Reg. No. 61,948)
`AXINN, VELTROP & HARKRIDER LLP
`114 West 47th Street, 22nd Floor
`New York, NY 10036
`(212) 261-5651
`
`Counsel for Petitioner
`Par Pharmaceutical, Inc.
`
`
`
`
`
`
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