UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`PAR PHARMACEUTICAL, INC.,
`
`and
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS, INC.
`Petitioners,
`
`v.
`
`HORIZON THERAPEUTICS, INC.,
`Patent Owner.
`_____________________
`
`Case IPR2015-011171
`Patent 8,642,012
`_____________________
`
`PETITIONERS’ SUPPLEMENTAL REPLY TO
`PATENT OWNER’S CORRECTED RESPONSE
`
`
`
`
`
`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 IPR2015-00283, instituted on a petition filed by Lupin Ltd. and Lupin
`
`Pharmaceuticals, Inc., has been joined with this proceeding.
`
`
`
`
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`PAR PHARMACEUTICAL, INC.,
`
`and
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS, INC.
`Petitioners,
`
`v.
`
`HORIZON THERAPEUTICS, INC.,
`Patent Owner.
`_____________________
`
`Case IPR2015-011171
`Patent 8,642,012
`_____________________
`
`PETITIONERS’ SUPPLEMENTAL REPLY TO
`PATENT OWNER’S CORRECTED RESPONSE
`
`
`
`
`
`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 IPR2015-00283, instituted on a petition filed by Lupin Ltd. and Lupin
`
`Pharmaceuticals, Inc., has been joined with this proceeding.
`
`
`
`
`
`
`
`IPR2015-01117
`Patent No. 8,642,012
`Petitioners’ Supp. Reply to POs Corrected Response
`
`
`PATENT OWNER MISCHARACTERIZES DR. SONDHEIMER’S
`TESTIMONY ABOUT THE ’647 PATENT AND OTHER PRIOR ART.
`
`
`I.
`
`Patent Owner, without the aid of its own expert, attempts to make Sherwin
`
`(Ambrose ’33) relevant by (1) misleadingly citing Dr. Sondheimer’s testimony
`
`about the ’647 patent and (2) arguing that Dr. Sondheimer allegedly failed to
`
`objectively consider certain prior art. (Paper 41 at 46, 48 (citing Ex. 2012 10:11-
`
`11:2;2 30:11-23; 31:11-17; 103:19-104:7).) Patent Owner’s arguments fail for at
`
`least two reasons.
`
`First, Petitioners do not rely on the ’647 patent to establish a rate of
`
`conversion of PAA to UPAGN. (Pet. at 31-32.) As Dr. Sondheimer testified, “the
`
`’647 patent . . . teaches the use of ratios of urinary PAGN to creatinine as a
`
`convenient measure for an increase in urinary excretion of nitrogen that doesn’t
`
`require collection of total daily urine.” (Ex. 2012 at 105:21-106:18.) Patent
`
`Owner, however, cites testimony regarding the conversion of PAA to UPAGN,
`
`which neither responds to Petitioners’ argument nor addresses what the ’647 patent
`
`discloses.
`
`Second, Dr. Sondheimer’s testimony belies any assertion that he did not
`
`“objectively evaluate the prior- art” for the conversion of PAA to UPAGN. (Paper
`
`
`2 Despite filing a corrected Response, Patent Owner now cites incomplete portions
`of Dr. Sondheimer’s testimony. (See, e.g., Paper 41 at 47, 48 (citing Ex. 2012
`34:1-35:6, 10:11-11:2).)
`
`1
`
`
`
`
`IPR2015-01117
`Patent No. 8,642,012
`Petitioners’ Supp. Reply to POs Corrected Response
`
`
`41 at 46 (citing Ex. 2012 at 10:11-11:2; 30:11-23; 31:11-17).) The only
`
`“limitation” he placed on his consideration of the prior art was the “earliest priority
`
`date.” (Ex. 2012 at 265:22-269:14.) Patent Owner therefore has failed to establish
`
`the relevance of Sherwin (Ambrose ’33).
`
` DR. SONDHEIMER TESTIFIED WHY A POSA WOULD
`II.
`READ BRUSILOW ’91 TO TEACH INCOMPLETE CONVERSION.
`
`Without any expert testimony of its own, Patent Owner faults Dr.
`
`Sondheimer for both ignoring the conversion of PAA to UPAGN reported in
`
`Brusilow ’91 (Paper 41 at 44-45 (citing Ex. 2012 at 49:10-14; 71:24-72:13), and
`
`determining that Brusilow ’91 adjusted dosages to account for incomplete
`
`conversion (id. at 40 (citing Ex. 2012 at 120:7-25)). A POSA would have
`
`recognized that the data set in Brusilow ’91 describes the incomplete conversion of
`
`PAA to PAGN. (Ex. 1002 at ¶¶ 34-36, 63; Ex. 2012 at 119:3-120:4.) Contrary to
`
`Patent Owner’s assertion, Dr. Sondheimer did not ignore that data. Indeed, Dr.
`
`Sondheimer’s evaluation of the dosing adjustment in Period III exemplifies his
`
`careful consideration of the incomplete conversion reported in Periods I and II.
`
`(Ex. 2012 at 119:3-120:19) Moreover, Dr. Sondheimer explained why a POSA
`
`would not have relied solely on Brusilow ’91 for information about the rate of
`
`conversion of PAA to PAGN. (Ex. 1002 at ¶¶ 40, 43.) Thus, his consideration of
`
`other references, including, for example, Sherwin ’19, is well justified.
`
`2
`
`
`
`
`IPR2015-01117
`Patent No. 8,642,012
`Petitioners’ Supp. Reply to POs Corrected Response
`
`
` PATENT OWNER IGNORES TESTIMONY
`III.
`REGARDING THE URINE COLLECTION TIMES IN COMTE.
`
`Patent Owner seeks to discount Comte’s disclosure of incomplete conversion
`
`(54%) of PAA to UPAGN over eight hours by selectively citing and then
`
`embellishing Dr. Sondheimer’s testimony regarding collecting urine samples over
`
`eight versus twenty-four hours. (Paper 41 at 47, 50 (citing Ex. 2012 at 34:1-35:6;
`
`124:14-21).) Specifically, citing Dr. Sondheimer’s testimony, Patent Owner
`
`contends that a POSA could not have drawn any conclusions concerning
`
`conversion of PAA to PAGN because Comte did not provide any data on 24-hour
`
`excretion of PAGN. (Id.) Contrary to Patent Owner’s contention, however, Dr.
`
`Sondheimer actually testified that a POSA “might have expected . . . total PAGN,
`
`very slightly more to have appeared in a 24-hour period than in the eight-hour
`
`period.” (Ex. 2012 at 34:16-35:8 (emphasis added).) Patent Owner ignores
`
`subsequent testimony explaining how a POSA would consider or understand urine
`
`collection times, and confirming that urine collected over the two periods may be
`
`“equivalent.” (Ex. 2012 at 35:9-37:13.) Moreover, Patent Owner ignores both that
`
`the ’012 patent does not require any specific period for the collection of urine and
`
`that Comte illustrates a declining rate of conversion. (Ex. 1025 at 589.)
`
`3
`
`
`
`
`
`
`IPR2015-01117
`Patent No. 8,642,012
`Petitioners’ Supp. Reply to POs Corrected Response
`
`
`Respectfully Submitted,
`
`
`
`David H. Silverstein
`Registration No. 61,948
`Attorney for Petitioner
`Par Pharmaceutical, Inc.
`
`
`/Cynthia Lambert Hardman/
`Cynthia Lambert Hardman
`Registration No. 53,179
`Attorney for the Lupin
`Petitioners
`
`4
`
`
`
`
`Date: June 30, 2016
`Axinn, Veltrop & Harkrider LLP
`950 F Street, N.W.
`Washington, DC 20004
`Tel: (202) 912-4700
`
`
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`Tel: (212) 813-8800
`
`
`
`
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))
`
`IPR2015-01117
`Patent No. 8,642,012
`Certificate of Service
`
`
`The undersigned hereby certifies that the above-captioned “Petitioners’
`
`Supplemental Reply to Patent Owner’s Corrected Response” was served in its
`
`entirety on June 30, 2016 through the Patent Review Processing System, and
`
`additionally upon the following parties via Electronic Mail:
`
`For Patent Owner:
`
`For Petitioner Lupin:
`
`Elizabeth J. Holland
`Cynthia Lambert Hardman
`GOODWIN PROCTER LLP
`eholland@goodwinproctor.com
`chardman@goodwinprocter.com
`
`Respectfully Submitted,
`
`
`
`David H. Silverstein
`Registration No. 61,948
`Attorney for Petitioner
`Par Pharmaceutical, Inc.
`
`Lauren Stevens:
`lstevens@horizonpharma.com
`Matthew C. Phillips:
`matthew.phillips@renaissanceiplaw.com
`Dennis Bennett:
`dennisbennett@globalpatentgroup.com
`
`Robert Green:
`rgreen@greengriffith.com
`Emer Simic: esimic@greengriffith.com
`Jessica Tyrus: jtyrus@greengriffith.com
`
`
`Date: June 30, 2016
`Axinn, Veltrop & Harkrider LLP
`950 F Street, N.W.
`Washington, DC 20004
`Tel: (202) 912-4700
`
`
`
`
`
`1
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