UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS, INC.
`Petitioners,
`
`v.
`
`HORIZON THERAPEUTICS, LLC
`Patent Owner
`
`
`Case IPR2017-01159
`Patent 9,254,278
`
`
`PETITIONERS’ REPLY IN SUPPORT OF ITS
`MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`
`
`
`
`
`
`
`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS, INC.
`Petitioners,
`
`v.
`
`HORIZON THERAPEUTICS, LLC
`Patent Owner
`
`
`Case IPR2017-01159
`Patent 9,254,278
`
`
`PETITIONERS’ REPLY IN SUPPORT OF ITS
`MOTION TO EXCLUDE EVIDENCE
`
`
`
`
`
`
`
`
`
`
`
`
`
`I.
`
`Case IPR2017-01159
`Patent 9,254,278
`
`Exhibit 2019 Should Be Excluded Because It Is Not Prior Art
`
`Horizon does not dispute that the Häberle reference, Ex. 2019, was
`
`published many months after the September 2011 priority date of the ’278 patent,
`
`and is not itself prior art. (Paper 31 at 2.) It argues, however, that Ex. 2019 is
`
`relevant because development of the guidelines referenced in Häberle occurred
`
`between October 2008 and August 2011. (Id.) While a later publication can be
`
`used as evidence of the state of the art existing as of a patent’s priority date, the
`
`purported fact that these guidelines were in development prior to the filing date of
`
`the ’278 patent does not demonstrate that the guidelines themselves were part of
`
`the state of the art as of the priority date. A POSA would not have known about
`
`these guidelines until they were published. The testimony of Dr. Enns regarding
`
`the relevance of the Häberle reference is conclusory (Ex. 2006 at ¶ 109) and
`
`Horizon has provided no other evidence to show that a POSA knew or could have
`
`known of these guidelines prior to the priority date of the ’278 patent. Therefore,
`
`Ex. 2019 is irrelevant under FRE 402/403, as it is neither prior art nor evidence of
`
`the “state of the art” available to a POSA at the priority date of the ’278 patent.
`
`For this reason and the reasons presented in Lupin’s motion, the Board
`
`should exclude Ex. 2019.
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`- 2 -
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`
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`II. The Board Should Exclude Portions of Dr. Enns’s Declaration that Rely
`on Ex. 2019
`
`Case IPR2017-01159
`Patent 9,254,278
`
`The Board should also exclude portions of Dr. Enns’s Declaration to the
`
`extent they rely on Ex. 2019. Horizon argues that Dr. Enns does not rely on Ex.
`
`2019 to prove the state of the art, but rather as additional support for his opinions.
`
`(Paper 31 at 6-7.) This argument is unavailing. Dr. Enns’s testimony purportedly
`
`relates to the practices of POSAs as of the priority date of the patent, and thus the
`
`purpose of his reliance on Ex. 2019 is to demonstrate the alleged state of the art.
`
`For example, in ¶¶ 95 and 112 of his declaration, Dr. Enns relies on Ex. 2019 to
`
`opine on the state of the art. (Ex. 2006 at ¶¶ 95, 112.) Because Ex. 2019 is post-
`
`art and not indicative of the prior art, the portions of Dr. Enns’ declaration that rely
`
`on Ex. 2019 to address the state of the art should also be excluded under FRE
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`402/403.
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`For this reason and the reasons presented in Lupin’s motion, the Board
`
`should exclude portions of Dr. Enns’s Declaration to the extent they rely on Ex.
`
`2019.
`
`III. The Board Should Exclude Ex. 2041
`Horizon does not dispute that the RAVICTI label, Ex. 2041, was published
`
`years after the September 2011 priority date of the ’278 patent, and is not itself
`
`prior art. (Paper 31 at 8-9.) To avoid the implications of this fact, Horizon tries to
`
`
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`- 3 -
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`
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`recast its reliance on this document as merely cumulative of an undisputed fact set
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`Case IPR2017-01159
`Patent 9,254,278
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`forth in the ’859 Publication (Ex. 1007). (Id.) However, examination of Horizon’s
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`reliance on this document reveals that in connection with its arguments about
`
`motivation to combine, it in fact seeks to rely on the FDA-approved indications of
`
`RAVICTI. (Paper 19 at 43.) But RAVICTI itself was not approved until years
`
`after the priority date at issue here, and nothing in Exhibits 2041 or 1007 say
`
`differently. Accordingly, Horizon improperly uses this post-art document in an
`
`attempt to undercut motivation to combine, but a POSA would not have been
`
`aware of the indications of RAVICTI as of the priority date of the ’278 patent.
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`For this reason and the reasons presented in Lupin’s motion, the Board
`
`should exclude Ex. 2041.
`
`IV. Conclusion
`For the reasons herein and the reasons presented in Lupin’s motion, Lupin
`
`respectfully requests that the Board grant its Motion to Exclude, and exclude
`
`Exhibits 2019 and 2041, as well as portions of Ex. 2006, to the extent they rely on
`
`Ex. 2019.
`
`Dated: June 22, 2018
`
`Respectfully submitted,
`/Cynthia Lambert Hardman/
`Elizabeth J. Holland (Reg. No. 47,657)
`Cynthia Lambert Hardman (Reg. No.
`53,179)
`GOODWIN PROCTER LLP
`The New York Times Building
`
`
`
`- 4 -
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`
`
`
`
`
`
`Case IPR2017-01159
`Patent 9,254,278
`
`620 Eighth Avenue
`New York, NY 10018
`(212) 813-8800 (telephone)
`(212) 355-3333 (facsimile)
`
`Counsel for Petitioners
`
`
`
`- 5 -
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`
`
`
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`CERTIFICATE OF SERVICE
`
`Case IPR2017-01159
`Patent 9,254,278
`
`The undersigned hereby certifies that PETITIONERS’ REPLY IN SUPPORT OF
`
`ITS MOTION TO EXCLUDE EVIDENCE was served electronically via email on
`
`June 22, 2018 on the following:
`
`Matthew Phillips (backup counsel, Reg. No. 43,403)
`LAURENCE & PHILLIPS IP LAW LLP
`mphillips@lpiplaw.com
`
`
`Robert Green (Reg. No. 27,555)
`Emer Simic (Reg. No. 61,235)
`Ann Kotze (Reg. No. 76,570)
`GREEN, GRIFFITH & BORG-BREEN, LLP
`rgreen@greengriffith.com
`esimic@greengriffith.com
`akotze@greengriffith.com
`
`
`Dennis Bennett (Reg. No. 34,457)
`GLOBAL PATENT GROUP LLC
`dennisbennett@globalpatentgroup.com
`
`Dated: June 22, 2018
`
`/Cynthia Lambert Hardman/
`Cynthia Lambert Hardman
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`- 6 -
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