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`Case IPR2017-01159
`Patent 9,254,278
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`___________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
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`LUPIN LTD. and LUPIN PHARMACEUTICALS, INC.
`Petitioner,
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`v.
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`HORIZON THERAPEUTICS, INC.
`Patent Owner
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`Case IPR2017-01159
`Patent 9,254,278
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`PETITIONERS’ OBJECTIONS TO EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
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`Case IPR2017-01159
`Patent 9,254,278
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`Petitioners Lupin Ltd. and Lupin Pharmaceuticals, Inc. (“Lupin”) hereby
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`object pursuant to 37 C.F.R. § 42.64(b)(1) and the Federal Rules of Evidence
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`(“FRE”) to the admissibility of certain exhibits served by Patent Owner Horizon
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`Therapeutics, Inc. on July 24, 2017 in connection with its Preliminary Response to
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`Lupin’s Petition for Inter Partes Review of U.S. Patent No. 9,254,278 (“the ’278
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`patent”). The exhibits objected to, and grounds for Lupin’s objections, are listed
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`below. Lupin also objects to Patent Owner’s reliance on or citations to any
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`objected evidence in its papers.
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`I.
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`IDENTIFICATION OF CHALLENGED EVIDENCE AND GROUNDS
`FOR OBJECTIONS
`A. Exhibit 2001 (IPR2016-00829 Enns Declaration)
`Lupin objects to Exhibit 2001 under FRE 402 and 403 because it is
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`irrelevant and its probative value is substantially outweighed by the danger of
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`wasting time in this compressed proceeding. Exhibit 2001 is an expert declaration
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`submitted by Patent Owner in a different proceeding on a different patent, i.e.,
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`IPR2016-00829. Therefore, Exhibit 2001 should be excluded under FRE 402 and
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`403. Lupin further objects to Exhibit 2001 under FRE 802 because it is
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`inadmissible hearsay, not within a hearsay exception.
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`Case IPR2017-01159
`Patent 9,254,278
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`Exhibit 2006 (IPR2017-01159 Enns Declaration)
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`B.
`Lupin objects to Exhibit 2006, the declaration of Dr. Gregory M. Enns,
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`under FRE 402 to the extent that it includes or relies on irrelevant or inadmissible
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`information and under FRE 403 to the extent that it includes or relies on
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`information that probative value of which is substantially outweighed by the
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`danger of unfair prejudice, wasting time, or needlessly presenting cumulative
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`evidence as set forth herein. Lupin further objects to Exhibit 2006 under FRE 901
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`on the basis that it cites or relies on exhibits that have not been properly
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`authenticated or lack foundation, as set forth herein.
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`C. Exhibit 2012 (’157 Publication)
`Lupin objects to Exhibit 2012 under FRE 402 and 403 because it is
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`irrelevant and its probative value is substantially outweighed by the danger of
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`wasting time in this compressed proceeding. Exhibit 2012 was published in 2012
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`and, therefore, bears no relevance to what the person of ordinary skill in the art
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`would have known by Sept. 30, 2011, the priority date used for the purposes of this
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`proceeding. Therefore, Exhibit 2012 should be excluded under FRE 402 and 403.
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`Lupin further objects to Exhibit 2012 under FRE 802 on the basis that it is
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`inadmissible hearsay, not within a hearsay exception.
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`Case IPR2017-01159
`Patent 9,254,278
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`D. Exhibit 2019 (Haberle)
`Lupin objects to Exhibit 2019 under FRE 402 and 403 because it is
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`irrelevant and its probative value is substantially outweighed by the danger of
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`wasting time in this compressed proceeding. Exhibit 2019 is dated after Sept. 30,
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`2011, and therefore bears no relevance to what the person of ordinary skill in the
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`art would have known by the priority date used for the purposes of this proceeding.
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`Therefore, Exhibit 2019 should be excluded under FRE 402 and 403. Lupin
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`further objects to Exhibit 2019 under FRE 802 on the basis that it is inadmissible
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`hearsay, not within a hearsay exception.
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`E.
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`Exhibit 2026 (ABMGG Webpage regarding Specialties of
`Genetics)
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`Lupin objects to Exhibit 2026 under FRE 402 and 403 because it is
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`irrelevant and its probative value is substantially outweighed by the danger of
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`wasting time in this compressed proceeding. Exhibit 2026 is dated after Sept. 30,
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`2011, and therefore bears no relevance to what the person of ordinary skill in the
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`art would have known by the priority date used for the purposes of this proceeding.
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`Therefore, Exhibit 2026 should be excluded under FRE 402 and 403. Lupin
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`further objects to Exhibit 2026 under FRE 802 on the basis that it is inadmissible
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`hearsay, not within a hearsay exception. Lupin also objects to Exhibit 2026 under
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`Case IPR2017-01159
`Patent 9,254,278
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`FRE 901 on the basis that it has not been properly authenticated and lacks
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`foundation.
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`F.
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`Exhibit 2027 (About Us Webpage for Urea Cycle Disorders
`Consortium)
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`Lupin objects to Exhibit 2027 under FRE 402 and 403 because it is
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`irrelevant and its probative value is substantially outweighed by the danger of
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`wasting time in this compressed proceeding. Exhibit 2027 does not have a
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`discernible publication date and Patent Owner has not established that it is prior
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`art. Absent such a showing, it bears no relevance to what the person of ordinary
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`skill in the art would have known by the priority date used for the purposes of this
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`proceeding. Therefore, Exhibit 2027 should be excluded under FRE 402 and 403.
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`Lupin further objects to Exhibit 2027 under FRE 802 on the basis that it is
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`inadmissible hearsay, not within a hearsay exception. Lupin also objects to Exhibit
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`2027 under FRE 901 on the basis that it has not been properly authenticated and
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`lacks foundation.
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`G. Exhibit 2029 (Enns Article on Hyperammonemia)
`Lupin objects to Exhibit 2029 under FRE 402 and 403 because it is
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`irrelevant and its probative value is substantially outweighed by the danger of
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`wasting time in this compressed proceeding. Exhibit 2029 is dated after September
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`30, 2011, and therefore bears no relevance to what the person of ordinary skill in
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`Case IPR2017-01159
`Patent 9,254,278
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`the art would have known by the priority date used for the purposes of this
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`proceeding. Therefore, Exhibit 2026 should be excluded under FRE 402 and 403.
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`Lupin further objects to Exhibit 2026 under FRE 802 on the basis that it is
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`inadmissible hearsay, not within a hearsay exception.
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`H. Exhibit 2033 (Brusilow Web Article on Urea Cycle Enzymes)
`Lupin objects to Exhibit 2033 under FRE 402 and 403 because it is
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`irrelevant and its probative value is substantially outweighed by the danger of
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`wasting time in this compressed proceeding. Exhibit 2033 does not have a
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`discernible publication date and Patent Owner has not established that it is prior
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`art. Absent such a showing, it bears no relevance to what the person of ordinary
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`skill in the art would have known by the priority date used for the purposes of this
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`proceeding. Therefore, Exhibit 2033 should be excluded under FRE 402 and 403.
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`Lupin further objects to Exhibit 2033 under FRE 802 on the basis that it is
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`inadmissible hearsay, not within a hearsay exception. Lupin also objects to Exhibit
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`2033 under FRE 901, 1002 and 1003 on the basis that it has not been properly
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`authenticated and lacks foundation.
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`Exhibit 2034 (Transcript of Vaux Deposition in IPR2016-00829)
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`I.
`Lupin objects to Exhibit 2034 under FRE 402 and 403 because it is
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`irrelevant and its probative value is substantially outweighed by the danger of
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`Case IPR2017-01159
`Patent 9,254,278
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`wasting time in this compressed proceeding. Exhibit 2034 is the transcript of the
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`deposition of Dr. Vaux which took place in a different proceeding on a different
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`patent, i.e., IPR2016-00829. Therefore, Exhibit 2034 should be excluded under
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`FRE 402 and 403. Lupin further objects to Exhibit 2034 under FRE 802 because it
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`is inadmissible hearsay, not within a hearsay exception. Lupin also objects to
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`Exhibit 2034 under FRE 901 on the basis that it has not been properly
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`authenticated and lacks foundation as incomplete to the extent that it does not
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`include errata. It should therefore be excluded under FRE 106 and 403.
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`Exhibit 2037 (Vaux Book Review)
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`J.
`Lupin objects to Exhibit 2037 under FRE 402 and 403 because it is
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`irrelevant and its probative value is substantially outweighed by the danger of
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`wasting time in this compressed proceeding. Lupin also objects to Exhibit 2037
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`under FRE 901 on the basis that it has not been properly authenticated and lacks
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`foundation.
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`K. Exhibit 2041 (RAVICTI Label)
`Lupin objects to Exhibit 2041 under FRE 402 and 403 because it is
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`irrelevant and its probative value is substantially outweighed by the danger of
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`wasting time in this compressed proceeding. Exhibit 2041 is dated after September
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`30, 2011, and therefore bears no relevance to what the person of ordinary skill in
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`Case IPR2017-01159
`Patent 9,254,278
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`the art would have known by the priority date used for the purposes of this
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`proceeding. Therefore, Exhibit 2041 should be excluded under FRE 402 and 403.
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`Lupin further objects to Exhibit 2041 under FRE 802 on the basis that it is
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`inadmissible hearsay, not within a hearsay exception. Lupin also objects to Exhibit
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`2041 under FRE 901 on the basis that it has not been properly authenticated and
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`lacks foundation.
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`Exhibit 2042 (Summar)
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`L.
`Lupin objects to Exhibit 2042 under FRE 402 and 403 because it is
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`irrelevant and its probative value is substantially outweighed by the danger of
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`wasting time in this compressed proceeding. Exhibit 2042 is dated after September
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`30, 2011, and therefore bears no relevance to what the person of ordinary skill in
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`the art would have known by the priority date used for the purposes of this
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`proceeding. Therefore, Exhibit 2042 should be excluded under FRE 402 and 403.
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`Lupin further objects to Exhibit 2042 under FRE 802 on the basis that it is
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`inadmissible hearsay, not within a hearsay exception.
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`M. Exhibit 2045 (Buphenyl Drugs@FDA Webpage)
`Lupin objects to Exhibit 2045 under FRE 402 and 403 because it is
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`irrelevant and its probative value is substantially outweighed by the danger of
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`wasting time in this compressed proceeding. Exhibit 2045 has no discernible
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`Case IPR2017-01159
`Patent 9,254,278
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`publication date and Patent Owner has not established that it is prior art. Absent
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`such a showing, it bears no relevance to what the person of ordinary skill in the art
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`would have known by the priority date used for the purposes of this proceeding,
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`Sept. 30, 2011. Therefore, Exhibit 2045 should be excluded under FRE 402 and
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`403. Lupin further objects to Exhibit 2045 under FRE 802 on the basis that it is
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`inadmissible hearsay, not within a hearsay exception. Lupin also objects to Exhibit
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`2045 under FRE 901 on the basis that it has not been properly authenticated and
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`lacks foundation.
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`Dated: October 13, 2017
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`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
`620 Eighth Avenue
`New York, NY 10018
`(212) 813-8800 (telephone)
`(212) 355-3333 (facsimile)
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`Counsel for Petitioners
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`Case IPR2017-01159
`Patent 9,254,278
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that PETITIONERS’ OBJECTIONS TO
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`EVIDENCE PURSUANT TO 37 C.F.R. 42.64 was served electronically via email
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`on October 13, 2017 on the following:
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`Matthew Phillips (backup counsel, Reg. No. 43,403)
`Laurence & Phillips IP Law LLP
`mphillips@lpiplaw.com
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`Robert Green (Reg. No. 27,555)
`Emer Simic (Reg. No. 61,235)
`Green, Griffith & Borg-Breen, LLP
`rgreen@greengriffith.com
`esimic@greengriffith.com
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`Dennis Bennett (Reg. No. 34,547)
`GLOBAL PATENT GROUP, LLC
`dennisbennett@globalpatentgroup.com
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`Dated: October 13, 2017
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`/Cynthia Lambert Hardman/
`Cynthia Lambert Hardman
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