Case IPR2016-00829
`Patent 9,095,559 B2
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
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`
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`LUPIN LTD. and LUPIN PHARMACEUTICALS, INC.
`Petitioner,
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`v.
`
`HORIZON THERAPEUTICS, INC.
`Patent Owner
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`
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`Case IPR2016-00829
`Patent 9,095,559 B2
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`
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`PETITIONERS’ OBJECTIONS TO EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
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`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`
`
`
`Patent 9,095,559 B2
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS, INC.
`Petitioner,
`
`v.
`
`HORIZON THERAPEUTICS, INC.
`Patent Owner
`
`
`
`Case IPR2016-00829
`Patent 9,095,559 B2
`
`
`
`PETITIONERS’ OBJECTIONS TO EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
`
`
`
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`
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`
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`Petitioners Lupin Ltd. and Lupin Pharmaceuticals, Inc. (“Lupin”) hereby
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`Case IPR2016-00829
`Patent 9,095,559 B2
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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 purported evidence served by Patent
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`Owner’s Horizon Therapeutics, Inc. on February 10, 2017 in connection with its
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`Response to Lupin’s Petition for Inter Partes Review of U.S. Patent No. 9,095,559
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`(“the ’559 patent”). The exhibits objected to, and grounds for Lupin’s objections,
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`are listed below. Lupin also objects to Patent Owner’s reliance on or citations to
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`any objected evidence in its papers.
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`Some of the exhibits served by Horizon Therapeutics, Inc. on February 10,
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`2016 were introduced during the deposition of Keith Vaux in this proceeding, and
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`Lupin objected to those exhibits at the deposition as required by 37 C.F.R. §
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`42.64(a). Nothing contained herein shall be deemed to withdraw any of Lupin’s
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`objections to deposition evidence or the requirement that evidence to cure those
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`objections must have been provided during the deposition.
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`I.
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`IDENTIFICATION OF CHALLENGED EVIDENCE AND GROUNDS
`FOR OBJECTIONS
`A. Exhibit 2001
`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 a litigation document
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`which bears no relevance to the issue of patentability of the ’559 patent claims.
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`Lupin further objects to Exhibit 2001 under FRE 802 because it is inadmissible
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`Case IPR2016-00829
`Patent 9,095,559 B2
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`hearsay, specifically a complaint in a district court litigation, Horizon
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`Therapeutics, Inc. v. Lupin Ltd., 1:15-cv-07624-RBK-JS (D.N.J.). Lupin also
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`objects to Exhibit 2001 under FRE 901 on the basis that it has not been properly
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`authenticated and lacks foundation.
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`Exhibit 2002
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`B.
`Lupin objects to Exhibit 2002 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 2002 is a litigation document
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`which bears no relevance to the issue of patentability of the ’559 patent claims.
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`Lupin further objects to Exhibit 2002 under FRE 802 because it is inadmissible
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`hearsay, specifically an amended complaint in a district court litigation, Horizon
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`Therapeutics, Inc. v. Lupin Ltd., 1:15-cv-07624-RBK-JS (D.N.J.). Lupin also
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`objects to Exhibit 2002 under FRE 901 on the basis that it has not been properly
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`authenticated and lacks foundation.
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`C. Exhibit 2003
`Lupin objects to Exhibit 2003 as incomplete. It should therefore be
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`excluded under FRE 106 and 403.
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`D. Exhibit 2004
`Lupin objects to Exhibit 2004 as incomplete. It should therefore be
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`Case IPR2016-00829
`Patent 9,095,559 B2
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`excluded under FRE 106 and 403.
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`Exhibit 2005
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`E.
`Lupin objects to Exhibit 2005 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 2005 is a litigation document
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`served by Par Pharmaceuticals, Inc. in a different proceeding regarding different
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`patents, and therefore bears no relevance to the issue of patentability of the ’559
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`patent claims. Lupin further objects to Exhibit 2005 under FRE 802 because it is
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`inadmissible hearsay, specifically a non-party’s invalidity and non-infringement
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`contentions in an unrelated district court litigation, Horizon Therapeutics, Inc. v.
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`Par Pharmaceuticals, Inc., C.A. No. 2:14-cv-00384-JRG-RSP (E.D. Tex). Lupin
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`also objects to Exhibit 2005 under FRE 901 on the basis that it has not been
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`properly authenticated and lacks foundation. Lupin further objects to Exhibit 2005
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`as incomplete because it contains only certain portions of Par Pharmaceutical’s
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`Invalidity and Non-infringement Contentions, and should therefore be excluded
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`under FRE 106.
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`Exhibit 2006
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`F.
`Lupin objects to Exhibit 2006, the declaration of Dr. Gregory M. Enns,
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`Case IPR2016-00829
`Patent 9,095,559 B2
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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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`G. Exhibit 2012
`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 the relevant date, Sept. 30, 2011. Therefore, Exhibit 2012
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`should be excluded under FRE 402 and 403. Lupin further objects to Exhibit 2012
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`under FRE 802 on the basis that it is inadmissible hearsay, not within a hearsay
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`exception.
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`H. Exhibit 2015
`Lupin objects to Exhibit 2015 under FRE 402 and 403 because it is
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`Case IPR2016-00829
`Patent 9,095,559 B2
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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 2015 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 relevant date. Therefore, Exhibit 2015 should be
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`excluded under FRE 402 and 403. Lupin further objects to Exhibit 2015 under
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`FRE 802 on the basis that it is inadmissible hearsay, not within a hearsay
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`exception.
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`Exhibit 2019
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`I.
`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 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 relevant date. Therefore, Exhibit 2019 should be
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`excluded under FRE 402 and 403. Lupin further objects to Exhibit 2019 under
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`FRE 802 on the basis that it is inadmissible hearsay, not within a hearsay
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`exception.
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`Exhibit 2026
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`J.
`Lupin objects to Exhibit 2026 under FRE 402 and 403 because it is
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`Case IPR2016-00829
`Patent 9,095,559 B2
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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 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 relevant date. Therefore, Exhibit 2026 should be
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`excluded under FRE 402 and 403. Lupin further objects to Exhibit 2026 under
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`FRE 802 on the basis that it is inadmissible hearsay, not within a hearsay
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`exception. Lupin also objects to Exhibit 2026 under FRE 901 on the basis that it
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`has not been properly authenticated and lacks foundation.
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`K. Exhibit 2027
`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 relevant date, Sept. 30, 2011. Therefore,
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`Exhibit 2027 should be excluded under FRE 402 and 403. Lupin further objects to
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`Exhibit 2027 under FRE 802 on the basis that it is inadmissible hearsay, not within
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`a hearsay exception. Lupin also objects to Exhibit 2027 under FRE 901 on the
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`Case IPR2016-00829
`Patent 9,095,559 B2
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`basis that it has not been properly authenticated and lacks foundation.
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`Exhibit 2029
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`L.
`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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`the art would have known by the relevant date. Therefore, Exhibit 2026 should be
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`excluded under FRE 402 and 403. Lupin further objects to Exhibit 2026 under
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`FRE 802 on the basis that it is inadmissible hearsay, not within a hearsay
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`exception.
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`M. Exhibit 2033
`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 relevant date, Sept. 30, 2011. Therefore,
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`Exhibit 2033 should be excluded under FRE 402 and 403. Lupin further objects to
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`Exhibit 2033 under FRE 802 on the basis that it is inadmissible hearsay, not within
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`Case IPR2016-00829
`Patent 9,095,559 B2
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`a hearsay exception. Lupin also objects to Exhibit 2033 under FRE 901, 1002 and
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`1003 on the basis that it has not been properly authenticated and lacks foundation.
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`N. Exhibit 2034
`Lupin objects to Exhibit 2034 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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`O. Exhibit 2035
`Lupin objects to Exhibit 2035 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 2035 has no discernible
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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 relevant date, Sept. 30, 2011. Therefore, Exhibit 2035
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`should be excluded under FRE 402 and 403. Lupin further objects to Exhibit 2035
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`under FRE 802 on the basis that it is inadmissible hearsay, not within a hearsay
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`exception. Lupin also objects to Exhibit 2035 under FRE 901 on the basis that it
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`has not been properly authenticated and lacks foundation.
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`Exhibit 2036
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`P.
`Lupin objects to Exhibit 2036 under FRE 402 and 403 because it is
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`Case IPR2016-00829
`Patent 9,095,559 B2
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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 2036
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`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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`Q. Exhibit 2037
`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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`R. Exhibit 2038
`Lupin objects to Exhibit 2038 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 2038 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 relevant date, Sept. 30, 2011. Therefore,
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`Exhibit 2038 should be excluded under FRE 402 and 403. Lupin further objects to
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`Exhibit 2038 under FRE 802 on the basis that it is inadmissible hearsay, not within
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`Case IPR2016-00829
`Patent 9,095,559 B2
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`a hearsay exception. Lupin also objects to Exhibit 2038 under FRE 901 on the
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`basis that it has not been properly authenticated and lacks foundation.
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`Exhibit 2041
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`S.
`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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`the art would have known by the relevant date. Therefore, Exhibit 2041 should be
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`excluded under FRE 402 and 403. Lupin further objects to Exhibit 2041 under
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`FRE 802 on the basis that it is inadmissible hearsay, not within a hearsay
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`exception. Lupin also objects to Exhibit 2041 under FRE 901 on the basis that it
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`has not been properly authenticated and lacks foundation.
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`Exhibit 2042
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`T.
`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 relevant date. Therefore, Exhibit 2042 should be
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`excluded under FRE 402 and 403. Lupin further objects to Exhibit 2042 under
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`Case IPR2016-00829
`Patent 9,095,559 B2
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`FRE 802 on the basis that it is inadmissible hearsay, not within a hearsay
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`exception.
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`U. Exhibit 2045
`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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`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 relevant date, Sept. 30, 2011. Therefore, Exhibit 2045
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`should be excluded under FRE 402 and 403. Lupin further objects to Exhibit 2045
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`under FRE 802 on the basis that it is inadmissible hearsay, not within a hearsay
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`exception. Lupin also objects to Exhibit 2045 under FRE 901 on the basis that it
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`has not been properly authenticated and lacks foundation.
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`Case IPR2016-00829
`Patent 9,095,559 B2
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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)
`
`Counsel for Petitioners
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`Dated: February 17, 2016
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`CERTIFICATE OF SERVICE
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`Case IPR2016-00829
`Patent 9,095,559 B2
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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 February 17, 2017 on the following:
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`James B. Monroe (lead counsel, Reg. No. 33,971)
`Maureen D. Queler (backup counsel, Reg. No. 61,879)
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`James.monroe@finnegan.com
`Maureen.queler@finnegan.com
`
`
`
`Matthew Phillips (backup counsel, Reg. No. 43,403)
`Renaissance IP Law Group LLP
`matthew.phillips@renaissanceiplaw.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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`Dated: February 17, 2017
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`
`
`/Cynthia Lambert Hardman/
`Cynthia Lambert Hardman
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