`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`PAR PHARMACEUTICAL, INC.,
`Petitioner,
`
`v.
`
`HORIZON THERAPEUTICS, LLC,
`Patent Owner.
`
`_____________________
`
`Case IPR2017-01768
`Patent 9,095,559
`_____________________
`
`PETITIONER’S OBJECTIONS TO
`EVIDENCE PURSUANT TO 37 C.F.R. § 42.64
`
`
`
`
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`IPR2017-01768
`Patent No. 9,095,559
`Par’s Objections to Evidence
`
`Petitioner Par Pharmaceutical, Inc. (“Par”) hereby objects pursuant to
`
`
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`37 C.F.R. § 42.64(b)(1) to the admissibility of certain exhibits submitted by Patent
`
`Owner Horizon Therapeutics, LLC (“Patent Owner”) on November 6, 2017 in
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`connection with Patent Owner’s Preliminary Response (“Preliminary Response,”
`
`Paper No. 7) to Par’s Petition for Inter Partes Review of U.S. Patent No. 9,095,559
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`(“the ’559 patent”).
`
`Par’s objections to the admissibility of exhibits submitted with Patent
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`Owner’s Preliminary Response are made in accordance with the Federal Rules of
`
`Evidence (“FRE”). Par’s objections are also made pursuant to the Code of Federal
`
`Regulations (“C.F.R.”) governing this proceeding, including without limitation
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`37 C.F.R. §§ 42.61-42.65 and § 42.6(a)(3).
`
`
`
`THE CHALLENGED EVIDENCE AND GROUNDS FOR OBJECTIONS
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`Exhibit 2002
`Par objects to Exhibit 2002 on the grounds of completeness and authenticity
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`to the extent Exhibit 2002 was neither certified nor submitted with an attestation of
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`completeness and accuracy. FRE 106, 901, 902. Par also objects to Exhibit 2002
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`under FRE 802 as inadmissible hearsay, and is not within a hearsay exception, to
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`the extent it or any of its contents are offered for the truth of the matter asserted.
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`Furthermore, Par objects to Exhibit 2002 under FRE 402 and 403 because it is
`
`irrelevant and its probative value is substantially outweighed by the danger of
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`1
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`wasting time in this compressed proceeding.
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`IPR2017-01768
`Patent No. 9,095,559
`Par’s Objections to Evidence
`
`
`Exhibit 2003
`Par objects to Exhibit 2003 on the ground that it was not cited in the
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`Preliminary Response, and is therefore irrelevant (FRE 402) and a waste of time
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`(FRE 403), as uncited evidence may not be incorporated by reference. 37 C.F.R.
`
`§ 42.6(a)(3).
`
`
`Exhibit 2004
`Par objects to Exhibit 2004 on the ground that it was not cited in the
`
`Preliminary Response, and is therefore irrelevant (FRE 402) and a waste of time
`
`(FRE 403), as uncited evidence may not be incorporated by reference. 37 C.F.R.
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`§ 42.6(a)(3).
`
`
`Exhibit 2005
`Par objects to Exhibit 2005 under FRE 402 and 403 because it is irrelevant
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`and its probative value is substantially outweighed by the danger of wasting time in
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`this compressed proceeding. Exhibit 2005 is a litigation document served by Par
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`in a different proceeding regarding different patents, and therefore bears no
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`relevance to the issue of patentability of the ’559 patent claims. Par also objects to
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`Exhibit 2005 under FRE 901 and 902 on the basis that it has not been properly
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`authenticated and lacks foundation. Par further objects to Exhibit 2005 as
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`incomplete because it contains only certain portions of Par’s Initial Invalidity
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`2
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`
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`Contentions and Non-Infringement Contentions, and should therefore be excluded
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`IPR2017-01768
`Patent No. 9,095,559
`Par’s Objections to Evidence
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`under FRE 106. Moreover, Par objects to Exhibit 2005 under FRE 802 as
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`inadmissible hearsay, and is not within a hearsay exception, to the extent it or any
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`of its contents are offered for the truth of the matter asserted.
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`
`Exhibit 2006
`Par objects to Exhibit 2006 under FRE 402 to the extent it includes or relies
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`on irrelevant or inadmissible information and under FRE 403 to the extent that it
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`includes or relies on information whose probative value of which is substantially
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`outweighed by the danger of unfair prejudice, wasting time, or needlessly
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`presenting cumulative evidence as set forth herein. Par further objects to
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`Exhibit 2006 under FRE 901 on the basis that it cites or relies on exhibits that have
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`not been properly authenticated or lack foundation, as set forth herein. Moreover,
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`Par objects to Exhibit 2006 under FRE 802 as inadmissible hearsay, and is not
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`within a hearsay exception, to the extent it is being offered for the truth of any
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`matter asserted therein.
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`Exhibit 2006 is also inadmissible expert evidence. FRE 702, 703. The
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`opinions expressed in Exhibit 2006 are not “based on sufficient facts or data” or
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`“the product of reliable principles and methods.” FRE 702. For example,
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`Exhibit 2006 relies on unsupported and conclusory statements relating to plasma
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`ammonia levels. FRE 702, 703. Exhibit 2006 misinterprets the prior art references
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`3
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`and provides statements that are unsupported by the prior art. (See e.g.,
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`IPR2017-01768
`Patent No. 9,095,559
`Par’s Objections to Evidence
`
`Exhibit 2006, ¶¶ 66, 95.) Moreover, Exhibit 2006 relies on alleged facts that have
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`no support in the record. (See e.g., id. at ¶ 104.) In addition, Exhibit 2006 fails to
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`“reliably appl[y] the principles and methods to the facts of the case.” FRE 702,
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`703. For at least these reasons, Exhibit 2006 is not based on sufficient facts or
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`reliable methods and does not fit the facts presented in this proceeding. Par also
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`objects to Exhibit 2006 for failure to comply with 37 C.F.R. § 42.51 to the extent
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`Patent Owner has not served relevant information that is inconsistent with a
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`position advanced in Exhibit 2006 concurrent with its filing. Par further objects to
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`Exhibit 2006 for failure to comply with 37 C.F.R. § 42.65 to the extent it relies on
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`underlying facts or data that have not been disclosed or that have not been cited in
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`the Preliminary Response.
`
`
`Exhibit 2007
`Par objects to Exhibit 2007 under FRE 802 because it is inadmissible
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`hearsay that is not within a hearsay exception. In addition, Par objects to
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`Exhibit 2007 under FRE 402 because it lacks relevance to any issue in this
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`proceeding and does not itself set forth any “evidence” supporting the Preliminary
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`Response.
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`Exhibit 2010
`Par objects to Exhibit 2010 on the ground that it was not cited in the
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`4
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`
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`Preliminary Response, and is therefore irrelevant (FRE 402) and a waste of time
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`IPR2017-01768
`Patent No. 9,095,559
`Par’s Objections to Evidence
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`(FRE 403), as uncited evidence may not be incorporated by reference. 37 C.F.R.
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`§ 42.6(a)(3).
`
`
`Exhibit 2011
`Par objects to Exhibit 2011 on the ground that it was not cited in the
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`Preliminary Response, and is therefore irrelevant (FRE 402) and a waste of time
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`(FRE 403), as uncited evidence may not be incorporated by reference. 37 C.F.R.
`
`§ 42.6(a)(3).
`
`
`Exhibit 2012
`Par objects to Exhibit 2012 under FRE 402 and 403 because it is irrelevant
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`and its probative value is substantially outweighed by the danger of wasting time in
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`this compressed proceeding. Exhibit 2012 was published in 2012 and, therefore,
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`bears no relevance to what a person of ordinary skill in the art would have known
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`by September 30, 2011, the priority date used for the purposes of this proceeding.
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`Therefore, Exhibit 2012 should be excluded under FRE 402 and 403. Par further
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`objects to Exhibit 2012 under FRE 802 on the basis that it is inadmissible hearsay,
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`and is not within a hearsay exception, to the extent it is being offered for the truth
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`of any matter asserted therein.
`
`
`Exhibit 2014
`Par objects to Exhibit 2014 on the ground that it was not cited in the
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`5
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`
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`Preliminary Response, and is therefore irrelevant (FRE 402) and a waste of time
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`IPR2017-01768
`Patent No. 9,095,559
`Par’s Objections to Evidence
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`(FRE 403), as uncited evidence may not be incorporated by reference. 37 C.F.R.
`
`§ 42.6(a)(3).
`
`
`Exhibit 2015
`Par objects to Exhibit 2015 under FRE 402 and 403 because it is irrelevant
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`and its probative value is substantially outweighed by the danger of wasting time in
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`this compressed proceeding. Exhibit 2015 was published online on
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`November 18, 2011 and in print in 2012 and, therefore, bears no relevance to what
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`a person of ordinary skill in the art would have known by September 30, 2011, the
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`priority date used for the purposes of this proceeding. Therefore, Exhibit 2015
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`should be excluded under FRE 402 and 403. Par further objects to Exhibit 2015
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`under FRE 802 on the basis that it is inadmissible hearsay, and is not within a
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`hearsay exception, to the extent it is being offered for the truth of any matter
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`asserted therein.
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`Exhibit 2019
`Par objects to Exhibit 2019 under FRE 402 and 403 because it is irrelevant
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`and its probative value is substantially outweighed by the danger of wasting time in
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`this compressed proceeding. Exhibit 2019 was published in 2012 and, therefore,
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`bears no relevance to what a person of ordinary skill in the art would have known
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`as of September 30, 2011, the priority date used for the purposes of this
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`6
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`
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`proceeding. Therefore, Exhibit 2019 should be excluded under FRE 402 and 403.
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`IPR2017-01768
`Patent No. 9,095,559
`Par’s Objections to Evidence
`
`Par further objects to Exhibit 2019 under FRE 802 on the basis that it is
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`inadmissible hearsay, and is not within a hearsay exception, to the extent it is being
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`offered for the truth of any matter asserted therein.
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` Exhibit 2022
`Par objects to Exhibit 2022 on the ground that it was not cited in the
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`Preliminary Response, and is therefore irrelevant (FRE 402) and a waste of time
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`(FRE 403), as uncited evidence may not be incorporated by reference. 37 C.F.R.
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`§ 42.6(a)(3).
`
`
`Exhibit 2024
`Par objects to Exhibit 2024 on the ground that it was not cited in the
`
`Preliminary Response, and is therefore irrelevant (FRE 402) and a waste of time
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`(FRE 403), as uncited evidence may not be incorporated by reference. 37 C.F.R.
`
`§ 42.6(a)(3).
`
`
`Exhibit 2026
`Par objects to Exhibit 2026 under FRE 402 and 403 because it is irrelevant
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`and its probative value is substantially outweighed by the danger of wasting time in
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`this compressed proceeding. Exhibit 2026 is dated after September 30, 2011, the
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`priority date used for the purposes of this proceeding, and, therefore, bears no
`
`relevance to what a person of ordinary skill in the art would have known as of the
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`7
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`
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`priority date. Therefore, Exhibit 2026 should be excluded under FRE 402 and 403.
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`IPR2017-01768
`Patent No. 9,095,559
`Par’s Objections to Evidence
`
`Par further objects to Exhibit 2026 under FRE 802 on the basis that it is
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`inadmissible hearsay, and is not within a hearsay exception, to the extent it is being
`
`offered for the truth of any matter asserted therein. Moreover, Par objects to
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`Exhibit 2026 under FRE 901 and 902 on the basis that it has not been properly
`
`authenticated and lacks foundation.
`
`
`Exhibit 2027
`Par objects to Exhibit 2027 on the ground that it was not cited in the
`
`Preliminary Response, and is therefore irrelevant (FRE 402) and a waste of time
`
`(FRE 403), as uncited evidence may not be incorporated by reference. 37 C.F.R.
`
`§ 42.6(a)(3). Par also objects to Exhibit 2027 under FRE 402 and 403 because it is
`
`irrelevant and its probative value is substantially outweighed by the danger of
`
`wasting time in this compressed proceeding. Exhibit 2027 is dated after
`
`September 30, 2011, the priority date used for the purposes of this proceeding, and,
`
`therefore, bears no relevance to what a person of ordinary skill in the art would
`
`have known as of the priority date. Therefore, Exhibit 2027 should be excluded
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`under FRE 402 and 403. Par further objects to Exhibit 2027 under FRE 802 on the
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`basis that it is inadmissible hearsay, and is not within a hearsay exception, to the
`
`extent it is being offered for the truth of any matter asserted therein. Moreover, Par
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`objects to Exhibit 2027 under FRE 901 on the basis that it has not been properly
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`8
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`authenticated and lacks foundation.
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`IPR2017-01768
`Patent No. 9,095,559
`Par’s Objections to Evidence
`
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`Exhibit 2028
`Par objects to Exhibit 2028 on the ground that it was not cited in the
`
`Preliminary Response, and is therefore irrelevant (FRE 402) and a waste of time
`
`(FRE 403), as uncited evidence may not be incorporated by reference. 37 C.F.R.
`
`§ 42.6(a)(3).
`
`
`Exhibit 2029
`Par objects to Exhibit 2029 on the ground that it was not cited in the
`
`Preliminary Response, and is therefore irrelevant (FRE 402) and a waste of time
`
`(FRE 403), as uncited evidence may not be incorporated by reference. 37 C.F.R.
`
`§ 42.6(a)(3). Par also objects to Exhibit 2029 under FRE 402 and 403 because it is
`
`irrelevant and its probative value is substantially outweighed by the danger of
`
`wasting time in this compressed proceeding. Exhibit 2029 is dated after September
`
`30, 2011, the priority date used for the purposes of this proceeding, and, therefore,
`
`bears no relevance to what a person of ordinary skill in the art would have known
`
`as of the priority date. Therefore, Exhibit 2029 should be excluded under FRE 402
`
`and 403. Par further objects to Exhibit 2029 under FRE 802 on the basis that it is
`
`inadmissible hearsay, and is not within a hearsay exception, to the extent it is being
`
`offered for the truth of any matter asserted therein.
`
`9
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`IPR2017-01768
`Patent No. 9,095,559
`Par’s Objections to Evidence
`
`
`Exhibit 2030
`Par objects to Exhibit 2030 on the ground that it was not cited in the
`
`Preliminary Response, and is therefore irrelevant (FRE 402) and a waste of time
`
`(FRE 403), as uncited evidence may not be incorporated by reference. 37 C.F.R.
`
`§ 42.6(a)(3).
`
`
`Exhibit 2033
`Par objects to Exhibit 2033 on the ground that it was not cited in the
`
`Preliminary Response, and is therefore irrelevant (FRE 402) and a waste of time
`
`(FRE 403), as uncited evidence may not be incorporated by reference. 37 C.F.R.
`
`§ 42.6(a)(3). Par also objects to Exhibit 2033 under FRE 402 and 403 because it is
`
`irrelevant and its probative value is substantially outweighed by the danger of
`
`wasting time in this compressed proceeding. Exhibit 2033 is dated after September
`
`30, 2011, the priority date used for the purposes of this proceeding, and, therefore,
`
`bears no relevance to what a person of ordinary skill in the art would have known
`
`as of the priority date. Therefore, Exhibit 2033 should be excluded under FRE 402
`
`and 403. Par further objects to Exhibit 2033 under FRE 802 on the basis that it is
`
`inadmissible hearsay, and is not within a hearsay exception, to the extent it is being
`
`offered for the truth of any matter asserted therein. Moreover, Par objects to
`
`Exhibit 2033 under FRE 901 on the basis that it has not been properly
`
`authenticated and lacks foundation.
`
`10
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`
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`IPR2017-01768
`Patent No. 9,095,559
`Par’s Objections to Evidence
`
`
`Exhibit 2035
`Par objects to Exhibit 2035 under FRE 402 and 403 because it is irrelevant
`
`and its probative value is substantially outweighed by the danger of wasting time in
`
`this compressed proceeding. Exhibit 2035 is dated after September 30, 2011, the
`
`priority date used for the purposes of this proceeding, and therefore, bears no
`
`relevance to what a person of ordinary skill in the art would have known as of the
`
`priority date. Therefore, Exhibit 2035 should be excluded under FRE 402 and 403.
`
`Par further objects to Exhibit 2035 under FRE 802 on the basis that is inadmissible
`
`hearsay, and is not within a hearsay exception, to the extent it is being offered for
`
`the truth of any matter asserted therein.
`
`
`Exhibit 2038
`Par objects to Exhibit 2038 under FRE 402 and 403 because it is irrelevant
`
`and its probative value is substantially outweighed by the danger of wasting time in
`
`this compressed proceeding. Exhibit 2038 is dated after September 30, 2011, the
`
`priority date used for the purposes of this proceeding, and, therefore, bears no
`
`relevance to what a person of ordinary skill in the art would have known as of the
`
`priority date. Therefore, Exhibit 2038 should be excluded under FRE 402 and 403.
`
`Par further objects to Exhibit 2038 under FRE 802 on the basis that it is
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`inadmissible hearsay, and is not within a hearsay exception, to the extent it is being
`
`offered for the truth of any matter asserted therein. Moreover, Par objects to
`
`11
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`
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`Exhibit 2038 under FRE 901 on the basis that it has not been properly
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`IPR2017-01768
`Patent No. 9,095,559
`Par’s Objections to Evidence
`
`authenticated and lacks foundation.
`
` Exhibit 2040
`Par objects to Exhibit 2040 under FRE 402 and 403 because it is irrelevant
`
`and its probative value is substantially outweighed by the danger of wasting time in
`
`this compressed proceeding. Exhibit 2040 is dated after September 30, 2011, the
`
`priority date used for the purposes of this proceeding, and therefore, bears no
`
`relevance to what a person of ordinary skill in the art would have known as of the
`
`priority date. Therefore, Exhibit 2040 should be excluded under FRE 402 and 403.
`
`Par further objects to Exhibit 2040 under FRE 802 on the basis that it is
`
`inadmissible hearsay, and is not within a hearsay exception, to the extent it is being
`
`offered for the truth of any matter asserted therein. Moreover, Par objects to
`
`Exhibit 2040 under FRE 901 on the basis that it has not been properly
`
`authenticated and lacks foundation.
`
`
`Dated: February 13, 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
`
`Attorney for Petitioner
`Par Pharmaceutical, Inc.
`
`12
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`
`
`
`
`IPR2017-01768
`Patent No. 9,095,559
`Certificate of Service
`
`CERTIFICATION OF SERVICE
`The undersigned hereby certifies that the above-captioned “Petitioner’s
`
`Objections to Evidence Pursuant to 37 C.F.R. § 42.64” was served in its entirety on
`
`February 13, 2018 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
`
`
`Dated: February 13, 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
`
`Attorney for Petitioner
`Par Pharmaceutical, Inc.
`
`
`
`
`
`
`
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