`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`AMNEAL PHARMACEUTICALS LLC AND
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioners,
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner.
`
`_____________________
`
`Case IPR2018-00608
`
`Patent 9,161,926 B2
`_____________________
`
`PETITIONERS’ OBJECTIONS TO EVIDENCE AS OF
`DECEMBER 6, 2018
`
`
`
`
`IPR2018-00608
`Patent 9,161,926 B2
`Pursuant to 37 C.F.R. § 42.64(b)(1), Amneal Pharmaceuticals LLC and
`
`Amneal Pharmaceuticals of New York, LLC (collectively, “Petitioners”) timely
`
`objects under the Federal Rules of Evidence (FRE) to the admissibility of Exhibits
`
`2004, 2010-2012, 2014, 2015, 2019, 2021, 2023, 2025, 2027, 2028, 2030-2035,
`
`2038-2041, 2043-2047, 2050, and 2051. In addition, Petitioners object to the
`
`admissibility of paragraphs 1-40, 43, 61, 62, 64, 66-68, 71-80, 88-90, 92-98, 100,
`
`104-112, 116-122, 125-143, 146-148, 152-158, 164-167, 161-171, 173, 175-181,
`
`183-192, 194-196, 200, and 202-218 of Exhibit 2003 and paragraphs 1-32, 35-39,
`
`65, 78-80, 85-94, 96-112, 115-132, 150, 163, and 173-200 of Exhibit 2022.
`
`Collectively, these exhibits (“Challenged Evidence”) were served by Patent
`
`Owner, Almirall, LLC, with its Patent Owner’s Response filed on November 29,
`
`2018. Petitioners file these objections to provide notice to Patent Owner that
`
`Petitioners may move to exclude the Challenged Evidence under 37 C.F.R. §
`
`42.64(c), unless timely cured by Patent Owner.
`
`IDENTIFICATION OF CHALLENGED EVIDENCE AND GROUNDS
`FOR OBJECTIONS
`
`A. Numerous exhibits and three hundred and eleven of the four
`hundred and eighteen declaration paragraphs should be excluded
`as irrelevant.
`
`Petitioners object to the use of Exhibits 2004, 2015, 2019, 2023, 2027, 2028,
`
`2030, 2031, 2032, 2033, 2034, 2035, 2038- 2041, 2043, and 2044-2047 under FRE
`
`401 and 403. These exhibits are not substantively relied on, or even cited, in Patent
`
`- 1 -
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`
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`IPR2018-00608
`Patent 9,161,926 B2
`Owner’s Response. Consequently, these exhibits do not appear to make any fact of
`
`consequence more or less probable than it would be without them.
`
`Petitioners also object to paragraphs 1-40, 43, 61, 62, 64, 66-68, 71-80, 88-
`
`90, 92-98, 100, 104-112, 116-122, 125-143, 146-148, 152-158, 164-167, 169-171,
`
`173, 175-181, 183-192, 194-196, 200, and 202-218 of Exhibit 2003, and
`
`paragraphs 1-32, 35-39, 65, 78-80, 85-94, 96-112, 115-132, 150, 163, and 173-200
`
`of Exhibit 2022 under FRE 401 and 403. These declaration paragraphs are not
`
`substantively relied on, or even cited, in Patent Owner’s Response. Consequently,
`
`these declaration paragraphs do not appear to make any fact of consequence more
`
`or less probable than the fact would be without these exhibits. Alternatively, if
`
`Patent Owner asserts that the aforementioned paragraphs are relevant, then Patent
`
`Owner must incorporate by reference into its Response these 311 declaration
`
`paragraphs. Doing so, however, would add at least 311 or at most over two
`
`thousand words to Patent Owner’s Response when Patent Owner only had 1,569
`
`words to spare, thereby violating the word count limit set forth in 37 C.F.R. §
`
`42.24(b).
`
`In addition, Petitioners object to Exhibit 2039 because it is not substantively
`
`relied on, or even cited, in Patent Owner’s Response, Exhibit 2003, or Exhibit
`
`2022. Thus, Exhibit 2039 is irrelevant to the instituted grounds.
`
`- 2 -
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`IPR2018-00608
`Patent 9,161,926 B2
`B. Multiple exhibits are inadmissible as not relevant, not
`authenticated, and/or contain hearsay, and are therefore more
`prejudicial than probative as to any fact of consequence.
`
`Exhibits 2010, 2012, 2014, 2018, 2031, 2035, 2043, 2044, 2050, and 2051
`
`are inadmissible for at least the following reasons:
`
`Exhibit 2010: This exhibit lacks authentication, and this is inadmissible
`
`under FRE 901. Exhibit 2010 purports to be a website printout but there is no
`
`evidence establishing that it contains true and correct content. Accordingly, Patent
`
`Owner has not provided evidence sufficient to support a finding that Exhibit 2010
`
`“is what [Patent Owner] claims it is.” See FRE 901.
`
`Exhibit 2010 is also inadmissible under FRE 401 and 403. Exhibit 2010
`
`purports to be a website printout showing a July 23, 2012 date. But there is no
`
`evidence that Exhibit 2010 is a prior-art publication that is available to the public.
`
`Therefore, Exhibit 2010 is inadmissible as not relevant.
`
`Exhibit 2010 is inadmissible as hearsay under FRE 801 and 802. Patent
`
`Owner relies on the dates in Exhibit 2010 for the truth of the matter asserted.
`
`Patent Owner cannot rely on any date shown in Exhibit 2010 because these dates
`
`are not evidence that the reference was a printed publication as of a particular date.
`
`No exception applies.
`
`To the extent that the Patent Owner relies on the contents of this document
`
`to prove the content of the original document, Petitioners object to this document
`
`- 3 -
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`IPR2018-00608
`Patent 9,161,926 B2
`as not being an original document under FRE 1002, an authentic duplicate under
`
`FRE 1003, or a document that falls under any exception to the original-document
`
`requirement, including those of FRE 1004.
`
`Exhibit 2012: This exhibit lacks authentication, and this is inadmissible
`
`under FRE 901. Exhibit 2012 purports to be a World Health Organization
`
`document, but there is no evidence establishing that it contains true and correct
`
`content. Accordingly, Patent Owner has not provided evidence sufficient to
`
`support a finding that Exhibit 2012 “is what [Patent Owner] claims it is.” See FRE
`
`901.
`
`Exhibit 2012 is also inadmissible under FRE 401 and 403. Exhibit 2012
`
`purports to be a World Health Organization document dated March 4, 2008. But
`
`there is no evidence that Exhibit 2012 is a prior-art publication that is available to
`
`the public. Therefore, Exhibit 2012 is inadmissible as not relevant.
`
`Exhibit 2012 is inadmissible as hearsay under FRE 801 and 802. Patent
`
`Owner relies on the March 4, 2008 date in Exhibit 2012 for the truth of the matter
`
`asserted. Patent Owner cannot rely on the March 4, 2008 date shown in Exhibit
`
`2012 because there is no evidence that the reference was a printed publication as of
`
`a particular date. No exception applies.
`
`To the extent that the Patent Owner relies on the contents of this document
`
`to prove the content of the original document, Petitioners object to this document
`
`- 4 -
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`
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`IPR2018-00608
`Patent 9,161,926 B2
`as not being an original document under FRE 1002, an authentic duplicate under
`
`FRE 1003, or a document that falls under any exception to the original-document
`
`requirement, including those of FRE 1004.
`
`Exhibit 2014: This exhibit lacks authentication, and this is inadmissible
`
`under FRE 901. Exhibit 2014 purports to be the Prescribing Information for
`
`Azcone Gel, 5%, but there is no evidence establishing that it contains true and
`
`correct content. Accordingly, Patent Owner has not provided evidence sufficient to
`
`support a finding that Exhibit 2014 “is what [Patent Owner] claims it is.” See FRE
`
`901.
`
`Exhibit 2014 is also inadmissible under FRE 401 and 403. Exhibit 2014
`
`purports to be the Prescribing Information for Azcone Gel, 5% with a “March
`
`2008” date on the document. But there is no evidence that Exhibit 2014 is a prior-
`
`art publication that is available to the public. Therefore, Exhibit 2014 is
`
`inadmissible as not relevant.
`
`Exhibit 2014 is inadmissible as hearsay under FRE 801 and 802. Patent
`
`Owner relies on the “March 2008” date in Exhibit 2014 for the truth of the matter
`
`asserted. Patent Owner cannot rely on the “March 2008” date shown in Exhibit
`
`2014 because there is no evidence that the reference was a printed publication as of
`
`a particular date. No exception applies.
`
`To the extent that the Patent Owner relies on the contents of this document
`
`- 5 -
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`IPR2018-00608
`Patent 9,161,926 B2
`to prove the content of the original document, Petitioners object to this document
`
`as not being an original document under FRE 1002, an authentic duplicate under
`
`FRE 1003, or a document that falls under any exception to the original-document
`
`requirement, including those of FRE 1004.
`
`Exhibit 2018: This exhibit lacks authentication, and this is inadmissible
`
`under FRE 901. Exhibit 2018 purports to be a listing of excipients approved by the
`
`U.S. Food and Drug Administration, but there is no evidence establishing that it
`
`contains true and correct content. Accordingly, Patent Owner has not provided
`
`evidence sufficient to support a finding that Exhibit 2018 “is what [Patent Owner]
`
`claims it is.” See FRE 901.
`
`Exhibit 2018 is also inadmissible under FRE 401 and 403. Exhibit 2018
`
`purports to be a listing of excipients approved by the U.S. Food and Drug
`
`Administration but the document is undated. But there is no evidence that Exhibit
`
`2018 is a prior-art publication that is available to the public. Therefore, Exhibit
`
`2018 is inadmissible as not relevant.
`
`Exhibit 2018 is inadmissible as hearsay under FRE 801 and 802. Patent
`
`Owner relies on the information in Exhibit 2018 for the truth of the matter asserted.
`
`Patent Owner cannot rely on this information because there is no evidence that the
`
`reference was a printed publication as of a particular date. No exception applies.
`
`To the extent that the Patent Owner relies on the contents of this document
`
`- 6 -
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`
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`IPR2018-00608
`Patent 9,161,926 B2
`to prove the content of the original document, Petitioners object to this document
`
`as not being an original document under FRE 1002, an authentic duplicate under
`
`FRE 1003, or a document that falls under any exception to the original-document
`
`requirement, including those of FRE 1004.
`
`Exhibit 2031: This exhibit lacks authentication, and this is inadmissible
`
`under FRE 901. Exhibit 2031 purports to be an excerpt from the Physicians’ Desk
`
`Reference 66th Ed. (2012), but there is no evidence establishing that it contains true
`
`and correct content. Accordingly, Patent Owner has not provided evidence
`
`sufficient to support a finding that Exhibit 2031 “is what [Patent Owner] claims it
`
`is.” See FRE 901.
`
`Exhibit 2031 is also inadmissible under FRE 401 and 403. Exhibit 2031
`
`purports to be an excerpt from the Physicians’ Desk Reference 66th Ed. from 2012.
`
`But there is no evidence that Exhibit 2031 is a prior-art publication that is available
`
`to the public. Therefore, Exhibit 2031 is inadmissible as not relevant.
`
`Exhibit 2031 is inadmissible as hearsay under FRE 801 and 802. Patent
`
`Owner relies on the “2012” date in Exhibit 2031 for the truth of the matter
`
`asserted. Patent Owner cannot rely on the “2012” date shown in Exhibit 2031
`
`because there is no evidence that the reference was a printed publication as of a
`
`particular date. No exception applies.
`
`To the extent that the Patent Owner relies on the contents of this document
`
`- 7 -
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`IPR2018-00608
`Patent 9,161,926 B2
`to prove the content of the original document, Petitioners object to this document
`
`as not being an original document under FRE 1002, an authentic duplicate under
`
`FRE 1003, or a document that falls under any exception to the original-document
`
`requirement, including those of FRE 1004.
`
`Exhibit 2035: This exhibit lacks authentication, and this is inadmissible
`
`under FRE 901. Exhibit 2035 purports to be a publication from 2012 but there is
`
`no evidence establishing that it contains true and correct content. Accordingly,
`
`Patent Owner has not provided evidence sufficient to support a finding that Exhibit
`
`2035 “is what [Patent Owner] claims it is.” See FRE 901.
`
`Exhibit 2035 is also inadmissible under FRE 401 and 403. Exhibit 2035
`
`purports to be a publication from 2012. But there is no evidence that Exhibit 2035
`
`is a prior-art publication that is available to the public. Therefore, Exhibit 2035 is
`
`inadmissible as not relevant.
`
`Exhibit 2035 is inadmissible as hearsay under FRE 801 and 802. Patent
`
`Owner relies on the “2012” date in Exhibit 2035 for the truth of the matter
`
`asserted. Patent Owner cannot rely on the “2012” date shown in Exhibit 2035
`
`because there is no evidence that the reference was a printed publication as of a
`
`particular date. No exception applies.
`
`To the extent that the Patent Owner relies on the contents of this document
`
`to prove the content of the original document, Petitioners object to this document
`
`- 8 -
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`
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`IPR2018-00608
`Patent 9,161,926 B2
`as not being an original document under FRE 1002, an authentic duplicate under
`
`FRE 1003, or a document that falls under any exception to the original-document
`
`requirement, including those of FRE 1004.
`
`Exhibit 2043: This exhibit lacks authentication, and this is inadmissible
`
`under FRE 901. Exhibit 2043 purports to be clinical study report dated “05
`
`February 2007.” There is no evidence establishing that it contains true and correct
`
`content. Accordingly, Patent Owner has not provided evidence sufficient to
`
`support a finding that Exhibit 2043 “is what [Patent Owner] claims it is.” See FRE
`
`901.
`
`Exhibit 2043 is also inadmissible under FRE 401 and 403. Exhibit 2043
`
`purports to be a clinical study report from 2007. But there is no evidence that
`
`Exhibit 2043 is a prior-art publication that is available to the public. Therefore,
`
`Exhibit 2043 is inadmissible as not relevant.
`
`Exhibit 2043 is inadmissible as hearsay under FRE 801 and 802. Patent
`
`Owner relies on the “05 February 2007” date and the signature dates in Exhibit
`
`2043 for the truth of the matter asserted. Patent Owner cannot rely on this date
`
`because there is no evidence that the reference was a printed publication as of a
`
`particular date. No exception applies.
`
`To the extent that the Patent Owner relies on the contents of this document
`
`to prove the content of the original document, Petitioners object to this document
`
`- 9 -
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`
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`IPR2018-00608
`Patent 9,161,926 B2
`as not being an original document under FRE 1002, an authentic duplicate under
`
`FRE 1003, or a document that falls under any exception to the original-document
`
`requirement, including those of FRE 1004.
`
`Exhibit 2044: This exhibit lacks authentication, and this is inadmissible
`
`under FRE 901. Exhibit 2044 purports to be clinical study document. There is no
`
`evidence establishing that it contains true and correct content. Accordingly, Patent
`
`Owner has not provided evidence sufficient to support a finding that Exhibit 2044
`
`“is what [Patent Owner] claims it is.” See FRE 901.
`
`Exhibit 2044 is also inadmissible under FRE 401 and 403. Exhibit 2044
`
`purports to be a clinical study document, but it is undated. There is no evidence
`
`that Exhibit 2044 is a prior-art publication that is available to the public. Therefore,
`
`Exhibit 2044 is inadmissible as not relevant.
`
`Exhibit 2044 is inadmissible as hearsay under FRE 801 and 802. Patent
`
`Owner relies on the dates of enrollment in Exhibit 2044 for the truth of the matter
`
`asserted. Patent Owner cannot rely on these dates because there is no evidence that
`
`the reference was a printed publication as of a particular date. No exception
`
`applies.
`
`To the extent that the Patent Owner relies on the contents of this document
`
`to prove the content of the original document, Petitioners object to this document
`
`as not being an original document under FRE 1002, an authentic duplicate under
`
`- 10 -
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`IPR2018-00608
`Patent 9,161,926 B2
`FRE 1003, or a document that falls under any exception to the original-document
`
`requirement, including those of FRE 1004.
`
`Exhibit 2050: This exhibit lacks authentication, and this is inadmissible
`
`under FRE 901. Exhibit 2050 purports to be a communication from the U.S. Food
`
`and Drug Administration purportedly sent on “7/7/05.” There is no evidence
`
`establishing that it contains true and correct content. Accordingly, Patent Owner
`
`has not provided evidence sufficient to support a finding that Exhibit 2050 “is what
`
`[Patent Owner] claims it is.” See FRE 901.
`
`Exhibit 2050 is also inadmissible under FRE 401 and 403. Exhibit 2050
`
`purports to be a communication from the U.S. Food and Drug Administration
`
`purportedly sent on “7/7/05.” There is no evidence that Exhibit 2050 is a prior-art
`
`publication that is available to the public. Therefore, Exhibit 2050 is inadmissible
`
`as not relevant.
`
`Exhibit 2050 is inadmissible as hearsay under FRE 801 and 802. Patent
`
`Owner relies on the “7/7/05” signature date in Exhibit 2050 for the truth of the
`
`matter asserted. Patent Owner cannot rely on this date because there is no evidence
`
`that the reference was a printed publication as of a particular date. No exception
`
`applies.
`
`To the extent that the Patent Owner relies on the contents of this document
`
`to prove the content of the original document, Petitioners object to this document
`
`- 11 -
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`
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`IPR2018-00608
`Patent 9,161,926 B2
`as not being an original document under FRE 1002, an authentic duplicate under
`
`FRE 1003, or a document that falls under any exception to the original-document
`
`requirement, including those of FRE 1004.
`
`Exhibit 2051: This exhibit lacks authentication, and this is inadmissible
`
`under FRE 901. Exhibit 2051 purports to be a communication from the U.S. Food
`
`and Drug Administration purportedly sent on “3/14/2008.” There is no evidence
`
`establishing that it contains true and correct content. Accordingly, Patent Owner
`
`has not provided evidence sufficient to support a finding that Exhibit 2051 “is what
`
`[Patent Owner] claims it is.” See FRE 901.
`
`Exhibit 2051 is also inadmissible under FRE 401 and 403. Exhibit 2051
`
`purports to be a communication from the U.S. Food and Drug Administration
`
`purportedly sent on “3/14/2008.” There is no evidence that Exhibit 2051 is a prior-
`
`art publication that is available to the public. Therefore, Exhibit 2051 is
`
`inadmissible as not relevant.
`
`Exhibit 2051 is inadmissible as hearsay under FRE 801 and 802. Patent
`
`Owner relies on the “3/14/2008” signature date in Exhibit 2051 for the truth of the
`
`matter asserted. Patent Owner cannot rely on this date because there is no evidence
`
`that the reference was a printed publication as of a particular date. No exception
`
`applies.
`
`To the extent that the Patent Owner relies on the contents of this document
`
`- 12 -
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`IPR2018-00608
`Patent 9,161,926 B2
`to prove the content of the original document, Petitioners object to this document
`
`as not being an original document under FRE 1002, an authentic duplicate under
`
`FRE 1003, or a document that falls under any exception to the original-document
`
`requirement, including those of FRE 1004.
`
`C. The Warner Declaration in Exhibit 1017 and Dr. Klibanov’s
`reliance on the Warner Declaration in Exhibit 2003 are
`inadmissible hearsay.
`
`Petitioners object to the Warner Declaration in Exhibit 1017 (pp. 350-355)
`
`as inadmissible hearsay under FRE 801 and 802. The document is relied upon for
`
`the truth of the matter asserted (POR at 6-7, 47; Ex. 2003 at ¶¶ 204-217) and
`
`Petitioner has not had the opportunity to subject the declarant (Dr. Kevin Warner)
`
`to cross examination. No exception applies. In addition, Dr. Klibanov, in ¶¶ 204-
`
`217 of Exhibit 2003, relies on the Warner Declaration for the truth of the matter
`
`asserted, and is therefore inadmissible under FRE 801, 802, and 805. No exception
`
`applies.
`
`D. Exhibit 2011 violates 37 C.F.R. § 42.63(b) because it contains
`untranslated foreign language.
`
`Petitioners object to Exhibit 2011 because it fails to comply with FRE 401,
`
`403, 1002, and 1003, as well as 37 C.F.R. § 42.63(b), which states that “when a
`
`party relies on a document … in a language other than English, a translation of the
`
`document into English and an affidavit attesting to the accuracy of the translation
`
`must be filed with the document.” Portions of Exhibit 2011 are written in foreign
`
`- 13 -
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`IPR2018-00608
`Patent 9,161,926 B2
`language, and Patent Owner has not provided either a translation and/or an
`
`affidavit regarding the foreign language contained in Exhibit 2011. Because Patent
`
`Owner failed to provide a translated copy, Patent Owner has also failed to provide
`
`a complete and relevant copy of the original document pursuant to the FRE 1002.
`
`Exhibit 2025 is irrelevant.
`
`E.
`Petitioners object to the use of Exhibit 2025 under FRE 401. Pursuant to 37
`
`C.F.R. § 42.120 and § 42.23, Patent Owner’s opposition is required to comply with
`
`the requirements for motions. Accordingly, Patent Owner’s Response was required
`
`to address the relevance of submitted evidence by “including a detailed explanation
`
`of the significance of the evidence.” 37 C.F.R. § 42.22(a)(2). Yet the Patent
`
`Owner’s Response cites to Exhibit 2025 only once (see POR at 49), yet the citation
`
`to Exhibit 2025 is nonsensical. Because Patent Owner failed to provide a relevant
`
`citation to Exhibit 2025, and the parallel citation to Exhibit 2022 at paragraphs
`
`168-170 also fails to explain the relevance of Exhibit 2025, Patent Owner has
`
`failed to properly explain the significance of Exhibit 2025.
`
`F. Any paragraphs in Exhibits 2003 and/or 2022 that rely on the
`exhibits identified above should be excluded.
`
`Any paragraph of Exhibit 2003 and/or any paragraph of Exhibit 2022 that
`
`relies on any of the exhibits identified above is objected to for the same reason as
`
`Petitioners’ objection to the underlying exhibit.
`
`
`
`
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`- 14 -
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`IPR2018-00608
`Patent 9,161,926 B2
`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`Date: December 6, 2018
`1100 New York Avenue, N.W.
`Washington, DC 20005-3934
`(202) 371-2600
`
`
`
`Dennies Varughese, Pharm.D.
`Registration No. 61,868
`Attorney for Petitioners
`
`
`
`- 15 -
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`
`
`CERTIFICATE OF SERVICE (37 C.F.R. §§ 42.6(e))
`
`The undersigned hereby certifies that the above-captioned "Petitioners’
`
`Objections to Evidence as of December 6, 2018," were served in their entirety on
`
`December 6, 2018, via email on the following:
`
`James Trainor: jtrainor@fenwick.com
`Ewa Davidson: edavidson@fenwick.com
`Elizabeth Hagan: ehagan@fenwick.com
`
`
`
`
`
` Respectfully submitted,
`
`
`
`
`Date: December 6, 2018
`
`_______________________
` Dennies Varughese, Pharm.D.
`Lead Counsel for Petitioners
`1100 New York Avenue, N.W. Registration No. 61,868
`Washington, D.C.20005-3934
`
`(202) 371-2600
`
`
`
`
`
`
`
`
`
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