`
`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 IPR2019-00207
`
`Patent 9,517,219
`_____________________
`
`PETITIONERS’ OBJECTIONS TO EVIDENCE AS OF
`AUGUST 16, 2019
`
`
`
`
`IPR2019-00207
`Patent 9,517,219 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
`
`2010-2011, 2013, 2017-2018, 2021, 2024, 2026-2027, 2029, 2032, 2038-2040,
`
`2041-2052, and 2054. In addition, Petitioners object to the admissibility of
`
`paragraphs 1-19, 21-22, 57, 60-62, 65, 76-79, 83-93, 95, 98-100, 102-105, and
`
`113-114 of Exhibit 2055 and paragraphs 1-37, 87-88, 109, 173-174, and 197 of
`
`Exhibit 2057. Collectively, these exhibits (“Challenged Evidence”) were served by
`
`Patent Owner, Almirall, LLC, with its Patent Owner’s Response filed on August 9,
`
`2019. 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 declaration paragraphs should be
`excluded as irrelevant.
`
`Petitioners object to the use of Exhibits 2010-2011, 2013, 2017-2018, 2021,
`
`2024, 2026-2027, 2029, 2032, 2038-2040, and 2050-2052 under FRE 401 and 403.
`
`These exhibits are not substantively relied on, or even cited, in Patent 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.
`
`- 1 -
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`IPR2019-00207
`Patent 9,517,219 B2
`Petitioners also object to paragraphs 1-19, 21-22, 57, 60-62, 65, 76-79, 83-
`
`93, 95, 98-100, 102-105, and 113-114 of Exhibit 2055 and paragraphs 1-37, 87-88,
`
`109, 173-174, and 197 of Exhibit 2057 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
`
`paragraphs. Alternatively, if Patent Owner asserts that the aforementioned
`
`paragraphs are relevant, then Patent Owner must incorporate by reference into its
`
`Response these declaration paragraphs. Doing so, however, would add far more
`
`than the 525 words left to spare in Patent Owner’s Response, thereby violating the
`
`word count limit set forth in 37 C.F.R. § 42.24(b).
`
`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 2013, 2040, 2041, 2042, 2043, 2044, 2045, 2046, 2048, 2049, 2050,
`
`and 2054 are inadmissible for at least the following reasons:
`
`Exhibit 2013: This exhibit lacks authentication, and is inadmissible under
`
`FRE 901. Exhibit 2013 purports to be an article from Drug Therapy Topics, but
`
`there is no evidence establishing that it contains true and correct content. A table
`
`on page 7 and a figure on page 9 are not available in this exhibit and cannot be
`
`seen in the document. Accordingly, Patent Owner has not provided evidence
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`IPR2019-00207
`Patent 9,517,219 B2
`sufficient to support a finding that Exhibit 2013 “is what [Patent Owner] claims it
`
`is.” See FRE 901.
`
`Exhibit 2013 is also inadmissible under FRE 401 and 403. Exhibit 2013
`
`purports to be an article from Drug Therapy Topics, but is missing a table on page
`
`7 and a figure on page 9. There is no evidence that Exhibit 2013 is a prior-art
`
`publication that was fully available to the public. Therefore, Exhibit 2013 is
`
`inadmissible as not relevant.
`
`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
`
`FRE 1003, or a document that falls under any exception to the original-document
`
`requirement, including those of FRE 1004. Petitioners also object to Exhibit 2013
`
`to the extent it violates the Best Evidence Rule under FRE 1002, which provides
`
`that the original of a “writing, recording, or photograph” is required to prove the
`
`contents thereof.
`
`Exhibit 2040: Exhibit 2040 is inadmissible under FRE 401 and 403. Exhibit
`
`2040 purports to be an excerpt from the Physicians’ Desk Reference 66th Ed. from
`
`2012. But there is no evidence that Exhibit 2040 is a prior-art publication that was
`
`available to the public. Therefore, Exhibit 2040 is inadmissible as not relevant.
`
`Exhibit 2040 is inadmissible as hearsay under FRE 801 and 802. Patent
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`IPR2019-00207
`Patent 9,517,219 B2
`Owner relies on the “2012” date in Exhibit 2040 for the truth of the matter
`
`asserted. Patent Owner cannot rely on the “2012” date shown in Exhibit 2040
`
`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
`
`FRE 1003, or a document that falls under any exception to the original-document
`
`requirement, including those of FRE 1004.
`
`Exhibit 2041: This exhibit lacks authentication, and is inadmissible under
`
`FRE 901. Exhibit 2041 purports to be a printout or partial printout of a webpage
`
`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 2041 “is what [Patent Owner] claims it is.” See FRE 901.
`
`Exhibit 2041 is also inadmissible under FRE 401 and 403. Exhibit 2041 is a
`
`web article from Galderma US purportedly dated “December 15, 2011.” There is
`
`no evidence that Exhibit 2041 is a prior-art publication that was available to the
`
`public. Therefore, Exhibit 2041 is inadmissible as not relevant.
`
`Exhibit 2041 is inadmissible as hearsay under FRE 801 and 802. Patent
`
`Owner relies on the “December 15, 2011” date in Exhibit 2041 for the truth of the
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`IPR2019-00207
`Patent 9,517,219 B2
`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.
`
`Exhibit 2042: This exhibit lacks authentication, and is inadmissible under
`
`FRE 901. Exhibit 2042 is a document from the Center for Drug Evaluation and
`
`Research purportedly dated “June 29, 2005,” “6/30/05,” or “7/5/05.” 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 2042
`
`“is what [Patent Owner] claims it is.” See FRE 901.
`
`Exhibit 2042 is also inadmissible under FRE 401 and 403. Exhibit 2042 is a
`
`document from the Center for Drug Evaluation and Research purportedly dated
`
`“June 29, 2005,” “6/30/05,” or “7/5/05.” There is no evidence that Exhibit 2042 is
`
`a prior-art publication that was available to the public. Therefore, Exhibit 2042 is
`
`inadmissible as not relevant.
`
`Exhibit 2042 is inadmissible as hearsay under FRE 801 and 802. Patent
`
`Owner relies on the “June 29, 2005,” “6/30/05,” or “7/5/05” signature date in
`
`Exhibit 2042 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
`
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`IPR2019-00207
`Patent 9,517,219 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 2043: This exhibit lacks authentication, and is inadmissible under
`
`FRE 901. Exhibit 2043 purports to be a document from the Center for Drug
`
`Evaluation and Research purportedly sent on “6/3/05.” 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 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 document from the Center for Drug Evaluation and Research
`
`purportedly sent on “6/3/05.” There is no evidence that Exhibit 2043 is a prior-art
`
`publication that was 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 “6/3/05” signature date 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.
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`IPR2019-00207
`Patent 9,517,219 B2
`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
`
`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 is inadmissible under
`
`FRE 901. Exhibit 2044 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 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 the Prescribing Information for Azcone Gel, 5% with a “March
`
`2008” date on the document. But there is no evidence that Exhibit 2044 is a prior-
`
`art publication that was 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 “March 2008” date in Exhibit 2044 for the truth of the matter
`
`asserted. Patent Owner cannot rely on the “March 2008” date shown in Exhibit
`
`2044 because there is no evidence that the reference was a printed publication as of
`
`a particular date. No exception applies.
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`IPR2019-00207
`Patent 9,517,219 B2
`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
`
`FRE 1003, or a document that falls under any exception to the original-document
`
`requirement, including those of FRE 1004.
`
`Exhibit 2045: This exhibit lacks authentication, and is inadmissible under
`
`FRE 901. Exhibit 2045 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 2045 “is what
`
`[Patent Owner] claims it is.” See FRE 901.
`
`Exhibit 2045 is also inadmissible under FRE 401 and 403. Exhibit 2045
`
`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 2045 is a prior-art
`
`publication that was available to the public. Therefore, Exhibit 2045 is
`
`inadmissible as not relevant.
`
`Exhibit 2045 is inadmissible as hearsay under FRE 801 and 802. Patent
`
`Owner relies on the “7/7/05” signature date in Exhibit 2045 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
`
`- 8 -
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`IPR2019-00207
`Patent 9,517,219 B2
`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
`
`FRE 1003, or a document that falls under any exception to the original-document
`
`requirement, including those of FRE 1004.
`
`Exhibit 2046: This exhibit lacks authentication, and is inadmissible under
`
`FRE 901. Exhibit 2046 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 2046 “is what
`
`[Patent Owner] claims it is.” See FRE 901.
`
`Exhibit 2046 is also inadmissible under FRE 401 and 403. Exhibit 2046
`
`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 2046 is a prior-
`
`art publication that was available to the public. Therefore, Exhibit 2046 is
`
`inadmissible as not relevant.
`
`Exhibit 2046 is inadmissible as hearsay under FRE 801 and 802. Patent
`
`Owner relies on the “3/14/2008” signature date in Exhibit 2046 for the truth of the
`
`matter asserted. Patent Owner cannot rely on this date because there is no evidence
`
`- 9 -
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`IPR2019-00207
`Patent 9,517,219 B2
`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
`
`FRE 1003, or a document that falls under any exception to the original-document
`
`requirement, including those of FRE 1004.
`
`Exhibit 2048: This exhibit lacks authentication, and is inadmissible under
`
`FRE 901. Exhibit 2048 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 2048 “is what [Patent Owner] claims it is.” See FRE 901.
`
`Exhibit 2048 is also inadmissible under FRE 401 and 403. Exhibit 2048
`
`purports to be a World Health Organization document dated March 4, 2008. But
`
`there is no evidence that Exhibit 2048 is a prior-art publication that was available
`
`to the public. Therefore, Exhibit 2048 is inadmissible as not relevant.
`
`Exhibit 2048 is inadmissible as hearsay under FRE 801 and 802. Patent
`
`Owner relies on the March 4, 2008 date in Exhibit 2048 for the truth of the matter
`
`asserted. Patent Owner cannot rely on the March 4, 2008 date shown in Exhibit
`
`2048 because there is no evidence that the reference was a printed publication as of
`
`- 10 -
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`IPR2019-00207
`Patent 9,517,219 B2
`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
`
`FRE 1003, or a document that falls under any exception to the original-document
`
`requirement, including those of FRE 1004.
`
`Exhibit 2049: This exhibit lacks authentication, and is inadmissible under
`
`FRE 901. Exhibit 2049 purports to be program from the AAPS/FDA Joint
`
`Workshop on Topical Product Development, 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 2049 “is what [Patent
`
`Owner] claims it is.” See FRE 901.
`
`Exhibit 2049 is inadmissible under FRE 401 and 403. Patent Owner has not
`
`established that Exhibit 2049 is prior art that was available to a POSA or if it was
`
`publicly accessible or otherwise available to the public. Therefore, Exhibit 2049 is
`
`inadmissible as not relevant.
`
`Exhibit 2049 is inadmissible as hearsay under FRE 801 and 802. Patent
`
`Owner relies on the information in Exhibit 2049 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.
`
`- 11 -
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`IPR2019-00207
`Patent 9,517,219 B2
`Further, the handwritten language appearing on pages 8, 11, 16, 21-24, 46, and 49
`
`of Exhibit 2049 is also inadmissible as hearsay-within-hearsay under FRE 805.
`
`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
`
`FRE 1003, or a document that falls under any exception to the original-document
`
`requirement, including those of FRE 1004. The handwritten language appearing on
`
`pages 8, 11, 16, 21-24, 46, and 49 changes the substantive content of the exhibit
`
`and shows that Exhibit 2049 is not an original document under FRE1002.
`
`Exhibit 2050: This exhibit lacks authentication, and is inadmissible under
`
`FRE 901. Exhibit 2050 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 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 listing of excipients approved by the U.S. Food and Drug
`
`Administration but the document is undated. But there is no evidence that Exhibit
`
`2050 is a prior-art publication that was available to the public. Therefore, Exhibit
`
`2050 is inadmissible as not relevant.
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`IPR2019-00207
`Patent 9,517,219 B2
`Exhibit 2050 is inadmissible as hearsay under FRE 801 and 802. Patent
`
`Owner relies on the information in Exhibit 2050 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
`
`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 2054: This exhibit lacks authentication, and is inadmissible under
`
`FRE 901. Exhibit 2054 purports to be the Package Insert 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 2054 “is what [Patent Owner] claims it is.” See FRE 901.
`
`Exhibit 2054 is also inadmissible under FRE 401 and 403. Exhibit 2054
`
`purports to be the Package Insert for Azcone Gel, 5% with a “6/29/05”or “6/30/05”
`
`date on the document. But there is no evidence that Exhibit 2054 is a prior-art
`
`publication that was available to the public. Therefore, Exhibit 2054 is
`
`inadmissible as not relevant.
`
`Exhibit 2054 is inadmissible as hearsay under FRE 801 and 802. Patent
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`Patent 9,517,219 B2
`Owner relies on the “6/29/05” or “6/30/05” date in Exhibit 2054 for the truth of the
`
`matter asserted. Patent Owner cannot rely on the “6/29/05” or “6/30/05” date
`
`shown in Exhibit 2054 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
`
`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. Osborne’s
`reliance on the Warner Declaration in Exhibit 2057 are
`inadmissible hearsay and improper expert testimony.
`
`Petitioners object to the Warner Declaration in Exhibit 1017 (pp. 289-293)
`
`as inadmissible hearsay under FRE 801 and 802. The document is relied upon for
`
`the truth of the matter asserted (POR at 59-64; Ex. 2057 at ¶¶ 165, 175-181) and
`
`Petitioner has not had the opportunity to subject the declarant (Dr. Kevin Warner)
`
`to cross examination. No exception applies. In addition, Dr. Osborne, in ¶¶ 165,
`
`175-181 of Exhibit 2057, 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.
`
`Petitioners also object to Exhibit 2057 as improper expert testimony under
`
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`FRE 702 and 703. The Warner Declaration and Exhibit 2057 do not disclose the
`
`underlying facts or data, that the opinions expressed are the product of reliable
`
`principles and methods, or that either Dr. Warner or Dr. Osborne reliably applied
`
`the principles and methods to the facts of the case. Therefore, Exhibit 2057 and
`
`Exhibit 1017 (pages 289-293) are inadmissible under FRE 702. To the extent that
`
`Patent Owner intends to argue that they are not relying on any underlying facts or
`
`data in the Warner Declaration, 37 CFR § 42.65(a) states that expert testimony that
`
`does not disclose the underlying facts or data is entitled to “little or no weight.”
`
`In addition, there has been no showing that experts in the field would rely on
`
`these kinds of facts or data in forming an opinion, and therefore Exhibit 2057 and
`
`Exhibit 1017 (pages 289-293) are also inadmissible under FRE 703.
`
`D. Exhibit 2047 violates 37 C.F.R. § 42.63(b) because it contains
`untranslated foreign language.
`
`Petitioners object to Exhibit 2047 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 2047 are written in foreign
`
`language, and Patent Owner has not provided either a translation and/or an
`
`affidavit regarding the foreign language contained in Exhibit 2047. Because Patent
`
`Owner failed to provide a translated copy, Patent Owner has also failed to provide
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`IPR2019-00207
`Patent 9,517,219 B2
`a complete and relevant copy of the original document pursuant to the FRE 1002.
`
`E. Any paragraphs in Exhibits 2055 and/or 2057 that rely on the
`exhibits identified above should be excluded.
`
`Any paragraph of Exhibit 2055 and/or any paragraph of Exhibit 2057 that
`
`relies on any of the exhibits identified above is objected to for the same reason as
`
`Petitioners’ objection to the underlying exhibit.
`
`
`
`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`Date: August 16, 2019
`1100 New York Avenue, N.W.
`Washington, DC 20005-3934
`(202) 371-2600
`
`
`
`Dennies Varughese, Pharm.D.
`Registration No. 61,868
`Attorney for Petitioners
`
`
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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 August 16, 2019," were served in their entirety on
`
`August 16, 2019, via email on the following:
`
`James Trainor: jtrainor@fenwick.com
`Vanessa Park-Thompson: vpark-thompson@fenwick.com
`Elizabeth Hagan: ehagan@fenwick.com
`Jennifer Bush: jbush@fenwick.com
`
`
`
`
`
` Respectfully submitted,
`
`
`
`
`Date: August 16, 2019
`
`_______________________
` 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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