IPR2017-01995
`Patent No. 9,220,698
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`
`v.
`
`
`POZEN INC. and HORIZON PHARMA USA, INC.,
`Patent Owners.
`
`___________
`
`
`Case IPR2017-01995
`Patent 9,220,698
`
`___________
`
`
`PATENT OWNERS POZEN INC. AND HORIZON PHARMA USA, INC.’S
`OBJECTIONS TO PETITIONER’S EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(b)(1)
`
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`Patent No. 9,220,698
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`
`v.
`
`
`POZEN INC. and HORIZON PHARMA USA, INC.,
`Patent Owners.
`
`___________
`
`
`Case IPR2017-01995
`Patent 9,220,698
`
`___________
`
`
`PATENT OWNERS POZEN INC. AND HORIZON PHARMA USA, INC.’S
`OBJECTIONS TO PETITIONER’S EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(b)(1)
`
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`I.
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`IPR2017-01995
`Patent No. 9,220,698
`
`INTRODUCTION
`Pursuant to 37 C.F.R. § 42.64(b)(1) and the Federal Rules of Evidence
`
`(“FRE”), Patent Owners Horizon Pharma USA, Inc. (“Horizon”) and Pozen Inc.
`
`(“Pozen”) (collectively, “Patent Owner”) submit the following objections to
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`evidence filed by Mylan Pharmaceuticals, Inc. (“Mylan” or “Petitioner”) with
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`Mylan’s Petition for Inter Partes Review of U.S. Patent No. 9,220,698 (the
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`“Petition”). These objections are timely filed within ten business days of the
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`institution of the trial, March 8, 2018. (Paper 18.)
`
`II.
`
`IDENTIFICATION OF CHALLENGED EXHIBITS AND GROUNDS
`FOR OBJECTIONS
`A. Exhibit 1006
`Exhibit 1006 is purportedly an article authored by Howden and published in
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`the journal Alimentary Pharmacology & Therapeutics in 2005. Patent Owner
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`objects to Exhibit 1006 as not properly authenticated under FRE 901. Petitioner has
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`produced insufficient evidence to support a finding that this exhibit is what Petitioner
`
`claims it is. Patent Owner further objects to this exhibit as inadmissible hearsay
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`under FRE 802 and as not supporting Petitioner’s characterization of the truth of the
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`matter asserted. (See, e.g., Pet. at 28-29; Ex. 1002 at 24 (citing Ex. 1006); Ex. 1003
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`at 56 (citing Ex. 1006).)
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`1
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`B.
`Exhibit 1008
`Exhibit
`1008
`is
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`IPR2017-01995
`Patent No. 9,220,698
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`a webpage
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`printout
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`purportedly
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`from
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`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=
`
`overview.process&ApplNo=020067. Patent Owner objects to Exhibit 1008 as not
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`properly authenticated under FRE 901. Petitioner has produced insufficient
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`evidence to support a finding that this exhibit is what Petitioner claims it is. Patent
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`Owner further objects to this exhibit as inadmissible hearsay under FRE 802 and as
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`not supporting Petitioner’s characterization of the truth of the matter asserted. (See,
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`e.g., Pet. at 48-49; Ex. 1002 at 25 (citing Ex. 1008).)
`
`C. Exhibit 1009
`Exhibit 1009 is purportedly an EC-Naprosyn® (delayed-release naproxen)
`
`package insert published in 2007. Patent Owner objects to Exhibit 1009 as not
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`properly authenticated under FRE 901. Petitioner has produced insufficient
`
`evidence to support a finding that this exhibit is what Petitioner claims it is.
`
`Petitioner has not submitted sufficient evidence that this exhibit originated from a
`
`package of EC-Naprosyn® sold in 2007. Patent Owner further objects to this exhibit
`
`as inadmissible hearsay under FRE 802 and as not supporting Petitioner’s
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`characterization of the truth of the matter asserted. (See, e.g., Pet. at 29-31; Ex. 1002
`
`at 25-26 (citing Ex. 1009); Ex. 1003 at 52-53 (citing Ex. 1009).)
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`D. Exhibit 1010
`Exhibit 1010 is purportedly a Zegerid® (omeprazole) label published in 2004.
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`IPR2017-01995
`Patent No. 9,220,698
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`Patent Owner objects to Exhibit 1010 as not properly authenticated under FRE 901.
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`Petitioner has produced insufficient evidence to support a finding that this exhibit is
`
`what Petitioner claims it is. Petitioner has not submitted sufficient evidence that this
`
`exhibit originated from a package of Zegerid® sold in 2004. Patent Owner further
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`objects to this exhibit as inadmissible hearsay under FRE 802 and as not supporting
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`Petitioner’s characterization of the truth of the matter asserted. (See, e.g., Pet. at 29-
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`31; Ex. 1002 at 26-27 (citing Ex. 1010); Ex. 1003 at 557-58 (citing Ex. 1010).)
`
`E.
`Exhibit 1011
`Exhibit 1011 is purportedly an article authored by Goldstein and published in
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`the journal Gastroenterology in 2004. Patent Owner objects to Exhibit 1011 as not
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`properly authenticated under FRE 901. Petitioner has produced insufficient
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`evidence to support a finding that this exhibit is what Petitioner claims it is. Patent
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`Owner further objects to this exhibit as inadmissible hearsay under FRE 802 and as
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`not supporting Petitioner’s characterization of the truth of the matter asserted. (See,
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`e.g., Pet. at 26-27; Ex. 1002 at 27-28 (citing Ex. 1011); Ex. 1003 at 70 (citing Ex.
`
`1011).)
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`3
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`F.
`Exhibit 1012
`Exhibit 1012 is purportedly a publication by Hochberg published in 2008.
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`IPR2017-01995
`Patent No. 9,220,698
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`Patent Owner objects to Exhibit 1012 as not properly authenticated under FRE 901.
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`Petitioner has produced insufficient evidence to support a finding that this exhibit is
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`what Petitioner claims it is. Patent Owner further objects to this exhibit as
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`inadmissible hearsay under FRE 802 and as not supporting Petitioner’s
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`characterization of the truth of the matter asserted. (See, e.g., Pet. at 25-26; Ex. 1002
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`at 28 (citing Ex. 1012); Ex. 1003 at 48 (citing Ex. 1012).)
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`G. Exhibit 1014
`Exhibit 1014 is purportedly an article authored by Wolfe and published in the
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`journal Gastroenterology in 2000. Patent Owner objects to Exhibit 1014 as not
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`properly authenticated under FRE 901. Petitioner has produced insufficient
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`evidence to support a finding that this exhibit is what Petitioner claims it is. Patent
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`Owner further objects to this exhibit as inadmissible hearsay under FRE 802 and as
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`not supporting Petitioner’s characterization of the truth of the matter asserted. (See,
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`e.g., Pet. at 61; Ex. 1002 at 39 (citing Ex. 1014); Ex. 1003 at 97 (citing Ex. 1014).)
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`H. Exhibit 1015
`Exhibit 1015 is purportedly an article authored by Bell and published in the
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`journal Digestion in 1992. Patent Owner objects to this exhibit as inadmissible
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`hearsay under FRE 802 and as not supporting Petitioner’s characterization of the
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`truth of the matter asserted. (See, e.g., Pet. at 61; Ex. 1002 at 39 (citing Ex. 1015);
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`IPR2017-01995
`Patent No. 9,220,698
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`Ex. 1003 at 87, 91, 97 (citing Ex. 1014).)
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`I.
`Exhibit 1016
`Exhibit 1016 is purportedly an article authored by Hassan-Alin and published
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`in the journal Clinical Drug Investigation in 2006. Patent Owner objects to Exhibit
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`1016 as not properly authenticated under FRE 901. Petitioner has produced
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`insufficient evidence to support a finding that this exhibit is what Petitioner claims
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`it is. Patent Owner further objects to this exhibit as inadmissible hearsay under FRE
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`802 and as not supporting Petitioner’s characterization of the truth of the matter
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`asserted. (See, e.g., Pet. at 27-28; Ex. 1003 at 50-52 (citing Ex. 1016).)
`
`J.
`Exhibit 1017
`Exhibit 1017 is purportedly an article authored by Khosravan and published
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`in the Journal of Clinical Pharmacology in 2006. Patent Owner objects to Exhibit
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`1017 as not properly authenticated under FRE 901. Petitioner has produced
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`insufficient evidence to support a finding that this exhibit is what Petitioner claims
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`it is. Patent Owner further objects to this exhibit as inadmissible hearsay under FRE
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`802 and as not supporting Petitioner’s characterization of the truth of the matter
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`asserted. (See, e.g., Pet. at 32; Ex. 1003 at 53-54 (citing Ex. 1017).)
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`K. Exhibit 1018
`Exhibit 1018 is purportedly an article authored by Jung and published in the
`5
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`journal Clinical Therapeutics in 1994. Patent Owner objects to this exhibit as
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`IPR2017-01995
`Patent No. 9,220,698
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`inadmissible hearsay under FRE 802 and as not supporting Petitioner’s
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`characterization of the truth of the matter asserted. (See, e.g., Pet. at 33; Ex. 1003 at
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`54-55 (citing Ex. 1018).)
`
`L.
`Exhibit 1019
`Exhibit 1019 is purportedly an article authored by Davies and published in the
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`journal Clinical Pharmacokinetics in 1997. Patent Owner objects to this exhibit as
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`inadmissible hearsay under FRE 802 and as not supporting Petitioner’s
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`characterization of the truth of the matter asserted. (See, e.g., Pet. at 33-34; Ex. 1003
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`at 55 (citing Ex. 1019).)
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`M. Exhibit 1020
`Exhibit 1020 is purportedly a Naprosyn label published in 2017. Patent
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`Owner objects to Exhibit 1020 as not properly authenticated under FRE 901.
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`Petitioner has produced insufficient evidence to support a finding that this exhibit is
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`what Petitioner claims it is. For example, Petitioner has not submitted sufficient
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`evidence that this exhibit originated from a package of Naprosyn sold in 2017.
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`Patent Owner further objects to this exhibit as inadmissible hearsay under FRE 802
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`and as not supporting Petitioner’s characterization of the truth of the matter asserted.
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`(See, e.g., Pet. at 8; Ex. 1002 at 12 (citing Ex. 1020).)
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`6
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`N. Exhibit 1021
`Exhibit 1021 is purportedly an excerpt from a book authored by Roden and
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`IPR2017-01995
`Patent No. 9,220,698
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`published in 2005. Patent Owner objects to Exhibit 1021 as not properly
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`authenticated under FRE 901. Petitioner has produced insufficient evidence to
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`support a finding that this exhibit is what Petitioner claims it is. Patent Owner further
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`objects to this exhibit as inadmissible hearsay under FRE 802 and as not supporting
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`Petitioner’s characterization of the truth of the matter asserted. (See, e.g., Ex. 1003
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`at 12-13 (citing Ex. 1021).)
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`O. Exhibit 1022
`Exhibit 1022 is purportedly an excerpt from a book authored by Rowland and
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`Tozer and published in 1995. Patent Owner objects to this exhibit as inadmissible
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`hearsay under FRE 802 and as not supporting Petitioner’s characterization of the
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`truth of the matter asserted. (See, e.g., Ex. 1003 at 13-14, 20 (citing Ex. 1022).)
`
`P.
`Exhibit 1023
`Exhibit 1023 is purportedly an article authored by Clissold and published in
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`the journal Drugs in 1986. Patent Owner objects to this exhibit as inadmissible
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`hearsay under FRE 802 and as not supporting Petitioner’s characterization of the
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`truth of the matter asserted. (See, e.g., Ex. 1003 at 49 (citing Ex. 1023).)
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`Q. Exhibit 1026
`Exhibit 1026 is purportedly an excerpt from a book authored by Mayersohn
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`IPR2017-01995
`Patent No. 9,220,698
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`and published in 1996. Patent Owner objects to this exhibit as inadmissible hearsay
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`under FRE 802 and as not supporting Petitioner’s characterization of the truth of the
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`matter asserted. (See, e.g., Ex. 1003 at 64 (citing Ex. 1026).)
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`R. Exhibit 1027
`Exhibit 1027 is purportedly an article authored by Howden and published in
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`the journal Clinical Pharmacokinetics in 1991. Patent Owner objects to this
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`exhibit as inadmissible hearsay under FRE 802 and as not supporting Petitioner’s
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`characterization of the truth of the matter asserted. (See, e.g., Ex. 1003 at 73, 92
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`(citing Ex. 1042).)
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`S.
`Exhibit 1028
`Exhibit 1028 is purportedly an article authored by Lind and published in the
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`Alimentary Pharmacology & Therapeutics in 2000. Patent Owner objects to Exhibit
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`1028 as not properly authenticated under FRE 901. Petitioner has produced
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`insufficient evidence to support a finding that this exhibit is what Petitioner claims
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`it is. Patent Owner further objects to this exhibit as inadmissible hearsay under FRE
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`802 and as not supporting Petitioner’s characterization of the truth of the matter
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`asserted. (See, e.g., Pet. at 57, Ex. 1003 at 86-87 (citing Ex. 1028).)
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`T.
`Exhibit 1029
`Exhibit 1029 is purportedly an article authored by Regårdh and published in
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`IPR2017-01995
`Patent No. 9,220,698
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`the Scandinavian Journal of Gastroenterology in 1985. Patent Owner objects to this
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`exhibit as inadmissible hearsay under FRE 802 and as not supporting Petitioner’s
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`characterization of the truth of the matter asserted. (See, e.g., Ex. 1003 at 86-87
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`(citing Ex. 1029).)
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`U. Exhibit 1030
`Exhibit 1030 is purportedly a Vimovo label published in 2014. Patent Owner
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`objects to Exhibit 1030 as not properly authenticated under FRE 901. Petitioner has
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`produced insufficient evidence to support a finding that this exhibit is what Petitioner
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`claims it is. For example, Petitioner has not submitted sufficient evidence that this
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`exhibit originated from a package of Vimovo sold in 2014. Patent Owner further
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`objects to this exhibit as inadmissible hearsay under FRE 802 and as not supporting
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`Petitioner’s characterization of the truth of the matter asserted. (See, e.g., Pet. at 35,
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`52.)
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`V. Exhibit 1042
`Exhibit 1042 is purportedly an article authored by Goldlust and published in
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`the American Journal of Gastroenterology in 2004. Patent Owner objects to Exhibit
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`1042 as not properly authenticated under FRE 901. Petitioner has produced
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`insufficient evidence to support a finding that this exhibit is what Petitioner claims
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`it is. Patent Owner further objects to this exhibit as inadmissible hearsay under FRE
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`IPR2017-01995
`Patent No. 9,220,698
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`802 and as not supporting Petitioner’s characterization of the truth of the matter
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`asserted. (See, e.g., Ex. 1003 at 87 (citing Ex. 1042).)
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`III. CONCLUSION
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`To the extent Mylan fails to correct the defects associated with the Challenged
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`Exhibits in view of Patent Owner’s objections herein, Patent Owner may file a
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`motion to exclude the Challenged Exhibits under 37 C.F.R. § 42.64(c).
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`Date: March 22, 2018
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`Respectfully submitted,
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`/Thomas A. Blinka/
`Thomas A. Blinka, Ph.D.
`Reg. No. 44,541
`Counsel for Patent Owner
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`IPR2017-01995
`Patent No. 9,220,698
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`CERTIFICATION OF SERVICE UNDER 37 C.F.R. § 42.6(e)
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`I, Thomas A. Blinka, hereby certify that on this 22nd day of March 2018, the
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`
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`foregoing Patent Owners Pozen Inc. and Horizon Pharma USA, Inc.’s Objections
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`to Petitioner’s Evidence Pursuant to 37 CFR § 42.64(b)(1) was served
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`electronically via email on the following:
`
`Brandon M. White
`bmwhite@perkinscoie.com
`700 13th St., NW Suite 600
`Washington, DC 20005
`
`Emily Greb
`egreb@perkinscoie.com
`One East Main St., Suite 201
`Madison, WI 53703
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`EsoNaproxen@perkinscoie.com
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`Date: March 22, 2018
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`
`BY:
`
`
`/Thomas A. Blinka/
`Thomas A. Blinka, Ph.D.
`Reg. No. 44,541
`Counsel for Patent Owner
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