`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`AMGEN INC.,
`Petitioner,
`
`v.
`
`ALEXION PHARMACEUTICALS, INC.,
`Patent Owner.
`___________________
`
`Case IPR2019-00740
`U.S. Patent No. 9,718,880 B2
`___________________
`
`AMGEN INC.’S
`OBJECTIONS TO EVIDENCE
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`IPR2019-00740
`Patent 9,718,880 B2
`Petitioner, Amgen Inc. (“Amgen”), objects under the Federal Rules of
`
`Evidence (FRE) and 37 C.F.R. § 42.64(b)(1) to the admissibility of Exhibits 2005-
`
`2015 and 2017-2021 (the “Challenged Evidence”), filed by Patent Owner Alexion
`
`Pharmaceuticals, Inc. (“Alexion”) on June 6, 2019, with Alexion’s Preliminary
`
`Response. Amgen’s Objections are filed within ten business days of the Board’s
`
`August 30, 2019 Decision on Institution; therefore, Amgen’s Objections to
`
`Evidence are timely under 37 C.F.R. § 42.64(b)(1). Amgen files these Objections
`
`to provide notice to Alexion that Amgen may move to exclude the Challenged
`
`Evidence under 37 C.F.R. § 42.64(c).
`
`I.
`
`IDENTIFICATION OF GROUNDS FOR OBJECTIONS
`A. Exhibit 2005
`Amgen objects to Exhibit 2005 as lacking authentication under FRE 901.
`
`Alexion has failed to provide sufficient evidence indicating that Exhibit 2005 is
`
`what Alexion claims it is.
`
`Amgen also objects to Exhibit 2005 under FRE 802 as containing
`
`inadmissible hearsay. Alexion relies on Exhibit 2005 for the truth of the matter
`
`asserted in the Patent Owner Preliminary Response at, e.g., page 6.
`
`Exhibit 2006
`
`B.
`Amgen objects to Exhibit 2006 as lacking authentication under FRE 901. In
`
`particular, Amgen objects to Exhibit 2006 because Alexion has failed to provide
`
`sufficient evidence that Exhibit 2006 is what Alexion claims it is.
`
`- 1 -
`
`
`
`IPR2019-00740
`Patent 9,718,880 B2
`Amgen also objects to Exhibit 2006 under FRE 1003 because the presence
`
`of multiple date markings indicates that it is not a "duplicate" as defined by FRE
`
`1001(e) insofar as the exhibit is not "a copy . . . which accurately reproduces the
`
`original."
`
`Amgen also objects to Exhibit 2006 under FRE 802 as containing
`
`inadmissible hearsay. Alexion relies on Exhibit 2006 for the truth of the matter
`
`asserted in the Patent Owner Preliminary Response at, e.g., page 7.
`
`C. Exhibit 2007
`Exhibit 2007 is incomplete because it is only a portion of a book chapter.
`
`Therefore, Amgen objects to Exhibit 2007 under FRE 403 because it is misleading
`
`and confusing, and creates unfair prejudice to Amgen.
`
`Amgen objects to Exhibit 2007 under FRE 1002 and 1003 because, as an
`
`excerpt, it is not the original document and is not a duplicate of the original
`
`publication. Amgen also objects to Exhibit 2007 under FRE 1002 and 1003
`
`because the presence of hand-written markings indicate that it is not a copy which
`
`accurately reproduces the original.
`
`Amgen objects to Exhibit 2007 under FRE 802 as containing inadmissible
`
`hearsay. Alexion relies on Exhibit 2007 for the truth of the matter asserted in the
`
`Patent Owner Preliminary Response at, e.g., pages 8-11.
`
`- 2 -
`
`
`
`IPR2019-00740
`Patent 9,718,880 B2
`D. Exhibit 2008
`Amgen objects to Exhibit 2008 as lacking authentication under FRE 901. In
`
`particular, Amgen objects to Exhibit 2008 because Alexion has failed to provide
`
`sufficient evidence that Exhibit 2008 is what Alexion claims it is.
`
`Amgen also objects to Exhibit 2008 under FRE 802 as containing
`
`inadmissible hearsay. Alexion relies on Exhibit 2008 for the truth of the matter
`
`asserted in the Patent Owner Preliminary Response at, e.g., pages 10 and 40.
`
`Exhibit 2009
`
`E.
`Amgen objects to Exhibit 2009 as lacking authentication under FRE 901. In
`
`particular, Amgen objects to Exhibit 2009 because Alexion has failed to provide
`
`sufficient evidence that Exhibit 2009 is what Alexion claims it is.
`
`Exhibit 2009 is incomplete because it references supplemental data that is
`
`not present in the exhibit. Therefore, Amgen objects to Exhibit 2009 under FRE
`
`403 because it is misleading and confusing, and creates unfair prejudice to Amgen.
`
`Amgen also objects to Exhibit 2009 under FRE 1002 and 1003 because, as
`
`an incomplete document, it is not the original document and is not a duplicate of
`
`the original publication. Amgen also objects to Exhibit 2009 under FRE 1002 and
`
`1003 because the presence of date markings from after the purported publication
`
`date indicate that it is not a "duplicate" as defined by FRE 1001(e) insofar as the
`
`exhibit is not "a copy . . . which accurately reproduces the original."
`
`- 3 -
`
`
`
`IPR2019-00740
`Patent 9,718,880 B2
`Amgen also objects to Exhibit 2009 under FRE 802 as containing
`
`inadmissible hearsay. Alexion relies on Exhibit 2009 for the truth of the matter
`
`asserted in the Patent Owner Preliminary Response at, e.g., pages 10 and 41.
`
`Exhibit 2010
`
`F.
`Amgen objects to Exhibit 2010 as lacking authentication under FRE 901. In
`
`particular, Amgen objects to Exhibit 2010 because Alexion has failed to provide
`
`sufficient evidence that Exhibit 2010 is what Alexion claims it is.
`
`Amgen also objects to Exhibit 2010 under FRE 802 as containing
`
`inadmissible hearsay. Alexion relies on Exhibit 2010 for the truth of the matter
`
`asserted in the Patent Owner Preliminary Response at, e.g., pages 11 and 41.
`
`G. Exhibit 2011
`Amgen objects to Exhibit 2011 as lacking authentication under FRE 901. In
`
`particular, Amgen objects to Exhibit 2011 because Alexion has failed to provide
`
`sufficient evidence that Exhibit 2011 is what Alexion claims it is.
`
`Amgen also objects to Exhibit 2011 under FRE 1003 because the presence
`
`of multiple date markings indicates that it is not a "duplicate" as defined by FRE
`
`1001(e) insofar as the exhibit is not "a copy . . . which accurately reproduces the
`
`original."
`
`- 4 -
`
`
`
`IPR2019-00740
`Patent 9,718,880 B2
`Amgen also objects to Exhibit 2011 under FRE 802 as containing
`
`inadmissible hearsay. Alexion relies on Exhibit 2011 for the truth of the matter
`
`asserted in the Patent Owner Preliminary Response at, e.g., pages 11 and 40.
`
`H. Exhibit 2012
`Amgen objects to Exhibit 2012 as lacking authentication under FRE 901. In
`
`particular, Amgen objects to Exhibit 2012 because Alexion has failed to provide
`
`sufficient evidence that Exhibit 2012 is what Alexion claims it is.
`
`Amgen also objects to Exhibit 2012 under FRE 802 as containing
`
`inadmissible hearsay. Alexion relies on Exhibit 2012 for the truth of the matter
`
`asserted in the Patent Owner Preliminary Response at, e.g., pages 11 and 41.
`
`Exhibit 2013
`
`I.
`Amgen objects to Exhibit 2013 under FRE 802 as containing inadmissible
`
`hearsay. Alexion relies on Exhibit 2013 for the truth of the matter asserted in the
`
`Patent Owner Preliminary Response at, e.g., pages 11 and 40.
`
`Exhibit 2014
`
`J.
`Amgen objects to Exhibit 2014 as lacking authentication under FRE 901. In
`
`particular, Amgen objects to Exhibit 2014 because Alexion has failed to provide
`
`sufficient evidence that Exhibit 2014 is what Alexion claims it is.
`
`Amgen also objects to Exhibit 2014 under FRE 802 as containing
`
`inadmissible hearsay. Alexion relies on Exhibit 2014 for the truth of the matter
`
`asserted in the Patent Owner Preliminary Response at, e.g., page 11.
`
`- 5 -
`
`
`
`IPR2019-00740
`Patent 9,718,880 B2
`K. Exhibit 2015
`Amgen objects to Exhibit 2015 as lacking authentication under FRE 901. In
`
`particular, Amgen objects to Exhibit 2015 because Alexion has failed to provide
`
`sufficient evidence that Exhibit 2015 is what Alexion claims it is.
`
`Amgen also objects to Exhibit 2015 under FRE 802 as containing
`
`inadmissible hearsay. Alexion relies on Exhibit 2015 for the truth of the matter
`
`asserted in the Patent Owner Preliminary Response at, e.g., pages 11 and 40-41.
`
`Exhibit 2017
`
`L.
`Amgen objects to Exhibit 2017 as lacking authentication under FRE 901. In
`
`particular, Amgen objects to Exhibit 2017 because Alexion has failed to provide
`
`sufficient evidence that Exhibit 2017 is what Alexion claims it is.
`
`Amgen also objects to Exhibit 2017 under FRE 802 as containing
`
`inadmissible hearsay. Alexion relies on Exhibit 2017 for the truth of the matter
`
`asserted in the Patent Owner Preliminary Response at, e.g., pages 29 and 40.
`
`M. Exhibit 2018
`Exhibit 2018 purports to be excerpts from Alexion Pharmaceuticals, Inc.’s
`
`Form 10-K for the fiscal year ending December 31, 2018. This exhibit is an
`
`incomplete document. Therefore, Amgen objects to Exhibit 2018 under FRE 403
`
`because it is misleading and confusing, and creates unfair prejudice to Amgen.
`
`Amgen also objects to Exhibit 2018 under FRE 1002 and 1003 because as an
`
`- 6 -
`
`
`
`IPR2019-00740
`Patent 9,718,880 B2
`excerpt, it is not the original document nor is it a duplicate of the original
`
`publication.
`
`Amgen also objects to Exhibit 2018 under FRE 802 as containing
`
`inadmissible hearsay. Alexion relies upon Exhibit 2018 for the truth of the matter
`
`asserted in the Patent Owner Preliminary Response at, e.g., page 61.
`
`Amgen objects to Exhibit 2018 as lacking authentication under FRE 901. In
`
`particular, Amgen objects to Exhibit 2018 because Alexion has failed to provide
`
`sufficient evidence that Exhibit 2018 is what Alexion claims it is.
`
`N. Exhibit 2019
`Amgen objects to Exhibit 2019 as lacking authentication under FRE 901. In
`
`particular, Amgen objects to Exhibit 2019 because Alexion has failed to provide
`
`sufficient evidence that Exhibit 2019 is what Alexion claims it is.
`
`Amgen also objects to Exhibit 2019 under FRE 802 as containing
`
`inadmissible hearsay. Alexion relies on Exhibit 2019 for the truth of the matter
`
`asserted in the Patent Owner Preliminary Response at, e.g., page 62.
`
`O. Exhibit 2020
`Amgen objects to Exhibit 2020 as lacking authentication under FRE 901. In
`
`particular, Amgen objects to Exhibit 2020 because Alexion has failed to provide
`
`sufficient evidence that Exhibit 2020 is what Alexion claims it is.
`
`- 7 -
`
`
`
`IPR2019-00740
`Patent 9,718,880 B2
`Amgen also objects to Exhibit 2020 under FRE 802 as containing
`
`inadmissible hearsay. Alexion relies on Exhibit 2020 for the truth of the matter
`
`asserted in the Patent Owner Preliminary Response at, e.g., page 62.
`
`Exhibit 2021
`
`P.
`Amgen objects to Exhibit 2021 as lacking authentication under FRE 901. In
`
`particular, Amgen objects to Exhibit 2021 because Alexion has failed to provide
`
`sufficient evidence that Exhibit 2021 is what Alexion claims it is.
`
`Amgen also objects to Exhibit 2021 under FRE 802 as containing
`
`inadmissible hearsay. Alexion relies on Exhibit 2021 for the truth of the matter
`
`asserted in the Patent Owner Preliminary Response at, e.g., page 62.
`
`II. CONCLUSION
`To the extent Alexion fails to correct the defects associated with the
`
`Challenged Evidence in view of Amgen’s objections herein, Amgen may file a
`
`motion to exclude the Challenged Evidence under 37 C.F.R. § 42.64(c).
`
`Respectfully submitted,
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
`Deborah A. Sterling, Ph.D.
`Date: September 16, 2019
`1100 New York Avenue, N.W. Registration No. 62,732
`Washington, D.C. 20005-3934
`Lead Attorney for Petitioner
`(202) 371-2600
`
`- 8 -
`
`
`
`
`
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`The undersigned hereby certifies that the above-captioned “AMGEN INC.’S
`
`OBJECTIONS TO EVIDENCE” was served in its entirety on September 16, 2019,
`
`upon the following parties via email:
`
`
`Gerald J. Flattmann, Jr.
`Vanessa Y. Yen
`Evan D. Diamond
`James T. Evans
`KING & SPALDING LLP
`1185 Avenue of the Americas
`New York, NY 10036
`(212) 556-2157
`gflattmann@kslaw.com
`vyen@kslaw.com
`ediamond@kslaw.com
`jevans@kslaw.com
`
`
`Lori A. Gordon
`KING & SPALDING LLP
`1700 Pennsylvania Ave NW
`Washington, D.C. 20006
`(202) 737-0500 (reception)
`lgordon@kslaw.com
`
`
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
`
`
`Deborah A. Sterling, Ph.D.
`Date: September 16, 2019
`1100 New York Avenue, N.W. Registration No. 62,732
`Washington, D.C. 20005-3934
`Lead Attorney for Petitioner
`(202) 371-2600
`
`13756444_2.docx
`
`
`
`
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