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`IPR2017-01648
`U.S. Patent No. 6,866,866
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________
`Aurobindo Pharma USA Inc.
`Petitioners,
`v.
`Andrx Labs, LLC
`Patent Owner
`____________________________________________
`Case IPR2017-01648
`U.S. Patent No. 6,866,866
`____________________________________________
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`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
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`IPR2017-01648
`U.S. Patent No. 6,866,866
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`Pursuant to 37 C.F.R. § 42.64, Patent Owner Andrx Labs (“Andrx”) presents
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`the following objections to evidence served with the Corrected Petition of
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`Aurobindo (“Aurobindo” or “Petitioner”), Paper No. 8.
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`I.
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`Exhibits 1004, 1005, 1008, 1009, 1011-1018
`Patent Owner objects to Exhibits 1004-1005, 1008-1009, and 1011-1018,
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`which are not cited in the Petition, or in any paragraph of the Akhlaghi Declaration
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`that is cited to by the Petition, and are impermissibly incorporated by reference.
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`See Fed. R. Evid. 401, 402, 403; 37 C.F.R. § 42.6(a)(3).
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`II. Exhibit 1006
`Patent Owner objects to Exhibit 1006, Sciele Pharma Inc. v. Lupin Ltd., No.
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`2012-1228 (Fed. Cir. July 2, 2012) (slip op.). Specifically, Patent Owner objects to
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`the relevance and probative value of Exhibit 1006, in light of the potential for
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`undue prejudice and confusion of the issues. See Fed. R. Evid. 401, 402, 403.
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`III. Exhibit 1007
`Patent Owner objects to Exhibit 1007, WO 00/12097 (“Chen et al.”).
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`Specifically, Patent Owner objects to the relevance and probative value of Exhibit
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`1007, in light of the potential for undue prejudice and confusion of the issues. See
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`Fed. R. Evid. 401, 402, 403, 901. As the Board determined in its Institution
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`Decision, Paper No. 12 at 10, the Petition did not demonstrate that Exhibit 1007
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`qualifies as prior art to the ’866 patent, and accordingly this Exhibit forms no part
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`IPR2017-01648
`U.S. Patent No. 6,866,866
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`of the ground on which inter partes review was instituted.
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`IV. Exhibit 1019
`Patent Owner objects to Exhibit 1019, Declaration of Dr. Fatemeh Akhlaghi.
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`Patent Owner objects to ¶¶ 12-25, 27-30, 32-90, 97, 99-131, 133-134, 136-
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`143, 145-147, 150-154, 156-166, 168-169, 171-172, 174-175, 178-182, 184-191,
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`193-194, and 196-204. These paragraphs are not directly cited in the Petition and
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`the relevance of these paragraphs is not apparent. Patent Owner objects to the
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`blanket citation in the Petition to paragraphs 197-204 as comprising an
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`impermissible incorporation by reference of a declaration. See
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`37 C.F.R. § 42.6(a)(3). Patent Owner further objects to the citation in the Petition
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`to purported Appendix XIII of Exhibit 1019 (Paper No. 8 at 13). First, Exhibit
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`1019 does not include an Appendix XIII. Even presuming the Petition attempted
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`to cite to Appendix XII of Exhibit 1019, this citation does not describe the
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`relevance of that Appendix with sufficient specificity.
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`Patent Owner objects to ¶¶ 15, 17, 19, 23-24, 26, 31, 61, 66, 71, 73, 74, 127,
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`144, 156, 158, 160, 162-165, 174, 182, 184, 191, 203, heading IX(A)(1), IX(A)(2),
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`heading IX(A)(3), heading IX(B)(1), the heading labeled “C.” (appearing after
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`heading IX(B)(1)), heading IX(C), and heading X as testimony on a topic
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`(including legal conclusions and interpretations) on which the declarant is not
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`IPR2017-01648
`U.S. Patent No. 6,866,866
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`qualified to opine. See Fed. R. Evid. 702, 703.
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`Patent Owner objects to ¶¶ 10, 15, 26, 31, 36-51, 54-65, 125-135, 137-139,
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`142-144, 145, 147, 168-173, 175, 177-179, 185, 190, heading IX(A)(1) and
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`heading IX(B)(1), which contain citations to Exhibits that are not cited in the
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`Petition, and/or that form no part of the ground on which inter partes review was
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`instituted, as irrelevant. See Fed. R. Evid. 402. All of the portions of the Akhlaghi
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`Declaration objected to in this paragraph are impermissibly incorporated by
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`reference and therefore objectionable. See Fed. R. Evid. 402;
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`37 C.F.R. § 42.6(a)(3).
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`Respectfully Submitted,
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`Date: January 16, 2018
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`/David L. Cavanaugh/
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`David L. Cavanaugh
`Registration No. 36,476
`1875 Pennsylvania Avenue NW
`Washington, DC 20006
`(202) 663-6025
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`IPR2017-01648
`U.S. Patent No. 6,866,866
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`CERTIFICATE OF SERVICE
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`I hereby certify that, on January 16, 2018, I caused a true and correct copy of the
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`foregoing materials:
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`•
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`Patent Owner’s Objections to Evidence
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`to be served via electronic mail on the following attorney of record for Petitioner:
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`Steven J. Moore, Esq.
`Withers Bergman LLP
`Suite 400
`1700 East Putnam Avenue
`Greenwich, CT 06870
`steven.moore@withersworldwide.com
`John Winterle
`Withers Bergman LLP
`Suite 400
`1700 East Putnam Avenue
`Old Greenwich, CT 06870
`john.winterle@withersworldwide.com
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`Hans Peter Hoffmann
`Withers Bergman
`Suite 400
`1700 East Putnam Avenue
`Old Greenwich, CT 06870
`peter.hoffmann@withersworldwide.com
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`Alan Gardner
`Withers Bergman
`Suite 400
`1700 East Putnam Avenue
`Old Greenwich, CT 06870
`alan.gardner@withersworldwide.com
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`IPG-AUR@withersworldwide.com
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`IPR2017-01648
`U.S. Patent No. 6,866,866
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`__/Jonathan Ben-Ur Roses/__
`Jonathan B. Roses
`Reg. No. 61,115
`Wilmer Cutler Pickering Hale and Dorr LLP
`60 State Street
`Boston, MA 02109
`617-526-6048
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