`Petition for Inter Partes Review
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`FRESENIUS KABI USA, LLC,
`Petitioner
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`v.
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`CEPHALON, INC.,
`Patent Owner
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`Case IPR2016-00111
`Patent No. 8,895,756
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`PETITIONER’S OBJECTIONS TO EVIDENCE
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`Mail Stop: Patent Board
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`IPR2016-00111
`Petition for Inter Partes Review
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`Pursuant to 37 C.F.R. § 42.63(b)(1), Petitioner Fresenius Kabi USA, LLC
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`(“Fresenius”) asserts the following objections to evidence submitted by Patent
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`Owner Cephalon, Inc. (“Cephalon”) in its Preliminary Patent Owner Response
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`(“Prel. Resp.”). Fresenius reserves the right to file a motion to exclude the
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`evidence to which these objections are directed.
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`Fresenius objects to Exhibits 2002, 2004, and 2005 under FRE 801-802 and
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`901. These exhibits appear to be printouts from a website, Drugs.com. Cephalon
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`is proffering these exhibits for the truth of the matter asserted in support of certain
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`secondary considerations arguments (Prel. Resp. at 11), but has not shown that any
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`applicable exception to the hearsay rule applies. Cephalon has also not provided
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`any evidence demonstrating the authenticity of the website printouts.
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`Fresenius objects to Exhibits 2006-2010 and 2011-2015 under FRE 401-403.
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`Cephalon offered
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`these exhibits
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`in connection with purported secondary
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`considerations arguments. Prel. Resp. at 11. These exhibits should be excluded
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`because Cephalon has failed to establish a nexus between the claimed invention
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`and the alleged secondary consideration.
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`In particular, Cephalon has not provided any evidence or analysis showing
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`that the alleged secondary consideration is attributable to the claimed invention as
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`opposed to elements in the prior art, such as the bendamustine hydrochloride active
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`pharmaceutical ingredient. See In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed.
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`IPR2016-00111
`Petition for Inter Partes Review
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`Cir. 2011) (“Where the offered secondary consideration actually results from
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`something other than what is both claimed and novel in the claim, there is no nexus
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`to the merits of the claimed invention.”). Cephalon’s failure to establish such a
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`nexus renders its alleged secondary consideration evidence inadmissible. See, e.g.,
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`Merck & Co. v. Teva Pharms. USA, Inc., 395 F.3d 1364, 1376-77 (Fed. Cir. 2005);
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`Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1312 (Fed. Cir. 2006) (absent
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`nexus, “[e]vidence of commercial success, or other secondary considerations” is
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`“irrelevant”).
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`IPR2016-00111
`Petition for Inter Partes Review
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`Respectfully submitted,
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`WILEY REIN LLP
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`By:
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`/Lawrence Sung, #38,330/
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`Lawrence Sung, Reg. No. 38,330
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`IPR2016-00111
`Petition for Inter Partes Review
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`CERTIFICATE OF SERVICE ON PATENT OWNER
`UNDER 37 C.F.R. § 42.105(A)
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`The undersigned hereby certifies that a copy of the foregoing document was
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`served via electronic mail on May 18, 2016 to the following counsel of record for
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`the Petitioner:
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`Soumitra Deka
`Aaron Stiefel
`KAYE SCHOLER LLP
`Soumitra.deka@kayescholer.com
`Aaron.stiefel@kayescholer.com
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`/Lawrence Sung, #38,330/
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` Lawrence Sung, Reg. No. 38,330
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