`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`STEADYMED LTD.
`
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION
`
`Patent Owner.
`
`
`
`Case IPR 2016-00006
`
`Patent No. 8,497,393B2
`
`____________
`
`PETITIONER’S OBJECTIONS TO NON-SEALED EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
`
`
`
`
`Mail Stop "Patent Board"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`WEST\269146970.3
`
`
`
`
`
`
`
`
`
`Petitioner SteadyMed Ltd. (“Petitioner”) hereby files its objections to the
`
`non-sealed evidence1 submitted with Patent Owner United Therapeutics’
`
`Preliminary Response to Petition for Inter Partes Review, Paper 8, in Case No.
`
`IPR2016-00006 (the “Response”). Petitioner’s objections to the below identified
`
`evidence include the following:
`
`Evidence
`
`Objection(s)
`
`Ex. 2002 (Remodulin Label)
`
`This exhibit is objected to as irrelevant to the
`
`grounds upon which trial has been instituted
`
`(FRE 401-402), and as unduly prejudicial (FRE
`
`403). Ex. 2002 was not substantively relied
`
`upon in the Response. Ex. 2002 is cited only for
`
`the statement that “Remodulin® was the second
`
`drug to receive FDA approval for the treatment
`
`of PAH” (p. 1), which is not relevant to any
`
`issue in this proceeding.
`
`
`1 Petitioner will submit its objections to Patent Owner’s sealed evidence (Exs.
`2003, 2004, 2005, and 2006) on or before April 29, 2016. See (Paper 16).
`2
`
`
`
`
`
`Ex. 2009 (U.S. Patent No.
`
`This exhibit is objected to as irrelevant to the
`
`8,748,657; the ’657 patent)
`
`grounds upon which trial has been instituted
`
`(FRE 401-402), and as unduly prejudicial (FRE
`
`403). Ex. 2009 concerns a continuation
`
`application of the ‘393 Patent, which is not
`
`relevant to any issue in this proceeding.
`
`Ex. 2010 (The ’657 patent
`
`This exhibit is objected to as irrelevant to the
`
`prosecution history)
`
`grounds upon which trial has been instituted
`
`(FRE 401-402), and as unduly prejudicial (FRE
`
`403). Ex. 2010 concerns statements from the
`
`prosecution history of a continuation application
`
`of the ‘393 Patent, which is not relevant to any
`
`issue in this proceeding.
`
`
`
`3
`
`
`
`Ex. 2013 (Trial testimony of Dr.
`
`This exhibit is objected to as irrelevant to the
`
`Williams and Dr. Aristoff)
`
`grounds upon which trial has been instituted
`
`(FRE 401-402), and as unduly prejudicial (FRE
`
`403). Ex. 2013 was not substantively relied
`
`upon in Patent Owner’s Response. Petitioner
`
`further objects to Ex. 2013 to the extent such
`
`testimony offers improper expert opinions in
`
`violation of 37 C.F.R. § 42.65(a) and/or FRE
`
`702. Dr. Williams and Dr. Aristoff have not
`
`been designated as experts in this proceeding, in
`
`the form of an expert declaration or otherwise,
`
`and thus, are shielded from cross-examination.
`
`Their testimony from a prior litigation –
`
`involving a patent not at issue in this proceeding
`
`– is accordingly improper. Petitioner further
`
`objects to Ex. 2013 as constituting hearsay for
`
`which no exception has been established (FRE
`
`801/802).
`
`4
`
`
`
`
`
`Ex. 2015 (U.S. Patent No.
`
`This exhibit is objected to as irrelevant to the
`
`4,668,814; the ’814 patent)
`
`grounds upon which trial has been instituted
`
`(FRE 401-402), and as unduly prejudicial (FRE
`
`403).
`
`Ex. 2016 (UTC Form 10K 2014
`
`This exhibit is objected to as irrelevant to the
`
`Annual Report)
`
`grounds upon which trial has been instituted
`
`(FRE 401-402), and as unduly prejudicial (FRE
`
`403). Ex. 2016 was not substantively relied
`
`upon in the Response. Patent Owner cites Ex.
`
`2016 only to discuss revenues for its
`
`Remodulin® product (p. 56), which is not
`
`relevant to any issue in this proceeding.
`
`
`
`Petitioner reserves the right to further object to this and other evidence based
`
`on Patent Owner’s subsequent use of and arguments based on such evidence.
`
`
`
`
`
`
`
`Date: April 22, 2016
`
`
`/s Stuart E. Pollack /
`Stuart E. Pollack, J.D. Ph.D.
`Reg. No. 43,862
`DLA Piper LLP (US)
`
`
`
`Respectfully submitted,
`
`/s Lisa A. Haile / __________
`Lisa A. Haile, J.D., Ph.D.
` Reg. No. 38,347
`DLA Piper LLP (US)
`
`5
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the attached Petitioner’s Objections
`
`to Non-Sealed Evidence was served via electronic mail to the following:
`
`Stephen B. Maebius
`George Quillin
`FOLEY & LARDNER LLP
`UT393-IPR@foley.com
`
`Shaun R. Snader
`UNITED THERAPEUTICS CORP.
`ssnader@unither.com
`
`Douglas Carsten
`Richard Torczon
`Robert Delafield
`WILSON, SONSINI, GOODRICH & ROSATI
`dcarsten@wsgr.com
`rtorczon@wsgr.com
`bdelafield@wsgr.com
`
`
`
`Respectfully submitted,
`
`
`/s Lisa A. Haile /
`Lisa A. Haile, J.D., Ph.D.
`Reg. No. 38,347
`DLA Piper LLP (US)
`
`
`
`Date: April 22, 2016
`
`
`/s Stuart E. Pollack /
`Stuart E. Pollack, J.D., Ph.D.
`Reg. No. 43,862
`DLA Piper LLP (US)
`
`
`
`
`6
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