UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`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 MOTION FOR SUPPLEMENTAL INFORMATION
`UNDER 37 C.F.R. § 42.123
`
`
`
`
`Mail Stop "Patent Board"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`1
`
`
`
`____________
`
`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 MOTION FOR SUPPLEMENTAL INFORMATION
`UNDER 37 C.F.R. § 42.123
`
`
`
`
`Mail Stop "Patent Board"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`1
`
`
`
`Petitioner SteadyMed Ltd. (“Petitioner”) hereby moves for leave to submit
`
`supplemental information pursuant to 37 C.F.R. § 42.123. On a conference call
`
`between the parties dated May 10, 2016, the PTAB panel provided authorization
`
`for Petitioner to file this motion. Furthermore, it is noted that Patent Owner’s
`
`representative, Steve Maebius, who was on the conference call, indicated that he
`
`did not oppose the filing of this motion. The present motion seeks to submit
`
`Exhibit 1019 and Exhibit 1020 which are supplemental declarations attesting to the
`
`accuracy of the English translation of Japanese Patent Application No. 56-
`
`122328A, “Crystalline Amine Salt of Methanoprostacyclin Derivative,
`
`Manufacturing Method Thereof, and Purifying Method Thereof,” referred to as
`
`“Kawakami.”
`
`I.
`
`The Present Motion Complies with the Rules
`
`The present motion complies with the requirements of 37 C.F.R. § 42.123.
`
`First, the Board instituted the above-identified inter partes review in a Decision
`
`dated April 8, 2016. (Paper 12). Petitioner timely made a request for the
`
`authorization to file a motion to submit supplemental information within one
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`month of the date trial was instituted, on Friday, May 6, 2016, pursuant to 37
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`C.F.R. § 42.123(a)(1). Second, the Decision in the present inter partes review
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`relies on Kawakami as a key reference for invalidating at least one claim. As such,
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`Kawakami is relevant to a claim for which the trial has been instituted, pursuant to
`
`
`
`2
`
`
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`37 C.F.R. § 42.123(a)(2).
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`II. The Requested Supplemental Information
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`As mentioned above, the present inter partes review refers to and relies on
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`Kawakami for invalidating at least one claim. Exhibit 1006 refers to the original,
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`Japanese language version of Kawakami, and Exhibit 1007 refers to the certified
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`English translation of Kawakami. With its petition, Petitioner submitted Exhibit
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`1011, a declaration attesting to the accuracy of the English translation of
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`Kawakami, from Mr. Boris Levine, president, owner, and chief Japanese translator
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`at Technical Language Services, Inc. Mr. Levine, who is fluent in Japanese and
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`English, oversaw and personally checked the English translation of Kawakami that
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`one of his employees, Mr. James Dowdle, created. Patent Owner, however,
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`objected to Mr. Levine’s declaration (Exhibit 1007) because “there is no evidence
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`that the translator Boris Levine has personal knowledge of the translation of
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`Kawakami in Exhibit 1007 or even that he knows how to translate any document
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`from Japanese to English.” (Paper 20, Patent Owner’s Objections to Petitioner’s
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`Evidence).
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`Petitioner seeks to submit two declarations: (1) Exhibit 1019 is a
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`supplemental declaration from Mr. Levine, who served as check translator of
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`Kawakami; and (2) Exhibit 1020 is a declaration from Mr. Dowdle, who
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`performed the English translation of Kawakami. Both declarations certify that Mr.
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`
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`3
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`
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`Levine and Mr. Dowdle are fluent in both Japanese and English, the English
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`translation is true and correct, and satisfies all of the formalities of 37 C.F.R. §
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`1.68. Petitioner submits that the English translation of Kawakami as provided in
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`the originally filed Exhibit 1007 has not been changed, and notes, similar to the
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`Board, that Patent Owner has not presently identified any error with the translation
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`that would call into question its authenticity.
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`As additional grounds for granting this motion, Petitioner directs the Board
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`to Taiwan Semiconductor v. DSS Technology Management, Inc., IPR No. 2014-
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`01030 (Paper 11, p. 3), where the Board, on nearly identical facts, granted a similar
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`motion, and held that the supplemental information Petitioner sought "to submit
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`does not change the grounds of unpatentability authorized in this proceeding, nor
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`does it change the evidence initially presented in the Petition to support those
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`grounds of patentability. Instead, such information merely constitutes additional
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`evidence that allegedly confirms the accuracy of the English translation …."
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`Accordingly, and for the reasons set forth above, Petitioner asks that the
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`Board accept this motion.
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`
`
`
`
`Date: May 11, 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)
`
`4
`
`
`
`
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`The undersigned certifies
`
`the attached Motion for
`
`CERTIFICATE OF SERVICE
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`that a copy of
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`Supplemental Information 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
`
`
`
`
`/s Lisa A. Haile /
`Lisa A. Haile, J.D., Ph.D.
`Reg. No. 38,347
`DLA Piper LLP (US)
`
`
`
`
`
`Date: May 11, 2016
`
`
`/s Stuart E. Pollack /
`Stuart E. Pollack, J.D., Ph.D.
`Reg. No. 43,862
`DLA Piper LLP (US)
`
`
`
`
`
`5
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