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Paper _____
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`STEADYMED LTD.
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORPORATION
`Patent Owner
`
`U.S. Patent No. 8,497,393
`Issue Date: Jul. 30, 2013
`Title: PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE
`INGREDIENT IN REMODULIN®
`_______________
`
`Case IPR2016-00006
`_______________
`
`
`
`
`
`PATENT OWNER’S OBJECTIONS TO PETITIONER’S REPLY &
`EVIDENCE SUBMITTED WITH PETITIONER’S REPLY
`
`
`
`
`4850-9319-7872.1
`
`

`
`IPR2016-00006
`Patent 8,497,393
`
`
`Patent Owner Docket No. 080618-1601
`
`
`
`Patent Owner United Therapeutics Corporation (“Patent Owner”) hereby
`
`objects to the admissibility of certain evidence cited in support of the Petitioner’s
`
`Reply to Patent Owner’s Response to Petition filed on September 27, 2016
`
`(“Reply”), as well as to the portions of the Reply that rely upon such objectionable
`
`evidence. Patent Owner’s objections are based on the Federal Rules of Evidence
`
`(“FRE”), relevant case law, and the Patent Trial and Appeal Board (“PTAB”)
`
`Rules. Patent Owner’s objections are set forth with particularity below.
`
`EXHIBIT 1021
`
`Exhibit 1021 is described as “Spreadsheet of 46 batches from Exs. 2053 and
`
`2036.” Patent Owner objects to Exhibit 1021 under FRE 901 as not being properly
`
`authenticated. Petitioner relies on the exhibit to prove the truth of the matter
`
`asserted therein, but the exhibit fails to meet the requirements of any hearsay
`
`exception or exemption under FRE 803-807.
`
`EXHIBIT 1022
`
`Exhibit 1022 is described as “Dr. Robin D. Rogers Declaration.”
`
`(a) Patent Owner objects to Exhibit 1022 under 37 CFR 42.23 because the
`
`opinion testimony contained in this exhibit contains opinions, including
`
`paragraphs 44-48, that are not responsive to the Patent Owner Response and,
`
`4850-9319-7872.1
`
`2
`
`

`
`IPR2016-00006
`Patent 8,497,393
`
`
`Patent Owner Docket No. 080618-1601
`
`
`
`thus, should not be considered by the PTAB in this proceeding. See 37
`
`C.F.R. § 41.41(b);
`
`(b) Patent Owner objects to Exhibit 1022 under 37 CFR 42.6(a)(3) because it
`
`contains arguments improperly incorporated by reference into the
`
`Petitioner’s Reply, including paragraphs 24-48, 53-63, 65-73, 75-83, and 85-
`
`88; and
`
`(c) Patent Owner objects to Exhibit 1022 under FRE 702-703 as including
`
`opinions, including paragraphs 84-86, that rely on facts and data that are not
`
`in the record as to how a melting point was calculated;
`
`(d) Patent Owner objects to Exhibit 1022 under FRE 702-703 as including
`
`opinions, including paragraph 87, that rely on facts and data that are not in
`
`the record to conclude that a melting point range is narrow.
`
`EXHIBIT 1024
`
`Exhibit 1024 is described as “Stephen R. Byrn et al., Solid-State Chemistry of
`
`Drugs, Chapter 10, ‘Polymorphs,’ 143-231 (2d ed. 1999).” Patent Owner objects
`
`to Exhibit 1024, which is purported to be a chapter from a chemistry textbook,
`
`under FRE 802. The Petitioner relies on this exhibit to prove the truth of the
`
`matter asserted therein, but it fails to meet the requirements of any hearsay
`
`exception or exemption under FRE 803-807.
`
`4850-9319-7872.1
`
`3
`
`

`
`IPR2016-00006
`Patent 8,497,393
`
`
`Patent Owner Docket No. 080618-1601
`
`
`
`EXHIBIT 1025
`
`Exhibit 1025 is described as “Terence L. Threlfall, ‘Analysis of Organic
`
`Polymorphs: A Review,’ Analyst 120(10): 2435 (1995).” Patent Owner objects to
`
`Exhibit 1025, which is purported to be a scientific journal article, under FRE 802.
`
`The Petitioner relies on this exhibit to prove the truth of the matter asserted therein,
`
`but it fails to meet the requirements of any hearsay exception or exemption under
`
`FRE 803-807.
`
`EXHIBIT 1026
`
`Exhibit 1026 is described as “ANDAs: Pharmaceutical Solid Polymorphism--
`
`Chemistry, Manufacturing, and Controls Information.” Patent Owner objects to
`
`Exhibit 1026, which is purported to be a Food and Drug Administration Guidance
`
`Document, under FRE 802. The Petitioner relies on this exhibit to prove the truth
`
`of the matter asserted therein, but it fails to meet the requirements of any hearsay
`
`exception or exemption under FRE 803-807.
`
`EXHIBIT 1027
`
`Exhibit 1027 is described as “Solid-State Chemistry of Drugs, Chapter 5,
`
`‘Thermal Methods of Analysis,’ 81-901 (2d ed. 1999).” Patent Owner objects to
`
`Exhibit 1027, which is purported to be a chapter from a chemistry textbook, under
`
`FRE 802. The Petitioner relies on this exhibit to prove the truth of the matter
`
`4850-9319-7872.1
`
`4
`
`

`
`IPR2016-00006
`Patent 8,497,393
`
`
`Patent Owner Docket No. 080618-1601
`
`
`
`asserted therein, but it fails to meet the requirements of any hearsay exception or
`
`exemption under FRE 803-807.
`
`EXHIBIT 1028
`
`Exhibit 1028 is described as “Drawings made of the compound in the
`
`Kawakami reference.” Patent Owner objects to Exhibit 1028, which is purported
`
`to be a diagram of a chemical compound, under FRE 802. The Petitioner relies on
`
`this exhibit to prove the truth of the matter asserted therein, but it fails to meet the
`
`requirements of any hearsay exception or exemption under FRE 803-807.
`
`Petitioner further objects to this exhibit under FRE 402-403, as being irrelevant
`
`and likely to cause confusion.
`
`PORTIONS OF PETITIONER’S REPLY
`
`Patent Owner objects to the Reply at pages 2, 3, 4, 7, 8, and 24 for citing
`
`portions of Ex. 2059 (Williams deposition transcript at 112-113 and 217-219)
`
`under FRE 402-403 as being likely to cause confusion pursuant to the objection
`
`made at the deposition at p. 112 of the transcript that the questions
`
`mischaracterized earlier testimony and documents shown to the witness.
`
`Patent Owner objects to the Reply at page 15 for citing portions of Ex. 2059
`
`(Williams deposition transcript at 180) under FRE 402-403 as being likely to cause
`
`confusion pursuant to the objection made at the deposition at p. 181 of the
`
`4850-9319-7872.1
`
`5
`
`

`
`IPR2016-00006
`Patent 8,497,393
`
`
`Patent Owner Docket No. 080618-1601
`
`
`
`transcript that the earlier questions misrepresented the document shown to the
`
`witness.
`
`
`
`Respectfully submitted,
`
`Date: October 4, 2016
`
`
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`
`
`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`Counsel for Patent Owner
`
`
`
`
`
`
`
`
`4850-9319-7872.1
`
`6
`
`

`
`IPR2016-00006
`Patent 8,497,393
`
`
`Attorney Docket No. 080618-1601
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent
`
`Owner’s Objections to Petitioner’s Evidence Submitted With Petitioner’s Reply
`
`was served on counsel of record on October 4, 2016, by filing this document
`
`through the PTAB E2E System as well as delivering a copy via email to the
`
`counsel of record for the Petitioner at the following address: Steadymed-
`
`IPR@dlapiper.com.
`
`
`
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`
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`Date: October 4, 2016
`
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Foley & Lardner LLP
`
`
`
`
`
`4850-9319-7872.1

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