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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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`STEADYMED LTD.
`Petitioner
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`v.
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`UNITED THERAPEUTICS CORPORATION
`Patent Owner
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`U.S. Patent No. 8,497,393
`Issue Date: Jul. 30, 2013
`Title: PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE
`INGREDIENT IN REMODULIN®
`_______________
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`Case IPR2016-00006
`_______________
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`PATENT OWNER’S OBJECTIONS TO PETITIONER’S REPLY &
`EVIDENCE SUBMITTED WITH PETITIONER’S REPLY
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`4850-9319-7872.1
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`IPR2016-00006
`Patent 8,497,393
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`Patent Owner Docket No. 080618-1601
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`Patent Owner United Therapeutics Corporation (“Patent Owner”) hereby
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`objects to the admissibility of certain evidence cited in support of the Petitioner’s
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`Reply to Patent Owner’s Response to Petition filed on September 27, 2016
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`(“Reply”), as well as to the portions of the Reply that rely upon such objectionable
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`evidence. Patent Owner’s objections are based on the Federal Rules of Evidence
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`(“FRE”), relevant case law, and the Patent Trial and Appeal Board (“PTAB”)
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`Rules. Patent Owner’s objections are set forth with particularity below.
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`EXHIBIT 1021
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`Exhibit 1021 is described as “Spreadsheet of 46 batches from Exs. 2053 and
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`2036.” Patent Owner objects to Exhibit 1021 under FRE 901 as not being properly
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`authenticated. Petitioner relies on the exhibit to prove the truth of the matter
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`asserted therein, but the exhibit fails to meet the requirements of any hearsay
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`exception or exemption under FRE 803-807.
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`EXHIBIT 1022
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`Exhibit 1022 is described as “Dr. Robin D. Rogers Declaration.”
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`(a) Patent Owner objects to Exhibit 1022 under 37 CFR 42.23 because the
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`opinion testimony contained in this exhibit contains opinions, including
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`paragraphs 44-48, that are not responsive to the Patent Owner Response and,
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`Patent Owner Docket No. 080618-1601
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`thus, should not be considered by the PTAB in this proceeding. See 37
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`C.F.R. § 41.41(b);
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`(b) Patent Owner objects to Exhibit 1022 under 37 CFR 42.6(a)(3) because it
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`contains arguments improperly incorporated by reference into the
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`Petitioner’s Reply, including paragraphs 24-48, 53-63, 65-73, 75-83, and 85-
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`88; and
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`(c) Patent Owner objects to Exhibit 1022 under FRE 702-703 as including
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`opinions, including paragraphs 84-86, that rely on facts and data that are not
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`in the record as to how a melting point was calculated;
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`(d) Patent Owner objects to Exhibit 1022 under FRE 702-703 as including
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`opinions, including paragraph 87, that rely on facts and data that are not in
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`the record to conclude that a melting point range is narrow.
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`EXHIBIT 1024
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`Exhibit 1024 is described as “Stephen R. Byrn et al., Solid-State Chemistry of
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`Drugs, Chapter 10, ‘Polymorphs,’ 143-231 (2d ed. 1999).” Patent Owner objects
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`to Exhibit 1024, which is purported to be a chapter from a chemistry textbook,
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`under FRE 802. The Petitioner relies on this exhibit to prove the truth of the
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`matter asserted therein, but it fails to meet the requirements of any hearsay
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`exception or exemption under FRE 803-807.
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`IPR2016-00006
`Patent 8,497,393
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`Patent Owner Docket No. 080618-1601
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`EXHIBIT 1025
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`Exhibit 1025 is described as “Terence L. Threlfall, ‘Analysis of Organic
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`Polymorphs: A Review,’ Analyst 120(10): 2435 (1995).” Patent Owner objects to
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`Exhibit 1025, which is purported to be a scientific journal article, under FRE 802.
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`The Petitioner relies on this exhibit to prove the truth of the matter asserted therein,
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`but it fails to meet the requirements of any hearsay exception or exemption under
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`FRE 803-807.
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`EXHIBIT 1026
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`Exhibit 1026 is described as “ANDAs: Pharmaceutical Solid Polymorphism--
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`Chemistry, Manufacturing, and Controls Information.” Patent Owner objects to
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`Exhibit 1026, which is purported to be a Food and Drug Administration Guidance
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`Document, under FRE 802. The Petitioner relies on this exhibit to prove the truth
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`of the matter asserted therein, but it fails to meet the requirements of any hearsay
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`exception or exemption under FRE 803-807.
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`EXHIBIT 1027
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`Exhibit 1027 is described as “Solid-State Chemistry of Drugs, Chapter 5,
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`‘Thermal Methods of Analysis,’ 81-901 (2d ed. 1999).” Patent Owner objects to
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`Exhibit 1027, which is purported to be a chapter from a chemistry textbook, under
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`FRE 802. The Petitioner relies on this exhibit to prove the truth of the matter
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`asserted therein, but it fails to meet the requirements of any hearsay exception or
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`exemption under FRE 803-807.
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`EXHIBIT 1028
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`Exhibit 1028 is described as “Drawings made of the compound in the
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`Kawakami reference.” Patent Owner objects to Exhibit 1028, which is purported
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`to be a diagram of a chemical compound, under FRE 802. The Petitioner relies on
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`this exhibit to prove the truth of the matter asserted therein, but it fails to meet the
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`requirements of any hearsay exception or exemption under FRE 803-807.
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`Petitioner further objects to this exhibit under FRE 402-403, as being irrelevant
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`and likely to cause confusion.
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`PORTIONS OF PETITIONER’S REPLY
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`Patent Owner objects to the Reply at pages 2, 3, 4, 7, 8, and 24 for citing
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`portions of Ex. 2059 (Williams deposition transcript at 112-113 and 217-219)
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`under FRE 402-403 as being likely to cause confusion pursuant to the objection
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`made at the deposition at p. 112 of the transcript that the questions
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`mischaracterized earlier testimony and documents shown to the witness.
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`Patent Owner objects to the Reply at page 15 for citing portions of Ex. 2059
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`(Williams deposition transcript at 180) under FRE 402-403 as being likely to cause
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`confusion pursuant to the objection made at the deposition at p. 181 of the
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`Patent Owner Docket No. 080618-1601
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`transcript that the earlier questions misrepresented the document shown to the
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`witness.
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`Respectfully submitted,
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`Date: October 4, 2016
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`Counsel for Patent Owner
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`4850-9319-7872.1
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`IPR2016-00006
`Patent 8,497,393
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`Attorney Docket No. 080618-1601
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Patent
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`Owner’s Objections to Petitioner’s Evidence Submitted With Petitioner’s Reply
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`was served on counsel of record on October 4, 2016, by filing this document
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`through the PTAB E2E System as well as delivering a copy via email to the
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`counsel of record for the Petitioner at the following address: Steadymed-
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`IPR@dlapiper.com.
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`Date: October 4, 2016
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Foley & Lardner LLP
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`4850-9319-7872.1