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
`_______________
`
`
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`
`
`PATENT OWNER’S OBJECTIONS TO PETITIONER’S EVIDENCE
`SUBMITTED WITH PETITION
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`
`
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`4850-9319-7872.1
`
`
`
`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 EVIDENCE
`SUBMITTED WITH PETITION
`
`
`
`
`4850-9319-7872.1
`
`
`
`IPR2016-00006
`Patent 8,497,393
`
`
`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 Petition for
`
`Inter Partes Review filed on October 1, 2015 (“Petition”). Patent Owner’s
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`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
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`objections are set forth with particularity below.
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`EXHIBIT 1003
`
`Exhibit 1003 is described as “U.S. Patent No. 6,765,117 to Moriarty, et al.”
`
`Patent Owner objects to Exhibit 1003, which is purported to be a United States
`
`patent, under FRE 802 to the extent Petitioner has asserted that its products are
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`inherently the same as a product claimed in the ‘393 patent. The Patent Owner
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`relies on this exhibit to prove the truth of the matter asserted therein, but it fails to
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`meet the requirements of any hearsay exception or exemption under FRE 803-807.
`
`EXHIBIT 1004
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`Exhibit 1004 is described as “J. Org. Chem. 2004, 1890-1902 by Moriarty, et
`
`al.” Patent Owner objects to Exhibit 1004, which is purported to be an article from
`
`the Journal of Organic Chemistry, under FRE 802 to the extent Petitioner has
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`asserted that its products are inherently the same as a product claimed in the ‘393
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`patent. The Petitioner relies on this exhibit to prove the truth of the matter asserted
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`4850-9319-7872.1
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`2
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`IPR2016-00006
`Patent 8,497,393
`
`
`Patent Owner Docket No. 080618-1601
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`
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`therein, but it fails to meet the requirements of any hearsay exception or exemption
`
`under FRE 803-807.
`
`EXHIBIT 1005
`
`Exhibit 1005 is described as “International Publication No. WO 2005/007081 to
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`Phares, et al.” Patent Owner objects to Exhibit 1005, which is purported to be an
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`International application published under the Patent Cooperation Treaty, under
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`FRE 802 to the extent Petitioner has asserted that its products are inherently the
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`same as a product claimed in the ‘393 patent. The Petitioner relies on this exhibit
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`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.
`
`EXHIBIT 1006
`
`Exhibit 1006 is described as “Japanese Patent App. No. 56-122328A to
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`Kawakami, et al. (Japanese).” Patent Owner objects to Exhibit 1006 under 37
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`C.F.R. § 42.63(b) because the rule requires a translation and an affidavit attesting
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`to accuracy for foreign language publications. Patent Owner further objects to
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`Exhibit 1006, which is purported to be a Japanese patent application, under FRE
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`802. The Petitioner relies on this exhibit to prove the truth of the matter asserted
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`therein, but it fails to meet the requirements of any hearsay exception or exemption
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`under FRE 803-807.
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`4850-9319-7872.1
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`3
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`IPR2016-00006
`Patent 8,497,393
`
`
`Patent Owner Docket No. 080618-1601
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`
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`EXHIBIT 1007
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`Exhibit 1007 is described as “Certified English translation of Japanese Patent
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`App. No. 56-122328A to Kawakami, et al.” (Kawakami). Patent Owner objects to
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`Exhibit 1007 under FRE 602 because there is no evidence that the translator Boris
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`Levine has personal knowledge of the translation of Kawakami in Exhibit 1007 or
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`even that he knows how to translate any document from Japanese to English.
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`Patent Owner further objects to this exhibit under FRE 402 and 403 because an
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`inadequate translation is irrelevant.
`
`EXHIBIT 1008
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`Exhibit 1008 is described as “Ege, S. (1989). Organic Chemistry Second
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`Edition (pp. 543-547).” Patent Owner objects to Exhibit 1008, which is purported
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`to be an organic chemistry textbook, under FRE 802. The Petitioner relies on this
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`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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`EXHIBIT 1009
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`Exhibit 1009 is described as “Declaration of Jeffrey D. Winkler, Ph.D.” Patent
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`Owner objects to Exhibit 1009, under FRE 701, because the opinion testimony
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`contained in this exhibit reaches legal conclusions for which the declarant has not
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`established that he is capable of providing, for example, paragraphs 3, 31, 46, 48,
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`4850-9319-7872.1
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`4
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`IPR2016-00006
`Patent 8,497,393
`
`
`Patent Owner Docket No. 080618-1601
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`
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`54, 57, 63, 71, and 72 each recite an unsupported legal conclusion and, thus,
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`should not be considered by the PTAB is this proceeding.
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`EXHIBIT 1011
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`Exhibit 1011 is described as “Affidavit of Boris Levine certifying Translation
`
`of Japanese Patent App. No. 56- 122328A to Kawakami, et al.” Patent Owner
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`objects to Exhibit 1011 under FRE 402 and 403, because there is no evidence that
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`the translator Boris Levine has personal knowledge of the translation of Kawakami
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`in Exhibit 1007 or even that he knows how to translate any document from
`
`Japanese to English.
`
`EXHIBIT 1012
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`Exhibit 1012 is described as “Wiberg, Kenneth (1960), LaboratoryTechnique in
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`Organic Chemistry (p. 112).” Patent Owner objects to Exhibit 1012, which is
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`purported to be an organic chemistry lab textbook, under FRE 802. The Petitioner
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`relies on this exhibit to prove the truth of the matter asserted therein, but it fails to
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`meet the requirements of any hearsay exception or exemption under FRE 803-807.
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`EXHIBIT 1013
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`Exhibit 1013 is described as “U.S. Patent No. 6,441,245 to Moriarty, et al.”
`
`Patent Owner objects to Exhibit 1013, which is purported to be a United States
`
`patent, under FRE 802. The Petitioner relies on this exhibit to prove the truth of
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`4850-9319-7872.1
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`5
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`IPR2016-00006
`Patent 8,497,393
`
`
`Patent Owner Docket No. 080618-1601
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`
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`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 1014
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`Exhibit 1014 is described as “Schoffstall, ‘Microscale and Miniscale Organic
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`Chemistry Laboratory Experiments,’ 200-202 (2d ed.) (2004).” Patent Owner
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`objects to Exhibit 1014, which is purported to be an organic chemistry lab
`
`textbook, under FRE 802. The Petitioner relies on this exhibit to prove the truth of
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`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 1015
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`Exhibit 1015 is described as “U.S. Patent No. 3,703,544 to Morozowich, et al.”
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`Patent Owner objects to Exhibit 1015, which is purported to be a United States
`
`patent, under FRE 802. The Petitioner relies on this exhibit to prove the truth of
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`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 1016
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`Exhibit 1016 is described as “U.S. Patent No. 3,888,916 to Sinkula, et al.”
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`Patent Owner objects to Exhibit 1016, which is purported to be a United States
`
`patent, under FRE 802. The Petitioner relies on this exhibit to prove the truth of
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`4850-9319-7872.1
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`6
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`IPR2016-00006
`Patent 8,497,393
`
`
`Patent Owner Docket No. 080618-1601
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`
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`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 1017
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`Exhibit 1017 is described as “‘Getting Started in HPLC,’ Section 4D: Precision
`
`and Accuracy, available at http://www.lcresources.com/resources/getstart/
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`4d01.htm (accessed Sept. 29, 2015).” Patent Owner objects to Exhibit 1017 under
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`FRE 901 as not being properly authenticated. Petitioner relies on the exhibit to
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`prove the truth of the matter asserted therein, but the exhibit fails to meet the
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`requirements of any hearsay exception or exemption under FRE 803-807.
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`EXHIBIT 1018
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`Exhibit 1018 is described as “Gilbert, ‘Experimental Organic Chemistry: A
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`Miniscule and Microscale Approach,’ 113-117 (5th. ed.) (2011).” Patent Owner
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`objects to Exhibit 1018, which is purported to be an organic chemistry lab
`
`textbook, under FRE 802. The Petitioner relies on this exhibit to prove the truth of
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`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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`4850-9319-7872.1
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`7
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`IPR2016-00006
`Patent 8,497,393
`
`
`
`
`Patent Owner Docket No. 080618-1601
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`
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`Respectfully submitted,
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`Date: April 22, 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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`8
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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 Petition was served
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`on counsel of record on April 22, 2016, by filing this document through the Patent
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`Review Processing System as well as delivering a copy via email to the counsel of
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`record for the Petitioner at the following address: Steadymed-IPR@dlapiper.com.
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`Date: April 22, 2016
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` /Stephen B. Maebius/
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`Stephen B. Maebius
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`Foley & Lardner LLP
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`4850-9319-7872.1
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