IPR2017-01622
`U.S. Patent No. 9,339,507 B2
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORP.
`Patent Owner
`
`
`
`Case : IPR2017-01622
`U.S. Patent 9,339,507 B2
`
`Before the Honorable LORA M. GREEN, ERICA A. FRANKLIN, and DAVID
`COTTA, Administrative Patent Judges.
`
`PETITIONER’S FIRST SET OF OBJECTIONS
`TO PATENT OWNER’S EXHIBITS
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), the undersigned, on behalf of and acting
`
`in a representative capacity for Petitioner Watson Laboratories, Inc., hereby submit
`
`the following objections to Patent Owner United Therapeutics Corp.’s (“Patent
`
`Owner”) Exhibits 2001, 2006, 2009-2020, 2026-2030, and any reference to/reliance
`
`on the foregoing. As required by 37 C.F.R § 42.62, Petitioners’ objections below
`
`apply the Federal Rules of Evidence and are based on currently-applicable law.
`
`
`
`1
`
`
`U.S. Patent No. 9,339,507 B2
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORP.
`Patent Owner
`
`
`
`Case : IPR2017-01622
`U.S. Patent 9,339,507 B2
`
`Before the Honorable LORA M. GREEN, ERICA A. FRANKLIN, and DAVID
`COTTA, Administrative Patent Judges.
`
`PETITIONER’S FIRST SET OF OBJECTIONS
`TO PATENT OWNER’S EXHIBITS
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), the undersigned, on behalf of and acting
`
`in a representative capacity for Petitioner Watson Laboratories, Inc., hereby submit
`
`the following objections to Patent Owner United Therapeutics Corp.’s (“Patent
`
`Owner”) Exhibits 2001, 2006, 2009-2020, 2026-2030, and any reference to/reliance
`
`on the foregoing. As required by 37 C.F.R § 42.62, Petitioners’ objections below
`
`apply the Federal Rules of Evidence and are based on currently-applicable law.
`
`
`
`1
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`
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`IPR2017-01622
`U.S. Patent No. 9,339,507 B2
`Petitioner reserves the right to amend or supplement its objections in response to any
`
`change in law or fact.
`
`
`
`OBJECTIONS TO EXHIBIT 2001
`
`Evidence objected to: Exhibit 2001
`
`Grounds for objection: Exhibit 2001, a document titled “Declaration of Dr.
`
`Richard Dalby,” is objected to under Fed. R. Evid. 401, 403, 801 and 802. Exhibit
`
`2001 includes statements that do not make any fact relevant to the grounds upon
`
`which trial was instituted more or less probable and any facts that might be
`
`established based on this exhibit is of no consequence in determining the issues on
`
`which trial was instituted. Introduction and evaluation of Exhibit 2001 would further
`
`lead to undue delay, confusion, and a waste of time. Exhibit 2001 also contains out-
`
`of-court statements made by one or more declarants for the purpose of proving the
`
`truth of the matter asserted, and on which Petitioner has not had a chance to cross
`
`exam.
`
` OBJECTIONS TO EXHIBIT 2006
`Evidence objected to: Exhibit 2006
`
`Grounds for objection: Exhibit 2006, a document titled “Declaration Under
`
`37 C.F.R. § 1.132 of Dr. Edmund J. Elder, Jr.,” and allegedly filed with the United
`
`States Patent and Trademark Office in connection with Application No. 12/591,200,
`
`is objected to under Fed. R. Evid. 401 and 403. Exhibit 2006 does not make any fact
`
`
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`2
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`IPR2017-01622
`U.S. Patent No. 9,339,507 B2
`relevant to the grounds upon which trial was instituted more or less probable and
`
`any facts that might be established based on this exhibit is of no consequence in
`
`determining the issues on which trial was instituted. Introduction and evaluation of
`
`Exhibit 2006 would further lead to undue delay, confusion, and a waste of time.
`
` OBJECTIONS TO EXHIBIT 2009
`Evidence objected to: Exhibit 2009
`
`Grounds for objection: Exhibit 2009, a document titled “Plaintiff United
`
`Therapeutics’ Memorandum of Law in Support of Its Motion for Leave to Amend
`
`Its Complaint,” and allegedly filed in connection with an action styled United
`
`Therapeutics Corporation v. Watson Laboratories, Inc., Civ. A. No. 3:15-cv-05723-
`
`PGS-LHG (D. N.J.) and identified by document number 46-1, is objected to under
`
`Fed. R. Evid. 401 and 403. Exhibit 2009 does not make any fact relevant to the
`
`grounds upon which trial was instituted more or less probable and any facts that
`
`might be established based on this exhibit is of no consequence in determining the
`
`issues on which trial was instituted. Introduction and evaluation of Exhibit 2009
`
`would further lead to undue delay, confusion, and a waste of time.
`
` OBJECTIONS TO EXHIBIT 2010
`Evidence objected to: Exhibit 2010
`
`Grounds for objection: Exhibit 2010, an email with the subject line: “United
`
`Therapeutics Corp. v. Watson Laboratories, Inc.: Civ A. No. 3:15-cv-05723 –
`
`
`
`3
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`IPR2017-01622
`U.S. Patent No. 9,339,507 B2
`Motion for leave to file an amended complaint,” is objected to under Fed. R. Evid.
`
`401 and 403. Exhibit 2010 does not make any fact relevant to the grounds upon
`
`which trial was instituted more or less probable and any facts that might be
`
`established based on this exhibit is of no consequence in determining the issues on
`
`which trial was instituted. Introduction and evaluation of Exhibit 2010 would further
`
`lead to undue delay, confusion, and a waste of time.
`
` OBJECTIONS TO EXHIBIT 2011
`Evidence objected to: Exhibit 2011
`
`Grounds for objection: Exhibit 2011, an order allegedly granting Plaintiff’s
`
`Motion for Leave to File an Amended Complaint and allegedly filed in connection
`
`with an action styled United Therapeutics Corporation v. Watson Laboratories, Inc.,
`
`Civ. A. No. 3:15-cv-05723-PGS-LHG (D. N.J.) is objected to under Fed. R. Evid.
`
`401 and 403. Exhibit 2011 does not make any fact relevant to the grounds upon
`
`which trial was instituted more or less probable and any facts that might be
`
`established based on this exhibit is of no consequence in determining the issues on
`
`which trial was instituted. Introduction and evaluation of Exhibit 2011 would further
`
`lead to undue delay, confusion, and a waste of time.
`
`
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`4
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`IPR2017-01622
`U.S. Patent No. 9,339,507 B2
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` OBJECTIONS TO EXHIBIT 2012
`Evidence objected to: Exhibit 2012
`
`Grounds for objection: Exhibit 2012, a document that is allegedly an entry in
`
`the online version of the Orange Book: Approved Drug Products with Therapeutic
`
`Equivalence Evaluations, specifically relating to NDA 022387, is objected to under
`
`Fed. R. Evid. 401 and 403. Exhibit 2012 does not make any fact relevant to the
`
`grounds upon which trial was instituted more or less probable and any facts that
`
`might be established based on this exhibit is of no consequence in determining the
`
`issues on which trial was instituted. Introduction and evaluation of Exhibit 2012
`
`would further lead to undue delay, confusion, and a waste of time.
`
` OBJECTIONS TO EXHIBIT 2013
`Evidence objected to: Exhibit 2013
`
`Grounds for objection: Exhibit 2013, a document titled “Notification of
`
`Certification for U.S. Patent Nos. 6,521,212; 6,756,033; and 8,497,393 pursuant to
`
`§ 505(j)(2)(B)(iv) of the Federal Food, Drug, and Cosmetic Act,” is objected to
`
`under Fed. R. Evid. 401 and 403. Exhibit 2013 does not make any fact relevant to
`
`the grounds upon which trial was instituted more or less probable and any facts that
`
`might be established based on this exhibit is of no consequence in determining the
`
`issues on which trial was instituted. Introduction and evaluation of Exhibit 2013
`
`would further lead to undue delay, confusion, and a waste of time.
`
`
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`5
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`IPR2017-01622
`U.S. Patent No. 9,339,507 B2
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` OBJECTIONS TO EXHIBIT 2014
`Evidence objected to: Exhibit 2014
`
`Grounds for objection: Exhibit 2014, a document titled “Issue Notification”
`
`and allegedly filed with the United States Patent and Trademark Office in connection
`
`with Application No. 13/469,854 and Application No. 12/591,200, is objected to
`
`under Fed. R. Evid. 401 and 403. Exhibit 2014 does not make any fact relevant to
`
`the grounds upon which trial was instituted more or less probable and any facts that
`
`might be established based on this exhibit is of no consequence in determining the
`
`issues on which trial was instituted. Introduction and evaluation of Exhibit 2014
`
`would further lead to undue delay, confusion, and a waste of time.
`
` OBJECTIONS TO EXHIBIT 2015
`Evidence objected to: Exhibit 2015
`
`Grounds for objection: Exhibit 2015, a document titled “Patent Information
`
`Submitted Upon and After Approval of an NDA or Supplement,” is objected to
`
`under Fed. R. Evid. 401 and 403. Exhibit 2015 does not make any fact relevant to
`
`the grounds upon which trial was instituted more or less probable and any facts that
`
`might be established based on this exhibit is of no consequence in determining the
`
`issues on which trial was instituted. Introduction and evaluation of Exhibit 2015
`
`would further lead to undue delay, confusion, and a waste of time.
`
`
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`6
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`IPR2017-01622
`U.S. Patent No. 9,339,507 B2
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` OBJECTIONS TO EXHIBIT 2016
`Evidence objected to: Exhibit 2016
`
`Grounds for objection: Exhibit 2016, a document titled “Patent Information
`
`Submitted Upon and After Approval of an NDA or Supplement,” is objected to
`
`under Fed. R. Evid. 401 and 403. Exhibit 2016 does not make any fact relevant to
`
`the grounds upon which trial was instituted more or less probable and any facts that
`
`might be established based on this exhibit is of no consequence in determining the
`
`issues on which trial was instituted. Introduction and evaluation of Exhibit 2016
`
`would further lead to undue delay, confusion, and a waste of time.
`
` OBJECTIONS TO EXHIBIT 2017
`Evidence objected to: Exhibit 2017
`
`Grounds for objection: Exhibit 2017, an email with the subject line: “RE: UTC
`
`v. Watson Laboratories, Inc.,” is objected to under Fed. R. Evid. 401 and 403.
`
`Exhibit 2017 does not make any fact relevant to the grounds upon which trial was
`
`instituted more or less probable and any facts that might be established based on this
`
`exhibit is of no consequence in determining the issues on which trial was instituted.
`
`Introduction and evaluation of Exhibit 2017 would further lead to undue delay,
`
`confusion, and a waste of time.
`
`
`
`7
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`IPR2017-01622
`U.S. Patent No. 9,339,507 B2
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` OBJECTIONS TO EXHIBIT 2018
`Evidence objected to: Exhibit 2018
`
`Grounds for objection: Exhibit 2018, a letter titled “Notification of
`
`Certification for U.S. Patent Nos. 9,339,507 and 9,358,240 pursuant to §
`
`505(j)(2)(B)(iv) of the Federal Food, Drug, and Cosmetic Act,” is objected to under
`
`Fed. R. Evid. 401 and 403. Exhibit 2018 does not make any fact relevant to the
`
`grounds upon which trial was instituted more or less probable and any facts that
`
`might be established based on this exhibit is of no consequence in determining the
`
`issues on which trial was instituted. Introduction and evaluation of Exhibit 2018
`
`would further lead to undue delay, confusion, and a waste of time.
`
` OBJECTIONS TO EXHIBIT 2019
`Evidence objected to: Exhibit 2019
`
`Grounds for objection: Exhibit 2019, a document that is titled “Motion
`
`Success,” and appears to be gathered from DocketNavigator Analytics, is objected
`
`to under Fed. R. Evid. 401 and 403. Exhibit 2019 does not make any fact relevant
`
`to the grounds upon which trial was instituted more or less probable and any facts
`
`that might be established based on this exhibit is of no consequence in determining
`
`the issues on which trial was instituted. Introduction and evaluation of Exhibit 2019
`
`would further lead to undue delay, confusion, and a waste of time.
`
`
`
`8
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`IPR2017-01622
`U.S. Patent No. 9,339,507 B2
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` OBJECTIONS TO EXHIBIT 2020
`Evidence objected to: Exhibit 2020
`
`Grounds for objection: Exhibit 2020, a document that is titled “Declaration of
`
`Dr. Werner Seeger,” is objected to under Fed. R. Evid. 801 and 802. Exhibit 2026
`
`contains out-of-court statements made by one or more declarants for the purpose of
`
`proving the truth of the matter asserted, and on which Petitioner has not had a chance
`
`to cross exam.
`
` OBJECTIONS TO EXHIBIT 2026
`Evidence objected to: Exhibit 2026
`
`Grounds for objection: Exhibit 2026, a document that is titled “Declaration of
`
`Dr. Hossein A. Ghofrani,” is objected to under Fed. R. Evid. 602 and 801. Exhibit
`
`2026 contains statements which speculate on the motivations and rationales of others
`
`and/or relies on out-of-court statements made by one or more declarants for the
`
`purpose of proving the truth of the matter asserted, and on which Petitioner has not
`
`had a chance to cross exam.
`
` OBJECTIONS TO EXHIBIT 2027
`Evidence objected to: Exhibit 2027
`
`Grounds for objection: Exhibit 2027, a document that is titled “Declaration of
`
`Dr. Frank Reichenberger,” is objected to under Fed. R. Evid. 602 and 801. Exhibit
`
`2027 contains statements which speculate on the motivations and rationales of others
`
`and/or relies on out-of-court statements made by one or more declarants for the
`9
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`IPR2017-01622
`U.S. Patent No. 9,339,507 B2
`purpose of proving the truth of the matter asserted, and on which Petitioner has not
`
`had a chance to cross exam.
`
`OBJECTIONS TO EXHIBIT 2028
`
`
`Evidence objected to: Exhibit 2028
`
`Grounds for objection: Exhibit 2028, a document that is titled “Declaration of
`
`Dr. Friedrich Grimminger,” is objected to under Fed. R. Evid. 602 and 801. Exhibit
`
`2028 contains statements which speculate on the motivations and rationales of others
`
`and/or relies on out-of-court statements made by one or more declarants for the
`
`purpose of proving the truth of the matter asserted, and on which Petitioner has not
`
`had a chance to cross exam.
`
`OBJECTIONS TO EXHIBIT 2029
`
`
`Evidence objected to: Exhibit 2029
`
`Grounds for objection: Exhibit 2029, a document allegedly containing
`
`excerpts from the deposition of Dr. Maureen Donovan, PhD, in connection with an
`
`action styled United Therapeutics Corporation v. Watson Laboratories, Inc., Civ.
`
`A. No. 3:15-cv-05723-PGS-LHG (D. N.J.), is objected to under Fed. R. Evid. 401
`
`and 403. Exhibit 2029 does not make any fact relevant to the grounds upon which
`
`trial was instituted more or less probable and any facts that might be established
`
`based on this exhibit is of no consequence in determining the issues on which trial
`
`
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`10
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`IPR2017-01622
`U.S. Patent No. 9,339,507 B2
`was instituted. Introduction and evaluation of Exhibit 2029 would further lead to
`
`undue delay, confusion, and a waste of time.
`
` OBJECTIONS TO EXHIBIT 2030
`Evidence objected to: Exhibit 2030
`
`Grounds for objection: Exhibit 2030, an email with the subject line: “RE:
`
`Orange Book Listing Date,” is objected to under Fed. R. Evid. 401 and 403. Exhibit
`
`2030 does not make any fact relevant to the grounds upon which trial was instituted
`
`more or less probable and any facts that might be established based on this exhibit
`
`is of no consequence in determining the issues on which trial was instituted.
`
`Introduction and evaluation of Exhibit 2030 would further lead to undue delay,
`
`confusion, and a waste of time.
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`
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`
`
`Dated: January 26, 2018
`
`
`
`Respectfully submitted,
`
`/Michael K. Nutter/
`Michael K. Nutter, Lead Counsel
`Reg. No. 44,979
`Andrew R. Sommer, Back-Up Counsel
`Reg. No. 53,932
`Kurt A. Mathas, Back-Up Counsel
`WINSTON & STRAWN LLP
`
`
`
`11
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`IPR2017-01622
`U.S. Patent No. 9,339,507 B2
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing Petitioner’s First Set of
`
`Objections to Patent Owner’s Exhibits For Inter Partes Review of U.S. Patent
`
`No. 9,339,507 is being served on January 26, 2018, by filing this document through
`
`the PTAB E2E System as well as delivering a copy via email to the following
`
`counsel for the Patent Owner:
`
`Stephen B. Maebius – Lead Counsel
`Email: smaebius@foley.com
`George Quillin
`Email: gquillin@foley.com
`UT507-IPR@foley.com
`FOLEY & LARDNER LLP
`
`Shaun R. Snader
`Email: ssnader@unither.com
`UNITED THERAPEUTICS CORP.
`
`Douglas Carsten
`Email: dcarsten@wsgr.com
`Richard Torczon
`Email: rtorczon@wsgr.com
`Robert Delafield
`Email: bdelafield@wsgr.com
`Veronica Ascarrunz
`Email: vascarrunz@wsgr.com
`WILSON, SONSINI, GOODRICH & ROSATI
`
`
`
`
`
`
`
`
`Dated: January 26, 2018
`
`
`
`IPR2017-01622
`U.S. Patent No. 9,339,507 B2
`
`Respectfully submitted,
`
`/Michael K. Nutter/
`Michael K. Nutter, Lead Counsel
`Reg. No. 44,979
`Andrew R. Sommer, Back-Up Counsel
`Reg. No. 53,932
`Kurt A. Mathas, Back-Up Counsel
`WINSTON & STRAWN LLP
`
`
`
`
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