UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORP.
`Patent Owner
`_______________
`
`Patent No. 9,358,240
`Issue Date: June 7, 2016
`Title: TREPROSTINIL ADMINISTRATION BY INHALATION
`_______________
`
`Inter Partes Review No. 2017-01621
`__________________________________________________
`
`
`
`PATENT OWNER REPLY TO PETITIONER’S RESPONSE TO
`REQUEST FOR REHEARING UNDER 37 C.F.R. § 42.71
`
`4830-1547-0430.4
`
`
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORP.
`Patent Owner
`_______________
`
`Patent No. 9,358,240
`Issue Date: June 7, 2016
`Title: TREPROSTINIL ADMINISTRATION BY INHALATION
`_______________
`
`Inter Partes Review No. 2017-01621
`__________________________________________________
`
`
`
`PATENT OWNER REPLY TO PETITIONER’S RESPONSE TO
`REQUEST FOR REHEARING UNDER 37 C.F.R. § 42.71
`
`4830-1547-0430.4
`
`
`
`IPR2017-01621
`
`PO Reply to Response to Request for Rehearing
`
`TABLE OF CONTENTS
`
`
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`I. INTRODUCTION ..................................................................................................................... 1
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`II. ARGUMENT ............................................................................................................................ 1
`
`A.
`
`B.
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`Petitioner cannot manufacture a genuine issue of material fact with
`speculation ............................................................................................................. 1
`
`There is no legal requirement to analyze inventorship in order to
`disqualify Ghofrani as prior at “by another.” ................................................... 4
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`III. CONCLUSION ....................................................................................................................... 5
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`
`
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`4830-1547-0430.4
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`
`
`i
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`IPR2017-01621
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`PO Reply to Response to Request for Rehearing
`
`TABLE OF AUTHORITIES
`
`
`
`Cases
`
`Applied Materials Inc. v. Gemini Research Corp.,
`835 F.2d 279 (Fed. Cir. 1987) .............................................................................. 5
`
`Emerachem Holdings, LLC v. Volkswagen Group of America, Inc.,
`859 F.3d 1341 (Fed. Cir. 2017) ........................................................................2, 3
`
`Ex parte Kroger,
`Appeal No. 442-62 (BPAI November 22, 1982) .................................................. 4
`
`In re Katz,
`687 F.2d 450 (CCPA 1982) .............................................................................1, 4
`
`Nelson Prods., Inc. v. Bal Seal Eng’g, Inc.,
`IPR2014-00573 (PTAB September 29, 2014) ..................................................3, 4
`
`Varian Med. Systs. v. Wm. Beaumont Hosp.,
`IPR2016-00163 (PTAB May 4, 2017) ..............................................................3, 5
`
`
`
`Regulations
`
`37 C.F.R § 42.108(c) .................................................................................................. 2
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`4830-1547-0430.4
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`ii
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`
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`IPR2017-01621
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`I. INTRODUCTION
`
`PO Reply to Response to Request for Rehearing
`
`The Patent Trial and Appeal Board’s conclusion that Ghofrani was the work
`
`of another (Decision, 14) was premised on an incorrect legal standard. Petitioner’s
`
`speculation and inapposite authority do not remedy this error.
`
`II. ARGUMENT
`A. Petitioner cannot manufacture a genuine issue of material fact with
`speculation
`
`Patent Owner filed four sworn declarations from Ghofrani authors, both a
`
`named inventor and other authors, showing that Ghofrani is not prior art. Yet
`
`Petitioner argues that the authorship of a separate reference, Voswinckel,
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`“contradict[s]” the declarations. Response, 4,6. Thus, Petitioner is arguing—
`
`based entirely on its own speculation about Voswinckel—that the four sworn
`
`declarations are untrue.
`
`Petitioner’s speculation that Voswinckel’s authorship is inconsistent with
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`Ghofrani’s cannot create a genuine issue of material fact as a matter of law. In re
`
`Katz, 687 F.2d 450, 455 (CCPA 1982) (“[J]oint inventorship cannot be inferred in
`
`the face of sworn statements to the contrary”). First, Ghofrani contains material
`
`concededly absent from Voswinckel, which makes Voswinckel’s authorship of
`
`little to no value in evaluating Ghofrani’s authorship. See, e.g., Petition, 29.
`
`Second, even if Petitioner has raised a peripheral question about the naming of
`
`authors on Voswinckel, that does not contradict the authors’ testimony about who
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`4830-1547-0430.4
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`1
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`IPR2017-01621
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`PO Reply to Response to Request for Rehearing
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`“contributed” the relevant subject matter of Ghofrani. Ex. 2020, ¶ 7 (this material
`
`“was contributed” by Voswinckel and Seeger); Ex. 2026 at ¶ 5, Ex. 2027 at ¶ 5,
`
`and Ex. 2028 at ¶ 5 (Ghofrani, Reichenberger, and Grimminger “did not
`
`contribute” to this material). At best, Petitioner has raised a question about why
`
`certain authors were included on Voswinckel, but Petitioner has not presented a
`
`sufficient basis to dispute Patent Owner’s corroborated testimony about who
`
`contributed the relevant portion of Ghofrani. Thus, the Board was not obliged by
`
`37 C.F.R. § 42.108(c) to resolve this issue in favor of Petitioner.
`
`Furthermore, the Seeger Declaration directly addressed Petitioner’s
`
`speculation and establishes that the determination of authorship in Voswinckel is
`
`not a determination of inventorship. Ex. 2020, ¶¶10-11. Contrary to Petitioner’s
`
`assertion (Response, 5-6), the Board’s institution decision provides no indication
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`that the Board considered this portion of the Seeger Declaration in view of
`
`Petitioner’s arguments.
`
`Petitioner relies on Emerachem Holdings, LLC v. Volkswagen Group of
`
`America, Inc., 859 F.3d 1341 (Fed. Cir. 2017), for the proposition that the four
`
`declarations are insufficient to disqualify Ghofrani as prior art because Emerachem
`
`supposedly requires contemporaneous documentary evidence to support the
`
`testimony of an interested party (i.e., the inventor). Response, 4-5. But
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`Emerachem did not require contemporaneous documentary evidence. In
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`4830-1547-0430.4
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`2
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`IPR2017-01621
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`PO Reply to Response to Request for Rehearing
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`Emerachem, the uncorroborated testimony of a single inventor co-author was
`
`insufficient to disqualify a reference listing other non-inventor co-authors as prior
`
`art “by another.” Id at 1345-46. In fact, Emerachem mentioned at least one other
`
`alternative to contemporaneous documentary evidence to corroborate such
`
`testimony: testimony from the non-inventor co-authors of the cited reference. Id.
`
`(“Mr. Campbell did not call Mr. Danzinger or Ms. Padron as witnesses or produce
`
`any contemporaneous documentary evidence in support of the Campbell
`
`Declaration.”). Here, Patent Owner has provided both testimony from an inventor
`
`co-author and corroborating testimony from multiple non-inventor co-authors.
`
`Thus, the record evidence is more than sufficient to disqualify Ghofani as prior art
`
`“by another.”
`
`The institution decisions in Varian Med. Systs. v. Wm. Beaumont Hosp. and
`
`Nelson Prods., Inc. v. Bal Seal Eng’g, Inc. are likewise distinguishable. Response,
`
`10; IPR2016-00163, Paper 14 (PTAB May 4, 2017); IPR2014-00573, Paper 9
`
`(PTAB September 29, 2014). At the institution stage of Varian, no declaration
`
`testimony was submitted to disqualify the prior art as “by another.” Varian, Papers
`
`11 and 14. Here, four declarations were provided to support disqualification of
`
`Ghofrani as prior art “by another.” In Nelson, the sole declaration was neither
`
`corroborated nor unequivocal regarding the relevant authors’ contributions.
`
`Nelson, Paper 9, 10-11 (“Mr. Poon indicates that the subject matter of Figures 1-
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`4830-1547-0430.4
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`3
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`IPR2017-01621
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`PO Reply to Response to Request for Rehearing
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`10 may have involved contribution from both co-inventors [of the alleged prior
`
`art]” and “Patent Owner offered the Poon Declaration, but nothing further, and
`
`notably, no declaration by [the inventor on both the prior art and the patent at
`
`issue].”) Here, the statements are both corroborated and unequivocal.
`
`Petitioner’s citation of Ex parte Kroger does not contradict this conclusion.
`
`Appeal No. 442-62 (BPAI November 22, 1982); Response, 5. The Board in
`
`Varian clarified that Ex Parte Kroger “does not stand for the proposition that
`
`declarations from only a subset of named inventors is per se insufficient to satisfy
`
`Katz.” Paper 79, 28. Rather, “the issue in Ex Parte Kroger was that a co-author of
`
`the publication being relied upon as prior art refused to agree that he was not a co-
`
`inventor.” Id. No such disagreement is evidenced by the testimony presented by
`
`Patent Owner. Rather, the statements of the four Ghofrani authors are unequivocal
`
`that the non-inventor co-authors did not contribute to the relevant portion of
`
`Ghofrani and that the material originated with the inventors.
`
`B. There is no legal requirement to analyze inventorship in order to
`disqualify Ghofrani as prior at “by another.”
`
`Petitioner’s remaining arguments (Response, 6-10) rest on the assumption
`
`that “the inventive entity of Ghofrani is Seeger, Voswinckel, Ghofrani,
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`Grimminger and Richenberg [sic.].” Response, 7. As explained above and in the
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`Request for Rehearing, the four sworn statements from the Ghofrani authors
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`explicitly contradict this assumption and suffice to remove the non-inventor co-
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`4830-1547-0430.4
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`4
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`IPR2017-01621
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`PO Reply to Response to Request for Rehearing
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`authors as authors of the relevant portion of Ghofrani. Supra II.A.; Request for
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`Rehearing, 2-11. Petitioner offers no alternative “inventive entity” other than the
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`full list of authors on Ghofrani. Petitioner does not comment on whether
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`additional evidence regarding inventorship should be required if the “inventive
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`entity” of the relevant portion of Ghofrani was found to exclude the non-inventor
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`co-authors.
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`No additional evidence should have been required, and the decision
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`misapprehends the test in requiring it. Indeed, as the Board held in Varian,
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`“[u]nlike the inclusion of a non-inventor co-author on a publication, however, the
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`omission of a named inventor from co-authorship has no significance for whether
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`the publication is the work of ‘others.’” Varian, Paper 79, 31; Applied Materials
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`Inc. v. Gemini Research Corp., 835 F.2d 279, 281 (Fed. Cir. 1987). Thus, once
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`Ghofrani, Grimminger, and Reichenberger disclaimed the relevant portion of
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`Ghofrani, and Seeger confirmed that it originated with the inventors, the reference
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`was no longer “by another,” and should have been disqualified as prior art.
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`III. CONCLUSION
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`Patent Owner disqualified Ghofrani. Its rehearing request should be granted.
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`Date: February 28, 2018
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`4830-1547-0430.4
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`Respectfully submitted,
`
`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`
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`5
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`IPR2017-01621
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`PO Reply to Response to Request for Rehearing
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`George E. Quillin
`Registration No. 32,792
`
`Foley & Lardner LLP
`3000 K Street, N.W.
`Suite 600
`Washington, D.C. 20007
`
`Shaun R. Snader
`Registration No. 59,987
`United Therapeutics Corporation
`2nd Fl., 1735 Connecticut Avenue, N.W.
`Washington, DC 20009
`Counsel for Patent Owner
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`4830-1547-0430.4
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`6
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`IPR2017-01621
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`
`PO Reply to Response to Request for Rehearing
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`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing PATENT OWNER
`REPLY TO PETITIONER’S RESPONSE TO REQUEST FOR REHEARING
`UNDER 37 C.F.R. § 42.71 is being served on February 28, 2018, by filing this
`document through the PTAB E2E System as well as delivering copies via email to
`the following counsel for the Petitioner:
`
`Michael K. Nutter (Reg. No. 44,979)
`WINSTON & STRAWN LLP
`35 W. Wacker Dr.
`Chicago, IL 60601
`Email: mnutter@winston.com
`
`Andrew R. Sommer (Reg. No. 53,932)
`WINSTON & STRAWN LLP
`1700 K Street, N.W.
`Washington, DC 20006-3817
`Email: asommer@winston.com
`
`Kurt A. Mathas
`WINSTON & STRAWN LLP
`35 W. Wacker Dr.
`Chicago, IL 60601
`Email: kmathas@winston.com
`
`/Stephen B. Maebius/
`
`Stephen B. Maebius
`Registration No. 35,264
`
`George E. Quillin
`Registration No. 32,792
`
`Shaun R. Snader
`Registration No. 59,987
`
`Counsel for Patent Owner
`
`
`
`4830-1547-0430.4
`
`
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