Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`
`
` Paper No. 39
` Entered: April 27, 2018
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`WATSON LABORATORIES, INC.
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS, CORP.
`Patent Owner.
`____________
`
`Case IPR2017-01621 and IPR2017-01622
`Patents 9,358,240 B2 and 9,339,507 B2
`____________
`
`
`Before TONI R. SCHEINER, ERICA A. FRANKLIN, and
`DAVID COTTA, Administrative Patent Judges.
`
`COTTA, Administrative Patent Judge.
`
`
`
`ORDER
`Conduct of the Proceeding
`Filing of Supplemental Information
`37. C.F.R. § 42.5; 37 C.F.R 42.123(a)
`
`
`
`
`
`
`
`
`571.272.7822
`
`
`
`
`
`
`
` Paper No. 39
` Entered: April 27, 2018
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`WATSON LABORATORIES, INC.
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS, CORP.
`Patent Owner.
`____________
`
`Case IPR2017-01621 and IPR2017-01622
`Patents 9,358,240 B2 and 9,339,507 B2
`____________
`
`
`Before TONI R. SCHEINER, ERICA A. FRANKLIN, and
`DAVID COTTA, Administrative Patent Judges.
`
`COTTA, Administrative Patent Judge.
`
`
`
`ORDER
`Conduct of the Proceeding
`Filing of Supplemental Information
`37. C.F.R. § 42.5; 37 C.F.R 42.123(a)
`
`
`
`
`
`
`
`
`
`IPR2017-01621 (Patent 9,358,240 B2)
`IPR2017-01622 (Patent 9,339,507 B2)
`
`
` INTRODUCTION
`
`Watson Laboratories, Inc. (“Petitioner” or “Watson”) filed Petitions
`
`requesting an inter partes review of claims 1‒9 of U.S. Patent No. 9,358,240
`
`B2 (Ex. 1001 in IPR2017-01621, “the ’240 patent”) and of claims 1–9 of
`
`U.S. Patent No. 9,339,507 (Ex. 1001 in IPR 2017-01622, “the ’507 patent”).
`
`IPR2017-01621, Paper 1; IPR 2017-01622, Paper 2. United Therapeutics
`
`Corp. (“Patent Owner” or “UTC”) filed Preliminary Responses to the
`
`Petitions, opposing institution. IPR2017-01621, Paper 6; IPR2017-01622,
`
`Paper 5. On January 11, 2018, after consideration of the Petition and
`
`Preliminary Response, we entered a Decision granting institution of inter
`
`partes review. IPR2017-01621, Paper 10; IPR2017-01622, Paper 9.
`
`On February 9, 2018, by email within one month of our Decision,
`
`Petitioner requested authorization to file a motion to submit supplemental
`
`information pursuant to 37 C.F.R. § 42.123(a). Ex. 3004.1 On March 9,
`
`2018, as authorized by the Board (Paper 22), Petitioner filed a Motion to File
`
`Supplemental Information pursuant to 37 C.F.R. § 42.123(a). Paper 26
`
`(“Motion” or “Mot.”). Petitioner filed the proposed supplemental
`
`information as Exhibits 1170–1172 for our consideration with the Motion.
`
`Mot. 2. Patent Owner filed an Opposition to the Motion (Paper 30
`
`(“Opposition” or “Opp.”)) supported by Exhibits 2201–2204.
`
`
`
`1 There are slight differences in the numbering of Papers and Exhibits in
`IPR2017-01621 and IPR2017-01622. Notwithstanding these differences, the
`papers relating to the motion addressed herein are substantively identical.
`Unless otherwise noted, for the convenience of the Board, citations to Papers
`and Exhibits referenced herein are only to IPR2017-01621, with the
`understanding that there exists a corresponding, substantively identical,
`Paper or Exhibit in IPR2017-01622.
`
`2
`
`
`
`IPR2017-01621 (Patent 9,358,240 B2)
`IPR2017-01622 (Patent 9,339,507 B2)
`
`
`Petitioner contends that the “proposed supplemental information
`
`speaks directly to the inventive entity of the challenged claims and thus is
`
`plainly relevant to the prior art status of Ghofrani,” a reference relied upon
`
`in connection with the instituted ground. Mot. 4. Patent Owner asserts that
`
`“none of the proposed exhibits even mention, much less address, Ghofrani or
`
`its authorship” and that “none of the proposed exhibits even mention, much
`
`less address, the challenged claims, their specific limitations, or the
`
`inventorship thereof.” Opp. 2. For the reasons expressed below, Petitioner’s
`
`Motion is granted.
`
`II. ANALYSIS
`
`37 C.F.R. § 42.123(a) concerns supplemental information and states:
`
`(a) Motion to submit supplemental information. Once a trial has
`been instituted, a party may file a motion to submit
`supplemental information in accordance with the following
`requirements:
`(1) A request for the authorization to file a motion to
`submit supplemental information is made within one month of
`the date the trial is instituted.
`(2) The supplemental information must be relevant to a
`claim for which the trial has been instituted.
`
`Satisfaction of the above-listed requirements for filing the motion,
`
`however, does not mean the Board will grant the motion. Redline Detection,
`
`LLC v. Star Envirotech, Inc., 811 F.3d 435, 445 (Fed. Cir. 2015). Instead,
`
`the “guiding principle” for the Board is to “ensure efficient administration of
`
`the Office and the ability of the Office to complete IPR proceedings in a
`
`timely manner.” Id. Under this “guiding principle,” the Board has broad
`
`discretion in granting or denying motions to submit supplemental
`
`information. Id.
`
`There is no question that Patent Owner made its request within one
`
`3
`
`
`
`IPR2017-01621 (Patent 9,358,240 B2)
`IPR2017-01622 (Patent 9,339,507 B2)
`
`month of the date trial was instituted. The relevance of proffered Exhibits,
`
`however, is disputed.
`
`Exhibit 1170 is a complaint from a Maryland state court litigation
`
`between Dr. Lewis J. Rubin, a named inventor, and the Patent Owner over
`
`ownership of the patents at issue in this proceeding. The complaint states, in
`
`relevant part:
`
`23. During [a] Mid-September 2003 Luncheon, Dr. Rubin
`mentioned that he had conceived a new PAH [pulmonary
`arterial hypertension] treatment program using an inhalation
`methodology for the administration of the drug treprostinil,
`which he believed offered distinct advantages over known
`intravenous and subcutaneous PAH treatments. Dr. Rubin’s
`proposed program was of great interest to Rothblatt and the
`social luncheon turned to a discussion of a proposed UTC
`development program, relating to Dr. Rubin’s new PAH
`treatment methodology.
`
`24. The Mid-September 2003 Luncheon lasted for no less
`than 4 hours. Dr. Rubin fully outlined a program to develop his
`new PAH treatment, providing Rothblatt with full particulars
`concerning his inventions which later became the subject of the
`claims in the ’507 and ’240 patents. . . .
`
`25. As more fully discussed at the Mid-September 2003
`Luncheon, Dr. Rubin proposed the administration of treprostinil
`by a metered dose inhaler or pulsed nebulizer that would
`effectively deliver the medication in a single event consisting of
`fewer than 18 breaths. This disclosure provided the approach
`for UTC’s program to develop Dr. Rubin’s inventions . . .
`
`Ex. 1170, 8.
`
`
`
`Exhibit 1171 is an affidavit from Dr. Rubin submitted in connection
`
`with the Maryland state court litigation. In it, Dr. Rubin states, in relevant
`
`part:
`
`4
`
`
`
`IPR2017-01621 (Patent 9,358,240 B2)
`IPR2017-01622 (Patent 9,339,507 B2)
`
`
`I conceptualized the invention which is the subject of the patent
`rights at issue in this case – the treatment of PAH by
`administration of treprostinil by a metered dose inhaler or
`pulsed nebulizer. An aspect of the invention, which I believe is
`critical is the delivery of the medication in a single even
`consisting of fewer than 18 breaths.
`
`
`Ex. 1171, 2.
`
`Exhibit 1172 is the Declaration of Rachel Turow (“the Turow
`
`Declaration”), which was submitted in U.S. Application No. 11/748,205
`
`(“the ’205 application”), a parent of the applications that ultimately issued as
`
`the patents at issue in these proceedings. It was submitted under 37 C.F.R. §
`
`1.47(a) to request that the Patent Office accept inventors’ oaths in without
`
`the signatures of Horst Olschewski, Thomas Schmehl, Werner Seeger, and
`
`Robert Voswinckel, all four of whom are identified as inventors on the
`
`patents at issue. Ex. 1172, 2. The Turow Declaration attaches a number of
`
`exhibits, including email correspondence with the non-signing inventors. In
`
`one of the emails attached to the Turow Declaration, Dr. Seegar states:
`
`Should, against this background, you and our further Lung Rx
`partners insist on the views expressed in Paul’s email [that UTC
`owned intellectual property rights to the non-signing inventors’
`work], I would like to clarify that we are willing to withdraw
`from the patent, giving you absolute freedom for the further
`promotion of the patent, independent of our group.
`
`
`Ex. 1072, 25. In another email attached to the Turow Declaration,
`
`Dr. Seegar states:
`
`Sorry, this is a misunderstanding. Our suggestion is that (in
`case Lung RX insists on the view you expressed in your emails,
`what apparently is the case) our names (Olschewski,
`Voswinckel, Schmehl, and Seeger) are removed from the
`patent.
`
`Ex. 1072, 27.
`
`5
`
`
`
`IPR2017-01621 (Patent 9,358,240 B2)
`IPR2017-01622 (Patent 9,339,507 B2)
`
`
`To determine whether Ghofrani constitutes the work of another under
`
`35 U.S.C. § 102(a), we will need to determine whether the inventorship
`
`entity of the Ghofrani reference is the same as that of the challenged claims.
`
`Exhibits 1070 and 1071 directly address the contribution Dr. Rubin
`
`made to the subject matter claimed in the patents at issue. Patent Owner
`
`asserts that the documents from the Maryland state court action do not
`
`suggest that “Dr. Rubin conceived or invented every claim limitation” and
`
`“[i]f anything, . . . confirm the collaboration between Dr. Rubin and the
`
`inventors . . . demonstrating that the work Watson relies on in Ghofrani was
`
`the work of the named inventors jointly, and thus not ‘of another.’” Opp. 3.
`
`However, even if we were to accept Patent Owner’s contention that the
`
`Rubin documents confirm the joint inventorship of the each of the claims of
`
`the patents at issue, Exhibits 1070 and 1071 would still be relevant to the
`
`identity of the inventorship entity for the claims at issue.
`
`
`
`Exhibit 1172, the Turow Declaration, includes statements that certain
`
`of the named inventors were willing to withdraw and have their names
`
`removed from a related patent application. Ex. 1172, 25, 27. We find that
`
`these statements are relevant because they have a tendency to make its less
`
`likely that these inventors considered themselves to be joint inventors of
`
`subject matter similar to that of the claims at issue. Fed. R. Evid. 401.
`
`While the relevance of these statements appears diminished by the context in
`
`which they were made – i.e., in a contract dispute rather than in a substantive
`
`discussion of the contributions made by individual inventors – we cannot say
`
`here that they are irrelevant. We acknowledge Patent Owner’s argument
`
`that the Turow Declaration was submitted in connection with a different
`
`patent having different claims (Opp. 7), but find that the subject matter
`
`6
`
`
`
`IPR2017-01621 (Patent 9,358,240 B2)
`IPR2017-01622 (Patent 9,339,507 B2)
`
`implicated by the Turow Declaration was sufficiently related to the subject
`
`matter at issue in the challenged claims to have relevance in this proceeding.
`
`We also acknowledge Patent Owner’s argument that nothing in the Turow
`
`Declaration is inconsistent with joint inventorship. Id. at 6–7. However, as
`
`discussed above, even if the proffered exhibit simply confirms the joint
`
`inventorship of the each of the claims of the patents at issue, it would still be
`
`relevant to establishing the inventorship of those claims.
`
`III. CONCLUSION
`
`
`
`For the reasons discussed above, we grant Petitioner’s motion to
`
`submit Exhibits 1170–1172 as supplemental information under 37 C.F.R.
`
`§ 42.123(a).
`
`7
`
`
`
`IPR2017-01621 (Patent 9,358,240 B2)
`IPR2017-01622 (Patent 9,339,507 B2)
`
`
`IV. ORDER
`
`
`
`In accordance with the foregoing, it is hereby ORDERED that
`
`Petitioner’s Motion to file Exhibits 1170–1172 is granted, as those exhibits
`
`have been filed, no further action is required by Petitioner in this regard.
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`8
`
`
`
`IPR2017-01621 (Patent 9,358,240 B2)
`IPR2017-01622 (Patent 9,339,507 B2)
`
`
`
`PETITIONER:
`
`Michael K. Nutter
`Andrew R. Sommer
`WINSTON & STRAWN LLP
`mnutter@winston.com
`asommer@winston.com
`
`
`
`PATENT OWNER:
`
`Stephen B. Maebius
`George Quillin
`FOLEY & LARDNER LLP
`smaebius@foley.com
`gquillin@foley.com
`
`
`
`Shaun R. Snader
`
`UNITED THERAPEUTICS CORP.
`ssnader@unither.com
`
`
`Douglas Carsten
`Richard Torczon
`Robert Delafield
`Veronica Ascarrunz
`WILSON, SONSINI, GOODRICH & ROSATI
`dcarsten@wsgr.com
`rtorczon@wsgr.com
`bdelafield@wsgr.com
`vascarrunz@wsgr.com
`
`
`
`
`
`9
`
`
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