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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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`WATSON LABORATORIES, INC.
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORP.
`Patent Owner
`
`
`
`Patent No. 9,339,507
`Issue Date: July 13, 2017
`Title: TREPROSTINIL ADMINISTRATION BY INHALATION
`_______________
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`Inter Partes Review No. 2017-01622
`____________________________________________________________
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`PATENT OWNER’S OPPOSITION TO PETITIONER’S COMBINED
`MOTION
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`4832-5505-2895
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`IPR2017-01622
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`PO Opposition to Combined Motion
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`TABLE OF CONTENTS
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`
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`I.
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`II.
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`INTRODUCTION ........................................................................................... 1
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`LEGAL STANDARDS ................................................................................... 1
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`III. OPPOSITION TO MOTION TO SUBMIT SUPPLEMENTAL
`INFORMATION ............................................................................................. 2
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`A.
`
`B.
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`The Rubin Complaint and the supporting Rubin Declaration are
`from a dismissed case and are not relevant. .......................................... 2
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`The Turow Declaration shows no disagreement as to
`inventorship and is not relevant to the claims at issue. ......................... 5
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`C.
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`Conclusion ............................................................................................. 8
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`IV. OPPOSITION TO MOTION FOR ADDITIONAL DISCOVERY ................ 8
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`A.
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`B.
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`Petitioner cannot show that there is more than a possibility and
`mere allegation that something useful will be discovered. ................... 8
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`The request seeks protected and privileged information of the
`Patent Owner even though direct information about
`inventorship is already of record and available, creating an
`undue burden on Patent Owner. ............................................................ 9
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`C.
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`Conclusion ........................................................................................... 10
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`V.
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`CONCLUSION .............................................................................................. 10
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`TABLE OF AUTHORITIES
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`CASES
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`Garmin Int'l, Inc. v. Cuozzo Speed Techs., LLC, IPR2012–00001 (PTAB Mar. 5,
`2013) .................................................................................................................1, 8
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`Redline Detection, LLC v. Star Envirotech, Inc., 811 F. 3d 435 (Fed. Cir. 2015) .... 1
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`Trovan, Ltd. v. Sokymat SA, Irori, 299 F.3d 1292 (Fed.Cir.2002) ............................ 6
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`REGULATIONS
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`37 C.F.R. § 1.47(a) ..................................................................................................... 6
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`37 C.F.R. § 42.123 ..................................................................................................... 1
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`37 C.F.R. § 42.51 ....................................................................................................... 1
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`PO Opposition to Combined Motion
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`EXHIBITS CITED
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`Description
`Claims of Abandoned U.S. Application No. 11/748,205
`Inventor Oaths filed in U.S. Application No. 12/591,200 (granted as
`the ’240 patent) and U.S. Application No. 13/469,854 (granted as the
`’507 patent)
`Dismissal of Complaint of Dr. Lewis Rubin and Motion for
`Attorney’s Fees
`Excerpts from Deposition of Dr. Lewis Rubin
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`Exhibit No.
`2201
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`2202
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`2203
`2204
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`PO Opposition to Combined Motion
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`I.
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`INTRODUCTION
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`
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`Patent Owner opposes Petitioner’s request to submit three exhibits as
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`supplemental information and to obtain an unredacted copy of one of the three
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`exhibits. None of the three exhibits is relevant to the issue identified by Petitioner
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`or to a claim for which the trial has been instituted.
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`II. LEGAL STANDARDS
`A party filing a motion to submit supplemental information must show that
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`the supplemental information is “relevant to a claim for which the trial has been
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`instituted.” 37 C.F.R. § 42.123. Even if this condition is met, the Board may
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`exercise its discretion and deny the motion. Redline Detection, LLC v. Star
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`Envirotech, Inc., 811 F. 3d 435, 446 (Fed. Cir. 2015).
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`A party requesting additional discovery bears the burden of demonstrating it
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`is “in the interests of justice.” 37 C.F.R. § 42.51. To determine whether to grant
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`the motion, the Board considers the five Garmin factors, i.e., whether the request:
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`(1) is based on more than a mere possibility of finding something useful; (2) seeks
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`the other party’s litigation positions or the basis for those positions; (3) seeks
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`information that reasonably can be generated without the discovery request; (4) is
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`easily understandable; and (5) is overly burdensome to answer. Garmin Int’l, Inc.
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`v. Cuozzo Speed Techs., LLC, IPR2012–00001, Paper 26, 6–7 (PTAB Mar. 5,
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`2013).
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`III. OPPOSITION TO MOTION TO SUBMIT SUPPLEMENTAL
`INFORMATION
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`Petitioner asserts that the Rubin Complaint, the supporting Rubin
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`Declaration, and the Turow Declaration are relevant to determining whether
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`Ghofrani is prior art “by another.” Combined Motion, 1, 5. But none of the
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`proposed exhibits even mention, much less address, Ghofrani or its authorship.
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`Petitioner asserts that the proposed exhibits nevertheless are relevant to
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`determining the “inventive entity” of each of the challenged claims because they
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`tend to show that Dr. Rubin conceived the challenged claims without involvement
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`of the other co-inventors, some of who “were willing to be withdrawn from the
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`patent.” Combined Motion, 1, 5. But, again, none of the proposed exhibits even
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`mention, much less address, the challenged claims, their specific limitations, or the
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`inventorship thereof. And at no point were any inventors “willing to be withdrawn
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`from the patent,” as Watson suggests, and regardless, an inventor’s willingness to
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`be listed or not as an inventor is not the test of inventorship. The proposed exhibits
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`simply are not relevant to a claim for which trial was instituted.
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`A. The Rubin Complaint and the supporting Rubin Declaration are
`from a dismissed case and are not relevant.
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`The Rubin Complaint is not even evidence—it contains merely hearsay
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`allegations that were in fact dismissed by the Maryland court and are subject to a
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`motion for attorneys’ fees. Ex. 2203. The Rubin Declaration is also a self-serving
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`justification to avoid an award of attorneys’ fees for frivolous litigation. Neither
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`document presents any evidence that contradicts or relates to the Declarations
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`discussing the contributions of the respective Ghofrani authors. Neither document
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`alleges or even suggests that Dr. Rubin conceived or invented every claim
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`limitation,1 including the critical limitations in every claim relating to the very
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`specific pulsed ultrasonic nebulizer with very specific features for a sophisticated
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`synchronization scheme to match pulses to breath.2
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`If anything, the documents confirm the collaboration between Dr. Rubin and
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`the inventors as early as 2003, demonstrating that the work Watson relies on in
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`Ghofrani was the work of the named inventors jointly, and thus not “of another.”
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`1 For Watson’s relevance claim to succeed, the proposed exhibits must have a
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`“tendency to make…more probable” that “the invention of the challenged claims
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`originated with Dr. Rubin without the involvement of the other co-inventors.”
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`Combined Motion, 5-6. But at most Dr. Rubin alleges the conception of some
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`limitations, which is expected and not disputed as he is a joint co-inventor.
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`2 The sole limitation Dr. Rubin even alleges to have conceived in the two proposed
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`exhibits is “a single event consisting of fewer than 18 breadths [sic.].” Ex. 1171,
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`¶ 5. Thus, even if his allegations were taken as true, they do not tend to show that
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`he is the sole inventor of the claims, but merely, as expected, a co-inventor.
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`3
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`Ex. 1170 at ¶ 26 (Dr. Rubin recommended Drs. Seeger and Olschewski join him in
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`the development program due to their expertise in inhalation treatments); id. at
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`¶ 27 (“It was agreed that Drs. Seeger and Olschewski would work with Dr. Rubin
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`on the TRIUMPH development program” in Mid-September 2003); id. at ¶ 28 (In
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`agreements signed on or around September 23-30, 2003, Drs. Rubin and Seeger
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`assumed titles of co-chair of the development program).3
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`If the Board permits Petitioner to introduce the proposed exhibits, Patent
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`Owner will introduce other documents from that case and the district court case
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`between the parties directly refuting Watson’s speculation including admissions,
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`elicited by and known to Watson, demonstrating that Dr. Rubin had no
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`involvement in critical claim limitations and his co-inventors did.4 See e.g., Ex.
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`3 Indeed, documents already of record refute Watson’s speculation. Ex. 1011, ¶ 4
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`and ¶ 8 (sworn declaration from Dr. Rubin admitting he is a “co-inventor” of the
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`claimed subject matter and that he and the co-inventors performed the claimed
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`methods prior to Sept. 1, 2005); 1058, ¶ 4 (sworn declaration from Dr. Rubin
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`admitting co-inventorship and detailing the joint studies and unexpected results
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`obtained with his co-inventors).
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`4 Notably, this deposition testimony was elicited by counsel for Watson from the
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`same law firm that is representing Watson as Petitioner in this inter partes review
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`2204, 75 (admitting he was not involved in determining the drug concentration in
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`the formulation, which is a critical claim limitation found in every claim); id. at
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`80:10-13; 81:18- 23 (admitting he was not involved in and provided no input into
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`the design for the device that was used); id. at 92:3-6 (admitting he had no
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`involvement in configuring the visual and audio signals on the device used); and
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`id. at 117-120 (describing the inventive contributions of co-inventors who were
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`“instrumental in the selection and development of the delivery device, the
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`nebulizer ” and “critical in further developing the concept, particularly focusing on
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`the delivery mechanism, which is a critical element of the patents;” another co-
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`inventor’s contribution to the patent was focused on the delivery system that is a
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`component of the patents; and a co-inventor whose contribution to the patent was
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`the mechanisms of delivery.).
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`B.
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`The Turow Declaration shows no disagreement as to inventorship
`and is not relevant to the claims at issue.
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`Petitioner argues that the Turow Declaration has a tendency to make the
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`“fact” of the inventors’ contributions to the claims of the ’507 patent “less
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`probable.” Combined Motion, 6. Petitioner’s argument, however, contradicts a
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`where Watson is suggesting that Dr. Rubin developed the invention without input
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`from his co-inventors.
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`basic tenet of patent law: inventorship is determined on a claim by claim basis.
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`Trovan, Ltd. v. Sokymat SA, Irori, 299 F.3d 1292, 1302 (Fed.Cir.2002) . The
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`Turow Declaration refers only to the claims of a ’205 “metered-dose inhaler”
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`application, which differ markedly from the claims at issue, which all require a
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`pulsed ultrasonic nebulizer. The Declaration and its exhibits are thus not relevant
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`to a claim for which trial has been instituted. Even if any discussion in the Turow
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`Declaration could be incorrectly deemed to be relevant to the separate application
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`leading to the ’507 patent, it is clear that the inventors never disavowed
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`contributions or invention.
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`The Turow Declaration was submitted in U.S. Application No. 11/748,205
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`(“the ’205 application”), an abandoned parent of the ’507 patent. Ex. 1173, 1. It
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`was submitted under 37 C.F.R. § 1.47(a) to request acceptance of the inventors’
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`oaths in this application with non-signing inventors. Ex. 1173. The declaration
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`itself states that the inventors’ request for withdrawal “does not indicate that any
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`of…[the inventors]…denies being an inventor” but rather was based on the desire
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`of one or more co-inventors for “additional compensation.” Ex. 1173, 6. Indeed,
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`rather than disavow any inventive contribution, the inventors were arguing that
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`they should get additional compensation for their development of the metered-dose
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`inhaler (MDI) approach. Ex. 1172, 24-25. Thus, the Turow Declaration does not
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`raise a dispute as to the correct inventive entity even of the ’205 application, much
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`less to the claims of the ’507 patent or any of the Ghofrani subject matter.
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`In the ’507 patent and the provisional parent application to both the ’507
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`patent and ’205 application, all the named inventors submitted oaths confirming
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`that they were co-inventors as to that claimed subject matter. Ex. 2202.
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`Petitioner’s implication that the Turow Declaration could erase the effect of these
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`oaths and call into question “the proper co-inventors of the subject matter claimed
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`in the [challenged patent]” (Combined Motion, 5) is incorrect. The claims of the
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`’205 application markedly differ from the claims of the ’507 patent. The ’205
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`application requires the use of a “metered dose inhaler”, MDI, as the relevant
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`device. It is this device that is in dispute in the Turow Declaration exhibits. Ex.
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`1001; 2201; see also Ex. 1172, 24 (where Dr. Seeger explicitly references the
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`“metered dose inhaler approach”). In contrast, the ’507 patent does not require a
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`MDI, but a pulsed ultrasonic nebulizer with specific features and function. A
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`simple comparison of the ’205 application claims 1-54 and the ’507 patent claims
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`1-9 reveals numerous other distinct claim limitations, as well. Ex. 1001; Ex. 2201.
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`Given the differences between the claims of the ’205 application and the ’507
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`patent (id.), it cannot be assumed that questions as to inventorship of the MDI of
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`the ’205 application are relevant to inventorship of the ’507 patent, which does not
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`claim an MDI.
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`C. Conclusion
`Petitioner has failed to show the relevance of any of the three proposed
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`exhibits to a claim for which trial was instituted. Accordingly, Petitioner’s motion
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`should be denied.
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`IV. OPPOSITION TO MOTION FOR ADDITIONAL DISCOVERY
`Petitioner requests additional discovery in the form of an unredacted copy of
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`the Turow Declaration, contending that this is “in the interests of justice.”
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`Combined Motion, 7. Notably, Petitioner’s motion is contingent on demonstrating
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`that the Turow Declaration is relevant, which it has not. See supra III.B.
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`Furthermore, the request does not meet at least four critical Garmin factors. Even
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`if the Garmin factors had been satisfied, the redactions based on attorney-client
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`and common interest privilege are not discoverable.
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`A.
`
`Petitioner cannot show that there is more than a possibility and
`mere allegation that something useful will be discovered.
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`As noted above, the Turow Declaration does not mention Ghofrani, its non-
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`inventor co-authors, or the relevant subject matter in Ghofrani or the challenged
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`claims. Indeed, the dispute referenced in the Turow Declaration was strictly
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`related to an MDI approach and was not related to inventorship, but rather
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`compensation. Ex. 1173, 6; supra III.B. The Turow Declaration does not relate to
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`the claims of the ’507 patent. Ex. 1173, 1; supra III.B. Accordingly, the notion
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`that redacted material in the Turow Declaration should have any bearing on facts
`8
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`relating to the ’507 patent claims is no more than a strained possibility and
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`allegation, lacking basis in any analysis presented by Petitioner or evidence
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`available in the Turow Declaration.
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`B.
`
`The request seeks protected and privileged information of the
`Patent Owner even though direct information about inventorship
`is already of record and available, creating an undue burden on
`Patent Owner.
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`Petitioner asserts that the unredacted Turow Declaration will not reveal
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`anything relating to Patent Owner’s positions in this or “any other litigation.”
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`Combined Motion, 9 (emphasis in original). However, the Turow Declaration
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`explicitly relates to a contractual disagreement and the desire of certain inventors
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`to obtain more compensation, resulting in their refusal to sign inventor oaths in the
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`’205 application, which was abandoned. Accordingly, the circumstances of the
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`Turow Declaration explicitly relate to an underlying legal dispute, and additional
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`discovery in the form of the unredacted version would have the effect of seeking
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`Patent Owner’s litigation positions and the underlying basis for these positions.
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`Even if this is not of the type contemplated by the second Garmin factor, the
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`redacted information discusses and refers to attorney-client privileged
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`communications with patent counsel, common interest privilege, and confidential
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`business information about a technology not even related to the claims here at issue.
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`The burden on Patent Owner to disclose privileged and protected information
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`about an unrelated technology concerning different patent claims is not justified by
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`the strained speculation of finding something useful, particularly in light of
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`voluminous evidence of the inventors’ roles and contributions found and known to
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`Watson in a heavily developed district court record and sworn file history
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`declarations.
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`C. Conclusion
`Petitioner has shown no more than a possibility and mere allegation of
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`uncovering something useful, additional discovery seeks privileged information,
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`seeks information that reasonably can be generated without the request, and is
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`burdensome to Patent Owner where it is not even related to the claims (or even
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`technology) here at issue. The request for additional discovery is not in the
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`interests of justice and should be denied.
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`V. CONCLUSION
`Patent Owner urges denial of Petitioner’s Combined Motion and
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`expungement of the Rubin complaint, Rubin Declaration, and Turow Declaration
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`from the record of this proceeding.
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`Date: March 23, 2018
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`Respectfully submitted,
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
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`George E. Quillin
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`Registration No. 32,792
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`Foley & Lardner LLP
`3000 K Street, N.W.
`Suite 600
`Washington, D.C. 20007
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`Shaun R. Snader
`Registration No. 59,987
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`United Therapeutics Corporation
`1735 Connecticut Avenue, N.W.
`Second Floor
`Washington, DC 20009
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`Counsel for Patent Owner
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of the foregoing Patent Owner
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`Response and Exhibits 2201-2204 are being served on March 23, 2018, by filing
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`these documents through the PTAB E2E System as well as delivering copies via
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`email to the following counsel for the Petitioner:
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`
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`Michael K. Nutter (Reg. No. 44,979)
`WINSTON & STRAWN LLP
`35 W. Wacker Dr.
`Chicago, IL 60601
`Email: mnutter@winston.com
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`Andrew R. Sommer (Reg. No. 53,932)
`WINSTON & STRAWN LLP
`1700 K Street, N.W.
`Washington, DC 20006-3817
`Email: asommer@winston.com
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`Kurt A. Mathas
`WINSTON & STRAWN LLP
`35 W. Wacker Dr.
`Chicago, IL 60601
`Email: kmathas@winston.com
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`4832-5505-2895
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`/Stephen B. Maebius/
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`Stephen B. Maebius
`Registration No. 35,264
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`George E. Quillin
`Registration No. 32,792
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`Shaun R. Snader
`Registration No. 59,987
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`Counsel for Patent Owner
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