throbber
Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`
` Paper No. 33
` Entered: March 26, 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
`Patents 9,358,240 B2
`____________
`
`
`Before TONI R. SCHEINER, ERICA A. FRANKLIN, and DAVID
`COTTA,1 Administrative Patent Judges.
`
`COTTA, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`1 Please note that the panel for this proceeding has changed, with Judge
`Scheiner replacing Judge Green.
`
`
`
`

`

`IPR2017-01621
`Patent 9,358,240 B2
`
`
` INTRODUCTION
`Watson Laboratories, Inc. (“Petitioner” or “Watson”) filed a Petition
`requesting an inter partes review of claims 1‒9 of U.S. Patent No. 9,358,240
`B2 (Ex. 1001, “the ’240 patent”). Paper 1 (“Pet.”). United Therapeutics
`Corp. (“Patent Owner” or “UTC”) filed a Preliminary Response to the
`Petition opposing institution. Paper 6 (Prelim. Resp.). On January 11, 2018,
`after consideration of the Petition and Preliminary Response, we entered a
`Decision granting institution of inter partes review. Paper 10 (“Dec.”). On
`January 25, 2018, Patent Owner filed a Request for Rehearing (Paper 14,
`“Req. Reh’g”) seeking reconsideration of our Decision.
`For the reasons stated below, Patent Owner’s Request for Rehearing is
`denied.
`
`II. ANALYSIS
`Standard of Review
`When reconsidering a decision on institution, we review the decision
`for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may
`be found if a decision is based on an erroneous interpretation of law, if a
`factual finding is not supported by substantial evidence, or if the decision
`represents an unreasonable judgment in weighing relevant factors. Star
`Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold
`P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203
`F.3d 1305, 1315–16 (Fed. Cir. 2000). The party requesting rehearing has the
`burden of showing the decision should be modified, which includes
`specifically identifying all matters the party believes we misapprehended or
`overlooked. 37 C.F.R. § 42.71(d).
`
`
`
`2
`
`

`

`IPR2017-01621
`Patent 9,358,240 B2
`
`
`Background
`Petitioner challenged claims 1–9 of the ’240 Patent under 35 U.S.C.
`
`§ 103(a) as obvious over the combination of Voswinckel (Ex. 1003,
`“Voswinckel”), Patton (Ex. 1012, “Patton”), and Ghofrani (Ex. 1005,
`“Ghofrani”). We instituted inter partes review based on this ground. Dec.
`38–39. We declined to institute inter partes review based on two additional
`grounds that relied upon different combinations of art. Id.
`Patent Owner’s Request for Rehearing focuses on our determination
`that Petitioner provided sufficient evidence that Ghofrani was the work of
`another to institute inter parties review. Ghofrani is a journal article
`published in the June 2005 issue of Herz. Ex. 1005. Ghofrani lists as
`authors two persons identified on the face of the ’240 patent as inventors
`(Robert Voswinckel and Werner Seeger) as well as three non-inventors
`(Hossein Ardeschir Ghofrani, Frank Reichenberger, and Friedrich
`Grimminger). Ex. 1001, Ex.1005. The ’240 Patent lists as inventors five
`persons who are not listed as authors of Ghofrani (Horst Olschewski, Robert
`Roscigno, Lewis J. Rubin, Thomas Schmel, and Carl Sterritt). Id. Petitioner
`asserts that Ghofrani is a prior art printed publication under 35 U.S.C.
`§ 102(a). Pet. 15-16. Patent Owner contends that Ghofrani does not qualify
`as prior art because it is not the work of “another.” Prelim. Resp. 21–24;
`Req. Reh’g 2–11.
`
`Our Decision identified two factual disputes relating to the issue of
`whether Ghofrani constitutes the work of another with respect to the ’240
`patent: 1) the extent to which Ghofrani represents the work of the five non-
`author inventors, and 2) the extent to which the three non-inventor authors
`contributed to the portion of Ghofrani relied upon by Petitioner. Dec. 13–
`
`3
`
`

`

`IPR2017-01621
`Patent 9,358,240 B2
`
`14. Viewing the declaratory evidence “in the light most favorable to the
`petitioner solely for purposes of deciding whether to institute an inter partes
`review,” as required by 37 C.F.R. 42.108(c), we found that Petitioner’s
`evidence was sufficient to support institution. Id. Patent Owner’s Request
`for Rehearing challenges our findings with respect to both of the factual
`disputes we identified. Req. Reh’g. 2–11.
`Legal Principles
`“A [reference] is [considered] ‘to another’ when the ‘inventive
`entities’ are different.” In re Fong, 378 F.2d 977, 980 (CCPA 1967). A
`reference may be considered “by another” with respect to a patent even
`though they share common authors and/or inventors. See In re Land, 368
`F.2d 866, 881 (CCPA 1966) (holding that individual applications to Land
`and to Rogers were prior art with respect to joint application to Land and
`Rogers). The determination of whether the disclosure in a reference is the
`work of another focuses on the authorship of the portions of the reference
`relied upon as prior art. Riverwood Int’l Corp. v. R.A. Jones & Co., Inc.,
`324 F.3d 1346, 1356 (Fed. Cir. 2003) (“What is significant is not merely the
`differences in the listed inventors, but whether the portions of the reference
`relied on as prior art, and the subject matter of the claims in question,
`represent the work of a common inventive entity.”).
`Contribution of Non-Author Co-Inventors
`In our Decision, we found that a genuine issue of material fact exists
`regarding the extent to which Ghofrani represents the work of the five non-
`author inventors. Dec. 13–14. We analyzed the declarations provided by
`the Patent Owner and concluded that “[t]he declarations from the Ghofrani
`authors leave some ambiguity as to whether and to what extent the five
`
`4
`
`

`

`IPR2017-01621
`Patent 9,358,240 B2
`
`persons who were listed as inventors of the ’240 patent, but who were not
`listed as authors of Ghofrani, contributed to the relevant portion of
`Ghofrani.” Id. at 13. In particular, we found ambiguity in Dr. Seegar’s
`statement that the work described in the relevant portion of Ghofrani
`“originated with Dr. Voswinckel and myself, in view of our work with the
`other inventors listed on the ’240 patent.” Id. at 13–14 (citing Ex. 2020 ¶ 7)
`(emphasis added).
`We continue to find ambiguity in Dr. Seegar’s statement. The phrase
`“in view of” is commonly understood to mean “taking into consideration” or
`“in consideration of.” Ex. 3005. Particularly when viewed “in the light
`most favorable to the petitioner,” Dr. Seegar’s testimony does not establish
`that the authorship entity for the relevant passage of Ghofrani is the same as
`the inventorship entity of the ’240 patent (or any of its individual claims).
`Put another way, paragraph 7 of the Seegar Declaration could mean that the
`work of all of the inventors together merely informed, served as a starting
`point, provided inspiration, or even acted as a counter example for the work
`that “originated with Drs. Seegar and Voswinckel.” None of these
`interpretations would serve to disqualify Ghofrani as prior art.
`Patent Owner argues that to disqualify Ghofrani as a prior art
`reference, “the patent owner needs only to provide declarations from non-
`inventor co-authors of the reference stating that they did not contribute to the
`relevant portion of the reference.” Req. Reh’g 4. We disagree. The inquiry
`as to whether a reference is the work of “another” is not limited to the
`contribution of the non-inventor co-authors. Rather, the inquiry is whether
`the inventive entities are the same for the relevant portion of Ghofrani and
`for the challenged claims of the ’240 patent. Fong, 378 F.2d at 980; Land,
`
`5
`
`

`

`IPR2017-01621
`Patent 9,358,240 B2
`
`368 F.2d at 881; Riverwood 324 F.3d at 1356. The testimony of the non-
`inventor co-authors, while relevant to this inquiry, does not speak to the
`contribution of the non-author co-inventors to the relevant passage of
`Ghofrani.
`In re Katz, 687 F.2d 450 (C.C.P.A. 1982), cited by Patent Owner, is
`not to the contrary. In Katz, the Board sustained the rejection of claims in a
`patent application over a reference authored by the sole inventor and two
`other persons. The Board found that the inventor’s declaration stating the
`“he [wa]s the sole inventor of the subject matter described and claimed in his
`application and also that disclosed in the [prior art reference]” was
`insufficient to disqualify the reference as the work of “another” because it
`was not corroborated. Katz, 687 F.2d 455. Our reviewing court noted that
`corroborating affidavits would have “ended the inquiry,” but found that they
`were unnecessary. Id. The court explained “[w]hat is required is a
`reasonable showing supporting the basis for the applicant’s position,” which
`the court found in the declaration of the sole inventor averring that the work
`described in the reference at issue was his own work. Id. Here, as discussed
`above, Dr. Seegar’s declaration leaves ambiguity as to whether the work
`described in Ghofrani is the work of the joint inventors of the ’240 patent.
`Accordingly, the declarations of the Ghofrani co-authors does not “end the
`inquiry.”2
`
`2 We note that the Katz appeal arose during prosecution, during which the
`Examiner bore the burden to establish a prima facie case of unpatentability.
`See, In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). In determining
`whether to institute inter partes review, the Petitioner bears the burden of
`establishing a “reasonable likelihood that at least one of the claims
`challenged in the petition is unpatentable.” 37 C.F.R. 42.108(c). At the
`institution stage, as we determine whether a Petitioner has met that burden,
`6
`
`

`

`IPR2017-01621
`Patent 9,358,240 B2
`
`
`Patent Owner argues that our Decision conflicts with that of the panel
`in Varian Med. Systs. v. Wm. Beaumont Hosp., IPR2016-00163, Paper 79
`(PTAB May 4, 2017). Req. Reh’g 5. Patent Owner asserts that the fact that
`Ghofrani does not name as authors five co-inventors of the ’240 patent is
`irrelevant in determining whether Ghofrani is the work of another because
`Varian stated that “the omission of a named inventor from co-authorship has
`no significance for whether the publication is the work of ‘others’” Req.
`Reh’g at 5. We are not persuaded.
`Varian does not stand for the absolute proposition that the
`contribution of co-inventors is irrelevant to determining whether a disputed
`reference represents the work of another. Rather, the quoted statement from
`Varian must be viewed in context of the facts and the procedural posture of
`that case. In Varian, an inventor testified that a reference relied upon by
`petitioner as prior art disclosed “work done at the direction of me and [a co-
`inventor] in support of the joint research conducted by the two of us.”
`Varian, Paper 79, 24. In view of this testimony, at the final written decision
`stage of the inter partes review, the panel found that Petitioner could not
`rely solely on the omission of a joint inventor as an author on a reference to
`establish that the reference was the work of “another.” The panel explained:
`Finally, we are unpersuaded by Petitioner’s argument that the
`Declarations “leave unresolved questions regarding the inventive
`entity of Jaffray 1999 SPIE.” Pet. Reply 19. Specifically,
`Petitioner suggests that Dr. Wong’s omission as a co-author of
`Jaffray 1999 SPIE is significant. Id. (“Absent any explanation
`for Wong’s omission, it is unreasonable to conclude that Jaffray
`and Wong were the inventors of the subject matter of Jaffray
`1999 SPIE.”). Unlike the inclusion of a non-inventor co-author
`
`we view testimonial evidence “in the light most favorable to the petitioner.”
`Id.
`
`7
`
`

`

`IPR2017-01621
`Patent 9,358,240 B2
`
`
`on a publication, however, the omission of a named inventor
`from co-authorship has no significance for whether the
`publication is the work of “others.” If, for example, Dr. Wong
`was erroneously omitted as a co-author of Jaffray 1999 SPIE,
`that would not establish that the portions of Jaffray 1999 SPIE
`relied upon by Petitioner are the work of someone other than Dr.
`Jaffray, Dr. Wong, or Dr. Siewerdsen—i.e., the named inventors
`of the ’502 patent. Furthermore, despite Petitioner’s innuendo
`about the significance of Dr. Wong’s omission, Petitioner did not
`bother to ask Dr. Jaffray about this very issue at his deposition.
`Moreover, Petitioner has not put forth any affirmative evidence
`to suggest that the work described in Jaffray 1999 SPIE was the
`work of someone other than Dr. Jaffray, Dr. Wong, or Dr.
`Siewerdsen.
`Id. at 31. As is apparent, the Varian panel did not apply a per se rule that the
`contribution of co-inventors to a disputed reference was irrelevant to the
`status of that reference as the work of another. Rather, the panel treated the
`“by another” issue as a factual issue to be determined based on the facts of
`the case at hand. We did the same in our institution decision, reaching a
`different result than was reached in the Varian decision because we found
`ambiguity in the inventor’s declaration and because, unlike the Varian
`decision, we are at the institution stage and are thus required to view
`testimonial evidence “in the light most favorable to the petitioner.”3 37
`C.F.R. 42.108(c).
`Accordingly, Patent Owner has not persuaded us that we have
`misapprehended or overlooked any matters with respect to the contribution
`of the non-author co-inventors to the Ghofrani reference. See 37 C.F.R.
`§ 42.71(d).
`
`
`3 Moreover, we note that Varian is not binding as it has not been designated
`as “Precedential.”
`
`8
`
`

`

`IPR2017-01621
`Patent 9,358,240 B2
`
`
`Contribution of Non-Inventor Co-Authors
`In our Decision, we found that a genuine issue of material fact exists
`with respect to the contribution of the three non-inventor co-authors to
`Ghofrani. Dec. 14. We balanced declarations provided by the Patent Owner
`testifying that the three non-inventor authors did not make material
`contributions to the portion of the Ghofrani article discussing a study of
`inhaled treprostinil, against the fact that the three non-inventor authors were
`authors of Voswinckel (Ex. 1003), a reference with subject matter limited to
`inhaled treprostinil. Id. We noted that “Voswinckel references a 17 patient
`study that appears to be the same as the 17 patent study discussed in the
`relevant portions of Ghofrani.” Id. We concluded that “[t]he narrow focus
`of Voswinckel and the potential that Voswinckel involved the same study as
`disclosed in Ghofrani, create a genuine issue of material fact as to the
`contribution of these non-inventors to Voswinckel and, by extension, to the
`relevant portions of Ghofrani.” Id.
`Patent Owner argues: “Voswinckel is a conference abstract containing
`different material than Ghofrani, which is a journal publication. Nothing in
`the stated authorship of Voswinckel does or ought to affect the unrebutted
`statements in the declarations of the Ghofrani authors.” Req. Reh’g 9.
`Patent Owner further argues “[s]peculation . . . about a separate reference
`cannot create a genuine issue of material fact in the face of four sworn
`declarations regarding the authorship of Ghofrani.” Id. We are not
`persuaded.
`
`We recognize that Voswinckel and Ghofrani “contain[] different
`material,” but the studies in Voswinckel and Ghofrani both involved the
`administration of treprostinil to 17 patients. Ex, 1003; Ex. 1005, 298. The
`
`9
`
`

`

`IPR2017-01621
`Patent 9,358,240 B2
`
`studies reported similar results and had overlapping authors. Id. In addition,
`the study in Ghofrani occurred in Giessen while Voswinckel acknowledges
`“Univ Hosp Giessen, Giessen, Germany” among the authors. Id. At this
`stage in the proceeding, this evidence suggests that Voswinckel and
`Ghofrani involve the same patient study.
`
`Voswinckel is reproduced in its entirety below. Ex. 1003.
`
`Ex. 1003. As can be seen, the subject matter of Voswinckel is limited to a
`17 patient study of inhaled treprostinil. Id. Based on the current record, the
`narrow focus of Ghofrani suggests, contrary to the impression created by
`their declaratory testimony,4 that the three non-inventor authors of Ghofrani
`were involved in the 17 patient study of treprostinil described in Ghofrani.
`
`Patent Owner directs us to Dr. Seegar’s testimony that Ghofrani co-
`authors made largely administrative contributions to Voswinckel. Dr.
`Seegar testifies:
`
`
`4 Each of the non-inventor co-authors describes the sections of the Ghofrani
`article they drafted and then testifies: “I did not make material contributions
`to any other section of the Ghofrani article, and I specifically did not
`contribute to the [passage describing the study of inhaled treprostinil].” Ex.
`2026 ¶ 5, see also, Ex. 2027 ¶ 5, Ex. 2028 ¶ 5.
`10
`
`

`

`IPR2017-01621
`Patent 9,358,240 B2
`
`
`In general, when my research center submits abstracts to a
`conference or articles for publication, we include members of
`the research group who contributed in some way to the abstract
`or article as authors.
`
`titled “Pulmonary Arterial
`the abstract
`For example,
`Hypertension: New Therapies,”
`[Voswinckel] which
`I
`understand was submitted by Watson as Exhibit 1003, lists as
`authors members of my research center who contributed by
`performing the administrative work supporting the trial, taking
`care of patients enrolled in the trial, and/or collecting data for the
`trial. Drs. Ghofrani, Reichenberger, and Grimminger are among
`the authors who contributed to the trial in this manner.
`
`Ex. 2020 ¶¶ 10–11. While this testimony provides a potential explanation
`for the apparent inconsistency between the authorship of the Voswinckel
`reference and the assertion that Drs. Ghofrani, Reichenberger, and
`Grimminger did not contribute to the relevant subject matter in the Ghofrani
`reference, Patent Owner has not persuaded us that we erred in failing to
`resolve this disputed factual issue in its favor.
`Petitioner has not yet had the opportunity to cross-examine any of the
`Patent Owner’s declarants on this issue. Moreover, the only testimony of
`record specifically addressing what the non-inventor co-authors did in
`connection with the 17 patient study is the above quoted testimony of the
`inventor, Dr. Seegar.5 Drs. Ghofrani, Reichenberger, and Grimminger
`provide declarations, but do not testify as to their contribution to Voswinckel
`or otherwise describe the work they did in connection with the 17 patient
`study. In sum, we consider the contribution of the non-inventor co-authors
`
`
`5 While it is implied, Dr. Seegar never states that the administrative work
`described in his declaration is the only contribution of the non-inventor
`authors to Voswinckel.
`
`11
`
`

`

`IPR2017-01621
`Patent 9,358,240 B2
`
`to present a genuine issue of material fact which we must view “in the light
`most favorable to the petitioner.” 37 C.F.R. 108(c).
`Accordingly, Patent Owner has not persuaded us that we have
`misapprehended or overlooked any matters with respect to the contribution
`of the non-inventor co-authors to the Ghofrani reference. 37 C.F.R. §
`42.71(d).
`
`III. CONCLUSION
`For the foregoing reasons, we conclude that Patent Owner has not
`shown that the Board abused its discretion in denying institution of the
`challenged claims. See 37 C.F.R. § 42.71(d).
`
`ORDER
`
`Accordingly, it is
`ORDERED that Patent Owner’s Request for Rehearing is denied.
`
`
`
`
`
`
`
`
`
`
`12
`
`

`

`IPR2017-01621
`Patent 9,358,240 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
`
`
`13
`
`

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