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,
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`v.
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`UNITED THERAPEUTICS, INC.,
`Patent Owner.
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`Case No. IPR2017-01622
`Patent No. 9,358,507
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`PETITIONER’S RESPONSE TO PATENT OWNER’S REQUEST FOR
`REHEARING UNDER 37 C.F.R. § 42.71
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`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`PO Box 1450
`Alexandria, Virginia 22313-1450
`Submitted Electronically via the Patent Review Processing System
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`WATSON LABORATORIES, INC.,
`Petitioner,
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`v.
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`UNITED THERAPEUTICS, INC.,
`Patent Owner.
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`
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`
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`Case No. IPR2017-01622
`Patent No. 9,358,507
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`
`
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`PETITIONER’S RESPONSE TO PATENT OWNER’S REQUEST FOR
`REHEARING UNDER 37 C.F.R. § 42.71
`
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`PO Box 1450
`Alexandria, Virginia 22313-1450
`Submitted Electronically via the Patent Review Processing System
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`
`
`I.
`II.
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`C.
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`INTRODUCTION ........................................................................................... 1
`ARGUMENT ................................................................................................... 1
`A.
`Background ........................................................................................... 1
`B.
`The Contribution of the Non-Inventor Authors to Ghofrani
`Raised a Genuine Issue of Material Fact That Cannot Be
`Resolved Pre-Institution. ....................................................................... 2
`The Ambiguity as to Inventorship of the Challenged Claims
`Raised a Genuine Issue of Material Fact That Cannot be
`Resolved Pre-Institution. ....................................................................... 6
`III. CONCLUSION .............................................................................................. 10
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`
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`TABLE OF CONTENTS
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`Page
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`i
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`TABLE OF AUTHORITIES
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` Page(s)
`
`Cases
`Cognex Corp. v. Microscan Sys., Inc.,
`No. 13 CIV. 2027 JSR, 2013 WL 5550092 (S.D.N.Y. Sept. 30,
`2013) ..................................................................................................................... 9
`
`Emerachem Holdings, LLC v. Volkswagen Group of Am.,
`859 F.3d 1341 (Fed. Cir. 2017) ........................................................................ 4, 5
`
`Ethicon Endo-Surgery, Inc. v. Hologic, Inc.,
`689 F. Supp. 2d 929 (S.D. Ohio 2010) ................................................................. 7
`
`In re Fong,
`378 F.2d 977 (CCPA 1967) .................................................................................. 7
`
`Ex parte Kroger,
`219 USPQ 370, 1982 WL 50447 (Pat. Bd. App. 1982) ....................................... 5
`
`In re Land,
`368 F.2d 866 (CCPA 1966) .................................................................................. 8
`
`Nelson Prods., Inc. v. Bal Seal Eng’g, Inc.
`IPR2014-573, Paper 9 (Sep. 2014) ..................................................................... 10
`
`Riverwood Int’l Corp. v. R.A. Jones & Co., Inc.,
`324 F.3d 1346 (Fed. Cir. 2003) ............................................................................ 7
`
`Sprint Communications Company L.P. v. Comcast IP Holdings, LLC,
`2015 WL 452289 (D. Del. 2015) .......................................................................... 9
`
`Varian Med. Sys. v. Wm. Beaumont Hosp.,
`IPR2016-163, Paper 79 (PTAB May 4, 2017) ............................................... 9, 10
`
`Viskase Corp. v. American Nat. Can Co.,
`261 F.3d 1316 (Fed. Cir. 2001) ............................................................................ 8
`
`
`
`ii
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`
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`Other Authorities
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`37 C.F.R. § 42.108(c) ................................................................................................. 3
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`Amendments to the Rules of Practice for Trials Before the Patent
`Trial and Appeal Board, 81 Fed. Reg. 18750 (April 1, 2016) .............................. 3
`
`MPEP § 2132.01 ........................................................................................................ 1
`
`
`
`
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`iii
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`
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`I.
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`INTRODUCTION
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`
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`In instituting trial on Ground 1, the Board determined that “Petitioner ha[d]
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`provided a sufficient basis on which to conclude that Ghofrani was the work of
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`another.” Inst. Dec., 15. The Board’s decision was correct. Nevertheless, Patent
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`Owner alleges that the Board erred in its “erroneous interpretation of the law” and
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`in its allegedly improper “weighing the facts of record.” Reh’g Req., 2-3. Patent
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`Owner misapprehends the Board’s discussion of controlling law and rules. And a
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`disagreement over how evidence was weighed is no grounds for rehearing.
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`Institution was proper and rehearing should be denied.
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`II. ARGUMENT
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`A. Background
`Ghofrani is a June 2005 journal article that discusses, among other things, a
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`clinical trial in Giesen, Germany in which inhaled treprostinil was administered to
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`patients with pulmonary hypertension. Ex. 1005. Ghofrani lists five authors, two of
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`whom are identified as inventors of the challenged patent (Seeger and Voswinckel)
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`and three who are not listed as inventors (Ghofrani, Reichenberger and
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`Grimminger). In addition to Seeger and Voswinckel, the challenged patent lists five
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`additional inventors who are not included as authors of Ghofrani. Petitioner
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`therefore made out a prima facie case that Ghofrani is prior art because its
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`“authorship differs . . . from the inventive entity” of the challenged claims. MPEP
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`1
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`§ 2132.01.
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`Patent Owner submitted declarations from four of the five authors of Ghofrani
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`trying to show that Ghofrani was the inventors’ own work. See Exs. 2020, 2026,
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`2027, 2028. Petitioner’s reply identified certain inconsistencies between the
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`uncorroborated declarations and other evidence of record that at the very least raised
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`a factual dispute as to whether Ghofrani was “by another.” Paper 9 at 3-5. The
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`Board agreed with Petitioner and identified two independent material fact disputes
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`as to whether Ghofrani was the work of another: (1) the contribution of the non-
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`inventor authors to the cited passage of Ghofrani; and (2) an ambiguity as to the
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`inventorship of the challenged claims. Inst. Dec., 13-14. Both of the Board’s
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`determinations were correct. Either supports institution and denying rehearing.
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`B.
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`The Contribution of the Non-Inventor Authors to Ghofrani
`Raised a Genuine Issue of Material Fact That Cannot Be
`Resolved Pre-Institution.
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`The parties and the Board agree that if the non-inventor authors substantively
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`contributed to the passage of Ghofrani relied on by Petitioner then the legal effect of
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`such a contribution is that Ghofrani is prior art. Pet., 15; Reh’g Req., 2-3; Inst. Dec.
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`14. The dispute here is a factual one—did the non-inventor authors substantively
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`contribute to the inhaled treprostinil study described in Ghofrani? Petitioner
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`contends that they did, Patent Owner says they didn’t.
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`At a minimum, the pre-institution record left the Board with a material dispute
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`2
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`of fact. And, consistent with governing regulations, the Board viewed that dispute
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`in the light most favorable to Petitioner. See Inst. Dec. at 14 (citing 37 C.F.R. §
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`42.108(c)). Specifically, the Board found that “the narrow focus of Voswinckel and
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`the potential that Voswinckel involved the same study as disclosed in Ghofrani,
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`create a genuine issue of material fact as to the contribution of these non-inventors
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`to Voswinckel, and, by extension, to the relevant portion of Ghofrani.” Inst. Dec.,
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`14. This was reason enough to warrant institution.
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`Patent Owner lodges several related challenges to the Board’s finding on this
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`point. None undermines the soundness of the Board’s decision. First, Patent Owner
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`argues that the Board’s decision was not based on a “proper weighing” of the facts
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`of record. Reh’g Req., 9. By this, Patent Owner seems to argue that the dispute of
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`fact was not weighed in its favor. Of course, the Board’s rules require just the
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`opposite. See 37 C.F.R. § 42.108(c). Indeed, the PTO promulgated this rule because
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`the Petitioner does not have the ability to cross-examine a Patent Owner’s declarant
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`before the institution decision. 81 Fed. Reg. 18755. As the PTO recognized,
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`“deciding disputed factual issues in favor of the patent owner when a petitioner has
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`not had the opportunity to cross-examine patent owner’s declarant is inappropriate
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`and contrary to the statutory framework for AIA review.” Id. at 18756.
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`Second, and relatedly, Patent Owner argues that the Ghofrani authors’
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`declarations were “unrebutted.” Reh’g Req., 9. By this, Patent Owner seems to
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`3
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`(wrongly) suggest that the declarations were unchallenged. This is plainly
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`contradicted by the record. Petitioner’s reply directly challenged the declarants’
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`statements with other evidence of record. While the declarations claimed that the
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`non-inventor authors were not involved in Ghofrani’s discussion of a study
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`involving inhaled treprostinil, other evidence casts doubt on their recollections.
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`Indeed, the Voswinckel reference relied on by the Board, shows that the declarants
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`were involved in studies of inhaled treprostinil, contrary to their declarations. Inst.
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`Dec., 14. Patent Owner does not account for this contrary evidence. The
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`declarations were not “unrebutted” and will be fully vetted during trial.
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`Patent Owner goes so far as to suggest that the (purportedly “unrebutted”)
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`declarations themselves are dispositive of this issue in its favor. Reh’g Req., 4
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`(arguing that it “need[] only to provide declarations from the non-inventor co-
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`authors of the reference stating that they did not contribute to the relevant portion of
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`the reference.”). But Patent Owner’s view of the law ignores Emerachem Holdings,
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`LLC v. Volkswagen Group of Am., 859 F.3d 1341 (Fed. Cir. 2017)—the Federal
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`Circuit’s most recent pronouncement on this issue and a case cited in the Petition.
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`In Emerachem, the Court affirmed the Board’s finding that a prior art
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`reference (Campbell ‘558) was “by another” despite an inventor declaration alleging
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`that it was the inventors’ own work. Specifically, the Board and Federal Circuit
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`rejected Patent Owner’s argument that the inventor declaration “alone is sufficient
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`4
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`to demonstrate a common inventive entity.” Id. at 1346. Rather, the “declaration
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`amount[ed] to a naked assertion by an inventor that he and a co-inventor are the true
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`inventors of the passages cited. Nothing in the declaration itself, or in addition to
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`the declaration, provides any context, explanation, or evidence to lend credence to
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`the inventor’s bare assertion.” Id. at 1346. The facts here more closely match the
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`facts in Emerachem than the cases it distinguishes where: (i) the inventor’s
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`explanation of the non-inventor’s role in the relevant prior art was unchallenged
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`(Katz); or (ii) the inventor corroborated his testimony with contemporaneous
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`documentary evidence (DeBaun). Id. at 1347 (“Both DeBaun and Katz required
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`more than a naked assertion by the inventor. Mr. DeBaun included an attached
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`drawing, and Mr. Katz provided an additional explanation as to the facts in his
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`case.”). Here, declarants’ “explanation” of the non-inventors’ role in Ghofrani is
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`contested and Patent Owner has not corroborated the say-so of its declarants. Thus,
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`the declarations alone are not dispositive. Id. at 1346; see also Ex parte Kroger, 219
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`USPQ 370, 1982 WL 50447 (Pat. Bd. App. 1982) (refusing to credit inventor
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`declarations that another (Knaster) was not a co-inventor of prior art where inventor
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`declarations were challenged by contrary evidence).
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`Third, Patent Owner characterizes the Board’s finding as being based on
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`“[s]peculation of Petitioner’s counsel” that “improperly exalts attorney argument
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`over record evidence.” Reh’g Req., 9. Again, however, Patent Owner ignores the
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`5
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`record. The fact dispute raised by the non-inventors role was based on the
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`Voswinckel reference itself, which is “record evidence” and not attorney argument.
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`Indeed, the Board’s institution decision on this score cites only the Voswinckel and
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`Ghofrani references (Exs. 1004 and 1005), and does not reference Petitioner’s
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`arguments in reply. See Inst. Dec., 14.
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`Finally, Patent Owner argues that the Board “overlook[ed]” a portion of the
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`Seeger declaration that asserted that the non-inventor authors played only an
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`administrative role in the Ghofrani study. Reh’g Req., 11. The Board didn’t
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`overlook that assertion—it plainly understood that this was Patent Owner’s primary
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`position on the disputed fact at issue. See Inst. Dec., 13-14. Instead, the Board
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`weighed the dispute of fact in the light most favorable to Petitioner, even crediting
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`Patent Owner’s claims about the non-inventor authors’ purported “limited and
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`specific” role in Ghofrani, and rightfully concluded that “Petitioner has provided a
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`sufficient basis on which to conclude that Ghofrani was the work of another.” Inst.
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`Dec., 15. The Board weighed the disputed facts in Petitioner’s favor and properly
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`instituted trial where the factual record will be fully developed.
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`C. The Ambiguity as to Inventorship of the Challenged Claims
`Raised a Genuine Issue of Material Fact That Cannot be
`Resolved Pre-Institution.
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`Patent Owner’s argument on the other alleged error by the Board fares no
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`better. Patent Owner acknowledges that the prior art status of Ghofrani “turns on
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`6
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`
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`‘whether Ghofrani is the work of another.’” Reh’g Req., 3. As recognized by the
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`Board (and decades of case law), inherent in that analysis is a determination of the
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`inventive entity of the challenged claims. Where the “‘inventive entities’ are
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`different,” a reference is considered by another, and thus can be used as prior art.
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`Inst. Dec., 12 (citing In re Fong, 378 F.2d 977 (CCPA 1967)). This analysis asks
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`“whether the portions of the reference relied on as prior art, and the subject matter
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`of the claims in question, represent the work of a common inventive entity.” Id.
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`(quoting Riverwood Int’l Corp. v. R.A. Jones & Co., Inc., 324 F.3d 1346 (Fed. Cir.
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`2003)). In Riverwood, the prior art status of the alleged references turned on the
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`inventive entity of the challenged claims. 324 F.3d at 1357 (“[I]f Riverwood sustains
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`its burden of proof that Ziegler is the sole inventor of the [challenged] ’361 patent
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`[claims], then the ’806 patent would not be prior art to the ’361 patent [because
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`Ziegler was the sole inventor of the relevant prior art].”); see also Ethicon Endo-
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`Surgery, Inc. v. Hologic, Inc., 689 F. Supp. 2d 929, 942 (S.D. Ohio 2010) (“[A]
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`factual inquiry needs to be done to determine what claims or elements of the
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`[reference] patents were invented by John Hibner and/or Mark Burdorff and which
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`claims or elements of [two asserted] patents were also invented by them.”).
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`Patent Owner overreads the Board’s discussion of In re Land, 368 F.2d 866
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`(CCPA 1966) and accuses the Board of requiring an evidentiary showing
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`inconsistent with the case law. Reh’g Req., 3-4. But Patent Owner appears to
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`7
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`misapprehend the Board’s discussion of Land. The Board correctly cited Land as
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`“holding that individual applications to Land and Rogers were prior art with respect
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`to joint application to Land and Rogers.” Inst. Dec., 14 (citing Land, 368 F.2d at
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`881). In questioning the non-author inventors’ contribution to the relevant portion
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`of Ghofrani, Inst. Dec., 13-14, the Board was simply analyzing whether the inventive
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`entity of the claims is the same as the inventive entity of Ghofrani.
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`If, as urged by Petitioner, the inventive entity of Ghofrani is Seeger,
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`Voswinckel, Ghofrani, Grimminger and Reichenberg, that is a different inventive
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`entity from the challenged claims, which on their face list seven inventors.1 Patent
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`Owner chose to name seven inventors “and certain legal consequences flow from
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`such fact.” Land, 368 F.2d at 879. A different group of researchers, even with some
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`overlapping inventors, can be a different inventive entity. See, e.g., Viskase Corp.
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`v. Am. Nat. Can Co., 261 F.3d 1316, 1328 (Fed. Cir. 2001) (finding different
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`inventive entities where the “named inventors for the first family were Lustig,
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`Mack–Roble, Vicik, and Schuetz; for the second family they were Lustig and
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`Schuetz.”); Sprint Communications Co. L.P. v. Comcast IP Holdings, LLC, No. 12–
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`1 Patent Owner now suggests that less than all of the named inventors may have
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`contributed to the claims, see Rehearing Req., 7, and wrongly argues that each
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`inventors’ contributed to the claims “has no bearing” on the analysis. Id. at 6-7, n.5.
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`
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`8
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`
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`1013–RGA, 2015 WL 452289, *2-*3 (D. Del. Jan. 30, 2015) (“Therefore, even
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`though Mr. Bog was an inventor of both the ’832 and the Kaplan patent, the two
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`patents do not share a common inventive entity, as there is no evidence from which
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`the factfinder could conclude that Mr. Bog was solely responsible for the asserted
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`claims of the ’832 patent and the anticipating disclosures of the Kaplan patent.”);
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`Cognex Corp. v. Microscan Sys., Inc., No. 13 CIV. 2027 JSR, 2013 WL 5550092,
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`at *2 (S.D.N.Y. Sept. 30, 2013) (“While the prior art and the patent share one author,
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`the presence of other authors on each patent means that the prior art and the ’487
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`patent have different ‘inventive entities,’ and thus the ’601 publication was ‘by
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`another’ for purposes of the statute.”).
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`Patent Owner’s reliance on Varian is not to the contrary. If anything, Varian
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`confirms that the Board’s institution decision here was correct. In Varian, the Board
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`ultimately found—on a full trial record—that the cited prior art was not the work of
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`“others.” See Varian Med. Sys. v. Wm. Beaumont Hosp., IPR2016-163, Paper 79
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`(PTAB May 4, 2017). It did so only after first accepting Patent Owner’s evidence
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`as to inventorship of the challenged claims. Id. at 21. It then recognized that “the
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`inclusion of a non-inventor co-author on a publication” is significant to the question
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`of “whether the publication is the work of ‘others.’” Id. at 31.
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`While the Board found in Varian that the fully developed factual record,
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`including cross examination of the declarants, did not support Petitioner’s claim that
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`9
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`
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`the prior art at issue was by another, the facts here are different. Compare id. at 29
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`(finding evidence insufficient to cast “doubt on Patent Owner’s representations
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`concerning the proper co-inventors of the subject matter claimed in the [challenged]
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`patent, or the proper attribution of the subject matter of [the asserted prior art]”) with
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`Inst. Dec. at 14-15 (finding that contrary evidence raises a genuine issue of material
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`fact as to assertions in the Ghofrani authors’ declarations).
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`More importantly, however, for present purposes, the Board instituted trial in
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`Varian, correctly finding that “Petitioner ha[d] shown sufficiently at this stage of the
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`proceeding that the different inventive and authoring entities evidence that the
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`articles are by ‘another.’” Varian, Paper 16, at 15; see also Nelson Prods., Inc. v.
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`Bal Seal Eng’g, Inc. IPR2014-573, Paper 9 at 11-12 (Sept. 2014) (granting
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`institution despite inventor declaration challenging the prior art status of reference,
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`and noting “we hesitate to rely solely on Mr. Poon’s testimony at this stage of the
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`proceeding where it would result in a final, non-appealable denial of institution”).
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`So too here. Patent Owner will have the opportunity to submit argument and
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`evidence on this issue at trial, and Petitioner will have the opportunity to cross
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`examine witnesses and respond. The Board will then makes its decision, as it should,
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`on the fully developed factual record.
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`III. CONCLUSION
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`Petitioner respectfully requests that the Board deny the request for rehearing.
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`10
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`
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`Dated: February 19, 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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`
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`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing Petitioner’s Response
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`to Patent Owner’s Request for Rehearing is being served on February 19, 2018, by
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`filing this document through the PTAB E2E System as well as delivering a copy via
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`email to the following counsel for the Patent Owner:
`
`Stephen B. Maebius – Lead Counsel
`
`Email: smaebius@foley.com
`
`George Quillin
`
`Email: gquillin@foley.com
`
`FOLEY & LARDNER LLP
`
`
`
`Shaun R. Snader
`
`Email: ssnader@unither.com
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`UNITED THERAPEUTICS CORP.
`
`
`
`Douglas Carsten
`
`Email: dcarsten@wsgr.com
`
`Richard Torczon
`
`Email: rtorczon@wsgr.com
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`Robert Delafield
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`
`
`
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`
`
`Email: bdelafield@wsgr.com
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`Veronica Ascarrunz
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`Email: vascarrunz@wsgr.com
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`WILSON, SONSINI, GOODRICH & ROSATI
`
`Email: UT507-IPR@foley.com
`
`
`
`Dated: February 19, 2018
`
`Respectfully submitted,
`
`/Michael K. Nutter/
`Michael K. Nutter, Lead Counsel
`Reg. No. 44,979
`
`
`
`
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