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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________________
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`MYLAN LABORATORIES LTD.
`Petitioner
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`v.
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`JANSSEN PHARMACEUTICA NV
`Patent Owner
`____________________
`
`Case IPR2020-00440
`Patent 9,439,906
`____________________
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`PATENT OWNER’S AUTHORIZED SURREPLY
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`IPR2020-00440
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`TABLE OF CONTENTS
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`Page
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`The Apple Factors Favor Denying Mylan’s Petition Under § 314(a) ............. 1
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`The Intrinsic Record Demonstrates that PI-74 and PI-75 are Antedated
`Under the Stempel Doctrine ............................................................................. 5
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`1.
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`2.
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`i
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`Cases
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`TABLE OF AUTHORITIES
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`IPR2020-00440
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` Page(s)
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`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) ...............passim
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`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper 15 (PTAB May 13, 2020) (informative) ..................... 3, 4
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`Apple Inc. v. Maxell, Ltd.,
`IPR2020-00203, Paper 12 (PTAB July 6, 2020) .................................................. 3
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`Cisco Sys., Inc. v. Ramot at Tel Aviv Univ. Ltd,
`IPR2020-00122, Paper 15 (PTAB May 15, 2020) ............................................... 4
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`In re Clarke,
`356 F.2d 987 (C.C.P.A. 1966) .............................................................................. 8
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`In re Dardick,
`496 F.2d 1234 (C.C.P.A. 1974) ............................................................................ 7
`
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) ............................................................................ 6
`
`Frazer v. Schlegel,
`498 F.3d 1283 (Fed. Cir. 2007) ............................................................................ 8
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`Mylan Pharm. Inc. v. Merck Sharp & Dohme Corp.,
`IPR2020-00040, Paper 21 (PTAB May 12, 2020) ........................................... 1, 2
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`Pernix Ir. Pain DAC v. Alvogen Malta Operations, Ltd.,
`U.S. Dist. LEXIS 81419 (D. Del. 2018) (Bryson, C.J.) ....................................... 8
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`Pfizer Inc. v. Teva Pharm. USA, Inc.,
`No. 04-754 (JCL), 2006 U.S. Dist. LEXIS 98765 (D.N.J. Oct. 25,
`2006) ....................................................................................................... 1, 4, 7, 10
`
`In re Spiller,
`500 F.2d 1170 (C.C.P.A. 1974) ...................................................................... 9, 10
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`ii
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`
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`In re Stempel,
`241 F.2d 755 (C.C.P.A. 1957) .....................................................................passim
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`In re Stryker,
`435 F.2d 1340 (C.C.P.A. 1971) .................................................................. 7, 9, 10
`
`In re Tanczyn,
`347 F.2d 830 (C.C.P.A. 1965) .................................................................. 6, 7, 8, 9
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`Statutes
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`21 U.S.C. § 355(j)(5)(B)(iii) ...................................................................................... 2
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`35 U.S.C. § 119(a) ..................................................................................................... 8
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`35 U.S.C. § 314(a) ....................................................................................... 1, 3, 5, 10
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`iii
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`1.
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`The Apple Factors Favor Denying Mylan’s Petition Under § 314(a)
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`In about two months, District Judge Cecchi will hold a bench trial to
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`IPR2020-00440
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`consider Teva’s obviousness challenges to each and every claim of the 906 Patent.
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`In a related case before Judge Cecchi, Mylan also challenges the validity of the 906
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`Patent claims. Both challenges rely on the same or similar art that Mylan relies on
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`here. In light of the advanced stages of these two co-pending Hatch-Waxman
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`litigations, and given the substantive flaws in the merits of Mylan’s Petition, the
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`Board should deny the Petition under 35 U.S.C. § 314(a).
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`Apple Factor 1: Mylan’s Reply argues that this factor is neutral. That is not
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`correct. Neither co-pending case is stayed, Teva is scheduled for trial in
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`September, and Mylan has not indicated it would seek a stay (which would be an
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`unlikely move by a defendant in a Hatch-Waxman case). This factor favors denial.
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`See Mylan Pharm. Inc. v. Merck Sharp & Dohme Corp., IPR2020-00040, Paper
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`21, at 33 (PTAB May 12, 2020) (“Petitioner and Patent Owner agree that a stay has
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`not been sought and is unlikely, which weighs in favor of denial.”).
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`Apple Factor 2: Mylan’s Reply argues that the trial dates of the co-pending
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`litigations favor institution. That, too, is incorrect. Trial in the Teva case is
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`imminent (ordered to commence on September 28, 2020). Ex. 2005 ¶ 4; see Apple
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`Inc. v. Fintiv, Inv., IPR2020-00019, Paper 11, at 14 (PTAB Mar. 20, 2020)
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`(precedential) (“Apple”) (discretionary denial appropriate “[e]ven when a petitioner
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`1
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`is unrelated to a defendant . . . if the issues are the same as, or substantially similar
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`to those already or about to be litigated”) (emphasis added). In the Mylan case,
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`the statutory Hatch-Waxman 30-month stay expires in January 2022. Ex. 2004, at
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`5. Trial in Mylan is, therefore, likely to commence in June 2021, not only because
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`the parties proposed that date to the court, but also because courts recognize the
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`need to complete their written decision on these cases within the 30-month stay
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`period. Id. at 5, 10. Indeed, the Hatch-Waxman statutory framework requires the
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`parties to “reasonably cooperate in expediting the action.” 21 U.S.C. §
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`355(j)(5)(B)(iii). This factor favors denial.
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`Apple Factor 3: Mylan argues that—despite the significant investments in
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`the district court litigations (including by Janssen, Mylan, Teva, and Judge
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`Cecchi)—this factor somehow favors institution. Again, Mylan has it wrong.
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`First, Mylan’s attempts to characterize Teva’s obviousness theories as
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`different from Mylan’s—based solely on Mylan’s reliance on the Citrome
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`reference here—lack merit. Reply 3. As shown in Janssen’s POPR, all of Teva’s
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`obviousness grounds rely on “NCT 548,” a clinical trial protocol; Mylan’s Petition
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`relies on the disclosure about NCT 548 in Citrome. See POPR 15-16 & nn.7-8.
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`Indeed, where the Petition cites Citrome, it by and large relies on the NCT 548
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`entry in Citrome’s table of clinical trials. See, e.g., Petition 27, 29-30, 32, 35, 37-
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`38, 45, 54, 60. Mylan even attached NCT 548 as an exhibit to its Petition to
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`2
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`illustrate (improperly) the content of Citrome. See, e.g., id. at 25 (citing Ex. 1032).
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`Mylan’s effort to downplay the similarity of NCT 548 and its Citrome-based
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`obviousness arguments is disingenuous.
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`Second, Mylan’s suggestion that the one-year statutory bar insulates its
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`timing from § 314(a) scrutiny ignores Apple itself, which instructs panels to
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`consider a petitioner’s delay “notwithstanding that a defendant has one year to file
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`a petition.” Apple, at 11; see also Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper
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`15, at 11 (PTAB May 13, 2020) (informative) (“Apple II”) (“[C]onsiderations of
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`the state of a parallel proceeding may require petitioners to act more quickly than
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`the maximum amount of time permitted by Congress.”). Apple is on all fours;
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`Mylan’s failure to file expeditiously—and its failure to explain that delay even in
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`its Reply—warrants denial. POPR 8 (quoting Apple, at 11-12).
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`Apple Factor 4: The obviousness issues in the co-pending litigations
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`substantially overlap with those presented by Mylan’s Petition. As explained
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`above and in the POPR, both Teva and Mylan rely on NCT 548, which is
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`substantially similar to the portions of Citrome on which Mylan relies; thus, this
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`factor favors denial. See Apple, at 12; see also Apple Inc. v. Maxell, Ltd.,
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`IPR2020-00203, Paper 12, at 12-16 (PTAB July 6, 2020) (finding that Factor 4
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`favored denying institution where obviousness ground in IPR was substantially the
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`same, though not identical, to obviousness grounds in district court litigation).
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`3
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`Moreover, Mylan’s district court invalidity contentions explicitly rely on Citrome,
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`so that reference will be presented to the district court. See Ex. 2008, at 32-34 &
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`n.5. The fact that “[t]he same art is presented in Petitioner’s final invalidity
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`contentions” warrants denial. See Apple II, at 15. And, Mylan’s Grounds 3 and 4
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`do nothing to negate the substantial overlap of issues, as they rely on a subset of
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`the references relied on Grounds 1 and 2.
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`Apple Factor 5: Factor 5 also favors denial. First, Mylan is the same party
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`in one of the co-pending litigations; this favors denial. Apple, at 14; Apple II, at 15
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`(“Because the petitioner and the defendant in the parallel proceeding are the same
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`party, this factor weighs in favor of discretionary denial.”). Second, even where
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`the parties are different (as in Teva), discretionary denial may be warranted. See
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`POPR 16; Apple, at 14. Mylan’s only answer on this point relies on the dissenting
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`opinion of a single APJ that, in light of Apple II, plainly does not reflect PTAB
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`precedent. Reply 5 (citing Cisco Sys., Inc. v. Ramot at Tel Aviv Univ. Ltd.,
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`IPR2020-00122, Paper 15, at 10 (PTAB May 15, 2020) (Crumbley, J., dissenting)).
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`This factor decisively favors denial.
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`Apple Factor 6: On the merits of its Petition, Mylan argues that it has “an
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`unopposed expert and only attorney argument in response.” Id. at 6. But it is
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`Mylan’s burden to establish that IPR institution is warranted and, as Janssen’s
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`POPR pointed out, Mylan failed to address necessary elements of the claims, and
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`4
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`there were numerous substantive flaws in Mylan’s Petition that were not supported
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`by any credible expert analysis. POPR 25-64.
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`As to § 325(d) issues—relevant to § 314(a) denial under Apple’s “other
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`considerations” (Apple, at 16)—Mylan has no answer to the Examiner’s direct
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`consideration of PI-74/PI-75 and the 544 Patent, relied upon by Mylan in Grounds
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`1 and 2. POPR 18-19. Instead, Mylan doubles down on Grounds 3 and 4 (its
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`fallback position), because those Grounds do not rely on PI-74/PI-75. But they do
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`rely on the 544 Patent, which the Examiner expressly found does not render
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`obvious the claimed invention. See id. This § 325(d) consideration further weighs
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`in favor of denial.
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`2.
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`The Intrinsic Record Demonstrates that PI-74 and PI-75 are Antedated
`Under the Stempel Doctrine
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`The intrinsic evidence demonstrates that PI-74 and PI-75 are not prior art
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`under the long-established legal doctrine first set forth in In re Stempel, 241 F.2d
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`755, 759 (C.C.P.A. 1957). Although antedating questions may need to be reserved
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`for trial—if there is a dispute of fact raised in the POPR that requires resolution
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`at trial—there is no need for that here. Janssen is relying on intrinsic evidence, the
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`content of which cannot be disputed.1
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`1 Janssen is prepared to prove prior invention based on inventor testimony and
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`documentary evidence as well (and is doing so in the co-pending litigations), but
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`5
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`IPR2020-00440
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`Mylan is wrong in stating that it is Janssen’s burden “to antedate PI-74 and
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`PI-75.” Reply 7. Although a patent owner bears the burden of coming forward
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`with evidence that a reference is antedated, a petitioner bears the ultimate burden
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`of proving that a reference is prior art, and that burden never shifts. See Dynamic
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`Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1379 (Fed. Cir. 2015).
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`The question for the Board is, therefore: Given the intrinsic evidence of record and
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`Mylan’s admissions about its contents, has Mylan met its burden to show that PI-
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`74 and PI-75 qualify as § 102(a) prior art? Mylan has not and cannot do so.
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`The 918 provisional application establishes that, as of December 19, 2007,
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`the inventors were in possession of (1) the subject matter of PI-74 and PI-75, and
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`(2) “either the whole invention claimed or something falling within the claim, in
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`the sense that the claim as a whole reads on it.” In re Tanczyn, 347 F.2d 830, 833
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`(C.C.P.A. 1965) (emphases in original). Accordingly, the 918 provisional
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`application provides indisputable evidence that PI-74/PI-75 are not prior art under
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`§ 102(a). Indeed, while Mylan disagrees on the law, it never disputes that these
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`two evidentiary bases for antedation under Stempel and Tancyzn are established by
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`the intrinsic evidence. See POPR 23 (citing Petition 10-12); Reply 8-10. The only
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`disclosure that Mylan contends is missing from the 918 provisional application is a
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`does not rely on any such evidence in its POPR.
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`IPR2020-00440
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`±7 day dosing window around the maintenance dose. POPR 23 (citing Petition 10-
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`12). But, as explained in In re Stryker, it “cannot be the law” that the addition of
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`claim limitations can prevent a patent owner from antedating a reference where, as
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`here, the reference would be antedated if those claim limitations were simply
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`“delete[d].” See In re Stryker, 435 F.2d 1340, 1341-42 (C.C.P.A. 1971).
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`Lacking any factual basis for disputing the intrinsic evidence, Mylan resorts
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`to misstating the law. Mylan erroneously asserts that Tanczyn “restrict[ed] the
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`application of Stempel to its facts.” Reply 8. That is incorrect. Stryker, for
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`example, confirmed that the Stempel principles can be used to antedate alleged §
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`102(a) prior art references, even after Tanczyn. See Stryker, 435 F.2d at 1341.
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`This has been reaffirmed and applied in patent cases subsequently and specifically
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`on the issue of whether a reference qualifies as prior art under § 102(a). See POPR
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`21-23.
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`Also contrary to Mylan’s suggestion (Reply 8), the Stempel doctrine is not
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`limited to antedating references only for the purposes of an anticipation challenge.
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`To the contrary, Stempel principles apply equally to determining whether a
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`reference qualifies as prior art in the context of an obviousness challenge. See
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`Stryker, 435 F.2d at 1341; Pfizer Inc. v. Teva Pharm. USA, Inc., No. 04-754 (JCL),
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`2006 U.S. Dist. LEXIS 98765, at *8-9 (D.N.J. Oct. 25, 2006); see also In re
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`Dardick, 496 F.2d 1234, 1240 (C.C.P.A. 1974).
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`7
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`IPR2020-00440
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`Mylan also tries to conflate the Stempel/Tanczyn antedation analysis with
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`written description and enablement under § 112, arguing that “Janssen must
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`demonstrate that the ’918 provisional provides both written description and
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`enablement support for the claimed invention.” Reply 9. That argument is
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`incorrect. Antedating a reference does not require § 112 support. See In re Clarke,
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`356 F.2d 987, 991-92 (C.C.P.A. 1966) (holding that to antedate a reference, an
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`applicant is not “required to show as much as is required by 35 U.S.C. § 112”);
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`accord Pernix Ir. Pain DAC v. Alvogen Malta Operations, Ltd., No. 16-139
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`(WCB), 2018 U.S. Dist. LEXIS 81419, at *47-49 (D. Del. May 15, 2018) (Bryson,
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`C.J.) (holding that “Clarke is still good law.”). The case on which Mylan relies,
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`Frazer v. Schlegel, 498 F.3d 1283, 1287 (Fed. Cir. 2007), is inapposite. In Frazer,
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`the question was whether the junior party in an interference could claim the benefit
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`of the effective filing date of a foreign patent application pursuant to 35 U.S.C. §
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`119(a). Frazer, 498 F.3d at 1287. That § 119 inquiry, by statute, requires
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`consideration of written description and enablement under § 112. See 35 U.S.C. §
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`119(a).
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`Here, by contrast, the benefit of an earlier filing date is not the issue. Mylan
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`does not (and cannot) contend that PI-74 and PI-75 are § 102(b) prior art regardless
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`of what filing date is applied. The 918 provisional application is simply
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`documentary evidence of what the Janssen inventors had in their possession by no
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`8
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`IPR2020-00440
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`later than December 19, 2007. It provides indisputable proof that the inventors
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`were in possession of the contents of PI-74 and PI-75, as well as something falling
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`within the claim in the sense that the claim as a whole reads on it. The
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`Stempel/Tanczyn analysis requires nothing more to antedate the references. See
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`POPR 21 (collecting PTAB and district court cases). Written description and
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`enablement under § 112 are not part of the Stempel/Tanczyn analysis.
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`Finally, Mylan’s arguments regarding PI-74 and PI-75 run afoul of a long-
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`established principle of law that is a corollary of the Stempel doctrine. According
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`to Mylan, PI-74 and PI-75 render the 906 Patent claims obvious. But Mylan does
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`not dispute that the inventors possessed those references, almost word-for-word,
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`before they published, as demonstrated by the 918 provisional. If Mylan were
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`correct that the differences between the claims of the 906 Patent and PI-74 and PI-
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`75 were obvious (and as explained in Janssen’s POPR, it is not), then possession of
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`the content of PI-74 and PI-75 would antedate them because “possession of what is
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`shown [in the references] carries with it possession of variations and adaptations
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`which would, at the same time, be obvious to one skilled in the art.” In re Spiller,
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`500 F.2d 1170, 1178 n.5 (C.C.P.A. 1974). As the law has long held, prior
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`possession of the content of an obviousness reference suffices to remove it as prior
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`art where “the differences between the claimed invention and the reference
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`disclosure are so small as to render the claims obvious over the reference.” In re
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`9
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`IPR2020-00440
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`Stryker, 435 F.2d at 1341 (sufficed to antedate); Pfizer, 2006 U.S. Dist. LEXIS
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`98765, at *9 (reference antedated by showing “prior possession of such as to make
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`the entire invention or that part obvious to one of ordinary skill in the art”)
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`(internal quotation marks omitted).
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`Here, because Janssen indisputably possessed an embodiment of the claims
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`of the 906 Patent, as well as the subject matter of PI-74 and PI-75, as of December
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`19, 2007, the references are antedated under the Stempel doctrine. And even if that
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`were not the case, PI-74 and PI-75 would be antedated under Spiller and Stryker to
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`the extent they rendered the claims of the 906 Patent obvious. Either way, Mylan’s
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`Petition fails to establish that PI-74 and PI-75 are prior art.
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`*
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`*
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`*
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`Mylan’s Reply should firm the Board’s resolve to deny the Petition under §
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`314(a). None of the Apple factors favor institution, and the overall weakness of the
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`Petition (including Mylan’s heavy reliance on references that it cannot qualify as
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`prior art) puts a heavy thumb on the scale in favor of denial. Janssen respectfully
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`requests that the Board deny the Petition.
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`10
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`Date: July 17, 2020
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`Respectfully submitted,
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`IPR2020-00440
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`/Barbara L. Mullin/
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`Barbara L. Mullin (Reg. No. 38,250)
`Lead counsel for Patent Owner
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`Rubén H. Muñoz (Reg. No. 66,998)
`Back-up counsel for Patent Owner
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`Andrew D. Cohen (Reg. No. 61,508)
`Back-up counsel for Patent Owner
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`J. Jay Cho (Reg. No. 75,052)
`Back-up counsel for Patent Owner
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`11
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Patent
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`IPR2020-00440
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`Owner’s Authorized Surreply was served on counsel of record on July 17, 2020 by
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`filing this document through the End-to-End System, as well as delivering a copy
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`via electronic mail to counsel of record for Petitioner at the following addresses:
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`Jitendra Malik – jitty.malik@katten.com
`Guylaine Haché – guylaine.hache@katten.com
`Jillian Schurr – jillian.schurr@katten.com
`Alissa M. Pacchioli – alissa.pacchioli@katten.com
`Lance Soderstrom – lance.soderstrom@katten.com
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`
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`Date: July 17, 2020
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`Respectfully submitted,
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`/Barbara L. Mullin/
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`Barbara L. Mullin (Reg. No. 38,250)
`Lead counsel for Patent Owner
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`12
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