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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`
`Case IPR2022-00722
`U.S. Patent No. 7,041,786
`__________________
`
`PATENT OWNER’S SUR-REPLY REGARDING DISCRETIONARY
`DENIAL UNDER 35 U.S.C. § 325(d) AND PATENT OWNER’S
`OPPOSITION TO MOTION TO AMEND REAL PARTY-IN-INTEREST
`(Filed Pursuant to Paper 12)
`
`
`
`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`
`TABLE OF CONTENTS
`
`I.
`
`Page
`The Board Should Deny Institution Under 35 U.S.C. § 325(d) ...................... 1
`A. Mylan Misstates the § 325(d) Analysis Under Becton
`Dickinson ............................................................................................... 1
`B. Mylan’s Petition Fails to Present New or Different Evidence .............. 3
`C. Mylan’s Reply Improperly Addresses Lead Compound
`Analysis ................................................................................................. 4
`II. Mylan’s Motion to Amend Real Party-In-Interest Should Be Denied ............ 4
`
`
`
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`
`
`i
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`
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`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Becton, Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper No. 8 (P.T.A.B. Dec. 15, 2017)
`(precedential) .................................................................................................... 1, 2
`SharkNinja Operating LLC v. iRobot Corp.,
`IPR2020-00734, Paper 11 (P.T.A.B. Oct. 6, 2020) (precedential)....................... 5
`Adello Biologics LLC v. Amgen Inc.,
` PGR2019-00001, Paper 11 (P.T.A.B. Feb. 14, 2019) (precedential) ................... 5
`
`Federal Statutes
`35 U.S.C. § 102 .......................................................................................................... 2
`35 U.S.C. § 103 ...................................................................................................... 1, 2
`35 U.S.C. § 112 .......................................................................................................... 1
`35 U.S.C. § 315(b) ..................................................................................................... 5
`35 U.S.C. § 325(d) ................................................................................................. 1, 4
`
`ii
`
`
`
`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`I. The Board Should Deny Institution Under 35 U.S.C. § 325(d)
`
`The thrust of the Petitioner (Mylan)’s argument is that the Examiner did not
`
`make any obviousness rejection. Reply (Paper 13), 1-2. Mylan, however, misstates
`
`the law. Under Becton Dickinson, the relevant question under § 325(d) is whether a
`
`particular item of prior art was “evaluated during examination,” not the grounds of
`
`any particular rejection for which the prior art was cited. Here, the Examiner’s
`
`finding of “unpredictability” of the art is applicable to both §§ 112 and 103 as they
`
`both involve an unpredictability analysis. Moreover, Mylan improperly injects new
`
`substantive arguments into its purported § 325(d) argument, attempting to shore up
`
`its entirely deficient lead compound analysis in the Petition. Notably, Mylan does
`
`not point out any “material error [] of the Advanced Bionics framework” that the
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`Board explicitly permitted Mylan to attempt to identify. Order (Paper 12), 3.
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`A. Mylan Misstates the § 325(d) Analysis Under Becton Dickinson
`
`Mylan attempts to undermine the Examiner’s finding that this field is
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`“unpredictable” by arguing the finding was the basis of a § 112 rejection, rather than
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`a § 103 rejection. Reply, 1-2. Mylan ignores, however, that the Examiner’s
`
`“unpredictability” analysis is applicable to both §§ 112 and 103. The fact that the
`
`Examiner undertook an unpredictability analysis, regardless of the particular
`
`statutory basis for the rejection, is relevant here. Contrary to Mylan’s argument, the
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`proper test under § 325(d) is whether the prior art was “involved” (factor (a)) and
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`1
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`
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`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`“evaluated during examination” (factor (b)). Becton, Dickinson & Co. v. B. Braun
`
`Melsungen AG, IPR2017-01586, Paper No. 8 at 17-18. The specific ground by
`
`which the prior art was used by the Examiner for a rejection is irrelevant.
`
`Here, the Examiner conclusively determined during prosecution that the
`
`nature of this art is “unpredictable.” See POPR, 34-38. To support this conclusion,
`
`the Examiner thoroughly analyzed numerous prior art references. Id. Having fully
`
`considered these numerous references, the Examiner determined that the nature of
`
`the art is unpredictable and did not reject the claims under § 103.
`
`Mylan nevertheless accuses the Patent Owner of misrepresenting the
`
`prosecution history, asserting that the Examiner “never addressed predictability of
`
`the proposed conservative (i.e., very predictable) substitution.” Reply, 2. But the
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`Examiner, in fact, did so. Specifically, the Examiner initially rejected the pending
`
`claims under § 102 because, in his view, the original claims could encompass human
`
`uroguanylin, which was disclosed in the prior art. EX1004, 172-73. When the
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`applicant amended the claims to exclude human uroguanylin but encompass
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`plecanatide, the Examiner withdraw the rejections under § 102 and allowed the
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`claims. Id., 192, 274. Ultimately, having fully considered the very modification
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`(i.e., from uroguanylin to plecanatide)
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`that Mylan suggests as being
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`“conservative,” the Examiner decided that “the skilled artisan cannot reliably and
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`accurately predict whether [plecanatide] or a variant thereof will retain the
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`2
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`
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`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`bioactivity of uroguanylin.” Id., 168 (emphasis added). For at least these reasons,
`
`Mylan’s mischaracterizations and irrelevant arguments should be rejected.
`
`B. Mylan’s Petition Fails to Present New or Different Evidence
`
`Mylan further mischaracterizes the prosecution history in the second prong of
`
`its argument. Mylan argues that “the examiner only cited Hidaka 2000 to establish
`
`that ‘a mutant peptide’ in which the first two residues were deleted lacked the
`
`ability.” Reply, 4. This is incorrect. Rather, the Examiner cited Hidaka 2000 as
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`one of many examples showing that modifying the amino sequence of uroguanylin
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`leads to unpredictable effects. EX1004, 164-71. Based on Hidaka 2000, the
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`Examiner concluded that the specification does not support a peptide genus claim
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`because, inter alia, any modification to SEQ ID NO:20 can deprive its bioactivity
`
`considering the modification’s unpredictable effects. Id., 165.
`
`Mylan also argues that the POPR “identifies no evidence suggesting the
`
`examiner was aware of … uroguanylin variant having a glutamate residue at position
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`3.” Reply, 3. As discussed in the POPR, Hidaka 2000 discloses the sequence of rat
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`(and opossum) uroguanylin having a glutamate residue at the corresponding
`
`position. POPR, 34. Contrary to Mylan’s argument, the Examiner was aware that
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`“amino acid substitutions among different members of the family of guanylin-like
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`peptides have unexpected effects.” EX1004, 167 (emphasis added). Indeed, after
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`reviewing such substitutions, the Examiner found the claimed subject matter
`
`3
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`
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`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`allowable. Tellingly, Mylan has failed to identify any “material error” under
`
`Advanced Bionics, further warranting rejection of Mylan’s § 325(d) arguments.
`
`C. Mylan’s Reply Improperly Addresses Lead Compound Analysis
`
`During the conference call with the Board, the Patent Owner pointed out
`
`Mylan’s entirely deficient lead compound analysis in the Petition, as discussed in
`
`the POPR. Recognizing that such a deficiency is fatal, Mylan now attempts to shore
`
`up this deficiency under the guise of a § 325(d) argument, arguing that uroguanylin
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`would have been “a natural lead for a synthetic ligand.” Reply, 4. Such an attempt
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`is beyond what Mylan represented to the Patent Owner and the Board in requesting
`
`a Reply (i.e., limited to § 325(d) issues) and the Board’s explicit basis for authorizing
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`the Reply.1 See EX1056 (Hearing Transcript), 24-25; Order, 2-3. Mylan’s
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`arguments in this regard should be rejected.
`
`II. Mylan’s Motion to Amend Real Party-In-Interest Should Be Denied
`
`Mylan’s Motion to Amend should be denied. Mylan knows its parent
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`companies, Mylan Inc. and Viatris Inc., qualify as RPIs—in other cases, Mylan has
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`properly disclosed them as such. POPR, 12. Here, however, Mylan has failed to
`
`disclose that its parents are RPIs. In the updated Mandatory Notice (Paper 9), filed
`
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`1 Similarly, Mylan’s repeated reference to “expert testimony” should also be rejected
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`as improper attempts to address the merit beyond the § 325(d) analysis. Reply, 2-3.
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`4
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`
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`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`without the Board’s authorization, Mylan still did not properly disclose its parents
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`as RPIs. During the call with the Board, Mylan finally admitted that “Viatris Inc.
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`and Mylan Inc. were [RPIs].” EX1056, 16. This belated admission, however, does
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`not change the fact that Mylan could not provide any good reason when it was asked
`
`“why weren’t they identified in the notices in the original petition?” Id., 18-19.
`
`Notably, in the related district court case, Mylan has vigorously tried, and
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`succeeded, to obtain a dismissal of its parents from the lawsuit. Mylan’s failure to
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`disclose its parents as RPIs here mirrors its attempt to dismiss them in the district
`
`court case. Mylan’s actions here, coupled with its actions in the parallel lawsuit,
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`evidences its intention “to gain some advantage” of insulating its parents from the
`
`proceedings. SharkNinja Operating LLC v. iRobot Corp., IPR2020-00734, Paper 11
`
`at 19. This case also differs from Adello Biologics, where the omission of an RPI
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`was inadvertent because, inter alia, the parallel lawsuit involved different counsel.
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`Adello Biologics LLC v. Amgen Inc., PGR2019-00001, Paper 11 at 5. Mylan’s
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`failure to disclose its parents as RPIs here was neither inadvertent nor unintentional
`
`for many reasons, not the least of which is the fact that Mylan is represented by the
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`very same counsel in the parallel lawsuit. Moreover, Mylan is currently time barred
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`under § 315(b), unless the Board were to allow Mylan to retroactively amend its RPI
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`disclosure. Thus, Mylan’s cost and efficiency arguments (Reply, 4-5) do not apply
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`here. Accordingly, the Board should deny Mylan’s Motion to Amend.
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`5
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`
`
`Date: August 18, 2022
`
`
`
`
`
`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`
`Respectfully submitted,
`
`
`
`
`/Justin J. Hasford/
`By:
`Justin J. Hasford, Reg. No. 62,180
`Bryan C. Diner, Reg. No. 32,409
`Joshua L. Goldberg, Reg. No. 59,369
`Caitlin E. O’Connell, Reg. No. 73,934
`Kyu Yun Kim, Reg. No. 72,783
`
`Finnegan, Henderson, Farabow,
` Garrett & Dunner, LLP
`
`
`6
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`
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`Case No. IPR2022-00722
`U.S. Patent No. 7,041,786
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing Patent Owners’ Sur-
`
`
`
`Reply Regarding Discretionary Denial Under 35 U.S.C. § 325(d) and Patent
`
`Owner’s Opposition to Motion to Amend Real Party-In-Interest was served
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`electronically via email on August 18, 2022, in their entirety on the following:
`
`Jad Mills
`Richard Torczon
`Nicole Stafford
`Dennis Gregory
`701 Fifth Avenue, Suite 5100,
`Seattle, WA 98104-7036
`jmills@wsgr.com
`rtorczon@wsgr.com
`nstafford@wsgr.com
`dgregory@wsgr.com
`4863-5899-2145@mail.vault.netdocuments.com
`
`The Petitioner has consented to service by electronic mail.
`
`
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`
` /Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER LLP
`
`
`
`Dated: August 18, 2022
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`7
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