UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`DR. REDDY’S LABORATORIES S.A. AND
`DR. REDDY’S LABORATORIES, INC.
`Petitioners,
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`v.
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`INDIVIOR UK LIMITED,
`Patent Owner.
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`––––––––––––––
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`IPR2019-00328
`Patent 9,687,454
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`PATENT OWNER’S SUR-REPLY TO PETITIONER’S REPLY
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`DR. REDDY’S LABORATORIES S.A. AND
`DR. REDDY’S LABORATORIES, INC.
`Petitioners,
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`v.
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`INDIVIOR UK LIMITED,
`Patent Owner.
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`––––––––––––––
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`IPR2019-00328
`Patent 9,687,454
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`––––––––––––––
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`PATENT OWNER’S SUR-REPLY TO PETITIONER’S REPLY
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`Petitioner’s Reply (Paper 19) attempts to re-raise the same arguments made
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`in its Petition. As already addressed in Indivior UK Limited’s (“Indivior”) Patent
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`Owner Preliminary Response (Paper 12, “POPR”), and as discussed here, the factors
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`established under Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-
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`01586, 2018 WL 2671360 (PTAB Dec. 15, 2017) (informative) strongly favor denial
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`of institution under 35 U.S.C. 325(d).
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`I.
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`Section 325(d) Factors Favor Denial of Institution
`Petitioner relies on Navistar, Inc. v. Fatigue Fracture Tech., LLC, IPR2018-
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`00853, Paper 13 (PTAB Sept. 12, 2018), and St. Jude Medical, LLC v. Snyders Heart
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`Valve LLC, IPR2018-00105, Paper 15 (PTAB May 3, 2018), in alleging that the
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`consideration of Fuisz and EMEA during examination is immaterial so long as “the
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`Examiner’s rejections never cited most of DRL’s references individually, much less
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`in the particular combination set forth in the asserted ground.” (Reply, Paper 19, at
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`5.) These cases do not support Petitioner’s claim.
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`In Navistar, the Board declined to exercise its discretion to deny institution
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`under § 325(d) because the examiner had not relied on the Cavallo and Becker
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`references in a rejection and, to the contrary, had explicitly listed the references as
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`“prior art made of record and not relied upon.” Navistar, IPR2018-00853, Paper 13
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`at 16–18. In fact, the examiner did not present any rejections under 35 U.S.C. §§ 102
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`1
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`or 103 during examination. Id. at 17. In explaining how these circumstances related
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`to the Becton, Dickinson factors, the Board significantly noted:
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`[T]o the extent “the prior art involved during examination” and “the
`prior art evaluated during examination” set out
`in [Becton]
`considerations (a) and (b) refer mainly to prior art applied by the
`Examiner in a rejection during examination, because the Examiner did
`not make any prior art rejections during prosecution of the ’915 patent,
`these factors do not persuade us to exercise our discretion under
`§ 325(d) in this case.
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`Id. at 17–18.
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`Moreover, unlike the combination of references in Navistar, Petitioner’s
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`proposed combination of prior art is cumulative of the prior art evaluated by the
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`examiner. As addressed in Indivior’s POPR, the examiner thoroughly analyzed the
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`Euro-Celtique and Suboxone® Tablet references and ultimately withdrew her 35
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`U.S.C. § 103 non-final rejection after the applicants amended their proposed claims
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`to require an “acidic buffer.” The remaining references, Fuisz, Suboxone® PDR,
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`EMEA, and the IIG Database, do not disclose any material information that is not
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`already disclosed by the other references. Suboxone® PDR, EMEA, and the IIG
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`Database all relate to the Suboxone® sublingual tablet, and do not disclose more
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`information about the tablet than the many Suboxone® Tablet references relied upon
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`and discussed by the examiner. Furthermore, Fuisz was explicitly cited and
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`discussed in Euro-Celtique, which was thoroughly examined. (Ex. 1007, 14.)
`2
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`Petitioner fails to identify any section of Fuisz providing alleged “non-cumulative
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`information” that is not already described in Euro-Celtique. (Paper 1 at 59.)
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`There are likewise clear and significant differences between the references at
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`issue in St. Jude Medical and the prior art references here. In St. Jude Medical, the
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`Leonhardt prior art reference was not before the examiner, and the petitioner was
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`not relying on Leonhardt in a manner cumulative of the prior art evaluated by the
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`examiner. Here, in stark contrast, the few remaining references are clearly
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`cumulative of the prior art evaluated and applied by the examiner, as discussed above
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`and in Indivior’s POPR (Paper 12, at 1–21).
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`Separately, Petitioner attempts to argue that Indivior raises “factual disputes”
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`as to whether the Das Declaration warrants reconsideration of the prior art. (Reply,
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`Paper 19, at 5–6.) To the contrary, Indivior’s arguments highlight that the Das
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`Declaration “does not present any substantively new information that was not
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`already before the examiner.” (POPR, Paper 12, at 28.) As explained in detail in
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`Indivior’s POPR, Dr. Das relies on references or arguments that were already before
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`the examiner in opining that a POSA would have known that the citric acid disclosed
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`in Euro-Celtique could serve as an “acidic buffer” in a buprenorphine and naloxone
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`sublingual film formulation. (Id. at 22–23.) Indeed, Dr. Das’s arguments regarding
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`the effects of pH on the absorption of buprenorphine were rejected in a separate IPR
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`proceeding regarding the ’832 Patent. See Teva Pharm. USA, Inc. v. Indivior UK
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`3
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`Ltd., IPR2016-00280, Paper No. 23, 13–15 (PTAB June 10, 2016). The Board’s
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`decision and reasoning rejecting Dr. Das’s statement on pH and buprenorphine
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`absorption were disclosed to the examiner during prosecution of the ’454 Patent.
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`(Ex. 1002, 604.)
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`Petitioner also attempts to argue that Becton, Dickinson mandates considering
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`the applicant’s characterizations of the prior art in a separate IPR proceeding, after
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`the patent has issued, and in the context of a different patent. (Reply, Paper 19, at 5.)
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`This is not a Becton, Dickinson factor. Indeed, the factor that Petitioner relies on
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`clearly states, “the extent of the overlap between the arguments made during
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`examination and the manner in which Petitioner relies on the prior art or Patent
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`Owner distinguishes the prior art.” Becton, Dickinson & Co. v. B. Braun Melsungen
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`AG, IPR2017-01586, Paper No. 8, 17–18, 2018 WL 2671360 (PTAB Dec. 15, 2017)
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`(informative) (emphasis added).
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`Furthermore, Petitioner erroneously argues that Indivior’s “easy dismissal of
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`its reversal in positions on the prior art is legal error.” As Indivior explained in its
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`POPR, Petitioner attempts to mischaracterize Indivior’s arguments made about a
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`different patent with different claims that are directed to different subject matter.
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`Indivior has already explained why its statements concerning U.S. Patent No.
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`9,370,512 in IPR2018-00795 were directed to whether the prior art discloses the
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`“instant release” capability of a film—not whether the references disclose or suggest
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`4
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`use of an acidic buffer to achieve desired pharmacokinetic values. Indeed, Indivior’s
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`POPR addresses each prior statement that Petitioner mischaracterizes as an
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`“admission,” explaining how these statements addressed the prior art’s disclosure of
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`pharmaceutical dosage forms with fast-dissolving properties which would lead to
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`the “instant release” of the active agents from the dosage form. (POPR, Paper 12, at
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`40–44.) Petitioner’s attempt to recast the same arguments it made in its Petition is
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`unavailing.
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`For the foregoing reasons, and those in Indivior’s POPR, the Board should
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`deny institution of inter partes review of challenged claims 1–3 and 5–14 of the ’454
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`Patent.
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`II.
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`
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`LTS is a Real Party in Interest and DRL Has Failed to Present
`Sufficient Evidence Suggesting Otherwise
`Indivior’s POPR explained that Dr. Reddy’s Laboratories S.A. and Dr.
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`Reddy’s Laboratories, Inc. (“Petitioner” or “DRL”) failed to identify LTS Lohmann
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`Therapy Systems, Corp. (“LTS”) as a real party in interest. During the conference
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`call on April 16, 2019, the Board asked DRL’s counsel whether DRL could simply
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`file an updated mandatory notice identifying LTS as a real party in interest. DRL’s
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`Reply fails to respond to the Board’s inquiry, and DRL has chosen not to identify
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`LTS as a real party in interest. Instead, DRL argues that LTS is not a real party in
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`interest. DRL’s argument relies on a conclusory declaration consisting primarily of
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`four brief paragraphs (Ex. 1052, ¶¶ 7–10) that fail to refute any of the seven pages
`5
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`of testimony by the CEO of LTS about the importance of its preexisting business
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`relationship with DRL (POPR, Paper 12, at 50–52; Ex. 2004). Indivior submits that
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`on the record evidence, and under Federal Circuit authority, as argued in the POPR,
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`the Board may find LTS to be a real party in interest, and proceed accordingly.
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`Date: May 2, 2019
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`Respectfully submitted,
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`By /Peter P. Chen /
`David A. Garr
` Registration No.: 74,932
`Peter P. Chen
` Registration No.: 39,631
`COVINGTON & BURLING LLP
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`Attorneys for Patent Owner
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`6
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6, I hereby certify that the foregoing Patent Owner’s Sur-
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`Reply was served by email, by agreement of the parties, on the following counsel of
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`record for petitioner.
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`
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`Ira J. Levy (ilevy@goodwinlaw.com)
`John Coy Stull (jstull@goodwinlaw.com)
`Robert Frederickson III (rfrederickson@goodwinlaw.com)
`GOODWIN PROCTER LLP
`DG-Suboxone@goodwinlaw.com
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`Date: May 2, 2019
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`/Peter P. Chen /
`Peter P. Chen
`Registration No.: 39,631
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`7
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