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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`DR. REDDY’S LABORATORIES S.A. AND
`DR. REDDY’S LABORATORIES, INC.
`Petitioners
`
`v.
`
`INDIVIOR UK LIMITED.
`Patent Owner
`
`
`
`U.S. PATENT NO. 9,687,454
`
`TITLE: SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
`
`Case No. IPR2019-00328
`
`
`
`Petitioners’ Reply to Patent Owner’s Preliminary Response
`
`
`
`Exhibits
`
`Ex. No.
`1001
`
`Description
`U.S. Patent No. 9,687,454
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`File History of U.S. Patent Application No. 14/989,669
`
`Expert Declaration of Nandita Das, Ph.D.
`
`Curriculum Vitae of Nandita Das, Ph.D.
`
`U.S. Patent No. 8,475,832
`
`Reckitt Benckiser Pharma, Inc. v. Watson Labs., Inc., 2016
`WL 3186659 (D. Del. June 3, 2016)
`
`PCT Application No. WO 2008/02579 (“Euro-Celtique”)
`
`PCT Application No. WO 2003/030883 (“Fuisz”)
`
`2004 Physician’s Desk Reference (“Suboxone PDR”)
`
`European Medicines Agency Initial Marketing-Authorisation
`Document for Suboxone® Tablet (“EMEA”)
`
`Affidavit of Christopher Butler
`
`File History of U.S. Patent Application No. 12/537,571
`
`Aulton, et al., Pharmaceutics The Science of Dosage Form
`Design, Second Edition (2002) (“Aulton”)
`
`Dawson, et al., pH, buffers, and physiological media, Data for
`Biochemical Research, 428 (1986) (“Dawson”)
`
`U.S. Patent Application Publication No.: US 2005/0085440
`A1 (“Birch”)
`
`Cassidy, et al., Controlled buccal delivery of buprenorphine,
`Journal of Controlled Release, 21-29 Volume 25 (1993)
`(“Cassidy”)
`
`
`
`i
`
`
`
`
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`Campbell, et al., The history of the development of
`buprenorphine as an addiction therapeutic, Ann. N.Y. Acad.
`Sci. 124–139 (2012) (“Campbell”)
`
`Chiang, et al., Pharmacokinetics of the combination tablet of
`buprenorphine and naloxone, Drug and Alcohol Dependence
`S39 - S47 Volume 70 (2003) (“Chiang”)
`
`Bullingham, et al., Sublingual Buprenorphine Used
`Postoperatively: Clinical Observations and Preliminary
`Pharmacokinetic Analysis, British Journal of Clinical
`Pharmacology, 117-122 Volume 12 (1981) (“Bullingham”)
`
`European Patent Application No.: 82303582.9 (“Todd”)
`
`U.S. Patent No. 5,288,497 (“Stanley”)
`
`Suboxone, European Medicines Agency,
`https://www.ema.europa.eu/medicines/human/EPAR/suboxone
`(Last visited Oct. 26, 2018) (“EMEA Web”)
`
`Ciraulo, et al., Pharmacokinetics and Pharmacodynamics of
`Multiple Sublingual Buprenorphine Tablets in Dose-
`Escalation Trials, The Journal of Clinical Pharmacology, 179-
`192 Volume 46 (2006) (“Ciraulo”)
`
`Reckitt Benckiser Pharma, Inc. v. Watson Labs., Inc., 13-cv-
`1674-RGA (D. Del. June 26, 2015)
`
`Suboxone® Tablet Label (2002)
`
`FDA Office of Generic Drugs, Manual of Policies and
`Procedures: Review of Investigational New Drug Applications
`(Bio-INDs) by the Office of Generic Drugs, MAPP 5210.5
`(July 7, 2006) (“2006 MAPP”)
`
`FDA Guidance for Industry: Changes to an Approved NDA or
`ANDA (April 2004)
`
`Chaplin, et al., Buprenorphine plus naloxone, a new
`substitution treatment, Prescriber August 2007, 14-17 (2007)
`
`
`
`ii
`
`
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`(“Chaplin”)
`
`Press Release, European Medicines Agency, EPAR summaries
`for the public: A further step for the provision of better
`information about medicines (February 2, 2006)
`
`Regulation of the European Parliament and of the Council No.
`726/2004 laying down Community procedures for the
`authorization and supervision of medicinal products for human
`and veterinary use and establishing a European Medicines
`Agency (March 31, 2004)
`
`International Pharmaceutical Council, Qualification of
`Excipients for Use in Pharmaceuticals, (2008)
`
`Drakulich, Angie, IPEC Conference Creates Excitement about
`Excipients, PharmTech.com, (September 13, 2017)
`
`Approved Drug Products With Therapeutic Equivalence
`Evaluations, 12th Edition (1992)
`
`Official Journal of the European Union C 259, Volume 49
`(October 27, 2006)
`
`European Medicines Agency, Reflection Paper: EPAR
`Summary for the Public, EMEA/126757/2005 (January 26,
`2006)
`
`Magnelli, et al., Safety and Efficacy of
`Buprenorphine/Naloxone in Opioid-Dependent Patients,
`Clinical Drug Investigation, 21-26 (2010)
`
`Schering-Plough Corporation Release: SUBOXONE®
`(Buprenorphine/Naloxone) Approved In European Union for
`Treatment of Opioid Dependence (October 6, 2006)
`
`Orman, et al., Spotlight on Buprenorphine/Naloxone in the
`Treatment of Opioid Dependence, CNS Drugs, 899-902 (2009)
`
`Schering's Suboxone approved in EU, United Press
`International, Inc., (October 6, 2006)
`
`
`
`iii
`
`
`
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`Jacobsi, et al., Web Watch - Food and Drug Administration,
`Center for Drug Evaluation and Research, Toxicologic
`Pathology, 323–324, (2007)
`
`Excipient Development for Pharmaceutical, Biotechnology,
`and Drug Delivery Systems (Katdare, A. and Chaubal, M.,
`eds.) (2006)
`
`Handbook of Pharmaceutical Excipients Fifth Edition
`(Raymond Rowe et al., eds.) (2006)
`
`Batheja, P. et al., Basic Biopharmaceutics of Buccal and
`Sublingual Absorption in Enhancement in Drug Delivery (Elke
`Touitou and Brian W. Barry, eds., 2007) (“Batheja”)
`
`Allen, Loyd V., Buprenorphine 2 mg/mL Sublingual Drops,
`U.S. Pharmacist (Feb. 20, 2009) (“Allen”)
`
`U.S. Patent No. 4,935,428 (“Lewis”)
`
`Handbook of Pharmaceutical Excipients Third edition (Arthur
`Kibbe, ed.) (2000)
`
`Indivior Inc. v. Rhodes Pharms. L.P., IPR2018-00795, Paper
`No. 1 (Mar. 16, 2018)
`
`Indivior Inc. v. Rhodes Pharms. L.P., IPR2018-00795, Ex.
`1006 – Declaration of Rodolfo Pinal, Ph.D., in Support of
`Indivior’s Petition for Inter Partes Review of U.S. Patent No.
`9,370,512 (Mar. 15, 2018)
`
`About Us, Transparency, European Medicines Agency,
`https://www.ema.europa.eu/about-us/how-we-
`work/transparency (last visited Nov. 9, 2018)
`
`Regulation of the European Parliament and of the Council No.
`1049/2001 regarding public access to European Parliament,
`Council and Commission documents (May 30, 2001)
`
`Corrected Declaration of Robert Frederickson III in Support of
`Renewed Motion For Pro Hac Vice Admission
`
`
`
`iv
`
`
`
`1052
`
`1053
`
`Declaration of Anjum Swaroop
`
`Transcript of June 28, 2018 Hearing of Motion for Preliminary
`Injunction
`
`
`
`v
`
`
`
`Contrary to the assertions in the Patent Owner Preliminary Response (Paper
`
`12) submitted by Indivior UK Limited (“Indivior”), institution should be granted
`
`because Petitioners Dr. Reddy’s Laboratories S.A. and Dr. Reddy’s Laboratories,
`
`Inc. (“DRL”) have identified all real-parties-in-interest and the factors relevant to
`
`the Board’s exercise of discretion under Section 325(d) favor institution.
`
`I.
`
`LTS is Not a Real Party-in-Interest
`
`Indivior asserts that DRL should have identified a third party, LTS Lohmann
`
`Therapy Systems, Corp. (“LTS”) as a real party-in-interest (“RPI”). LTS is an
`
`unrelated corporate entity with which DRL has contracted to manufacture the DRL
`
`product accused in the underlying district court litigation. Ex. 1052 ¶ 2. But that is
`
`as far as the relationship goes. LTS has had no part in filing (including
`
`contributing to the financing of) the instant Petition, has no control over DRL’s
`
`positions in this proceeding, is not represented by counsel for DRL in this
`
`proceeding, is not a party to any litigation concerning the instant patent, and is not
`
`bound by any legal agreement regarding the outcome of this proceeding or that of
`
`the underlying district court litigation. Id. ¶¶ 3-4, 7-10. In short, there is no factual
`
`or legal basis to support identifying LTS as a real party-in-interest to this
`
`proceeding.
`
`A “petitioner’s initial identification of the [RPIs] should be accepted unless
`
`and until . . . a patent owner [produces] some evidence to support its argument that
`
`
`
`1
`
`
`
`a particular third party should be named a real party in interest.” Worlds Inc. v.
`
`Bungie, Inc., 903 F.3d 1237, 1242 (Fed. Cir. 2018). “To decide whether a party
`
`other than the petitioner is [an RPI], the Board seeks to determine whether some
`
`party other than the petitioner is the ‘party or parties at whose behest the petition
`
`has been filed.’” Google LLC v. Seven Networks LLC, IPR2018-01051, Paper 28
`
`at 10 (P.T.A.B. Jan. 14, 2019) (quoting Wi-Fi One, LLC v. Broadcom Corp., 887
`
`F.3d 1329, 1336 (Fed. Cir. 2018)); see also Applications in Internet Time, LLC v.
`
`RPX Corp., 897 F.3d 1336, 1351 (Fed. Cir. 2018) (“[T]he two questions lying at
`
`the heart of the [RPI] inquiry are whether a non-party ‘desires review of the
`
`patent,’ and whether a petition has been filed at a non-party’s ‘behest.’”) (quoting
`
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,759 (Aug. 14, 2012)).
`
`Indivior has not presented “sufficient rebuttal evidence [to] reasonably
`
`bring[] into question the accuracy of” DRL’s “identification of the [RPIs].”
`
`Worlds Inc., 903 F.3d at 1242 (quoting Atlanta Gas Light Co. v. Bennett Regulator
`
`Guards, Inc., IPR2013-00453, Paper 88 at 8 (P.T.A.B. Jan. 6, 2015)). Indivior
`
`argues that LTS should be identified as an RPI because, “as the exclusive
`
`manufacturer” of the DRL product accused in the underlying district court
`
`litigation, LTS has an interest in the product’s commercial success. Paper 12 at 51.
`
`But a manufacturer’s generalized interest in the success of a product it has
`
`contracted to make does not make it an RPI. See WesternGeco LLC v. ION
`
`
`
`2
`
`
`
`Geophysical Corp., 889 F.3d 1308, 1321 (Fed. Cir. 2018) (a “contractual and fairly
`
`standard customer-manufacturer relationship regarding the accused product” is
`
`insufficient to show that a third party is an RPI). “An RPI analysis requires more
`
`than determining whether an unnamed party benefits generally from the filing of a
`
`petition and has a relationship with the petitioner.” Google, IPR2018-01051, Paper
`
`28 at 14 (emphasis in original). And for good reason: if this were “the sole
`
`requirement for being named an RPI, . . . it would ensnare third parties, such as
`
`suppliers and contract research organizations, with no connection to the Petition.”
`
`Merck Sharp & Dohme Corp. v. GlaxoSmithKline Biologicals SA, IPR2018-01229,
`
`Paper 13 at 12 (P.T.A.B. Dec. 18, 2018).
`
`To bring in LTS as an RPI, there must be some evidence that it desired
`
`review of the challenged patent, that the Petition was filed at LTS’s behest, or that
`
`LTS exercises (or could exercise) control over DRL’s participation in the present
`
`proceeding, such that LTS should be precluded from bringing its own challenge in
`
`a later proceeding. See id. There is no such evidence present here. The mere fact
`
`that DRL’s interests are aligned with LTS’s in commercializing the product
`
`accused in the underlying litigation does not support an allegation that DRL was
`
`acting at LTS’s behest or on its behalf. Wi-Fi, 887 F.3d at 1341 (rejecting Patent
`
`Owner’s RPI argument where evidence “showed that [Petitioner’s] interests as to
`
`the issue of infringement were generally aligned with those of” the alleged RPIs,
`
`
`
`3
`
`
`
`but there was “no evidentiary support for [Patent Owner’s] theory that [Petitioner]
`
`was acting at the behest or on behalf of the” alleged RPIs).
`
`LTS played no role in deciding to file this IPR, and has no control over this
`
`proceeding. Ex. 1052 ¶¶ 7-8. DRL alone directed the preparation of the petition,
`
`and DRL alone pays the fees and costs for this proceeding. Id. ¶¶ 8-9. LTS’s
`
`distance from this proceeding is further evidenced by the fact that it is not party to
`
`the underlying district court litigation. Id. ¶ 4. In fact, Indivior asserted in the
`
`litigation that LTS’s interests and injuries cannot be attributed to DRL because
`
`they are separate entities. Ex. 1053 at 136:5-15 (“LTS isn’t a party to this case.
`
`Any harm it might suffer is irrelevant to the balancing of hardships analysis.”). In
`
`short, none of the considerations that could make a third party an RPI are satisfied
`
`here.
`
`Finally, even if LTS were an RPI, it could be added without rendering the
`
`Petition time-barred under § 315(b), as LTS was never sued on the subject patent.
`
`See T-Mobile USA, Inc. v. Vertical Connection Techs., IPR2018-01388, Paper 14
`
`at 16-19 (P.T.A.B. Jan. 13, 2019) (instituting IPR without ruling on RPI objection,
`
`where adding the alleged RPI would not make the petition untimely, as “precedent
`
`generally allows a party to update its identification of real parties in interest”).
`
`II. The § 325(d) Factors Weigh in Favor of Institution
`
`The Becton factors favor institution, and Indivior’s arguments to the contrary
`
`4
`
`
`
`
`
`
`
`are unavailing.
`
`First, Indivior misses the point regarding whether the asserted references
`
`were considered by the Examiner. The relevant question is not whether the
`
`Examiner was “aware of” the references by virtue of their citation in an IDS or in
`
`another reference. Paper 12 at 20-21. Instead, what matters is that the Examiner’s
`
`rejections never cited most of DRL’s references individually, much less in the
`
`particular combination set forth in the asserted ground. 1 See Paper 1 at 58-59.
`
`This weighs against a § 325(d) denial. See Navistar, Inc. v. Fatigue Fracture
`
`Tech., LLC, IPR2018-00853, Paper 13 at 16-17 (P.T.A.B. Sept. 12, 2018) (“[T]he
`
`fact that [references] were of record, but not applied in any rejection by the
`
`Examiner . . . provides little impetus for us to” deny institution); St. Jude Med.,
`
`LLC v. Snyders Heart Valve LLC, IPR2018-00105, Paper 15 at 12 (P.T.A.B. May
`
`3, 2018) (instituting IPR where the evidence did “not demonstrate that the
`
`Examiner considered the references in the combinations relied upon by Petitioner
`
`or addressed arguments similar to” Petitioner’s) (emphasis added).
`
`Second, Indivior improperly discounts the importance of the Das
`
`Declaration (Ex. 1003). While Indivior suggests that the Declaration is not
`
`“persuasive” or “has not established” its conclusions (Paper 12 at 22, 24), these are
`
`disputes as to the Declaration’s factual significance. As the Board has noted, such
`
`1 The references are also not cumulative of the considered art. Paper 1 at 58-61.
`
`
`
`5
`
`
`
`“factual disputes [are] best resolved during trial.” Coherus Biosci. Inc. v. AbbVie
`
`Biotech. Ltd., IPR2016-00172, Paper 9 at 19 (P.T.A.B. May 17, 2016); see also
`
`Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 11 at 13-14 (P.T.A.B. July 18,
`
`2017) (instituting IPR over § 325(d) objection where Petitioner offered new expert
`
`testimony and disputed the legitimacy of Patent Owner’s positions in prosecution).
`
`Third, Indivior mischaracterizes the legal significance of the change in its
`
`own arguments between prosecution and the present. Indivior asserts that “the
`
`nature of [its] arguments during prosecution” is not a “relevant factor[] . . . under
`
`Becton.” Paper 12 at 29 n.4. But “the extent of the overlap between the arguments
`
`made during examination and the manner in which . . . Patent Owner distinguishes
`
`the prior art” is explicitly one such relevant factor. Becton, Dickinson & Co. v. B.
`
`Braun Melsungen AG, IPR2017-01586, Paper 8 at 17-18 (P.T.A.B. Dec. 15, 2017)
`
`(emphasis added). Indivior’s easy dismissal of its reversal in positions on the prior
`
`art is legal error. See Petition at 60-61.
`
`III. Conclusion
`
`
`
`Contrary to Indivior’s assertions in the POPR, DRL respectfully submits that
`
`institution is warranted and requests that the Board grant its Petition.
`
`Dated: April 24, 2019
`
`
`
`
`
`
`
`By: /Ira J. Levy/
`Ira J. Levy
`Registration No. 35,587
`Goodwin Procter LLP
`The New York Times
`Building 620 Eighth Avenue
`6
`
`
`
`New York, NY 10018
`T: 212-459-7456
`F: 646-558-4143
`ILevy@goodwinlaw.com
`
`Robert Frederickson III (admitted pro hac
`vice)
`Goodwin Procter LLP
`100 Northern Ave.
`Boston, MA 02210
`T: 617-570-1947
`F: 617-321-4773
`
`John Coy Stull
`Registration No. 62,599
`Goodwin Procter LLP
`901 New York Avenue, NW
`Washington, DC 20001
`T: 202-346-4042
`F: 202-204-7303
`JStull@goodwinlaw.com
`
`Counsel for Petitioners
`
`
`
`
`
`
`
`
`
`
`
`7
`
`
`
`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(a), the undersigned certifies
`
`
`
`that on April 24, 2019, a copy of the foregoing Petitioners’ Reply to Patent
`
`Owner’s Preliminary Response and copies of Exhibit 1052 – Declaration of
`
`Anjum Swaroop and Exhibit 1053 – Transcript of June 28, 2018 Hearing of
`
`Motion for Preliminary Injunction were served by email on the lead and back-up
`
`counsel for Patent Owners at:
`
`dgarr@cov.com
`pchen@cov.com
`IndiviorSBX@cov.com
`
`
`
`
`Date: April 24, 2019
`
`
`
`
`
`
`
`
`
`
`
`By: /Ira J. Levy/
`Registration No. 35,587
`Goodwin Procter LLP
`The New York Times
`Building 620 Eighth Avenue
`New York, NY 10018
`T: 212-459-7456
`F: 646-558-4143
`ILevy@goodwinlaw.com
`
`8
`
`
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