Paper No. 17
`Filed: January 3, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`DR. REDDY’S LABORATORIES, LTD. AND DR. REDDY’S
`LABORATORIES, INC.,
`Petitioners,
`
`v.
`
`INDIVIOR UK LIMITED,
`Patent Owner.
`
`
`
`
`Patent No. 8,475,832
`Issue Date: July 2, 2013
`Title: SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
`Inter Partes Review No. IPR2016-01113
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`REQUEST FOR REHEARING UNDER 37 C.F.R. § 42.71(d)
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`
`Filed: January 3, 2017
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`DR. REDDY’S LABORATORIES, LTD. AND DR. REDDY’S
`LABORATORIES, INC.,
`Petitioners,
`
`v.
`
`INDIVIOR UK LIMITED,
`Patent Owner.
`
`
`
`
`Patent No. 8,475,832
`Issue Date: July 2, 2013
`Title: SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
`Inter Partes Review No. IPR2016-01113
`
`
`
`
`
`
`
`
`
`
`
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`
`
`REQUEST FOR REHEARING UNDER 37 C.F.R. § 42.71(d)
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`TABLE OF CONTENTS
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`Page
`INTRODUCTION ........................................................................................... 1
`I.
`LEGAL STANDARD ..................................................................................... 2
`II.
`III. BACKGROUND ............................................................................................. 2
`IV. THE BOARD CLEARLY ERRED IN APPLYING AN
`OVERLY RESTRICTIVE STANDARD AS TO THE
`MOTIVATION TO COMBINE THE CITED REFERENCES
`IN THE PETITION ......................................................................................... 3
`CONCLUSION ..............................................................................................13
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`V.
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`
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`i
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`TABLE OF AUTHORITIES
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`Page(s)
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`Cases
`In re Applied Materials, Inc.,
`692 F.3d 1289 (Fed. Cir. 2012) .....................................................................13
`KSR International Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007)......................................................................................... 3
`Wyers v. MasterLock Co.,
`616 F.3d 1231 (Fed. Cir. 2010) ....................................................................... 3
`Statutes
`35 U.S.C. § 21 ............................................................................................................ 2
`Rules
`37 C.F.R. § 42.63 ....................................................................................................... 2
`37 C.F.R. § 42.71 ...................................................................................................1, 2
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`ii
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`I.
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`INTRODUCTION
`Pursuant to 37 C.F.R. § 42.71(c) and (d), Petitioners, Dr. Reddy’s
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`Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively “Petitioner”),
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`hereby submit this Request for Rehearing on the Decision Denying Institution of
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`Inter Partes Review in the above-captioned matter. Paper No. 16, “Inst. Dec.” In
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`the Institution Decision, all of Petitioner’s grounds for obviousness of claims 1-7
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`and 9-12 of U.S. Patent No. 8,475,832 (“the ‘832 patent”) were denied.
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`Petitioner respectfully submits that the Board erred as a matter of law in
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`denying Petitioner’s proposed grounds and such errors constitute an abuse of
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`discretion. Petitioner respectfully requests reconsideration of the Board’s denial of
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`the following grounds:
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`A.
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`Claims 1-2, 4-7, and 9-10 are obvious under § 103 over LabTec in
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`view of Yang, the Suboxone® 2002 Label, SBOA, and Birch;
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`B.
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`Claims 3, 11, and 12 are obvious under § 103 over LabTec in view of
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`Yang, the Suboxone® 2002 Label, SBOA, Birch, and the ‘055 publication;
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`C.
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`Claims 1-2, 4-7, and 9-10 are obvious under § 103 over Oksche in
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`view of Yang, the Suboxone® 2002 Label, SBOA, and Birch;
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`D.
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`Claims 3, 11, and 12 are obvious under § 103 over Oksche in view of
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`Yang, the Suboxone® 2002 Label, SBOA, Birch, and the ‘055 publication.
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`1
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`II. LEGAL STANDARD
`A request for rehearing is appropriate when the requesting party believes
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`“the Board misapprehended or overlooked” a matter that was previously addressed
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`in the record. See 37 C.F.R. § 42.71(d). The request “must specifically identify all
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`matters the party believes the Board misapprehended or overlooked, and the place
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`where each matter was previously addressed in a motion, an opposition, or a
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`reply.” Id. In reviewing such a request, the “panel will review the decision for an
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`abuse of discretion.” 37 C.F.R. § 42.71(c). Moreover, for evidence to be
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`considered by the Board, “all evidence must be filed in the form of an exhibit.” 37
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`C.F.R. § 42.63(a). This Request is timely under 37 C.F.R. § 42.71(d)(2) and 35
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`U.S.C. § 21(b).
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`III. BACKGROUND
`On December 2, 2016, the Board denied institution of Petitioner’s Petition
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`on the grounds that the Board was “not persuaded that the Petitioner has
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`demonstrated that there is a reasonable likelihood that it would prevail in showing
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`that [the] challenged claims [of the ’832 patent] are unpatentable over any cited art,
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`including LabTec, Oksche, Yang, and the ’055 publication, in view of the
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`Suboxone® 2002 Label, SBOA, and Birch”. Inst. Dec. at 19.
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`2
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`IV. THE BOARD CLEARLY ERRED IN APPLYING AN OVERLY
`RESTRICTIVE STANDARD AS TO THE MOTIVATION TO
`COMBINE THE CITED REFERENCES IN THE PETITION
`In KSR International Co. v. Teleflex, Inc., the Supreme Court explicitly
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`rejected a rigid approach to determining whether references can be combined for
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`obviousness purposes. 550 U.S. 398, 415 (2007). Instead, the Supreme Court
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`instructed courts to take a more “expansive and flexible approach” in determining
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`whether a patented invention was obvious at the time it was made. Id. at 421. In
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`particular, the Court emphasized that “[w]hen there is a design need or market
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`pressure to solve a problem and there are a finite number of identified, predictable
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`solutions, a person of ordinary skill has good reason to pursue the known options
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`within his or her technical grasp. If this leads to the anticipated success, it is likely
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`the product not of innovation but of ordinary skill and common sense.” Id.
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`Moreover, “KSR [establishes] that the legal determination of obviousness may
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`include recourse to logic, judgment, and common sense…” Wyers v. MasterLock
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`Co., 616 F.3d 1231, 1239 (Fed. Cir. 2010). Here, the Board erred in applying a
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`legally improper, overly restrictive obviousness analysis and ignoring the ample
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`evidence provided by Petitioner and its expert.
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`In its Decision (Paper 16), the Board found that “Petitioner does not point to
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`where [LabTec, SBOA, and the Suboxone® 2002 Label], individually or in
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`combination, teach or suggest any buffer in an amount that provides a local pH that
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`3
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`is ‘about 3 to about 3.5…’” Id. at 13. Further, the Board found that “neither
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`Petitioner nor Dr. Çelik explains adequately why an ordinary artisan would have
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`wanted to try to make a composition that produced a local pH of 3 to 3.5 in the
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`mouth in the first place, based on teachings in Oksche, Yang, the Suboxone® 2002
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`Label, and/or the SBOA.” Id. at 19. Still further, the Board found that “Petitioner
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`does not explain adequately how Birch’s pH information in relation to
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`buprenorphine formulations (lacking naloxone) administered intranasally teaches
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`or suggests a buffer providing a specific ‘local pH’ in the oral cavity, as it pertains
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`to a composition comprising both buprenorphine and another drug, naloxone, as
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`required in the challenged claims.” Id. at 15.
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`In its Petition for Inter Partes Review, Petitioner presented grounds for how
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`the elements of the challenged claims of the ‘832 patent are taught in the prior art.
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`Nevertheless, the Board stated that Petitioner does “not point to where the SBOA,
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`the Suboxone® 2002 Label, and/or LabTec suggest that anyone actually measured a
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`local pH for the Suboxone tablets in an oral cavity, much less determined that local
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`pH should be from about 3 to about 3.5.” While these references do teach the
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`importance of pH in the oral cavity, Petitioner does not rely solely on these
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`references.
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`Petitioner described how LabTec taught the use of an orally-disintegrating
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`film dosage form comprising, inter alia, a film-forming agent for transmucosally
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`4
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`delivering buprenorphine and naloxone that is bioequivalent to Suboxone® tablets.
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`Petition at 15, 24, 25. LabTec taught that such bioequivalence can be
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`accomplished by following the same metabolic and bioabsorption pathways as the
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`tablets to achieve the proven clinical efficacy of the tablet product. Id. at 16, 24,
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`25.
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`Petitioner described how Oksche taught an orally-disintegrating film dosage
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`form for sublingual administration of buprenorphine and naloxone which
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`contained, inter alia, at least one matrix-forming polymer and pH modifiers. Id. at
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`16, 40-43. Oksche expressly referenced Suboxone® tablets. Id. Both LabTec and
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`Oksche, respectively, taught the need to achieve bioequivalence between film
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`dosage forms and Suboxone® tablets. Id. at 15-16, 24-25, 41. Petitioner described
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`how Yang taught rapidly dissolving films employing a polymeric carrier matrix
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`and, further that the ‘832 patent admits that the processes taught in Yang were
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`suitable for creating an embodiment of the ‘832 patent. Id. at 16-17 and 26-27.
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`Petitioner described how the Suboxone® 2002 Label and the SBOA
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`identified Suboxone®, a FDA approved drug, as a tablet containing buprenorphine
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`hydrochloride and naloxone hydrochloride and, inter alia, a citric acid/sodium
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`citrate buffer system. Id. at 17. Moreover, the pharmacokinetic profile of
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`Suboxone® sublingual tablets was published in the SBOA. Id. Dr. Metin Çelik,
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`Petitioner’s expert witness, testified it was known that under the conditions
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`5
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`provided by the tablets at the site of administration in the mouth, buprenorphine
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`absorbed transmucosally, while naloxone was not significantly absorbed, either
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`transmucosally or through the GI tract. Id., see also Ex. 1003, Çelik Decl. at ¶¶ 75,
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`83.
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`Petitioner described how Birch taught pharmaceutical formulations designed
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`to provide transmucosal absorption of the buprenorphine into the plasma. Petition
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`at 22. Notably, Birch taught administration of aqueous solutions of buprenorphine-
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`containing formulations to the nasal mucosa at a pH of about 3.5—within the ’832
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`patent’s claimed pH range. Id. at 21. Claim 1 of Birch further taught
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`administration of a buprenorphine solution at a narrow pH range of 3 to 4.2. Id. at
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`21-22.
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`Petitioner described how the ’055 publication taught a uniform, mucosally-
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`adhesive, water-soluble, dissolving film product for buccal and sublingual
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`administration of buprenorphine and naloxone and methods for preparing such a
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`product. Id. at 21-22. The ’055 publication taught the use of both low and high
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`molecular weight polyethylene oxide (PEO) for adjusting various properties of the
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`finished film product. Id. at 23.
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`Petitioner described how a person of ordinary skill in the art (POSA) would
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`have been motivated by either LabTec or Oksche in view of Yang, the Suboxone®
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`2002 Label, SBOA, Birch, and the ’055 publication to make the invention of the
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`6
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`challenged claims. As Petitioner stated, a POSA would have been motivated by
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`the teachings of LabTec to develop a film version of Suboxone® tablets in view of
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`the explicit and unambiguous identification of the tablets as a drug of interest that
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`has the particular pharmacokinetic profile suitable for developing an orally
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`disintegrating film dosage form. Id. at 25-26. Dr. Çelik testified that “[a] key
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`teaching of LabTec is the use of an orally disintegrating film dosage form for
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`delivering buprenorphine and naloxone that is bioequivalent to
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`buprenorphine/naloxone tablets.” Ex. 1003, Çelik Decl. at ¶ 111. Further, Dr.
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`Çelik testified that “[a] POSA would have been motivated by the teachings of
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`LabTec to develop a film formulation for Suboxone®, especially given the explicit
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`and unambiguous identification of Suboxone® as a ‘drug[] of interest’ that is
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`suitable for developing an ‘orally disintegrating film dosage form.’” Id. at ¶ 114
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`citing LabTec, Ex. 1007 at 2, 20, 22. Dr. Çelik further testified that “a POSA
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`would be motivated to convert a sublingual tablet formulation to a sublingual film
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`formulation in order to prevent the misuse of buprenorphine.” Id.
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`Petitioner described that Oksche taught oral, transmucosal buprenorphine
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`and naloxone administration utilizing a film composition that is bioequivalent to
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`Suboxone® tablets. Id. at 41-42, see also Ex. 1005, Oksche at 20. Oksche would
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`have motivated a POSA to create a film just as effective as Suboxone® tablets.
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`Petition at 42, see also Ex. 1003, Çelik Decl. at ¶¶ 116 and 138-139. Dr. Çelik
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`7
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`testified that “a POSA would have been motivated to create the claimed film,
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`because the film would be just as effective as Suboxone® tablets.” Ex. 1003, Çelik
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`Decl. at ¶ 139.
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`Petitioner described that Yang provided a POSA with all the necessary
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`knowledge needed in order to have a reasonable expectation of success regarding
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`the manufacture of oral film products bioequivalent to Suboxone® tablets. Petition
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`at 26. Yang taught a POSA how to create a film dosage composition formed of a
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`polymeric carrier matrix having an active agent with no more than 10% variance of
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`the active per unit area of the film. Id. at 26-27, see also Ex. 1003, Çelik Decl. at ¶
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`116.
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`Petitioner discussed that a POSA knew pH is generally important to the
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`absorption of a drug through the mucosal membranes in the mouth. Petition at 27,
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`see also Ex. 1003, Çelik Decl. at ¶¶ 97-102, 109, 119-135. LabTec teaches that pH
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`can be adjusted to decrease or increase absorption of the actives and methods for
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`adjusting the pH at the site of absorption to obtain a desired absorption, as well as
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`the buffers that can be used to effect this adjustment. Petition at 27-28. Because
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`LabTec taught a film designed to mimic Suboxone® tablets, a POSA would have
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`looked to any publicly available source teaching the specific buffer system utilized
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`to adjust the pH of the Suboxone® tablets. Id. at 28, see also Ex. 1003, Çelik Decl.,
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`8
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`at ¶ 118. Such sources included the SBOA and the Suboxone® 2002 Label.
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`Petition at 28.
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`Further, in its Decision, the Board stated:
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`LabTec teaches that ‘formulations can rely on various means for
`retarding absorption of the active ingredient through the oral
`mucosa,’ including by using ‘pH adjusting agents that adjust the pH
`of the environment surrounding the dosage form to a pH that renders
`the active agent less permeable.’ In this context, LabTec states that
`‘[s]uitable pH adjusting agents function by ionizing the active agent to
`a less permeable state,’ and ‘[f]or a basic active ingredient, one
`would adjust the pH of the solution to below the pKa of the
`conjugate acid.’
`Inst. Dec. at 17 (internal citations omitted) (emphasis in original). However, these
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`quotations are taken out of context in light of the overall teaching of LabTec.
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`The section of LabTec discussing the above retardation technique is entitled
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`“Means for Retarding Buccal Absorption (or for Promoting GI Absorption).” Ex.
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`1007, LabTec at 14. Specifically, LabTec states in this section, along with the
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`quotations immediately above, that the goal of such retardation is to “[assure] that
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`the active agent is absorbed through the gastrointestinal tract instead of the oral
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`mucosa.” Id. Naloxone, which is disclosed in LabTec at page 27, is precisely the
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`active ingredient a POSA desires to be retarded from transmucosal absorption in
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`the presence of buprenorphine. Moreover, while the pH of a basic active
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`9
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`ingredient can be adjusted below the pKa of the conjugate acid, common sense
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`dictates that the converse is equally true. That is, for a basic active ingredient, one
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`would adjust the pH of the solution to above the pKa of the conjugate acid to
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`enhance transmucosal absorption. See Petition at 27-28. This very application was
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`discussed in Dr. Çelik’s testimony. See Ex. 1003, Çelik Decl. at ¶¶ 97-102, 109,
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`119-135. Success by a POSA would be reasonably expected since enhanced
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`buprenorphine transmucosal absorption was achieved along with retarded naloxone
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`transmucosal absorption by the Suboxone® tablets.
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`The Board applied an overly restrictive standard in requiring the SBOA, the
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`Suboxone® 2002 Label, and/or LabTec to “actually measure a local pH for the
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`Suboxone tablets in an oral cavity” or to “[determine] that a local pH should be
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`from about 3 to about 3.5.” Inst. Dec. at 13. The Board ignored the teachings in
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`these references of the importance of pH, including specifically teaching that a pH
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`range exists, for dissolution and transmucosal absorption. Petitioner described
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`how the SBOA taught the POSA that pH produced in saliva as the Suboxone®
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`tablet disintegrates is important for optimal absorption of buprenorphine. Id. at 28-
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`29. Although the pH values were redacted, a POSA nevertheless knew from the
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`SBOA that the pH generated by the tablet had to be below a certain pH for
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`buprenorphine to dissolve and above a certain pH to hinder naloxone dissolution.
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`Id. at 29. Petitioner also discussed that the SBOA identified the mean Cmax and
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`10
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`AUC values for buprenorphine for the Suboxone® tablet, which were exactly those
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`disclosed in LabTec. Id. at 30. Based on the SBOA, the POSA would have
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`concluded that (1) pH is important to achieving the Cmax and AUC values
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`necessary for bioequivalence, i.e., transmucosal absorption, and (2) that an
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`optimum range of pH values had been achieved by the Suboxone® tablet
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`formulation. Id. at 31, see also Ex. 1003, Çelik Decl., at ¶¶ 121 and 123. Further,
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`a POSA knew from the Suboxone® 2002 Label that Suboxone® tablets utilized a
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`citric acid/sodium citrate buffering system (Petition at 31, see also Ex. 1003, Çelik
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`Decl. at ¶¶ 85, 87, 119, 126), motivating the POSA to look for a desirable pH range
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`of from about 3 to about 6, the narrow operating range of citric acid-based buffers.
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`Petition at 32, see also Ex. 1003, Çelik Decl. at ¶¶ 85, 96, 119, 129, 131.
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`Petitioner described how Birch taught that buprenorphine solubility
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`increases as pH decreases, and local transmucosal absorption and resulting
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`bioequivalence of buprenorphine are enhanced at low pH. Petition at 32-33, see
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`also Ex. 1003, Çelik Decl. at ¶¶ 140. Birch taught a POSA that a pH of 3.4
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`successfully resulted in transmucosal absorption of buprenorphine and the desired
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`bioequivalence. Petition at 32-33. As the Board recognized, Dr. Çelik testified
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`that “[t]he anatomy of the oral and nasal mucosa is quite similar, thus, one of
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`ordinary skill would expect that the same principle of drug delivery will apply to
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`both tissues.” Ex. 1003, Çelik Decl. at ¶ 105. However, the Board erred in
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`11
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`discounting this testimony as a “conclusory statement.” Inst. Dec. at 15. The
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`Board failed to credit Dr. Çelik’s testimony in the very same paragraph that a) the
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`formulation of Birch is an aqueous solution, i.e. solubilized, (Ex. 1003, Çelik Decl.
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`at ¶ 105), b) the delivery site consists of mucosa tissue (id.), and c) the ionic state
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`of buprenorphine is such that it is absorbable across the mucosa at the recited pHs
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`and claimed pH range in Birch. Thus, Dr. Çelik’s conclusion was supported when
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`reviewed in the context of its presentation. Moreover, Birch, as Dr. Çelik
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`concluded, provided a POSA with a target pH for transmucosal absorption of
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`buprenorphine.
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`The POSA recognized that a) a pH of 3.4 falls within the pH range from
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`about 3 to about 6, which is the pH range of the citric acid/sodium citrate buffering
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`system of the Suboxone® tablet, b) buprenorphine at pH 3.4 was both in solution
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`and in a transmucosally absorbable state, and c) naloxone transmucosal
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`absorption should not be problematic because it was not seen with Suboxone®
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`tablets. Id. at 32-33. Thus, a POSA would have been motivated to utilize a pH of
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`3.4 for a film dosage form containing the combination of buprenorphine and
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`naloxone with a reasonable expectation of success of achieving bioequivalence to
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`the Suboxone® tablets. Petition at 33, see also Ex. 1003, Çelik Decl. at ¶¶ 131-135
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`and Ex. 1004, Birch at Figures 1, 3, Examples 3, 5, 8.
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`12
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`Petitioner explained that a POSA had (i) the ability to prepare buffered
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`films; (ii) a 3.4 pH starting point for testing; (iii) the published target Cmax and
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`AUC values of Suboxone® tablets, and (iv) knowledge of the pH dependence of the
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`transmucosal absorption of buprenorphine and naloxone. Id. at 33. It would have
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`been routine experimentation and optimization to arrive at a pH range of about 3 to
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`about 3.5. Petition at 33, see also Ex. 1003, Çelik Decl. at ¶¶ 133-134, 141.
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`“[W]here the general conditions of a claim are disclosed in the prior art, it is not
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`inventive to discover the optimum or workable ranges by routine experimentation.”
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`In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012) (internal
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`citation omitted).
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`As Petitioner explained, a POSA would have followed the motivation
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`described in the prior art to combine these elements and used, at most, only routine
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`experimentation to arrive at the subject matter claimed in the ’832 patent. Petition
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`at 34, see also Çelik Decl. at ¶¶ 125, 132-135. Additionally, a POSA would have
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`conducted these activities with a reasonable expectation of success of achieving
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`bioequivalence to that of the Suboxone® tablets. Therefore, the teachings of the
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`prior art, combined with the knowledge of those of ordinary skill in the art, render
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`each of the challenged claims invalid as obvious.
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`V. CONCLUSION
`The Board has overlooked specific evidence in support thereof provided by
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`13
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`the Petitioner and its expert. Petitioner respectfully requests that the Board grant
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`this request for rehearing and institute trial on Petitioner’s Petition.
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`Respectfully submitted,
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`
`/s/ Jeffery B. Arnold
`Jeffery B. Arnold
`USPTO Reg. No. 39,540
`Cantor Colburn LLP
`1180 Peachtree Street, Suite 2050
`Atlanta, Georgia 30309
`Telephone: (404) 607-9991
`Facsimile: (404) 607 9981
`jarnold@cantorcolburn.com
`
`Lead Counsel for Petitioners
`Dr. Reddy’s Laboratories, Ltd. and
`Dr. Reddy’s Laboratories, Inc.
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`Dated: January 3, 2017
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`14
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that on January 3, 2017, a true and correct copy of
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`the foregoing REQUEST FOR REHEARING UNDER 37 C.F.R. § 42.71(d) was
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`served pursuant to 37 C.F.R. § 42.6(e) on attorneys of record for the Patent Owner
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`by filing this document through the Patent Trial and Appeal Board End to End
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`(PTAB E2E) system and delivering a copy via electronic mail as follows:
`
`Andrea G. Reister
`Enrique D. Longton
`Covington & Burling LLP
`One CityCenter, 850 Tenth Street, NW
`Washington, DC 20001
`areister@cov.com
`rlongton@cov.com
`
`Dustin B. Weeks
`Troutman Sanders LLP
`600 Peachtree Street NE, Suite 5200
`Atlanta, GA 30308
`dustin.weeks@troutmansanders.com
`
`Daniel A. Ladow
`Troutman Sanders LLP
`875 Third Avenue
`New York, NY 10022
`daniel.ladow@troutmansanders.com
`
`Counsel for Indivior UK Limited
`Dated: January 3, 2017
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`15
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`/s/ Jeffery B. Arnold
`Jeffery B. Arnold
`USPTO Reg. No. 39,540
`
`Lead Counsel for Petitioners
`Dr. Reddy’s Laboratories, Ltd. and
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`
`Dr. Reddy’s Laboratories, Inc.
`Dr. Reddy’s Laboratories, Inc.
`
`16
`
`16
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