Paper No. 44
`Date Filed: July 14, 2017
`
`Filed On Behalf Of:
`
`Alkermes Pharma Ireland Limited and
`Alkermes Controlled Therapeutics, Inc.
`
`By:
`
`Scott K. Reed
`sreed@fchs.com
`212-218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`LUYE PHARMA GROUP LTD., LUYE PHARMA (USA) LTD., SHANDONG
`LUYE PHARMACEUTICAL CO., LTD., and NANJING LUYE
`PHARMACEUTICAL CO., LTD.,
`Petitioners,
`v.
`ALKERMES PHARMA IRELAND LTD and ALKERMES CONTROLLED
`THERAPEUTICS, INC.
`Patent Owners.
`________________
`
`Case IPR2016-01096
`U.S. Patent No. 6,667,061
`________________
`
`PATENT OWNERS’ IDENTIFICATION OF PORTIONS
`OF PETITIONERS’ REPLY THAT EXCEED THE
`PROPER SCOPE OF REPLY OR RAISE NEW ARGUMENTS
`
`
`Date Filed: July 14, 2017
`
`Filed On Behalf Of:
`
`Alkermes Pharma Ireland Limited and
`Alkermes Controlled Therapeutics, Inc.
`
`By:
`
`Scott K. Reed
`sreed@fchs.com
`212-218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`LUYE PHARMA GROUP LTD., LUYE PHARMA (USA) LTD., SHANDONG
`LUYE PHARMACEUTICAL CO., LTD., and NANJING LUYE
`PHARMACEUTICAL CO., LTD.,
`Petitioners,
`v.
`ALKERMES PHARMA IRELAND LTD and ALKERMES CONTROLLED
`THERAPEUTICS, INC.
`Patent Owners.
`________________
`
`Case IPR2016-01096
`U.S. Patent No. 6,667,061
`________________
`
`PATENT OWNERS’ IDENTIFICATION OF PORTIONS
`OF PETITIONERS’ REPLY THAT EXCEED THE
`PROPER SCOPE OF REPLY OR RAISE NEW ARGUMENTS
`
`
`
`Pursuant to the Board’s conference call of June 30, 2017 and the parties’
`
`agreement (Exh. 2080)1, Patent Owners submit the following list setting forth the
`
`portions of Petitioners’ Reply (Paper 40) that exceed the proper scope of reply
`
`and/or raise new arguments and evidence that could and should have been raised as
`
`part of their prima facie case, but were not included in the Petition, along with a
`
`brief explanation. These improper, new arguments by Petitioners should not be
`
`considered.
`
`I.
`
`Petitioners’ Late Attempts to Newly Define the Injection Vehicles
`Disclosed by Gustafsson and Johnson
`
`1.
`
`Reply at 8-11, 18-19; Exh. 1024 at ¶¶ 31-35, 40-45, 50-52, 86-89.
`
`Petitioners attempt to newly define the Gustafsson injection vehicle and make new
`
`arguments about how a POSA would have allegedly understood the disclosure. In
`
`contrast, in the Petition, Petitioners argued only that “a POSA would reasonably
`
`expect the injection vehicle of Gustafsson – having 3% CMC – to have a viscosity
`
`greater than 27cp at 20°C and certainly within the claimed range of 20-600cp at
`
`20°C” (Petition at 39-40; see also id. at 11, 49; Exh. 1002 at ¶ 70; see also id. at
`
`¶¶ 28, 57) and did not specify, for instance, that low viscosity, pharmaceutical
`
`1 Exh. 2080 is the transcript of the conference call with the Board.
`
`1
`
`
`
`grade and/or commercially available CMC would have been used in the Gustafsson
`
`vehicle.1
`
`2.
`
`Reply at 8-14; Exh. 1024 at ¶¶ 31-35, 40-45, 50-54, 57-60, 65.
`
`Petitioners attempt to newly define the Johnson injection vehicle and make new
`
`arguments about how a POSA would have allegedly understood the disclosure. In
`
`contrast, in the Petition, Petitioners argued only that “a POSA would reasonably
`
`expect the injection vehicle of Johnson – having 3% CMC – to have a viscosity
`
`greater than 27cp at 20°C and certainly within the claimed range of 20-600cp at
`
`20°C” (Petition at 25-26; see also id. at 10, 32-33; Exh. 1002 at ¶60; see also id. at
`
`¶¶ 27, 59) and did not specify, for instance, that pharmaceutical and/or
`
`commercially available CMC would have been used in the Johnson vehicle or
`
`explain why a POSA would have understood the same CMC was used throughout
`
`the examples of Johnson.
`
`II.
`
`Petitioners’ Late Attempts to Satisfy the Microparticle and Polymeric
`Binder Limitations
`
`3.
`
`Reply at 6-8, 17-22; Exh. 1024 at ¶¶ 25-30, 91-97, 100-102, 104; Exh.
`
`1036, Exh. 1037; Exh. 1043. Petitioners assert new theories as to how Gustafsson
`
`1 Petitioners also fail to explain, in both the Petition and Reply, what
`
`“pharmaceutical grade,” “low viscosity” and/or “commercially available” means
`
`with respect to CMC.
`
`2
`
`
`
`allegedly satisfies the microparticle and polymeric binder limitations of the claims
`
`of the ’061 patent, including newly arguing that starch satisfies the limitations. In
`
`contrast, in the Petition, Petitioners argued only that the PLGA coating of
`
`Gustafsson satisfied the limitations for claims 17-19 (Petition at 10-11, 45-46, 49,
`
`53-54; Exh. 1002 at ¶¶ 78-79; see also id. at ¶ 28 (failing to identify with
`
`specificity how Gustafsson satisfied the microparticle limitation, which requires a
`
`polymer that serves as a matrix or binder, and polymeric binder limitations for
`
`claims 1-16, 22-23)), Petitioners made no mention of starch, and, at deposition,
`
`Petitioners’ expert expressly testified that the starch of Gustafsson’s microparticles
`
`was not a polymer (Exh. 2016 at 243:7-12).
`
`4.
`
`Reply at 7-8, 19, 21-24; Exh. 1024 at ¶¶ 30, 91, 93-94, 96, 100, 104;
`
`Exh. 1036. Petitioners assert new theories that the PLGA coating of Gustafsson
`
`satisfies the microparticle and/or polymeric binder limitations for claims 1-3, 6-9,
`
`12-13, 20-21, and 22-23. In contrast, in the Petition, Petitioners relied on the
`
`PLGA coating of Gustafsson to meet these limitations only for claims 17-19.
`
`(Petition at 10-11, 45-46, 49, 53; Exh. 1002 at ¶¶ 28, 78-79).
`
`III.
`
`Petitioners’ Late Attempts to Argue New Combinations
`
`5.
`
`Exh. 1024 at ¶ 101. Petitioners assert a new theory that a POSA
`
`would have combined the microparticles of Ramstack with the injection vehicle of
`
`Gustafsson to arrive at claims 17-19. In contrast, in the Petition, Petitioners argued
`
`3
`
`
`
`that Gustafsson alone met every limitation of claims 17-19. (Petition at 45-46, 49,
`
`53; Exh. 1002 at ¶¶ 78, 79).
`
`6.
`
`Reply at 20; Exh. 1024 at ¶¶ 95, 102; Exh. 1043; Exh. 1011 at 3:31-
`
`36. Petitioners assert a new theory that a POSA would have combined the
`
`microparticles of WO 90/13780 (Exh. 1043), a newly asserted prior art reference,
`
`with the injection vehicle of Example 6 in Gustafsson to arrive at claims 17-19 and
`
`assert that a POSA would do so because Gustafsson allegedly “acknowledges that
`
`any microparticle can be used.” Exh. 1024 at ¶ 102. In contrast, in the Petition,
`
`Petitioners argued that Gustafsson alone met every limitation of claims 17-19 and
`
`did not mention or rely upon WO 90/13780. (Petition at 45-46, 49, 53; Exh. 1002
`
`at ¶¶ 78, 79).
`
`7.
`
`Reply at 23-26; Exh. 1024 at ¶¶ 106-112. Petitioners assert a new
`
`theory that a POSA could combine the risperidone active of Ramstack with the
`
`microparticles and injection vehicle of Gustafsson to arrive at claims 20-21. In
`
`contrast, in the Petition, Petitioners argued that a POSA could combine the
`
`risperidone microparticles of Ramstack with the injection vehicle of Gustafsson.
`
`(Petition at 45-47, 53-54; Exh. 1002 at ¶ 80).
`
`4
`
`
`
`IV.
`
`Petitioners’ Late Attempts to Satisfy the Density Enhancing Agent
`Limitation
`
`8.
`
`Exh. 1024 at ¶¶73-78. Petitioners assert new theories as to how Kino
`
`allegedly satisfies the density enhancing agent limitation of claims 4, 5, 10 and 11
`
`of the ’061 patent, including newly arguing that the sorbitol added to the Kino
`
`microparticle would dissolve into, and thus become part of the injection vehicle
`
`when the composition is reconstituted. In contrast, in the Petition, Petitioners
`
`argued that the “injection vehicle means the aqueous or non-aqueous fluid medium
`
`prior to the addition of microparticles to form a suspension” (Petition at 20-21;
`
`Exh. 1002 at ¶ 49) and Kino “teaches that fillers, such as sorbitol [ . . . ], are useful
`
`for enhancing the stability of a microparticle suspension” (Petition at 27; Exh.
`
`1002 at ¶¶ 56, 62).
`
`V.
`
`Petitioners’ Late Attempts to Support Motivation to Combine and
`Expectation of Success
`
`9.
`
`Reply at 17; Exh. 1024 at ¶ 76. Petitioners newly assert that a POSA
`
`would have been motivated to combine the teachings of Kino and Johnson in order
`
`to minimize the difference between the densities of the particles and the vehicle to
`
`reduce sedimentation to arrive at claims 4, 5, 10 and 11. In contrast, in the
`
`Petition, Petitioners only argued that “[i]ncreasing the density of an injectable
`
`suspension may be desirable to stabilize the formulation” and did not mention
`
`“sedimentation” or introduce any evidence suggesting a correlation between
`
`5
`
`
`
`stabilizing the formulation and avoiding sedimentation. (Petition at 26-27; Exh.
`
`1002 at ¶ 62.)
`
`10. Reply at 22-26; Exh. 1024 at ¶¶ 103-112. Petitioners newly assert
`
`that a POSA would have been motivated to combine Gustafsson and Ramstack to
`
`arrive at claims 20 and 21 since a POSA would have been motivated by the
`
`common and interchangeable components of Gustafsson and Ramstack to combine
`
`these references. In contrast, in the Petition, Petitioners argued only that
`
`“Gustafsson teaches that the active may be any substance desirable for sustained or
`
`controlled release as a microparticle” and Ramstack teaches microparticles of
`
`risperidone. (Petition at 46-47; Exh. 1002 at ¶¶ 79-80.)
`
`VI.
`
`Petitioners’ Late Attempts to Define the Motivations and Knowledge of
`a POSA
`
`11. Reply at 4-6, 15; Exh. 1024 at ¶¶ 14-24; Exh. 1028; Exh. 1032; Exh.
`
`1034. Petitioners newly assert that a POSA would have been motivated by
`
`suspendability to arrive at viscosities within the claimed range. In contrast, in the
`
`Petition, Petitioners identified only syringeability and injectability as factors that
`
`implicate viscosity. (Petition at 8-9; Exh. 1002 at ¶¶ 22-25.)
`
`12. Reply at 2-4; Exh. 1024 at ¶¶ 7-24; Exh. 1027, Exh. 1028, Exh. 1030,
`
`Exh. 1032, Exh. 1034. Petitioners newly assert that viscosities within the claimed
`
`range were already known and would be a product of routine optimization,
`
`6
`
`
`
`including newly arguing that a POSA would have understood Decapeptyl to have a
`
`viscosity within the margin of error of that claimed in the ’061 patent, that aqueous
`
`suspensions of risperidone prodrug with a viscosity within the claimed range could
`
`be used as a depot injection, and that a POSA would not know what constitutes
`
`low viscosity for an injection vehicle at the time of the invention. In contrast, in the
`
`Petition, Petitioners argued that “[a] POSA would appreciate the term ‘greater than
`
`about 20’ to mean greater than 19.7cp as the background of the ’061 patent clearly
`
`teaches with respect to a prior art injectable suspension having a viscosity of
`
`approximately 19.7cp when prepared as directed.” (Petition at 22; Exh. 1002 at ¶
`
`53.).
`
`July 14, 2017
`
`Respectfully submitted,
`
`/Scott Reed/
`Scott K. Reed (Reg. No. 32,433)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`Counsel for Patent Owners
`
`7
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that a copy of the foregoing PATENT OWNER’S
`
`IDENTIFICATION OF PORTIONS OF PETITIONERS’ REPLY THAT
`
`EXCEED THE PROPER SCOPE OF REPLY OR RAISE NEW ARGUMENTS
`
`was served on July 14, 2017 by causing it to be sent by email to counsel for
`
`Petitioners, who have consented to electronic service, at the following email
`
`addresses:
`
`wmentlik.ipr@lernerdavid.com
`
`pkochanski@lernerdavid.com
`
`tvanbuskirk@lernerdavid.com
`
`nvaleyko@lernerdavid.com
`
`July 14, 2017
`
`Respectfully submitted,
`
`/Scott Reed/
`Scott K. Reed (Reg. No. 32,433)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`Counsel for Patent Owners
`
`8
`
`
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