UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`CIPLA LTD.,
`Petitioner
`
`v.
`
`ABRAXIS BIOSCIENCE, LLC,
`Patent Owner
`
`Case IPR2018-00164
`Patent 8,138,229 B2
`Issued: March 20, 2012
`
`Title: COMPOSITIONS AND METHODS OF
`DELIVERY OF PHARMACOLOGICAL AGENTS
`
`MOTION FOR JOINDER
`Pursuant to 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 and 42.122(b)
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`CIPLA LTD.,
`Petitioner
`
`v.
`
`ABRAXIS BIOSCIENCE, LLC,
`Patent Owner
`
`Case IPR2018-00164
`Patent 8,138,229 B2
`Issued: March 20, 2012
`
`Title: COMPOSITIONS AND METHODS OF
`DELIVERY OF PHARMACOLOGICAL AGENTS
`
`MOTION FOR JOINDER
`Pursuant to 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 and 42.122(b)
`
`
`
`IPR2018-00164 (8,138,229 B2)
`
`TABLE OF CONTENTS
`
`Page
`STATEMENT OF THE PRECISE RELIEF REQUESTED .......................... 1
`
`STATEMENT OF MATERIAL FACTS ........................................................ 2
`
`I.
`
`II.
`
`III. DISCUSSION .................................................................................................. 3
`
`A.
`
`B.
`
`Cipla’s Motion for Joinder is Timely .................................................... 4
`
`The Four Factors Weigh in Favor of Joinder ........................................ 4
`
`1.
`
`2.
`
`3.
`
`4.
`
`Joinder is Appropriate Because it Will Promote an
`Efficient Determination of the Validity of the ’229
`Patent Without Prejudice to any Party. ....................................... 5
`
`The Cipla Petition Does Not Raise Any New Grounds
`of Unpatentability and Therefore Does Not Add
`Additional Complexity to the Grounds in the Actavis
`Petition ........................................................................................ 6
`
`Joinder Would Not Affect the Schedule of the Actavis
`IPR ............................................................................................... 7
`
`Joinder Will Simplify Briefing and Discovery Because
`Cipla Will Agree to Consolidate Filings and Coordinate
`Discovery .................................................................................... 7
`
`IV. CONCLUSION ................................................................................................ 8
`
`i
`
`
`
`IPR2018-00164 (8,138,229 B2)
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Abraxis BioScience, LLC, et al. v. Actavis LLC,
`C.A. No. 2:16-cv-01925 ....................................................................................... 2
`
`Abraxis BioScience, LLC, et al., v. Cipla Ltd.,
`C.A. No. 2:16-cv 0974-JMV-MF ......................................................................... 2
`
`Actavis LLC v. Abraxis Bioscience, LLC,
`IPR2017-01104, Paper 7 (PTAB Oct, 10, 2017) .......................................... 1, 2, 3
`
`Amerigen Pharm Ltd, v. UCB Pharma GMBH,
`IPR2016-01665, Paper 8 (PTAB Dec. 7, 2016) ................................................... 8
`
`Dell Inc. v. Network-1 Sec. Sols., Inc.,
`IPR2013-00385, Paper 17 (PTAB July 29, 2013) ................................................ 6
`
`Hyundai Motor Co. v. Am. Vehicular Scis. LLC,
`IPR2014-01543, Paper 11 (PTAB Oct. 24, 2014) ................................................ 6
`
`Lupin Ltd. v. Horizon Therapeutics, Inc.,
`IPR2016-00284, Paper 11 (PTAB June 8, 2016) ................................................. 6
`
`Samsung Bioepis Co., Ltd. v. Genentech, Inc.,
`IPR2017-01960, Paper 1 (PTAB Aug. 25, 2017) ................................................. 4
`
`Samsung Elecs., Co., Lt.d v. Raytheon Co.,
`IPR2016-00962, Paper 12 (PTAB Aug. 24, 2016) ............................................... 6
`
`Sony Corp. of Am. v. Network-1 Sec. Sols., Inc.,
`IPR2013-00495, Paper 13 (PTAB Sept. 16, 2013) ............................................... 6
`
`Sony Corp. v. Memory Integrity, LLC,
`IPR2015-01353, Paper 11 (PTAB Oct. 15, 2015) ................................................ 7
`
`Torrent Pharm Ltd, v. UCB Pharma GMBH,
`IPR2016-01636, Paper 10 (PTAB Dec. 7, 2016) ................................................. 8
`
`ii
`
`
`
`IPR2018-00164 (8,138,229 B2)
`
`Statutes
`
`35 U.S.C. § 102 .......................................................................................................... 2
`
`35 U.S.C. § 102(b) ..................................................................................................... 3
`
`35 U.S.C. § 103 .......................................................................................................... 2
`
`35 U.S.C. § 103(a) ..................................................................................................... 3
`
`35 U.S.C. § 315(c) ................................................................................................. 1, 3
`
`Other Authorities
`
`37 C.F.R. § 42.22 ....................................................................................................... 1
`
`37 C.F.R. § 42.122(b) ........................................................................................ 1, 3, 4
`
`iii
`
`
`
`IPR2018-00164 (8,138,229 B2)
`
`I.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`
`Petitioner Cipla Ltd. respectfully requests its petition for Inter Partes
`
`Review of claims 1–48 of U.S. Patent No. 8,138,229 B2 (the “’229 patent”) (the
`
`“Cipla Petition”), be granted and joined pursuant to 35 U.S.C. § 315(c) and 37
`
`C.F.R. §§ 42.22 and 42.122(b) with the petition for inter partes review filed by
`
`Actavis LLC concerning the ’229 patent: Actavis LLC v. Abraxis Bioscience, LLC,
`
`IPR2017-01104 (the “Actavis Petition”). Cipla timely submits this request for
`
`joinder less than one month after the institution of the Actavis Petition by the
`
`Patent Trial and Appeal Board (the “Board”). See 37 C.F.R. § 42.122(b).
`
`The Board instituted review of the Actavis Petition on October 10, 2017.
`
`The Cipla Petition is identical to the Actavis Petition in all substantive respects,
`
`includes identical exhibits to the Actavis Petition, and relies upon the same expert
`
`declarant as the Actavis Petition.1 Actavis does not oppose this motion. As such,
`
`institution and joinder will not create an additional burden for the Board and will
`
`lead to efficient resolution of the inter partes review proceeding.
`
`
`1 Cipla relies on an expert declaration that is substantively identical to the Actavis
`
`expert declaration, except for a single sentence that indicates that Cipla has
`
`retained Cory J. Berkland, Ph.D. See EX1002 ¶ 1.
`
`1
`
`
`
`IPR2018-00164 (8,138,229 B2)
`
`II.
`
`1.(cid:3)
`
`STATEMENT OF MATERIAL FACTS
`
`The Cipla Petition and the Actavis Petition are related to patents that are
`
`being asserted by Abraxis BioScience, LLC and Celgene Corp. in the District of
`
`New Jersey in at least Abraxis BioScience, LLC, et al., v. Cipla Ltd., C.A. No.
`
`2:16-cv 0974-JMV-MF and Abraxis BioScience, LLC, et al. v. Actavis LLC, C.A.
`
`No. 2:16-cv-01925. Abraxis BioScience, LLC and Celgene Corp. have asserted
`
`U.S. Patent Nos. 7,820,788; 7,923,536; 8,138,229; and 8,853,260 (“the Abraxis
`
`patents”) in the district court litigation.
`
`2.(cid:3)
`
`The Board has already issued its decision instituting inter partes review
`
`(“Decision”) on all challenged claims of the ’229 patent on the same grounds
`
`raised in the concurrently filed Petition for Inter Partes Review.2 See IPR2017-
`
`1104 (Paper 7). In its October 10, 2017 Decision, the Board found that Petitioner
`
`Actavis has demonstrated a reasonable likelihood that claims 1–19 and 21–48 of
`
`the ’229 patent are unpatentable for failing to satisfy the novelty requirement of 35
`
`U.S.C. § 102 and claims 1–48 of the ’229 patent are unpatentable for failing to
`
`satisfy the nonobviousness requirement of 35 U.S.C. § 103. Id.
`
`
`2 The Board has instituted review in IPR2017-01101, IPR 2017-01103, and
`
`IPR2017-01104 (collectively, “the Actavis IPRs” and individually, “the Actavis
`
`IPR”).
`
`2
`
`
`
`IPR2018-00164 (8,138,229 B2)
`
`3.(cid:3)
`
`The Board instituted inter partes review of the challenged claims on the
`
`following separate grounds:
`
`Ground 1: Claims 1–19 and 21–48 of the ’229 patent under 35 U.S.C. §
`
`102(b) as anticipated by Desai.
`
`Ground 2.A: Claims 1–19 and 21–48 of the ’229 patent under 35 U.S.C. §
`
`103(a) as obvious over Desai.
`
`Ground 2.B: Claims 1–19 and 21–48 of the ’229 patent under 35 U.S.C. §
`
`103(a) as obvious over Desai, Kadima, and Liversidge.
`
`Ground 3.A: Claim 20 of the ’229 patent under 35 U.S.C. § 103(a) as
`
`obvious over Desai and Taxol label.
`
`Ground 3.B: Claim 20 of the ’229 patent under 35 U.S.C. § 103(a) as
`
`obvious over Desai, Taxol label, Kadima, and Liversidge.
`
`See IPR2017-1104 (Paper 7).
`
`The Cipla Petition is based on the same grounds and seeks to join the
`
`instituted inter partes review on these challenged claims.
`
`III. DISCUSSION
`
`Under 35 U.S.C. § 315(c), the Board may join any person who properly files
`
`a petition for inter partes review to an existing inter partes review. A request for
`
`joinder must be filed “no later than one month after the institution date of any inter
`
`partes review for which joinder is requested.” 37 C.F.R. § 42.122(b).
`
`3
`
`
`
`IPR2018-00164 (8,138,229 B2)
`
`A motion for joinder should “(1) set forth the reasons why joinder is
`
`appropriate; (2) identify any new grounds of unpatentability asserted in the
`
`petition; (3) explain what impact (if any) joinder would have on the trial schedule
`
`for the existing review; and (4) address specifically how briefing and discovery
`
`may be simplified.” Samsung Bioepis Co., Ltd. v. Genentech, Inc., IPR2017-
`
`01960, Paper 1 at 2 (PTAB Aug. 25, 2017) (quoting Macronix Int’l Co., Ltd. v.
`
`Spansion LLC, IPR2014-00898, Paper 15 at 4 (PTAB Aug. 13, 2014)).
`
`Cipla’s motion is timely, and the Board should grant joinder because
`
`consideration of the foregoing factors weighs in favor of joinder.
`
`A.
`
`Cipla’s Motion for Joinder is Timely
`
`Joinder may be requested “no later than one month after the institution date
`
`of any inter partes review for which joinder is requested.” 37 C.F.R. § 42.122(b).
`
`Here, the Board instituted review of the Actavis Petition on October 10, 2017, and
`
`Cipla files this motion for joinder less than one month after this institution date.
`
`B.
`
`The Four Factors Weigh in Favor of Joinder
`
`Each of the four factors that the Board considers in motions for joinder
`
`favors granting of Cipla’s motion. Joinder will not add further complication to the
`
`proceedings or cause prejudice to the parties. Joinder will significantly simplify
`
`briefing, discovery, and trial associated with review of the ’229 patent.
`
`4
`
`
`
`IPR2018-00164 (8,138,229 B2)
`
`1.
`
`Joinder is Appropriate Because it Will Promote an Efficient
`Determination of the Validity of the ’229 Patent Without
`Prejudice to any Party
`
`Joinder is appropriate because it will promote efficiency by determining
`
`validity of the same patent claims in a single proceeding. The Cipla Petition and
`
`Actavis Petition are substantively the same, challenging the validity of the same
`
`claims of the ’229 patent on identical grounds. Cipla also relies on the same
`
`supporting evidence in its petition as Actavis, and even submits a supporting
`
`declaration from the same expert, including the same discussion of the prior art and
`
`the same analysis as the declaration Actavis submitted. A consolidated proceeding
`
`will also be more efficient, less wasteful, and avoid duplication because all the
`
`issues raised in both the Actavis Petition and the Cipla Petition can be resolved in a
`
`single trial.
`
`Joining Cipla as a party to the Actavis IPR also would not cause prejudice to
`
`any party. Joinder will instead streamline the proceedings and reduce the costs and
`
`burdens on the parties. For example, joinder will decrease the number of papers
`
`the parties must file and the time and expense for depositions and other discovery
`
`required by duplicative proceedings. In addition, the Cipla Petition has been filed
`
`early enough that it will not affect the schedule of the inter partes review or the
`
`costs associated with a full trial.
`
`This factor favors joinder.
`
`5
`
`
`
`IPR2018-00164 (8,138,229 B2)
`
`2.
`
`The Cipla Petition Does Not Raise Any New Grounds of
`Unpatentability and Therefore Does Not Add Additional
`Complexity to the Grounds in the Actavis Petition
`
`The Board “routinely grants motions for joinder where the party seeking
`
`joinder introduces identical arguments and the same grounds raised in the existing
`
`proceeding.” Samsung Elecs., Co., Ltd. v. Raytheon Co., IPR2016-00962, Paper
`
`12 at 9 (PTAB Aug. 24, 2016) (emphasis in original) (citations omitted). Joinder
`
`of this proceeding with the Actavis IPR will not raise any new issues of
`
`patentability and will not add complexity to the case. The Cipla Petition does not
`
`add any grounds for unpatentability that are not already present in the Actavis IPR.
`
`As explained above, the Cipla Petition is substantially identical to the Actavis
`
`Petition and relies upon the same expert declarant, the same prior art, and the same
`
`analysis. The Board has granted motions for joinder in similar factual scenarios.
`
`See Lupin Ltd. v. Horizon Therapeutics, Inc., IPR2016-00284, Paper 11 at 6
`
`(PTAB June 8, 2016); Hyundai Motor Co. v. Am. Vehicular Scis. LLC, IPR2014-
`
`01543, Paper 11 at 2–4 (PTAB Oct. 24, 2014); Sony Corp. of Am. v. Network-1
`
`Sec. Sols., Inc., IPR2013-00495, Paper 13 at 5–9 (PTAB Sept. 16, 2013); Dell Inc.
`
`v. Network-1 Sec. Sols., Inc., IPR2013-00385, Paper 17 at 6–10 (PTAB July 29,
`
`2013).
`
`This factor favors joinder.
`
`6
`
`
`
`IPR2018-00164 (8,138,229 B2)
`
`3.
`
`Joinder Would Not Affect the Schedule of the Actavis IPR
`
`The Board has granted motions for joinder when “joinder should not
`
`necessitate any additional briefing or discovery from Patent Owner beyond that
`
`already required in [the original IPR].” See Sony Corp. v. Memory Integrity, LLC,
`
`IPR2015-01353, Paper 11 at 6 (PTAB Oct. 15, 2015). Because the substantial
`
`similarity between the Cipla IPR and the Actavis IPR, joinder should not have a
`
`substantial impact on the parties or the trial schedule. To the extent joinder would
`
`cause any delay, Cipla agrees to coordinate with Actavis such that Cipla’s
`
`participation would result in no changes to the schedule.
`
`This factor favors joinder.
`
`4.
`
`Joinder Will Simplify Briefing and Discovery Because Cipla Will
`Agree to Consolidate Filings and Coordinate Discovery
`
`To prevent joinder from imposing any additional burden and to further
`
`ensure that there are no changes in the potential trial schedule, Cipla will agree, if
`
`joinder is granted and as long as Actavis remains a party to the proceeding, to
`
`coordinate discovery with Actavis and to consolidate filings with Actavis for all
`
`substantive papers except motions that do not involve Actavis. Furthermore if
`
`joinder is granted and as long as Actavis remains a party to the proceeding, Cipla
`
`agrees that cross-examinations will occur within the timeframe normally allotted
`
`by the rules to one party and will not need to be extended in light of the joinder.
`
`7
`
`
`
`IPR2018-00164 (8,138,229 B2)
`
`Thus, no further time to address additional arguments or discovery will be
`
`required by any party, and the consolidated trial can proceed at the same pace as if
`
`Cipla were not joined. Joinder is appropriate under these circumstances. See
`
`Torrent Pharm. Ltd., v. UCB Pharma GmbH, IPR2016-01636, Paper 10 at 5–6
`
`(PTAB Dec. 7, 2016); Amerigen Pharm. Ltd., v. UCB Pharma GmbH, IPR2016-
`
`01665, Paper 8 at 6 (PTAB Dec. 7, 2016).
`
`This factor favors joinder.
`
`IV. CONCLUSION
`
`For the foregoing reasons, Cipla respectfully requests that the Board grant its
`
`concurrently filed Petition for inter partes review of the ’229 patent and join the
`
`grounds of invalidity therein raised with the Actavis IPR.
`
`Dated: November 9, 2017
`
`Respectfully submitted,
`
`/s/
`Michael J. Freno (Reg. No. 57,163)
`K&L GATES LLP
`925 Fourth Avenue, Suite 2900
`Seattle, WA 98104
`T: 206.370.7947
`F: 206.623.7022
`michael.freno@klgates.com
`
`Lead Counsel for Petitioner
`
`Anil Patel (pro hac vice to be filed)
`K&L GATES LLP
`
`8
`
`
`
`IPR2018-00164 (8,138,229 B2)
`
`1000 Main Street, Suite 2550
`Houston, TX 77002
`T: 713.815.7304
`F: 713.583.9417
`anil.patel@klgates.com
`
`Jason A. Engel (Reg. No. 51,654)
`K&L GATES LLP
`70 W. Madison Street, Suite 3100
`Chicago, IL 60602
`T: 312.807.4236
`F: 312.827.8145
`jason.engel.ptab@klgates.com
`
`Peter L. Giunta (Reg. No. 55,207)
`K&L GATES LLP
`599 Lexington Avenue
`New York, NY 10022
`T: 212.536.3910
`F: 212.536.3901
`peter.giunta@klgates.com
`
`Elizabeth Weiskopf (pro hac vice to
`be filed)
`K&L GATES LLP
`925 Fourth Avenue, Suite 2900
`Seattle, WA 98104
`T: 206.370.7964
`F: 206.623.7022
`elizabeth.weiskopf@klgates.com
`
`Back-Up Counsel for Petitioner
`
`9
`
`
`
`IPR2018-00164 (8,138,229 B2)
`
`CERTIFICATE OF COMPLIANCE WITH TYPE-VOLUME LIMITATION
`
`Pursuant to 37 C.F.R. § 42.24, I certify that the foregoing MOTION FOR
`
`JOINDER contains less than 15 pages, pursuant to 37 C.F.R. § 42.24(a)(1).
`
`Dated: November 9, 2017
`
`Respectfully submitted,
`
`
`
`/s/
`Michael J. Freno (Reg. No. 57,163)
`K&L GATES LLP
`925 Fourth Avenue, Suite 2900
`Seattle, WA 98104
`T: 206.370.7947
`F: 206.623.7022
`michael.freno@klgates.com
`
`Lead Counsel for Petitioner
`
`
`
`IPR2018-00164 (8,138,229 B2)
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e) , I certify that, on November 9, 2017, true
`
`and correct copies of the foregoing MOTION FOR JOINDER, were served by
`
`FedEx overnight delivery on Patent Owner at the correspondence address of record
`
`for U.S. Patent No. 8,138,229 B2, and other addresses known as likely to effect
`
`service, as follows:
`
`MORRISON & FOERSTER LLP
`755 Page Mill Rd.
`Palo Alto, CA 94304-1018
`Customer Number: 25226
`
`F. Dominic Cerrito
`Eric C. Stops
`Evangeline Shih
`Andrew S. Chalson
`Catherine T. Mattes
`Ross C. Misskelley
`Robert B. Wilson
`Daniel C. Wiesner
`QUINN EMANUEL URQUHART
`& SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`
`Anthony M. Insogna
`J. Patrick Elsevier, Ph.D.
`Cary Miller, Ph.D.
`Steven J. Corr
`JONES DAY
`4655 Executive Drive, Suite 1500
`San Diego, CA 92121
`
`
`
`IPR2018-00164 (8,138,229 B2)
`
`Dated: November 9, 2017
`
`Respectfully submitted,
`
`
`
`/s/
`Michael J. Freno (Reg. No. 57,163)
`K&L GATES LLP
`925 Fourth Avenue, Suite 2900
`Seattle, WA 98104
`T: 206.370.7947
`F: 206.623.7022
`michael.freno@klgates.com
`
`Lead Counsel for Petitioner
`
`
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