PETITIONER’S MOTION FOR JOINDER
`IPR2016-01596
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`
`ALEMBIC PHARMACEUTICALS LIMITED
`Petitioner
`
`v.
`
`UCB PHARMA GMBH
`Patent Owner
`
`
`Patent No. 6,858,650
`Filing Date: November 15, 2000
`Issue Date: February 22, 2005
`Title: STABLE SALTS OF NOVEL DERIVATIVES
`OF 3,3-DIPHENYLPROPYLAMINES
`
`_______________
`
`
`Inter Partes Review No. IPR2016-01596
`
`______________________________________________________________
`
`MOTION FOR JOINDER PURSUANT TO 35 U.S.C. § 315(c)
`AND 37 C.F.R. § 42.122(b)
`
`SMRH:225686151.2
`
`
`
`-1-
`
`
`
`
`
`

`
`
`PETITIONER’S MOTION FOR JOINDER
`IPR2016-01596
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`II.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED ............................ 1
`
`STATEMENT OF MATERIAL FACTS ........................................................ 2
`
`III.
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED ......................... 4
`
`A.
`
`B.
`
`C.
`
`Legal Standard ....................................................................................... 4
`
`Joinder is Appropriate Because the Grounds and Arguments
`Concerning Unpatentability Raised in Alembic’s Petition are
`Identical to those in IPR 510 ................................................................. 6
`
`Joinder Will Promote Efficiency and Will not Impact the
`Scheduling Order ................................................................................... 7
`
`D. Alembic Agrees to Simplify Discovery and Briefing ........................... 9
`
`IV. CONCLUSION .............................................................................................. 10
`
`SMRH:225686151.2
`
`
`
`-i-
`
`
`
`
`
`

`
`
`PETITIONER’S MOTION FOR JOINDER
`IPR2016-01596
`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Alembic Pharms. Ltd. v. UCB Pharma GmbH
`Case No. IPR2016-01596, Paper 1 ....................................................................... 3
`
`Dell Inc. v. Network-1 Security Solutions, Inc.
`IPR2013-00385, Paper 17 (July 29, 2013) ....................................................... 4, 5
`
`Pfizer Inc. et al v. Mylan Pharms. Inc.
`1-15-cv-00079 (D. Del. 2015) .............................................................................. 2
`
`Statutes
`
`35 U.S.C. section 103(a) ........................................................................................ 2, 3
`
`35 U.S.C. section 311 ................................................................................................ 4
`
`35 U.S.C. section 313 ................................................................................................ 4
`
`35 U.S.C. section 314 ................................................................................................ 4
`
`35 U.S.C. section 315(c) ........................................................................................ 1, 4
`
`35 U.S.C. section 316(a)(1) ....................................................................................... 8
`
`Leahy-Smith America Invents Act ............................................................................ 4
`
`Other Authorities
`
`37 C.F.R. section 1.7(a) ............................................................................................. 1
`
`37 C.F.R. section 42.1(a) ........................................................................................... 1
`
`37 C.F.R. section 42.22 .............................................................................................. 8
`
`37 C.F.R. section 42.100(c) ....................................................................................... 8
`
`37 C.F.R. section 42.122(a) ....................................................................................... 4
`
`37 C.F.R. section 42.122(b) ................................................................................... 1, 8
`
`SMRH:225686151.2
`
`
`
`-ii-
`
`
`
`
`
`

`
`
`PETITIONER’S MOTION FOR JOINDER
`IPR2016-01596
`
`157 Cong. Rec. S1376 (daily ed. Mar. 8, 2011) (statement of Sen.
`Kyl) ................................................................................................................... 5, 7
`
`Frequently Asked Question H5, https://www.uspto.gov/patents-
`application-process/appealing-patent-decisions/trials/patent-
`review-processing-system-prps-0#heading-13 (last visited Aug. 17,
`2016) ..................................................................................................................... 4
`
`
`
`SMRH:225686151.2
`
`
`
`-iii-
`
`
`
`
`
`

`
`
`PETITIONER’S MOTION FOR JOINDER
`IPR2016-01596
`
`I.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`
`Alembic Pharmaceuticals Limited (“Alembic”) respectfully submits this
`
`Motion for Joinder pursuant to 35 U.S.C. § 315(c) and 37 C.F.R. § 42.122(b),
`
`together with a Petition for Inter Partes Review (“Alembic’s Petition” or
`
`“Petition”) of U.S. Patent No. 6,858,650 (“the ’650 Patent”). Alembic requests
`
`institution of the Petition and joinder with the proceeding styled Mylan
`
`Pharmaceuticals, Inc. et al. v. UCB Pharma GmbH, Case IPR2016-00510
`
`(“IPR 510”), instituted on July 20, 2016, concerning the ’650 Patent. This Motion
`
`is timely submitted within one month of the July 20, 2016 institution date of
`
`IPR 510. See 37 C.F.R. §§ 1.7(a), 42.1(a).
`
`In accordance with prior decisions granting joinder, Alembic submits that its
`
`Petition is substantively identical to the corrected petition filed by Mylan in
`
`IPR 510 (“Mylan Petition”) in that Alembic’s Petition: (1) identifies identical
`
`grounds of rejection, (2) contains identical arguments and prior art combinations
`
`for each of the grounds of rejection, (3) references the same exhibits, and (4) relies
`
`on the same expert declarations. See IPR 510, Paper 4. Alembic’s Petition does
`
`not introduce any new prior art or arguments, and joinder would not affect the
`
`completion of IPR 510 in accordance with the Scheduling Order set forth in that
`
`proceeding. See id. at Paper 13. To the contrary, joinder will promote
`
`administrative efficiency and ensure efficient and consistent resolution of the
`
`SMRH:225686151.2
`
`
`
`-1-
`
`
`
`
`
`

`
`
`PETITIONER’S MOTION FOR JOINDER
`IPR2016-01596
`
`validity of the ’650 Patent without prejudicing the existing parties. Finally,
`
`Alembic agrees to an understudy role to limit its participation on briefing and
`
`discovery in order to minimize any burden of joinder on the Board and on the
`
`parties.
`
`II.
`
`STATEMENT OF MATERIAL FACTS
`1.
`
`UCB Pharma GmbH (“UCB”) and Pfizer Inc. (“Pfizer”) sued
`
`Mylan for infringement of the ’650 Patent in January 2015, and that case is
`
`currently pending. Pfizer Inc. et al v. Mylan Pharms. Inc., 1-15-cv-00079
`
`(D. Del. 2015).
`
`2.
`
`3.
`
`UCB purports to own the ’650 Patent. Id., Dkt No. 1, at p. 2.
`
`As of the filing of this Motion, the ’650 Patent has not been
`
`asserted against Alembic.
`
`4.
`
`Mylan filed a petition for inter partes review of the ’650 Patent
`
`(“Mylan Petition”) on January 28, 2016. See IPR 510, Papers 1, 4.
`
`5.
`
`The Mylan Petition includes the following two grounds of
`
`rejection:
`
`a)
`
`Claims 1-5 and 21-24 are invalid under 35 U.S.C. §103(a) as
`
`obvious over the Postlind and Bundgaard publications in view of the
`
`Detrol® label and Berge.
`
`SMRH:225686151.2
`
`
`
`-2-
`
`
`
`
`
`

`
`
`PETITIONER’S MOTION FOR JOINDER
`IPR2016-01596
`
`b)
`
`Claims 1-5 and 21-24 are invalid as obvious under 35 U.S.C.
`
`§103(a) over the Byrnne 1998 and Bundgaard publications in view of
`
`Johansson.
`
`Id., Paper 4.
`
`6.
`
`The Mylan Petition was instituted on July 20, 2016, on both
`
`grounds. Id., Paper 12.
`
`7.
`
`The two invalidity grounds raised in Alembic’s Petition filed in the
`
`present IPR proceeding are identical to the two invalidity grounds raised in the
`
`Mylan Petition and instituted in the IPR 510, namely:
`
`a)
`
`Claims 1-5 and 21-24 are invalid under 35 U.S.C. §103(a) as
`
`obvious over the Postlind and Bundgaard publications in view of the
`
`Detrol® label and Berge.
`
`b)
`
`Claims 1-5 and 21-24 are invalid as obvious under 35 U.S.C.
`
`§103(a) over the Byrnne 1998 and Bundgaard publications in view of
`
`Johansson.
`
`Alembic Pharms. Ltd. v. UCB Pharma GmbH, Case No. IPR2016-01596,
`
`Paper 1.
`
`8.
`
`Alembic’s Petition relies on the same arguments raised in the
`
`Mylan Petition and references the same exhibits and expert declarations that
`
`SMRH:225686151.2
`
`
`
`-3-
`
`
`
`
`
`

`
`
`PETITIONER’S MOTION FOR JOINDER
`IPR2016-01596
`
`Mylan submitted in IPR 510. Indeed, Alembic’s Petition is substantively
`
`identical to Mylan’s Petition. Compare id., Paper 1 with IPR 510, Papers 1, 4.
`
`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
`A. Legal Standard
`The Leahy-Smith America Invents Act (“AIA”) permits joinder of like
`
`review proceedings, e.g., an IPR may be joined with another IPR. 37 C.F.R.
`
`§ 42.122(a). The Board has discretion to join parties to an existing IPR pursuant to
`
`35 U.S.C. § 315(c), which states:
`
`(c) JOINDER.—If the Director institutes an inter partes review, the
`Director, in his or her discretion, may join as a party to that inter
`partes review any person who properly files a petition under section
`311 that the Director, after receiving a preliminary response under
`section 313 or the expiration of the time for filing such a response,
`determines warrants the institution of an inter parties review under
`section 314.
`
`The Board considers at least the following factors in deciding whether to
`
`exercise its discretion to join a party to an existing IPR: (1) the movant’s reasons
`
`why joinder is appropriate; (2) whether the new petition presents any new grounds
`
`of unpatentability; (3) what impact (if any) joinder would have on the trial
`
`schedule for the existing review; and (4) how briefing and discovery may be
`
`simplified. Dell Inc. v. Network-1 Security Sols., Inc., IPR2013-00385, Paper 17
`
`at 4 (July 29, 2013) (granting motion for joinder); see Frequently Asked Question
`
`SMRH:225686151.2
`
`
`
`-4-
`
`
`
`
`
`

`
`
`PETITIONER’S MOTION FOR JOINDER
`IPR2016-01596
`
`H5, https://www.uspto.gov/patents-application-process/appealing-patent-
`
`decisions/trials/patent-review-processing-system-prps-0#heading-13 (last visited
`
`Aug. 17, 2016).
`
`In deciding whether to allow joinder, the Board takes into account “the
`
`particular facts of each case, substantive and procedural issues, and other
`
`considerations,” while remaining “mindful that patent trial regulations, including
`
`the rules for joinder, must be construed to secure the just, speedy, and
`
`inexpensive resolution of every proceeding.” Dell, IPR2013-00385, Paper 17 at 3.
`
`The Board also considers “the policy preference for joining a party that does
`
`not present new issues that might complicate or delay an existing proceeding.”
`
`Id. at 10 (citing 157 Cong. Rec. S1376 (daily ed. Mar. 8, 2011) (statement of
`
`Sen. Kyl) (“The Office anticipates that joinder will be allowed as of right – if an
`
`inter partes review is instituted on the basis of a petition, for example, a party
`
`that files an identical petition will be joined to that proceeding, and thus
`
`allowed to file its own briefs and make its own arguments.”)). The facts of this
`
`case, as applied to this framework, support joinder of the present proceeding with
`
`IPR 510.
`
`SMRH:225686151.2
`
`
`
`-5-
`
`
`
`
`
`

`
`
`PETITIONER’S MOTION FOR JOINDER
`IPR2016-01596
`
`B.
`
`Joinder is Appropriate Because the Grounds and Arguments
`Concerning Unpatentability Raised in Alembic’s Petition are
`Identical to those in IPR 510
`
`Alembic’s Petition requests cancellation of claims 1-5 and 21-24 of the
`
`’650 Patent on the same two grounds that were raised by the Mylan Petition and
`
`that are the subject of IPR 510.1 Further, Alembic’s Petition relies on the same
`
`prior art references, arguments, and expert testimony in support of the two grounds
`
`that are currently at issue in IPR 510. Indeed, Alembic’s Petition (aside from the
`
`Mandatory Notices) and accompanying exhibits are identical to Mylan’s
`
`corresponding filings in IPR 510.
`
`Alembic submits that joinder of these proceedings is appropriate and will
`
`promote the efficient and consistent resolution of the validity of the ’650 Patent.
`
`Indeed, Mylan has advised that it will not oppose Alembic’s Motion for Joinder.
`
`Further, joinder will not impact the Board’s ability to complete its review in the
`
`statutorily prescribed timeframe because the invalidity arguments presented in
`
`Alembic’s Petition are identical to those raised in IPR 510. Moreover, joinder will
`
`not prejudice the parties to IPR 510 because the scope and timing of the IPR 510
`
`proceeding should remain the same. Finally, the Board can implement procedures
`
`
`1 The Board instituted the IPR 510 on both proposed grounds in Mylan’s petition.
`
`Compare IPR2016-00510, Paper 4 at 3 with IPR2016-00510, Paper 12 at 29.
`
`SMRH:225686151.2
`
`
`
`-6-
`
`
`
`
`
`

`
`
`PETITIONER’S MOTION FOR JOINDER
`IPR2016-01596
`
`that are designed to avoid any impact to the schedule of IPR 510, by requiring, for
`
`example, consolidated filings and coordination among petitioners.
`
`In such circumstances, Congress anticipated that joinder would be granted as
`
`a matter of right. See 157 CONG. REC. S1376 (daily ed. Mar. 8, 2011) (statement
`
`of Sen. Kyl) (“The Office anticipates that joinder will be allowed as of right – if an
`
`inter partes review is instituted on the basis of a petition, for example, a party that
`
`files an identical petition will be joined to that proceeding, and thus allowed to file
`
`its own briefs and make its own arguments.”) (emphasis added). Thus, Alembic
`
`has met its burden of demonstrating that joinder is warranted under the
`
`circumstances.
`
`C.
`
`Joinder Will Promote Efficiency and Will not Impact the
`Scheduling Order
`
`In light of the similarities between Alembic’s Petition and IPR 510 , joinder
`
`is appropriate because it will promote administrative efficiency by avoiding
`
`duplicative reviews and filings of the same invalidity issues across multiple
`
`PTAB proceedings. Joinder will also eliminate any risk of inconsistent results
`
`and piecemeal review. Moreover, joinder is likely more convenient and efficient
`
`for UCB because it will provide a single trial on the ’650 Patent. By allowing all
`
`grounds of invalidity to be addressed in a single proceeding, the interests of all
`
`parties and the Board will be well served. For these reasons, joinder will not
`
`SMRH:225686151.2
`
`
`
`-7-
`
`
`
`
`
`

`
`
`PETITIONER’S MOTION FOR JOINDER
`IPR2016-01596
`
`prejudice any party, but rather will promote the just, speedy, and efficient
`
`resolution of these proceedings involving the ’650 Patent.
`
`This Motion is timely under 37 C.F.R. §§ 42.22, 42.122(b) because it and
`
`Alembic’s Petition are being submitted within one month of the July 20, 2016
`
`institution date of IPR 510. See Taiwan Semiconductor Mfg. Co. v. Zond, LLC,
`
`IPR2014-00781, -00782, Paper 5 (May 29, 2014). Because Alembic filed this
`
`Motion to join IPR 510 within one month of the July 20, 2016 date of institution of
`
`that proceeding, and Alembic’s Petition presents identical grounds of
`
`unpatentability and arguments in support thereof, there will be no need to modify
`
`the Scheduling Order issued by the Board in IPR 510. IPR2016-00510, Paper 13.
`
`Subject to certain exceptions, 35 U.S.C. §316(a)(1) and 37 C.F.R. § 42.100(c)
`
`require that inter partes review proceedings be completed and the Board’s final
`
`decision to be issued within one year of the institution date of the review. Joinder
`
`will not delay this deadline because Alembic’s Petition is substantively identical to
`
`the Mylan IPR Petition. Furthermore, joinder will not add to the substantive issues
`
`already pending in IPR 510, since there will be no introduction of new prior art,
`
`expert declarations, or grounds into the instituted proceeding. Therefore, this
`
`proceeding does not raise any new issues beyond those already before the Board in
`
`IPR 510.
`
`SMRH:225686151.2
`
`
`
`-8-
`
`
`
`
`
`

`
`
`PETITIONER’S MOTION FOR JOINDER
`IPR2016-01596
`
`D. Alembic Agrees to Simplify Discovery and Briefing
`To further minimize any perceived disruption to IPR 510, Alembic will
`
`agree to proceed upon the schedule already set in IPR 510 and based only upon
`
`the arguments and evidence advanced by Mylan. Alembic is willing to accept a
`
`back seat, “understudy” role in those joined proceedings, without any right to
`
`separate or additional briefing or discovery unless authorized by the Board upon a
`
`request to address an issue that is unique to Alembic.2 Only if Mylan drops out of
`
`the proceedings for any reason, will Alembic assume an active role. The Board
`
`has previously acknowledged that such concessions on the part of a party seeking
`
`to join are sufficient to minimize the impact on the original proceeding. See SAP
`
`2 On August 18, 2016, Torrent Pharmaceuticals Ltd. (“Torrent”) filed a petition for
`
`Inter Partes Review of the ’650 Patent and a motion to join IPR 510. Torrent
`
`Pharms. Ltd. v. UCB Pharma GmbH, IPR2016-01636, Paper 2, 3. Like Alembic,
`
`Torrent relies on the same prior art, same bases for rejection, and the same experts
`
`as Mylan and agrees to “maintain a secondary, ‘understudy’ role in the joined
`
`proceeding.” Id., Paper 3 at 7. Therefore, Alembic and Torrent are similarly
`
`situated, and the joinder of Alembic to IPR 510 will not cause any disruption to the
`
`proceeding in the event Torrent is also joined to that proceeding. To the contrary,
`
`there will be increased administrative efficiency as a result of joining two
`
`proceedings to IPR 510 by avoiding three separate proceedings on the ’650 Patent.
`
`SMRH:225686151.2
`
`
`
`-9-
`
`
`
`
`
`

`
`
`PETITIONER’S MOTION FOR JOINDER
`IPR2016-01596
`
`Am. Inc. v. Clouding IP, LLC, IPR2014-00306, Paper 13 at 4 (acknowledging that
`
`the impact of joinder will be minimal where, inter alia, the party seeking to join
`
`the proceeding agreed to procedural protections that allowed the original
`
`petitioner to retain control over the proceeding). Alembic’s willingness to limit its
`
`active participation in IPR 510 in the event joinder is granted further minimizes
`
`any disruption to that proceeding.
`
`IV. CONCLUSION
`For the foregoing reasons, Petitioner respectfully requests that its Petition
`
`for IPR of the ’650 Patent be instituted and that this proceeding be joined with
`
`Mylan Pharmaceuticals, Inc. et al. v. UCB Pharma GmbH, Case IPR2016-
`
`00510. Although Petitioner believes that no fee is required for this Motion, the
`
`Commissioner is hereby authorized to charge any additional fees that may be
`
`required for this Motion to Deposit Account No. 50-4562, referencing Docket
`
`No. 45GW-245491.
`
`
`
`
`
`SMRH:225686151.2
`
`
`
`-10-
`
`
`
`
`
`

`
`
`PETITIONER’S MOTION FOR JOINDER
`IPR2016-01596
`
`Dated: August 22, 2016
`
`Respectfully submitted,
`
`
`/Manish K. Mehta Reg. No 64570/
`Manish K. Mehta
`Registration No. 64,570
`Sheppard Mullin Richter & Hampton, LLP
`70 W. Madison St., 48th Floor
`Chicago, Illinois 60602
`T: (312) 499-6352
`F: (312) 499-4749
`
`Laura Burson
`Reg. No. 40,929
`lburson@sheppardmullin.com
`Sheppard Mullin Richter & Hampton, LLP
`333 S. Hope St., 43rd Floor
`Los Angeles, California 90071
`T: (213) 617-5527
`F: (213) 443-2794
`
`
`Bradley C. Graveline
`(permission to file motion for pro hac vice
`admission to be sought)
`Sheppard Mullin Richter & Hampton, LLP
`70 W. Madison St., 48th Floor
`Chicago, Illinois 60602
`T: (312) 499-6316
`F: (312) 499-4735
`
`Counsel for Alembic Pharmaceuticals
`Limited
`
`
`
`
`
`
`
`SMRH:225686151.2
`
`
`
`-11-
`
`
`
`
`
`

`
`
`PETITIONER’S MOTION FOR JOINDER
`IPR2016-01596
`
`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(a), the undersigned hereby
`certifies that a copy of this MOTION FOR JOINDER PURSUANT TO
`35 U.S.C. § 315(c) AND 37 C.F.R. § 42.122(b) has been served in its entirety
`via PRIORITY EXPRESS MAIL on August 22, 2016, upon the Patent Owner at
`the correspondence address of record for U.S. Patent No. 6,858,650 as follows:
`
`
`
`Jeffrey Ginsberg
`Joseph A. Coppola
`Kenyon & Kenyon LLP
`One Broadway
`New York, New York 10004-1007
`
`
`In addition, the undersigned hereby certifies that a service copy of this
`MOTION has been served via PRIORITY EXPRESS MAIL and via electronic
`mail on August 22, 2016, upon counsel of record in IPR 510 at the following
`addresses:
`
`Jeffrey J. Oelke
`James S. Trainor, Jr.
`Robert E. Counihan
`White & Case LLP
`1155 Avenue of the Americas
`New York, NY 10036
`(212) 819-8200
`joelke@whitecase.com
`jtrainor@whitecase.com
`rcounihan@whitecase.com
`
`
`
`
`/Manish Mehta/
`Manish Mehta
`
`
`
`By:
`
`
`
`
`
`
`
`
`
`
`Date: August 22, 2016
`
`
`SMRH:225686151.2