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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`DR. REDDY’S LABORATORIES, INC.
`Petitioner
`
`v.
`
`POZEN INC. and HORIZON PHARMA USA, INC.
`Patent Owner
`
`_____________________
`
`Inter Partes Review IPR2018-00894
`Patent No. 9,220,698 B2
`_____________________
`
`MOTION FOR JOINDER
`PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. § 42.122(b)
`
`
`
`

`

`TABLE OF CONTENTS
`
`Page
`
`
`TABLE OF AUTHORITIES ...................................................................................... ii 
`I. 
`STATEMENT OF THE PRECISE RELIEF REQUESTED ........................... 1 
`II. 
`STATEMENT OF MATERIAL FACTS ......................................................... 1 
`III.  STATEMENT OF REASONS FOR RELIEF REQUESTED ......................... 3 
`A. 
`Legal Standard ....................................................................................... 3 
`B. 
`Joinder Will Not Impact the Mylan IPR’s Schedule ............................. 5 
`C. 
`Joinder Will Enhance Efficiency by Avoiding Duplicate Efforts
`and Inconsistencies ................................................................................ 9 
`D.  A Joined Proceeding Avoids Prejudice to DRL and Will Not
`Prejudice Mylan or Pozen ...................................................................... 9 
`Joinder Will Not Prejudice Pozen or Mylan ........................................ 10 
`E. 
`IV.  CONCLUSION .............................................................................................. 11 
`
`
`
`
`
`i
`
`

`

`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`Page
`
`Apotex, Inc. and Mylan Pharmaceuticals Inc. v. Novartis AG and Mitsubishi
`Pharma Corp., IPR2015-00518 ................................................................................ 8
`
`Dell, Inc. v. Network-1 Security Solutions, Inc., IPR2013-00385 ........................... 4, 5
`
`Horizon Pharma, Inc. v. Dr. Reddy’s Laboratories Inc., Civil Action No.
`2:16-cv-04918-SRC-CLW (D.N.J.) .......................................................................... 2
`
`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.,
`IPR2015-01871 ......................................................................................................... 8
`
`Macronix Int’l Co. v. Spansion, IPR2014-00898 ......................................................... 5
`
`Motorola Mobility, Inc. v. Softview, Inc. IPR2013-00256 ........................................... 6
`
`Mylan Pharmaceuticals Inc. v. Pozen Inc. and Horizon Pharma USA, Inc.,
`IPR2017-01995 ......................................................................................................... 1
`
`Qualcomm Inc. v. DSS Technology Management, Inc., IPR2016-01312 .................... 8
`
`Samsung Elec. Co., Ltd. v. Arendi S.A.R.L., IPR2014-01518 ...................................... 7
`
`SAP America Inc. v. Clouding IP, LLC, IPR2014-00306 ............................................ 8
`
`Teva Pharmaceuticals USA, Inc. v. Allegan, Inc., IPR2017-00586 ............................ 8
`
`Torrent Pharmaceuticals Ltd. v. Novartis AG and Mitsubishi Pharma Corp.,
`IPR2014-00784 ......................................................................................................... 8
`
`
`
`Statutes and Rules
`
`35 U.S.C. § 102 ............................................................................................................ 2
`
`35 U.S.C. § 103 ............................................................................................................ 2
`
`35 U.S.C. § 315(c) .................................................................................................... 1, 4
`
`
`
`ii
`
`

`

`35 U.S.C. § 316(a)(1) ................................................................................................. 11
`
`35 U.S.C. § 316(a)(11) ................................................................................................. 5
`
`35 U.S.C. § 316(b) ........................................................................................................ 9
`
`35 U.S.C. § 317(a) ...................................................................................................... 10
`
`37 C.F.R. § 42.1(b) ....................................................................................................... 9
`
`37 C.F.R. § 42.100(c) ............................................................................................. 5, 11
`
`37 C.F.R. § 42.122(b) ............................................................................................... 1, 4
`
`37 C.F.R. § 42.22 .......................................................................................................... 1
`
`
`
`Other Authorities
`
`157 CONG. REC. S1376 (daily ed. Mar. 8, 2011) ...................................................... 6
`
`  
`
`
`
`iii
`
`

`

`I.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`
`Petitioner Dr. Reddy’s Laboratories, Inc. (“DRL” or “Petitioner”) respectfully
`
`requests joinder pursuant to 35 U.S.C. § 315(c) and 37 C.F.R. § 42.122(b) of the
`
`above-captioned inter partes review (“the DRL IPR”) with the pending inter partes
`
`review concerning the same patent and the same grounds of invalidity in Mylan
`
`Pharmaceuticals Inc. v. Pozen Inc. and Horizon Pharma USA, Inc., IPR2017-01995
`
`(“the Mylan IPR”), which was instituted on March 8, 2018 (Paper 18). The DRL
`
`IPR and the Mylan IPR both concern U.S. Patent No. 9,220,698 (“the ’698 patent”).
`
`Joinder is appropriate because it will promote efficient and consistent resolution of
`
`the invalidity grounds at issue and will not prejudice any of the parties in the Mylan
`
`IPR, namely Mylan Pharmaceuticals Inc. (“Mylan”) or patent owners Pozen Inc. or
`
`Horizon Pharma USA, Inc. (collectively “Pozen” or “Patent Owners”). Absent
`
`joinder, Petitioner could be prejudiced if the Mylan IPR is terminated before a final
`
`written decision is issued because Petitioner’s interests would not be adequately
`
`represented before the Board. Accordingly, joinder should be granted.
`
`This Motion for Joinder and accompanying Petition for Inter Partes Review
`
`of the ’698 patent are timely under 37 C.F.R. §§ 42.22 and 42.122(b) because
`
`Petitioner submitted both within one month of the March 8, 2018 date of institution
`
`of the Mylan IPR.
`
`II.
`
`STATEMENT OF MATERIAL FACTS
`
`
`
`1
`
`

`

`1.
`
`Petitioner is not aware of any reexamination certificates or pending
`
`prosecution concerning the ’698 patent.
`
`2.
`
`On August 11, 2016, Pozen filed a complaint accusing DRL and real
`
`party in interest Dr. Reddy’s Laboratories, Ltd. of infringing the ’698 patent. On
`
`September 29, 2016, DRL and Dr. Reddy’s Laboratories, Ltd. filed their Answer to
`
`the Complaint. D.E. 11, Horizon Pharma, Inc. v. Dr. Reddy’s Laboratories Inc.,
`
`Civil Action No. 2:16-cv-04918-SRC-CLW (D.N.J.).
`
`3.
`
`Mylan filed its petition for inter partes review of the ’698 patent on
`
`August 24, 2017. (IPR2017-01995).
`
`4.
`
`The Mylan IPR included three grounds for challenging the validity of
`
`the ’698 patent:
`
`Ground 1: Claims 1-7 are unpatentable as anticipated under 35 U.S.C. § 102
`
`by U.S. Patent No. 8,557,285 (“the ’285 patent”).
`
`Ground 2: Claims 1-7 are unpatentable as obvious under 35 U.S.C. § 103
`
`over the ’285 patent.
`
`Ground 3: Claims 1-7 are unpatentable as obvious under 35 U.S.C. § 103
`
`over the ’285 patent in view of the EC-Naprosyn® label and Howden 2005. (See
`
`IPR2017-01995, Petition at 34-59).
`
`5.
`
`On December 12, 2017 Pozen filed a Preliminary Response
`
`(IPR2017-01995, Paper 10).
`
`
`
`2
`
`

`

`6.
`
`The Board instituted the Mylan IPR on March 8, 2018 on Grounds 1
`
`- 3. (IPR2017-01995, Paper 18 at 21 - 23, 29).
`
`7.
`
`The DRL IPR Petition, filed earlier today, is filed within one month
`
`of the March 8, 2018 decision to institute the Mylan IPR, and presents only the
`
`identical grounds on which the Mylan IPR was instituted — Grounds 1 - 3 of the
`
`Mylan IPR. The DRL IPR Petition is timely under 37 C.F.R. § 42.122, which
`
`provides that the time period set forth in 37 C.F.R. § 42.101(b) shall not apply when
`
`the petition is accompanied by a request for joinder.
`
`8.
`
`Mylan, DRL, Dr. Reddy’s Laboratories, Ltd., Lupin Ltd., and Lupin
`
`Pharmaceuticals, Inc. are defendants involved in pending litigations regarding the
`
`’698 patent in the District of New Jersey.1
`
`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
`
`As discussed below, joinder of this proceeding with the Mylan IPR will not
`
`enlarge the Mylan IPR nor negatively affect its case schedule. But a decision not to
`
`grant Petitioner’s motion for joinder could severely prejudice Petitioner. Thus,
`
`joinder is appropriate and warranted.
`
`A.
`
`Legal Standard
`
`
`1 For a list of related matters involving the ’698 patent, see DRL’s Petition for Inter
`
`Partes review, pages 1- 2, submitted earlier today with its joinder motion.
`
`
`
`
`
`3
`
`

`

`The Leahy-Smith America Invents Act (AIA) permits joinder of inter partes
`
`review proceedings. The statutory provision governing joinder of inter partes review
`
`proceedings is 35 U.S.C. § 315(c), which reads as follows:
`
`(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 partes review under
`section 314.
`
`
`
`Under 35 U.S.C. § 315(c), the Board has authority to join a second inter partes
`
`review proceeding to an instituted first inter partes review proceeding. The motion
`
`for joinder must be filed within one month of institution of the first inter partes
`
`review proceeding. 37 C.F.R. § 42.122(b).
`
`In exercising its discretion to grant joinder, the Board considers the impact of
`
`substantive and procedural
`
`issues on
`
`the proceedings, as well as other
`
`considerations, while being “mindful that patent trial regulations, including the rules
`
`for joinder, must be construed to secure the just, speedy, and inexpensive resolution
`
`of every proceeding.” See Dell, Inc. v. Network-1 Security Solutions, Inc., IPR2013-
`
`00385, Paper No. 17 (July 29, 2013) at 3. The Board should consider “the policy
`
`preference for joining a party that does not present new issues that might complicate
`
`or delay an existing proceeding.” Id. at 10.
`
`“A motion for joinder should: (1) set forth the reasons why joinder is
`
`
`
`4
`
`

`

`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.” Id. at 4 and Macronix Int’l Co. v. Spansion, IPR2014-00898, Paper 15
`
`at 4 (Aug. 13, 2014). The Board should also consider “the policy preference for
`
`joining a party that does not present new issues that might complicate or delay an
`
`existing proceeding.” See Dell, Inc. v. Network-1 Security Solutions, Inc., IPR2013-
`
`00385, Paper No. 17 (July 29, 2013) at 3. Under this framework, joinder of the DRL
`
`IPR with the Mylan IPR is appropriate because the DRL IPR presents no new
`
`grounds for invalidity and, as discussed below, Petitioner, would agree to conditions
`
`to insure minimal or no impact to the Mylan IPR schedule.
`
`B.
`
`Joinder Will Not Impact the Mylan IPR’s Schedule
`
`Joinder in this case will not impact the Board’s ability to complete its review
`
`of the ’698 patent in a timely manner. 35 U.S.C. § 316(a)(11) and associated rule 37
`
`C.F.R. § 42.100(c) provide that inter partes review proceedings should be completed
`
`and the Board’s final decision issued within one year of institution of the review. In
`
`this case, joinder will not affect the Board’s ability to issue the decision within this
`
`required one-year timeframe because the Petition filed in the present DRL IPR is
`
`substantially identical to the Mylan IPR. Indeed, in circumstances such as these, the
`
`PTO anticipated that joinder would be granted as a matter of right. See 157 CONG.
`
`
`
`5
`
`

`

`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).
`
`Petitioner raises no issues that are not already before the Board in the Mylan
`
`IPR. DRL’s Petition seeks review of claims 1-7 of the ’698 patent based on the
`
`identical grounds and combinations of prior art considered by the Board in
`
`instituting review in the Mylan IPR petition. See, e.g., Motorola Mobility, Inc. v.
`
`Softview, Inc. IPR2013-00256, Paper No. 10 (granting motion for joinder under
`
`similar circumstances). Indeed, DRL’s Petition is substantially identical to the
`
`corresponding Mylan IPR petition (Mylan IPR, Paper 2). Moreover, Petitioner will
`
`agree to consolidated filings2 and discovery and will accept a back-seat,
`
`“understudy” role in the joint proceedings.3 While Petitioner filed declarations of
`
`
`2 Petitioner agrees to consolidated filings for all substantive papers in the respective
`
`proceedings, except for motions that do not involve Mylan. Petitioner agrees to
`
`incorporate its filings with those of Mylan in a consolidated filing, subject to the
`
`ordinary rules for one party on page limits.
`
`3 To the extent the Board considers granting Petitioner’s motion for joinder,
`
`
`
`6
`
`

`

`two experts different from the two experts relied upon by Mylan in the Mylan IPR,
`
`the substance of the Mylan expert declarations is the same as the substance of
`
`Petitioner’s respective expert declarations.
`
`In order to simplify the proceeding further, Petitioner will rely on the same
`
`experts as Mylan, should Mylan permit Petitioner to do so. If Mylan allows Petitioner
`
`to retain the same experts, Petitioner will withdraw its expert declarations of Drs.
`
`Solny and Bergstrom and rely solely on the declarations and testimony of Mylan’s
`
`experts, Drs. Metz and Mayersohn. 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 America Inc. v. Clouding IP, LLC,
`
`
`Petitioner is willing to take a passive role. For example, Petitioner agrees to not file
`
`additional papers, not file additional pages to Mylan’s papers, not present any new,
`
`additional, or supplemental arguments, not cross-examine Patent Owners’ expert(s)
`
`or attempt to offer a rebuttal expert of its own, and not present any arguments at oral
`
`hearings. See e.g., Samsung Elec. Co., Ltd. v. Arendi S.A.R.L., IPR2014-01518,
`
`Paper 10 at 6 (PTAB Mar. 18, 2015) (allowing joinder where movants take a “limited
`
`understudy role” without a separate opportunity to actively participate). Only if
`
`Mylan drops out of the proceedings for any reason, will Petitioner cease its passive
`
`role.
`
`
`
`7
`
`

`

`IPR2014-00306, Paper 13, page 4. The Board has granted joinder under
`
`circumstances like those presented by the DRL IPR and Petitioner’s joinder
`
`application. See Teva Pharmaceuticals USA, Inc. v. Allegan, Inc., IPR2017-00586,
`
`Paper 8, p. 3; Qualcomm Inc. v. DSS Technology Management, Inc., IPR2016-01312,
`
`Paper 6, pp. 2, 6; Apotex, Inc. and Mylan Pharmaceuticals Inc. v. Novartis AG and
`
`Mitsubishi Pharma Corp., IPR2015-00518, Paper 8, pp. 3 – 4; Torrent
`
`Pharmaceuticals Ltd. v. Novartis AG and Mitsubishi Pharma Corp., IPR2014-
`
`00784, Paper 17, p. 2; Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju
`
`Pharmaceutical Co., Ltd., IPR2015-01871, Paper 13, p. 4-6.
`
`Even if, through no fault of its own, Petitioner were required to proceed with
`
`its own experts, there would be no impact on the Board’s ability to complete its
`
`review in a timely manner. Moreover, there would be only a modest impact on Patent
`
`Owners given that little additional preparation would be needed for the deposition of
`
`Petitioner’s experts beyond that required for the deposition of Mylan’s experts
`
`because the substance of the respective Petitioner expert declarations is the same as
`
`that of the respective declarations of Mylan’s experts.
`
`There are no substantive differences. Further, DRL’s Petition proposes the
`
`same claim construction positions as the petition in the Mylan IPR, and relies upon
`
`the same exhibits.
`
`To the extent that DRL’s Petition in this proceeding differs from the petition
`
`
`
`8
`
`

`

`that Mylan filed in the Mylan IPR, Petitioner agrees to withdraw all additional
`
`arguments, as well as the supporting Declarations of Drs. Solny and Bergstrom, and
`
`proceed based on the arguments and evidence provided by Mylan in the Mylan IPR.
`
`DRL agrees to assume a primary role in the Mylan IPR only if Mylan ceases to
`
`participate in it. In other words, DRL requests permission to be added to the case
`
`caption as a petitioner in the Mylan IPR, without any active participation or
`
`involvement that is separate from Mylan, unless authorized by the Board upon a
`
`request pertaining to an issue unique to DRL alone.
`
`DRL expects that any cross-examination(s) carried out by Mylan will occur
`
`within the timeframe normally allotted by the rules to one party. As such, the time
`
`will not need to be extended in light of the joinder.
`
`C.
`
`Joinder Will Enhance Efficiency by Avoiding Duplicate
`Efforts and Inconsistencies
`
`Joinder is appropriate because it is the most expedient way to secure the just,
`
`speedy, and inexpensive resolution of two related proceedings in a single inter partes
`
`review. See 35 U.S.C. § 316(b); 37 C.F.R. § 42.1(b).
`
`D. A Joined Proceeding Avoids Prejudice to DRL and Will
`Not Prejudice Mylan or Pozen
`
`Joinder is also warranted in order to permit DRL to protect its interests related
`
`to the validity and interpretation of the ’698 patent claims, and DRL could be
`
`prejudiced if it is not permitted to participate in the Mylan IPR. For example,
`
`
`
`9
`
`

`

`allowing a joined inter partes review would avoid potential inconsistency and avoid
`
`prejudice to DRL in the event that Mylan and Pozen reach a resolution of their
`
`disputes during the pendency of the Mylan IPR. 35 U.S.C. § 317(a) provides that an
`
`inter partes review “shall be terminated with respect to any petitioner upon the joint
`
`request of the petitioner and the patent owner” unless the Board has already reached
`
`its decision on the merits. If no petitioner remains after settlement, “the Office may
`
`terminate the review.” Id. Here, if Pozen and Mylan settled, the Mylan IPR could
`
`terminate without proceeding to a final written decision, prejudicing Petitioner.
`
`Permitting joinder will not prejudice Pozen or Mylan. Petitioner raises no
`
`issues not already before the Board, so joinder will not affect the timing of the Mylan
`
`IPR. Petitioner also believes that given the procedural safeguards proposed here, any
`
`additional costs to Pozen and Mylan associated with DRL’s participation in the
`
`Mylan IPR will be minimal, and not so great as to justify the potential prejudice to
`
`Petitioner if the Mylan IPR were otherwise terminated before a final written decision
`
`by the Board.
`
`Joinder Will Not Prejudice Pozen or Mylan
`
`E.
`Permitting joinder will not prejudice Pozen or Mylan. Petitioner’s proposed
`
`grounds for instituting an IPR are identical to those proposed the Mylan IPR. Thus,
`
`neither Pozen nor Mylan need expend any additional resources beyond those
`
`required in the Mylan IPR. Joinder will not affect the timing of the Mylan IPR, and
`
`
`
`10
`
`

`

`any extension to the schedule that may be required is permitted by law and the
`
`applicable rules. 35 U.S.C. § 316(a)(1); 37 C.F.R. § 42.100(c). By allowing the
`
`identical grounds of invalidity to be addressed in a single proceeding, the interests
`
`of all parties and the Board will be well served.
`
`IV. CONCLUSION
`
`For all the foregoing reasons, Petitioner respectfully requests this proceeding
`
`be joined with the Mylan IPR.
`
`Although Petitioner believes that no fee is required for this Motion, the
`
`Commissioner may charge any additional fees which may be required for this
`
`Motion to Deposit Account No. 506688.
`
`Date: April 6, 2018
`
`
`
`Respectfully submitted,
`
`/ Alan H. Pollack /
`Alan H. Pollack (Reg. No. 39,802)
`Stuart D. Sender (Reg. No. 34,248)
`Louis H. Weinstein (Reg. No. 45,205)
`BUDD LARNER, P.C.
`150 John F. Kennedy Parkway
`Short Hills, NJ 07078
`apollack@buddlarner.com
`ssender@buddlarner.com
`lweinstein@buddlarner.com
`Telephone: (973) 379-4800
`Facsimile: (973) 379-7734
`
`
`
`11
`
`

`

`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105, I certify that I caused to be
`
`
`
`
`served a true and correct copy of the foregoing MOTION FOR JOINDER
`
`PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. § 42.122(b) by Federal
`
`Express Next Business Day Delivery on this day on the Patent Owners’
`
`correspondence address of record for the subject patent as follows:
`
`Steven L. Highlander
`Parker Highlander PLLC
`1120 South Capital of Texas Highway
`Bldg. 1, Suite 200
`Austin, TX 78746
`
`
`Courtesy copies of the MOTION FOR JOINDER PURSUANT TO 35
`
`U.S.C. § 315(c) AND 37 C.F.R. § 42.122(b) have been sent by Federal Express
`
`Next Business Day Delivery on this day to:
`
`(1) Patent Owner’s:
`
`Horizon Pharma USA, Inc.
`150 South Saunders Road
`Lake Forest, IL 60045
`
`Pozen Inc.
`8310 Bandford Way
`Raleigh, NC 27615
`
`
`
`(2) counsel of record for the Patent Owners in Mylan Pharmaceuticals Inc. v.
`Pozen Inc, Case No. IPR2017-01995
`
`Stephen M. Hash
`BAKER BOTTS LLP
`98 San Jacinto Boulevard Suite 1500
`Austin, Texas 78701-4078
`
`Ellen Scordino
`COOLEY LLP
`500 Boylston Street
`14th Floor
`Boston, MA 02116-3736
`
`
`
`12
`
`

`

`Thomas A. Blinka, Ph.D.
`COOLEY LLP
`1299 Pennsylvania Avenue, N.W., Suite 700
`Washington, DC 20004-2400
`
`Jonathan G. Graves
`COOLEY LLP
`1299 Pennsylvania Avenue, N.W., Suite 700
`Washington, DC 20004-2400
`
`Margaret J. Sampson, Ph.D.
`BAKER BOTTS LLP
`98 San Jacinto Blvd. Suite 1500
`Austin, TX 78701-4078
`
`Jeffrey S. Gritton
`BAKER BOTTS LLP
`98 San Jacinto Blvd. Suite 1500
`Austin, TX 78701-4078
`
`
`(3) and counsel of record for Mylan in Mylan Pharmaceuticals Inc. v. Pozen Inc,
`Case No. IPR2017-01995
`
`Brandon M. White
`PERKINS COIE LLP
`700 13th St., NW Suite 600
`Washington, DC 20005
`
`
`
`Emily Greb
`PERKINS COIE LLP
`One East Main St., Suite 201
`Madison, WI 53703
`
`April 6, 2018
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` By: /s/ Alan H. Pollack
`
` Alan H. Pollack
`
` Reg. No. 39,802
`
`
`
`
`
`
`Dated:
`
`
`
`
`
`
`
`
`
`
`
`
`
`13
`
`