In the United States Patent and Trademark Office
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`Before the Patent Trial and Appeal Board
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`AMERIGEN PHARMACEUTICALS LIMITED,
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`Petitioner
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`v.
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`UCB PHARMA GMBH
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`Patent Owner
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`U.S. 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
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`Title: COMPOSITIONS AND METHODS FOR TREATMENT OF BOWEL
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`DISEASES WITH GRANULATED MESALAMINE
`Inter Partes Review No.: Unassigned
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`MOTION FOR JOINDER PURSUANT TO 35 U.S.C. § 315(c), 37 C.F.R. §§
`42.22 AND 42.122(b)
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`Before the Patent Trial and Appeal Board
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`AMERIGEN PHARMACEUTICALS LIMITED,
`
`Petitioner
`
`v.
`
`UCB PHARMA GMBH
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`
`Patent Owner
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`U.S. 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
`
`
`
`
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`
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`Title: COMPOSITIONS AND METHODS FOR TREATMENT OF BOWEL
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`DISEASES WITH GRANULATED MESALAMINE
`Inter Partes Review No.: Unassigned
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`MOTION FOR JOINDER PURSUANT TO 35 U.S.C. § 315(c), 37 C.F.R. §§
`42.22 AND 42.122(b)
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`I.
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`INTRODUCTION
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`Amerigen Pharmaceuticals Limited (“Amerigen”) submits, concurrently with
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`this motion, a petition for inter partes review (“IPR”) of U.S. Patent No. 6,858,650
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`(“the ‘650 patent”) (“Petition”). Amerigen respectfully requests joinder pursuant to
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`35 U.S.C. § 315(c) and 37 C.F.R. § 42.122(b) of its concurrently filed Petition with
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`a pending inter partes review initiated by Mylan Pharmaceuticals Inc. and Mylan
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`Laboratories Limited against the ’650 patent (see Mylan Pharmaceuticals Inc., et al.
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`v. UCB Pharma GmbH, IPR 2016-00510 on February 2, 2016, and which the Board
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`instituted on July 20, 2016) (“the Mylan IPR”).
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`This Motion for Joinder is timely under 37 C.F.R. §§ 42.22 and 42.122(b), as
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`it is submitted within one month of the date on which the Mylan IPR was instituted.
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`Joinder is appropriate because of the substantial similarity between Amerigen’s
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`Petition and the Mylan IPR. The Amerigen Petition relies on the same grounds as
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`those instituted by the Board in the Mylan IPR. Indeed the each of the grounds set
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`forth in Amerigen’s Petition are practical copies of the grounds presented in the
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`Mylan IPR, and challenge the same claims over the same prior art using the same
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`arguments and expert testimony. Absent termination of Mylan as a party to IPR
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`2016-00510, Amerigen anticipates participating in the proceeding in a limited
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`capacity as an understudy. Moreover, joinder will have no impact on the trial
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`schedule of IPR2016-00510 because that IPR is still in its early stages, and
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`Amerigen, in its presently limited role, is agreeable to the same schedule.
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`Factors that favor joining proceedings include the following: (i) adoption of
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`same or existing schedules; (ii) absence of new expert testimony, and thus, no
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`impact on discovery; (iii) no material effect on the range of issues to be addressed
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`by the Board and by the parties in the joined proceedings; (iv) absence of prejudice
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`to any party; and (v) willingness to agree to procedural safeguards to minimize
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`burden. See Kyocera Corp. v. Softview LLC, IPR 2013-00004, Paper 15 at 4 (Apr.
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`24, 2013). Here, these factors provide adequate support for joining these
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`proceedings and Amerigen requests that the Board grant this motion for joinder.
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`II.
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`STATEMENT OF PRECISE RELIEF REQUESTED
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`Amerigen requests joinder under 35 U.S.C. § 315(c) and 37 C.F.R. §§ 42.22
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`and 42.122(b) of its Petition for inter partes review of the ’650 patent with the
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`related and instituted IPR 2016-00510.
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`III. STATEMENT OF RELEVANT FACTS
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`1. UCB is the owner of the ’650 patent.
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`2. On February 2, 2016, Mylan filed its petition for inter partes review of
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`claims 1-5 and 21-24 of the ’650 patent.
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`3. On July 20, 2016, a decision instituting inter partes review of claims 1-5
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`and 21-24 of the ’650 patent was entered in the Mylan IPR (Paper 12, IPR2016-
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`00510) on the grounds that claims 1-5 and 21-24 are unpatentable over the
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`Postlind, Bundgaard, Detrol® Label, and Berge publications under 35 U.S.C. §
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`103, and that claims 1-5 and 21-24 are unpatentable over the Brynne, Bundgaard,
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`and Johansson publications.
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`4. Oral argument is currently set for April 5, 2017 in the Mylan IPR.
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`5. Concurrently filed with this Motion for Joinder, is Amerigen’s Petition for
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`inter partes review of claims 1-5 and 21-24 of the ’650 patent.
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`6. The Amerigen Petition includes grounds that are the same as and practical
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`copies of the grounds instituted in the Mylan IPR.
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`IV. ARGUMENT
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`A. Legal Standard
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`The Board has authority to join as a party any person who properly files a
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`petition for inter partes review to an instituted inter partes review. 35 U.S.C.
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`§ 315(c). A motion for joinder must be filed within one month of institution of any
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`inter partes review for which joinder is requested. 37 C.F.R. § 42.122(b). In
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`deciding whether to grant a motion for joinder, the Board considers several factors
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`including: (1) the reasons why joinder is appropriate; (2) whether the party to be
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`joined has presented any new grounds of unpatentability; (3) what impact, if any,
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`joinder would have on the trial schedule for the existing review; and (4) how
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`briefing and discovery may be simplified. See, e.g., Hyundai Motor Co. v. Am.
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`Vehicular Sciences LLC, IPR2014-01543, Paper No. 11 at 3 (Oct. 24, 2014);
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`Macronix Int’l Co. v. Spansion, IPR2014-00898, Paper 15 at 4 (Aug. 13, 2014)
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`(quoting Kyocera Corp. v. Softview LLC, IPR2013-00004, Paper 15 at 4 (April 24,
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`2013); InnoPharma Licensing Inc. et al. v. Senju Pharmaceutical Co. Ltd., IPR
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`2016-00089, Paper 13 at 7 (PTAB Feb. 25, 2016)).
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`B.
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`Petitioner’s Motion for Joinder is Timely
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`Joinder may be requested no later than one month after the institution date of
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`an inter partes review for which joinder is requested. 37 C.F.R. § 42.122. Here,
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`because the Board issued its institution decision in IPR2016-00510 on July 20,
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`2016, this Motion for Joinder and the accompanying Petition are timely.
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`C. The Relevant Factors Weigh in Favor of Joinder
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`Each of the four factors considered by the Board weighs in favor of joinder.
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`As discussed below, granting joinder will not enlarge the scope of the IPR2016-
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`00510 and will not negatively impact the IPR2016-00510 schedule, but a decision
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`denying joinder could severely prejudice Petitioner. Thus, joinder is appropriate
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`and warranted.
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`1.
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`Joinder is Appropriate
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`Joinder with IPR2016-00510 is appropriate because Amerigen’s Petition is
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`limited to the same grounds instituted in the IPR2016-00510 petition, and expressly
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`does not advance for joinder purposes in this proceeding the grounds that were not
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`instituted in IPR2016-00510. It also relies on the same prior art analysis and expert
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`testimony submitted by Mylan. Indeed, the Petition is nearly identical with respect
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`to the grounds raised in the IPR2016-00510 petition, and does not include any
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`grounds not raised in that petition. Other than certain formalities, the present
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`petition and evidence is virtually identical in content to the IPR2016-00510
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`petition. No substantive differences exist between the present Petition and the
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`IPR2016-00510 petition.
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`Joinder is also appropriate because it will promote the just, speedy, and
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`inexpensive resolution of patentability issues, including the determination of
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`validity of the challenged claims of the ’650 patent. For example, a final written
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`decision on the validity of the ’650 patent has the potential to minimize issues and
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`potentially resolve any litigation—current or future— altogether with respect to the
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`’650 patent.
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`Moreover, granting joinder will not prejudice Patent Owner or Mylan, while
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`Amerigen could be prejudiced if joinder is denied. As mentioned above, the
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`accompanying Petition does not raise any new ground that is not raised in the
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`IPR2016-00510 petition. Therefore, joinder should not significantly affect the
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`timing in IPR2016-00510. Also, there should be little to no additional cost to
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`Patent Owner or Mylan given the overlap in the petitions. On the other hand,
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`Amerigen and the public may be potentially prejudiced if joinder is denied. For
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`example, absent joinder, Patent Owner and Mylan might settle and request
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`termination of the proceedings, leaving facially intact a patent that the Board has
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`already found is likely unpatentable.
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`2.
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`No New Grounds Are Presented
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`Amerigen’s Petition does not present any new grounds of unpatentability.
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`As mentioned above, the Petition presents for review only grounds from the
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`petition in IPR2016-00510 that have been instituted. The present Petition is based
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`on the same prior art analysis and expert testimony submitted by Mylan. The
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`petitions do not differ in any substantive way. In similar circumstances, the Board
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`has granted joinder, because doing so does not introduce any additional arguments,
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`briefing, or need for discovery. See, e.g., Hyundai, IPR2014-01543, Paper No. 11
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`at 2-4; Sony Corp. of Am. v. Network-1 Sec. Solutions, Inc., IPR2013-00495, Paper
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`No. 13 at 5-9 (Sep. 16, 2013); Dell Inc. v. Network-1 Solutions, Inc., IPR2013-
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`00385, Paper No. 17, at 6-10 (Jul. 29, 2013); Motorola Mobility LLC v. Softview
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`LLC, IPR2013-00256, Paper 10 at 4-10 (June 20, 2013).
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`3.
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`Joinder Will Not Negatively Impact the IPR2016-00510
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`Trial Schedule
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`Because Amerigen’s Petition essentially copies grounds raised in the
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`IPR2016-00510 petition, including the prior art analysis and expert testimony
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`submitted by Mylan, joinder will have no substantial effect on the parties, or
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`prevent the Board from issuing a timely, final written decision. The timing and
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`content of Amerigen’s Petition and motion for joinder minimize any impact to the
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`IPR2016-00510 trial schedule. Moreover, as discussed above, Amerigen
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`anticipates participating in the proceeding in a limited capacity as an understudy,
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`absent termination of Mylan as a party. For example, if the proceedings are joined
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`and absent termination of Mylan, it is anticipated that no expert witnesses beyond
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`those presented by Mylan and Patent Owner will present testimony. Accordingly,
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`Amerigen does not believe that any extension of the schedule will be required by
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`virtue of joinder of Amerigen as a petitioner to this proceeding.
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`4.
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`Discovery and Briefing Can Be Simplified
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`Given that the Petition is identical to the IPR2016-00510 petition with
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`respect to grounds of unpatentability raised, the Board may adopt procedures
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`similar to those used in other cases to simplify briefing and discovery during trial.
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`See e.g., Hyundai, IPR2014-01543, Paper No. 11 at 5; Dell, IPR2013-00385, Paper
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`No. 17 at 8-10; Motorola, IPR2013-00256, Paper 10 at 8-10. Specifically, as long
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`as Mylan remains a party, the Board may order petitioners to consolidate filings,
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`and limit Amerigen to no additional filings in its understudy role. As long as
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`Mylan remains a party, Amerigen will not submit any separate filings unless it
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`disagrees with Mylan’s position(s) (which is not anticipated), and in the event of
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`any disagreement it will request authorization from the Board to submit a short
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`separate filing directed only to points of disagreement with Mylan. The Board may
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`allow the Patent Owner a corresponding number of pages to respond to any
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`separate filings. See Dell Inc., supra, at 8-9.
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`Further, no additional depositions will be needed and depositions will be
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`completed within ordinary time limits. Additionally, Amerigen will not seek to
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`submit any new expert declarations from those entered by Mylan, except to the
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`extent that Petitioner may be precluded from relying on Mylan’s experts, e.g., if
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`Mylan settles with Patent Owner and contractually binds its experts from
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`continuing in the IPR with Amerigen.
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`Moreover, to the extent that Amerigen does participate in the proceedings, it
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`will endeavor to coordinate with Mylan to consolidate authorized filings, manage
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`questioning at depositions, ensure that briefing and discovery occur within the time
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`normally allotted, and avoid redundancies. Amerigen will maintain a secondary
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`role in the joined proceeding, and will assume a primary role only Mylan ceases to
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`participate in the IPR. As noted above, Amerigen would not file any separate
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`papers without consultation with Mylan and prior authorization from the Board.
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`These procedures should simplify briefing and discovery and remove any
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`“complication or delay” that might allegedly be caused by joinder, while providing
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`the parties an opportunity to address all issues that may arise, and avoiding any
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`undue burden on Patent Owner, Mylan, and the Board.
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`V. CONCLUSION
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`For the foregoing reasons, Amerigen respectfully requests that this motion
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`be granted and an inter partes review of the challenged claims 1-5 and 21-24 of the
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`’650 patent be instituted based on the same grounds authorized and for the same
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`reasons discussed in the Institution Decision in IPR2016-00510, and that this
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`proceeding be joined with IPR2016-00510.
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`Respectfully submitted,
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`By: /s/William D. Hare/
`William D. Hare
`Reg. No. 44,739
`Lead Counsel for Petitioner Amerigen Pharmaceuticals Limited.
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`Gabriela Materassi (Reg. No. 47,774)
`McNeely Hare & War LLP
`12 Roszel Road, Suite C104
`Princeton, NJ 08540
`Telephone: (347) 684-4154
`Fax: (202) 478-1813
`materassi@miplaw.com
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`Renita S. Rathinam (Reg. No. 53,502)
`McNeely Hare & War LLP
`5335 Wisconsin Avenue, NW, Suite 440
`Washington D.C. 20015
`Telephone: (202) 253 4903
`Fax: (202) 478-1813
`rathinam@miplaw.com
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`William Hare (Reg. No. 44,739)
`McNeely Hare & War LLP
`12 Roszel Road, Suite C104
`Princeton, NJ 08540
`Telephone: (202) 640-1801
`Fax: (202) 478-1813
`bill@miplaw.com
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`11
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(a), I certify that, on August 22,
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`2016, I caused to be served true and correct copies of the above document by
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`overnight courier on the Patent Owner at the correspondence address of the Patent
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`Owner, as follows:
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`Jeffrey Ginsberg
`Kenyon & Kenyon LLP
`One Broadway
`New York, New York 10004-1007
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`with a courtesy copy to counsel for Pfizer Inc. and UCB Pharma GMBH as follows:
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`Jack Blumenfeld
`Morris, Nichols, Arsht & Tunnell LLP
`1201 North Market Street
`Wilmington, DE 19899
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`Dimitrios T. Drivas
`Jeffrey J. Oelke
`James S. Trainor, Jr.
`Ryan P. Johnson
`Robert Counihan
`WHITE &CASE LLP
`1155 Avenue of the Americas
`New York, NY 10036
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`By: /s/William D. Hare/
`William D. Hare
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`12
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