Trials@uspto.gov
`571-272-7822
`
`
`
`
`
` Paper No. 8
`Entered: December 7, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMERIGEN PHARMACEUTICALS LIMITED,
`Petitioner,
`
`v.
`
`UCB PHARMA GMBH,
`Patent Owner.
`____________
`
`Case IPR2016-01665
`Patent 6,858,650 B1
`____________
`
`
`Before KRISTINA M. KALAN, ROBERT A. POLLOCK, and
`MICHELLE N. ANKENBRAND, Administrative Patent Judges.
`
`ANKENBRAND, Administrative Patent Judge.
`
`
`DECISION
`Institution of Inter Partes Review and Grant of Motion for Joinder
`37 C.F.R. § 42.108; 37 C.F.R. § 42.122(b)
`
`
`571-272-7822
`
`
`
`
`
` Paper No. 8
`Entered: December 7, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMERIGEN PHARMACEUTICALS LIMITED,
`Petitioner,
`
`v.
`
`UCB PHARMA GMBH,
`Patent Owner.
`____________
`
`Case IPR2016-01665
`Patent 6,858,650 B1
`____________
`
`
`Before KRISTINA M. KALAN, ROBERT A. POLLOCK, and
`MICHELLE N. ANKENBRAND, Administrative Patent Judges.
`
`ANKENBRAND, Administrative Patent Judge.
`
`
`DECISION
`Institution of Inter Partes Review and Grant of Motion for Joinder
`37 C.F.R. § 42.108; 37 C.F.R. § 42.122(b)
`
`
`
`IPR2016-01665
`Patent 6,858,650 B1
`
`
`INTRODUCTION
`I.
`Amerigen Pharmaceuticals Limited (“Petitioner”) filed a Petition
`(“Pet.”) requesting an inter partes review of claims 1–5 and 21–24 of U.S.
`Patent No. 6,858,650 B1 (Ex. 1001, “the ’650 patent”). Paper 1.
`Concurrently with its Petition, Petitioner filed a Motion for Joinder (Paper 3,
`“Mot.”) with the inter partes review in Mylan Pharms., Inc. v. UCB Pharma
`GmbH, Case IPR2016-00510 (the “Mylan IPR” and Petitioner “Mylan”), an
`ongoing inter partes review, which was instituted on July 20, 2016. See
`IPR2016-00510, Paper 12. UCB Pharma GmbH (“Patent Owner”) did not
`file a Preliminary Response or a response to Petitioner’s Motion for Joinder.
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 42.4(a). We may not institute an inter partes review
`“unless . . . there is a reasonable likelihood that the petitioner would prevail
`with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C.
`§ 314(a). A petitioner may be joined as a party to a previously instituted
`inter partes review if that petitioner “properly files a petition . . . that we
`determine[] warrants the institution of an inter partes review.” 35 U.S.C.
`§ 315(c); 37 C.F.R. § 42.4(a).
`After considering the Petition and the evidence currently of record, we
`conclude that Petitioner has demonstrated that there is a reasonable
`likelihood that it would prevail with respect to at least one of the claims
`challenged in the Petition. Our conclusion is consistent with our institution
`decision in the Mylan IPR. See IPR2016-00510, Paper 12. Thus, we
`institute an inter partes review of claims 1–5 and 21–24 of the ’650 patent.
`Further, we grant Petitioner’s Motion for Joinder and exercise our discretion
`
`
`
`2
`
`
`
`IPR2016-01665
`Patent 6,858,650 B1
`
`to join Petitioner to the Mylan IPR. We further terminate the present
`proceeding, IPR2016-01665.
`PETITION FOR INTER PARTES REVIEW
`II.
`The parties indicate that the ’650 patent is the subject of several
`district court cases filed in the U.S. District Court for the District of
`Delaware and the U.S. District Court for the District of West Virginia.
`Pet. 9; Paper 6, 2. In addition, the ’650 patent is subject to the Mylan IPR,
`which has been instituted, and pending inter partes review proceedings,
`IPR2016-01596 and IPR2016-01636. See Paper 6, 3–4.
`In the Mylan IPR, we instituted inter partes review of claims 1–5 and
`21–24 of the ’650 patent on the same grounds of unpatentability asserted in
`the present Petition, which are reproduced below. Pet. 11; Mot. 2; IPR2016-
`00510, Paper 12, 29.
`References
`Postlind,1 “Bundgaard
`publications,”2,3,4 Detrol
`Label,5 and Berge6
`
`1 Postlind et al., Tolterodine, A New Muscarinic Receptor Antagonist, is
`Metabolized by Cytochromes P450 2D6 and 3A in Human Liver
`Microsomes, 26(4) DRUG METABOLISM & DISPOSITION 289–293 (1998)
`(Ex. 1010) (“Postlind”).
`2 As in the Mylan IPR, we interpret Petitioner’s reference to “Bundgaard
`publications” as referring to Exhibits 1012 and 1020. IPR2016-00510,
`Paper 12, 5 n.3; Pet. 5, 11–12, 27–29, 36–37, 39.
`3 Bundgaard, Design of Prodrugs Elsevier (1985) (Ex. 1012) (“Bundgaard”).
`4 WO 92/08459, published May 29, 1992 (Ex. 1020) (“Bundgaard PCT”).
`5 Detrol™ (tolterodine tartrate tablets) prescribing information (1998) (Ex.
`1009) (“Detrol Label”).
`6 Berge et al., Pharmaceutical Salts, 66(1) J. PHARM. SCI. 1–19 (1977) (Ex.
`1013) (“Berge”).
`
`Claims Challenged
`1–5 and 21–24
`
`Basis
`§ 103
`
`
`
`3
`
`
`
`IPR2016-01665
`Patent 6,858,650 B1
`
`
`References
`Brynne,7 Bundgaard
`publications, and Johansson8
`
`Basis
`§ 103
`
`Claims Challenged
`1–5 and 21–24
`
`Petitioner supports its assertions with the same evidence and
`arguments proffered in the Mylan IPR. Pet. 14–68. Petitioner asserts that its
`Petition “is limited to the same grounds instituted in the [Mylan IPR],” and
`that Petitioner “relies on the same prior art analysis and expert testimony
`submitted by Mylan.” Mot. 6. Petitioner also represents that “no
`substantive differences exist between the present Petition and the [Mylan
`IPR] petition.” Id.
`Because the asserted grounds of unpatentability, the arguments, and
`the supporting evidence here are identical to those in the Mylan IPR, we
`adopt the analysis from our institution decision in that case. IPR2016-
`00510, Paper 12, 6–28. Consistent with that analysis, we determine that
`Petitioner has shown a reasonable likelihood that it will prevail with respect
`to its challenges to claims 1–5 and 21–24 of the ’650 patent on the asserted
`grounds. Accordingly, we institute an inter partes review in this proceeding
`on the same grounds as those on which we instituted trial in the Mylan IPR.
`We do not institute an inter partes review on any other grounds.
`III. MOTION FOR JOINDER
`Petitioner seeks joinder with the inter partes review in the Mylan IPR.
`Mot. 2. Petitioner filed the present Motion on August 22, 2016, which is
`
`
`7 Brynne et al., Influence of CYP2D6 polymorphism on the pharmacokinetics
`and pharmacodynamics of tolterodine, 63(5) CLIN. PHARMACOL. &
`THERAPEUTICS 529–539 (1998) (Ex. 1011) (“Brynne”).
`8 Johansson et al., WO 94/11337, published May 26, 1994 (Ex. 1005)
`(“Johansson”).
`
`
`
`4
`
`
`
`IPR2016-01665
`Patent 6,858,650 B1
`
`thirty-two days after our July 20, 2016 decision instituting inter partes
`review in the Mylan IPR. The date falling one month after our institution
`decision, however, was Saturday, August 20, 2016, and Monday, August 22,
`2016 was the next succeeding business day. Pursuant to 37 C.F.R. § 1.7,
`when “the last day fixed . . . by or under this part for taking any action . . .
`falls on Saturday, Sunday, or on a Federal holiday within the District of
`Columbia, the action may be taken . . . on the next succeeding business day
`which is not a Saturday, Sunday, or a Federal holiday.” 37 C.F.R. § 1.7(a).
`The Motion, therefore, is timely under 37 C.F.R. § 42.122(b) (“Any request
`for joinder must be filed, as a motion under § 42.22, no later than one month
`after the institution date of any inter partes review for which joinder is
`requested.”). Accordingly, we must consider whether to exercise our
`discretion to join Petitioner as a party to the Mylan IPR.
`In its Motion for Joinder, Petitioner asserts that “[a]bsent termination
`of Mylan as a party to [the Mylan IPR], [Petitioner] anticipates participating
`in the proceeding in a limited capacity as an understudy.” Mot. 2. In that
`regard, Petitioner represents that it “will not submit any separate filings
`unless it disagrees with Mylan’s position(s) (which is not anticipated), and in
`the event of any disagreement it will request authorization to submit a short
`separate filing directed only to points of disagreement with Mylan.” Id. at
`8–9. Petitioner further states that it “will not seek to submit any new expert
`declarations from those entered by Mylan” unless Mylan settles with Patent
`Owner and that settlement contractually binds Mylan’s experts from
`continuing to support Petitioner. Id. at 9. Petitioner also states that it “will
`endeavor to coordinate with Mylan to consolidate authorized filings, manage
`
`
`
`5
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`
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`IPR2016-01665
`Patent 6,858,650 B1
`
`questioning at depositions, ensure that briefing and discovery will occur
`within the time normally allotted, and avoid redundancies.” Id.
`Given Petitioner’s concessions, and because Petitioner has satisfied
`the requirements of § 315(c), we grant Petitioner’s Motion for Joinder and
`exercise our discretion to join Petitioner as a party to the Mylan IPR, subject
`to the conditions detailed below.9 We further terminate the trial in IPR2016-
`01665.
`Petitioner shall adhere to the existing schedule in the Mylan IPR. All
`filings by Petitioner in the Mylan IPR shall be consolidated with the filings
`of the other Mylan IPR Petitioner(s), unless the filing involves an issue
`unique to Petitioner or states a point of disagreement related to the
`consolidated filing. In such circumstances, Petitioner shall seek
`authorization from the Board to file a separate paper. The Board expects
`Petitioner and Mylan to resolve any disputes between them and to contact
`the Board only if such matters cannot be resolved after a meaningful meet
`and confer between the two parties. The page limits set forth in 37 C.F.R.
`§ 42.24 will apply to all consolidated filings.
`Petitioner is bound by any discovery agreements, including deposition
`arrangements between Patent Owner and Mylan, and shall not seek any
`discovery beyond that sought by Mylan. Patent Owner shall not be required
`to provide any additional discovery or deposition time as a result of joinder.
`
`
`
`9 We issue this decision concurrently with decisions in IPR2016-01596 and
`IPR2016-01636. In each case, we institute an inter partes review based on
`the same grounds as those on which we instituted trial in the Mylan IPR and
`grant Petitioner’s motion for joinder.
`
`
`
`6
`
`
`
`IPR2016-01665
`Patent 6,858,650 B1
`
`
`IV. ORDER
`
`Accordingly, it is
`ORDERED that the Petition is granted and an inter partes review is
`instituted as to:
`Claims 1–5 and 21–24 of the ’650 patent under 35 U.S.C. § 103 over
`the combination of Postlind, Bundgaard publications, Detrol Label, and
`Berge; and
`Claims 1–5 and 21–24 of the ’650 patent under 35 U.S.C. § 103 over
`the combination of Brynne, Bundgaard publications, and Johansson;
`FURTHER ORDERED that notice is hereby given of the institution of
`a trial commencing on the entry date of this decision, pursuant to 35 U.S.C.
`§ 314(c) and 37 C.F.R. § 42.4;
`FURTHER ORDERED that Petitioner’s Motion for Joinder is
`granted;
`FURTHER ORDERED that Petitioner is joined as a party to
`IPR2016-00510;
`FURTHER ORDERED that the trial in this case is consolidated with
`IPR2016-00510;
`FURTHER ORDERED that the present proceeding, IPR2016-01665,
`is terminated under 37 C.F.R. § 42.72, and all further filings shall be made
`only in IPR2016-00510;
`FURTHER ORDERED that the asserted grounds of unpatentability on
`which a trial was instituted in IPR2016-00510 are unchanged;
`FURTHER ORDERED that the current Scheduling Order for
`IPR2016-00510 shall continue to govern the consolidated proceeding;
`
`
`
`7
`
`
`
`IPR2016-01665
`Patent 6,858,650 B1
`
`
`FURTHER ORDERED that Petitioner shall adhere to the existing
`schedule in IPR2016-00510;
`FURTHER ORDERED that all filings by Petitioner in the Mylan IPR
`shall be consolidated with the filing of the other Mylan IPR Petitioner(s),
`unless the filing involves an issue unique to Petitioner or states a point of
`disagreement related to the consolidated filing. In such circumstances,
`Petitioner shall seek authorization from the Board to file a separate paper;
`FURTHER ORDERED that Petitioner and Mylan shall resolve any
`disputes between them and contact the Board only if such matters cannot be
`resolved after a meaningful meet and confer between the two parties;
`FURTHER ORDERED that Petitioner shall be bound by any
`discovery agreements, including deposition arrangements, between Patent
`Owner and Mylan, and shall not seek any discovery beyond that sought by
`Mylan;
`FURTHER ORDERED that all page limits set forth in 37 C.F.R.
`§ 42.24 will apply to all consolidated filings;
`FURTHER ORDERED that Patent Owner shall not be required to
`provide any additional discovery or deposition time as a result of joinder;
`FURTHER ORDERED that the case caption in IPR2016-00510 shall
`be changed to reflect the joinder of Petitioner as a party in accordance with
`the attached example; and
`FURTHER ORDERED that a copy of this Decision be entered into
`the file of IPR2016-00510.
`
`
`
`
`
`8
`
`
`
`IPR2016-01665
`Patent 6,858,650 B1
`
`PETITIONER:
`William Hare
`bill@miplaw.com
`
`Gabriela Materassi
`materassi@miplaw.com
`
`Renita S. Rathinam
`rathinam@miplaw.com
`
`PATENT OWNER:
`Jeffrey Oelke
`joelke@whitecase.com
`
`James Trainor
`jtrainor@whitecase.com
`
`Robert Counihan
`rcounihan@whitecase.com
`
`
`
`
`
`
`
`9
`
`
`
`IPR2016-01665
`Patent 6,858,650 B1
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.
`and MYLAN LABORATORIES LIMITED,
`Petitioner,
`
`v.
`
`UCB PHARMA GMBH,
`Patent Owner.
`____________
`
`Case IPR2016-005101
`Patent 6,858,650 B1
`____________
`
`
`
`
`1 Petitioners Alembic Pharmaceuticals Limited from IPR2016-01596,
`Torrent Pharmaceuticals Limited from IPR2016-01636, and Amerigen
`Pharmaceuticals Limited from IPR2016-01665 have been joined as
`Petitioners to this proceeding.
`
`
`
`10
`
`
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