Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`
`Paper 9
`Entered: September 11, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`ACTAVIS ELIZABETH LLC and
`TEVA PHARMACEUTICALS USA, INC.,
`Petitioner,
`v.
`NOVARTIS AG,
`Patent Owner.
`_______________
`
`Case IPR2017-01946
`Patent US 9,187,405 B2
`_______________
`
`Before LORA M. GREEN, CHRISTOPHER M. KAISER, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`DECISION
`Instituting Inter Partes Review and Granting Motion for Joinder
`37 C.F.R. § 42.108; 37 C.F.R. § 42.122(b)
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`Paper 9
`Entered: September 11, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`ACTAVIS ELIZABETH LLC and
`TEVA PHARMACEUTICALS USA, INC.,
`Petitioner,
`v.
`NOVARTIS AG,
`Patent Owner.
`_______________
`
`Case IPR2017-01946
`Patent US 9,187,405 B2
`_______________
`
`Before LORA M. GREEN, CHRISTOPHER M. KAISER, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`POLLOCK, Administrative Patent Judge.
`
`
`DECISION
`Instituting Inter Partes Review and Granting Motion for Joinder
`37 C.F.R. § 42.108; 37 C.F.R. § 42.122(b)
`
`
`
`
`
`
`
`
`
`
`IPR2017-01946
`Patent US 9,187,405 B2
`
`
`INTRODUCTION
`I.
`Actavis Elizabeth LLC and Teva Pharmaceuticals USA, Inc.
`(collectively, “Teva”) filed a Petition requesting an inter partes review of
`claims 1–6 of U.S. Patent No. 9,187,405 B2 (“the ’405 patent”). Paper 2
`(“Pet.”). Along with the Petition, Teva filed a Motion for Joinder to join this
`proceeding with IPR2017-00854. Paper 3 (“Mot.”). Teva filed the Petition
`and Motion for Joinder in the present proceeding on August 15, 2017, within
`one month after we instituted trial in IPR2017-00854. Novartis AG,
`(“Novartis”) has not filed a Preliminary Response to the Petition, and any
`such response is due November 15, 2017. Novartis does not oppose Teva’s
`motion for joinder. Ex. 3001; Mot., 1.
`As explained further below, we institute trial on the same grounds as
`instituted in IPR2017-00854 and grant Teva’s Motion for Joinder.
`
`DISCUSSION
`II.
`In IPR2017-00854, Apotex, Inc. and Apotex Corp. (“Apotex”)
`challenged claims 1–6 of the ’405 Patent on the following grounds:
`Ground Claims
`References
`Basis
`1
`1–6
`Kovarik1 and Thomson
`§ 103
`2
`1–6
`Chiba,2 Kappos 2005,3 and Budde4
`§ 103
`
`
`1 Kovarik and Appel-Dingemanse, WO 2006/058316, published June 1,
`2006.
`2 Chiba et al., US 6,004,565, issued Dec. 21, 1999. Ex. 1006.
`3 Kappos et al., “FTY720 in Relapsing MS: Results of a Double-Blind
`Placebo-Controlled Trial with a Novel Oral Immunomodulator,” 252 (Suppl
`2) J. NEUROLOGY Abstract O141 (2005). .
`4 Budde, et al., “First Human Trial of FTY720, a Novel Immunomodulator,
`in Stable Renal Transplant Patients,” 13 J. AM. SOC. NEPHROLOGY 1073-
`1083 (2002). .
`
`2
`
`
`
`IPR2017-01946
`Patent US 9,187,405 B2
`
`Ground Claims
`3
`1–6
`
`
`References
`Kappos 20105
`
`Basis
`§ 102
`
`After considering the Petition and Patent Owner’s Preliminary
`Response, we instituted trial in IPR2017-00854 on each of the three asserted
`grounds. IPR2017-00854, Paper 11, 27. On August 9, 2017, we instituted
`inter partes review on those same grounds in IPR2017-01550 and granted
`Petitioner Argentum Pharmaceuticals LLC’s motion for joinder with
`IPR2017-00854. IPR2017-00854, Paper 10, 5.
`As with Argentum’s Petition, Teva’s Petition is substantively identical
`to Apotex’s Petition, challenging the same claims based on the same art and
`the same grounds. Compare IPR2017-01946, Paper 2, with IPR2017-00854,
`Paper 2. For the same reasons stated in our Decision on Institution in
`IPR2017-00854, we institute trial in this proceeding on the same three
`grounds.
`Having determined that institution is appropriate, we now turn to
`Teva’s Motion for Joinder. 35 U.S.C. § 315(c). Section 315(c) provides, in
`relevant part, that “[i]f 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.” Id.
`When determining whether to grant a motion for joinder we consider factors
`such as timing and impact of joinder on the trial schedule, cost, discovery,
`and potential simplification of briefing. Kyocera Corp. v. SoftView, LLC,
`Case IPR2013-00004, slip op. at 4 (PTAB Apr. 24, 2013) (Paper 15).
`
`
`5 Kappos et al., “A Placebo-Controlled Trial of Oral Fingolimod
`in Relapsing Multiple Sclerosis,” 362(5) N. ENGL. J. MED. 387–401.
`
`3
`
`
`
`IPR2017-01946
`Patent US 9,187,405 B2
`
`
`Under the circumstances of this case, we determine that joinder is
`appropriate. Teva raises no new grounds of unpatentability from IPR2017-
`00854 and contends that there will be no impact on the trial schedule
`previously set in that case. Mot. 5–6; see IPR2017-00854, Paper 12. As
`Teva notes, the Petition in IPR2017-00854 is substantively identical to the
`grounds, analysis, exhibits,6 and expert declarations relied on in the instant
`proceeding. Mot. 2, 4, 5. Teva agrees “to submit consolidated filings for all
`substantive papers in the respective proceedings with Apotex and to
`incorporate its filings with those of Apotex in a consolidated filing, subject
`to the ordinary rules for one party on page limits. Id. at 6. Teva further
`agrees “to let Apotex take the lead at the hearing and depositions and will
`agree that cross examinations will occur within the timeframe normally
`allotted to one party.” Id.
`Teva represents that Apotex does not oppose Argentum’s Motion for
`Joinder. Id. at 3. By email to the Board dated September 5, 2017, counsel
`for Novartis represents that, 1) Novartis does not object to the Motion; 2)
`Teva has agreed not to pursue any arguments or make any filings separate
`from those made by Apotex in IPR2017-00854 (subject to Petitioner’s right
`to take a lead role in the proceeding if Apotex drops out of IPR2017-00854);
`and 3) that it will not submit a Preliminary Response in IPR2017-01946.
`Ex. 3001.
`
`
`6 Teva notes that it has “added one additional exhibit (EX1041) which is a
`copy of the Federal Circuit Decision of April 12, 2017 affirming the Final
`Written Decision in IPR2014-00784, an IPR related to the present
`proceeding.” Mot., 4, fn.1.
`
`4
`
`
`
`IPR2017-01946
`Patent US 9,187,405 B2
`
`
`In view of the foregoing, we find that joinder based upon the
`conditions stated in Teva’s Motion for Joinder and Novartis’ September 5
`email will have little or no impact on the timing, cost, or presentation of the
`trial on the instituted grounds. Moreover, discovery and briefing will be
`simplified if the proceedings are joined. Thus, without opposition to the
`Motion for Joinder from any of the parties, the Motion is granted.
`
`III.
`
`ORDER
`
`Accordingly, it is
`ORDERED that inter partes review is instituted in IPR2017-01946 on the
`following grounds:
`
`Claims 1–6 under 35 U.S.C. § 103 as unpatentable over the
`combination of Kovarik and Thomson;
`
`Claims 1–6 under 35 U.S.C. § 103 as unpatentable over the
`combination of Chiba, Kappos 2005, and Budde;
`
`Claims 1–6 under 35 U.S.C. § 102 as anticipated by Kappos 2010.
`
`FURTHER ORDERED that Teva’s Motion for Joinder with IPR2017-00854
`is granted;
`
`FURTHER ORDERED that IPR2017-01946 is terminated and joined to
`IPR2017-00854, pursuant to 37 C.F.R. §§ 42.72, 42.122, based on the
`conditions discussed above;
`
`FURTHER ORDERED that the Scheduling Order in place for
`IPR2017-00854 (Paper 12) shall govern the joined proceedings;
`
`FURTHER ORDERED that all future filings in the joined proceeding are to
`be made only in IPR2017-00854;
`
`5
`
`
`
`IPR2017-01946
`Patent US 9,187,405 B2
`
`
`FURTHER ORDERED that the case caption in IPR2017-00854 for all
`further submissions shall be changed to add Actavis Elizabeth LLC and
`Teva Pharmaceuticals USA, Inc. as named Petitioners after Apotex and
`Argentum, and to indicate by footnote the further joinder of IPR2017-01946
`to that proceeding, as indicated in the attached sample case caption;
`
`FURTHER ORDERED that a copy of this Decision shall be entered into the
`record of IPR2017-00854.
`
`
`
`
`
`
`
`6
`
`
`
`IPR2017-01946
`Patent US 9,187,405 B2
`
`
`
`FOR PETITIONER TEVA:
`
`Amanda Hollis
`Eugene Goryunov
`KIRKLAND & ELLIS LLP
`amanda.hollis@kirkland.com
`egoryunov@kirkland.com
`
`FOR PETITIONER ARGENTUM:
`
`Teresa Stanek Rea
`Deborah H. Yellin
`Shannon M. Lentz
`CROWELL & MORING LLP
`TRea@Crowell.com
`DYellin@crowell.com
`SLentz@Crowell.com
`
`Tyler C. Liu
`ARGENTUM PHARMACEUTICALS, LLC
`TLiu@agpharm.com
`
`FOR PATENT OWNER:
`
`Jane M. Love
`GIBSON, DUNN & CRUTCHER LLP
`jlove@gibsondunn.com
`
`FOR PETITIONER APOTEX:
`
`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`WILSON SONSINI GOODRICH & ROSATI
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`
`
`
`
`
`7
`
`
`
`IPR2017-01946
`Patent US 9,187,405 B2
`
`
`Sample Case Caption
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`APOTEX INC., APOTEX CORP.,
`ARGENTUM PHARMACEUTICALS LLC,
`ACTAVIS ELIZABETH LLC, and
`TEVA PHARMACEUTICALS USA, INC.,
`Petitioners,
`
`v.
`
`NOVARTIS AG.,
`Patent Owner.
`____________
`Case IPR2017-008547
`Patent US 9,187,405 B2
`____________
`
`
`
`
`
`
`
`
`7 Cases IPR2017-01550 and IPR2017-01946 have been joined with this
`proceeding.
`
`8
`
`
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