Paper No. 11
`
`
`
`
`
`Trials@uspto.gov
`571.272.7822 Filed: June 8, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS, INC.
`Petitioner,
`
`v.
`
` HORIZON THERAPEUTICS, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-00284
`Patent 8,404,215 B1
`____________
`
`
`
`Before TONI R. SCHEINER, DEBORAH KATZ, and GRACE KARAFFA
`OBERMANN, Administrative Patent Judges.
`
`KATZ, Administrative Patent Judge.
`
`
`
`DECISION
`Instituting Inter Partes Review and
`Granting Petitioner’s Unopposed Motion for Joinder
`37 C.F.R. § 42.108
`37 C.F.R. § 42.122(b)
`
`
`
`
`Introduction
`I.
`Petitioner, Lupin Ltd. and Lupin Pharmaceuticals, Inc. (“Lupin”)
`requests inter partes review under 35 U.S.C. § 311 of claims 1–11 of U.S.
`
`
`
`
`
`
`
`Trials@uspto.gov
`571.272.7822 Filed: June 8, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS, INC.
`Petitioner,
`
`v.
`
` HORIZON THERAPEUTICS, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-00284
`Patent 8,404,215 B1
`____________
`
`
`
`Before TONI R. SCHEINER, DEBORAH KATZ, and GRACE KARAFFA
`OBERMANN, Administrative Patent Judges.
`
`KATZ, Administrative Patent Judge.
`
`
`
`DECISION
`Instituting Inter Partes Review and
`Granting Petitioner’s Unopposed Motion for Joinder
`37 C.F.R. § 42.108
`37 C.F.R. § 42.122(b)
`
`
`
`
`Introduction
`I.
`Petitioner, Lupin Ltd. and Lupin Pharmaceuticals, Inc. (“Lupin”)
`requests inter partes review under 35 U.S.C. § 311 of claims 1–11 of U.S.
`
`
`
`IPR2016-00284
`Patent 8,404,215 B1
`
`Patent No. 8,404,215 B1 (Ex. 1001, “the ’215 patent”), owned by Horizon
`Therapeutics, Inc. (“Patent Owner”). Paper 1 (Lupin Pet.”). Inter partes
`review 2015-01127 was previously instituted regarding the same claims of
`the ’215 patent in light of the Petition filed by Par Pharmaceutical, Inc.
`(“Par”) and the Preliminary Response filed by Patent Owner. See IPR2015-
`01127 (“Par IPR”), Paper 13. In addition to institution of review, Lupin
`requests that the proceeding be joined with the IPR2015-01127 proceeding
`under 35 U.S.C. § 315(c). Paper 4 (“Mot.”).
`Patent Owner did not file either a Preliminary Response or an
`opposition to Lupin’s Motion to Join.
`II.
`Additional Related Matters
`Lupin represents that Patent Owner filed a complaint in the United
`States District Court for the District of New Jersey (Case No. 1:15-cv-
`07624-RBK-JS) alleging that Lupin infringes three United States patents,
`including the ’215 patent. Lupin represents that Patent Owner has also
`asserted the ’215 patent against Par in the United States District Court for
`the Eastern District of Texas (Case No. 14-cv-00384).
`Lupin represents further that it is contemporaneously filing a second
`petition for inter partes review of the ’215 patent, although no other petition
`challenging the ’215 patent has been identified. (Pet. 7.) Lupin also filed a
`petition for inter partes review of U.S. Patent 9,095,559, which issued from
`an application that is a divisional of the application from which the ’215
`patent issued. See IPR2016-00829.
`Contemporaneous with this Petition, Lupin also filed a Petition and
`Motion for Joinder in IPR2016-00283, requesting review of Horizon’s U.S.
`Patent 8,642,012. The claims of that patent are to subject matter similar to
`
`
`
`2
`
`
`
`IPR2016-00284
`Patent 8,404,215 B1
`
`the claims of the ’215 patent, but the patents do not share prior applications.
`Like the Petition and Motion for Joinder in this proceeding, Lupin represents
`that the arguments and evidence presented in IPR2016-00283 are
`substantially identical to the grounds of challenge raised by Par against the
`same Horizon patent in IPR2015-01117. See IPR2016-00283, Paper 4, 4.
`Patent Owner represents that on April 1, 2016, Lupin filed a Petition
`for inter partes review of U.S. Patent 9,095,559, which issued from U.S.
`Patent Application 13/775,000 as a divisional of the ʼ215 patent. See Patent
`Owner’s Updated Mandatory Notices, Paper 10, identifying IPR2016-00829.
`III.
`Institution of Review
`Lupin seeks review of claims 1–11 of the ’215 patent based on the
`following grounds:
`
`Ground
`1
`
`References
`Fernandes1 in view of Blau,2 Simell,3 and
`the ’859 Publication4
`
`Claim(s)
`1, 3–7, and 9
`
`
`1 INBORN METABOLIC DISEASES: DIAGNOSIS AND TREATMENT,
`214–22 (J. Fernandes et al. eds., 3d ed. 2000).
`2 PHYSICIAN’S GUIDE TO THE LABORATORY DIAGNOSIS OF
`METABOLIC DISEASES, 261– 76 (Nenad Blau et al. eds., 2d ed. 1996).
`3 Olli Simell et al., Waste Nitrogen Excretion Via Amino Acid Acylation:
`Benzoate and Phenylacetate in Lysinuric Protein Intolerance, 20
`PEDIATRIC RESEARCH 1117–21 (1986).
`4 U.S. Patent Publication No. 2010/0008859 A1, filed January 7, 2009,
`published January 14, 2010.
`
`
`
`3
`
`
`
`IPR2016-00284
`Patent 8,404,215 B1
`
`
`2
`
`3
`
`4
`
`Fernandes in view of Blau, Simell, and
`Brusilow ’915
`Fernandes in view of Blau, Simell, and
`the ’859 Publication
`Fernandes and Brusilow ’846 in view of
`Blau, and Simell
`
`8
`
`10–11
`
`2, 4–7, 9, and 10
`
`
`Lupin Pet. 10. These grounds are the same as Grounds 1–4 asserted by Par
`in the Petition in the Par IPR. See Par IPR, Paper 2, 10. Lupin does not
`assert the grounds for which review was not instituted in the Par IPR. See
`Mot. 4.
`Lupin represents, and we find, that Lupin’s petition regarding these
`grounds of review is substantially identical to the Petition filed by Par in the
`Par IPR. Mot. 4. Lupin also represents that it relies on the same exhibits
`and the same expert declaration (Declaration of Neal Sondheimer, M.D.,
`Ph.D., Ex. 1002) relied upon by Par in the Par IPR to support its arguments
`for review. Id.
`Patent Owner did not file a Preliminary Response regarding Lupin’s
`Petition. Thus, Patent Owner raises no new arguments against institution of
`review.
`
`
`5 Saul W. Brusilow, Phenylacetylglutamine May Replace Urea as a Vehicle
`for Waste Nitrogen Excretion, 29 PEDIATRIC RESEARCH 147–150
`(1991).
`6 Saul W. Brusilow et al., Treatment of Episodic Hyperammonia in Children
`with Inborn Errors of Urea Synthesis, 310 THE NEW ENGLAND
`JOURNAL OF MEDICINE 1630–34 (1984).
`4
`
`
`
`
`
`IPR2016-00284
`Patent 8,404,215 B1
`
`
`For the same reasons that we determined the arguments and
`supporting evidence put forth in the Par IPR meet the threshold for
`institution of review of claims 1–11 of the ’215 patent under Grounds 1–4 in
`the Par IPR, we also determine that the substantially identical arguments and
`evidence put forth by Lupin meet the threshold for institution of review of
`those same claims under the same grounds. Accordingly, we institute
`review of claims 1–11 of the ’215 patent on the grounds asserted by Lupin.
`IV.
`Joinder
`Having determined that Lupin’s Petition warrants institution, we must
`determine whether to exercise our discretion to join Lupin as a party to the
`Par IPR.
`Under 35 U.S.C. § 315(c),
`[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 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.
`
`By regulation, the Director’s discretion has been delegated to the Board. 37
`C.F.R. § 42.4(a). Therefore, we have discretion to join this proceeding to
`the instituted Par IPR if we determine that Lupin has met is burden of
`proving it is entitled to joinder. See 37 C.F.R. § 42.122(b); see also 37
`C.F.R. § 42.20(c) (“The moving party has the burden of proof to establish
`that it is entitled to the requested relief.”).
`We note that Lupin represents that neither Patent Owner nor Par
`opposes joining the proceedings. Mot 1.
`
`
`
`5
`
`
`
`IPR2016-00284
`Patent 8,404,215 B1
`
`
`Lupin argues that joinder is appropriate because it will promote the
`efficient and consistent resolution of issues of patentability of the ’215
`patent claims. Mot 1. Lupin represents that it raises no new issues of
`patentability that are not already before the Board in the Par IPR. Id. at 4.
`Lupin also represents that it relies on the same exhibits and declarations
`submitted by Par in the Par IPR. Id. In light of the substantial identity of
`Lupin’s Petition and Par’s Petition, we agree that no new grounds of
`unpatentability or issues have been raised by Lupin.
`Lupin also argues that joinder will not impact the schedule of the Par
`IPR because Lupin raises no new grounds of unpatentability. Mot. 4. Lupin
`represents that it has agreed that only Par will file papers, conduct cross-
`examinations (with Lupin participating only if time allows), and present oral
`argument (with Lupin requesting time only if Par concludes with time
`remaining). Mot. 8.
`Lupin argues further that Patent Owner will not be prejudiced by
`joinder because Lupin will not introduce any new prior art, expert
`declarations, or grounds of unpatentability into the joined proceeding. Id.
`at 6.
`
`In light of Lupin’s arguments and representations, Lupin has
`persuaded us that joinder of Lupin to the Par IPR is appropriate under the
`facts of this particular case and will lead to the more efficient resolution of
`the proceedings. Therefore, we grant Lupin’s Motion for Joinder, subject to
`the requirements set forth in the Order below.
`V. Order
`It is ORDERED that Lupin’s Petition for inter partes review of the
`’215 patent (Paper 1) is granted as to the grounds indicated in the Petition;
`
`
`
`6
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`
`
`IPR2016-00284
`Patent 8,404,215 B1
`
`
`FURTHER ORDERED that Lupin’s Motion for Joinder (Paper 4) is
`granted;
`FURTHER ORDERED that Par is joined as a Petitioner to IPR2015-
`01127;
`FURTHER ORDERED that the grounds on which IPR2015-01127
`was instituted are unchanged, and no other grounds are instituted in the
`consolidated proceeding beyond those set forth in IPR2015-01127, Paper 13;
`FURTHER ORDERED that the Scheduling Order in place for
`IPR2015-01127 (Paper 14) shall continue to govern the joined proceeding;
`FURTHER ORDERED that, throughout IPR2015-01127, any paper,
`except for a motion that does not involve the other party, shall be filed by
`Par as a single, consolidated filing on behalf of Par and Lupin, pursuant to
`the page limits set forth in 37 C.F.R. § 42.24, and Par will identify each such
`filing as a consolidated filing;
`FURTHER ORDERED that except as otherwise agreed by all parties,
`counsel for Par will conduct cross-examination and other discovery on
`IPR2015-01127 on behalf of Par and Lupin, and that Patent Owner is not
`required to provide separate discovery responses or additional deposition
`time as a result of the joinder;
`FURTHER ORDERED that IPR2016-00284 is terminated under 37
`C.F.R. § 42.72, and all further filings this proceeding are to be made in
`IPR2015-01127;
`FURTHER ORDERED that a copy of this Decision will be entered
`into the record of IPR2015-01127; and
`
`
`
`7
`
`
`
`IPR2016-00284
`Patent 8,404,215 B1
`
`
`FURTHER ORDERED that the case caption in IPR2015-01127 shall
`be changed to reflect consolidation with this proceeding in accordance with
`the attached example.
`
`
`
`
`For PETITIONER LUPIN:
`Elizabeth J. Holland
`Cynthia Lambert Hardman
`GOODWIN PROCTER LLP
`eholland@goodwinproctor.com
`chardman@goodwinprocter.com
`
`
`For PATENT OWNER:
`
`Robert Green
`Emer Simic
`Jessica Tyrus
`GREEN, GRIFFITH & BORG-BREEN, LLP
`rgreen@greengriffith.com
`esimic@greengriffith.com
`tyrus@greengriffith.com
`
`
`Lauren Stevens
`Dennis Bennett
`GLOBAL PATENT GROUP, LLC
`lstevens@globalpatentgroup.com
`dennisbennett@globalpatentgroup.com
`
`Matthew Phillips (Reg. No. 43,403)
`RENAISSANCE IP LAW GROUP LLP
`matthew.phillips@renaissanceiplaw.com
`
`
`
`
`
`8
`
`
`
`IPR2016-00284
`Patent 8,404,215 B1
`
`For PETITIONER PAR:
`David H. Silverstein: dsilverstein@axinn.com
`Aziz Burgy: aburgy@axinn.com
`
`
`
`
`
`9
`
`
`
`IPR2016-00284
`Patent 8,404,215 B1
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PAR PHARMACEUTICAL, INC.,
`
`and
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS, INC.
`Petitioners,
`
`v.
`
` HORIZON THERAPEUTICS, INC.,
`Patent Owner.
`____________
`
`Case IPR2015-011277
`Patent 8,404,215 B1
`____________
`
`
`
`
`
`7 Case IPR2015-00284, instituted on a petition filed by Lupin Ltd. and Lupin
`Pharmaceuticals, Inc., has been joined with this proceeding.
`10
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`
`
`
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