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` Paper 32
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` Entered: June 8, 2016
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`Trials@uspto.gov
`571-272-7822
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`HORIZON THERAPEUTICS, INC.,1
`Patent Owner.
`
`
`Case IPR2016-00283
`Patent 8,642,012 B2
`
`
`
`Before TONI R. SCHEINER, DEBORAH KATZ, and
`GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`SCHEINER, 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)
`
`
`
`
`
`
`
`1 Formerly known as Hyperion Therapeutics, Inc. Paper 9, 1.
`
`
`
`IPR2016-00283
`Patent 8,642,012 B2
`
`
`I. INTRODUCTION
`Lupin Ltd. and Lupin Pharmaceuticals Inc. (collectively, “Lupin” or
`“Petitioner”) filed a Petition (Paper 1, “Pet.”) on December 4, 2015,
`requesting an inter partes review of claims 1–12 of U.S. Patent No.
`8,642,012 B2 (Ex. 1001, “the ’012 patent”). With its Petition, Lupin timely
`filed a Motion for Joinder (Paper 4, “Mot.”), pursuant to 35 U.S.C. § 315(c)
`and 37 C.F.R. §§ 42.22 and 42.122(b), seeking to join this proceeding with
`Par Pharmaceutical, Inc. v. Horizon Therapeutics, Inc., Case IPR2015-
`01117 (“the Par IPR”), which was instituted on November 4, 2015. Horizon
`Therapeutics, Inc. (“Patent Owner”) did not file a Preliminary Response or
`an opposition to the Motion for Joinder.
`In the Motion for Joinder, Lupin confirms that it seeks review of the
`same claims at issue in the Par IPR, based solely on the grounds of
`unpatentability authorized by the Board in the Par IPR. Mot. 4. The
`petitioner in the Par IPR has not filed an opposition to Lupin’s request for
`joinder.
`For the reasons that follow, we institute an inter partes review of
`claims 1–12 of the ’012 patent based on the same grounds instituted in the
`Par IPR. We also grant the Motion for Joinder subject to the conditions
`discussed below.
`The Scheduling Order in place in the Par IPR shall govern the joined
`proceedings. Par IPR, Paper 14.
`
`2
`
`
`
`
`IPR2016-00283
`Patent 8,642,012 B2
`
`
`A. Additional Related Proceedings
`Patent Owner filed suit against Petitioner, alleging infringement of the
`’012 patent, in Horizon Therapeutics, Inc. v. Lupin Ltd., Case No. 1:15-cv-
`07624-RBK-JS (D. N.J. filed Oct. 19, 2015). Pet. 7; Paper 9, 2. In addition,
`concurrently with the Petition under consideration here, Lupin filed a
`petition challenging the claims of Horizon’s U.S. Patent 8,404,215 B1
`(IPR2016-00284), but represents that that patent is not related to the ’012
`patent. Pet. 8.
`Patent Owner also filed suit against Par, alleging infringement of the
`’012 patent in Hyperion Therapeutics Inc. v. Par Pharmaceutical, Inc., Case
`No. 14-cv-00384-JRG-RSP (E.D. Tex. Filed April 23, 2014).”2 Pet. 7;
`Paper 9, 2.
`
`II. ANALYSIS
`
`A. Instituting Review of Claims 1–12 of the ’012 Patent
`We first address whether the Petition warrants review—only then do
`
`we address whether joinder is appropriate. See 35 U.S.C. § 315(c) (joinder
`provision, relating to inter partes reviews, requires, as an initial matter, a
`determination that the petition accompanying the joinder motion warrants
`institution of review). We have jurisdiction under 35 U.S.C. § 314, which
`provides that review may be authorized only if “the information presented in
`
`
`2 Patent Owner represents that “the district court stayed that case pending
`resolution of IPR2015-01117 and IPR2015-01127.” Paper 9, 2.
`3
`
`
`
`
`IPR2016-00283
`Patent 8,642,012 B2
`
`the petition . . . and any [preliminary] response . . . shows that 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).
`
`In the Par IPR, we instituted review of claims 1–12 of the ’012 patent
`on the following grounds.
`
`References
`
`Basis Claims Challenged
`
`Brusilow ’91,3 Sherwin,4 Comte,5
`and Shiple6
`
`§ 103
`
`1, 3, 4, 7, 8, 10, 12
`
`
`3 Saul W. Brusilow, Phenylacetylglutamine May Replace Urea as a Vehicle
`for Waste Nitrogen Excretion, 29 PEDIATRIC RESEARCH 147–150 (1991)
`(“Brusilow ’91”) (Ex. 1012).
`4 Carl P. Sherwin at al., The Maximum Production of Glutamine by the
`Human Body as Measured by the Output of Phenylacetylglutamine, 37 J.
`BIOL. CHEM. 113–119 (1919) (“Sherwin”) (Ex. 1016).
`5 Blandine Comte et al., Identification of phenylbutyrylglutamine, a new
`metabolite of phenylbutyrate metabolism in humans, 37 J. MASS SPECTROM.
`581–590 (2002) (“Comte”) (Ex. 1025).
`6 George J. Shiple & Carl P. Sherwin, Synthesis of Amino Acids in Animal
`Organisms. I. Synthesis of Glycocoll and Glutamine in the Human
`Organism, 44 J. AMER. CHEM. SOC. 618–624 (1922) (“Shiple”) (Ex. 1017).
`4
`
`
`
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`IPR2016-00283
`Patent 8,642,012 B2
`
`
`References
`
`Basis Claims Challenged
`
`Brusilow ’91 , Sherwin, Shiple,
`and Fernandes7
`Brusilow ’91, Sherwin, Shiple,
`and the ’647 patent8
`
`§ 103
`
`5
`
`§ 103
`
`2, 9
`
`6, 11
`
`§ 103
`
`Brusilow ’91, Sherwin, Shiple,
`Kasumov,9 and the ’979 patent10
`
`
`The Instant Petition challenges the same claims of the ’012 patent as
`
`those we instituted on in the Par IPR, based on the same asserted prior art,
`and four proposed grounds of unpatentability that are substantially identical
`to the four grounds instituted in the Par IPR. Compare Pet. 15–36, with the
`Par IPR, Paper 2 (the “Par Pet.”), 15–36.
`Moreover, the present Petition involves the same arguments and
`evidence—including the same witness declaration—that supported our
`
`
`7 INBORN METABOLIC DISEASES: DIAGNOSIS AND TREATMENT 219–220
`(John Fernandes et al. eds., Springer Verlag 3d ed. 2000) (“Fernandes”)
`(Ex. 1011).
`8 U.S. Patent No. 4,284,647, issued August 18, 1981 to Brusilow et al. (“the
`’647 patent”) (Ex. 1018).
`9 Takhar Kasumov et al., New Secondary Metabolites of Phenylbutyrate in
`Humans and Rats, 32 DRUG METABOLISM AND DISPOSITION 10–19 (2004)
`(“Kasumov”) (Ex. 1015).
`10 U.S. Patent No. 5,968,979, issued October 19, 1999 to Brusilow (“the 979
`patent”) (Ex. 1026).
`
`5
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`IPR2016-00283
`Patent 8,642,012 B2
`
`decision to institute review in the Par IPR.11 Compare Pet. 10–12, 15–36,
`with Par Pet. 9–12, 15–36.
`We previously determined, upon consideration of Par Petition and
`Horizon’s Preliminary Response thereto, that the record in the Par IPR
`established a reasonable likelihood that Par would prevail with respect to
`claims 1–12 on the grounds outlined above. Par IPR, Paper 13, 21. Given
`the substantially identical grounds and evidence presented in the present
`proceeding, we likewise determine that Lupin’s Petition warrants institution
`on the grounds presented. We rely on, and incorporate by reference, the
`reasoning set forth in our Decision on Institution in the Par IPR, and institute
`an inter partes review of the challenged claims based on the same grounds
`authorized, and for the same reasons discussed, in our decision to institute
`the Par IPR. See id. at 11–19 (reflecting reasons for instituting review).
`
`B. Granting Motion for Joinder
`Lupin timely filed its Motion for Joinder on December 4, 2015,
`within one month of the institution of the Par IPR, as required by 37
`C.F.R. § 42.122(b). We note that Lupin represents that neither Patent
`Owner nor Par opposes joining the proceedings. Mot. 1.
`
`
`11 Lupin supports its challenge with a Declaration, executed April 29, 2015,
`by Neal Sondheimer, M.D., Ph.D (“Sondheimer Declaration” (Ex. 1002),
`and represents that this is “the same expert declaration of Dr. Sondheimer
`that Par submitted in [the Par IPR].” Mot. 4–5.
`6
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`IPR2016-00283
`Patent 8,642,012 B2
`
`
`An inter partes review may be joined with another inter partes
`review, subject to the provisions of 35 U.S.C. § 315(c), which
`provides:
`(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.
`By regulation, the Director’s discretion has been delegated to
`
`the Board. 37 C.F.R. § 42.4(a).
`As the moving party, Lupin bears the burden of proving that it
`is entitled to the requested relief. 37 C.F.R. § 42.20(c). A motion for
`joinder should (1) set forth the reasons joinder is appropriate; (2)
`identify any new grounds of unpatentability asserted in the petition;
`and (3) explain what impact (if any) joinder would have on the trial
`schedule for the existing review. See “Frequently Asked Questions
`H5,” http://www.uspto.gov/ip/boards/bpai/prps.jsp.
`Lupin argues that joinder is appropriate because it will promote the
`efficient and consistent resolution of issues of patentability of the ’012
`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
`
`7
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`IPR2016-00283
`Patent 8,642,012 B2
`
`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-
`examination of any witnesses (with Lupin participating only if time allows),
`and present oral argument (with Lupin requesting time only if Par concludes
`with time remaining). Id. at 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, we are persuaded
`that joinder of Lupin to the Par IPR is appropriate, and will lead to the more
`efficient resolution of the proceedings. We are satisfied that joinder will not
`unduly complicate or delay the proceedings. For these reasons, we grant
`Lupin’s Motion for Joinder, subject to the requirements set forth in the Order
`below.
`
`III. CONCLUSION
`Having considered the information presented in the Petition, we
`institute an inter partes review of claims 1–12 of the ’012 patent based on
`the same grounds instituted in the Par IPR. We also grant Lupin’s Motion
`for Joinder.
`
`8
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`IPR2016-00283
`Patent 8,642,012 B2
`
`
`IV. ORDER
`
`It is
`ORDERED that pursuant to 35 U.S.C. § 314(a), an inter partes
`review is instituted as to claims 1–12 of U.S. Patent No. 8,642,012 B2 on the
`following grounds of unpatentability:
`Claims 1, 3, 4, 7, 8, 10, and 12 under 35 U.S.C. § 103 as unpatentable
`over Brusilow ’91, Sherwin, Comte, and Shiple;
`claim 5 under 35 U.S.C. § 103 as unpatentable over Brusilow ’91,
`Sherwin, Shiple, and Fernandes;
`claims 2 and 9 under 35 U.S.C. § 103 as unpatentable over Brusilow
`’91, Sherwin, Shiple, and the ’647 patent; and
`claims 6 and 11 under 35 U.S.C. § 103 as unpatentable over Brusilow
`’91, Sherwin, Shiple, Kasumov, and the ’979 patent.
`It is
`FURTHER ORDERED that Lupin’s Motion for Joinder (Paper 4) is
`granted;
`FURTHER ORDERED that Par is joined as a Petitioner to IPR2015-
`01117;
`FURTHER ORDERED that the grounds on which IPR2015-01117
`was instituted are unchanged, and no other grounds are instituted in the
`consolidated proceeding beyond those set forth in IPR2015-01117, Paper 13;
`FURTHER ORDERED that the Scheduling Order in place for
`IPR2015-01117 (Paper 14) shall continue to govern the joined proceeding;
`
`9
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`IPR2016-00283
`Patent 8,642,012 B2
`
`
`FURTHER ORDERED that, throughout IPR2015-01117, 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
`IPR2015-01117 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 IPR2016-00283 is terminated under
`37 C.F.R. § 42.72, and all further filings this proceeding are to be made in
`IPR2015-01117;
`FURTHER ORDERED that a copy of this Decision will be entered
`into the record of IPR2015-01117; and
`FURTHER ORDERED that the case caption in IPR2015-01117 shall
`be changed to reflect consolidation with this proceeding in accordance with
`the attached example.
`
`
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`
`
`
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`10
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`IPR2016-00283
`Patent 8,642,012 B2
`
`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
`
`For PETITIONER PAR:
`David H. Silverstein: david.silverstein@axinn.com
`Aziz Burgy: aburgy@axinn.com
`
`
`
`
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`11
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`IPR2016-00283
`Patent 8,642,012 B2
`
`
`
`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 IPR2015-0111712
`Patent 8,642,012 B2
`____________
`
`
`
`
`
`
`12 Case IPR2015-00283, instituted on a petition filed by Lupin Ltd. and
`Lupin Pharmaceuticals, Inc., has been joined with this proceeding.
`
`
`12
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`
`
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