Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`
`
`Paper 11
`Date: October 24, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`
`MYLAN PHARMACEUTICALS INC., BRECKENRIDGE
`PHARMACEUTICAL, INC., and ALEMBIC PHARMACEUTICALS,
`LTD.,1
`Petitioners,
`
`v.
`
`RESEARCH CORPORATION TECHNOLOGIES, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01101, Case IPR2016-01242, Case IPR2016-01245
`Patent RE38,551 E
`____________
`
`
`Before FRANCISCO C. PRATS, JACQUELINE WRIGHT BONILLA, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`BONILLA, Administrative Patent Judge.
`
`
`
`DECISION
`Granting Institution of Inter Partes Reviews and Motions for Joinder
`35 U.S.C. § 314, 37 C.F.R. §§ 42.108 and 42.122
`
`
`
`
`
`1 Mylan Pharmaceuticals Inc. is Petitioner in Case IPR2016-01101,
`Breckenridge Pharmaceutical, Inc. is Petitioner in Case IPR2016-01242, and
`Alembic Pharmaceuticals, Ltd. is Petitioner in Case IPR2016-01245.
`
`
`571-272-7822
`
`
`
`
`
`
`
`Paper 11
`Date: October 24, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`
`MYLAN PHARMACEUTICALS INC., BRECKENRIDGE
`PHARMACEUTICAL, INC., and ALEMBIC PHARMACEUTICALS,
`LTD.,1
`Petitioners,
`
`v.
`
`RESEARCH CORPORATION TECHNOLOGIES, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01101, Case IPR2016-01242, Case IPR2016-01245
`Patent RE38,551 E
`____________
`
`
`Before FRANCISCO C. PRATS, JACQUELINE WRIGHT BONILLA, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`BONILLA, Administrative Patent Judge.
`
`
`
`DECISION
`Granting Institution of Inter Partes Reviews and Motions for Joinder
`35 U.S.C. § 314, 37 C.F.R. §§ 42.108 and 42.122
`
`
`
`
`
`1 Mylan Pharmaceuticals Inc. is Petitioner in Case IPR2016-01101,
`Breckenridge Pharmaceutical, Inc. is Petitioner in Case IPR2016-01242, and
`Alembic Pharmaceuticals, Ltd. is Petitioner in Case IPR2016-01245.
`
`
`
`IPR2016-01101; IPR2016-01242; IPR2016-01245
`Patent RE38,551 E
`
`I.
`
`INTRODUCTION
`Three Petitioners in the above-captioned cases, Mylan
`Pharmaceuticals, Inc., Breckenridge Pharmaceutical, Inc., and Alembic
`Pharmaceuticals, Ltd. (collectively “the later Petitioners”), each filed a
`Petition requesting an inter partes review of claims 1–13 of U.S. Patent No.
`RE38,551 E (Ex. 1001, “the ’551 patent”). Paper 2 (“Pet.”).2 Along with
`the Petitions, each of the later Petitioners filed a Motion for Joinder in the
`respective cases (see supra note 1) requesting that we join that Petitioner as
`a party to Argentum Pharmaceuticals LLC v. Research Corporation
`Technologies, Inc., IPR2016-00204 (“Argentum IPR”). Paper 3 (“Joinder
`Mot.”).
`As stated in the Motions for Joinder, “Grounds 1–4 of the
`accompanying Petition are practical copies of the grounds presented in the
`petition in IPR2016-00204, including Grounds 3A–3B that were instituted
`by the Board, and challenge the same claims over the same prior art and
`using the same arguments and expert testimony.” Joinder Mot. 1. The
`Motions for Joinder specify that “Petitioner requests joinder only as to
`Grounds 3A–3B, and not as to Grounds 1A–1B, 2A–2B, or 4A–4B” in the
`Petitions. Id. Thus, in all three cases, the Petitions only challenge claims
`based on grounds that “are practical copies of already instituted grounds” in
`the Argentum IPR. Id. at 1–2.
`
`
`2 Citations are to IPR2016-01101 as representative of corresponding papers
`in the three cases unless otherwise indicated.
`2
`
`
`
`
`
`IPR2016-01101; IPR2016-01242; IPR2016-01245
`Patent RE38,551 E
`
`II. DISCUSSION
`A. The Petition
`As authorized by the Board (Paper 7), Research Corporation
`Technologies, Inc. (“Patent Owner”) filed an Abbreviated Preliminary
`Response and Opposition to Petitioner’s Motion for Joinder. Paper 8. In
`that paper, Patent Owner contends that Petitions filed by all three later
`Petitioners should be denied as to asserted Grounds 1A, 1B, 2A, 2B, 4A, and
`4B. Id. at 2–3. In view of our prior Decision to Institute in the Argentum
`IPR (IPR2016-00204, Paper 19, “Inst. Dec.”), as well as statements by the
`later Petitioners that they each intend to pursue only Grounds 3A–3B as
`instituted in the Argentum IPR (Joinder Mot. 1–2), we agree. We deny the
`later Petitions as to those grounds.
`In relation to Grounds 3A–3B, Patent Owner points to In re Magnum
`Oil Tools (“Magnum Oil”), an opinion by the Federal Circuit that issued
`after we instituted trial in the Argentum IPR. In re Magnum Oil Tools Int’l,
`Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016) (“In an inter partes review, the
`burden of persuasion is on the petitioner to prove ‘unpatentability by a
`preponderance of the evidence,’ 35 U.S.C. § 316(e), and that burden never
`shifts to the patentee.” (quoting Dynamic Drinkware, LLC v. Nat’l Graphics,
`Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015))).
`Citing Magnum Oil, Patent Owner argues that “the prior art on which
`Petitioner relies in Grounds 3A and 3B fails to disclose a ‘therapeutic
`composition’ as construed by the Board, and as required by claim 10 of the
`’551 patent.” Paper 8, 5. According to Patent Owner, because the “burden
`of production never shifts from the Petitioner” and “Petitioner cannot cure
`its failure of proof in its Reply,” Petitioner “has not—and cannot—meet its
`
`
`
`3
`
`
`
`IPR2016-01101; IPR2016-01242; IPR2016-01245
`Patent RE38,551 E
`
`burden of proving unpatentability of the claims.” Id. at 5–6. Specifically,
`Patent Owner argues that the later Petitioners fail to establish sufficiently
`that an ordinary artisan “would have selected any functionalized amino acid
`(‘FAA’) as a lead compound, much less selected Compound 3l in Kohn
`1991 over other FAAs, including similarly potent FAAs, given Compound
`3l’s ‘synthetic and stability issues.’” Id. at 6 (footnote omitted).
`We squarely addressed Patent Owner’s position in this regard in our
`Decision to Institute in the Argentum IPR. Inst. Dec. 16–19. Patent
`Owner’s citation to Magnum Oil does not persuade us to come to a different
`result now. When instituting trial in the Argentum IPR, we understood that
`Petitioner would have the ultimate burden of persuasion during the trial to
`show by a preponderance of the evidence that the challenged claims were
`unpatentable. Nonetheless, at the institution stage, we were persuaded that
`there was “a reasonable likelihood that the petitioner would prevail with
`respect to at least 1 of the claims challenged in the petition,” as required
`under 35 U.S.C. § 314(a). For the same reasons stated in our prior
`Institution Decision (Inst. Dec. 16–19), we are persuaded that there is a
`reasonable likelihood that the later Petitioners would prevail in their
`challenges of claims 1–9 as obvious over Kohn 1991 and Silverman.
`In relation to claim 10, Patent Owner also points to where we adopt a
`district court’s claim construction (Ex. 1007, 5) of the term “therapeutic
`composition” in the preamble, i.e., where we interpret the term to be limiting
`and to mean “suitable for use as a treatment regimen over an extended
`period of time (chronic administration).” Inst. Dec. 8; Paper 8, 8–9.
`Referring to that claim construction, Patent Owner argues that the later
`Petitioners fail to address this “key limitation of claim 10,” and have not
`
`
`
`4
`
`
`
`IPR2016-01101; IPR2016-01242; IPR2016-01245
`Patent RE38,551 E
`
`shown that an ordinary artisan would have reasonably expected to achieve a
`therapeutic composition as claimed. Paper 8, 9–10. For instance, according
`to Patent Owner, “[n]o liver toxicity data, which would indicate to a [person
`of ordinary skill in the art] whether a composition is suitable for chronic
`administration, appeared in the prior art for any” relevant compound. Id. at
`10.
`
`As we stated in the Argentum IPR regarding claims 10–13, “[b]ased
`on the record before us, Petitioner provides adequate reasoning, with
`sufficient rational underpinning, for its contention that an ordinary artisan
`would have had reason to expect ‘that compounds falling within claim 132
`of the ’729 patent—such as racemic lacosamide and R-lacosamide—would
`be useful for treating CNS disorders, and would have a reasonable
`expectation of success in using them for this purpose.’” Inst. Dec. 21
`(quoting IPR2016-00204, Pet. 34 (citing Ex. 1002 ¶ 80; Ex. 1009, 3:9–17,
`claim 132)). The later Petitioners similarly argue that the ’729 patent
`discloses pharmaceutical compositions “useful in the treatment of epilepsy
`and other CNS disorders.” Pet. 31 (quoting Ex. 1009, 3:9–17); Inst. Dec.
`20–21 (citing IPR2016-00204, Pet. 34).
`Our rationale for including claim 10 in the instituted grounds in the
`Argentum IPR applies in these cases also. We are not persuaded otherwise
`by Patent Owner’s suggestion that the absence of liver toxicity data is
`dispositive. We leave it for trial as to the ultimate determination whether a
`compound “useful in the treatment of epilepsy and other CNS disorders,” as
`disclosed in the ’729 patent (Ex. 1009, 3:9–17, claim 132), corresponds to a
`“therapeutic composition.”
`
`
`
`5
`
`
`
`IPR2016-01101; IPR2016-01242; IPR2016-01245
`Patent RE38,551 E
`
`
`We incorporate our previous analysis regarding Grounds 3A–3B in
`the Petitions in the above-captioned case, and conclude that the later
`Petitioners have demonstrated a reasonable likelihood of prevailing on those
`grounds asserted in the Petitions for the same reasons. See Inst. Dec. 12–24.
`B. Motions for Joinder
`Based on authority delegated to us by the Director, we have discretion
`to join a party to another inter partes review, subject to certain exceptions
`not present here. See 35 U.S.C. § 315(c); 37 C.F.R. § 42.122. As the
`moving party, Petitioner has the burden of proof in establishing entitlement
`to the requested relief. 37 C.F.R. §§ 42.20(c), 42.122(b). A motion for
`joinder should: (1) set forth the reasons why joinder is appropriate;
`(2) identify any new ground(s) of unpatentability asserted in the petition; (3)
`explain what impact (if any) joinder would have on the trial schedule for the
`existing review; and (4) address how briefing and/or discovery may be
`simplified to minimize schedule impact. See Joinder Mot. 3; Kyocera Corp.
`v. SoftView LLC, Case IPR2013-00004, slip op. at 4 (PTAB Apr. 24, 2013)
`(Paper 15) (representative); Frequently Asked Question H5 on the Board’s
`website at http://www.uspto.gov/ip/boards/bpai/prps.jsp.
`Here, the later Petitioners contend, and Patent Owner does not
`dispute, that the Petitions are “practical copies of the grounds presented in
`the petition in IPR2016-00204, . . . and challenge the same claims over the
`same prior art and using the same arguments and expert testimony.” Joinder
`Mot. 1, 4–6; Paper 8, 1. The later Petitioners further contend that they each
`intend to pursue only Grounds 3A–3B, as instituted in the Argentum IPR.
`Joinder Mot. 1. In addition, they state that each later Petitioner will
`
`
`
`6
`
`
`
`IPR2016-01101; IPR2016-01242; IPR2016-01245
`Patent RE38,551 E
`
`participate “in the proceeding in a limited capacity as an understudy” to
`Petitioner in the Argentum IPR. Id. at 2.
`Based on the above, the later Petitioners argue that joinder is
`“appropriate because it will promote the just, speedy, and inexpensive
`resolution of patentability issues, including the determination of validity of
`the challenged claims of the ’551 patent,” and potentially minimize issues
`and resolve any litigation regarding the challenged claims. Id. at 5. In
`addition, the later Petitioners contend no new grounds are presented, and
`granting joinder will not prejudice Patent Owner or Petitioner in IPR2016-
`00204, Argentum Pharmaceuticals LLC (“Argentum”), or significantly
`affect the trial schedule in the case. Id. at 4–7.
`Lastly, the later Petitioners indicate that discovery and briefing can be
`simplified here because, in their understudy role, “as long as Argentum
`remains a party” (i.e., does not reach a settlement with Patent Owner), each
`of the later Petitioners “will not submit any separate filings unless it
`disagrees with Argentum’s position (which it is not anticipated), and in the
`event of such disagreement it will request authorization from the Board to
`submit a short separate filing directed only to points of disagreement with
`Argentum.” Id. at 7. As long as Argentum remains a party, the later
`Petitioners will not seek to submit any new declarations or request any
`additional depositions or time during depositions. Id. at 8.
`Given that the later Petitioners agree to be limited to an “understudy”
`role, and limited to evidence and arguments presented in the Argentum
`Petition in relation to instituted Grounds 3A–3B, we conclude all later
`Petitioners have demonstrated that joinder will not unduly complicate or
`
`
`
`7
`
`
`
`IPR2016-01101; IPR2016-01242; IPR2016-01245
`Patent RE38,551 E
`
`delay the Argentum IPR. Thus, we grant the later Petitioners’ Motions for
`Joinder and, as a result, join those parties to the Argentum IPR.
`III. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that inter partes reviews are instituted in Case IPR2016-
`01101, Case IPR2016-01242, and Case IPR2016-01245 as to claims 1–13 of
`the ’551 patent, but only based on the same grounds instituted in Case
`IPR2016-00204;
`FURTHER ORDERED that each of the later Petitioner’s Motion for
`Joinder is granted, and the later Petitioners are joined as parties to Case
`IPR2016-00204;
`FURTHER ORDERED that the grounds on which an inter partes
`review were instituted in Case IPR2016-00204 remain unchanged, and no
`other grounds are instituted in the joined proceedings;
`FURTHER ORDERED that Case IPR2016-01101, Case IPR2016-
`01242, and Case IPR2016-01245 are instituted, joined, and terminated under
`37 C.F.R. § 42.72, and all further filings in the joined proceedings shall be
`made in Case IPR2016-00204;
`FURTHER ORDERED that the Scheduling Order entered in Case
`Case IPR2016-00204 (Paper 20) shall govern the schedules of the joined
`proceedings;
`FURTHER ORDERED that the participation by the later Petitioners
`in the briefing, depositions, and oral argument of the joined proceedings
`shall be subject to Argentum’s acquiescence to their participation and,
`absent our express authorization, the later Petitioners shall not file papers or
`exhibits apart from Argentum;
`
`
`
`8
`
`
`
`IPR2016-01101; IPR2016-01242; IPR2016-01245
`Patent RE38,551 E
`
`
`FURTHER ORDERED that the case caption in Case IPR2016-00204
`shall be changed to reflect the joinder with this proceeding in accordance
`with the attached example; and
`FURTHER ORDERED that a copy of this Decision be entered into
`the files of Case IPR2016-00204, Case IPR2016-01101, Case IPR2016-
`01242, and Case IPR2016-01245.
`
`
`
`9
`
`
`
`IPR2016-01101; IPR2016-01242; IPR2016-01245
`Patent RE38,551 E
`
`
`PETITIONER (IPR2016-00204):
`Matthew J. Dowd
`Justin W. Crotty
`ANDREWS KURTH LLP
`matthewdowd@andrewskurth.com
`justincrotty@andrewskurth.com
`
`PETITIONER (IPR2016-01101):
`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`WILSON SONSINI GOODRICH & ROSATI
`sparmalee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`
`PETITIONER (IPR2016-01242):
`Matthew L. Fedowitz
`Daniel R. Evans
`MERCHANT & GOULD P.C.
`mfedowitz@merchantgould.com
`devans@merchantgould.com
`
`PETITIONER (IPR2016-01245):
`Gary J. Speier
`Jeffer Ali
`CARLSON, CASPERS, VANDENBURGH,
`LINDQUIST & SCHUMAN, P.A.
`gspeier@carlsoncaspers.com
`JAli@carlsoncaspers.com
`
`
`
`
`
`
`10
`
`
`
`IPR2016-01101; IPR2016-01242; IPR2016-01245
`Patent RE38,551 E
`
`PATENT OWNER:
`Andrea G. Reister
`Jennifer L. Robbins
`Enrique D. Longton
`COVINGTON & BURLING LLP
`areister@cov.com
`jrobbins@cov.com
`rlongton@cov.com
`
`
`
`
`11
`
`
`
`Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`
`
`Paper 11
`Date: October 24, 2016
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ARGENTUM PHARMACEUTICALS LLC, MYLAN
`PHARMACEUTICALS INC., BRECKENRIDGE PHARMACEUTICAL,
`INC., and ALEMBIC PHARMACEUTICALS, LTD.,
`Petitioners,
`
`v.
`
`RESEARCH CORPORATION TECHNOLOGIES, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-002041
`Patent RE38,551 E
`____________
`
`
`
`
`
`
`
`1 Case IPR2016-01101, Case IPR2016-01242, and Case IPR2016-01245
`have been joined with this proceeding.
`
`
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