Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`Paper 21
`Entered: April 1, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`DR. REDDY’S LABORATORIES, INC.,
`Petitioner
`v.
`HORIZON PHARMA USA, INC. and NUVO PHARMACEUTICALS
`(IRELAND) DESIGNATED ACTIVITY COMPANY,
`Patent Owners.
`_______________
`
`Case IPR2018-01341
`Patent 9,393,208 B2
`_______________
`
`
`Before TONI R. SCHEINER, MICHELLE N. ANKENBRAND, and
`DEBRA L. DENNETT, Administrative Patent Judges.
`
`DENNETT, Administrative Patent Judge.
`
`
`
`DECISION
`Granting Petitioner’s Motion for Joinder and
`Instituting Inter Partes Review
`35 U.S.C. § 314(a); 37 C.F.R. § 42.122
`
`
`
`
`
`Tel: 571-272-7822
`
`
`
`
`Paper 21
`Entered: April 1, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`DR. REDDY’S LABORATORIES, INC.,
`Petitioner
`v.
`HORIZON PHARMA USA, INC. and NUVO PHARMACEUTICALS
`(IRELAND) DESIGNATED ACTIVITY COMPANY,
`Patent Owners.
`_______________
`
`Case IPR2018-01341
`Patent 9,393,208 B2
`_______________
`
`
`Before TONI R. SCHEINER, MICHELLE N. ANKENBRAND, and
`DEBRA L. DENNETT, Administrative Patent Judges.
`
`DENNETT, Administrative Patent Judge.
`
`
`
`DECISION
`Granting Petitioner’s Motion for Joinder and
`Instituting Inter Partes Review
`35 U.S.C. § 314(a); 37 C.F.R. § 42.122
`
`
`
`
`
`
`IPR2018-01341
`Patent 9,393,208 B2
`
`
`I. INTRODUCTION
`Dr. Reddy’s Laboratories, Inc. (“Dr. Reddy’s” or “Petitioner”) filed a
`Petition (Paper 2, “Pet.”) on July 2, 2018, requesting an inter partes review
`of claims 1–7 of U.S. Patent No. 9,393,208 B2 (Ex. 1001, “the ’208 patent”).
`Concurrently with the Petition, Dr. Reddy’s filed a Motion for Joinder
`(Paper 3, “Mot.”) to the inter partes review in Mylan Pharms. Inc. v.
`Horizon Pharma USA, Inc., Case IPR2018-00272 (the “Mylan IPR” and
`Petitioner “Mylan”), an ongoing inter partes review, which we instituted on
`June 14, 2018. See IPR2018-00272, Paper 9. On August 31, 2018 (prior to
`the due date for Patent Owners’ Preliminary Response), we stayed the
`proceeding because one of the owners of the ’208 patent filed a bankruptcy
`petition.1 Paper 10. The bankruptcy court entered a sale order on December
`27, 2018, which lifted the stay of this proceeding. Mylan IPR, Ex. 1051.
`Horizon Pharma USA, Inc. and Nuvo Pharmaceuticals (Ireland) Designated
`Activity Company (“Patent Owners”) filed a Preliminary Response to the
`Petition on January 31, 2019. Paper 15 (“Prelim. Resp.”). Patent Owners
`did not file an opposition to the joinder motion.
`In the Motion for Joinder, Dr. Reddy’s confirms that it seeks review
`of the same claims at issue in the Mylan IPR, based solely on the grounds of
`unpatentability we instituted in the Mylan IPR. Mot. 1. Dr. Reddy’s
`commits to rely on the declarations and testimony of Mylan’s experts. Id.
`
`
`1 Pozen Inc. and Horizon Pharma USA, Inc. were the patent owners at the
`time the Petition was filed. See Paper 5. Nuvo Pharmaceuticals (Ireland)
`Limited acquired Pozen Inc.’s rights in the ’208 patent in September 2018.
`Mylan IPR, Ex. 1052.
`
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`IPR2018-01341
`Patent 9,393,208 B2
`
`We have authority to determine whether to institute an inter partes
`review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(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 Dr. Reddy’s 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 Mylan IPR, Paper 9. Thus, as we explain
`below, we institute an inter partes review of claims 1–7 of the ’208 patent
`on the same grounds we instituted in the Mylan IPR. We also grant the
`Motion for Joinder subject to the conditions discussed below.
`The Scheduling Order in place in the Mylan IPR shall govern. Mylan
`IPR, Paper 27.
`
`A. Additional Related Proceedings
`Dr. Reddy’s identifies the following pending litigation related to the
`’208 patent: Horizon Pharma, Inc. v. Dr. Reddy’s Labs., Inc., No. 15-3324
`(D.N.J.); Horizon Pharma, Inc. v. Dr. Reddy’s Labs., Inc., No. 16-4918
`(D.N.J.); Horizon Pharma, Inc. v. Dr. Reddy’s Labs., Inc., No. 16-9035
`(D.N.J.); Horizon Pharma, Inc. v. Mylan Pharms. Inc., No. 15-3327
`(D.N.J.); Horizon Pharma, Inc. v. Mylan Pharms. Inc., No. 16-4921
`(D.N.J.); and Horizon Pharma, Inc. v. Lupin Ltd., No. 16-4920 (D.N.J.).
`Pet. 2.
`
`II. ANALYSIS
`A. Instituting Review of Claims 1–7 of the ’208 Patent
`
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`IPR2018-01341
`Patent 9,393,208 B2
`
`We address whether joinder is appropriate only after determining that
`the Petition warrants review. 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 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 Mylan IPR, we instituted review of claims 1–7 of the ’208
`patent on the following grounds:
`
`Reference[s]
`’285 patent2
`
`’285 patent
`
`Statutory Basis
`§ 102(e)
`
`§ 103
`
`’285 patent, EC-Naprosyn
`label3, and Howden 20054
`
`§ 103
`
`Claims challenged
`1–7
`
`1–7
`
`1–7
`
`The Instant Petition challenges the same claims of the ’208 patent as
`those we instituted in the Mylan IPR, based on the same asserted prior art,
`
`
`2 U.S. Patent 8,557,285 B2, filed Aug. 23, 2011, issued Oct. 15, 2013 to
`John R. Plachetka (Ex. 1005, “the ’285 patent”).
`3 Prescription Drug Label for EC-Naprosyn® and other Naprosyn®
`formulations (Ex. 1009, “EC-Naprosyn label”).
`4 C.W. Howden, Review article: immediate-release proton-pump inhibitor
`therapy–potential advantages, 22 ALIMENT. PHARMACOL. THER. 25–30
`(2005) (Ex. 1006, “Howden 2005”).
`
` 4
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`IPR2018-01341
`Patent 9,393,208 B2
`
`and three proposed grounds of unpatentability that are identical to the three
`grounds instituted in the Mylan IPR. Compare Pet. 3-4, with the Mylan IPR,
`Paper 2 (the “Mylan Pet.”), 32–60.
`Dr. Reddy’s relies on the same declarations that Mylan submitted in
`the Mylan IPR. See Pet. 4. Therefore, Dr. Reddy’s Petition relies on the
`same arguments and evidence—including the same witness declarations—
`that supported our decision to institute review in the Mylan IPR. Compare
`Pet. 4, with Mylan Pet. 3, 17–60.
`Patent Owners’ Preliminary Response raises the same arguments
`against institution that Patent Owners raised in the Mylan IPR, except that
`Patent Owners additionally argue that we should deny the Petition because
`the district court in the co-pending litigation determined that the claims of
`the ’208 patent are invalid as indefinite. Compare Mylan IPR, Paper 7, with
`Prelim. Resp. 9–16; see Prelim. Resp. 6–9.
`We previously determined, upon consideration of Mylan’s Petition
`and Patent Owners’ Preliminary Response thereto, that the record in the
`Mylan IPR established a reasonable likelihood that Mylan would prevail
`with respect to claims 1–7 on the grounds outlined above. Mylan IPR, Paper
`9. Given the identical grounds and evidence presented in the present
`proceeding, we likewise determine that Dr. Reddy’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 Mylan
`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 Mylan IPR. See id. at 15–24 (reflecting reasons for
`instituting review). As to Patent Owners’ argument that we should deny
`
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`IPR2018-01341
`Patent 9,393,208 B2
`
`institution based on the district court’s invalidity determination, we find that
`argument moot in view of our decision denying Patent Owners’ motion to
`terminate this proceeding for the same reason. Paper 20.
`B. Granting Motion for Joinder
`Dr. Reddy’s timely filed its Motion for Joinder on July 2, 2018, within
`one month of the institution of the Mylan IPR, as required by 37 C.F.R.
`§ 42.122(b). Patent Owners have not opposed joining Dr. Reddy’s as a
`Petitioner to the Mylan IPR.
`A Petitioner in an inter partes review may be joined as a party to
`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, Dr. Reddy’s 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 that joinder is appropriate;
`(2) identify any new grounds 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 specifically how briefing and discovery
`may be simplified. See “Frequently Asked Questions H5,”
`
` 6
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`IPR2018-01341
`Patent 9,393,208 B2
`
`https://www.uspto.gov/patents-application-process/patent-trial-and-appeal-
`board/ptab-e2e-frequently-asked-questions#H5.
`Dr. Reddy’s represents that it raises only those patentability issues
`that already are before us in the Mylan IPR. Mot. 5–6. Dr. Reddy’s also
`represents that it relies on the same declarations Mylan submitted in the
`Mylan IPR. Id. at 1. In light of the substantial identity of Dr. Reddy’s
`Petition and Mylan’s Petition, we agree that Dr. Reddy’s raises no new
`grounds of unpatentability or issues.
`Dr. Reddy’s also argues that joinder will not affect the schedule of the
`Mylan IPR. Id. at 6. Dr. Reddy’s agrees to a passive role, explaining that it
`will not (1) file additional papers, (2) file additional pages to Mylan’s
`papers, (3) present any new, additional, or supplemental arguments,
`(4) cross-examine Patent Owners’ experts or attempt to offer a rebuttal
`expert of its own, and (5) present any arguments at oral hearing. Id. at 7.
`Dr. Reddy’s will cease its passive role only if Mylan ceases to participate in
`the proceeding. Id.
`In light of Dr. Reddy’s arguments and representations, we are
`persuaded that it is appropriate to join Dr. Reddy’s as a Petitioner to the
`Mylan IPR, and that joinder 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 Dr. Reddy’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 1–7 of the ’208 patent based on the
`
` 7
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`IPR2018-01341
`Patent 9,393,208 B2
`
`same grounds instituted in the Mylan IPR. We also grant Dr. Reddy’s
`Motion for Joinder.
`
`IV. ORDER
`
`It is
`ORDERED that pursuant to 35 U.S.C. § 314(a), an inter partes
`review is instituted as to:
`Claims 1–7 of the ’208 patent under 35 U.S.C § 102(e) as anticipated
`by the ’285 patent;
`Claims 1–7 of the ’208 patent under 35 U.S.C § 103 as obvious over
`the ’285 patent; and
`Claims 1–7 of the ’208 patent under 35 U.S.C § 103 as obvious over
`the combination of the ’285 patent, the EC-Naprosyn label, and Howden
`2005;
`
`FURTHER ORDERED that Dr. Reddy’s Motion for Joinder (Paper 3)
`is granted;
`FURTHER ORDERED that Dr. Reddy’s is joined as a Petitioner to
`IPR2018-00272;
`FURTHER ORDERED that the grounds on which IPR2018-00272
`was instituted are unchanged, and no other grounds are instituted in the
`consolidated proceeding beyond those set forth in IPR2018-00272, Paper 9;
`FURTHER ORDERED that the Scheduling Order in place for
`IPR2018-00272 (Paper 27) shall continue to govern the joined proceeding;
`FURTHER ORDERED that, throughout IPR2018-00272, any paper,
`except for a motion that does not involve the other party, shall be filed by
`Mylan as a single, consolidated filing on behalf of Mylan and Dr. Reddy’s,
`
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`IPR2018-01341
`Patent 9,393,208 B2
`
`pursuant to the page limits set forth in 37 C.F.R. § 42.24, and Mylan will
`identify each such filing as a consolidated filing;
`FURTHER ORDERED that except as otherwise agreed by all parties,
`counsel for Mylan will conduct cross-examination and other discovery on
`IPR2018-00272 on behalf of Mylan and Dr. Reddy’s, and that Patent
`Owners are not required to provide separate discovery responses or
`additional deposition time as a result of the joinder;
`FURTHER ORDERED that IPR2018-01341 is terminated under
`37 C.F.R. § 42.72, and all further filings this proceeding are to be made in
`IPR2018-00272;
`FURTHER ORDERED that a copy of this Decision will be entered
`into the record of IPR2018-00272; and
`FURTHER ORDERED that the case caption in IPR2018-00272 shall
`be changed to reflect that Dr. Reddy’s has been joined as a Petitioner to that
`proceeding in accordance with the attached example.
`
` 9
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`IPR2018-01341
`Patent 9,393,208 B2
`
`For PETITIONER DR. REDDY’S:
`
`Alan Pollack
`Louis Weinstein
`BUDD LARNER PC
`apollack@buddlarner.com
`lweinstein@buddlarner.com
`
`For PETITIONER MYLAN:
`Brandon M. White
`Emily Greb
`PERKINS COIE LLP
`bmwhite@perkinscoie.com
`egreb@perkinscoie.com
`
`
`For PATENT OWNERS:
`Thomas A. Blinka
`COOLEY LLP
`tblinka@cooley.com
`
`Margaret J. Sampson
`BAKER BOTTS LLP
`Margaret.Sampson@bakerbotts.com
`
`
`
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`10
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`IPR2018-01341
`Patent 9,393,208 B2
`
`
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`MYLAN PHARMACEUTICALS INC. and
`DR. REDDY’S LABORATORIEES, INC.,
`Petitioners
`v.
`HORIZON PHARMA USA, INC. and NUVO PHARMACEUTICALS
`(IRELAND) DESIGNATED ACTIVITY COMPANY,
`Patent Owners.
`_______________
`
`Case IPR2018-002725
`Patent 9,393,208 B2
`_______________
`
`
`5 Petitioner Dr. Reddy’s Laboratories, Inc., from IPR2018-01341, has been
`joined as a Petitioner to this proceeding.
`
`11
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`
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