throbber
Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`Paper 47
`Entered: August 14, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`DR. REDDY’S LABORATORIES, INC.,
`Petitioner
`v.
`POZEN INC. and HORIZON PHARMA USA, INC.,
`Patent Owners.
`_______________
`
`Case IPR2018-00894
`Patent 9,220,698 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
`
`
`
`
`

`

`IPR2018-00894
`Patent 9,220,698 B2
`
`
`I. INTRODUCTION
`Dr. Reddy’s Laboratories, Inc. (“DRL” or “Petitioner”) filed a Petition
`(Paper 1, “Pet.”) on April 6, 2018, requesting an inter partes review of claims 1–7
`of U.S. Patent No. 9,220,698 B2 (Ex. 1001, “the ’698 patent”). Concurrently with
`the Petition, DRL filed a Motion for Joinder (Paper 3, “Mot.”) to the inter partes
`review in Mylan Pharms. Inc. v. Horizon Pharma USA, Inc., Case IPR2017-01995
`(the “Mylan IPR” and Petitioner “Mylan”), an ongoing inter partes review, which
`we instituted on March 8, 2018. See IPR2017-01995, Paper 18. Pozen Inc. and
`Horizon Pharma USA, Inc. (“Patent Owners”) filed an Opposition to Petitioner’s
`Motion for Joinder (Paper 8, “Opp. to Joinder”), and DRL filed a Reply to
`Opposition to Motion for Joinder (Paper 9, “Reply to Opp. to Joinder”). Patent
`Owners did not file a preliminary response.
`In the Motion for Joinder and Reply to Opposition to Petitioner’s Motion for
`Joinder, DRL confirms that it seeks review of the same claims at issue in the
`Mylan IPR, based solely on the grounds of unpatentability we authorized in the
`Mylan IPR. Mot. 1; Reply to Opp. to Joinder 1–2. DRL commits to rely on the
`declarations and testimony of Mylan’s experts. Reply to Opp. to Joinder 2.
`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 DRL 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.
`
` 2
`
`
`
`
`
`

`

`IPR2018-00894
`Patent 9,220,698 B2
`
`Our conclusion is consistent with our institution decision in the Mylan IPR. See
`IPR2017-01995, Paper 18. Thus, we institute an inter partes review of claims 1–7
`of the ’698 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 the joined
`proceedings. Mylan IPR, Paper 19.
`A. Additional Related Proceedings
`DRL identifies the following pending litigation related to the ’698 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. 1–2.
`
`II. ANALYSIS
`A. Instituting Review of Claims 1–7 of the ’698 Patent
`We address whether joinder is appropriate only after determining that the
`Petition warrants the institution of an inter partes 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 authority 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).
`
` 3
`
`
`
`
`
`

`

`IPR2018-00894
`Patent 9,220,698 B2
`
`In the Mylan IPR, we instituted review of claims 1–7 of the ’698 patent on
`the following grounds:
`
`Reference[s]
`’285 patent1
`
`’285 patent
`
`’285 patent, EC-Naprosyn
`label2, and Howden 20053
`
`Statutory Basis
`§ 102(e)
`
`§ 103
`
`§ 103
`
`Claims challenged
`1–7
`
`1–7
`
`1–7
`
`The Instant Petition challenges the same claims of the ’698 patent as those
`challenged in the Mylan IPR, based on the same asserted prior art and grounds of
`unpatentability. Compare Pet. 3–4, with the Mylan IPR, Paper 2 (the “Mylan
`Pet.”), 34–59.
`DRL filed expert declarations by Drs. Solny and Bergstrom to support its
`Petition, but subsequently committed to relying on the same declarations that
`Mylan submitted in the Mylan IPR. See Pet. 4; Reply to Opp. to Joinder 1–2.
`Therefore, DRL’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 Reply to Opp. to Joinder 1–2, with Mylan Pet. 3, 19–59.
`
`
`1 U.S. Patent 8,557,285 B2, filed Aug. 23, 2011, issued Oct. 15, 2013 to John R.
`Plachetka (Ex. 1005, “the ’285 patent”).
`2 Prescription Drug Label for EC-Naprosyn® and other Naprosyn® formulations
`(Ex. 1009, “EC-Naprosyn label”).
`3 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
`
`
`
`
`
`

`

`IPR2018-00894
`Patent 9,220,698 B2
`
`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 18. Given the identical
`grounds and evidence presented in the present proceeding, we likewise determine
`that DRL’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 20–29 (reflecting reasons for
`instituting review).
`
`B. Granting Motion for Joinder
`DRL timely filed its Motion for Joinder on April 6, 2018, within one month
`of the institution of the Mylan IPR, as required by 37 C.F.R. § 42.122(b).4 Patent
`Owners oppose joining DRL as a Petitioner to the Mylan IPR (Opp. to Joinder 3),
`Mylan does not (Reply to Opp. to Joinder 1).
`A Petitioner in 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.
`
`4 Patent Owners argue that DRL’s Petition is time barred under 35 U.S.C. § 315(b).
`Opp. to Joinder 1. However, the one-year time limitation for filing a petition “shall
`not apply to a request for joinder” under § 315(c). 35 U.S.C. § 315(b). Patent
`Owners’ argument, thus, is without merit.
`
` 5
`
`
`
`
`
`

`

`IPR2018-00894
`Patent 9,220,698 B2
`
`By regulation, the Director’s discretion has been delegated to the Board.
`37 C.F.R. § 42.4(a).
`As the moving party, DRL 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 H5. Do I Need to
`File a Petition with a Motion for Joinder?, PTAB E2E Frequently Asked
`Questions, U.S. Patent & Trademark Office, https://www.uspto.gov/patents-
`application-process/patent-trial-and-appeal-board/ptab-e2e-frequently-asked-
`questions#H5 (last modified Nov. 27, 2017).
`DRL argues that joinder is appropriate because it will promote the efficient
`and consistent resolution patentability issues pertaining to the ’698 patent claims.
`Mot. 1. DRL represents that it raises only those patentability issues that already
`are before us in the Mylan IPR. See id. at 5. DRL also represents that it relies on
`the same declarations Mylan submitted in the Mylan IPR. Reply to Opp. to Mot. 2.
`In light of the substantial identity of DRL’s Petition and Mylan’s Petition, we
`agree that DRL raises no new grounds of unpatentability or new issues.
`DRL also argues that joinder will not affect the schedule of the Mylan IPR.
`Mot. 5. DRL 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. DRL will cease its passive role only if Mylan ceases to participate in the
`proceeding. Id.
`
` 6
`
`
`
`
`
`

`

`IPR2018-00894
`Patent 9,220,698 B2
`
`In light of DRL’s arguments and representations, we are persuaded that it is
`appropriate to join DRL 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
`DRL’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 ’698 patent based on the same grounds
`instituted in the Mylan IPR. We also grant DRL’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 ’698 patent under 35 U.S.C § 102(e) as anticipated by the
`’285 patent;
`Claims 1–7 of the ’698 patent under 35 U.S.C § 103 as obvious over the
`’285 patent; and
`Claims 1–7 of the ’698 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 DRL’s Motion for Joinder (Paper 3) is granted;
`FURTHER ORDERED that DRL is joined as a Petitioner to IPR2017-
`01995;
`FURTHER ORDERED that the grounds on which IPR2017-01995 was
`instituted are unchanged, and no other grounds are instituted in the consolidated
`proceeding beyond those set forth in IPR2017-01995, Paper 18;
`
` 7
`
`
`
`
`
`

`

`IPR2018-00894
`Patent 9,220,698 B2
`
`FURTHER ORDERED that the Scheduling Order in place for IPR2017-
`01995 (Paper 19) shall continue to govern the joined proceeding;
`FURTHER ORDERED that, throughout IPR2017-01995, 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 DRL, 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
`IPR2017-01995 on behalf of Mylan and DRL, 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 IPR2018-00894 is terminated under 37 C.F.R.
`§ 42.72, and all further filings this proceeding are to be made in IPR2017-01995;
`FURTHER ORDERED that a copy of this Decision will be entered into the
`record of IPR2017-01995; and
`FURTHER ORDERED that the case caption in IPR2017-01995 shall be
`changed to reflect that DRL has been joined as a Petitioner to that proceeding in
`accordance with the attached example.
`
`
`
` 8
`
`
`
`
`
`

`

`IPR2018-00894
`Patent 9,220,698 B2
`
`for PETITIONER DRL:
`Alan H. Pollack
`Stuart D. Sender
`Louis H. Weinstein
`BUDD LARNER, P.C.
`apollack@buddlarner.com
`ssender@buddlarner.com
`lweinstein@buddlarner.com
`
`for PATENT OWNER:
`Thomas A. Blinka, Ph.D.
`COOLEY LLP
`TBlinka@cooley.com
`Margaret J. Sampson, Ph.D.
`Stephen M. Hash, Ph.D.
`BAKER BOTTS LLP
`Margaret.Sampson@bakerbotts.com
`Stephen.Hash@bakerbotts.com
`
`for PETITIONER MYLAN:
`Brandon M. White
`Emily J. Greb
`PERKINS COIE LLP
`bmwhite@perkinscoie.com
`egreb@perkinscoie.com
`
` 9
`
`
`
`
`
`

`

`IPR2018-00894
`Patent 9,220,698 B2
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`MYLAN PHARMACEUTICALS INC.
`
`and
`
`DR. REDDY’S LABORATORIES, INC.,
`Petitioners
`v.
`POZEN INC. and HORIZON PHARMA USA, INC.,
`Patent Owners.
`_______________
`
`Case IPR2017-019955
`Patent 9,220,698 B2
`_______________
`
`
`5 Petitioner Dr. Reddy’s Laboratories, Inc., from IPR2018-00894, has been joined
`as a Petitioner to this proceeding.
`
`
`10
`
`
`
`

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