Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`
`Paper 19
`Entered: April 12, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ACTAVIS LABORATORIES FL, INC., AMNEAL
`PHARMACEUTICALS LLC, AMNEAL PHARMACEUTICALS OF NEW
`YORK, LLC, DR. REDDY'S LABORATORIES, INC., DR. REDDY'S
`LABORATORIES, LTD., SUN PHARMACEUTICALS
`INDUSTRIES, LTD., SUN PHARMACEUTICALS INDUSTRIES, INC.,
`TEVA PHARMACEUTICALS USA, INC., WEST-WARD
`PHARMACEUTICAL CORP., and HIKMA PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-00853
`Patent 8,822,438 B2
`____________
`
`Before LORA M. GREEN, RAMA G. ELLURU, and
`KRISTINA M. KALAN, Administrative Patent Judges.
`
`KALAN, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review and Grant of Motion for Joinder
`37 C.F.R. § 42.108
`37 C.F R § 42.122(b)
`
`
`
`
`
`Tel: 571-272-7822
`
`
`
`
`
`Paper 19
`Entered: April 12, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ACTAVIS LABORATORIES FL, INC., AMNEAL
`PHARMACEUTICALS LLC, AMNEAL PHARMACEUTICALS OF NEW
`YORK, LLC, DR. REDDY'S LABORATORIES, INC., DR. REDDY'S
`LABORATORIES, LTD., SUN PHARMACEUTICALS
`INDUSTRIES, LTD., SUN PHARMACEUTICALS INDUSTRIES, INC.,
`TEVA PHARMACEUTICALS USA, INC., WEST-WARD
`PHARMACEUTICAL CORP., and HIKMA PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-00853
`Patent 8,822,438 B2
`____________
`
`Before LORA M. GREEN, RAMA G. ELLURU, and
`KRISTINA M. KALAN, Administrative Patent Judges.
`
`KALAN, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review and Grant of Motion for Joinder
`37 C.F.R. § 42.108
`37 C.F R § 42.122(b)
`
`
`
`
`
`
`IPR2017-00853
`Patent 8,822,438 B2
`
`
`Petitioners, Actavis Laboratories FL, Inc., Amneal Pharmaceuticals
`LLC, Amneal Pharmaceuticals of New York, LLC, Dr. Reddy’s
`Laboratories, Inc., Dr. Reddy’s Laboratories, Ltd., Sun Pharmaceuticals
`Industries, Ltd., Sun Pharmaceuticals Industries, Inc., Teva Pharmaceuticals
`USA, Inc., West-Ward Pharmaceutical Corp., and Hikma Pharmaceuticals,
`LLC (collectively, the “Actavis Petitioners”) filed a Petition (Paper 8,
`“Pet.”) requesting inter partes review of claims 1–20 (the “challenged
`claims”) of U.S. Patent No. 8,822,438 B2 (Ex. 1001, “the ’438 patent”)
`pursuant to 35 U.S.C. §§ 311–19. Concurrently with the Petition, the
`Actavis Petitioners filed a Motion for Joinder (Paper 9, “Mot.”), seeking to
`join this case, under 35 U.S.C. § 315(c), with the inter partes review in
`Mylan Pharmaceuticals Inc., v. Janssen Oncology, Inc., Case IPR2016-
`01332 (“the Mylan IPR” and Petitioner “Mylan”), which was instituted on
`January 10, 2017. See IPR2016-01332, slip op. at 11–12 (PTAB January 10,
`2017) (Paper 21) (decision instituting review of claims 1–20 of the ’438
`patent).
`Patent Owner, Janssen Oncology, Inc. (“Janssen”), filed an
`Opposition to the Motion for Joinder (Paper 15, “Opp.”), to which Petitioner
`filed a Reply (Paper 17, “Reply”). Janssen also filed a Waiver of
`Preliminary Response (Paper 18, “Waiver”).
`For the reasons set forth below, we conclude that the Actavis
`Petitioners have shown that their Petition warrants institution of inter partes
`review of claims 1–20 of the ’438 patent. This conclusion is consistent with
`our institution decision in the Mylan IPR. See IPR2016-01332, Paper 21,
`11–12. Thus, we institute inter partes review, grant the Actavis Petitioners’
`Motion for Joinder, and exercise our discretion to join the Actavis
`
`2
`
`
`
`IPR2017-00853
`Patent 8,822,438 B2
`
`Petitioners as Petitioners to the Mylan IPR. We further terminate the present
`proceeding, IPR2017-00853.
`I. PETITION FOR INTER PARTES REVIEW
`The parties indicate that the ’438 patent is being asserted in a number
`of district court proceedings. Pet. 2–3; Paper 10, 2–4. In addition, the ’438
`patent is the subject of pending inter partes review proceedings, including
`the Mylan IPR, as noted above, which has been instituted, and IPR2016-
`00286 and IPR2016-01582, which also have been instituted. Janssen also
`states that the ’438 patent “was the subject of ex parte reexamination request
`No. 90/020,096,” but “will not be granted a filing date for failure to comply
`with the requirements of 37 C.F.R. § 1.501(a).” Paper 10, 2.
`In the Mylan IPR, we instituted inter partes review of claims 1–20 of
`the ’438 patent on the same grounds of unpatentability asserted in the
`present Petition:
`References
`O’Donnell1 and Gerber2
`
`Claims Challenged
`1–20
`
`Basis
`§ 103
`
`Barrie3 and Gerber
`
`§ 103
`
`1–4 and 6–114
`
`
`1 O’Donnell, A., et al., Hormonal impact of the 17α-hydroxylase/ C17, 20-
`lyase inhibitor abiraterone acetate (CB7630) in patients with prostate
`cancer, 90 British Journal of Cancer 2317–25 (2004) (“O’Donnell”)
`(Ex. 1003).
`2 Gerber, G.S. & Chodak, G.W., Prostate specific antigen for assessing
`response to ketoconazole and prednisone in patients with hormone
`refractory metastatic cancer, J. Urol. 144:1177–79 (1990) (“Gerber”)
`(Ex. 1004).
`3 U.S. Patent No. 5,604,213 to Barrie, issued February 18, 1997 (“Barrie”)
`(Ex. 1005).
`4 In the Petition, the Actavis Petitioners identify “Ground 2” as challenging
`“Claims 1–4 and 5–11.” Pet. 4. In the body of the Petition, however, the
`
`3
`
`
`
`IPR2017-00853
`Patent 8,822,438 B2
`
`Pet 4; Mot. 4; IPR2016-01332, Paper 21, 11–12.
`The Actavis Petitioners support their assertions with substantially the
`same evidence and arguments proffered by Mylan in the Mylan IPR. Pet.
`20–61. The Actavis Petitioners represent that joinder with the Mylan IPR is
`appropriate because the “grounds proposed in the present Petition are [] the
`same grounds of invalidity on which the Board instituted the Mylan IPR, and
`the Petition does not contain any additional arguments or evidence in
`support of the invalidity of claims 1–20 of the ’438 patent.” Mot. 4.
`In response to an exchange of correspondence with the Board, Janssen
`filed a Waiver of Preliminary Response on March 23, 2017, stating that
`Janssen “elects to waive its Patent Owner Preliminary Response to the
`Petition filed in the above-captioned proceeding (IPR2017-00853).”
`Waiver 1. Janssen emphasizes, however, that “no adverse inference should
`be taken by this election” and that “this election should not be deemed a
`waiver or admission on the part of Janssen of any material presented in the
`Petition.” Id.
`We incorporate our analysis from our institution decision in the Mylan
`IPR. IPR2016-01332, Paper 21, 2–11. For the same reasons, we determine
`that the Actavis Petitioners have demonstrated a reasonable likelihood that
`they will prevail with respect to their challenge to claims 1–20 of the ’438
`patent on the asserted grounds. In view of the identical challenges in the
`
`
`Actavis Petitioners only argue that that claim 5 is obvious over O’Donnell in
`view of Gerber, and do not argue that claim 5 is obvious over Barrie and
`Gerber. Pet. 44. Given this latter argument, and given the Actavis
`Petitioners’ representations that the arguments and Grounds are identical to
`those in the Mylan IPR (Mot. 6), we understand the Actavis Petitioners’
`Ground 2 to be limited to claims 1–4 and 6–11.
`
`4
`
`
`
`IPR2017-00853
`Patent 8,822,438 B2
`
`Petition and in view of Janssen’s Waiver of its Preliminary Response, we
`institute an inter partes review in this proceeding on the same grounds as
`those on which we instituted trial in IPR2016-01332. We do not institute an
`inter partes review on any other grounds.
`II. MOTION FOR JOINDER
`In the Motion for Joinder, the Actavis Petitioners seek joinder of their
`
`Petition with “a previously instituted and currently pending IPR” filed by
`Mylan, i.e., the Mylan IPR. Mot. 1. The Actavis Petitioners filed the
`present Motion on February 8, 2017, within one month of our decision
`instituting inter partes review in IPR2016-01332, which issued on
`January 10, 2017. See IPR2016-01332, Paper 21; Mot. Therefore, the
`Motion is timely under 37 C.F.R. § 42.122(b). See 37 C.F.R. § 42.122(b)
`(“Any request for joinder must be filed, as a motion under § 42.22, no later
`than one month after the institution date of any inter partes review for which
`joinder is requested.”).
`The Board, acting on behalf of the Director, has the discretion to join
`a party to a pending inter partes review where the conditions of 35 U.S.C.
`§ 315(c) are met. See 35 U.S.C. § 315(c); see also 37 C.F.R. § 42.4(a) (“The
`Board institutes the trial on behalf of the Director.”). Specifically, 35 U.S.C.
`§ 315(c) provides:
`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.
`
`5
`
`
`
`IPR2017-00853
`Patent 8,822,438 B2
`
`
`As the moving party, the Actavis Petitioners bear the burden of
`proving that they are entitled to the requested relief. 37 C.F.R. § 42.20(c).
`A motion for joinder should (1) set forth reasons why 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 Kyocera Corp. v. Softview LLC, Case IPR2013-
`00004, slip op. at 4 (PTAB Apr. 24, 2013) (Paper 15).
`As noted above, we have instituted inter partes review of claims 1–20
`of the ’438 patent in the Mylan IPR. See generally IPR2016–01332,
`Paper 21. In addition, we determine above that the Actavis Petitioners have
`filed a Petition that warrants institution of inter partes review of the same
`claims. Accordingly, the conditions of 35 U.S.C. § 315(c) are satisfied, and
`we must consider whether to exercise our discretion to join the Actavis
`Petitioners as Petitioners to the Mylan IPR.
`In the Motion for Joinder, the Actavis Petitioners assert that joinder is
`appropriate “because it will promote the efficient and consistent resolution
`of the same validity issues of the same single ’438 patent, it will not delay
`the Mylan IPR trial schedule, and the parties in the Mylan IPR will not be
`prejudiced.” Mot. 1–2. The Actavis Petitioners represent that (1) joinder is
`timely; (2) joinder is appropriate; (3) both IPRs present exactly the same
`grounds and evidence of obviousness concerning the same claims;
`(4) joinder will not impact the existing trial schedule; and (5) joinder would
`simplify briefing and discovery. Id. at 5–8.
`Janssen filed an Opposition to the Actavis Petitioners’ Motion for
`Joinder, stating that the “Board should exercise its discretion and deny
`
`6
`
`
`
`IPR2017-00853
`Patent 8,822,438 B2
`
`Petitioners’ motion for joinder because the attempt by these ten additional
`companies to serially attack the ’438 patent in staggered IPR petitions does
`not promote judicial efficiency and is prejudicial to Janssen.” Opp. 4.
`Furthermore, Janssen notes, “because the present petition was filed more
`than one year after Petitioners were served with a complaint alleging
`infringement of the ’438 patent, absent joinder, the Actavis IPR is time-
`barred under 35 U.S.C. § 315(b).” Id. Janssen also expresses a concern that
`“joinder could potentially complicate the already condensed Mylan IPR
`proceeding” because “Petitioners stop short of agreeing to rely on Mylan’s
`briefs and testimony in their entirety and, in doing so, leave open the
`possibility to set forth independent positions and opinions on issues that do
`not overlap with Mylan’s.” Id. at 9.
`If joinder is granted, Janssen argues, the Board should impose strict
`safeguards. Id. at 10. Regarding the details of the Actavis Petitioners’
`conditions to simplify discovery and briefing, Janssen requests that the
`Actavis Petitioners be required to abide by the following conditions:
`- Petitioners agree to “assert[] exactly the same grounds and rel[y]
`exactly on the same evidence for invalidity that formed the basis
`for institution in the Mylan IPR,” including “the same
`combinations of prior art references.” (Mot. 6; Ex. 2012, Email
`exchange between counsel for Actavis and counsel for Janssen);
`- Petitioners agree to rely on “the same experts, Dr. Garnick and Mr.
`Hofmann, [who] have submitted identical supporting declarations
`in both [the Actavis and Mylan] IPRs.” (Mot. 6);
`- Petitioners agree that they “will not request any alterations to the
`schedule in the Mylan IPR based on the requested joinder” and that
`
`7
`
`
`
`IPR2017-00853
`Patent 8,822,438 B2
`
`
`“[a]ccordingly, joinder will not at all impact the trial schedule for
`existing review of the Mylan IPR.” (Mot. 7);
`- Petitioners “agree to not submit any separate briefing on any issue
`(unless the issue pertains specifically to one of [the Petitioners] and
`not to Mylan).” (Ex. 2012);
`- Petitioners be ordered to work together to consolidate filings
`without authorizing expansion of page limits beyond the regular
`page limits allotted by the rules;
`- Petitioners agree to “coordinate with [Mylan] to facilitate the
`elimination of repetitive . . . testimony.” (Mot. 8);
`- Petitioners agree to participate only as observers during
`depositions (Ex. 1012), and further agree that no additional
`depositions will be needed, and that the depositions will be
`completed within the time limits agreed upon by Janssen and
`Mylan;
`- Petitioners agree that they will “maintain a secondary role in the
`proceeding, if joined,” and “will assume a primary role only if the
`Mylan IPR petitioner ceases to participate in the IPR.” (Mot. 8).
`Opp. 10–12.
`In the Reply supporting the Motion for Joinder, the Actavis
`Petitioners reiterate that the Petition is timely pursuant to 37 C.F.R.
`§ 42.122(b) because the Petition was filed within one month of the Mylan
`IPR’s institution. Reply 1. The Actavis Petitioners emphasize that they will
`only play a passive, secondary role in the proceedings, such that joinder will
`neither delay nor complicate the Mylan IPR. Id. at 4. Finally, the Actavis
`
`8
`
`
`
`IPR2017-00853
`Patent 8,822,438 B2
`
`Petitioners state that “Petitioners . . . agree to all of Patent Owner’s
`‘safeguards.’” Id. at 5.
`Having reviewed the Actavis Petitioners’ Motion for Joinder,
`Janssen’s Opposition, the Actavis Petitioners’ Reply, and the email
`exchange in evidence (Ex. 2012), we determine that joinder would be
`appropriate under the circumstances. Based on the record before us, we
`institute an inter partes review in IPR2017-00853. Because the Actavis
`Petitioners have satisfied the requirements of § 315(c), we grant the Motion
`for Joinder and join the Actavis Petitioners as Petitioners to the Mylan IPR.
`We further terminate the present proceeding.
`As Petitioners in the Mylan IPR, the Actavis Petitioners shall adhere
`to the existing schedule in the Mylan IPR and abide by the Actavis
`Petitioners’ representations as to consolidated filings, discovery and
`testimony, and other conditions and safeguards detailed in its Motion and in
`Janssen’s Opposition. Mot. 4–8; Opp. 10–12. Specifically, all filings by the
`Actavis Petitioners in the Mylan IPR shall be consolidated with the filings of
`Mylan, unless the filing involves an issue unique to the Actavis Petitioners.
`In such circumstances, the Actavis Petitioners shall seek authorization from
`the Board to file a separate paper. The page limits and word counts set forth
`in 37 C.F.R. § 42.24 will apply to all consolidated filings.
`The Actavis Petitioners are bound by any discovery agreements,
`including deposition arrangements, between Janssen and Mylan, and shall
`not seek any discovery beyond that sought by Mylan. Janssen shall not be
`required to provide any additional discovery or deposition time as a result of
`joinder.
`
`9
`
`
`
`IPR2017-00853
`Patent 8,822,438 B2
`
`
`The Board expects Mylan and the Actavis Petitioners to resolve any
`disputes between them and to contact the Board only if such matters cannot
`be resolved.
`
`III. ORDER
`
`Accordingly, it is
`ORDERED that trial is instituted in IPR2017-00853 as to claims 1–20
`of the ’438 patent on the following grounds only:
`Claims 1–20 as obvious under 35 U.S.C. § 103 over O’Donnell
`and Gerber;
`Claims 1–4 and 6–11 as obvious under 35 U.S.C. § 103 over
`Barrie and Gerber;
`FURTHER ORDERED that the Actavis Petitioners’ Motion for
`Joinder is granted;
`FURTHER ORDERED that the Actavis Petitioners are joined as
`Petitioners in IPR2016-01332;
`FURTHER ORDERED that the instant proceeding, IPR2017-00853,
`is terminated under 37 C.F.R. § 42.72, and all further filings in the joined
`proceeding shall be made only in IPR2016-01332;
`FURTHER ORDERED that the asserted grounds of unpatentability on
`which a trial was instituted in IPR2016-01332 are unchanged;
`FURTHER ORDERED that the current Scheduling Order for
`IPR2016-01332 (Paper 22, as modified by Paper 30) shall continue to
`govern IPR2017-01332;
`FURTHER ORDERED that the Actavis Petitioners shall adhere to the
`existing schedule in the Mylan IPR;
`
`10
`
`
`
`IPR2017-00853
`Patent 8,822,438 B2
`
`
`-
`
`FURTHER ORDERED that the Actavis Petitioners shall adhere to
`their representations and to Janssen’s safeguards with respect to consolidated
`filings, discovery and testimony, and other matters, and namely, the Actavis
`Petitioners shall:
`- assert exactly the same grounds and rely exactly on the same
`evidence for invalidity that formed the basis for institution in the
`Mylan IPR, including the same combinations of prior art
`references;
`rely on the same experts, Dr. Garnick and Mr. Hofmann, who have
`submitted identical supporting declarations in both the Actavis and
`Mylan IPRs;
`- not request any alterations to the schedule in the Mylan IPR based
`on the requested joinder and that accordingly, joinder will not at all
`impact the trial schedule for existing review of the Mylan IPR;
`- not submit any separate briefing on any issue unless the issue
`pertains specifically to one of the Petitioners and not to Mylan;
`- work together with Mylan to consolidate filings without
`authorizing expansion of page limits beyond the regular page
`limits allotted by the rules;
`- coordinate with Mylan to facilitate the elimination of repetitive
`testimony;
`- participate only as observers during depositions, agree that no
`additional depositions will be needed, and that the depositions will
`be completed within the time limits agreed upon by Janssen and
`Mylan;
`
`11
`
`
`
`IPR2017-00853
`Patent 8,822,438 B2
`
`
`- maintain a secondary role in the proceeding, and assume a primary
`role only if the Mylan IPR petitioner ceases to participate in the
`IPR;
`FURTHER ORDERED that Mylan will file all papers in the joined
`proceeding jointly on behalf of Mylan and the Actavis Petitioners, unless the
`filing involves an issue unique to the Actavis Petitioners. In such
`circumstances, the Actavis Petitioners shall seek authorization from the
`Board to file a separate paper;
`FURTHER ORDERED that all page limits and word counts set forth
`in 37 C.F.R. § 42.24 will apply to all consolidated filings;
`FURTHER ORDERED that the case caption in IPR2016-01332 shall
`be changed to reflect the joinder of the Actavis Petitioners as Petitioners in
`accordance with the attached example; and
`FURTHER ORDERED that a copy of this Decision be entered into
`the file of IPR2016-01332.
`
`
`12
`
`
`
`IPR2017-00853
`Patent 8,822,438 B2
`
`FOR PETITIONER MYLAN:
`
`Brandon M. White
`Crystal Canterbury
`PERKINS COIE LLP
`bmwhite@perkinscoie.com
`CCanterbury@perkinscoie.com
`
`
`
`FOR PETITIONER ACTAVIS:
`
`Samuel S. Park
`Jovial Wong
`Ryan B. Hauer
`WINSTON & STRAWN, LLP
`spark@winston.com
`jwong@winston.com
`rhauer@winston.com
`
`
`
`
`
`FOR PATENT OWNER JANSSEN:
`
`Dianne B. Elderkin
`Barbara L. Mullin
`Ruben H. Munoz
`AKIN GUMP STRAUSS HAUER & FELD LLP
`delderkin@akingump.com
`bmullin@akingump.com
`rmunoz@akingump.com
`
`13
`
`
`
`Example Case Caption
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`
`
`
`
`MYLAN PHARMACEUTICALS LIMITED, ACTAVIS
`LABORATORIES FL, INC., AMNEAL PHARMACEUTICALS LLC,
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC, DR. REDDY'S
`LABORATORIES, INC., DR. REDDY'S LABORATORIES, LTD.,
`SUN PHARMACEUTICALS INDUSTRIES, LTD.,
`SUN PHARMACEUTICALS INDUSTRIES, INC.,
`TEVA PHARMACEUTICALS USA, INC., WEST-WARD
`PHARMACEUTICAL CORP., and HIKMA PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-013321
`Patent 8,822,438 B2
`____________
`
`
`
`
`
`
`1 Case IPR2017-00853 has been joined with this proceeding.
`
`
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