`Tel: 571-272-7822
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`Paper 30
`Entered: September 19, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01317
`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)
`
`
`
`
`
`
`IPR2016-01317
`Patent 8,822,438 B2
`
`
`Argentum Pharmaceuticals LLC (“Argentum”) filed a Petition (Paper
`2, “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. §§ 311–319. Concurrently with its Petition, Argentum
`filed a Motion for Joinder (Paper 3, “Mot.”), seeking to join this case, under
`35 U.S.C. § 315(c), with the inter partes review in Amerigen
`Pharmaceuticals, Ltd. v. Janssen Oncology, Inc., Case IPR2016-00286 (“the
`Amerigen IPR” and Petitioner “Amerigen”), which was instituted on May
`31, 2016. See IPR2016-00286, slip op. at 19 (PTAB May 31, 2016) (Paper
`14) (decision instituting review of claims 1–20 of the ’438 patent).
`Patent Owner, Janssen Oncology, Inc. (“Janssen”), filed a Response to
`the Motion for Joinder (Paper 7, “Resp.”) and a Waiver of Preliminary
`Response (Paper 8, “Waiver”).
`For the reasons set forth below, we conclude that Argentum has
`shown that its 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 Amerigen IPR. See IPR2016-00286, Paper 14, 19.
`Thus, we institute inter partes review, grant Argentum’s Motion for Joinder,
`and exercise our discretion to join Argentum as a Petitioner to the Amerigen
`IPR. We further terminate the present proceeding, IPR2016-01317.
`I. PETITION FOR INTER PARTES REVIEW
`The parties indicate that the ’438 patent is being asserted in a number
`of district court proceedings. Pet. 1–2; Paper 5, 2–3. In addition, the ’438
`patent is the subject of pending inter partes review proceedings, including
`the Amerigen IPR, as noted above, which has been instituted, and IPR2016-
`01332 and IPR2016-01582, which are pending. Patent Owner also states
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`2
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`IPR2016-01317
`Patent 8,822,438 B2
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`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 5, 2.
`In the Amerigen 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 6–11
`
`Pet 4; Mot. 4; IPR2016-00286, Paper 14, 19.
`Argentum supports its assertions with substantially the same evidence
`and arguments proffered by Amerigen in the Amerigen IPR. Pet. 18–60.
`The only exception is the declaration of Argentum’s expert, Dr. Devalingam
`Mahalingam (Ex. 1073), which we discuss below. Argentum represents that
`joinder with the Amerigen IPR is appropriate because Argentum’s Petition
`is limited to the same grounds instituted in the IPR2016-00286
`petition. It also relies on the same prior art analysis and expert
`testimony submitted by Amerigen. Indeed, the Petition is
`nearly identical with respect to the grounds raised in the
`
`
`1 O’Donnell, A. et al., Hormonal impact of the 17α-hydroxylase/ C17, 20-lyase
`inhibitor abiraterone acetate (CB7630) in patients with prostate cancer,
`British Journal of Cancer 90:2317–2325 (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).
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`IPR2016-01317
`Patent 8,822,438 B2
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`IPR2016-00286 petition, and does not include any grounds not
`raised in that petition.
`Mot. 4.
`We incorporate our analysis from our institution decision in the
`Amerigen IPR. IPR2016-00286, Paper 14, 4–15. For the same reasons, we
`determine that Argentum has demonstrated a reasonable likelihood that it
`will prevail with respect to its challenge to claims 1–20 of the ’438 patent on
`the asserted grounds. In view of the identical challenges in the Petition and
`Patent Owner’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 IPR2016-00286. We do not institute an inter partes review
`on any other grounds.
`
`II. MOTION FOR JOINDER
`In the Motion for Joinder, Argentum seeks joinder “of the
`
`concurrently filed Petition with a pending inter partes review filed by
`Amerigen.” Mot. 1. Argentum filed the present Motion on June 29, 2016,
`within one month of our decision instituting inter partes review in IPR2016-
`00286, which issued on May 31, 2016. See IPR2016-00286, Paper 14; 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:
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`IPR2016-01317
`Patent 8,822,438 B2
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`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.
`
`As the moving party, Argentum 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 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 Amerigen IPR. See generally IPR2016–00286,
`Paper 14. In addition, we determine above that Argentum has 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 Argentum as a Petitioner
`to the Amerigen IPR.
`In its Motion for Joinder, Argentum asserts that joinder is appropriate
`“because it will promote efficient and consistent resolution of the validity of
`a single patent and will not prejudice any of the parties to the Amerigen
`IPR.” Mot. 2. Argentum represents that (1) joinder is appropriate; (2) no
`new grounds are presented; (3) joinder will not negatively impact the
`Amerigen IPR trial schedule; and (4) discovery and briefing can be
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`Patent 8,822,438 B2
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`simplified, as Argentum will withdraw the declaration of its expert, Dr.
`Devalingam Mahalingam, if Amerigen allows Argentum to retain the same
`expert, Dr. Scott Serels. Id. at 4–6; see also Ex. 2002.
`Janssen filed a Response to Argentum’s Motion for Joinder, stating
`that “Janssen does not oppose Argentum’s motion for joinder.” Resp. 2.
`Regarding the details of Argentum’s conditions to simplify discovery and
`briefing, Janssen summarizes that Argentum agrees to (i) rely on the same
`prior art analysis and expert testimony submitted by Amerigen, withdraw the
`declaration of Dr. Devalingam Mahalingam, rely solely on the testimony of
`Dr. Scott Serels, and require no additional depositions; (ii) present only
`grounds that have been instituted in the Amerigen IPR; (iii) participate in the
`proceeding in a limited capacity as an understudy, absent termination of
`Amerigen as a party, and not to extend the trial schedule; (iv) consolidate
`filings and limit Argentum to no additional filings in its understudy role, as
`long as Amerigen remains a party; and (v) not submit any separate filings
`unless it disagrees with Amerigen’s position, in which case it will submit a
`short separate filing directed only to points of disagreement. Id. at 3–4. In
`view of these representations by Argentum and Amerigen, Janssen states
`that it “does not oppose Argentum’s Motion for Joinder under the conditions
`listed above and agrees that judicial economy will be served by joining
`Argentum to the Amerigen IPR.” Id. at 4.
`In response to an exchange of correspondence with the Board,
`Argentum filed a Waiver of Preliminary Response on August 24, 2016,
`stating that Janssen “elects to waive its Patent Owner Preliminary Response
`to the Petition for inter partes review” but “reserves all rights to submit a
`Patent Owner Response and/or a Motion to Amend pursuant to 37 C.F.R.
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`IPR2016-01317
`Patent 8,822,438 B2
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`§§ 42.120 and 42.121.” Waiver 1. Janssen specifies that the Waiver does
`not constitute waiver or admission on the part of Janssen of any material
`presented in the Petition, or waiver of the arguments that Janssen raised in
`the Amerigen IPR. Id.
`We agree with the parties that joinder would be appropriate under the
`circumstances. Based on the record before us, we institute an inter partes
`review in IPR2016-01317. Because Argentum has satisfied the
`requirements of § 315(c), we grant Argentum’s motion and join Argentum
`as a Petitioner to the Amerigen IPR. We further terminate the present
`proceeding.
`As a Petitioner in the Amerigen IPR, Argentum shall adhere to the
`existing schedule in the Amerigen IPR and abide by Argentum’s
`representations as to consolidated filings, discovery and testimony, and other
`conditions detailed in its Motion. Mot. 4–7. Specifically, Argentum shall
`file a stipulation indicating that it withdraws the declaration of Dr.
`Devalingam Mahalingam and relies solely on the declaration and testimony
`of Amerigen’s expert, Dr. Scott Serels. More specifically, all filings by
`Argentum in the Amerigen IPR shall be consolidated with the filings of
`Amerigen, unless the filing involves an issue unique to Argentum or states a
`point of disagreement related to the consolidated filing. In such
`circumstances, Argentum 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.
`Argentum is bound by any discovery agreements, including
`deposition arrangements, between Janssen and Amerigen, and shall not seek
`any discovery beyond that sought by Amerigen. Janssen shall not be
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`IPR2016-01317
`Patent 8,822,438 B2
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`required to provide any additional discovery or deposition time as a result of
`joinder.
`The Board expects Amerigen and Argentum to resolve any disputes
`between them and to contact the Board only if such matters cannot be
`resolved.
`
`IV. ORDER
`
`Accordingly, it is
`ORDERED that trial is instituted in IPR2016-01317 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 Argentum’s Motion for Joinder is
`granted;
`FURTHER ORDERED that Argentum is joined as a Petitioner in
`IPR2016-00286;
`FURTHER ORDERED that the instant proceeding, IPR2016-01317,
`is terminated under 37 C.F.R. § 42.72, and all further filings in the joined
`proceeding shall be made only in IPR2016-00286;
`FURTHER ORDERED that the asserted grounds of unpatentability on
`which a trial was instituted in IPR2016-00286 are unchanged;
`FURTHER ORDERED that the current Scheduling Order for
`IPR2016-00286 (Paper 15, as modified by Paper 22 and Paper 29) shall
`continue to govern IPR2016-00286;
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`IPR2016-01317
`Patent 8,822,438 B2
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`FURTHER ORDERED that Argentum shall adhere to the existing
`schedule in the Amerigen IPR;
`FURTHER ORDERED that Argentum shall adhere to its
`representations with respect to consolidated filings, discovery and testimony,
`and other matters;
`FURTHER ORDERED that Argentum shall file a stipulation
`indicating that it withdraws the declaration of Dr. Devalingam Mahalingam
`and relies solely on the declaration and testimony of Amerigen’s expert, Dr.
`Scott Serels;
`FURTHER ORDERED that Amerigen will file all papers in the joined
`proceeding jointly on behalf of Amerigen and Argentum, except in the case
`of motions that do not involve the other party, unless the filing involves an
`issue unique to Argentum or states a point of disagreement related to the
`consolidated filing. In such circumstances, Argentum 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 IPR2016-00286 shall
`be changed to reflect the joinder of Argentum as a Petitioner in accordance
`with the attached example; and
`FURTHER ORDERED that a copy of this Decision be entered into
`the file of IPR2016-00286.
`
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`9
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`10
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`IPR2016-01317
`Patent 8,822,438 B2
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`FOR PETITIONER AMERIGEN:
`William Hare
`bill@miplaw.com
`Gabriela Materassi
`materassi@miplaw.com
`
`FOR PETITIONER ARGENTUM:
`
`Teresa Rea
`trea@crowell.com
`Shannon Lentz
`slentz@crowell.com
`
`FOR PATENT OWNER:
`Dianne Elderkin
`delderkin@akingump.com
`Barbara Mullin
`bmullin@akingump.com
`Ruben Munoz
`rmunoz@akingump.com
`
`
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`Example Case Caption
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`AMERIGEN PHARMACEUTICALS LIMITED and
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`
`
`
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-002864
`Patent 8,822,438 B2
`____________
`
`
`
`
`
`
`4 Case IPR2016-01317 has been joined with this proceeding.