throbber
Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`
`Paper 30
`Entered: September 19, 2016
`
`
`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
`
`2
`
`

`
`IPR2016-01317
`Patent 8,822,438 B2
`
`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).
`
`3
`
`

`
`IPR2016-01317
`Patent 8,822,438 B2
`
`
`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:
`
`4
`
`

`
`IPR2016-01317
`Patent 8,822,438 B2
`
`
`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
`
`5
`
`

`
`IPR2016-01317
`Patent 8,822,438 B2
`
`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.
`
`6
`
`

`
`IPR2016-01317
`Patent 8,822,438 B2
`
`§§ 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
`
`7
`
`

`
`IPR2016-01317
`Patent 8,822,438 B2
`
`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;
`
`8
`
`

`
`IPR2016-01317
`Patent 8,822,438 B2
`
`
`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.
`
`
`9
`
`

`
`10
`
`IPR2016-01317
`Patent 8,822,438 B2
`
`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
`
`
`
`
`
`

`
`Example Case Caption
`
`
`
`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.

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket