trials@uspto.gov Paper 21
`571.272.7822 Entered: January 10, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01332
`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 Denial of Motion for Joinder
`37 C.F.R. § 42.108
`37 C.F R § 42.122(b)
`
`
`
`
`
`571.272.7822 Entered: January 10, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01332
`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 Denial of Motion for Joinder
`37 C.F.R. § 42.108
`37 C.F R § 42.122(b)
`
`
`
`
`
`
`IPR2016-01332
`Patent 8,822,438 B2
`Mylan Pharmaceuticals Inc. (“Mylan”) filed a Petition (Paper 1,
`“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, Mylan
`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 Case 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 an Opposition to the
`Motion for Joinder (Paper 9, “Opp.”) and Mylan filed a Reply to Janssen’s
`Opposition (Paper 10, “Reply”). Janssen also filed a Preliminary Response
`to the Petition (Paper 14, “Prelim. Resp.”).
`For the reasons set forth below, we conclude that Mylan 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 an
`inter partes review. We, however, do not grant Mylan’s Motion for Joinder.
`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 7, 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; IPR2016-
`01317 (Argentum Pharmaceuticals LLC v. Janssen Oncology, Inc.), which
`was joined with the Amerigen IPR on September 19, 2016 (IPR2016-01317,
`
`
`
`2
`
`
`
`IPR2016-01332
`Patent 8,822,438 B2
`Paper 9); and IPR2016-01582, which is pending. 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 7, 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 3; Mot. 2; IPR2016-00286, Paper 14, 19.
`Mylan supports its assertions in its Petition with substantially the
`same art and arguments proffered by Amerigen in the Amerigen IPR. Pet.
`4–61. Mylan states that “the proposed grounds for instituting inter partes
`review in the Mylan IPR are identical to the ones on which the Amerigen
`IPR was instituted.” Mot. 6. The exceptions to the similarities between the
`present Petition and the petition in the Amerigen IPR are: the declaration of
`Mylan’s declarant, Marc B. Garnick, M.D. (Ex. 1002), the declaration of
`
`
`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
`
`
`
`
`
`IPR2016-01332
`Patent 8,822,438 B2
`Mylan’s declarant Ivan T. Hoffman (Ex. 1017);4 and the inclusion of
`Exhibits 1068–1080.5
`Additionally, Mylan notes that it would not be time-barred from filing
`the present Petition without a corresponding motion for joinder. Mot. 6; 35
`U.S.C. § 315(b).
`Janssen responds that, because “Mylan’s petition is merely a
`repetition of Amerigen’s first petition and Argentum’s second petition, it
`does nothing more than drain the Board’s resources with no added value.”
`Prelim Resp. 2. Janssen requests that the Board exercise its discretion and
`deny institution pursuant to 35 U.S.C. § 325(d). Id.
`We have discretion under 35 U.S.C. § 325(d) to reject a petition when
`the same or substantially the same prior art or arguments were presented
`previously to the Office. The relevant portions of that statute are reproduced
`below:
`In determining whether to institute or order a proceeding under
`this chapter, chapter 30, or chapter 31, the Director may take
`into account whether, and reject the petition or request because,
`the same or substantially the same prior art or arguments
`previously were presented to the Office.
`
`35 U.S.C. § 325(d). In exercising our discretion under § 325(d), we take
`into account numerous factors, including the facts of each case, and the
`
`
`4 Amerigen relied on the declarations of Dr. Scott R. Serels, M.D.
`(IPR2016-00286, Ex. 1002) and DeForest McDuff, Ph.D. (IPR2016-00286,
`Ex. 1017) in support of its assertions and arguments.
`5 Janssen also notes in its Opposition that “Mylan appears to withdraw, and
`does not appear to rely, on original Exhibits 1002, 1017, 1037, 1038, 1042–
`44, 1052, 1056, 1058–1063, and 1067 that were submitted in the Amerigen
`IPR.” Opp. 6 n.3.
`
`4
`
`
`
`
`
`IPR2016-01332
`Patent 8,822,438 B2
`burden on the parties and the Board. See Conopco, Inc. v. Proctor &
`Gamble Co., Case IPR2014-00506, slip op. at 4, 6 (PTAB Dec. 10, 2014)
`(Paper 25) (Informative), slip op. at 6 (PTAB July 7, 2014) (Paper 17), cited
`in NVIDIA Corp. v. Samsung Elec. Co., Case IPR2016-00134, slip op. at 6–
`7 (PTAB May 4, 2016) (Paper 9); see also Amendments to the Rules of
`Practice for Trials Before the Patent Trial and Appeal Board, 77 Fed. Reg.
`18750, 18759 (Apr. 1, 2016) (“[T]he current rules provide sufficient
`flexibility to address the unique factual scenarios presented to handle
`efficiently and fairly related proceedings before the Office on a case-by-case
`basis, and that the Office will continue to take into account the interests of
`justice and fairness to both petitioners and patent owners where multiple
`proceedings involving the same patent claims are before the Office.”).
`Having reviewed the Petition and Janssen’s Preliminary Response, we
`incorporate our analysis from our institution decision in the Amerigen IPR.
`IPR2016-00286, Paper 14, 4–15. For the same reasons given in the
`institution decision in the Amerigen IPR, we determine that Mylan has
`demonstrated a reasonable likelihood that it would prevail with respect to its
`challenge to claims 1–20 of the ’438 patent on the asserted grounds.
`Although we have discretion to reject a petition when the same or
`substantially the same prior art or arguments previously were presented to
`the Office (35 U.S.C. § 325(d)), we decline to exercise that discretion here.
`Mylan brings the same challenges brought by Amerigen and Argentum, but
`supports them with additional evidence and with two different declarations
`from two different declarants. The depositions of those declarants, as well
`as the additional evidence presented by Mylan, may affect the course of this
`trial relative to the course of the trial in IPR2016-00286. For example,
`
`
`
`5
`
`
`
`IPR2016-01332
`Patent 8,822,438 B2
`Janssen states that Mylan’s “new testimony would force Janssen to engage
`in discovery and briefing not currently contemplated” in the Amerigen IPR.
`Opp. 6–7.
`Moreover, it appears that this case will involve arguments concerning
`objective indicia of non-obviousness, which involves a fact-specific analysis
`that often turns on evidence presented during trial. Pet. 51–61. A patent
`owner generally presents arguments based on objective indicia in response
`to a petitioner’s allegations of obviousness. Here, Mylan preemptively
`presented arguments directed to objective indicia. Id. Janssen presented
`arguments directed to objective indicia in its Preliminary Response in the
`Amerigen IPR (IPR2016-00286, Paper 12, 46–52), but has not presented the
`same arguments in the Preliminary Response in this case. As such, the
`objective indicia arguments possibly differ between the Amerigen IPR and
`the present case. Because evidence directed to objective indicia typically
`develops during trial, we cannot assume, at this stage, that the arguments to
`be made during the course of the trial are the same or similar to those made
`in IPR2016-00286.
`Other than these differences, however, both the instant Petition and
`the petition in the Amerigen IPR assert substantially the same two
`challenges to patentability. Thus, given this substantial similarity in
`proceedings, we do not perceive that either Janssen or the Board will be
`overwhelmed with an unreasonable number of challenges to patentability.
`While we recognize Janssen’s concern with respect to the need to
`defend its patent in multiple inter partes review proceedings, the present
`Petition was timely filed within the one year time set by Congress in 35
`
`
`
`6
`
`
`
`IPR2016-01332
`Patent 8,822,438 B2
`U.S.C. § 315(b).6 The time elapsed between the filing of Amerigen’s
`petition in IPR2016-00286 and the filing of Mylan’s Petition in this case was
`approximately six months, which is not excessive for purposes of institution.
`Unlike other cases in which we have exercised our discretion under
`§ 325(d) to deny institution of a follow-on petition, based on the particular
`facts of this case, we are not presented with a second bite at the apple by an
`identical petitioner. In addition, Mylan does not seek to cure any problems
`of the petition in IPR2016-00286 with the filing of the present Petition.
`Also, we have not decided the outcome in IPR2016-00286.
`In view of the challenges in the Petition, and having considered
`Janssen’s arguments in the Patent Owner 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. We decline to exercise our discretion
`under 35 U.S.C. § 325(d) to reject the Petition.
`II. MOTION FOR JOINDER
`In the Motion for Joinder, Mylan seeks joinder “of the above-
`
`captioned inter partes review (hereinafter ‘Mylan IPR’) with the pending
`inter partes review concerning the same patent and the same grounds of
`invalidity in” the Amerigen IPR. Mot. 1. Mylan filed the present Motion on
`June 30, 2016, within one month of our decision instituting inter partes
`review in IPR2016-00286, which issued on May 31, 2016. See IPR2016-
`
`
`6 35 U.S.C. § 315(b) states, in part, that “[a]n inter partes review may not be
`instituted if the petition requesting the proceeding is filed more than 1 year
`after the date on which the petitioner . . . is served with a complaint alleging
`infringement of the patent.”
`
`7
`
`
`
`
`
`IPR2016-01332
`Patent 8,822,438 B2
`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:
`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.
`
`Joinder may be authorized when warranted, but the decision to grant joinder
`is discretionary. 35 U.S.C. § 315(c); 37 C.F.R. § 42.122(b).
`As the moving party, Mylan 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; and (3) explain what
`impact (if any) joinder would have on the trial schedule for the existing
`review. See Frequently Asked Question H5, https://www.uspto.gov/patents-
`application-process/patent-trial-and-appeal-board/ptab-e2e-frequently-
`asked-questions (last visited January 3, 2017). Patent trial regulations,
`including the rules for joinder, must be construed to secure the just, speedy,
`and inexpensive resolution of every proceeding. 37 C.F.R. § 42.1(b).
`
`
`
`8
`
`
`
`IPR2016-01332
`Patent 8,822,438 B2
`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 Mylan 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 Mylan as a Petitioner to
`the Amerigen IPR.
`In its Motion for Joinder, Mylan 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. 1. Mylan represents that joinder with the Amerigen IPR is
`appropriate because the grounds proposed in the present Petition are “the
`same grounds of invalidity on which the Board instituted the Amerigen
`IPR.” Mot. 3. Mylan further argues that (a) joinder will not impact the
`Board’s ability to complete the review in a timely manner; (b) joinder will
`promote efficiency by consolidating issues, avoiding duplicate efforts, and
`preventing inconsistencies; (3) joinder will not prejudice Janssen or
`Amerigen. Mot. 4–6.
`Janssen filed an Opposition to Mylan’s Motion for Joinder, stating
`that “the Board should deny Mylan’s motion because it introduces new
`exhibits, including two new expert declarations” and because “Mylan also
`fails to specify how its petition differs from Amerigen’s petition and it cites
`no Board decisions to support what it seeks to do here.” Opp. 1.
`Specifically, Janssen argues that (a) Mylan’s Petition introduces new
`evidence and testimony that would prejudice Janssen by unduly
`complicating the Amerigen IPR if joinder is allowed; (b) Mylan’s Motion
`
`
`
`9
`
`
`
`IPR2016-01332
`Patent 8,822,438 B2
`for Joinder fails to specify how its Petition differs from Amerigen’s petition
`and how briefing and discovery may be simplified; and (c) Mylan cites no
`Board decision granting joinder where a petitioner requesting joinder sought
`to rely on expert testimony from a different expert. Opp. 6–11.
`In its Reply, Mylan asserts that the Board should grant joinder,
`because its new exhibits, apart from the two expert declarations, “simply
`complete the record.” Reply 3. Regarding its expert declarations, Mylan
`argues that “taking a single deposition” does not present the type of
`prejudicial burden that counsels in favor of denying joinder.7 Id. at 2.
`Mylan relies on Torrent Pharms. Ltd. v. Novartis AG, Case IPR2014-00784,
`in support of its assertion that related discovery would not be an undue
`burden. Id. at 3–4.
`In view of the circumstances of this case, we are not persuaded that
`Mylan has established sufficiently that joinder to the Amerigen IPR is
`warranted. Granting joinder in view of Mylan’s two different declarations
`and new evidence would add an additional dimension to the substantive
`issues in the Amerigen IPR, and thus would be more significant than Mylan
`suggests. Although the parties have conferred and cooperated on certain
`matters in this proceeding, their inability to agree on several critical issues in
`connection with facilitating joinder further differentiates this case from other
`
`
`7 Janssen states that Mylan “has represented to Janssen off the record that it
`is willing to withdraw the Hofmann Declaration to rely solely on the
`McDuff Declaration,” but that “Mylan is not willing to withdraw the
`Garnick Declaration to rely solely on the Serels Declaration.” Opp. 3 n.2.
`Off-the-record representations notwithstanding, we have before us in this
`case two declarations from two different declarants on Mylan’s behalf.
`10
`
`
`
`
`
`IPR2016-01332
`Patent 8,822,438 B2
`cases in which the parties have cooperated and in which we have granted
`joinder.
`Additionally, granting joinder would add significant procedural
`complications and delay to the progress of the Amerigen IPR. In the
`Amerigen IPR, Janssen has filed its Response, and the date for the oral
`hearing is only a few weeks away. Granting joinder would require adjusting
`the schedule to allow Janssen discovery regarding the different declarants’
`testimony and the additional evidence associated with the present Petition.
`Mylan’s Motion for Joinder does not offer a practical way to accommodate
`the additional discovery without inconveniencing all involved or delaying
`the due dates in the Amerigen IPR.
`In view of the facts and circumstances of this case, Mylan, as movant,
`has not met its burden to show why joinder is appropriate, consistent with
`the goal of securing the just, speedy, and inexpensive resolution of every
`proceeding. Based on the record before us, and for the reasons given above,
`we institute an inter partes review in IPR2016-01332. However, we decline
`to exercise our discretion to join Mylan as a Petitioner to the Amerigen IPR.
`In view of the timeline of the Amerigen IPR, and in view of the number of
`common issues between the cases, we implement a condensed schedule in
`the present case to allow for resolution of these two cases involving the ’438
`patent in relative proximity to each other.
`
`IV. ORDER
`
`Accordingly, it is
`ORDERED that trial is instituted in IPR2016-01332 as to claims 1–20
`of the ’438 patent on the following grounds only:
`
`
`
`11
`
`
`
`IPR2016-01332
`Patent 8,822,438 B2
`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 no grounds other than the ones
`specifically granted above are authorized for inter partes review as to the
`claims of the ’438 patent;
`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(c) and
`37 C.F.R. § 42.4, notice is given of the institution of a trial commencing on
`the entry date of this Decision; and
`FURTHER ORDERED that Mylan’s Motion for Joinder is denied.
`
`
`
`
`
`12
`
`
`
`IPR2016-01332
`Patent 8,822,438 B2
`FOR PETITIONER:
`Brandon M. White
`bmwhite@perkinscoie.com
`Crystal Canterbury
`ccanterbury@perkinscoie.com
`
`FOR PATENT OWNER:
`Dianne Elderkin
`delderkin@akingump.com
`Barbara Mullin
`bmullin@akingump.com
`Ruben Munoz
`rmunoz@akingump.com
`
`
`
`13
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