Trials@uspto.gov
`571-272-7822
`
`
`
`
`Paper 29
`Entered: January 19, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`WOCKHARDT BIO AG,
`Petitioner,
`
`v.
`
`
`
`
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01582
`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
`37 C.F.R. § 42.108
`
`
`571-272-7822
`
`
`
`
`Paper 29
`Entered: January 19, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`WOCKHARDT BIO AG,
`Petitioner,
`
`v.
`
`
`
`
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-01582
`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
`37 C.F.R. § 42.108
`
`
`
`IPR2016-01582
`Patent 8,822,438 B2
`
`
`I. INTRODUCTION
`
`Wockhardt Bio AG (“Petitioner”) filed a Petition (Paper 4, “Pet.”) to
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`institute an inter partes review of claims 1–20 of U.S. Patent No. 8,822,438
`
`B2 (Ex. 1001, “the ’438 patent”) pursuant to 35 U.S.C. §§ 311–319. Janssen
`
`Oncology, Inc. (“Patent Owner”) filed a Preliminary Response (Paper 13,
`
`“Prelim. Resp.”). Pursuant to Board authorization (Paper 17), Petitioner filed
`
`a Reply to Patent Owner’s Preliminary Response (Paper 22, “Reply”) and
`
`Patent Owner filed a Surreply to Petitioner’s Reply (Paper 27, “Surreply”).
`
`Applying the standard set forth in 35 U.S.C. § 314(a), which requires
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`demonstration of a reasonable likelihood that Petitioner would prevail with
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`respect to at least one challenged claim, we institute an inter partes review as
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`to claims 1–20 as discussed below.
`
`Our findings of fact and conclusions of law, including those relating to
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`the broadest reasonable construction of the patent claim terms, are based on
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`the record developed thus far, prior to Patent Owner’s Response. This is not
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`a final decision as to the patentability of any challenged claim. Our final
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`decision will be based on the full record developed during trial.
`
`A. Related Matters
`
`II. BACKGROUND
`
`The parties indicate that the ’438 patent is being asserted in a number
`
`of district court proceedings, some of which have been terminated. Pet. 66;
`
`Paper 8, 2–4. Of those, Patent Owner represents that the following
`
`proceedings have not been terminated: BTG Int’l Ltd. v. Actavis Labs. FL,
`
`Inc., C.A. No. 2:15-cv-05909-KM-JBC (D. N.J.); Janssen Biotech, Inc. v.
`
`Mylan Pharm. Inc., C.A. No. 1:15-cv-00130-IMK (N.D. W. Va.); BTG Int’l
`
`Ltd. v. Amerigen Pharm., Inc., C.A. No. 2:16-cv-02449-KM-JBC (D. N.J.)
`
`
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`2
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`IPR2016-01582
`Patent 8,822,438 B2
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`and BTG Int’l Ltd. v. Glenmark Pharm. Inc., C.A. No. 2:16-cv-05909 (D.
`
`N.J.). Paper 8, 3–4. The ’438 patent is the subject of inter partes review
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`numbers IPR2016-00286 (instituted May 31, 2016), IPR2016-01337
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`(instituted and joined with IPR2016-00286 on September 19, 2016) and
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`IPR2016-01332. Id. at 2–3. Patent Owner also states that the ’438 patent
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`“was the subject of ex parte reexamination request No. 90/020,096,” but
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`“will not be granted a filing date for failure to comply with the requirements
`
`of 37 C.F.R. § 1.501(a).” Id. at 2.
`
`B. The ’438 Patent
`
`The ’438 patent, titled “Methods and Compositions for Treating
`
`Cancer,” describes methods that comprise “administering a 17α-
`
`hydroxylase/C17, 20-lyase inhibitor, such as abiraterone acetate (i.e., 3β-
`
`acetoxy-17-(3-pyridyl)androsta-5,16-diene), in combination with at least one
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`additional therapeutic agent such as an anti-cancer agent or a steroid.” Ex.
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`1001, Title, Abstract. As described in the ’438 patent, it is believed that
`
`testosterone and dihydrotestosterone promote the growth of prostate cancer.
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`Id. at 1:49–51. Hormone therapy can be used to suppress the production or
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`block the effects of hormones such as testosterone. Id. at 1:43–51.
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`The enzyme 17α-hydroxylase/C17, 20-lyase (“CYP17”) is involved in
`
`testosterone synthesis. Id. at 3:66–4:1. CYP17 inhibitors have been shown
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`to be useful in the treatment of cancer, specifically, androgen-dependent
`
`disorders like prostate cancer. Id. at 5:23–27. Abiraterone acetate, a prodrug
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`of abiraterone, is a CYP17 inhibitor. Id. at 2:10–12. The ’438 patent
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`describes administration of an effective amount of a CYP17 inhibitor, such as
`
`abiraterone acetate, with a steroid such as prednisone or dexamethasone. Id.
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`at 2:9–3:20.
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`IPR2016-01582
`Patent 8,822,438 B2
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`C. Claims
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`Claim 1 of the ’438 patent is reproduced below:
`
`1. A method for the treatment of a prostate cancer in a human
`comprising administering to said human a therapeutically
`effective amount of abiraterone acetate or a pharmaceutically
`acceptable salt thereof and a therapeutically effective amount
`of prednisone.
`
`Ex. 1001, 16:16–20. Dependent claims 2–20 of the ’438 patent describe
`
`additional limitations of the method, including the amount of abiraterone
`
`acetate and the amount of prednisone administered, and the type of prostate
`
`cancer being treated. Id. at 16:21–17:14.
`
`D. The Prior Art
`
`Petitioner relies on the following prior art:
`
`1. Gerber, G.S. & Chodak, G.W., Prostate specific antigen for
`assessing response to ketoconazole and prednisone in
`patients with hormone refractory metastatic cancer, 144 J.
`Urol. 1177–79 (1990) (“Gerber”) (Ex. 1004);
`
`2. 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 2317–2325 (2004) (“O’Donnell”) (Ex. 1005); and
`
`3. Sartor, O. et al., Effect of prednisone on prostate-specific
`antigen in patients with hormone-refractory prostate cancer,
`52 Urology 252–256 (1998) (“Sartor”) (Ex. 1006).
`
`
`Petitioner also relies on the Declarations of Dr. Paul A. Godley (Ex.
`
`1002, the “Godley Declaration”) and Dr. Robert Stoner (Ex. 1077, the
`
`“Stoner Declaration”) in support of its arguments.
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`IPR2016-01582
`Patent 8,822,438 B2
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`E. The Asserted Ground
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`Petitioner challenges claims 1–20 of the ’438 patent on the following
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`ground:
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`References
`
`Basis
`
`Claims Challenged
`
`Gerber, O’Donnell, and
`Sartor
`
`§ 103(a) 1–20
`
`
`
`III. ANALYSIS
`
`We turn now to Petitioner’s asserted ground of unpatentability, Patent
`
`Owner’s arguments in the Preliminary Response, the Reply, the Surreply, and
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`the supporting evidence to determine whether Petitioner has met the
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`threshold standard of 35 U.S.C. § 314(a).
`
`A. Claim Interpretation
`
`The Board interprets claims in an unexpired patent using the “broadest
`
`reasonable construction in light of the specification of the patent in which
`
`[they] appear[].” 37 C.F.R. § 42.100(b); see Cuozzo Speed Techs., LLC v.
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`Lee, 136 S.Ct. 2131, 2144–46 (2016) (upholding the use of the broadest
`
`reasonable interpretation standard). Under the broadest reasonable
`
`interpretation standard, claim terms are generally given their ordinary and
`
`customary meaning in view of the specification, as would be understood by
`
`one of ordinary skill in the art at the time of the invention. In re Translogic
`
`Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007).
`
`Petitioner proposes that we construe the claim terms “treat,” “treating,”
`
`“treatment,” and “therapeutically effective amount of prednisone.” Pet. 20–
`
`21. Petitioner notes that these claim terms have already been construed in
`
`IPR2016-00286, Paper 14, and states that it analyzes the claims under those
`
`constructions for the purpose of this proceeding. Id. Patent Owner does not
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`Patent 8,822,438 B2
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`propose any claim constructions in its Preliminary Response. As proposed
`
`by Petitioner, we apply our claim constructions of “treat,” “treating,”
`
`“treatment,” and “therapeutically effective amount of prednisone,” as set
`
`forth in IPR2016-00286, to the present case. IPR2016-00286, Paper 14, 5–7.
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`The terms “treat,” “treating,” and “treatment” are discussed and
`
`defined explicitly in the specification of the ’438 patent. Ex. 1001, 3:46–50.
`
`Accordingly, we construe those terms to “include the eradication, removal,
`
`modification, management or control of a tumor or primary, regional, or
`
`metastatic cancer cells or tissue and the minimization or delay of the spread
`
`of cancer.”
`
`Regarding the phrase “therapeutically effective amount of prednisone,”
`
`the definition in the specification provides: “As used herein, and unless
`
`otherwise defined, the phrase ‘therapeutically effective amount’ when used in
`
`connection with a 17α- hydroxylase/C17, 20-lyase inhibitor or therapeutic agent
`
`means an amount of the 17α-hydroxylase/C17, 20-lyase inhibitor or therapeutic
`
`agent effective for treating a disease or disorder disclosed herein, such as
`
`cancer.” Ex. 1001, 4:17–22. The specification’s definition of
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`“therapeutically effective amount,” applies to a therapeutic agent. Id. The
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`specification provides examples of a “therapeutic agent” such as “an anti-
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`cancer agent or a steroid, e.g., a corticosteroid or, more specifically, a
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`glucocorticoid.” Id. at 1:14–16. Thus, the definition of “therapeutically
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`effective amount” in the specification would apply to prednisone, a
`
`glucocorticoid. Id. at 3:10–11. Furthermore, claim 1 is directed to “A
`
`method for the treatment of a prostate cancer in a human.” Id. at 16:16–17.
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`Based on the definition and discussion the specification, and the manner in
`
`which the term is used in the claims, we construe “therapeutically effective
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`IPR2016-01582
`Patent 8,822,438 B2
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`amount of prednisone” as “an amount of prednisone effective for treating
`
`prostate cancer.”
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`B. Ground Asserted by Petitioner
`
`Petitioner challenges claims 1–20 as obvious under 35 U.S.C. § 103(a)
`
`over Gerber, O’Donnell, and Sartor. Pet. 23–46.
`
`Gerber
`
`Gerber, which is titled “Prostate Specific Antigen for Assessing
`
`Response to Ketoconazole and Prednisone in Patients with Hormone
`
`Refractory Metastatic Prostate Cancer,” discloses use of ketoconazole, a
`
`known CYP17 inhibitor and inhibitor of gonadal and adrenocortical steroid
`
`synthesis, with prednisone to treat patients with progressive prostate cancer.
`
`Ex. 1004, 1177. Gerber provides that patients exhibiting progressively
`
`increasing prostate specific antigen (“PSA”) levels, when treated with
`
`ketoconazole and prednisone, experienced a decrease in PSA levels. Id.
`
`at 1178–79.
`
`O’Donnell
`
`O’Donnell, which is titled “Hormonal impact of the 17α-
`
`hydroxylase/C17, 20-lyase inhibitor abiraterone acetate (CB7630) in patients
`
`with prostate cancer,” discloses that treatment of prostate cancer with
`
`abiraterone acetate, at a dose of 500–800 mg, can successfully suppress
`
`testosterone levels. Ex. 1005, Abstract. O’Donnell also discloses that
`
`ketoconazole, another CYP17 inhibitor, has been evaluated as a possible
`
`agent with which to achieve decreased production of adrenal steroids, but that
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`abiraterone acetate was developed as a more selective inhibitor. Id. at 2318.
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`O’Donnell further discloses that adrenocortical suppression may require
`
`administration of replacement glucocorticoid. Id. at Abstract, 2323.
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`IPR2016-01582
`Patent 8,822,438 B2
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`O’Donnell states that “[s]ome impact on adrenal reserve was predictable
`
`from the steroid synthesis pathway.” Id. at 2323. Regarding administration
`
`of ketoconazole, O’Donnell states that “it is common practice to administer
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`supplementary hydrocortisone” and that this may prove necessary with
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`abiraterone acetate. Id. On the basis of the clinical evidence, O’Donnell
`
`reports that the need for concomitant therapy of abiraterone acetate with a
`
`glucocorticoid needs to be further investigated. Id.
`
`Sartor
`
`Sartor, which is titled “Effect of Prednisone on Prostate-Specific
`
`Antigen in Patients with Hormone-Refractory Prostate Cancer,” discloses a
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`trial in which patients with hormone-refractory progressive prostate cancer,
`
`who were not receiving concomitant anticancer therapies, were treated with
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`10 mg of prednisone orally two times a day. Ex. 1006, Abstract. Sartor
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`discloses that administration of prednisone alone, as shown by its results, led
`
`to an average decline of 33% in PSA responses after initiating prednisone; a
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`majority of patients had PSA progression-free survival for a matter of months
`
`following treatment. Id. at 254, Table III. Sartor concludes that prednisone
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`“can decrease PSA by more than 50% in approximately one third of patients”
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`and hypothesizes “a dose-responsive relationship between glucocorticoid
`
`dose and PSA decline.” Id. at Abstract.
`
`Arguments
`
`Petitioner argues that Gerber teaches co-administering the CYP17
`
`inhibitor ketoconazole with prednisone to treat prostate cancer. Pet. 28–29
`
`(citing Ex. 1004, 1177–1179). Petitioner further argues that abiraterone
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`acetate “was known to be a potent and more specific inhibitor of CYP17 than
`
`ketoconazole and it effectively reduced testosterone levels” (citing Ex. 1002
`
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`IPR2016-01582
`Patent 8,822,438 B2
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`¶ 72) and that O’Donnell discloses administering abiraterone acetate to
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`castrate and non-castrate males (citing Ex. 1005, 2320–2321, 2324). Id.
`
`at 29–30. Finally, Petitioner argues that “prednisone was known to treat
`
`prostate cancer, as well as to offset the side effects from administering a
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`CYP17 inhibitor, such as abiraterone acetate and ketoconazole” (citing Ex.
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`1002 ¶¶ 75–84), and that Sartor “teaches administering 20 mg/day prednisone
`
`as a monotherapy in patients with mCRPC” (citing Ex. 1006, 252–254). Id.
`
`at 31. Petitioner presents a claim chart for claim 1, citing prior art disclosure
`
`that Petitioner alleges teaches each element of claim 1. Id. at 25–28.
`
`Petitioner argues that one of ordinary skill in the art “would have had a
`
`reason to modify Gerber’s method of administering ketoconazole to use
`
`abiraterone acetate, as taught in O’Donnell” because “abiraterone acetate is a
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`potent and more selective inhibitor of CYP17 than ketoconazole and that
`
`abiraterone acetate effectively suppressed testosterone levels in both castrate
`
`and non-castrate males.” Pet. 24 (citing Ex. 1002 ¶ 67). Additionally,
`
`Petitioner argues, one of ordinary skill in the art “would have had a reason to
`
`maintain coadministration of prednisone, as taught in Gerber, because
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`prednisone was known to treat prostate cancer on its own, as demonstrated by
`
`Sartor.” Id. (citing Ex. 1002 ¶ 68). Petitioner summarizes that one of
`
`ordinary skill in the art, reading Gerber, O’Donnell, and Sartor “would have
`
`had a reason to co-administer a therapeutically effective amount of
`
`prednisone with abiraterone acetate because (1) prednisone was known to
`
`treat prostate cancer and (2) prednisone would reduce the side effects of
`
`mineralocorticoid excess that could result from abiraterone acetate
`
`treatment.” Id. at 33–34 (citing Ex. 1002 ¶¶ 83–84). Patent Owner does not
`
`specifically address Petitioner’s arguments directed to how the prior art
`
`
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`9
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`allegedly teaches claim 1. See generally Prelim. Resp. Regarding dependent
`
`claims 2–20, Petitioner argues that the additional limitations found in the
`
`dependent claims also are obvious over Gerber, O’Donnell, and Sartor. Id. at
`
`36–46. Patent Owner does not specifically address Petitioner’s arguments
`
`directed to the dependent claims.
`
`On this record, we are persuaded by Petitioner’s arguments and
`
`presentation of the evidence. Gerber discloses co-administration of a
`
`glucocorticoid, prednisone, with ketoconazole for the safe and effective
`
`treatment of prostate cancer. Ex. 1004, 1179. O’Donnell suggests that co-
`
`administration of a glucocorticoid, of which prednisone is one, may be
`
`needed in connection with administration of abiraterone acetate in the
`
`treatment of prostate cancer. Ex. 1005, 2323. Ketoconazole and abiraterone
`
`acetate are both characterized as CYP17 inhibitors. Id. at 2318; Ex. 1002 ¶¶
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`36, 38. Sartor discloses that, even without a concomitant anticancer therapy
`
`such as a CYP17 inhibitor, prednisone as a monotherapy results in a PSA
`
`decline in patients with hormone-refractory prostate cancer. Ex. 1006, 253–
`
`254. We are persuaded, on this record, that that a person of ordinary skill in
`
`the art “would have reasonably expected each of abiraterone acetate and
`
`prednisone to treat prostate cancer when co-administered” (Pet. 25) and that,
`
`therefore, Petitioner has demonstrated a reasonable likelihood of prevailing
`
`on its obviousness challenge to claim 1.
`
`Claims 2–20 each depend directly or indirectly from claim 1.
`
`Petitioner contends these claims are also unpatentable under 35 U.S.C.
`
`§ 103(a) based on Gerber, O’Donnell, and Sartor. Pet. 36–46. Concerning
`
`these claims, we determine that the supporting evidence demonstrates a
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`reasonable likelihood that Petitioner would prevail in its showing, the
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`substance of which has not been addressed specifically by Patent Owner.
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`In view of the arguments and the evidence before us, therefore, we are
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`persuaded that Petitioner has demonstrated a reasonable likelihood of
`
`prevailing on its assertion that claims 1–20 are obvious over Gerber,
`
`O’Donnell, and Sartor.
`
`1. Objective Indicia of Non-Obviousness
`
`Petitioner contends that the Patent Owner may try to rely on secondary
`
`considerations of non-obviousness. Pet. 46–65. Specifically, Petitioner pre-
`
`emptively raises arguments and evidence relating to unexpected results,
`
`commercial success, long-felt need and failure of others, and copying. Pet.
`
`48–59. Patent Owner does not present any arguments directed to objective
`
`indicia of non-obviousness.
`
`The issue of secondary considerations is highly fact-specific. At this
`
`stage of the proceeding, the record regarding such secondary considerations
`
`is incomplete. Based on the record before us, and Patent Owner’s lack of
`
`argument on this issue, Petitioner’s preemptive evidence regarding lack of
`
`objective indicia anticipates arguments not yet made by Patent Owner. Thus,
`
`we have an inadequate framework to determine whether evidence of
`
`secondary considerations is insufficient to preclude trial. Evidence of
`
`secondary considerations should be more fully evaluated in the context of a
`
`trial when the ultimate determination of obviousness is made. We conclude
`
`that the information presented in the Petition on the matter of obviousness
`
`establishes a reasonable likelihood that the Petitioner will prevail in
`
`challenges to claims 1–20 of the ’438 patent, but we do not make any
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`determination as to objective indicia of non-obviousness on the record before
`
`us at present.
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`2. Patent Owner’s Arguments
`
`Patent Owner makes several arguments in its Preliminary Response,
`
`namely: (A) Petitioner fails to identify Amerigen as a real party-in-interest;
`
`and (B) the Petition should be denied under 35 U.S.C. § 325(d). We address
`
`these arguments in turn.
`
`(A) Real party-in-interest
`
`The Petition identifies as real parties-in-interest “Wockhardt Bio AG,
`
`Wockhardt Limited, Wockhardt USA LLC, Morton Grove Pharmaceuticals,
`
`Inc., and MGP Inc.” Pet. 66. According to Patent Owner, however, because
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`the Petition “fails to identify Amerigen as a RPI,” it is “defective on its face
`
`and should be denied pursuant to 35 U.S.C. § 312(a)(2).” Prelim. Resp. 8.
`
`A petition for inter partes review under 35 U.S.C. § 311 may be
`
`considered only if, among other things, the petition identifies all real parties-
`
`in-interest. 35 U.S.C. § 312(a)(2). The Office Patent Trial Practice Guide
`
`explains that, in the context of an inter partes review and at a general level,
`
`the real party-in-interest “is the party that desires review of the patent.”
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`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,759 (Aug. 14,
`
`2012). The real party-in-interest “may be the petitioner itself, and/or it may
`
`be the party or parties at whose behest the petition has been filed.” Id.
`
`Whether a non-identified party is a real party-in-interest to a
`
`proceeding is “a highly fact-dependent question” that is assessed “on a case-
`
`by-case basis taking into consideration how courts have viewed the term[]
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`‘real party-in-interest.’” Id. (citing Taylor v. Sturgell, 553 U.S. 880 (2008)).
`
`“A common consideration is whether the non-party exercised or could have
`
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`exercised control over a party’s participation in a proceeding.” Id. (citing
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`Taylor, 553 U.S. at 893–95). Relevant factors may include the non-party’s
`
`relationship with the petitioner; the non-party’s relationship to the petition
`
`itself, including the nature and/or degree of involvement in the filing; and the
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`nature of the petitioner. Id. at 48,760.
`
`The Board generally accepts a petitioner’s real party-in-interest
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`identification at the time of filing the petition. 77 Fed. Reg. 48,680, 48,695
`
`(Aug. 14, 2012) (Changes to Implement Inter Partes Review Proceedings,
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`Post-Grant Review Proceedings, and Transitional Program for Covered
`
`Business Method Patents, Response to Comment 9) (“The Office generally
`
`will accept the petitioner’s ‘real party-in-interest’ identification at the time of
`
`filing the petition.”). A “patent owner may provide objective evidence to
`
`challenge the identification in a preliminary response, which the Board will
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`consider in determining whether to grant the petition.” Id.
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`Patent Owner argues that, based on communications from Petitioner’s
`
`counsel to Patent Owner’s counsel, Petitioner and Amerigen are “engaged in
`
`a business relationship” that involves “common strategies relating to the ’438
`
`patent that have been (and remain) closely coordinated and structured.”
`
`Prelim. Resp. 10. Patent Owner analyzes the terms of the settlement offer set
`
`forth in an email exchange between Petitioner’s counsel and Patent Owner’s
`
`counsel (Ex. 2002) to conclude that Petitioner and Amerigen “effectively
`
`exercise a degree of control over the other’s efforts to attack the ’438 patent,
`
`including this IPR proceeding.” Id. at 11. Patent Owner also relies on the
`
`Declaration of Ms. Jennifer Reda, counsel for Patent Owner, relaying the
`
`details of a phone call in which Petitioner’s counsel indicated Petitioner
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`would file a separate IPR rather than filing a motion to join the Amerigen
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`IPR. Id. at 7 (citing Ex. 2003 ¶ 9).
`
`Petitioner responds that Amerigen is not a real party-in-interest,
`
`because “Amerigen has never funded, controlled, or in any other way been
`
`involved in this proceeding.” Reply 1. Relying on the Declaration of
`
`corporate representative Mr. Gopal Venkatesan (Ex. 1081), Petitioner asserts
`
`that Patent Owner has not demonstrated “that Amerigen funded or had any
`
`ability to control this proceeding;” that Petitioner and Amerigen “are entirely
`
`separate and unrelated corporations;” that Petitioner has “no corporate
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`relationship with Amerigen, has never entered into a contract of any sort with
`
`Amerigen, has never had a financial dealings with Amerigen, and did not
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`coordinate or otherwise collaborate with Amerigen with respect to this IPR.”
`
`Id. Rather, Petitioner and Amerigen “are nothing more than codefendants in
`
`a joint defense group with respect to the underlying district court litigation”
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`and “deliberately chose not to be involved in each other’s IPR filings.” Id. at
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`1–2. Petitioner characterizes the settlement negotiations embodied in Exhibit
`
`2002 as inadmissible under Fed. R. Evid. 408 as compromise offers and
`
`negotiations, but nevertheless argues that these communications do not
`
`establish funding or control by Amerigen, nor that Petitioner has authority to
`
`settle a dispute on Amerigen’s behalf. Id. at 6–7.
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`Patent Owner replies that the undisputed evidence demonstrates that
`
`Wockhardt and Amerigen are more than just codefendants in a patent lawsuit.
`
`Surreply 2. Patent Owner criticizes Mr. Venkatesan’s declaration for failing
`
`
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`14
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`
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`IPR2016-01582
`Patent 8,822,438 B2
`
`to refer to the communication between Petitioner’s counsel and Patent
`
`Owner’s counsel, and as not credible on the issue of control. Id. at 3–4.
`
`Although we may consider the relationship between the parties, the
`
`focus of our real party-in-interest inquiry is the relationship between a party
`
`and a proceeding. Aruze Gaming Macau, Ltd. v. MGT Gaming, Inc., Case
`
`IPR2014–01288, slip op. at 11 (PTAB Feb. 20, 2015) (Paper 13). Patent
`
`Owner may provide objective evidence to challenge Petitioner’s
`
`identification of real parties-in-interest in a preliminary response; here, Patent
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`Owner provided an exhibit containing an email exchange between counsel
`
`for Petitioner and counsel for Patent Owner as the initial basis for its
`
`allegation, supported by a Declaration by Patent Owner’s counsel. We are
`
`not persuaded at this juncture that FRE 408 applies to the email exchange, as
`
`the evidence is being offered for a purpose other than to prove or disprove the
`
`validity or amount of a disputed claim or to impeach by a prior inconsistent
`
`statement or a contradiction. We have reviewed this email exchange and the
`
`Declaration and do not find them supportive of Patent Owner’s allegations.
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`A reasonable reading of correspondence in Exhibit 2002 indicates that
`
`Petitioner’s counsel presented to Patent Owner’s counsel “Terms for
`
`Wockhardt,” a four-item outline of litigation settlement terms for Petitioner,
`
`and “Terms for Amerigen,” a separate three-item outline of litigation
`
`settlement terms for Amerigen. The terms proffered in the June 8, 2016
`
`email concerned the pending litigation, not the present Petition. Although
`
`Petitioner’s counsel presumably communicated with Amerigen’s counsel to
`
`be in possession of Amerigen’s litigation settlement terms and to have the
`
`authority to communicate them to Patent Owner, this communication does
`
`not rise to the level of demonstrating Amerigen’s control over the present
`
`
`
`15
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`
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`IPR2016-01582
`Patent 8,822,438 B2
`
`IPR proceeding. Patent Owner provides no other evidence regarding its
`
`allegations.
`
`In view of the arguments and testimony presented by the parties at this
`
`juncture regarding whether Amerigen is a real party-in-interest to this
`
`proceeding, we are not persuaded that Petitioner “fails to identify Amerigen”
`
`as a real party-in-interest.
`
`(B) 35 U.S.C. § 325(d)
`
`Patent Owner requests that the Board exercise its discretion under
`
`35 U.S.C. § 325(d) and decline to initiate inter partes review of the ’438
`
`patent because the Petition presents the same prior art and substantially the
`
`same arguments as those presented in co-pending IPRs. Prelim. Resp. 15–21.
`
`In the Petition, Petitioner preemptively makes arguments directed to
`
`Patent Owner’s anticipated § 325(d) arguments: (1) the Petition relies on a
`
`different combination of prior art than the 286 IPR, including Sartor; (2) the
`
`Petition addresses the Board’s construction of “therapeutically effective
`
`amount of prednisone;” (3) Petitioner’s ground relies on the Godley
`
`Declaration and the Stoner Declaration, which have not been previously
`
`considered by the Board; (4) Petitioner has not previously challenged the
`
`’438 Patent and is not a party to the 286 IPR; and (5) the 286 IPR is still in
`
`the beginning stages. Pet. 22.
`
`Patent Owner argues, first, that the petition in the Argentum IPR and
`
`the present petition “rely on the same prior art and the same or substantially
`
`the same arguments raised in the Amerigen IPR.” Prelim. Resp. 16. Patent
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`Owner discounts Sartor as “adding nothing of substance to the prior art and
`
`arguments already presented in the Amerigen IPR.” Id. at 18. Patent Owner
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`further argues that Petitioner is involved in the Amerigen IPR, as argued in
`
`
`
`16
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`
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`IPR2016-01582
`Patent 8,822,438 B2
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`connection with its real party-in-interest arguments; that Petitioner’s
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`addressing the Board’s claim construction is insufficient to justify institution
`
`of this petition; and that the Amerigen IPR is no longer in its beginning
`
`stages. Id. at 19–20.
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`We have discretion under 35 U.S.C. § 325(d) to reject a petition when
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`the same or substantially the same prior art or arguments were presented
`
`previously to 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 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.”).
`
`
`
`17
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`
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`IPR2016-01582
`Patent 8,822,438 B2
`
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`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, we decline to exercise that discretion here. We agree that the present
`
`Petition and the Amerigen IPR petition rely on some of the same prior art.
`
`The present Petition, however, relies on Sartor, which was not a reference in
`
`the Amerigen IPR. The present Petition also does not rely on Barrie, a
`
`reference relied upon in the Amerigen IPR petition. Petitioner relies on
`
`different declarants than those relied upon in the Amerigen IPR. The
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`depositions of those declarants, as well as the additional evidence and
`
`reference presented by Petitioner, may affect the course of this trial relative
`
`to the course of the trial in the Amerigen IPR.
`
`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. 46–65. A patent
`
`owner generally presents arguments based on objective indicia in response to
`
`a petitioner’s allegations of obviousness. Here, Petitioner preemptively
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`presented arguments directed to objective indicia. Id. Patent Owner
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`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.
`
`
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`18
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`IPR2016-01582
`Patent 8,822,438 B2
`
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`Other than these differences, however, both the instant Petition and the
`
`petition in the Amerigen IPR assert similar challenges to patentability. We
`
`are mindful of the burden on Patent Owner and the Office to rehear the same
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`or substantially the same prior art or arguments that were considered
`
`previously by the Office. However, given the similar challenges in these two
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`proceedings, we do not perceive that either Patent Owner or the Board will be
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`overwhelmed with an unreasonable number of challenges to patentability.
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`Unlike other cases in which we have exercised our discreti
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