Trials@uspto.gov
`571-272-7822
`
`
`
`
`Paper 14
`Entered: May 31, 2016
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`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMERIGEN PHARMACEUTICALS LIMITED,
`Petitioner,
`
`v.
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`____________
`
`IPR2016-00286
`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 14
`Entered: May 31, 2016
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMERIGEN PHARMACEUTICALS LIMITED,
`Petitioner,
`
`v.
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`____________
`
`IPR2016-00286
`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
`
`
`
`IPR2016-00286
`Patent 8,822,438 B2
`
`
`I. INTRODUCTION
`Amerigen Pharmaceuticals Limited (“Petitioner”) filed a Petition
`(Paper 1, “Pet.”) to 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 12, “Prelim. Resp.”). Applying the standard set forth in
`35 U.S.C. § 314(a), which requires demonstration of a reasonable likelihood
`that Petitioner would prevail with respect to at least one challenged claim, we
`institute an inter partes review as to claims 1–20 as discussed below.
`Our findings of fact and conclusions of law, including those relating to
`the broadest reasonable construction of the patent claim terms, are based on
`the record developed thus far, prior to Patent Owner’s Response. This is not
`a final decision as to the patentability of any challenged claim. Our final
`decision will be based on the full record developed during trial.
`
`II. BACKGROUND
`
`A. Related Matters
`The parties indicate that the ’438 patent is being asserted in a number
`of District Court proceedings, some of which have been terminated. Pet. 1–
`2; Paper 6, 2–3. Patent Owner represents that the following proceedings have
`not been terminated: BTG Int’l Ltd., et al. v. Actavis Labs. FL, Inc., et al.,
`C.A. No. 2:15-cv-05909-KM-JBC (D. N.J.); and Janssen Biotech, Inc., et al.
`v. Mylan Pharm. Inc., et al., C.A. No. 1:15-cv-00130-IMK (N.D. W. Va.).
`Paper 13, 2–3. Patent Owner also states that the ’438 patent is “the subject of
`ex parte reexamination request No. 90/020,096, which has been assigned to
`an Office examiner for determination.” Id. at 2.
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`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
`additional therapeutic agent such as an anti-cancer agent or a steroid.” Ex.
`1001, Title, Abstract. As described in the ’438 patent, it is believed that
`testosterone and dihydrotestosterone promote the growth of prostate cancer.
`Id. at 1:49–51. Hormone therapy can be used to suppress the production or
`block the effects of hormones such as testosterone. Id. at 1:43–51. The
`enzyme 17α-hydroxylase/C17, 20-lyase (“CYP17”) is involved in testosterone
`synthesis. Id. at 3:66–4:1. CYP17 inhibitors have been shown to be useful in
`the treatment of cancer, specifically, androgen-dependent disorders like
`prostate cancer. Id. at 5:23–27. Abiraterone acetate, a prodrug of
`abiraterone, is a CYP17 inhibitor. Id. at 2:10–12. The ’438 patent describes
`administration of an effective amount of a CYP17 inhibitor, such as
`abiraterone acetate, with a steroid such as prednisone or dexamethasone. Id.
`at 2:9–3:20.
`C. Claims
`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
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`acetate and the amount of prednisone used, 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. 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); and
`3. U.S. Patent No. 5,604,213 to Barrie, issued February 18, 1997
`(“Barrie”) (Ex. 1005).
`
`
`
`Petitioner also relies on the declarations of Scott R. Serels, M.D. (Ex.
`1002, the “Serels Declaration”) and DeForest McDuff, Ph.D. (Ex. 1017, the
`“McDuff Declaration”) in support of its arguments.
`E. The Asserted Grounds
`Petitioner challenges claims 1–20 of the ’438 patent on the following
`grounds:
`References
`O’Donnell and Gerber
`
`Basis
`§ 103
`
`Claims Challenged
`1–20
`
`Barrie and Gerber
`
`§ 103
`
`1–4 and 6–11
`
`
`
`III. ANALYSIS
`We turn now to Petitioner’s asserted grounds of unpatentability, Patent
`Owner’s arguments in the Preliminary Response, and the supporting evidence
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`to determine whether Petitioner has met the 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 In re Cuozzo Speed Techs., LLC,
`793 F.3d 1268, 1275–79 (Fed. Cir. 2015), cert. granted sub nom. Cuozzo
`Speed Techs. LLC v. Lee, 136 S. Ct. 890 (mem.) (2016). Under the broadest
`reasonable interpretation standard, claim terms are 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,” “anti-cancer agent,” and “refractory cancer.” Pet. 17–19. Patent
`Owner accepts Petitioner’s definitions of those terms. Prelim. Resp. 18.
`These claim terms are discussed and defined explicitly in the specification of
`the ’438 patent, as noted by Petitioner. Pet. 18. Accordingly, we construe
`those terms as set forth in the specification and below:
`
`Claim term(s)
`“treat,” “treating,” and
`“treatment
`
`“anti-cancer agent”
`
`Construction
`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
`Ex. 1001, 3:46–50
`any therapeutic agent that directly or
`indirectly kills cancer cells or directly or
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`“refractory cancer”
`
`indirectly prohibits, stops or reduces the
`proliferation of cancer cells
`Ex. 1001, 4:8–16
`cancer that is not responding to an anti-
`cancer treatment or cancer that is not
`responding sufficiently to an anti-cancer
`treatment
`Ex. 1001, 4:23–27.
`
`
`Patent Owner proposes that we construe the phrase “therapeutically
`effective amount of prednisone” to mean “an amount of prednisone effective
`for treating cancer.” Prelim. Resp. 19. In support of its proposed
`construction, Patent Owner points to the definition in the specification, which
`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.” Id. at 18–19
`(quoting Ex. 1001, 4:17–22) (emphasis by Patent Owner). The
`specification’s definition of “therapeutically effective amount,” applies to a
`therapeutic agent. Ex. 1001, 4:17–22. The specification provides examples
`of a “therapeutic agent” such as “an anti-cancer agent or a steroid, e.g., a
`corticosteroid or, more specifically, a glucocorticoid.” Id. at 1:14–16. Thus,
`the definition of “therapeutically 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.”
`Ex. 1001, 16:16–17. Based on the definition and discussion the specification,
`and the manner in which the term is used in the claims, we construe
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`“therapeutically effective amount of prednisone” as “an amount of
`prednisone effective for treating prostate cancer.”
`B. Grounds Asserted by Petitioner
`1. Ground Based on O’Donnell and Gerber
`Petitioner challenges claims 1–20 as obvious under 35 U.S.C. § 103
`over O’Donnell and Gerber. Pet. 36–48. Patent Owner disputes Petitioner’s
`contentions. Prelim. Resp. 32–44.
`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. 1003, 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
`abiraterone acetate was developed as a more selective inhibitor. Id. at 2318.
`O’Donnell further discloses that adrenocortical suppression may require
`administration of replacement glucocorticoid. Id. at Abstract, 2323.
`O’Donnell states that “some 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
`supplementary hydrocortisone” and that this may prove necessary with
`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.
`Gerber, which is titled “Prostate Specific Antigen for Assessing
`Response to Ketoconazole and Prednisone in Patients with Hormone
`
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`Refractory Metastatic Prostate Cancer,” discloses use of ketoconazole, a
`known CYP17 enzyme 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.
`Regarding claim 1, Petitioner argues that although O’Donnell does not
`disclose administration of abiraterone acetate with prednisone, “O’Donnell
`teaches that concomitant hormone replacement therapy with a glucocorticoid
`may be needed for continuous use of abiraterone acetate in treating a prostate
`cancer in a human patient.” Pet. 38. Gerber, Petitioner argues, teaches that
`“the combination of ketoconazole and prednisone is safe and effective in
`treating human patients with hormone-refractory advanced prostate cancer.”
`Id. Thus, Petitioner reasons, the “motivation to add prednisone to a method
`of treating prostate cancer in a human patient that includes abiraterone
`acetate is clearly seen in Gerber,” which “teaches that the administration of
`ketoconazole, a CYP17 inhibitor, in combination with 5 mg prednisone twice
`daily, is safe and effective in treating human patients with hormone-
`refractory prostate cancer.” Id. Regarding dependent claims 2–20, Petitioner
`argues that the additional limitations found in the dependent claims also are
`obvious over O’Donnell and Gerber. Id. at 40. Patent Owner does not
`separately address Petitioner’s arguments directed to the dependent claims.
`On this record, we are persuaded by Petitioner’s arguments and
`presentation of the evidence. O’Donnell suggests that co-administration of a
`glucocorticoid, of which prednisone is one, may be needed in connection
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`with use of abiraterone acetate. Ex. 1003, 2323. Gerber discloses co-
`administration of a glucocorticoid, prednisone, with ketoconazole for the safe
`and effective treatment of prostate cancer. Ex. 1004, 1179. Ketoconazole
`and abiraterone acetate are both characterized as CYP17 inhibitors. Ex.
`1003, 2318; Ex. 1002 ¶¶ 36, 45; see also Prelim. Resp. 42, Figs. 1, 2. We are
`persuaded, on this record, that the relative success of administration of
`ketoconazole together with prednisone to treat prostate cancer would lead one
`of ordinary skill in the art to expect that the “addition of 10 mg of prednisone
`daily according to Gerber to the treatment regimen of O’Donnell would be
`safe and effective in treating a prostate cancer, including prostate cancer
`refractory to anticancer therapy, including hormone and anti-androgen
`therapy.” Pet. 39.
`Patent Owner argues that Petitioner’s challenges to the claims based on
`O’Donnell and Gerber fail for a number of reasons. First, Patent Owner
`argues that the prior art does not teach the problem of mineralocorticoid
`excess. Prelim. Resp. 32. Patent Owner also challenges Petitioner’s and Dr.
`Serels’s assertion that administration of abiraterone acetate or ketoconazole
`causes mineralocorticoid excess. Id. at 32–33. Dr. Serels’s opinion that one
`of ordinary skill in the art would have expected that CYP17 inhibition would
`result in mineralocorticoid excess, according to Patent Owner, is erroneously
`based on “the experience of individuals with specific and rare forms of
`complete congenital CYP17 deficiency.” Id. at 34.
`Notwithstanding Patent Owner’s arguments that Dr. Serels’s reasoning
`is flawed, we are not persuaded that Dr. Serels’s analysis and reliance on
`certain resources is in error. We can accord appropriate weight to an expert’s
`testimony, taking into account the expert’s understanding of the level of skill
`
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`in the art at the time of the invention, and the references relied upon in
`support thereof. See, e.g., Yorkey v. Diab, 601 F.3d 1279, 1284 (Fed.
`Cir. 2010) (holding the Board has discretion to give more weight to one item
`of evidence over another “unless no reasonable trier of fact could have done
`so”). Our review of Dr. Serels’s declaration and supporting evidence leads us
`to credit his testimony that “one of skill in the art would have expected that
`the co-administration of prednisone with abiraterone would improve the
`safety and tolerability of administering abiraterone by reducing the potential
`for side effects associated with the administration of a CYP17 inhibitor.”
`Pet. 27–28 (citing Ex. 1002 ¶ 34).
`Next, Patent Owner argues that Petitioner fails to establish a
`motivation to combine the references, because both abiraterone acetate and
`ketoconazole can be safely administered alone. Id. at 37. Only with
`hindsight, Patent Owner argues, could Petitioner argue that prednisone
`should be administered with abiraterone acetate. Id. at 39. Patent Owner
`also argues that the prior art teaches away from concomitant administration
`of abiraterone acetate and prednisone. Id. at 44. As discussed above, we are
`persuaded that Petitioner has articulated a reason to combine the references
`that, on this record, demonstrates a reasonable likelihood that Petitioner
`would prevail on its arguments in this regard. We are unpersuaded, on this
`record, that Petitioner’s reasoning demonstrates impermissible hindsight;
`Petitioner’s reasoning incorporates and relies on the knowledge of those of
`ordinary skill in the art at the time of the invention. See, e.g., In re
`McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971) (“Any judgment on
`obviousness is in a sense necessarily a reconstruction based upon hindsight
`reasoning, but so long as it takes into account only knowledge which was
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`within the level of ordinary skill at the time the claimed invention was made
`and does not include knowledge gleaned only from applicant’s disclosure,
`such a reconstruction is proper.”). Nor are we persuaded that that the
`teachings of the references rise to the level of teaching away from
`Petitioner’s proposed combination – they do not criticize, discredit, or
`otherwise discourage the solution claimed, but rather, as Petitioner argues,
`encourage exploration of such a combination. In re Fulton, 391 F.3d 1195,
`1201 (Fed. Cir. 2004) (explaining “[t]he prior art’s mere disclosure of more
`than one alternative does not constitute a teaching away from any of these
`alternatives because such disclosure does not criticize, discredit, or otherwise
`discourage the solution claimed”). We are persuaded on the record thus far
`that 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
`based on O’Donnell and Gerber. Pet. 40–48. Concerning these claims, we
`determine that the supporting evidence demonstrates a reasonable likelihood
`that Petitioner would prevail in its showing, the substance of which has not
`been addressed specifically by Patent Owner. In view of the Petition, the
`Preliminary Response, and the evidence before us, we are persuaded that
`Petitioner has demonstrated a reasonable likelihood of prevailing on its
`assertion that claims 1–20 are obvious over O’Donnell and Gerber.
`
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`2. Ground Based on Barrie and Gerber
`Petitioner challenges claims 1–4 and 6–11 as obvious under 35 U.S.C.
`§ 103 over Barrie and Gerber. Pet. 36–45. Patent Owner disputes
`Petitioner’s contentions. Prelim. Resp. 44–46.
`Barrie, which is titled “17-Substituted Steroids Useful in Cancer
`Treatment,” is directed to a class of 17-substituted steroids and their use in
`the treatment of androgen-dependent and estrogen-dependent disorders. Ex.
`1005, 1:11–14. Specifically, Barrie discloses abiraterone, acid addition salts
`and 3-esters of abiraterone, and abiraterone acetate. Id. at 5:21–26, 7:23–26,
`11:39–55. Barrie discloses that abiraterone acetate may be administered in a
`method of treating disorders, including prostate cancer, as a pharmaceutical
`composition comprising a therapeutically effective amount of abiraterone
`acetate. Id. at 10:27–57. Barrie compares the inhibition levels of hormone
`production by abiraterone acetate with ketoconazole, concluding that the
`decrease in testosterone levels resulting from administration of abiraterone
`acetate was much more marked than for ketoconazole. Id. at 26:32–38.
`Regarding claim 1, Petitioner argues that although Barrie does not
`disclose co-administering abiraterone acetate with prednisone, it teaches “that
`abiraterone acetate is a CYP17 inhibitor that is more effective in suppressing
`testosterone levels in a mammal in vivo than ketoconazole, a CYP17
`inhibitor known in the art.” Pet. 39. Gerber, Petitioner argues, teaches that
`“the combination of ketoconazole and prednisone is safe and effective in
`treating human patients with hormone-refractory advanced prostate cancer.”
`Id. Thus, Petitioner reasons, the “motivation to add prednisone to the method
`of treating prostate cancer of [Barrie] is clearly seen in Gerber,” which
`“teaches that the administration of ketoconazole, a CYP17 inhibitor, in
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`combination with 5 mg prednisone twice daily, is safe and effective in
`treating human patients with hormone-refractory prostate cancer.” Id.
`Regarding dependent claims 2–4 and 6–11, Petitioner argues that the
`additional limitations found in the dependent claims also are obvious over
`Barrie and Gerber. Id. at 40–46. Patent Owner does not separately address
`Petitioner’s arguments directed to the dependent claims.
`We are persuaded, at this stage of the proceeding, by Petitioner’s
`arguments and presentation of the evidence. Barrie discloses use of
`abiraterone acetate for the treatment of prostate cancer. Ex. 1005, 1:11–13.
`Barrie contrasts the performance of ketoconazole with the performance of its
`disclosed compounds, including abiraterone acetate, in determining the
`relative activity of the tested compounds. Id. at 25:13–26:39, Table 3.
`Gerber discloses co-administration of a glucocorticoid, prednisone, with
`ketoconazole for the safe and effective treatment of prostate cancer. Ex.
`1004, 1179. Ketoconazole and abiraterone acetate are both characterized as
`CYP17 inhibitors. Ex. 1002 ¶¶ 36, 45; see also Prelim. Resp. 42, Figs. 1, 2.
`We are persuaded, on this record, that the relative success of administration
`of ketoconazole together with prednisone to treat prostate cancer would lead
`one of ordinary skill in the art to expect that the “addition of 5 mg twice daily
`prednisone to the treatment regimen of [Barrie] also would be safe and
`effective in treating a prostate cancer, including prostate cancer refractory to
`anti-cancer therapy, including hormone and anti-androgen therapy.” Pet. 39.
`Notwithstanding Patent Owner’s arguments that Dr. Serels’s reasoning is
`flawed, our review of Dr. Serels’s declaration and supporting evidence leads
`us to credit his testimony that “one of skill in the art would have expected
`that the co-administration of prednisone with abiraterone would improve the
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`safety and tolerability of administering abiraterone by reducing the potential
`for side effects associated with the administration of a CYP17 inhibitor.”
`Pet. 27–28 (citing Ex. 1002 ¶ 34).
`Patent Owner argues that Petitioner’s challenges to the claims based on
`Barrie and Gerber fail for “all of the same reasons discussed above with
`respect to the combination of” O’Donnell and Gerber. Prelim. Resp. 44. For
`the reasons articulated with respect to the combination of O’Donnell and
`Gerber, above, we are not persuaded by Patent Owner’s arguments. Patent
`Owner also argues that Barrie states that abiraterone acetate did not inhibit
`corticosterone biosynthesis in rodents, leading one of skill in the art to
`understand “that abiraterone acetate did not inhibit glucocorticoid
`production.” Id. at 45 (citing Ex. 1005, 25:45–48). Patent Owner also states
`that Barrie does not include clinical trial results, does not mention
`glucocorticoid replacement, and does not teach that abiraterone acetate could
`give rise to any side effects, let alone mineralocorticoid excess. Id. at 45–46.
`The portion of Barrie on which Patent Owner relies states that the
`compounds of the invention had no significant effect on adrenal weight,
`“suggesting that they did not inhibit corticosterone biosynthesis.” Ex, 1005,
`25:45–48. Although this suggestion is present in Barrie, it is insufficiently
`conclusive to unseat Petitioner’s arguments at this stage of the proceeding.
`The additional alleged shortcomings of Barrie noted by Patent Owner
`similarly do not unseat Petitioner’s arguments, which rely on sources other
`than Barrie, such as Gerber and the Serels Declaration, to demonstrate the
`presence of those elements. We are persuaded on the record thus far that
`Petitioner has demonstrated a reasonable likelihood of prevailing on its
`obviousness challenge to claim 1.
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`Claims 2–4 and 6–11 each depend directly or indirectly from claim 1.
`Petitioner contends these claims are also unpatentable under 35 U.S.C. § 103
`based on Barrie and Gerber. Pet. 40–45. Concerning these claims, we
`determine that the supporting evidence demonstrates a reasonable likelihood
`that Petitioner would prevail in its showing, the substance of which has not
`been addressed specifically by Patent Owner. In view of the Petition, the
`Preliminary Response, and the evidence before us, we are persuaded that
`Petitioner has demonstrated a reasonable likelihood of prevailing on its
`assertion that claims 1–4 and 6–11 are obvious over Barrie and Gerber.
`3. Objective Indicia of Non-Obviousness
`Petitioner contends that the Patent Owner may try to rely on secondary
`considerations of non-obviousness. Pet. 48–59. Patent Owner presents
`arguments directed to objective indicia of nonobviousness. Prelim. Resp.
`46–52. Specifically, Petitioner pre-emptively raises arguments and evidence
`relating to commercial success, unexpected benefits, long-felt need, the
`existence of a blocking patent, and copying. Pet. 48–59. Patent Owner
`presents arguments related to unexpected results, long-felt need, and
`commercial success. Prelim. Resp. 46–52.
`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, we determine that Patent
`Owner’s evidence of secondary considerations is insufficient to preclude
`trial. Such 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
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`Petition establishes a reasonable likelihood that the Petitioner will prevail in
`challenges to claims 1–20 of the ’438 patent.
`4. Patent Owner’s Additional Arguments
`Patent Owner makes several additional arguments in its Preliminary
`Response, namely: (A) Petitioner fails to meet the requirements of 35 U.S.C.
`§ 311(b), which requires that an IPR challenge can be brought “only on the
`basis of prior art consisting of patents and printed publications,”;
`(B) Petitioner’s obviousness arguments are redundant; (C) the Petition should
`be rejected under 35 U.S.C. § 325(d), which allows the Board to take into
`account whether the same or substantially the same prior art or arguments
`previously were presented to the Office; and (D) the Petition is an improper
`use of the IPR proceeding and/or an abuse of process under 35 U.S.C.
`§§ 316(a)(6) & 316(b), in that Petitioner is seeking to short circuit the Hatch
`Waxman process and deprive companies who have complied with ANDA
`procedure from obtaining the 180 day exclusivity period to which they will
`be entitled if their court challenges are successful. Prelim. Resp. 52–55. We
`address these arguments in turn.
`(A) 35 U.S.C. § 311(b)
`A conference call was held to discuss a similar issue on February 16,
`2016, and a subsequent Order issued on February 22, 2016. Paper 11. Patent
`Owner sought to file a motion to exclude the declaration of Petitioner’s
`expert and related arguments addressing commercial success. Id. As we
`stated in the Order of February 22, 2016: “There is no authority for
`excluding Petitioner’s arguments and evidence addressing commercial
`success at the petition stage. Moreover, as Petitioner notes, the petition is the
`
`
`
`16
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`IPR2016-00286
`Patent 8,822,438 B2
`
`first and last chance for a petitioner to present its case.” Id. at 3. We
`maintain the position articulated in the Order for purposes of this Decision.
`(B) Redundancy
`Our governing statute requires the Director of the Patent and
`Trademark Office to “prescribe regulations . . . setting forth the standards for
`the showing of sufficient grounds to institute a review under section 314(a),”
`and requires the Director to “consider the effect of any such regulation on the
`economy, the integrity of the patent system, the efficient administration of
`the Office, and the ability of the Office to timely complete proceedings
`instituted under this chapter.” 35 U.S.C. § 316(a)(2), (b). In view of the
`considerations listed in 35 U.S.C. § 316(b), the Director prescribed 37 C.F.R.
`§ 42.108, which provides: (1) “the Board may authorize the review to
`proceed on all or some of the challenged claims and on all or some of the
`grounds of unpatentability asserted for each claim,” and (2) “the Board may
`deny some or all grounds of unpatentability for some or all of the challenged
`claims.” 37 C.F.R. § 42.108(a), (b). Based on our analysis of the
`information before us at this point, we decline to exercise our discretion to
`deny institution based on redundancy.
`(C) 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 substantially the same prior art and arguments were before the
`Examiner during prosecution of the ’438 patent. Prelim. Resp. 54–55.
`Specifically, Patent Owner contends: “Obviousness based on the teachings
`of O’Donnell (2004) was one of the primary grounds that the Examiner relied
`on during the prosecution of the ‘438 Patent” and the argument now
`
`
`
`17
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`IPR2016-00286
`Patent 8,822,438 B2
`
`advanced by Petitioner in the context of Gerber “was specifically considered
`by the Examiner in the context of O’Donnell (2004).” Id. at 54.
`The permissive language of § 325(d) does not prohibit instituting inter
`partes review based on arguments previously presented to the Office. See
`35 U.S.C. § 325(d) (“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.”) (emphasis added). We are mindful of the burden
`on Patent Owner and the Office to rehear the same or substantially the same
`prior art or arguments that were considered previously by the Office. For the
`reasons discussed herein, however, we are persuaded that Petitioner’s
`arguments with respect to the combinations of O’Donnell and Gerber, and
`Barrie and Gerber, are supported by the evidence of record at this stage of the
`proceeding. Therefore, we do not exercise our authority to decline an inter
`partes review of the ’438 patent under 35 U.S.C. § 325(d).
`(D) 35 U.S.C. § 316(a)(6) and § 316(b)
`Regarding Patent Owner’s argument that the Petition is an improper
`
`use of the IPR proceeding and/or an abuse of process, we are mindful of the
`policy argument advanced by Patent Owner. Notwithstanding its citations to
`portions of our statute concerning abuse of process and the Director’s
`considerations in prescribing regulations (35 U.S.C. § 316(a)(6) and
`§ 316(b)), however, Patent Owner has demonstrated no statutory basis for a
`Hatch-Waxman carve-out in the arguments presented. Absent such authority,
`we decline to find abuse of process in Petitioner’s filing of its Petition in this
`case.
`
`
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`IPR2016-00286
`Patent 8,822,438 B2
`
`C. Conclusion
`We conclude that Petitioner has demonstrated a reasonable likelihood
`of prevailing with respect to its challenge of claims 1–20 of the ’438 patent.
`We have not made, however, a final determination under 35 U.S.C. § 318(a)
`with respect to the patentability of the challenged claims.
`IV. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that inter partes review is instituted on the following
`grounds of unpatentability asserted in the Petition:
`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; and
`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(a), inter
`
`partes review of the ’438 patent is hereby instituted commencing on the entry
`date of this decision, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R.
`§ 42.4, notice is hereby given of the institution of a trial; and
`FURTHER ORDERED that the trial is limited to the grounds
`identified above, and no other ground set forth in the Petition as to any
`challenged claim is authorized.
`
`
`
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`IPR2016-00286
`Patent 8,822,43
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