Trials@uspto.gov
`571-272-7822
`
` Paper 92
`Entered: December 3, 2018
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMERIGEN PHARMACEUTICALS LIMITED and
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-002861
`Patent 8,822,438 B2
`____________
`
`
`Before JEFFREY N. FREDMAN, KRISTINA M. KALAN and
`JACQUELINE T. HARLOW, Administrative Patent Judges.2
`
`KALAN, Administrative Patent Judge.
`
`
`DECISION
`Denying Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`
`1 Case IPR2016-01317 has been joined with this proceeding.
`2 A Panel Change Order issued on September 28, 2018, indicating that the
`judges named herein now constitute the panel. Paper 91.
`
`
`
`
`
`571-272-7822
`
` Paper 92
`Entered: December 3, 2018
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMERIGEN PHARMACEUTICALS LIMITED and
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-002861
`Patent 8,822,438 B2
`____________
`
`
`Before JEFFREY N. FREDMAN, KRISTINA M. KALAN and
`JACQUELINE T. HARLOW, Administrative Patent Judges.2
`
`KALAN, Administrative Patent Judge.
`
`
`DECISION
`Denying Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`
`1 Case IPR2016-01317 has been joined with this proceeding.
`2 A Panel Change Order issued on September 28, 2018, indicating that the
`judges named herein now constitute the panel. Paper 91.
`
`
`
`
`
`
`IPR2016-00286
`Patent 8,822,438 B2
`
`
`INTRODUCTION
`I.
`Janssen Oncology, Inc. (“Patent Owner”) filed a Request for
`Rehearing (Paper 90, “Request” or “Req.”) of our Final Written Decision
`(Paper 86, “Final Written Decision” or “Dec.”) in which claims 1–20 of U.S.
`Patent No. 8,822,438 B2 (Ex. 1001, “the ’438 patent”) are unpatentable. For
`the reasons that follow, Patent Owner’s Request for Rehearing is denied.
`
`THE REQUEST FOR REHEARING
`II.
`In pertinent part, 37 C.F.R. § 42.71(d) states:
`The burden of showing a decision should be modified lies with
`the party challenging the decision. The request must
`specifically identify all matters the party believes the Board
`misapprehended or overlooked, and the place where each
`matter was previously addressed in a motion, an opposition, or
`a reply.
`Thus, a request for rehearing is not an opportunity merely to disagree with
`the Board’s assessment of the arguments or weighing of the evidence, or to
`present new arguments or evidence.
`Patent Owner requests rehearing to address four issues with our Final
`Written Decision: first, whether the Board misapprehended evidence
`regarding Petitioner’s reasoning for administration of prednisone with
`abiraterone acetate; second, whether the Board overlooked or
`misapprehended Petitioner’s evidence concerning patients with congenital
`CYP17 deficiency; third, whether the Board overlooked or misapprehended
`evidence regarding abiraterone acetate and adrenal insufficiency; and fourth,
`whether the Board misapprehended Petitioner’s assertions as to the 1000 mg
`dose of abiraterone acetate in claims 4, 11, 19, and 20. Req. 1–3.
`
`
`
`2
`
`
`
`IPR2016-00286
`Patent 8,822,438 B2
`
`
`We have reviewed Patent Owner’s Request and carefully considered
`all the arguments presented. For the following reasons, we are not
`persuaded that the Board misapprehended or overlooked arguments or
`evidence with respect to the contentions asserted by Patent Owner.
`
`III. DISCUSSION
`(A) Patent Owner’s First Argument
`Patent Owner argues that the Board “overlooked or misapprehended
`the consequences of the now undisputed fact that ketoconazole does not
`cause mineralocorticoid excess.” Req. 7. Patent Owner argued, in its
`Response, that ketoconazole did not cause mineralocorticoid excess, and
`pointed to Dr. Serels’s testimony that it asserts supported its argument. Id.
`at 5 (citing PO Resp. 23–26, Ex. 1095 ¶ 10).
`We considered this evidence and argument in our Final Written
`Decision, and, as we stated, we did “not understand Petitioner’s argument
`for motivation to combine to be premised on this assertion alone.” Dec. 21–
`22 (citing Pet. 6, 26, 37–39). We noted that Dr. Serels appreciated that
`“mineralocorticoid excess does not occur with ketoconazole,” yet this did
`not change his opinion that “cortisol deficiency would have been expected to
`have significant negative clinical impact in mCRPC patients treated with
`abiraterone” and that one of ordinary skill in the art “would have been
`motivated to co-administer a glucocorticoid, and in particular prednisone, as
`a first choice to suppress predicted ACTH drive in patients administered
`abiraterone acetate to treat CRPC.” Id. at 22 (citing Ex. 1095 ¶ 10).
`Accordingly, we determined that Petitioner reasonably and with properly
`presented arguments established that one of ordinary skill in the art would
`have looked to the prior art’s co-administration of ketoconazole and a
`
`
`
`3
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`IPR2016-00286
`Patent 8,822,438 B2
`
`glucocorticoid to assess the possibility of administering a glucocorticoid
`with abiraterone acetate. We expressly addressed Dr. Serels’s testimony on
`this issue, and did not overlook Dr. Serels’s testimony or other testimony
`regarding the relationship between ketoconazole and mineralocorticoid
`excess. Id. Nor are we persuaded, given our consideration and analysis of
`Dr. Serels’s testimony and the other evidence we considered, that we
`misapprehended the import of this testimony and evidence, or Petitioner’s
`reliance on the same to support Petitioner’s arguments for motivation to
`combine the relied-upon references. Id.
`(B) Patent Owner’s Second Argument
`Patent Owner argues that the Board considered new arguments
`regarding congenital CYP17 deficiency that were allegedly improperly
`presented on Reply. Req. 9. Patent Owner argues that that the Board
`accepted and relied upon Petitioner’s claims regarding congenital CYP17
`deficiency despite Patent Owner’s advising the Board that these were new
`arguments. Id. at 9–10.
`We considered Patent Owner’s Identification of New Arguments and
`Evidence in Petitioner’s Reply (Paper 74) in rendering our Final Written
`Decision, as well Petitioner’s reply to the same (Paper 78) and the arguments
`presented by both parties on this issue. Dec. 2, 21. We have been cautioned
`that reply arguments should not be parsed “with too fine a filter.” Ericsson
`Inc. v. Intellectual Ventures I LLC, 901 F.3d 1374, 1380 (Fed. Cir. 2018).
`Accordingly, we evaluated the evidence and arguments in the Petition and
`those in the Reply we considered to be properly responsive, and stated that
`“Petitioner has reasonably established that one of ordinary skill in the art
`would have looked at mineralocorticoid production in the CYP17 inhibition
`
`
`
`4
`
`
`
`IPR2016-00286
`Patent 8,822,438 B2
`
`scheme to assess the possibility of mineralocorticoid imbalance in the
`administration of abiraterone acetate.” Dec. 21 (citing Ex. 1002 ¶¶ 31–32
`(Dr. Serels’s Declaration, submitted with the Petition, discussing CYP17
`inhibition); Ex. 1093 ¶¶ 25 (Dr. Serels’s Declaration, submitted with the
`Reply, discussing CYP17 inhibition)). We also found that, on the record
`before us, Petitioner reasonably established that one of ordinary skill in the
`art “would have analogized to congenital CYP17 deficiency to assess the
`possibility of mineralocorticoid excess in patients administered abiraterone
`acetate.” Id. (citing Ex. 1002 ¶¶ 31–32; Ex. 1085, 508; Reply 4). We
`acknowledged that “the analogy is not necessarily perfect or complete,” but
`concluded that “an analogy to the problems arising from a congenital CYP17
`deficiency likely would shed light on CYP17 inhibition in other, non-
`congenital situations.” Id. Accordingly, we did not simply accept
`Petitioner’s argument regarding congenital CYP17 deficiency on its face,
`but rather, we determined that Petitioner reasonably and with properly
`presented arguments established that one of ordinary skill in the art would
`have looked at the CYP17 inhibition scheme in general to assess the
`possibility of mineralocorticoid imbalance. Thus, we are not persuaded that
`we overlooked or misapprehended this argument.
`(C) Patent Owner’s Third Argument
`Patent Owner argues that the Board overlooked evidence that
`abiraterone acetate does not cause adrenal insufficiency. Req. 12 (citing
`Dec. 16). Patent Owner argues that “adrenal insufficiency” and “diminished
`adrenal reserve” are both distinct from “mineralocorticoid excess,” as
`demonstrated by opposite side effects—for example, hypertension for
`mineralocorticoid excess, and hypotension for adrenal insufficiency (i.e.,
`
`
`
`5
`
`
`
`IPR2016-00286
`Patent 8,822,438 B2
`
`cortisol deficiency). Id. Patent Owner also faults the Board for overlooking
`or misapprehending the Synacthen test results and the follow-on abiraterone
`acetate monotherapy study. Id. at 13.
`As noted above, we considered Patent Owner’s Identification of New
`Arguments (Paper 74) in rendering our Final Written Decision, as well as
`Petitioner’s Reply (Paper 78) and the arguments presented by both parties on
`this issue. Dec. 2, 15–19; see also Ericsson Inc., 901 F.3d at 1380. The
`arguments and evidence identified in Patent Owner’s third argument here are
`part of a broader argument concerning cortisol deficiency as a result of
`abiraterone acetate and/or ketoconazole activity. We stated in the Final
`Written Decision that “we understand that ketoconazole and abiraterone
`acetate do not have identical mechanisms,” but noted that the parties “appear
`to agree that, based on their respective mechanisms of action, administration
`of ketoconazole would inhibit production of cortisol, and administration of
`abiraterone acetate inhibits one of the pathways of cortisol production.” Id.
`at 17–18 (citing Pet. 29; Tr. 28:19–24; Ex. 1003, 2318). We also noted that
`Patent Owner agreed that abiraterone acetate “inhibits cortisol to an extent.”
`Id. (citing Tr. 29:10–14). We also considered and discussed the results of
`the Synacthen test. Dec. 19. Patent Owner’s disagreement with our
`conclusions is not a proper basis for a rehearing request. Regarding the
`argument based on abiraterone acetate monotherapy (Req. 13–14), Patent
`Owner does not point us to where these argument were raised previously.
`37 C.F.R. § 42.71(d).
`Thus, our Final Written Decision, as part of a broader inquiry, looked
`not only at the differences, but also at the similarities, of the mechanisms of
`ketoconazole and abiraterone, and to the comparative discussions of both in
`
`
`
`6
`
`
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`IPR2016-00286
`Patent 8,822,438 B2
`
`the prior art, to determine that one of ordinary skill would have been aware
`of the differences and the similarities in the mechanisms. Dec. 17 (citing
`Tr. 14:20–15:5; Ex. 1003, 2318, Figure 1; Ex. 1188, 168:22–169:23). We
`are not persuaded that this constitutes overlooking or misapprehending
`aspects of Patent Owner’s argument concerning cortisol deficiency.
`(D) Patent Owner’s Fourth Argument
`Patent Owner argues that the Board misapprehended that the prior art
`does not teach or suggest a 1000 mg abiraterone acetate dose. Req. 14.
`More particularly, Patent Owner faults the Board for adopting Petitioners’
`assertions made in support of its arguments that a skilled person would have
`been motivated to increase the dose of abiraterone acetate disclosed in the
`prior art references. Id.; see also Dec. 43 (“We also have considered
`Petitioner’s arguments and evidence as to dependent claims 2–20, which
`reasoning we adopt as our own.”).
`Patent Owner now presents a new argument that we misapprehended
`the teachings of the prior art with respect to claims 4, 11, 19, and 20.
`Req. 14–15. Patent Owner, however, does not point out where this matter
`was previously raised. Because Patent Owner has not previously raised any
`of its arguments presented in the Request, we are not permitted to consider
`its arguments now. 37 C.F.R. § 42.71(d). Moreover, we did not overlook
`Patent Owner’s arguments regarding these claims; rather, we considered and
`adopted Petitioner’s arguments regarding these claims. Dec. 43; cf.
`Cutsforth, Inc. v. Motive Power, Inc., 636 F. App’x 575 (Fed. Cir. 2016)
`(nonprecedential). Patent Owner’s failure to argue specifically against these
`claims during trial does not permit Patent Owner to now present arguments
`in this regard.
`
`
`
`7
`
`
`
`IPR2016-00286
`Patent 8,822,438 B2
`
`
`IV. CONCLUSION
`We have reviewed and considered the arguments in Patent Owner’s
`Request and conclude that Patent Owner has not carried its burden of
`demonstrating that the Board misapprehended or overlooked any matters in
`rendering the Final Written Decision. 37 C.F.R. § 42.71(d). Rather, Patent
`Owner uses its Request as an opportunity to argue positions with which we
`disagreed in our Final Written Decision. Merely disagreeing with our
`analysis or conclusions does not serve as a proper basis for a request for
`rehearing. Patent Owner also uses its Request to raise matters without
`adequately demonstrating where those matters previously were raised. Thus,
`Patent Owner’s challenge does not meet the standard set forth for a request
`for rehearing.
`The Request for Rehearing is denied.
`
`
`
`
`
`
`8
`
`
`
`IPR2016-00286
`Patent 8,822,438 B2
`
`
`FOR PETITIONER:
`
`William Hare
`Gabriela Materassi
`Christopher Casieri
`Renita Rathinam
`MCNEELY HARE & WAR LLP.
`bill@miplaw.com
`materassi@miplaw.com
`chris@miplaw.com
`rathinam@miplaw.com
`
`Teresa Stanek Rea
`Shannon Lentz
`CROWELL & MORING LLP
`TRea@Crowell.com
`SLentz@Crowell.com
`
`FOR PATENT OWNER:
`
`Dianne B. Elderkin
`Barbara L. Mullin
`Ruben H. Munoz
`AKIN GUMP STRAUSS HAUER & FELD LLP.
`delderkin@akingump.com
`bmullin@akingump.com
`rmunoz@akingump.com
`
`
`
`
`
`9
`
`
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