Trials@uspto.gov
`571-272-7822
`
` Paper 87
`Entered: December 3, 2018
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC., ACTAVIS LABORATORIES FL,
`INC., AMNEAL PHARMACEUTICALS LLC, AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC, DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD., SUN
`PHARMACEUTICALS INDUSTRIES, LTD., SUN
`PHARMACEUTICALS INDUSTRIES, INC., TEVA
`PHARMACEUTICALS USA, INC., WEST-WARD PHARMACEUTICAL
`CORP., and HIKMA PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-013321
`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 IPR2017-00853 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 86.
`
`
`
`
`
`571-272-7822
`
` Paper 87
`Entered: December 3, 2018
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC., ACTAVIS LABORATORIES FL,
`INC., AMNEAL PHARMACEUTICALS LLC, AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC, DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD., SUN
`PHARMACEUTICALS INDUSTRIES, LTD., SUN
`PHARMACEUTICALS INDUSTRIES, INC., TEVA
`PHARMACEUTICALS USA, INC., WEST-WARD PHARMACEUTICAL
`CORP., and HIKMA PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`____________
`
`Case IPR2016-013321
`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 IPR2017-00853 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 86.
`
`
`
`
`
`
`IPR2016-01332
`Patent 8,822,438 B2
`
`
`INTRODUCTION
`I.
`Janssen Oncology, Inc. (“Patent Owner”) filed a Request for
`Rehearing (Paper 85, “Request” or “Req.”) of our Final Written Decision
`(Paper 84, “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 three 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 improperly relied on new
`theories that Petitioners raised for the first time in the Reply to find a
`different motivation to combine prednisone with abiraterone acetate; and
`third, whether the Board misapprehended the Petitioner’s assertions as to the
`1000 mg dose of abiraterone acetate in claims 4, 11, 19, and 20. Req. 1–3.
`We have reviewed Patent Owner’s Request and carefully considered
`all the arguments presented. For the following reasons, we are not
`
`
`
`2
`
`
`
`IPR2016-01332
`Patent 8,822,438 B2
`
`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 “misapprehended the significance
`of Petitioner’s admission that ketoconazole does not cause mineralocorticoid
`excess.” Req. 3. Patent Owner indicates that, in its Response, it argued
`ketoconazole did not cause mineralocorticoid excess, and pointed to prior art
`that showed ketoconazole suppressed production of mineralocorticoids. Id.
`at 5 (citing PO Resp. 18–19). Patent Owner argues that the Board’s focus on
`the fact that ketoconazole would inhibit production of cortisol
`misapprehended that the Petition “did not portray the supposed inhibition of
`the production of cortisol as an ‘independent’ reason” to administer
`prednisone with abiraterone acetate. Id. at 6–7.
`We considered this evidence and argument in our Final Written
`Decision, particularly noting Patent Owner’s argument that “there is no prior
`art evidence that ketoconazole causes mineralocorticoid excess.” Dec. 17
`(citing PO Resp. 18). We also considered Petitioner’s countervailing
`evidence (id. at 17–18), Patent Owner’s Identification of New Arguments
`and Evidence in Petitioner’s Reply (Paper 65), and Petitioner’s reply to the
`same (Paper 74). We also noted in our Final Written Decision that
`Petitioner’s motivation to combine appeared to be premised on the adverse
`effects caused by reduced production of cortisol. Dec. 13. We also relied,
`in the Final Written Decision, on Dr. Garnick’s testimony that CYP17
`inhibitors undesirably suppressed the production of cortisol, which is
`necessary for other biochemical cycles in the body, and which led to adverse
`
`
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`3
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`IPR2016-01332
`Patent 8,822,438 B2
`
`side effects. Id. at 12–13 (citing Ex. 1002 ¶¶ 42, 44, 58). We also relied on
`Dr. Garnick’s testimony that “in light of steroid synthesis inhibitors’ known
`effects on the adrenal pathways,” one of ordinary skill in the art “would have
`been motivated to administer a glucocorticoid with administered abiraterone
`acetate to counteract expected endocrine disruptions.” Dec. 17 (citing
`Ex. 1097 ¶¶ 21–66). We expressly addressed Petitioner’s arguments and
`evidence, Patent Owner’s arguments and evidence, and the respective
`testimony on this issue, and did not overlook Patent Owner’s testimony or
`other testimony regarding the relationship between ketoconazole and
`mineralocorticoid excess. Nor are we persuaded, given our consideration
`and analysis of the testimony and other evidence, that we misapprehended
`the import of this testimony and evidence, or Petitioner’s reliance on the
`same for Petitioner’s arguments to support motivation to combine the relied-
`upon references.
`(B) Patent Owner’s Second Argument
`Patent Owner argues that the Board overlooked or misapprehended
`evidence that abiraterone acetate does not cause adrenal insufficiency.
`Req. 11. Patent Owner argues that the Board relied on Petitioner’s new
`theory, presented for the first time in the Reply, that skilled person would
`have been motivated to combine abiraterone acetate with prednisone because
`abiraterone acetate might cause “adrenal insufficiency” and/or a “low
`adrenal reserve.” 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
`
`
`
`4
`
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`IPR2016-01332
`Patent 8,822,438 B2
`
`Petitioner’s Reply (Paper 78) and the arguments presented by both parties on
`this issue. Dec. 2, 16–19; see also Ericsson Inc. v. Intellectual Ventures I
`LLC, 901 F.3d 1374, 1380 (Fed. Cir. 2018) (stating that reply arguments
`should not be parsed “with too fine a filter”). The arguments and evidence
`identified in Patent Owner’s second 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.” Dec. 18 (citing
`Pet. 26; Tr. 12:18–19; Ex. 1003, 2318). We also considered and discussed
`the results of the Synacthen test. Dec. 20–22. Patent Owner’s disagreement
`with our conclusions is not a proper basis for a rehearing request. 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 the prior art,
`to determine that one of ordinary skill would have been aware of the
`differences and the similarities in the mechanisms. Dec. 18 (citing Ex. 1003,
`2318, Figure 1). We are not persuaded that this constitutes overlooking or
`misapprehending aspects of Patent Owner’s argument concerning cortisol
`deficiency.
`Patent Owner also argues in the introduction of its second argument
`(Req. 2) that the Board disregarded the presumption of validity that
`patents—including those undergoing inter partes review—are entitled to
`
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`IPR2016-01332
`Patent 8,822,438 B2
`
`under 35 U.S.C. § 282. Patent Owner further argues that the Board
`overlooked or misapprehended that evidence that skilled artisans evaluated
`O’Donnell and nevertheless proceeded to undertake studies based on
`abiraterone acetate monotherapy. Req. 13. Patent Owner, however, does
`not point us to where these argument were raised previously. 37 C.F.R.
`§ 42.71(d). Therefore, Petitioners did not have an opportunity to respond to
`these issues. Nor did Patent Owner previously address the question of why
`the presumption of validity in 35 U.S.C. § 282 controls inter partes review
`proceedings in light of the statement in 35 U.S.C. § 316(e) that “In an inter
`partes review instituted under this chapter, the petitioner shall have the
`burden of proving a proposition of unpatentability by a preponderance of the
`evidence.” Accordingly, because Patent Owner does not demonstrate that
`these arguments were raised previously, and because we cannot be assured
`that Petitioner has had any opportunity to respond, we do not consider these
`arguments in our present order.
`(C) Patent Owner’s Third 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. at 15; 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.
`
`
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`IPR2016-01332
`Patent 8,822,438 B2
`
`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.
`
`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.
`
`
`
`
`
`
`7
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`
`IPR2016-01332
`Patent 8,822,438 B2
`
`
`FOR PETITIONER:
`Brandon M. White
`Crystal Canterbury
`PERKINS COIE LLP
`bmwhite@perkinscoie.com
`CCanterbury@perkinscoie.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
`
`
`
`
`8
`
`
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