Trials@uspto.gov
`571-272-7822
`
` Paper 76
`Entered: December 3, 2018
`
`
`
`
`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 JEFFREY N. FREDMAN, KRISTINA M. KALAN and
`JACQUELINE T. HARLOW, Administrative Patent Judges.1
`
`KALAN, Administrative Patent Judge.
`
`
`DECISION
`Denying Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`
`1 A Panel Change Order issued on September 28, 2018, indicating that the
`judges named herein now constitute the panel. Paper 75.
`
`
`
`
`
`571-272-7822
`
` Paper 76
`Entered: December 3, 2018
`
`
`
`
`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 JEFFREY N. FREDMAN, KRISTINA M. KALAN and
`JACQUELINE T. HARLOW, Administrative Patent Judges.1
`
`KALAN, Administrative Patent Judge.
`
`
`DECISION
`Denying Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`
`1 A Panel Change Order issued on September 28, 2018, indicating that the
`judges named herein now constitute the panel. Paper 75.
`
`
`
`
`
`
`IPR2016-01582
`Patent 8,822,438 B2
`
`
`INTRODUCTION
`I.
`Janssen Oncology, Inc. (“Patent Owner”) filed a Request for
`Rehearing (Paper 73, “Request” or “Req.”) of our Final Written Decision
`(Paper 72, “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 issues with our Final
`Written Decision, which Patent Owner groups into two arguments: first,
`whether the Board misapprehended evidence regarding Petitioner’s
`reasoning for administration of prednisone with abiraterone acetate and
`whether the Board overlooked or misapprehended the evidence regarding
`motivation to combine abiraterone acetate with prednisone based on the
`teachings of Sartor; and second, whether the Board misapprehended
`Petitioner’s arguments as to the 1000 mg dose of abiraterone acetate in
`claims 4, 11, 19, and 20. Req. 1–4.
`
`
`
`2
`
`
`
`IPR2016-01582
`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 Arguments
`Patent Owner argues that the Board “misapprehended or overlooked
`that Petitioner’s admissions negated the motivation to combine in the
`Petition.” Req. 4. Patent Owner argues that the Board overlooked Dr.
`Godley’s testimony that “no treating physician would prescribe prednisone
`alone as an anti-cancer agent to a patient with prostate cancer” (Ex. 1002
`¶ 116), which Patent Owner argues is an admission “at odds with the
`Board’s findings.” Id. at 6. Patent Owner further argues that we overlooked
`that Dr. Godley testified that Sartor is just a chart review that a skilled
`researcher would not rely on. Id. at 7. Patent Owner also argues that the
`Board advanced a new “palliation”-based motivation theory. Id. at 7–8. In
`sum, Patent Owner argues that the Board overlooked or misapprehended the
`evidence demonstrating there was no motivation to combine abiraterone
`acetate with prednisone based on the teachings of Sartor. Req. 11–12.
`In our Final Written Decision, in connection with our assessment of
`motivation to combine Sartor with Gerber and O’Donnell, we addressed the
`disputed portion of Dr. Godley’s testimony directly. Dec. 26 (“Fourth,
`Patent Owner argues that Petitioner’s expert agrees that prednisone was not
`known to have anti-cancer treatment effects in prostate cancer patients.”)
`There, we agreed with Petitioner that Dr. Godley’s interpretation of Sartor
`was “consistent with Petitioner’s position regarding Sartor, i.e., that
`
`
`
`3
`
`
`
`IPR2016-01582
`Patent 8,822,438 B2
`
`prednisone has its own anti-cancer effect.” Id. (citing Ex. 1002 ¶ 116;
`Ex. 2162, 61:15–62:17). Patent Owner’s disagreement with our analysis is
`not a proper basis for a rehearing request. Regarding the Board’s
`consideration of Sartor’s credibility, we evaluated the evidence and
`testimony before us to conclude that, despite the fact that Sartor was a chart
`review, it is a “peer-reviewed article published in a reputable journal” and its
`format did not undercut its teachings. Dec. 24. Regarding the Board’s use
`of the word “palliative,” we disagree that such use constitutes a new theory
`advanced by the Board. Req. 7–8. Rather, we used the term “palliative”
`three times in the Final Written Decision—once to accurately quote the
`language used by Dr. Godley in his Declaration (Dec. 26 (citing Ex. 1002
`¶ 116)), once to accurately quote Dr. Godley’s testimony (Dec. 26–27 (citing
`Ex. 2162, 66:1–10, 66:17–67:1), and once in our discussion of claim
`construction (Dec. 33). None of these instances advances a new theory.
`Although we noted that Dr. Godley stated that prednisone could be
`prescribed for palliative treatment in reconciling that statement with our
`claim construction (id. at 26–27), we relied on Petitioner’s arguments in
`chief regarding reasons to combine Gerber, O’Donnell, and Sartor in
`reaching our ultimate determination of unpatentability. Id. at 11–13.
`Patent Owner also argues that the Board disregarded the presumption
`of validity that patents—including those undergoing inter partes review—are
`entitled to under 35 U.S.C. § 282. Req. 3–4, 10–11. Patent Owner,
`however, does not point us to where this argument was raised previously. 37
`C.F.R. § 42.71(d). Therefore, Petitioners did not have an opportunity to
`respond to this issue, nor did Patent Owner previously address the question
`of why the presumption of validity in 35 U.S.C. § 282 controls inter partes
`
`
`
`4
`
`
`
`IPR2016-01582
`Patent 8,822,438 B2
`
`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
`this argument was raised previously and because we cannot be assured that
`Petitioner has had any opportunity to respond, we do not consider this
`argument in our present order.
`We considered the disputed evidence and argument in our Final
`Written Decision, and thus, we are not persuaded that we overlooked it.
`Dec. 26. We also are not persuaded by Patent Owner’s arguments that we
`misapprehended the evidence and arguments, or that we improperly created
`a new theory. In sum, we are not persuaded by Patent Owner’s arguments
`that we should grant a request for rehearing based on this group of
`arguments.
`(B) Patent Owner’s Second Argument
`Patent Owner argues that the Board misapprehended that the prior art
`did not teach or suggest a 1000 mg abiraterone acetate dose as required by
`claims 4, 11, 19, and 20. Req. 12. 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 13;
`see also Dec. 45 (“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.
`
`
`
`5
`
`
`
`IPR2016-01582
`Patent 8,822,438 B2
`
`Req. 12–14. 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. 45; 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.
`
`
`
`6
`
`
`
`IPR2016-01582
`Patent 8,822,438 B2
`
`
`
`FOR PETITIONER:
`Dennies Varughese
`Deborah Sterling
`Lestin Kenton
`Ralph Powers
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`dvarughe@skgf.com
`dsterlin-ptab@skgf.com
`lkenton-ptab@skgf.com
`tpowers@skgf.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
`JANS-SYTIGA@akingump.com
`
`Anthony C. Tridico
`Jennifer H. Roscetti
`FINNEGAN HENDERSON FARABOW
`GARRETT & DUNNER, LLP
`anthony.tridico@finnegan.com
`jennifer.roscetti@finnegan.com
`
`
`
`
`7
`
`
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