Trials@uspto.gov
`571-272-7822
`
`
`
`
`Paper 23
`Entered: July 21, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMERIGEN PHARMACEUTICALS LIMITED,
`Petitioner,
`
`v.
`
`
`
`
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`____________
`
`Case 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
`Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
`571-272-7822
`
`
`
`
`Paper 23
`Entered: July 21, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMERIGEN PHARMACEUTICALS LIMITED,
`Petitioner,
`
`v.
`
`
`
`
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner.
`____________
`
`Case 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
`Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`IPR2016-00286
`Patent 8,822,438 B2
`
`
`I. INTRODUCTION
`Patent Owner Janssen Oncology, Inc. (“Patent Owner”) filed a Request
`for Rehearing (Paper 16, “Req.”). In rendering the Decision to Institute
`(Paper 14, “Dec.”), we instituted an inter partes review as to claims 1–20 of
`U.S. Patent No. 8,822,438 B2 (Ex. 1001, “the ’438 patent”). In its Request
`for Rehearing, Patent Owner contends that the Board should grant rehearing
`and decline to institute inter partes review of claims 1–20 of the ‘438 patent.
`Req. 1.
`For the reasons set forth below, Patent Owner’s request for rehearing is
`denied.
`
`II. ANALYSIS
`A request for rehearing must identify specifically all matters the party
`believes the Board misapprehended or overlooked, and the place where each
`matter was addressed previously in a motion, an opposition, or a reply.
`37 C.F.R. § 42.71(d). The Board applies an abuse of discretion standard in
`reviewing institution decisions. 37 C.F.R. § 42.71(c).
`In its Request for Rehearing, Patent Owner contends that (1) the
`Decision to Institute ignores Petitioner’s admissions that the prior art does
`not teach or suggest the claim element “a therapeutically effective amount of
`prednisone” (Req. 5–10); and (2) the Board fails to credit the Patent Office’s
`prior determination of commercial success and Petitioner’s admission of
`unexpected results (id. at 10–13). We disagree.
`We instituted inter partes review on two obviousness grounds asserted
`by Petitioner in the Petition. Dec. 19. In doing so, we determined that
`Petitioner had demonstrated a reasonable likelihood of prevailing with
`respect to its challenge of claims 1–20 of the ’438 patent. Id. In our
`
`
`
`2
`
`
`
`IPR2016-00286
`Patent 8,822,438 B2
`
`Decision to Institute, we construed the terms “treat,” “treating,” and
`“treatment” 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.” Id. at 5. We
`construed the phrase “therapeutically effective amount of prednisone” to
`mean “an amount of prednisone effective for treating prostate cancer.” Id.
`at 7.
`
`With respect to its first contention, Patent Owner argues that “every
`challenged claim requires administering “a therapeutically effective amount
`of prednisone.” Req. 5. Patent Owner argues, therefore, that
`in keeping with its claim construction, in order to conclude that
`petitioner had demonstrated a reasonable likelihood of prevailing in its
`obviousness challenge under 35 U.S.C. § 314(a), the Board was
`required to determine if petitioner is likely to show at trial that the
`prior art patents and publications relied upon teach or suggest the
`claimed co-administration including a “therapeutically effective
`amount of abiraterone acetate,” and, separately, “an amount of
`prednisone effective for treating [i.e., having an anti-cancer effect on]
`prostate cancer.
`
`
`Id. at 6. Patent Owner’s related arguments expound on Petitioner’s failure to
`demonstrate that prednisone must have a “therapeutic anti-cancer effect.” Id.
`at 7–10.
`Although Patent Owner does not advocate for a new claim construction
`in its Request for Rehearing, its arguments are based on a construction that
`we have not adopted, namely, that “treating” must mean “having an anti-
`cancer effect on.” Id. A Request for Rehearing is not an opportunity to
`present a new argument about claim construction, notwithstanding its
`framing as a matter that we addressed in our Decision to Institute. We are
`
`
`
`3
`
`
`
`IPR2016-00286
`Patent 8,822,438 B2
`
`not persuaded by Patent Owner’s argument that we should revisit, on
`rehearing, our determination about the constructions of any terms in view of
`the arguments presented in the Request for Rehearing. In view of our claim
`constructions in the Decision to Institute, we considered both Petitioner’s and
`Patent Owner’s arguments and determined that Petitioner had demonstrated a
`reasonable likelihood of prevailing on its assertions. We are unpersuaded
`that this constitutes an abuse of discretion.
`With respect to Patent Owner’s second contention, we stated in our
`Decision to Institute:
`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.
`
`
`Dec. 15.
`Patent Owner argues that “the PTO previously determined that the
`invention of the ‘438 patent was commercially successful” and that “the
`preexisting record establishing commercial success is complete.” Req. 10–
`11. We disagree. In an inter partes review proceeding, we are not bound by
`an Examiner’s determinations in the prosecution of a patent. To the extent
`Patent Owner presented evidence that the Examiner had reasons for allowing
`the claims based on secondary considerations, we have considered that
`evidence in rendering our Decision to Institute.
`In reaching our determination in the Decision to Institute, we
`acknowledged Patent Owner’s arguments regarding secondary
`
`
`
`4
`
`
`
`IPR2016-00286
`Patent 8,822,438 B2
`
`considerations. Dec. 15. Accordingly, we did not overlook these arguments.
`Nor did we misapprehend Patent Owner’s secondary considerations
`arguments. Our review of secondary considerations took into account
`pre-emptive arguments raised by the Petitioner as well as Patent Owner’s
`arguments related to unexpected results, long-felt need, and commercial
`success. Id. We found, nevertheless, that Patent Owner’s evidence was
`insufficient to preclude trial, and that Petitioner had established a reasonable
`likelihood of prevailing on its challenges. Id. at 15–16. It is a matter of
`discretion to proceed or not to proceed with any ground, and Patent Owner
`has not demonstrated that we abused that discretion.
`For the forgoing reasons, Patent Owner has not shown that the Board
`misapprehended or overlooked any matter in instituting trial in this
`proceeding.
`
`III. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that Patent Owner’s request for rehearing is denied.
`
`
`5
`
`
`
`
`
`
`
`IPR2016-00286
`Patent 8,822,438 B2
`
`FOR PETITIONER:
`William Hare
`Gabriela Materassi
`MCNEELEY HARE & WAR LLP
`bill@miplaw.com
`materassi@miplaw.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
`
`
`
`6
`
`
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