Trials@uspto.gov
`571-272-7822
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`
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`
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`
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` Paper No. 18
`
`
` Entered: October 27, 2015
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`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`APOTEX INC.,
`Petitioner,
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`____________
`
`Case IPR2015-00419
`Patent 5,691,336
`____________
`
`Before LORA M. GREEN, ZHENYU YANG, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`DECISION
`Order Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`
`
`
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`
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`571-272-7822
`
`
`
`
`
`
`
` Paper No. 18
`
`
` Entered: October 27, 2015
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`APOTEX INC.,
`Petitioner,
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`____________
`
`Case IPR2015-00419
`Patent 5,691,336
`____________
`
`Before LORA M. GREEN, ZHENYU YANG, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`DECISION
`Order Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2015-00419
`Patent 5,691,336
`
`
`INTRODUCTION
`Apotex Inc. (“Petitioner”) filed a Petition for an inter partes review of
`claims 1, 3–8, and 10–25 of U.S. Patent No. 5,691,336 (“the ’336 patent,”
`Ex. 1001). Paper 1 (“Pet.”). The Board denied the Petition. Paper 14
`(“Dec.”). Petitioner filed a Request for Rehearing. Paper 15 (“Reh’g
`Req.”). Petitioner also filed a Petition under 37 C.F.R. § 41.3, suggesting
`reconsideration by an expanded panel. Paper 16.
`For the following reasons, we deny Petitioner’s Request for
`Rehearing. The Acting Chief Administrative Judge declined to expand the
`panel.
`
`
`STANDARD OF REVIEW
`When rehearing a decision on institution, the Board reviews the
`decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of
`discretion occurs when a decision was based on an erroneous conclusion of
`law or clearly erroneous factual findings, or a clear error of judgment. In re
`Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).
`The party requesting rehearing bears the burden of showing the
`decision should be modified. 37 C.F.R. § 42.71(d). Specifically, a request
`for rehearing must identify all matters the party believes the Board
`misapprehended or overlooked. Id.
`
`
`DISCUSSION
`In our Decision denying the Petition, we determined that Petitioner
`has failed to sufficiently explain why, at the time of the ’336 patent
`2
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`IPR2015-00419
`Patent 5,691,336
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`invention, a skilled artisan would have chosen compound 96 of Dorn ’699 to
`further develop its prodrug, which is the subject matter of the challenged
`claims. Dec. 12. In its Request, Petitioner argues that we erred in
`concluding that compound 96 is not a lead compound. Reh’g Req. 1. We
`are not persuaded.
`Petitioner relies on In re Dillon, 919 F.2d 688 (Fed. Cir. 1990) (en
`banc). According to Petitioner, “[u]nder Dillon, structural similarity alone is
`sufficient to provide motivation to a person skilled in the art (“POSA”) to
`modify a prior art compound.” Id. at 7. Dillon did not hold so. Instead,
`Dillon held that “structural similarity between claimed and prior art subject
`matter, proved by combining references or otherwise, where the prior art
`gives reason or motivation to make the claimed compositions, creates a
`prima facie case of obviousness.” Dillon, 919 F.2d at 692 (emphasis added).
`In other words, a patent challenger must provide “some articulated reasoning
`with some rational underpinning to support the legal conclusion of
`obviousness,” independent of the structural similarity. See KSR Int’l Co. v.
`Teleflex Inc., 550 U.S. 398, 418 (2007). Indeed, the Federal Circuit has
`repeatedly explained so. See e.g., Daiichi Sankyo Co., Ltd. v. Matrix
`Laboratories, Ltd., 619 F.3d 1346, 1352 (Fed. Cir. 2010) (“Proof of
`obviousness based on structural similarity requires . . . evidence that a
`medicinal chemist of ordinary skill would have been motivated to select and
`then to modify a prior art compound (e.g., a lead compound) to arrive at a
`claimed compound . . . .”). “Absent a reason or motivation based on such
`prior art evidence, mere structural similarity between a prior art compound
`
`3
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`IPR2015-00419
`Patent 5,691,336
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`and the claimed compound does not inform the lead compound selection.”
`Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 1292 (Fed. Cir. 2012).
`We recognize that the motivation to select and modify a lead
`compound need not be explicit in the art. Daiichi, 619 F.3d at 1352. Here,
`however, Petitioner does not offer any persuasive evidence or otherwise
`explain why a skilled artisan would have selected compound 96 of Dorn
`’699 for modification. As we pointed out in the Decision, Dorn ’699 lists
`over 600 compounds by their chemical names but provides no activity data
`for any of them. Dec. 11. Under such circumstances, Petitioner’s failure to
`articulate any reason why one of ordinary skill in the art would have selected
`compound 96 is fatal to its obviousness analysis.
`Petitioner contends that our lead compound analysis conflicts with Ex
`parte Dong, Appeal No. 2011-010047 (P.T.A.B. Jan. 28, 2013), and Ex
`parte Cao, Appeal No. 2010-004081 (B.P.A.I. Sept. 19, 2011). Id. at 2–6.
`According to Petitioner, we must follow Dong and Cao, in which the panels
`affirmed obviousness rejections, even though the prior art taught numerous
`compounds and did not provide activity data. Id. We disagree. First, the
`Board did not designate either Dong or Cao as precedential. Thus, those
`opinions do not bind this panel. More importantly, obviousness, while a
`question of law, is based on underlying factual findings. Graham v. John
`Deere Co., 383 U.S. 1, 17–18 (1966). And the facts in this case are
`distinguishable from those in Dong and Cao. For example, the reference in
`Dong did not only list the prior art compound among hundreds of others, it
`actually made the compound. Dong, 2013 WL 5375700, *3. In contrast, in
`this case, Dorn ’699 prepared over 90 specific compounds in Examples 1–85
`4
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`IPR2015-00419
`Patent 5,691,336
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`and 88–93. Ex. 1003, 60:58–102:1, 121:26–122:60. It also taught how to
`make nearly 500 other specific compounds in Examples 86 and 87. Id. at
`102:2–121:25. Dorn ’699, however, neither actually prepared compound 96,
`nor taught how to make it. Because of the different facts, the approach in
`Dong does not apply in this case.
`In the Decision, we also denied the Petition on an independent basis.
`We contrasted a body of well-studied, potent tachykinin receptor antagonists
`with Dorn ’699, which reported no biological or pharmacokinetic data. Dec.
`9. Petitioner argues that we erred in stating that a skilled artisan would have
`pursued those more promising compounds. Reh’g Req. 12 (citing Dec. 9).
`We are not persuaded. Our determination is not, as Petitioner asserts, an
`“assumption,” but a conclusion based on the evidence of record. Dec. 9
`(citing Prelim. Resp. 16–18, which in turn, relies on Exs. 2001–05, 2007,
`2008). Indeed, as Patent Owner pointed out in its Preliminary Response, by
`the time of the ’336 patent invention, very potent, selective tachykinin
`receptor antagonists with desirable pharmacokinetic properties had been
`discovered. Prelim. Resp. 17 (citing Ex. 2007). Specifically, Patent Owner
`itself identified compound 7b, a “highly potent” tachykinin receptor
`antagonist, as a lead for further optimization. Id. at 18 (citing Ex. 2005).
`Petitioner contends that those studies “do not disclose the numerous,
`specific human therapeutic applications disclosed in Dorn ʼ699 . . . that
`would have motivated those skilled in the art to pursue development of
`Dorn’s compounds.” Reh’g Req. 12. We disagree. For example, prior art
`teaches that compounds modulating or blocking activity of tachykinin are
`suitable for treating human diseases, such as pain, inflammation, rheumatoid
`5
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`IPR2015-00419
`Patent 5,691,336
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`arthritis, asthma, and bronchial hyperactivity. Ex. 2007, 315. In other
`words, one of ordinary skill would have had sufficient reason to pursue those
`promising compounds, instead of starting with Dorn ’699.
`Petitioner further contends that Patent Owner’s Preliminary Response
`is inconsistent with statements by the inventors during the prosecution.
`Reh’g Req. 13–15. This argument amounts to an unauthorized, improper
`reply to the Preliminary Response. Moreover, because Petitioner did not
`explain why a skilled artisan would have selected compound 96, we do not
`need to address whether a skilled artisan would have subsequently modified
`compound 96 based on the teachings of Murdock.
`In sum, in the Petition, Petitioner did not establish a reasonable
`likelihood that it would prevail in showing Dorn ’699, in combination with
`other asserted prior art, would have rendered the challenged claims obvious.
`On rehearing, we see no error in our fact findings or conclusions of law.
`Thus, we conclude that Petitioner has not demonstrated that we abused our
`discretion in denying institution of the challenged claims. We deny the
`Request for Rehearing. The Acting Chief Administrative Judge declined to
`expand the panel.
`
`
`ORDER
`
`Accordingly, it is
`ORDERED that Petitioner’s Request for Rehearing is denied.
`
`6
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`IPR2015-00419
`Patent 5,691,336
`
`PETITIONER:
`
`Kenneth J. Burchfiel
`Grant S. Shackelford
`SUGHRUE MION, PLLC
`kburchfiel@sughrue.com
`gshackelford@sughrue.com
`
`
`
`PATENT OWNER:
`
`Bruce M. Wexler
`Preston K. Ratliff II
`Gregory A. Morris
`Naveen Modi
`PAUL HASTINGS LLP
`brucewexler@paulhastings.com
`prestonratliff@paulhastings.com
`gregorymorris@paulhastings.com
`naveenmodi@paulhastings.com
`
`Gerard M. Devlin
`Richard C. Billups
`MERCK SHARP & DOHME CORP.
`gerard_devlin@merck.com
`richard_billups@merck.com
`
`7
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