Trials@uspto.gov Paper 12
`Tel: 571-272-7822
`
`Entered: January 26, 2017
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`
`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MYLAN LABORATORIES LIMITED,
`Petitioner,
`
`v.
`
`AVENTIS PHARMA S.A.,
`Patent Owner.
`_____________
`
`Case IPR2016-00627
`Patent 5,847,170
`
`
`______________
`Before BRIAN P. MURPHY, TINA E. HULSE, and CHRISTOPHER M.
`KAISER, Administrative Patent Judges.
`
`MURPHY, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`Entered: January 26, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MYLAN LABORATORIES LIMITED,
`Petitioner,
`
`v.
`
`AVENTIS PHARMA S.A.,
`Patent Owner.
`_____________
`
`Case IPR2016-00627
`Patent 5,847,170
`
`
`______________
`Before BRIAN P. MURPHY, TINA E. HULSE, and CHRISTOPHER M.
`KAISER, Administrative Patent Judges.
`
`MURPHY, Administrative Patent Judge.
`
`
`
`DECISION
`Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`
`
`
`IPR2016-00627
`Patent 5,847,170
`
`
`
`I.
`INTRODUCTION
`Mylan Laboratories Limited (“Petitioner”) filed a Request for
`Rehearing following our Decision Denying Institution of the Petition
`challenging the patentability of claims 1 and 2 in U.S. Patent No. 5,847,170
`(Ex. 1001, “the ’170 patent”). Paper 10 (“Decision” or “Dec.”); Paper 11
`(“Rehearing Request” or “Req. Reh’g”). Having considered Petitioner’s
`Rehearing Request, it is denied.
`
`
`II.
`STANDARD OF REVIEW
`A party who requests rehearing bears the burden of showing that a
`decision should be modified. 37 C.F.R. § 42.71(d). The party must identify
`all matters we misapprehended or overlooked, and the place where each
`matter was addressed previously in a motion, an opposition, or a reply. Id.
`When rehearing a decision on petition, we review the decision for an abuse
`of discretion. 37 C.F.R. § 42.71(c). “A Request for Rehearing is not an
`opportunity to re-argue old arguments.” Histologics, LLC v. CDX
`Diagnostics, Inc. et al., Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16,
`2014) (Paper 9). Petitioner’s Rehearing Request amounts to a re-argument
`of the contentions raised in the Petition and rejected by the Board. We
`briefly address Petitioner’s rehearing contentions below.
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`IPR2016-00627
`Patent 5,847,170
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`III. DISCUSSION
`
`A. Asserted Errors of Law
`Petitioner argues that the Board’s Decision applied “erroneous legal
`standards” in four different ways. Req. Reh’g 3–9.
`Petitioner first contends that our Decision improperly required “that
`Kant alone provide motivation to modify Compound 20 in order to select it
`as a lead compound.” Req. Reh’g 4–5. Our Decision cited and applied the
`law that governs Petitioner’s lead compound theory. Dec. 11 (citing Otsuka
`Pharm. Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1291–92 (Fed. Cir. 2012);
`Daiichi Sankyo Co. v. Matrix Labs., Ltd., 619 F.3d 1346, 1354 (Fed. Cir.
`2010) (“[T]he attribution of a compound as a lead compound after the fact
`must avoid hindsight bias; it must look at the state of the art at the time the
`invention was made to find a motivation to select and then modify a lead
`compound to arrive at the claimed invention.”) (emphases added); Takeda
`Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1357 (Fed. Cir.
`2007)). In particular, Daiichi Sankyo provides that a patent challenger must
`first establish a motivation for a person of ordinary skill in the art (“POSA”)
`“to select” a lead compound without hindsight bias, an issue addressed at
`length in our Decision. Dec. 12–14. The motivation to select a lead
`compound for further modification must be supported with persuasive
`evidence, whether it be the teachings of the Kant reference, the Klein
`reference, the knowledge of a POSA reflected in other prior art references,
`expert testimony, or some combination thereof. We did not “require” a
`motivation be found in Kant alone. Id. Petitioner misconstrues our Decision
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`IPR2016-00627
`Patent 5,847,170
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`and the law, focusing on selective snippets of our analysis while ignoring
`others and the evidence on which we relied for our determination.
`With regard to finding a motivation “to modify” a lead compound,
`once selected, we considered multiple factors regarding Petitioner’s
`assertion that a POSA “would have modified Kant Compound 20 in view of
`Klein’s Table III (compounds 8 and 10).” Dec. 11, 14–17. We provided a
`substantive discussion and analysis, and included extensive citations to the
`Petition and prior art Klein reference, in support of our determination that
`“Petitioner’s rationale and supporting evidence that a POSA would have
`modified Kant Compound 20 in view of Klein to make the required
`substitutions at C-7 and C-10 to synthesize cabazitaxel” was unpersuasive.
`Dec. 14–17. We see no reason to reconsider our analysis and determination
`regarding a motivation to select and modify a lead compound.
`Petitioner next asserts we confused a synthetic precursor, 10-DAB,
`with a lead compound. Req. Reh’g 5–6. To the contrary, we clearly
`indicated that Kant used 10-DAB as a starting material “for synthesizing
`analogues of paclitaxel with the ‘aim of obtaining drugs having more
`desirable properties,’” such as Kant Compound 20. Dec. 7 (citing Ex. 1005,
`5543 ¶¶ 2–3). In addition, rather than “misapprehend[] that Kant studied
`compounds with the paclitaxel and the docetaxel side chains,” as argued by
`Petitioner (Req. Reh’g 5), we explicitly acknowledged and discussed the
`point. Id. at 5–8, 12.
`Petitioner next asserts that we “erroneously requir[ed] superiority [of
`Kant Compound 20] over docetaxel” and overlooked Petitioner’s reliance on
`Table II of Kant. Req. Reh’g 7–8. We did not “require” such superiority.
`Rather, we noted that Kant did not provide any comparative performance
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`IPR2016-00627
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`data with respect to docetaxel, which, unlike paclitaxel, contains the same
`side chain as Compound 20. Dec. 12. We did not overlook Petitioner’s
`reliance on Kant Table II. We explained, annotated, and reproduced Kant
`Table II in our Decision, and we cited it in our analysis. Dec. 7–8, 12.
`Petitioner’s assertions are nothing more than re-arguments of those we
`considered and rejected in our Decision.
`Petitioner’s fourth contention of legal error, for “misattributing
`Graham factor 3 analysis as improper hindsight,” is based on the curious
`argument that “nowhere does the Petition argue that Compound 20 should be
`selected as a lead because of its structural similarity to cabazitaxel.” Req.
`Reh’g 8–9. Yet, the Petition begins, ends, and overflows with
`characterizations of cabazitaxel as 7,10-dimethoxy docetaxel, and repeatedly
`points to the structural similarities between docetaxel, Kant Compound 20,
`and 7,10-dimethoxy docetaxel (cabazitaxel) as the basis for selecting Kant
`Compound 20 as a lead compound for further modification in view of Klein.
`See Pet. 1–2 (“the only difference between the two [Kant Cpd 20 and
`cabazitaxel] is the methyl group on the C-7 hydroxyl”), 6–7 (“Kant discloses
`10-methoxy docetaxel (compound 20), which contains the same methoxy
`group at the C-10 position as 7,10-dimethoxy docetaxel. . . . Compound 20,
`which is methylated at the C-10 hydroxyl is shown below on the left,
`adjacent to 7,10-dimethoxy docetaxel for comparison [of the chemical
`structures]”), 30–31 (“The structure disclosed in Kant [Compound 20] is
`shown below, adjacent to the compound of claim 1 of the ’170 patent and
`adjacent to docetaxel. For ease of comparison, the identical portions of the
`molecules have been depicted in grey.”). We reiterate our determination that
`Petitioner “errs by starting with a hindsight-biased structural comparison of
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`IPR2016-00627
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`docetaxel, Kant Compound 20, and cabazitaxel in side-by-side fashion.”
`Dec. 12.
`B. Evidence Asserted to Have Been Overlooked
`Petitioner pivots from asserted legal error to an assertion that we
`overlooked evidence cited in the Petition and the Declaration of Dr.
`Jacobsen regarding the issue of taxane solubility. Req. Reh’g 9–10 (citing
`Pet. 25–26, 35–36, 47; Ex. 1002 ¶¶ 54–55, 93–94). Petitioner’s essential
`complaint is that we are allegedly not permitted to credit Patent Owner’s
`argument and extensively cited documentary evidence, in view of the
`declaration testimony of Dr. Jacobsen. Id. (citing 37 C.F.R. § 42.108(c)).
`Petitioner’s argument misses the mark.
`First, the portion of Rule 108(c) cited by Petitioner applies to
`resolution of genuine issues of material fact created by “testimonial
`evidence” submitted in support of a preliminary response. 37 C.F.R.
`§ 42.108(c). Patent Owner did not submit any testimonial evidence in
`support of its Preliminary Response (Paper 9). Therefore, the cited portion
`of Rule 108(c) does not apply here.
`Second, although Petitioner is correct that we did not cite to
`paragraphs 54–55 and 93–94 of Dr. Jacobsen’s Declaration in our Decision
`(Req. Reh’g 10), that testimony establishes only that known taxanes could be
`formulated for intravenous administration by using Cremophor EL. Ex.
`1002 ¶¶ 54–55, 93–94. Having further considered the cited Declaration
`testimony of Dr. Jacobsen, we re-state that it “does not address why a POSA
`would have simultaneously modified the C-7 and C-10 positions in Kant
`Compound 20 to optimize lipophilicity [of an unknown taxane], thereby
`minimizing aqueous solubility, when a POSA would have known docetaxel
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`IPR2016-00627
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`and paclitaxel were highly lipophilic and insoluble in water, which made
`their commercial formulation challenging.” Dec. 13 (citing Prelim. Resp.
`21–24; Ex. 1006; Ex. 1011, 495; Ex. 1015; Ex. 1019, 1:64–67; Ex. 1020,
`206; Ex. 2004, 2:42–44; Ex. 2015, 648; Ex. 2024, 45; Ex. 2025, 91; Ex.
`2026, 996). The cited testimony is not inconsistent with the knowledge that
`docetaxel and paclitaxel were highly lipophilic and challenging to formulate,
`based on the extensive documentary evidence cited by Patent Owner, which
`we credited.
`In short, there was no error in crediting Patent Owner’s cited
`documentary evidence. See Virnetx Inc. v. Apple Inc., 2016 WL 7174130, at
`*3 (Fed. Cir. Dec. 9, 2016) (“[T]he PTAB must weigh [expert] testimony
`against other record evidence in reaching its conclusion, and it may give that
`testimony less weight, so long as it supports its decision with substantial
`evidence.”). We also do not agree that we overlooked Dr. Jacobsen’s cited
`Declaration testimony or that it is inconsistent with Patent Owner’s
`documentary evidence.
`C. Other Arguments
`The remainder of Petitioner’s Rehearing Request reargues several
`other contentions raised in its Petition. Req. Reh’g 11–15. We see no
`reason to reconsider our Decision in view of those arguments.
`IV. ORDER
`
`Accordingly, it is
`ORDERED that Petitioner’s Rehearing Request is denied.
`
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`IPR2016-00627
`Patent 5,847,170
`
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`For PETITIONER:
`
`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`WILSON SONSINI GOODRICH & ROSATI
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`
`
`For PATENT OWNER:
`
`Dominic A. Conde
`FITZPATRICK CELLA HARPER & SCINTO
`dconde@fchs.com
`
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