Trials@uspto.gov
`Tel.: 571-272-7822
`
`Paper No. 10
`Entered: February 22, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`COALITION FOR AFFORDABLE DRUGS IX LLC,
`Petitioner,
`v.
`BRISTOL-MYERS SQUIBB COMPANY,
`Patent Owner.
`_____________
`
`Case IPR2015-01723
`Patent 6,967,208 B2
`_______________
`
`Before GRACE KARAFFA OBERMANN, BRIAN P. MURPHY, and
`TINA E. HULSE, Administrative Patent Judges.
`
`MURPHY, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`BMS 2010
`MYLAN v. BMS
`IPR2018-00892
`
`

`

`IPR2015-01723
`Patent 6,967,208 B2
`
`I.
`
`INTRODUCTION
`
`Coalition For Affordable Drugs IX LLC (“Petitioner”) filed a Petition
`requesting inter partes review of claims 1–13, 20–27, and 34–61 of U.S. Patent
`No. 6,967,208 B2 (“the ’208 patent”). Paper 1 (“Pet.”). Bristol-Myers Squibb
`Company (“Patent Owner”) filed a Preliminary Response to the Petition. Paper 8
`(“Prelim. Resp.”). We have statutory authority under 35 U.S.C. § 314(a), which
`provides that an inter partes review may not be instituted “unless . . . there is a
`reasonable likelihood that the petitioner would prevail with respect to at least 1 of
`the claims challenged in the petition.”
`Petitioner challenges claims 1–13, 20–27, and 34–61 of the ’208 patent as
`unpatentable for alleged anticipation under 35 U.S.C. § 102 and obviousness under
`35 U.S.C. § 103. Pet. 15. Based on the information presented in the Petition and
`Preliminary Response, we are not persuaded there is a reasonable likelihood
`Petitioner would prevail with respect to at least one of the claims challenged in the
`Petition. Therefore, we decline to institute inter partes review.
`A. Related Proceedings
`The parties do not identify any related matters. Pet. 2–3; Paper 6, 1.
`
`B. The ’208 Patent
`
`The ’208 patent, titled “Lactam-Containing Compounds and Derivatives
`Thereof as Factor Xa Inhibitors,” issued November 22, 2005 from an application
`filed September 17, 2002, which claims priority to provisional applications filed
`September 21, 2001 and August 9, 2002. Ex. 1001, (22), (45), (60). The ’208
`patent is directed to genus, sub-genus, and species claims for lactam-containing
`compounds, pharmaceutical compositions, and methods of treatment, particularly
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`including a compound called “apixaban.” Id. at 5:53–67. Apixaban is the active
`ingredient in ELIQUIS®, a lactam-containing compound used as an anticoagulant
`(blood factor Xa inhibitor) to reduce the risk of blood clots that can cause strokes
`and heart attacks. Ex. 1001, 1:20–25, 174:21–25; Ex. 1009. A lactam is a cyclic
`amide (O=C–N–) that includes a nitrogen in the ring structure. Prelim. Resp. 10
`n.3; Ex. 1003, 79, 83–84.
` Claim 1 of the ’208 patent is directed to lactam genera—that is, compounds
`(or pharmaceutically acceptable salts thereof) having the lactam-containing core
`structure below:
`
`Prelim. Resp. 12. The portion of the structure identified within the box, above, is
`a lactam ring. Id. In claim 1 of the ’208 patent (reproduced below), the lactam
`ring at issue is defined as “M4” substituent “B.”
`Claims 2 through 8 are claims to progressively smaller subgenera of claim 1.
`Claim 8 depends from claim 1 and is limited to 65 enumerated compounds (and
`their pharmaceutically acceptable salts). The ninth compound listed in claim 8 is
`apixaban. Claim 13 claims apixaban as a single species, dependent from claim 8.
`The chemical structure of apixaban is reproduced below.
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`Pet. 14 (citing Ex. 1008 ¶¶ 51, 52); Prelim. Resp. 16 (noting the synthesis of
`apixaban is described in Example 18 of the ’208 patent (Ex. 1001, 174:21–
`175:51)).
`
`C. The ’208 Patent Claims
`
`Abbreviated forms of claims 1 and 8, and claim 13 of the ’208 patent are
`illustrative and reproduced below (emphasis added):1
`1. A compound of Formula I:
`
`or a stereoisomer or pharmaceutically acceptable salt
`thereof, wherein;
`ring M, including P1, P2, M1, and M2 is substituted
`with 0–2 R1a and is2
`
`1 Claim 1 comprises over five columns of text in the ’208 patent and includes
`numerous Markush group substitutions. The claims of the patent were corrected
`by a thirteen-page Certificate of Correction issued December 2, 2008, which can
`be located in Exhibit 1001 following column 276. The claims reproduced here
`incorporate the changes identified in the Certificate of Correction. See Ex. 1001,
`Certificate of Correction, 1–2 (claim 1), 7 (claim 8), 10 (claim 13).
`2 We note ring M does not contain an R1a substitution group. See Ex. 1001,
`Certificate of Correction, 1–2.
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`ring P, including P1, P2, and P3, is
`
`M4 is –A–B;
`P4 is –G1–G;
`. . .
`A is selected from:
`C3-10 carbocycle substituted with 0–2 R4,
`B is
`
`. . .
`Q1 is C=O;
`ring Q is a 6 membered monocyclic ring, wherein: 0 double bond is
`present within the ring and the ring is substituted with 0–2 R4a ;
`X is absent; . . . .
`8. A compound according to claim 1, wherein the compound is selected
`from the group:
`[first 8 compounds] . . .
` 1-(4-methoxypheny1)-7-oxo-6-[4-(2-oxo-l-piperidinyl)
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`phenyl]-4,5,6,7-tetrahydro-1H-pyrazo1o-[3,4-c]
`pyridine-3-carboxamide; . . .;
`or a pharmaceutically acceptable salt form thereof.
`
`13. A compound according to claim 8, wherein the
`compound is:
`1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxo-1-piperidinyl)
`phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo-[3,4-c] pyridine-3-carboxamide
`or a pharmaceutically acceptable salt form thereof.
`
`D. Asserted Grounds of Unpatentability
`
`Petitioner asserts that claims 1–13, 20–27, and 34–61 of the ’208 patent are
`unpatentable as i) anticipated by Fevig I3 or Fevig II4 or ii) obvious over Fevig I or
`Fevig II. Pet. 15. Petitioner relies on the Declaration of Dr. George Burton in
`support of its arguments. Ex. 1008. 5 Patent Owner opposes. Prelim. Resp. 14–47.
`
`A. Claim Construction
`
`II.
`
`ANALYSIS
`
`In an inter partes review, we construe claim terms of an unexpired patent
`according to their broadest reasonable interpretation in light of the patent
`specification. 37 C.F.R. § 42.100(b); In re Cuozzo Speed Techs., LLC, 793 F.3d
`
`3 PCT Publication No. WO 00/39131 published July 6, 2000 on an application filed
`December 17, 1999 by Fevig et al. (“Fevig I”). Ex. 1003.
`4 U.S. Patent No. 6,413,980 B1 issued July 2, 2002 on an application filed
`December 22, 1999 by Fevig et al. (“Fevig II). Ex. 1004.
`5 The Burton Declaration is unsworn and technically inadmissible. Prelim. Resp.
`29 n.13 (citing Ex. 1008 at 70 (unsworn signature page); 37 C.F.R. §§ 41.2, 1.68);
`see also 37 C.F.R. §§ 42.53(a), 42.61(a) (uncompelled direct testimony “must be
`submitted in the form of an affidavit,” otherwise it is not admissible).
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`1268, 1279–81 (Fed. Cir. 2015), cert. granted sub nom. Cuozzo Speed Techs., LLC
`v. Lee, 84 U.S.L.W. 3218 (U.S. Jan. 15, 2016) (No. 15-446). Under the broadest
`reasonable interpretation standard, we assign claim terms their ordinary and
`customary meaning, as understood by one of ordinary skill in the art, in the context
`of the entire patent disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257
`(Fed. Cir. 2007). Any special definition for a claim term must be set forth in the
`specification with reasonable clarity, deliberateness, and precision. In re Paulsen,
`30 F.3d 1475, 1480 (Fed. Cir. 1994).
`We determine that no claim terms require express construction for purposes
`of this Decision.
`
`B. Asserted Anticipation of 1–13, 20–27, and 34–61 over Fevig I or Fevig II
`
`Petitioner alleges that species claim 13 (apixaban) and genus/sub-genus
`claims 1–8 are anticipated by Fevig I and Fevig II because apixaban is
`“specifically disclosed in Fevig I.” Pet. 21, 30, 43.6 Petitioner reasons that
`“[d]emonstration of the presence of this single compound in any of claims 1-8 is
`sufficient to invalidate each of those claims since each is a Markush-style claim
`and anticipation of a single member anticipates the entire group.” Id. at 21 (citing
`In re Ruff, 256 F.2d 590, 593 (C.C.P.A. 1958); Atlas Powder Co. v. Ireco, Inc., 190
`F.3d 1342, 1346 (Fed. Cir. 1999) (“In chemical compounds, a single prior art
`species within the patent’s claimed genus reads on the generic claim and
`anticipates.”)). Petitioner also argues, however, that a “broad prior art genus
`anticipat[es] specific compounds or render[s] later generic claims obvious.” Pet.
`21–22 (citing In re Susi, 440 F.2d 442 (C.C.P.A. 1971); Merck v Biocraft Labs.,
`
`6 Claims 9-12, 20-27 and 34–61 are addressed derivatively in claim charts.
`Pet. 51–54.
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`874 F2d 1843, 1846 (Fed. Cir. 1989)).
`Patent Owner opposes, arguing that Petitioner incorrectly asserts that
`apixaban and the challenged lactam genera claims are specifically disclosed in
`Fevig I and Fevig II. Prelim. Resp. 3. Patent Owner asserts:
`[T]here can be no dispute that neither Fevig reference
`specifically
`identifies apixaban,
`the
`lactam ring, or
`the
`compounds making up the lactam genera. At best, such
`compounds can be derived from the Fevig references only by
`selecting particular substituent groups from among numerous
`alternative choices at a number of different locations on the
`generic chemical structure identified by Petitioner (i.e., structure
`4, or the “Fevig genus”). To get from the compounds in the Fevig
`genus to apixaban, one must piece together the lactam ring,
`which is not specifically disclosed in the Fevig references.
`Indeed, as Petitioner acknowledges, the genera disclosed in the
`Fevig
`references encompass an “enormous number of
`compounds.” [Pet.] at 16.
`Id. Patent Owner also argues that, as a matter of well-established law, disclosure
`of a prior art genus “‘is not necessarily a disclosure of every species that is a
`member of that genus,’” rather a genus only anticipates a specific compound if a
`person of ordinary skill would “‘at once envisage’” the specific compound or class
`of compounds, for example, by “following ‘a pattern of preferences’ disclosed in
`the art.” Id. at 3–5 (citations omitted).
`1. Fevig I and Fevig II
` Petitioner provides a brief overview of Fevig I and Fevig II in the Petition.
`Pet. 16–19. Petitioner represents that “the specification of Fevig II is identical to
`Fevig I,” and Patent Owner does not dispute the point, so we will refer and cite to
`Fevig I. Pet. 38; Prelim. Resp. 18 n.9. A review of the dozens of compound
`genera in Fevig I indicates a disclosure of “an enormous number of compounds
`claimed to be Factor Xa inhibitors.” Pet. 16 (citing Ex. 1003 passim; Ex. 1008 ¶
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`55). Each structural genus alone bears numerous Markush group substitutions. Id.
`Fevig I was disclosed in the background section of the ’208 patent and is a cited
`reference on the cover page of the ’208 patent. Ex. 1001, 2:49–64. The ’208
`patent further states that “[c]ompounds specifically described in WO00/39131
`[Fevig I] are not considered to be part of the present invention.” Id. at 2:63–64.
`One structural formula representing a genus of compounds, referred to by
`Petitioner as “Structure 4” and by Patent Owner as the “Fevig genus,” is disclosed
`in the upper left corner of page 4 in Fevig I. Ex. 1003, 4; Ex. 1008 ¶¶ 66–67.
`Structure 4 of Fevig is reproduced below:
`
`Id. Substituents A, B, G, and Z are, in turn, defined by innumerable Markush
`group substitutions. Ex. 1003, 9–15. Petitioner bases its arguments of anticipation
`and obviousness on the disclosure of Structure 4 in Fevig I.
`2. Analysis
`a. The law of genus-species disclosures for chemical compounds
`“It is well established that the disclosure of a genus in the prior art is not
`necessarily a disclosure of every species that is a member of that genus.” Atofina
`v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). Rather, “whether
`a generic disclosure necessarily anticipates everything within the genus . . .
`depends on the factual aspects of the specific disclosure and the particular products
`at issue.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1083 (Fed. Cir. 2008).
`Of “critical importance” in conducting this analysis is “how one of ordinary skill in
`the art would understand the relative size of a genus or species in a particular
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`technology.” OSRAM Sylvania, Inc. v. Am. Induction Techs., Inc., 701 F.3d 698,
`706 (Fed. Cir. 2012). On the one hand, “when the class of compounds that falls
`within the genus is so limited that a person of ordinary skill in the art can ‘at once
`envisage each member of this limited class,’ . . . a reference describing the genus
`anticipates every species within the genus.” In re Gleave, 560 F.3d 1331, 1338
`(Fed. Cir. 2009) (quoting Eli Lilly & Co. v. Zenith Goldline Pharm., Inc., 471 F.3d
`1369, 1376 (Fed. Cir. 2006)) (emphasis added). However, where “the number of
`compounds actually disclosed by [the asserted prior art] numbers in the millions
`(including all proposed alternative substituents),” the prior art genus cannot
`anticipate a later species claim. Eli Lilly, 471 F.3d at 1376. A person of ordinary
`skill in the art would understand to look at any expressed “pattern of preferences”
`in the prior art, such as preferred embodiments, in assessing the scope of the
`generic disclosure. See, e.g., Sanofi-Synthelabo, 470 F.3d at 1377. Therefore, to
`anticipate a later-claimed species, a pattern of preferences or other related teaching
`or suggestion must lead to a genus small enough that a person of ordinary skill in
`the art would at once envisage the claimed species. Sanofi-Synthelabo, 550 F.3d at
`1083; Prelim. Resp. 19–21.
`b. Claims 8 and 13 – Petitioner has not shown that apixaban is
`specifically disclosed in Fevig I
`Petitioner’s factual assertion that apixaban is “specifically disclosed in Fevig
`I” is based solely on Dr. Burton’s hindsight reconstruction of the apixaban
`structure from “the appropriately disclosed alternative for each variable of
`[Structure 4 that] results in” apixaban. Pet. 23; see also id. at 24–27, 29–33 (citing
`Ex. 1008 ¶¶ 66–75 and describing the “appropriate” Markush group selections).
`Neither the Petition nor Dr. Burton’s Declaration, however, contains a citation to a
`disclosure of the apixaban species in Fevig I. Petitioner and Dr. Burton also
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`acknowledge that Structure 4 is a “general formula” (Pet. 23 (citing Ex. 1008
`¶ 66)), and they do not provide persuasive evidence that Fevig I discloses any
`preference or suggestion for selecting a lactam ring as substituent B in Structure 4
`(id. at 26), much less for selecting the other required substituents necessary to
`derive the apixaban species (id. at 23–27). In short, a person of ordinary skill
`“would be required to make many specific selections without any guidance from
`the Fevig specifications pointing to the selection of the particular combination of
`variables required to arrive at apixaban.”7 Prelim. Resp. 19 n.10.
`Dr. Burton derives a lactam ring for substituent B by making hindsight-
`based Markush group selections, including the selection of a carbonyl oxygen from
`a “long list of alternatives,” without citing anything in Fevig I that discloses or
`teaches one of ordinary skill to make such selections. Ex. 1008 ¶ 74 (citing Ex.
`1003, 12:27–28, 13:24). As Patent Owner notes, the preferred general compound
`structures identified in Fevig I do not indicate any preference for a lactam ring as
`substituent B, and Petitioner has not cited evidence to suggest such a preference.
`Prelim. Resp. 4; Ex. 1003, 12:24–13:29.8 We agree with Patent Owner that
`Petitioner has not shown Fevig I discloses apixaban or the claimed lactam genera.
`Prelim. Resp. 3–4, 19 n.10, 22–24. Petitioner also has not provided evidence of a
`reason why a person of ordinary skill would at once envisage apixaban, or the
`
`
`7 For purposes of this Decision, we accept Petitioner’s definition of a person of
`ordinary skill in the art as someone with “either a Pharm. D. or a Ph.D. in organic
`chemistry, pharmacy, pharmacology, or a related discipline; or a Bachelor’s or
`Master’s degree in organic chemistry or a related field with at least four years of
`experience relating to compounds that are or may be Factor Xa inhibitors.”
`Pet. 19–20 (citing Ex. 1008 ¶ 61).
`8 A word search of “lactam” in Fevig I reveals discussion of lactams in various
`compounds corresponding to ring “M” recited in claim 1, but not corresponding to
`substituent B. Ex. 1003, 79–83.
`
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`lactam genera claimed in the ’208 patent, from the disclosures in Fevig I.
`Therefore, we find that Petitioner has not established a reasonable likelihood that
`Fevig I anticipates claims 8 and 13.
`
`c. Claim 1 – Petitioner has not shown the claimed genus is disclosed
`in Fevig I
`Regarding the huge genus of compounds recited in claim 1 of the ’208
`patent, Petitioner does little more beyond showing how a single species, apixaban,
`could be derived in hindsight from the general formula of Structure 4 in Fevig I.
`Pet. 28–33, 45–50 (claim chart), 59; Prelim. Resp. 45 n.17. For example,
`Petitioner does not attempt to show that Fevig I discloses, suggests, or indicates a
`preference for a lactam ring as substituent B in Structure 4, where “Q1 is C=O” and
`“ring Q is a six membered monocyclic ring wherein 0 double bond is present
`within the ring,” as recited in claim 1. Compare Ex. 1001, 238:33–35 with Pet. 50
`(citing Ex. 1003, 12:24–28, 13:24). Petitioner’s Markush group selections, made
`from the enormous number of compounds represented by each genus disclosed in
`Fevig I, are hindsight-based presumptions. Petitioner has not shown such
`selections to be rational selections that would have been made by one of ordinary
`skill in the art of medicinal chemistry based on the disclosures and teachings of
`Fevig I. Pet. 28–33, 45–50 (claim chart), 59. The Petition and Dr. Burton’s
`Declaration, moreover, do not provide any meaningful technical analysis of the
`synthetic chemistry disclosed in Fevig I with respect to lactam-containing
`compounds, from which we might conclude that Dr. Burton’s Markush group
`selections were based on something more than a hindsight reconstruction of
`apixaban as described and claimed in the ’208 patent.
`Therefore, Petitioner has not made a sufficient showing that Fevig I
`anticipates the genus recited in claim 1 of the ’208 patent.
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`d. Petitioner’s legal arguments
`As indicated previously, Petitioner argues that a “broad prior art genus
`anticipat[es] specific compounds.” Pet. 21, 22. Petitioner’s argument is contrary
`to the law of genus-species anticipation, set forth above in Section B.2.a.
`The case of Eli Lilly & Co. v. Zenith Goldline Pharmaceuticals, Inc., 471
`F.3d 1369, 1376–77 (Fed. Cir. 2006) is particularly instructive in the present case.
`The prior art reference in Eli Lilly disclosed millions of potential compounds
`(including all Markush group alternative substituents) and listed several “preferred
`compounds and substituents, none of which resemble [the claimed compound].”
`Id. at 1376; see also Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1376–77
`(Fed. Cir. 2006) (prior art disclosure of hydrochloride salt of racemic compound
`insufficient to anticipate later-claimed bisulfate salt of the compound’s d-
`enantiomer, in the absence of a “pattern of preferences” that would further limit the
`prior art disclosure); Impax Labs., Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383
`(Fed. Cir. 2006) (disclosure of prior art genus (formula 1) included “hundreds of
`compounds” and was insufficient to anticipate later-claimed treatment method
`using single compound). Eli Lilly also distinguished In re Petering, 301 F.2d 676,
`681–82 (C.C.P.A. 1962) and In re Schaumann, 572 F.2d 312, 315 (C.C.P.A. 1978),
`two seminal cases in the art of medicinal chemistry not cited or addressed by
`Petitioner. “[I]n contrast to this case, the prior art in Petering did more than make
`a broad generic disclosure. In Petering, the prior art disclosed a limited number of
`specific preferences from a specifically defined group of isoalloxazines . . . a
`limited class of only ‘some 20 compounds.’” Eli Lilly, 471 F.3d at 1376. “[T]he
`prior art in both Petering and Schaumann expressly spelled out a definite and
`limited class of compounds that enabled a person of ordinary skill in the art to at
`once envisage each member of this limited class.” Id. (citing Petering, 301 F.2d at
`
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`681–82; Schaumann, 572 F.2d at 315).
`In contrast to Petering and Schaumann, Petitioner and Dr. Burton do not
`make a showing that Fevig I discloses a limited and defined group of compounds
`within the scope of the challenged patent claims, or that Fevig I indicates any
`preference for lactam rings as substituent B in Structure 4. The Petition and Dr.
`Burton’s Declaration do not indicate a disclosure in Fevig I that would lead one of
`ordinary skill in the art to “at once envisage” the claimed lactam genera or the
`apixaban species. The Petition and Dr. Burton’s Declaration do no more than
`show that “[a]t most, apixaban is encompassed by the enormous genera described
`in the Fevig references.” Prelim. Resp. 19. For example, “they do not offer
`helpful analyses of the size or scope of the earlier-disclosed genera; and they do
`not offer any insights about whether a person of ordinary skill in the art would at
`once envisage apixaban or the other lactam-genera claims in the ’208 patent from
`the Fevig genus.” Id. at 23.
`Petitioner also acknowledges that i) the Fevig I genus is “enormous” and
`“enormously complicated,” ii) the selection of substituents in Fevig I is a “puzzle,”
`and iii) one of ordinary skill would have to “piece together apixaban via a labyrinth
`of nested components with variations on variations.” Prelim. Resp. 24 (citing Pet.
`16, 17, 25, 60; Ex. 1008 ¶¶ 55–56). Petitioner’s hindsight reconstruction of the
`apixaban structure is not supported by citations to particular teachings, preferences,
`suggestions, or other reasons derived from Fevig I and the level of skill in the art
`that otherwise would limit the enormous number of disclosed compounds or solve
`the self-described apixaban puzzle. Petitioner’s evidence, therefore, is insufficient
`to satisfy the relevant legal standard for anticipation of genus and species claims
`directed to chemical compounds.
`Petitioner relies on Atlas Powder, 190 F.3d at 1346 and In re Ruff, 256 F.2d
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`at 593 to support its position that “when one member of a Markush group is
`anticipated, the entire group is anticipated.” Pet. 27, 44. Neither case is apposite
`to the present case.
`In Atlas Powder, the patent claimed blasting compositions consisting of
`several components within recited ranges by weight percent. Atlas Powder, 190
`F.3d at 1344. The prior art disclosed blasting compositions having the same
`components in ranges overlapping the claimed ranges, but there was an issue of
`whether a limitation regarding “sufficient aeration” was inherently disclosed by the
`prior art compositions. Id. at 1345. Inherency is not at issue here. Petitioner also
`misapplies the court’s statement that “[i]n chemical compounds, a single prior art
`species within the patent’s claimed genus reads on the generic claims and
`anticipates” (id. at 1346), because apixaban is not a disclosed prior art species in
`Fevig I or Fevig II. Pet. 27–28, 33–34, 44. Therefore, we are not persuaded that
`Atlas Powder supports Petitioner’s anticipation argument.
`The citation to In re Ruff is not explained by Petitioner, and we fail to see its
`relevance to the facts of the present case. In re Ruff stands for the proposition that
`a patent claim is invalid where the prior art teaches the functional equivalency
`between the claimed compound(s) and the prior art compounds. In re Ruff, 256
`F.2d at 593–94. Petitioner has not made a showing of functional equivalency here.
`Therefore, we are not persuaded by Petitioner’s citation to In re Ruff in support of
`its anticipation argument.
`In conclusion, we determine Petitioner has failed to show a reasonable
`likelihood of prevailing on its assertion that the challenged claims in the ’208
`patent are anticipated by Fevig I or Fevig II.9
`
`
`9 Claims 9–12, 20–27, and 34–61 of the ’208 patent are composition and method of
`treatment claims that depend from claims 1–8 and 13. Petitioner does not argue
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`C. Asserted Obviousness of Claims 1–13, 20–27, and 34–61 over Fevig I or
`Fevig II
`Petitioner asserts that either Fevig I or Fevig II, “each in its own right,”
`renders the challenged claims of the ’208 patent obvious under 35 U.S.C. § 103.
`Pet. 54–58. Petitioner’s argument, however, relies in part on the rejection of patent
`application claims in Fevig II over another prior art reference, the relevance of
`which is not sufficiently articulated by Petitioner, apart from Petitioner’s
`discussion of Merck v. Biocraft Labs., 874 F.2d 804, 807 (Fed. Cir. 1989). Id. at
`56–57. More fundamentally, Petitioner’s obviousness argument neither analyzes
`the facts of the present case in view of the Graham factors nor explains sufficiently
`why the challenged patent claims would have been obvious to one of ordinary skill
`in the art. See Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966); KSR Int’l Co.
`v. Teleflex Inc., 550 U.S. 398, 417–420 (2007). Petitioner does not offer a proper
`obviousness analysis, relying instead on a perfunctory reference to its anticipation
`argument, and arguing that the facts of the present case are “directly analogous to
`the facts in Merck.” Pet. 56–58.
`The claims in Merck recited a pharmaceutical composition comprising a
`combination of two known active compounds, amiloride hydrochloride and
`hydrochlorothiazide, within a range of weight ratios. Merck, 874 F.2d at 805–06.
`The prior art taught a limited genus of 1200 effective drug combinations that
`included the claimed combination. Id. at 806–07. The claims were found to be
`obvious because the claimed composition was used for “the identical purpose
`taught by the prior art,” and because the patent owner failed to prove any
`unexpected synergistic effect from the claimed combination of known active
`
`claims 9–12, 20–27, and 34–61separately from claims 1–8 and 13. Pet. 38, 51–54.
`Therefore, Petitioner fails to show a reasonable likelihood of prevailing on its
`assertion of anticipation of those claims for the same reasons explained above.
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`compounds. Id. at 807–08.
`The facts of Merck bear little relevance to the facts of the present case. The
`claimed compounds in the ’208 patent are not combinations of known species
`disclosed in the prior art, where evidence of synergistic effect of the claimed
`combination is often a determinative consideration. Furthermore, Petitioner’s
`evidence does not establish that either Fevig I or Fevig II discloses apixaban or any
`of the claimed lactam genera. Rather, Petitioner’s selection of the claimed species
`(apixaban) and lactam genera from the disclosed Fevig I and Fevig II genus is
`“dependent upon random variation of numerous parameters.” Merck v. Biocraft,
`874 F.2d at 807.
`Petitioner’s argument also is inconsistent with the substantial authority
`declining to apply Merck v. Biocraft in the way Petitioner suggests. The Federal
`Circuit has held that showing a prior art genus encompasses a later-claimed species
`is not sufficient, by itself, to render the later-claimed species obvious. See, e.g., In
`re Baird, 16 F. 3d at 382 (claims to bisphenol A not obvious over prior disclosure
`of a genus of diphenols encompassing bisphenol A); In re Jones, 958 F.2d 347,
`350 (Fed. Cir. 1992) (“We decline to extract from Merck the rule that the Solicitor
`appears to suggest—that regardless of how broad, a disclosure of a chemical genus
`renders obvious any species that happens to fall within it.”). Prelim. Resp. 41–42.
`Consistent with Baird and Jones, Petitioner has not provided sufficient evidence
`that one of ordinary skill would have been motivated to make the necessary
`selections in the disclosed Fevig I and Fevig II genus (Structure 4) to achieve
`apixaban or the lactam genera recited in the challenged ’208 patent claims.10
`For the reasons given above, we are not persuaded by Petitioner that Fevig I
`
`
`10 In view of our Decision, we need not consider the parties’ arguments regarding
`secondary considerations of nonobviousness or whether 35 U.S.C. § 103(c)
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`or Fevig II discloses the genera, sub-genera, or species of compounds recited in
`claims 1–13, 20–27, and 34–61 of the ’208 patent. We also are not persuaded that
`Petitioner has provided sufficient evidence to show a reasonable likelihood of
`prevailing on its assertion that at least one claim would have been obvious to one
`of ordinary skill in the art over Fevig I or Fevig II, at the time the ’208 patent
`claims were filed.
`
`III. CONCLUSION
`
`Petitioner has failed to demonstrate a reasonable likelihood of prevailing
`with respect to at least one of the claims challenged in this Petition, based on the
`grounds asserted and information presented therein.
`IV. ORDER
`
`For the reasons given, it is
`ORDERED that the Petition is denied.
`
`FOR PETITIONER:
`Thomas Wright
`twright@cunninghamswaim.com
`
`Lekha Gopalakrishnan
`lgopalakrishnan@winstead.com
`
`
`precludes consideration of Fevig II as a reference for purposes of Petitioner’s
`obviousness challenge. Pet. 58–59; Prelim. Resp. 44–47.
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`FOR: PATENT OWNER:
`David Cavanaugh
`david.cavanaugh@wilmerhale.com
`
`Heather Petruzzi
`heather.petruzzi@wilmerhale
`
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`