Coalition for Affordable Drugs IX, LLCv.Bristol-Myers Squibb Company

Patent Trial and Appeal Board

Feb 22, 2016

10245122 (P.T.A.B. Feb. 22, 2016)

Trials@uspto.gov Paper No. 10
Tel.: 571-272-7822 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

IPR2015-01723
Patent 6,967,208 B2

2

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
IPR2015-01723
Patent 6,967,208 B2

3

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.
IPR2015-01723
Patent 6,967,208 B2

4

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.
IPR2015-01723
Patent 6,967,208 B2

5

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)
IPR2015-01723
Patent 6,967,208 B2

6

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.
II. ANALYSIS
A. Claim Construction
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).
IPR2015-01723
Patent 6,967,208 B2

7

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.
IPR2015-01723
Patent 6,967,208 B2

8

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 ¶
IPR2015-01723
Patent 6,967,208 B2

9

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
IPR2015-01723
Patent 6,967,208 B2

10

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
IPR2015-01723
Patent 6,967,208 B2

11

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.
IPR2015-01723
Patent 6,967,208 B2

12

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.
IPR2015-01723
Patent 6,967,208 B2

13

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
IPR2015-01723
Patent 6,967,208 B2

14

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
IPR2015-01723
Patent 6,967,208 B2

15

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
IPR2015-01723
Patent 6,967,208 B2

16

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.
IPR2015-01723
Patent 6,967,208 B2

17

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)
IPR2015-01723
Patent 6,967,208 B2

18

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.
IPR2015-01723
Patent 6,967,208 B2

19

FOR: PATENT OWNER:
David Cavanaugh
david.cavanaugh@wilmerhale.com

Heather Petruzzi
heather.petruzzi@wilmerhale