Sanofi-Aventis Deutschland Gmbh v. Mylan Pharmaceuticals Inc.

Case: 21-1981 Document: 36 Page: 1 Filed: 05/09/2023
United States Court of Appeals
for the Federal Circuit
______________________
SANOFI-AVENTIS DEUTSCHLAND GMBH,
Appellant
v.
MYLAN PHARMACEUTICALS INC.,
Appellee
______________________
2021-1981
______________________
Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. IPR2019-
01657.
______________________
Decided: May 9, 2023
______________________
KENNETH WAYNE DARBY, Fish & Richardson PC, Aus-
tin, TX, argued for appellant. Also represented by MATT
COLVIN, Dallas, TX; LAUREN ANN DEGNAN, WALTER KARL
RENNER, Washington, DC; JOHN STEPHEN GOETZ, New
York, NY.
DOUGLAS H. CARSTEN, McDermott Will & Emery, Ir-
vine, CA, argued for appellee. Also represented by WENDY
L. DEVINE, Wilson, Sonsini, Goodrich & Rosati, PC, San
Francisco, CA; ELHAM FIROUZI STEINER, San Diego, CA;
TASHA THOMAS, RICHARD TORCZON, Washington, DC.
______________________
Case: 21-1981 Document: 36 Page: 2 Filed: 05/09/2023
2 SANOFI-AVENTIS DEUTSCHLAND GMBH v.
MYLAN PHARMACEUTICALS INC.
Before REYNA, MAYER, and CUNNINGHAM, Circuit Judges.
CUNNINGHAM, Circuit Judge.
Sanofi-Aventis Deutschland GmbH owns U.S. Patent
No. RE47,614 (“the ’614 patent”). Mylan Pharmaceuticals
Inc. petitioned the Patent Trial and Appeal Board
(“Board”) for inter partes review of claims 1–18 of the ’614
patent. In its final written decision, the Board found all
challenged claims unpatentable as obvious over prior art.
Mylan Pharms. Inc. v. Sanofi-Aventis Deutschland GmbH,
IPR2019-01657, Paper 39, 2021 WL 1158193 (P.T.A.B.
Mar. 26, 2021) (“Decision”). Sanofi argues on appeal that
Mylan failed to argue that U.S. Patent No. 4,144,957 (“de
Gennes”) constitutes analogous art to the ’614 patent and
instead compared de Gennes to another prior art reference.
We agree with Sanofi. Because Mylan argued that de
Gennes is analogous to another prior art reference and not
the challenged patent, Mylan did not meet its burden to
establish obviousness premised on de Gennes and the
Board’s factual findings regarding analogousness are not
supported by substantial evidence. We reverse.
I. BACKGROUND
A. The Challenged Patents
The ’614 patent is entitled “Drug Delivery Device and
Method of Manufacturing a Drug Delivery Device.” The
’614 patent’s stated invention relates to a “drug delivery
device” that can be “configured to allow setting of different
dose sizes.” ’614 patent col. 1 ll. 26–32.
The ’614 patent seeks to provide a drug delivery device
to improve “operability with respect to dosage control
and/or improved reproducibility of the dosage in connection
with different cartridges.” Id. col. 1 ll. 51–55. It purport-
edly achieves this objective using a “spring washer” that
can “exert a force on the cartridge and secure the cartridge
against movement” and is “secured to the housing so as to
prevent relative axial movement between [the] spring
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MYLAN PHARMACEUTICALS INC.
washer and housing.” Id. col. 1 ll. 59–67, col. 2 ll. 31–35.
The ’614 patent explains that spring washers are advanta-
geous because spring washers can secure the cartridge
“without requiring much space,” allowing for “a very com-
pact drug delivery device.” Id. col. 2 ll. 15–17.
The ’614 patent has 18 claims, all of which require a
“spring washer” secured by “at least two fixing elements.”
Id. col. 8 l. 1 to col. 10 l. 18. As an example, claim 1 recites:
1. A drug delivery device comprising:
a housing with a proximal end and a distal end,
a cartridge adapted to accommodate a drug,
a cartridge retaining member adapted to retain
the cartridge, the cartridge retaining member
releasably secured to the housing, and
a spring washer arranged within the housing so
as to exert a force on the cartridge and to se-
cure the cartridge against movement with re-
spect to the cartridge retaining member,
wherein the spring washer has at least two fixing
elements configured to axially and rotation-
ally fix the spring washer relative to the hous-
ing.
Id. col. 8 ll. 2–14 (emphases added).
B. IPR Proceedings
Mylan petitioned the Board to institute IPR proceed-
ings on the ground that all claims of the ’614 patent are
obvious based on a combination of three prior art refer-
ences: (1) U.S. Patent Application No. 2007/0021718 (“Bur-
ren”); (2) U.S. Patent No. 2,882,901 (“Venezia”); and (3) de
Gennes. J.A. 92. Mylan relied on Burren—cited as prior
art within the ’614 patent—to teach the use of springs
within a drug-delivery device. J.A. 107–09. Mylan sought
to combine Burren with Venezia to teach the use of spring
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4 SANOFI-AVENTIS DEUTSCHLAND GMBH v.
MYLAN PHARMACEUTICALS INC.
washers within drug-delivery devices and de Gennes to add
“snap-fit engagement grips” to secure the spring washer.
J.A. 109–11. In its petition, Mylan argued that “De
Gennes, while concerned with a clutch bearing [in automo-
biles], addresses a problem analogous to that addressed in
Burren (axially [sic] fixation and support of two compo-
nents relative to one another).” J.A. 111 (emphasis added).
Mylan’s expert reiterated the same point, stating that “alt-
hough De Gennes is concerned with a clutch bearing, it ad-
dresses a problem analogous to that addressed in Burren.”
J.A. 1507 (emphasis added).
In its patent owner response, Sanofi argued that de
Gennes is not analogous art to the ’614 patent. J.A. 2309.
Sanofi argued that de Gennes relates to cars and not drug
delivery devices or medical devices, such that a person of
ordinary skill in the art “would not have considered a
clutch bearing to be within the same field of endeavor.”
J.A. 2310. Sanofi further argued that de Gennes is not
“reasonably pertinent” to the ’614 patent’s problem, J.A.
2312, which it asserted is “secur[ing] a cartridge against
movement within a housing.” J.A. 2313; accord J.A. 2415
(Sanofi’s expert).
Mylan responded by repeating its Burren-centric argu-
ments. J.A. 3153–55; accord J.A. 3372–78 (Mylan’s ex-
pert). In its petitioner reply, Mylan argued that Sanofi’s
analogousness arguments relied on a “faulty understand-
ing of controlling law.” J.A. 3136. Mylan criticized Sanofi
as “tr[ying] to change the pertinent problem by importing
extraneous goals from” the ’614 patent, asserting that
“Burren’s suggestion . . . provides the pertinent problem in
this case,” and that a skilled artisan “reading Burren (ra-
ther than reading the goals of [the ’614 patent] with hind-
sight) would have considered” de Gennes highly relevant.
J.A. 3154–55. When asked during oral argument before
the Board as to which “problem” should be examined for
the analogous art test, Mylan’s counsel stated “[i]t doesn’t
really matter” and that “the problem to be solved . . . is
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really identical[ly] presented between Burren and [the ’614
patent]. They’re both interested in solving the same issue
and that is on the Burren side accommodating various car-
tridge lengths and on the [the ’614 patent] side identifying
the cartridges.” J.A. 3705.
In its final written decision, the Board determined that
Burren in combination with Venezia does not render the
challenged claims of the ’614 patent unpatentable. Deci-
sion at *15. However, the Board found that Burren in com-
bination with Venezia and de Gennes does render the
challenged claims unpatentable because, among other
things, the “snap-fit connection” of de Gennes taught the
“fixing elements” of the ’614 patent. Id. at *15–18, *25.
In reaching its conclusion, the Board found de Gennes
constituted analogous art to the ’614 patent. Id. at *7–9.
Because all parties agreed the ’614 patent and de Gennes
belong to distinct fields of endeavor, the Board focused on
whether de Gennes was “reasonably pertinent” to a prob-
lem faced by the inventor of the ’614 patent. Id. at *7–8.
The Board rejected Sanofi’s definition of the “problem” as
too narrow and adopted Mylan’s definition: “axially fixing
two components relative towards each other.” Id. at *8–9.
In a footnote, the Board agreed Mylan “refer[red] to Burren
when identifying a problem,” stating that Burren’s “defined
problem is also relevant to the ’614 patent, especially given
that the ’614 patent acknowledges that Burren’s spring
performs the same function (that is, solves a same problem)
as the ’614 patent.” Id. at *8 n.4. The Board found de
Gennes “analogous to the ’614 patent” because it “is rea-
sonably pertinent to axially fixing two components relative
towards each other, a problem addressed by the inventors
of the ’614 patent.” Id. at *9.
Sanofi timely appealed. We have jurisdiction under 28
U.S.C. § 1295(a)(4)(A).
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6 SANOFI-AVENTIS DEUTSCHLAND GMBH v.
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II. DISCUSSION
A. Standard of Review
“We review the [Board’s] factual findings for substan-
tial evidence and its legal conclusions de novo.” Donner
Tech., LLC v. Pro Stage Gear, LLC, 979 F.3d 1353, 1358
(Fed. Cir. 2020) (alteration in original) (quoting Redline
Detection, LLC v. Star Envirotech, Inc., 811 F.3d 435, 449
(Fed. Cir. 2015)). “Obviousness is a question of law based
on underlying facts.” Id. at 1359 (citing Eli Lilly & Co. v.
Teva Parenteral Meds., Inc., 845 F.3d 1357, 1372 (Fed. Cir.
2017)). “Whether a reference is analogous art is an issue
of fact.” Id. (citing In re ICON Health & Fitness, Inc., 496
F.3d 1374, 1378 (Fed. Cir. 2007)).
B. Analogous Art Arguments
Sanofi argues that the Board “altered and extended
Mylan’s deficient showing” by analyzing whether de
Gennes constitutes analogous art to the ’614 patent when
Mylan, the petitioner, only presented its arguments with
respect to Burren. Appellant’s Br. 25–26. Sanofi cites our
decision in In re Magnum Oil Tools International, Ltd. to
argue that the Board cannot “raise, address, and decide un-
patentability theories never presented by the petitioner
and not supported by record evidence.” Id. at 28 (quoting
829 F.3d 1364, 1381 (Fed. Cir. 2016)). Sanofi argues the
Board improperly shifted the burden of persuasion from
Mylan—to prove the claims of the ’614 patent are un-
patentable—to Sanofi—to defend the claims of the ’614 pa-
tent as patentable. Id. at 26–27. Sanofi argues the Board
“adopted Mylan’s problem statement derived from Burren
and then worked backward to relate that problem to the
’614 patent,” which led the Board to a “legally erroneous
conclusion that lacks substantial evidence.” Id. at 26.
Mylan argues its petition permitted the Board to eval-
uate de Gennes as analogous art because there is no func-
tional difference between the problem of Burren and the
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problem of the ’614 patent. Appellee’s Br. 25. Mylan also
argues Sanofi raises a distinction without a difference be-
cause “[t]he evidence and arguments underlying the
Board’s findings—whether linked to Burren or [the ’614 pa-
tent]—remained the same.” Id. at 27. Mylan argues the
Board “relied on substantial evidence to find Mylan’s defi-
nition of the ‘problem’ more appropriately defined the scope
of analogous art.” Id. at 28.
We agree with Sanofi that Mylan did not carry its bur-
den to argue that de Gennes is analogous to the ’614 patent.
Moreover, the Board’s factual findings regarding analo-
gousness are not supported by substantial evidence. See
Magnum Oil, 829 F.3d at 1381. Because the Board found
that Burren and Venezia alone do not render all the chal-
lenged claims unpatentable without the benefit of de
Gennes, the Board’s finding that de Gennes constitutes
analogous art is dispositive to its conclusion. Decision at
*15–21. Accordingly, we reverse.
We first examine the framework a fact finder must use
to evaluate whether a reference constitutes analogous art.
Next, we examine whether Mylan supported its arguments
properly under this framework.
1. Analogous Art Test
“Two separate tests define the scope of analogous prior
art: (1) whether the art is from the same field of endeavor,
regardless of the problem addressed and, (2) if the refer-
ence is not within the field of the inventor’s endeavor,
whether the reference still is reasonably pertinent to the
particular problem with which the inventor is involved.” In
re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004) (citations
omitted); see also In re Clay, 966 F.2d 656, 658–59 (Fed.
Cir. 1992); In re Wood, 599 F.2d 1032, 1036 (CCPA 1979).
The “problem” being examined must not be defined so nar-
rowly as to collapse these inquiries and only consider art
within the inventor’s field of endeavor. Donner Tech., 979
F.3d at 1360 (“Such a PHOSITA—resigned to considering
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8 SANOFI-AVENTIS DEUTSCHLAND GMBH v.
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art outside her field of endeavor—would thus not identify
the problems so narrowly so as to rule out all such art.”);
ICON Health, 496 F.3d at 1380 (refusing to limit problem
to treadmills and instead focusing on problems of “support-
ing the weight” of folding mechanism and “providing a sta-
ble resting position”).
Mylan argues we should reject Sanofi’s “rigid and le-
gally improper analogous-art test” that would set aside the
Board’s findings “simply because the petition allegedly an-
alyzed the ‘problem’ to be solved in terms of the prior art
instead of [the ’614 patent].” Appellee’s Br. 34. We disa-
gree.
In evaluating whether a reference is analogous, we
have consistently held that a patent challenger must com-
pare the reference to the challenged patent. Donner Tech.,
979 F.3d at 1359 (examining whether reference is “reason-
ably pertinent to one or more of the particular problems to
which the [challenged] patent relates” (emphasis added));
Unwired Planet, LLC v. Google Inc., 841 F.3d 995, 1001
(Fed. Cir. 2016) (“If a reference disclosure and the claimed
invention have a same purpose, the reference relates to the
same problem.” (emphasis added)); Bigio, 381 F.3d at 1325(examining whether prior art is “reasonably pertinent to
the particular problem with which the inventor is involved”
(emphasis added)). This conclusion is reinforced by the
purpose of the analogous art test, which is to examine
whether a reference can be considered as prior art to the
challenged patent in the first place. Chemours Co. FC, LLC
v. Daikin Indus., Ltd., 4 F.4th 1370, 1376 (Fed. Cir. 2021)
(analogous art test defines “scope of the relevant prior
art”); Donner Tech., 979 F.3d at 1359 (“The scope of the
prior art includes all analogous art.”); Cir. Check Inc. v.
QXQ Inc., 795 F.3d 1331, 1335 (Fed. Cir. 2015) (“To be con-
sidered within the prior art for purposes of the obviousness
analysis, a reference must be analogous.”).
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At most, the cases cited by Mylan confirm that an ad-
judicator must consider the “purposes of both the invention
and the prior art”—Clay, 966 F.2d at 659—but the purpose
of the “prior art” must be evaluated with reference to the
inventor’s purported invention disclosed within the chal-
lenged patent. Id. (“If a reference disclosure has the same
purpose as the claimed invention, the reference relates to
the same problem, and that fact supports use of that refer-
ence in an obviousness rejection.” (emphasis added)).
Mylan cites Mandel Bros., Inc. v. Wallace, 335 U.S. 291,
295–96 (1948), and In re Mariani, 177 F.2d 293, 294–96
(CCPA 1949), to argue it is proper to compare a reference
to other references for analogous art purposes. Appellee’s
Br. 35–36. We disagree with Mylan’s interpretation of
those cases. In Mandel Bros., the Court held that prior art
in the field of chemistry could be considered in examining
the patentee’s use of urea in the field of cosmetics. 335 U.S.
at 296; id. at 292 (“The claimed discovery of the patent is
in adding to the old acid-salts cosmetics certain types of the
reactive amino chemical group, particularly urea.”). Thus,
the Court’s analysis undeniably focused on the problem in
the challenged patent. Id. As to Mariani, that decision
declined to “express[] any view upon the question of non-
analogous art.” 177 F.2d at 296. Even so, Mylan appears
to acknowledge that the patentee in Mariani sought to
challenge that the prior art was “analogous to the claimed
invention.” Appellee’s Br. 36 (emphasis added); see Mari-
ani, 177 F.2d at 295 (“[T]he gravamen of the allegations of
error . . . is that both [prior art] patents are in fields of art
not analogous to the field of appellant’s application.” (em-
phasis added)).
Mylan’s arguments would allow a challenger to focus
on the problems of alleged prior art references while ignor-
ing the problems of the challenged patent. Even if a refer-
ence is analogous to one problem considered in another
reference, it does not necessarily follow that the reference
would be analogous to the problems of the challenged
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10 SANOFI-AVENTIS DEUTSCHLAND GMBH v.
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patent. Mylan argues that a fact finder must construe the
scope of analogous art broadly because “familiar items may
have obvious uses beyond their primary purposes.” Appel-
lee’s Br. 35 (emphasis in original) (quoting Wyers v. Master
Lock Co., 616 F.3d 1231, 1238 (Fed. Cir. 2010)); see also
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007). We
agree. But that conclusion does not allow a fact finder to
focus on the problems contained in other prior art refer-
ences to the exclusion of the problem of the challenged pa-
tent.
2. Mylan’s Analogous Art Arguments
Next, we turn to whether Mylan properly supported its
argument that de Gennes is analogous art to the ’614 pa-
tent. Because it did not, the Board’s conclusion that de
Gennes is analogous to the ’614 patent is not supported by
substantial evidence.
We have routinely held that the petitioner has the bur-
den of proving unpatentability. Magnum Oil, 829 F.3d at
1375; see also Intelligent Bio-Sys., Inc. v. Illumina Cam-
bridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (“It is of
the utmost importance that petitioners in the IPR proceed-
ings adhere to the requirement that the initial petition
identify ‘with particularity’ the ‘evidence that supports the
grounds for the challenge to each claim.’” (quoting 35
U.S.C. § 312(a)(3))). A petitioner has the ultimate burden
“to prove ‘unpatentability by a preponderance of the evi-
dence.’” Magnum Oil, 829 F.3d at 1375 (quoting 35 U.S.C.
§ 316(e)).
We have reversed the Board’s patentability determina-
tion where a petitioner did not adequately present a moti-
vation to combine. In Magnum Oil, the Petitioner analyzed
and asserted a first combination of prior art references and
argued that the “same analysis applies” to a second combi-
nation of prior art references based on a different primary
reference. Id. at 1372. The Board instituted the IPR and
issued a final written decision in view of the second
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combination. Id. at 1373. We held that the Board erred
because “[n]either the Board nor the petitioner explained
why borrowing the rationale for combining the first set of
references equally applies to the second set of references.”
Id. at 1378. We reversed because, among other things, the
petitioner’s conclusory statements could not satisfy the pe-
titioner’s burden of demonstrating a motivation to combine
and “the Board’s factual findings regarding the alleged mo-
tivation to combine lacked substantial evidence.” Id. at
1380–81. Similarly, in In re IPR Licensing, Inc., we re-
versed a Board decision finding claims unpatentable that
relied on draft Universal Mobile Telecommunications Sys-
tem (“UMTS”) standards because the petitioner had “not
relied on the UMTS standards in its petition” and “pointed
to nothing” to support its motivation to combine argu-
ments. 942 F.3d 1363, 1369–70 (Fed. Cir. 2019).
Here, Mylan did not make the analogous art argument
on which the Board’s obviousness finding relied—that de
Gennes is analogous to the ’614 patent. E.g., J.A. 111 (IPR
Petition) (“Professor Erdman explains how De Gennes,
while concerned with a clutch bearing, addresses a problem
analogous to that addressed in Burren . . . .”); J.A. 1507
(Expert Declaration) (“[A]lthough De Gennes is concerned
with a clutch bearing, it addresses a problem analogous to
that addressed in Burren.”). As we explain, Mylan’s argu-
ments as to Burren are insufficient to carry its burden be-
cause they do not address the ’614 patent.
Mylan cites several statements in its petition that dis-
cuss the purported problem of the ’614 patent and the prior
art generally to argue that it properly addressed the anal-
ogous art issue. See, e.g., Appellee’s Br. 23–25. Mylan
identified the alleged invention of the ’614 patent as “se-
curely holding a cartridge within a drug-delivery device” by
incorporating “a spring element—a spring washer—to ap-
ply an axially-directed biasing force.” J.A. 89. In discuss-
ing the level of ordinary skill in the art, Mylan explained
that a person of skill in the art “would have been familiar
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with elements commonly used to bias and secure compo-
nents within mechanical devices (e.g., spring elements, fas-
tening structures) and the mechanical principles involved,”
as “confirmed by [the ’614 patent’s] specification.” J.A. 99.
Mylan argued that Burren teaches “injection pens” with
“components that perform the same function as those
claimed by [the ’614 patent].” J.A. 112. Mylan also com-
pared de Gennes to elements of the challenged claims
within the ’614 patent. J.A. 114–48. None of these pas-
sages, however, explain how de Gennes is analogous to the
’614 patent.
A petitioner is not required to anticipate and raise
analogous art arguments in its petition; instead a peti-
tioner can use its reply to “respond to arguments raised in
the corresponding opposition, patent owner preliminary re-
sponse, patent owner response, or decision on institution.”
See 37 C.F.R. § 42.23. However, Mylan did not use its reply
to explain how de Gennes is analogous to the ’614 patent.
See J.A. 3153–56 (Mylan Reply Brief); J.A. 3372–78, 3382
(Mylan’s Second Expert Declaration). Instead, Mylan dis-
puted that it needed to frame its arguments as to the ’614
patent and accused Sanofi of misunderstanding the law.
J.A. 3136 (“Sanofi’s analysis of de Gennes’ analogousness
relies on a faulty understanding of controlling law . . . .”);
J.A. 3154 (“Sanofi tries to change the pertinent problem by
importing extraneous goals from [the ’614 patent] . . . .”);
J.A. 3155 (“De Gennes provides these functions, which a
POSA reading Burren (rather than reading the goals of
[the ’614 patent] with hindsight) would have considered
highly relevant.”). Thus, Mylan’s reply also did not argue
that de Gennes is analogous to the ’614 patent.
In a footnote, Mylan further argues that it carried its
burden by arguing at oral argument before the Board that
Burren and the ’614 patent have the same problem. Appel-
lee’s Br. 27 n.2. Although Mylan argued that Burren and
the ’614 patent address the “same problem,” Mylan pointed
to a different problem than it relied upon to argue that de
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Gennes was analogous. Compare Decision at *8 (“Peti-
tioner defines the problem as ‘axial[ ] fixation and support
of two components relative to one another.’”), with J.A.
3705 (“They’re both interest[ed] in solving the same issue
and that is on the Burren side accommodating various car-
tridge lengths and on the [’614 patent] side identifying the
cartridges.” (emphases added)). Recognizing that Mylan
raised a new problem, the Board questioned whether de
Gennes “address[ed] that problem at all,” and Mylan ex-
plained that de Gennes “address[es] the holding, the taking
up end play in a bearing by applying axial force to hold one
component and abut it against another[.]” J.A. 3706. Re-
gardless, Mylan’s conclusory statements arguing that Bur-
ren and the ’614 patent address the “same problem” are
insufficient to carry its burden to argue de Gennes is anal-
ogous to the ’614 patent. See Magnum Oil, 829 F.3d at 1380(holding that conclusory statements that “[t]he same anal-
ysis” applied to different prior art did not provide sufficient
evidence to base its legal conclusion of obviousness).
We do not interpret the Board’s decision as concluding
that Mylan argued de Gennes is analogous to the ’614 pa-
tent. To the contrary, the Board appears to have agreed
that “Petitioner and Petitioner’s declarant refer to Burren
when identifying a problem.” Decision at *8 n.4. Because
Mylan argued that de Gennes is analogous to another prior
art reference and not the challenged patent, Mylan did not
meet its burden to establish obviousness premised on de
Gennes. Thus, the Board’s factual finding that de Gennes
is analogous to the ’614 patent is unsupported by substan-
tial evidence.
III. CONCLUSION
We have considered the parties’ other arguments and
find them unpersuasive. For the above reasons, we re-
verse.
REVERSED