Case: 20-2066 Document: 85 Page: 1 Filed: 12/29/2021
NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
SANOFI-AVENTIS DEUTSCHLAND GMBH,
Appellant
v.
MYLAN PHARMACEUTICALS INC.,
Appellee
ANDREW HIRSHFELD, PERFORMING THE
FUNCTIONS AND DUTIES OF THE UNDER
SECRETARY OF COMMERCE FOR
INTELLECTUAL PROPERTY AND DIRECTOR OF
THE UNITED STATES PATENT AND TRADEMARK
OFFICE,
Intervenor
______________________
2020-2066, 2020-2068, 2020-2069
______________________
Appeals from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in Nos. IPR2018-
01679, IPR2018-01680, IPR2018-01682.
______________________
Decided: December 29, 2021
______________________
ADAM BANKS, Weil, Gotshal & Manges LLP, New York,
NY, argued for appellant. Also represented by ANISH R.
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2 SANOFI-AVENTIS DEUTSCHLAND v.
MYLAN PHARMACEUTICALS INC.
DESAI, SARAH M. STERNLIEB, ELIZABETH WEISWASSER;
WILLIAM SUTTON ANSLEY, Washington, DC; LAUREN ANN
DEGNAN, Fish & Richardson P.C., Washington, DC; SCOTT
MICHAEL FLANZ, JOHN STEPHEN GOETZ, New York, NY.
DOUGLAS H. CARSTEN, McDermott Will & Emery, Ir-
vine, CA, argued for appellee. Also represented by ADAM
WILLIAM BURROWBRIDGE, Washington, DC; WESLEY
EUGENE DERRYBERRY, STEFFEN NATHANAEL JOHNSON,
TASHA THOMAS, RICHARD TORCZON, Wilson, Sonsini,
Goodrich & Rosati, PC, Washington, DC; ELHAM FIROUZI
STEINER, San Diego, CA.
BRIAN RACILLA, Office of the Solicitor, United States
Patent and Trademark Office, Alexandria, VA, for interve-
nor. Also represented by KAKOLI CAPRIHAN, DANIEL
KAZHDAN, THOMAS W. KRAUSE, FARHEENA YASMEEN
RASHEED.
______________________
Before DYK, CLEVENGER, and TARANTO, Circuit Judges.
PER CURIAM.
Sanofi-Aventis Deutschland GmbH (“Sanofi”) owns
U.S. Patent Nos. 8,992,486 (“the ’486 Patent”) and
9,526,844 (“the ’844 Patent”). The patents, which relate to
pen-type injectors for administering medicinal products
from a multidose cartridge where the user may set the in-
jection dose, share a common specification and claim prior-
ity to GB Patent Application No. 0304822.0 (“GB
Application”). ’844 Patent col. 1 ll. 6–21, 25–29. 1
These consolidated appeals arise from three inter
partes reviews (“IPRs”). On appeal, Sanofi challenges the
1 Citations to the common specification are to the
’844 Patent.
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Board’s determinations that (1) substitute claims 58–64 of
the ’486 Patent would have been obvious over Steenfeldt-
Jensen 2 with Klitgaard, 3 Atterbury, 4 and/or Burroughs 5;
(2) original claims 21–30 of the ’844 Patent would have
been obvious over Steenfeldt-Jensen or Steenfeldt-Jensen
with Klitgaard; and (3) because the GB Application does
not provide written description support for an internally-
threaded piston rod, original claims 21–30 of the ’844 Pa-
tent are not entitled to claim priority to the GB Application
and substitute claims 31–38 of the ’844 Patent are unsup-
ported amendments. 6 We affirm.
THE ’486 PATENT
In IPR2018-01679, Sanofi proposed substitute claims
directed at three features. The first is an arc-shaped body
(“ASB”) that tracks each set dose of medicament. See
Mylan Pharm. Inc. v. Sanofi-Aventis Deutschland Gmbh,
IPR2018-01679, at 54–55 (P.T.A.B. May 29, 2020) (“1679
Final Written Decision”). The second and third are different
versions of a clicker (“Clicker A” and “Clicker B”) that pro-
duce audible clicks corresponding to a unit dose of medica-
ment. Id. at 55–57. In Clicker A, one element of the clicker
produces clicks only during dialing down of a dose and a
separate element produces clicks when rotating and mov-
ing in a specific manner. Id. at 55–56. In Clicker B, one
element of the clicker produces clicks only during dialing
2
U.S. Patent No. 6,235,004.
3
U.S. Patent No. 6,582,404.
4 W.O. Patent Publication No. 2002/092153.
5
U.S. Patent No. 6,221,046.
6 Under the governing statutory and regulatory re-
quirements, a substitute claim must have support in the
original disclosure, as well as in any earlier-filed disclosure
to which there is a priority claim, and may not enlarge the
scope of the claims or introduce new matter.
35 U.S.C.
§ 316(d);
37 C.F.R. § 42.121.
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4 SANOFI-AVENTIS DEUTSCHLAND v.
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up of a dose and a separate element provides clicks only
during dialing down of a dose.
Id. at 56–57. The Board con-
cluded that the ASB claims would have been obvious over
Steenfeldt-Jensen and Klitgaard, where Klitgaard’s nut
member (modified into a half-nut) would serve as the ASB
in Steenfeldt-Jensen’s device,
id. at 61–75; the Clicker A
claims would have been obvious over Steenfeldt-Jensen
and Atterbury, where Atterbury’s clickers would be incor-
porated into Steenfeldt-Jensen’s device,
id. at 77–90; and
the Clicker B claims would have been obvious over Steen-
feldt-Jensen, Burroughs, and Atterbury, where Atterbury’s
clickers and Burroughs’s cartridge would be combined with
Steenfeldt-Jensen’s device,
id. at 93–99.
Sanofi presents numerous arguments on appeal, chief
among these being that the Board inappropriately relied on
common knowledge to supply limitations missing in the
prior art and on its Clicker A analysis, which the Board
also used for the Clicker B claims. Based on the record be-
fore us, we find that substantial evidence supports the
Board’s obviousness determination. For the ASB claims,
the Board found, based on the arguments and evidence pre-
sented, that partial nuts and half-nuts were known, the
proposed modifications would have been within the skill of
a person of ordinary skill in the art (“POSA”), and a POSA
would have been motivated to make those modifications.
See 1679 Final Written Decision at 64–73. The Board cred-
ited the testimony of Mylan Pharmaceuticals Inc.’s
(“Mylan”) expert, Mr. Karl Leinsing, on what was known
in the art, a POSA’s motivations for modifying the prior art,
and the operation of the modified device. See
id. at 65–69,
71, 73. Sanofi provides no basis for disturbing the Board’s
credibility determinations. For the Clicker A claims, the
Board noted that Sanofi did not dispute the alleged benefit
of the modified device, nor that a POSA would have had a
reasonable expectation of success in arriving at the first el-
ement.
Id. at 85–86, 89. Although Sanofi disputed that the
modification for the second element could be readily
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accomplished, the Board found Mylan’s arguments and ev-
idence to be “more persuasive” in light of evidence demon-
strating a POSA’s knowledge.
Id. at 88–90. The numerous
exhibits on which the Board relied provide substantial evi-
dence for its findings. For the Clicker B claims, the Board
noted that Sanofi used the same arguments for both Click-
ers A and B.
Id. at 97. The Board therefore appropriately
relied on its analysis for the Clicker A claims in its analysis
for the Clicker B claims.
THE ’844 PATENT
Independent claim 21 of the ’844 Patent discloses “[a]
drug delivery device comprising” a number of components,
including “a driving member comprising a third thread”
and “a piston rod comprising either an internal or an exter-
nal fourth thread that is engaged with the third thread.”
’844 Patent col. 8 ll. 16–49.
In IPR2018-01680, Mylan’s grounds for unpatentabil-
ity all included Giambattista, 7 which issued from a patent
application filed one month after the GB Application.
Mylan Pharm. Inc. v. Sanofi-Aventis Deutschland Gmbh,
IPR2018-01680, at 13 (P.T.A.B. May 29, 2020) (“1680 Final
Written Decision”). The Board held that claims 21–30 are
not entitled to claim priority to the GB Application because
the GB Application does not provide written description
support for an internally-threaded piston rod.
Id. at 29.
The Board determined that (1) the GB Application as a
whole disclosed only a piston rod with external threads,
id.
at 16–22, and (2) a POSA reading the GB Application
would not understand the inventors to be in possession of
an internally-threaded piston rod,
id. at 22–29. After deter-
mining that Giambattista constituted prior art, the Board
found that claims 21–30 would have been unpatentable.
Id.
at 40–90, 128. In IPR2018-01682, the Board separately
7
U.S. Patent No. 6,932,794.
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6 SANOFI-AVENTIS DEUTSCHLAND v.
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found that claims 21–29 would have been obvious over
Steenfeldt-Jensen and claim 30 would have been obvious
over Steenfeldt-Jensen and Klitgaard. Mylan Pharm. Inc.
v. Sanofi-Aventis Deutschland Gmbh, IPR2018-01682, at
132 (P.T.A.B. May 29, 2020) (“1682 Final Written Deci-
sion”).
In both IPR2018-01680 and IPR2018-01682, Sanofi
filed a contingent motion to amend proposing substitute
claims 31–38. Substitute claim 31 is identical to claim 21
except for the removal of the phrase “either an internal or
an external” such that claim 31 recites “a piston rod com-
prising a fourth thread that is engaged with the third
thread.” 1680 Final Written Decision at 93, 101–102; 1682
Final Written Decision at 95–96, 105. The Board observed
that Sanofi, in making this amendment, sought to main-
tain the same claim scope while receiving the benefit of the
GB Application priority date. 1680 Final Written Decision
at 102–103; 1682 Final Written Decision at 106. As in its
analysis of the original claims, the Board found that the
GB Application did not provide written description support
for an internally-threaded piston rod and denied Sanofi’s
motion to amend. 1680 Final Written Decision at 103–115;
1682 Final Written Decision at 107–19.
Sanofi appeals the Board’s determination that claims
21–30 are not entitled to the priority date of the GB Appli-
cation; claims 21–30 separately would have been obvious
over Steenfeldt-Jensen or Steenfeldt-Jensen with
Klitgaard; and substitute claims 31–38 are unsupported
amendments. Sanofi does not contest the Board’s ultimate
determination in IPR2018-01680 that claims 21–30 would
have been anticipated by Giambattista and/or obvious in
view of Giambattista with Steenfeldt-Jensen or Klitgaard.
On appeal, Sanofi repeats its argument from below
that the GB Application provides sufficient written de-
scription for an internally-threaded piston rod because (1)
it broadly discloses a piston rod with “a first threaded
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portion at a first end and a second threaded portion at a
second end” without specifying whether the threading is
internal or external, J.A. 3935 (2:2–3), and (2) original
claim 1 of the GB Application broadly claims “a piston rod”
without reference to any threading, J.A. 3945 (12:3–4).
Sanofi also repeats its argument that the GB Application’s
disclosure of an externally-threaded piston rod is sufficient
to describe the genus of threaded piston rods because a
POSA would understand that externally-threaded and in-
ternally-threaded piston rods are the only two species in
that genus.
The Board, in its final written decision, correctly re-
sponded to these arguments in detail and its analysis
shows it considered the GB Application in its entirety, as
well as Sanofi’s additional references that allegedly dis-
close internally-threaded piston rods and testimony from
both parties’ experts on this issue. See 1680 Final Written
Decision at 16–29, 101–15; 1682 Final Written Decision at
105–19. Based on the record before us, substantial evi-
dence supports the Board’s written description analysis for
claims 21–30 and substitute claims 31–38. In particular,
the Board cited the GB Application’s claimed limitations
and the arrangement of the features in the disclosed injec-
tor as evidence that the threading on the piston rod is lim-
ited to external threading. See 1680 Final Written Decision
at 16–29, 102–107, 109–12; 1682 Final Written Decision at
105–10. The Board found Sanofi’s references to be uncon-
vincing, crediting Mr. Leinsing’s testimony regarding what
a POSA would understand from the GB Application and
Sanofi’s references. See 1680 Final Written Decision at 20–
22, 25–26, 107, 110–14; 1682 Final Written Decision at 111,
113–14, 116–18. Finally, the Board rejected the testimony
from Sanofi’s expert, Dr. Alexander Slocum, that a POSA
would have known to implement an alternative mechanism
with an internally-threaded piston rod in the disclosed in-
jector, finding Dr. Slocum’s testimony to be not credible,
conclusory, and inconsistent with the GB Application’s
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8 SANOFI-AVENTIS DEUTSCHLAND v.
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disclosures and crediting Mr. Leinsing’s testimony instead.
See 1680 Final Written Decision at 17, 19–29, 106–14; 1682
Final Written Decision at 110, 111–18. Sanofi provides no
basis for overturning these findings.
Because we affirm the Board’s determination in
IPR2018-01680 that claims 21–30 would have been un-
patentable as obvious and/or anticipated and the Board’s
decision to deny Sanofi’s motion to amend with substitute
claims 31–38, the appeal from the final written decision in
IPR2018-01682 is moot and we accordingly dismiss as moot
Appeal No. 2020-2069.
AFFIRMED IN PART, DISMISSED IN PART
COSTS
Costs to Appellee.
