Coherus BioSciences, Inc.

Patent Trials and Appeals Board

Jan 27, 2021

PGR2019-00064 (P.T.A.B. Jan. 27, 2021)

Trials@uspto.gov Paper 12
Tel: 571-272-7822 Entered: January 27, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE
_______________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________
FRESENIUS KABI USA, LLC and FRESENIUS KABI SWISSBIOSIM GmbH
Petitioner
v.
COHERUS BIOSCIENCES, INC.
Patent Owner
_______________

PGR2019-00064
Patent 10,155,039 B2
_______________

Before SUSAN L.C. MITCHELL, CHRISTOPHER G. PAULRAJ,
JOHN H. SCHNEIDER, Administrative Patent Judges.

PAULRAJ, Administrative Patent Judge.

DECISION
Denying Petitioner’s Requests for Rehearing
37 C.F.R. § 42.71(d)

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I. INTRODUCTION
Fresenius Kabi USA, LLC and Fresenius Kabi SwissBioSim GmbH
(collectively, “Petitioner”) filed a Request for Rehearing of our Decision Denying
Institution of inter partes review. Paper 11 (“Req. Reh’g”). To summarize,
Petitioner filed a petition seeking inter partes review of U.S. Patent No.
10,155,039 B2 (Ex. 1001, “the ’039 patent”). Paper 3 (“Pet.”). Coherus
BioSciences, Inc. (“Patent Owner”) filed a Preliminary Response to the Petition.
Paper 9 (“Prelim. Resp.”). We denied institution based upon our consideration of
the merits of the challenges presented, including the lack of written description and
enablement grounds. See Paper 10 (”Decision”).
In its Request for Rehearing, Petitioner contends that the “Decision
erroneously excluded the inventors’ preferred embodiments from the claims,
misapplied the law regarding the written description and enablement requirements
of 35 U.S.C. § 112, and is not supported by substantial evidence in the record.”
Req. Reh’g 1.
Having considered Petitioner’s arguments, we deny the Request for
Rehearing and do not modify our prior Decision.
II. DISCUSSION
A party requesting rehearing has the burden to show a decision should be
modified by specifically identifying all matters the party believes were
misapprehended or overlooked, and the place where each matter was addressed
previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When
rehearing a decision on institution, we review the decision for an abuse of
discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is
based on an erroneous interpretation of law, if a factual finding is not supported by
substantial evidence, or if the decision represents an unreasonable judgment in
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weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277,
1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir.
2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).
A. Construction of “Stable”
In its Request for Rehearing, Petitioner challenges our construction of
“stable” in claims 1–12. Req. Reh’g 2–6. Specifically, Petitioner argues that our
construction of “stable” was in error because we construed that term to exclude the
inventors’ preferred embodiments, including those “that do not lose more than 5%
of their activity during two years of long-term storage.” Id. at 2–3. Petitioner
contends a construction of “stable” that excludes the inventors’ preferred
embodiments contravenes well-established claim construction law. Id. at 4 (citing
SynQor, Inc. v. Artesyn Tech., Inc., 709 F.3d 1365, 1378–79 (Fed. Cir. 2013)).
Petitioner’s arguments are unpersuasive because our construction of “stable”
does not exclude the preferred embodiments. As Petitioner acknowledges, “[t]he
Board did not construe ‘stable’ to be limited to formulations that are as stable as
Humira or lose 20% of activity upon storage.” Id. at 3. Although our construction
encompasses the “most” preferred embodiment (e.g., those that do not lose more
than 5% of their activity during two years of long-term storage), it also
encompasses other embodiments that are considered less preferred but nonetheless
within the scope of what is defined to be “stable” in the specification, i.e.,
compositions that do “not lose more than 20%, or more preferably 15%, or even
more preferably 10%” of activity. Ex. 1001, 9:28–33. Furthermore, consistent
with the specification, our construction of “stable” encompasses embodiments in
which stability is determined by comparison to the commercial formulation of
adalimumab known in the prior art, i.e., Humira. Decision 8–9. We find no basis
to construe “stable” to be limited to the only most preferred embodiment by
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requiring a loss of no more than 5% activity. See Superguide Corp. v. DirecTV
Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (stating “a particular
embodiment appearing in the written description may not be read into a claim
when the claim language is broader than the embodiment”).
Petitioner further argues:
the Board also clearly erred when it “agree[d] with Patent Owner that
‘[a] POSA would not interpret the claims as covering a genus of
formulations having a range of different stabilities . . . , especially
because the claims simply do not recite a range of stability values to be
achieved over different periods of time
Req. Reh’g 5 (citing Decision 9). Petitioner contends that “[a] claim need not
recite a range to be a genus claim.” Id. As noted above, we agree that the claims
encompass a genus of formulations with different levels of stability. Nonetheless,
that conclusion does not support Petitioner’s argument that “since the claims
include all of the preferred embodiments, and those embodiments span a range of
stabilities, the claims span a range of stabilities.” Id. Nor is the relevance of
Petitioner’s argument entirely clear. For instance, Petitioner argues that “under the
Board’s construction, the broadest claim—claim 1—would be anticipated by a
narrow species in the prior-art: a formulation that met all of the ingredient
limitations of the claim and achieved the inventors’ most-preferred level of
stability (5% loss over two years of storage).” Id. at 5–6. Petitioner, however, did
not raise an anticipation challenge in this proceeding, and we decline to opine on
whether or not the claims would be anticipated by any prior art formulation under
our construction.
Accordingly, Petitioner has not established that we erred in our construction
of “stable.”

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B. Enablement for Claims 1–12
Petitioner argues in their Request for Rehearing that we erred in our
determination that Petitioner did not meet their burden of demonstrating that it is
more likely than not that claims 1–12 are unpatentable for lack of enablement.
Req. Reh’g 6–8. Specifically, Petitioner contends:
The Board erred when it held that “we do not find that the claims must
necessarily be enabled” for formulations that meet the most-preferred
level of stability, reasoning that “the specification only discloses that a
loss of no more than 5% is ‘most preferabl[e],’ but is not otherwise
required to achieve a stable pharmaceutical composition.”
Id. at 6 (citing Decision 17). Petitioner contends this is an error because the full
scope of the claims must be enabled. Id. Petitioner further contends that only one
embodiment, formulation D-12, included accelerated testing but “the specification
does not disclose any information from which a POSA could conclude that Humira
loses no more than 5% of activity over two years of storage, or that formulation
D-12 meets this level of stability.” Id. at 7. Petitioner further argues that “the level
of stability that a particular combination of ingredients will achieve is
unpredictable” and “a POSA seeking to practice the most preferred embodiments is
essentially left to perform the same laborious trial-and error experimentation that
the inventors engaged in and received a patent for.” Id. at 7–8 (citing Pet. 41–42,
60–61; Ex. 1002 ¶¶ 150–51, 186–87).
These arguments are also unpersuasive. As stated in the Decision:
[W]e find that the specification provides a detailed disclosure of the
testing used to assess stability (using Humira as the control), and
identifies specific ingredients to be included and excluded from the
claimed composition, and further identifies the pH that is necessary to
achieve the claimed stability. Although there may be certain
concentrations of adalimumab or certain types of buffers and sugars
that may render the compositions more difficult to stabilize, Petitioner
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does not explain sufficiently why a POSA would not have known how
to adjust or select those ingredients in order to achieve the claimed
stable aqueous pharmaceutical composition.
Decision 17. As further stated in the Decision:
Moreover, even if a POSA would have needed to test whether a
particular composition was stable, “[t]he fact that some
experimentation is necessary does not preclude enablement; what is
required is that the amount of experimentation ‘must not be unduly
extensive.” PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558,
1564 (Fed. Cir. 1996) (citing Atlas Powder Co. v. E.I. DuPont De
Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984)). Indeed, even
“a considerable amount of experimentation is permissible, if it is merely
routine, or if the specification in question provides a reasonable amount
of guidance with respect to the direction in which the experimentation
should proceed to enable the determination of how to practice a desired
embodiment of the invention claimed.” Id. (citing Ex parte Jackson,
217 USPQ 804, 807 (BPAI 1982)).
Id. at 17–18. Petitioner’s arguments do not persuade us that we committed legal or
factual error in making the foregoing determinations. Accordingly, we are not
persuaded that we abused our discretion in determining that Petitioner did not
satisfy its burden with respect to the lack of enablement ground for claims 1–12.
C. Written Description Support for Claims 1–12
Petitioner contends that we erred by finding that Petitioner failed to meet its
burden of demonstrating that it is more likely than not that claims 1–12 are
unpatentable for lack of written description support. Req. Reh’g 8–10. Petitioner
argues that because “stable” includes embodiments having the most preferred
stability, the specification of the ’039 patent must demonstrate possession of a
formulation with the most preferred stability. Id. at 8–9. Petitioner asserts “the
Board concluded that the testing of a single formulation, D-12, was sufficient to
demonstrate possession of all of the formulations of claim 1 because that testing
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purportedly demonstrated that D-12 was as stable as the Humira control
formulation.” Id. at 9. According to Petitioner, “a POSA would not have been
able to conclude from the specification that any of the disclosed formulations,
including those as stable as Humira, meet the inventors’ most-preferred levels of
stability.” Id. at 9–10 (citing Pet. 31–44; Ex. 1002 ¶¶ 154–63).
These arguments are unpersuasive. As stated in the Decision, the ’039
patent discloses a formulation (i.e., D-12) that falls within the scope of claim 1.
Decision 13. We further stated that:
the specification identifies with sufficient clarity each of the ingredients
that must be included as part of the claimed composition (i.e.,
adalimumab, a buffer, polysorbate 80, and a sugar) and further provides
a reason to exclude the ingredients that must not be included in
theclaimed composition (i.e., mannitol, a citrate/phosphate buffer
combination, and sodium chloride).
Id. at 13–14. The Decision also explained how one of ordinary skill in the art
would recognize that the inventors possessed the claimed invention:
Patent Owner identifies teachings in the specification indicating the
structural features required for achieving a stable adalimumab
composition, which include: 1) avoiding the citrate/phosphate buffer
combination in favor of another more stable buffer (such as an acetate
buffer); 2) including polysorbate 80 as a stabilizer; 3) removing
sodium chloride (NaCl) from the formulation; 4) using a sugar or
polyol as the tonicity modifier in place of mannitol/NaCl; and 5)
maintaining a pH of at least 5 (with an optimal pH near 5.2). Id. at 60
(citing Ex. 1001, 5:42–44, 21:40–47, 37:25–38:4, 38:1–7, 61:24–25).
Patent Owner further asserts, and we agree, that the specification
“provides working examples that demonstrate comparable or superior
stability to the commercial Humira® formulation” and that Petitioner
fails to demonstrate why a POSA would doubt that the formulations
that demonstrated improved stability relative to Humira would be
stable. Id. at 60–61.

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Id. at 14.
Petitioner’s arguments do not persuade us that we committed legal or
factual error in making the foregoing determinations. Accordingly, we are
not persuaded that we abused our discretion in determining that Petitioner
did not satisfy its burden with respect to the lack of written description
ground for claims 1–12.
D. Written Description Support and Enablement for Claims 9–12
In its Request for Rehearing, Petitioner also presents separate arguments
alleging that the Board’s finding that the specification adequately described and
enabled the acetate formulations of claims 9–12 is not supported by substantial
evidence. Req. Reh’g 10–15. Petitioner, however, did not present any
unpatentability grounds in the Petition specific to claims 9–12. Rather, Petitioner
only argued that the provisional applications on which the ’039 patent relied upon
for an earlier filing date did not provide written description or enablement support
for claims 9–12, and thus the’039 patent is not PGR-eligible. Pet. 20–44. As
noted in our Decision, we did not address Petitioner’s priority date arguments and
assumed arguendo that the ’039 patent is PGR-eligible for purposes of our
analysis. Decision 6. To the extent Petitioner now seeks to convert its PGR-
eligibility arguments into unpatentability arguments with respect to claims 9–12,
we decline to consider those arguments as they were not timely and specifically
presented in the Petition. A rehearing request is not an opportunity to present new
arguments.

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III. CONCLUSION
For the foregoing reasons, Petitioner has not demonstrated that we abused
our discretion, or that we misapprehended or overlooked any issue, in exercising
our discretion to deny institution.
IV. ORDER
Accordingly, it is
ORDERED that Petitioner’s Requests for Rehearing is denied.

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FOR PETITIONER:
Linnea Cipriano
Huiya Wu
GOODWIN PROCTER LLP
Lcipriano@goodwinlaw.com
HWu@goodwinlaw.com

FOR PATENT OWNER:
Joseph Hynds
Jennifer Nock
Aydin Harston
ROTHWELL, FIGG, ERNST & MANBECK, P.C.
jhynds@rfem.com
jnock@rfem.com
aharston@rfem.com