Trials@uspto.gov
`Tel: 571-272-7822
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`Paper 12
`Entered: January 27, 2021
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`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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`PGR2019-00064
`Patent 10,155,039 B2
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`INTRODUCTION
`I.
`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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`Enablement for Claims 1–12
`B.
`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.
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`IV. ORDER
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`Accordingly, it is
`ORDERED that Petitioner’s Requests for Rehearing is denied.
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`PGR2019-00064
`Patent 10,155,039 B2
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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
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