Trials@uspto.gov
`571-272-7822
` 
`
`Paper 10
`Entered: March 19, 2020
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
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`
`
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`
`
`
`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
`
`Before SUSAN L.C. MITCHELL, CHRISTOPHER G. PAULRAJ,
`JOHN H. SCHNEIDER, Administrative Patent Judges.
`PAULRAJ, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Post-Grant Review
`35 U.S.C. § 324 and 37 C.F.R. § 42.208
`
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`PGR2019-00064
`Patent 10,155,039 B2
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`
`I.
`INTRODUCTION
`Fresenius Kabi USA, LLC and Fresenius Kabi SwissBioSim GmbH
`(collectively, “Petitioner”) filed a Petition requesting post-grant review of claims
`1–12 (the “challenged claims”) 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 have
`jurisdiction under 35 U.S.C. § 324.
`To institute a post-grant review, we must determine whether the information
`presented in the petition “would demonstrate that it is more likely than not that at
`least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C.
`§ 324(a). After considering the Petition and the Preliminary Response, we
`determine, for the reasons set forth below, that Petitioner has failed to demonstrate
`that it is “more likely than not” that any of the challenged claims are unpatentable
`based on the grounds presented. Therefore, we do not institute a post-grant review
`of those claims.
`A. Related Matters
`Petitioner and Patent Owner both indicate that the ’039 patent is the subject
`of the following litigation: Coherus BioSciences, Inc. v. Amgen Inc., Case No.
`1:19-cv-00139-RGA (D. Del.). Pet. 2; Paper 6, 2.
`B. The ’039 Patent
`The ’039 patent, titled “Stable Aqueous Formulations of Adalimumab,”
`discloses pharmaceutical adalimumab compositions suitable for long-term storage.
`Ex. 1001, Abstract. The ’039 patent issued from an application (Appl. No.
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`15/799,851) filed October 31, 2017, and claims priority to three provisional
`applications, all of which were filed before the AIA critical date.
`Adalimumab is the active pharmaceutical ingredient in the drug Humira.
`Ex. 1001, 7:31–32. Adalimumab is described in U.S. Pat. No. 6,090,382, which is
`incorporated by reference in its entirety in the ’039 patent. Id. at 1:57–59.
`Although Humira was commercially available in an aqueous formulation at the
`time the ’039 patent was filed, the ’039 patent discloses that the stability of
`aqueous adalimumab could be improved by removing the citrate and phosphate
`buffer, mannitol, and sodium chloride. Ex. 1002, 5:5–27.
`According to the specification, “adalimumab compositions which comprise
`only one buffer (as opposed to two or more buffers) are more stable than
`adalimumab compositions comprising both a citrate buffer and a phosphate
`buffer.” Id. at 11:58–61. The specification provides acetate, succinate, histidine,
`phosphate, tartrate, maleate, and citrate as examples of sole buffers that are more
`stabilizing than the citrate and phosphate buffer combination. Id. at 16:26–27,
`21:46–47. The specification further describes that “sodium chloride is
`destabilizing” and that other stabilizers are “significantly better [options] . . . than
`mannitol.” Id. at 5:7–8, 14:23.
`The specification also provides testing data used to demonstrate the
`improved stability of the ’039 patent’s adalimumab compositions. Some of the
`tests used Humira as a control for purposes of stability comparison. See, e.g., id. at
`37:18–23. The data from the Humira-control tests show that single buffer
`adalimumab formulations are more stable than the commercially available Humira.
`Id. The ’039 specification further discloses analyzing the adalimumab
`compositions using size exclusion chromatography (“SEC”) and capillary
`isoelectric focusing (“cIEF”), among other techniques. See generally id. at 25:1–
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`63:49. Table E-1, reproduced below, displays examples of acetate-buffered
`formulations that exhibit comparable or superior stability to Humira.
`
`
`
`Id. at 39.
`C. Illustrative Claims
`Petitioner challenges claims 1–12 of the ’039 patent, of which claims 1, 5,
`and 9 are the only independent claims. Claim 1 is representative of the
`independent claims and recites:
`1. A stable aqueous pharmaceutical composition comprising:
`a) adalimumab;
`b) a buffer;
`c) polysorbate 80; and
`d) a sugar,
`wherein the composition is free of i) mannitol, ii) citrate and phosphate
`buffers, and iii) sodium chloride and wherein the composition has a pH of
`about 5 to about 6.
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`
`D. Asserted Grounds of Unpatentability
`Petitioner advances three grounds of unpatentability in relation to claims 1–
`12 of the ’039 patent and seek cancellation of those claims. Pet. 1. Petitioner
`argues that the challenged claims are unpatentable for: 1) lack of written
`description; 2) lack of enablement; and 3) indefiniteness. Id.
`Ground Claims
`Statutory Basis
`1
`1–12
`35 U.S.C. § 112 (written description)
`2
`1–12
`35 U.S.C. § 112 (enablement)
`3
`1–12
`35 U.S.C. § 112 (indefiniteness)
`Petitioner also relies on the declaration of Christian Schöneich, Ph.D.
`
`Ex. 1002.
`
`II. ANALYSIS
`
`A. Post-Grant Eligibility
`Post-grant reviews are only available for patents “described in section
`3(n)(1)” of the Leahy-Smith America Invents Act, Pub. L. No. 112-20, 125 Stat.
`284 (2011) (“AIA”). AIA § 6(f)(2)(A); see Arkema Inc. v. Honeywell Int’l Inc.,
`PGR2016-00011, Paper 13 at 15 (PTAB Sept. 2, 2016). These patents issue from
`applications “that contain[] or contained at any time . . . a claim to a claimed
`invention that has an effective filing date . . . on or after” March 16, 2013. AIA
`§ 3(n)(1). See also 37 C.F.R. § 42.204(a) (requiring that “petitioner . . . certify that
`the patent for which review is sought is available for post-grant review”).
`
`The ’039 patent issued on December 18, 2018, from U.S. Application No.
`15/799,851, filed on October 31, 2017. Ex. 1001, codes (45), (21), (22). The ’851
`application, through a continuation application, claims priority to U.S. Provisional
`Application No. 61/698,138, filed on September 7, 2012, U.S. Provisional
`Application No. 61/769,581, filed on Feb. 26, 2013, and U.S. Provisional
`Application No. 61/770,421, filed on Feb. 28, 2013. Id. at codes (60), (63).
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`Petitioner filed the request for post-grant review on September 17, 2019,
`
`which is within nine months of the grant of the ’039 patent. 35 U.S.C. § 321(c).
`See Pet. 2. Petitioner asserts that “the challenged claims have an effective filing
`date no earlier than September 6, 2013, because the earlier-filed priority
`provisional applications do not adequately disclose or enable them under 35 U.S.C.
`§112(a), and are thus eligible for PGR.” Pet. 1.
`Because Petitioner has failed to show it is more likely than not that any of
`the challenged claims are unpatentable based on the merits of the challenges
`presented, we determine that we need not address Petitioner’s priority date
`arguments or the issue of PGR eligibility for the ’039 patent. For purposes of our
`analysis herein, we will assume arguendo that the ’039 patent is PGR eligible.
`B. Level of Ordinary Skill in the Art
`Petitioner does not propose a level of ordinary skill in the art. Patent Owner,
`however, asserts that a person of ordinary skill in the art (“POSA”) would have “an
`advanced degree in biology, biochemistry, or chemistry (or related discipline), and
`at least two years of experience preparing formulations of proteins suitable for
`therapeutic use.” Prelim. Resp. 11. Patent Owner further contends that a POSA
`would have understood stability testing and partial least squares modeling for
`formulation development and would have been familiar with prior art concerning
`adalimumab formulations. Id.
`Patent Owner’s undisputed proposed definition is consistent with the cited
`prior art, and we adopt it for the purposes of this Decision. See Okajima v.
`Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings
`regarding ordinary skill level are not required “where the prior art itself reflects an
`appropriate level and a need for testimony is not shown” (quoting Litton Indus.
`Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).
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`
`C. Claim Construction
`We apply the claim construction standard articulated in Phillips v. AWH
`Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc), and used to construe claims in a
`civil action under 35 U.S.C. § 282(b). See Changes to the Claim Construction
`Standard for Interpreting Claims in Trial Proceedings Before the Patent Trial and
`Appeal Board, 83 Fed. Reg. 51,340 (Oct. 11, 2018); 37 C.F.R. § 42.100(b) (as
`amended). Under the Phillips standard, claim terms must be given “the meaning
`that the term would have to a person of ordinary skill in the art in question at the
`time of the invention.” Phillips, 415 F.3d at 1313.
`1. “stable aqueous pharmaceutical composition”
`Petitioner asserts that the term “stable aqueous pharmaceutical composition”
`should be construed as a range of stability, encompassing formulations that do not
`lose more than 5% to 20% of their activity during long-term storage. Pet. 10.
`Although the term “stable” appears in the preamble of the claim, Petitioner
`contends that it serves as a limitation because: 1) during prosecution, the applicant
`distinguished the claimed compositions from the prior-art formulations on the
`ground that they are “stable,” 2) and the applicant repeatedly described the
`“invention” as being “stable.” Id. at 12.
`In particular, Petitioner relies upon the following definition provided in the
`specification:
`The term ‘stable’ with respect to long-term storage is understood to
`mean that adalimumab contained in the pharmaceutical compositions
`does not lose more than 20%, or more preferably 15%, or even more
`preferably 10%, and even most preferably 5% of its activity relative to
`activity of the composition at the beginning of storage.
`Id. at 10. (citing Ex. 1001, 9:28–33; Ex. 1002 ¶ 44–51). Petitioner further contends
`that the term “stable” should be construed to refer to the stability during “long-term
`storage” of adalimumab, which is defined to mean “that the pharmaceutical
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`composition can be stored for three months or more, for six months or more, and
`preferably for one year or more, most preferably a minimum stable shelf life of at
`least two years.” Id. at 11 (citing Ex. 1001, 9:12–27; Ex. 1002 ¶¶ 49–51). From
`these ranges, Petitioner contends that the term “stable” encompasses “aqueous
`compositions that [do] not lose more than 5% of their biological activity when
`stored for a minimum of two years,” “[e]ither as a liquid at 2-8° C, or frozen, e.g.,
`at - 20° C or colder.” Id. at 12.
`Patent Owner does not dispute that the term “stable” in the preamble serves
`as a limitation. Rather, Patent Owner counters that the term “stable aqueous
`pharmaceutical formulation” “should be given its plain and ordinary meaning,”
`which only requires the formulation to maintain a “stability suitable for its
`intended pharmaceutical application.” Prelim. Resp. 12–13. Patent Owner argues
`that the term does not require “stability upon ‘long-term storage’” and that “[t]he
`specification as a whole does not show a ‘clear intent’ to redefine the term
`‘stable.’” Id. at 13. Additionally, Patent Owner argues that “[t]he plain language
`of the claims does not require ‘long term’ stability,” and the specification describes
`extensive stability testing techniques that do not require long term storage or a
`direct measurement of biological activity following long term storage. Id. at 13–
`14. Patent Owner contends definitions from the specification relied upon by
`Petitioner only relate to long-term storage, and do not constitute “a ‘clear intent’ to
`redefine the ‘term stable”’ to require the range of stabilities asserted by Petitioner.
`Id. at 15.
`
`We are unpersuaded by Petitioner’s argument that the term “stable” should
`be construed to include formulations that do not lose more than 5% of their activity
`during two years of long-term storage. Although the specification defines “‘stable’
`with respect to long-term storage” in terms of the biological activity of
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`adalimumab (Ex. 1001, 9:28–33), and defines “long-term storage” and “long term
`stability” in terms of a time period up to two years (id. at 9:12–16), other portions
`of the specification indicate that the required stability may be determined by a
`comparison to the commercial formulation of adalimumab known in the prior art,
`i.e., Humira. See id. at 9:16–23 (“Generally speaking, the terms ‘long term
`storage’ and ‘long term stability’ further include stable storage durations that are at
`least comparable to or better that [sic] the stable shelf typically required for
`currently available commercial formulations of adalimumab, without losses in
`stability that would render the formulation unsuitable for its intended
`pharmaceutical application”); see also id. at 4:43–47 (“The method is useful to
`obtain a formulation of adalimumab that exhibits long term stability comparable to
`or better than commercially available adalimumab formulations marked under the
`trademark Humira®.”). As noted by both Petitioner and Patent Owner, the testing
`methods described in the specification only included tests that measured chemical
`degradation, not changes in activity. Pet. 16; Prelim. Resp. 13. As such, we agree
`with Patent Owner that “[a] POSA would understand that at least the assays
`described in the specification, which use the commercial Humira® formulation as
`a control comparator, are sufficient to determine that an adalimumab formulation is
`‘stable’ within meaning of the claims.” Prelim. Resp. 13.
`Even taking into account the definitions cited by Petitioner, we agree 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.” Prelim. Resp. 15. Rather, the term “stable” is defined to only
`require a minimum level of stability (i.e., a loss of no more than 20% of activity)
`and notes optional “more preferable” levels, including most preferably no more
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`than 5%. Ex. 1001, 9:28–33. Likewise, the terms “long-term storage” and “long
`term stability” are only defined to require a minimum stability of three months, and
`the specification only states that the composition “most preferably” has a stable
`shelf life of at least two years. Id. at 9:12–16. As such, we do not find any
`intrinsic or extrinsic evidence of record suggesting that the applicant intended to
`require that the claimed formulations must be able to achieve the highest amount of
`stability over the longest time period identified in the specification.
`2. Citrate and Phosphate Buffers
`Petitioner asserts that a POSA would have understood that the phrase
`“citrate and phosphate buffers” recited among the excluded ingredients in the
`claims could reasonably be interpreted in one of two ways: (1) the claims exclude
`citrate buffer, phosphate buffer, and the combination of the two, or (2) the claims
`exclude only the combination of citrate and phosphate. Pet. 14. Petitioner further
`asserts that the specification does not define “citrate and phosphate buffers.” Id.
`Patent Owner responds that the correct interpretation of “citrate and phosphate
`buffer” is “the combination of citrate and phosphate buffers.” Prelim. Resp. 16–
`17.
`
`We determine that there is sufficient evidence in the intrinsic record to
`support Patent Owner’s assertion that a POSA would understand that the term
`“citrate and phosphate buffer” refers only to the combination of a citrate buffer and
`a phosphate buffer. As noted by Patent Owner, the specification consistently states
`that the combination of citrate and phosphate is to be avoided. Prelim. Resp. 17
`(citing Ex. 1001, 5:15–27, 21:43–47). For example, several embodiments
`disclosed in the specification identify citrate and phosphate individually among the
`buffers that may be included in the composition, but state that “said buffer does not
`comprise a combination of citrate and phosphate.” See, e.g., Ex. 1001, 2:9–19.
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`The specification further teaches that “the combination of citrate and phosphate is
`surprisingly significantly poorer in stabilizing adalimumab than other buffers” and
`further explains that “the present invention . . . is directed to adalimumab
`formulations . . . wherein a buffer combination of citrate and phosphate is
`avoided.” Id. at 5:14–16, 21:42–44. Additionally, the specification also contrasts
`the invention with prior art adalimumab formulations (i.e., Humira) containing a
`citrate/phosphate buffer combination. Id. at 5:18–27. Therefore, we are persuaded
`by and agree with Patent Owner’s construction of “citrate and phosphate buffer” as
`only excluding the combination of citrate and phosphate.
`3. Other Claim Terms
`Petitioner also proposes constructions for the terms “buffer,” “about,”
`“sugar,” and “single dose.” Pet. 13–16. To the extent the specification provides an
`express definition of these claim terms, we have taken those definitions into
`account. However, we decide that it is not necessary to construe these other terms
`for purposes of our analysis in this decision. See Nidec Motor Corp. v. Zhongshan
`Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need
`only construe terms ‘that are in controversy, and only to the extent necessary to
`resolve the controversy.’”).
`D. Ground 1: Lack of Written Description
`Petitioner argues that the challenged claims are unpatentable for lack of
`written description because the ’039 patent does not adequately disclose “examples
`of formulations that fall[] within the scope of the claims, empirical test data
`demonstrating that such formulations are ‘stable’ as defined in the patent, or
`guidance as to which particular combinations of ingredients and concentrations
`result in ‘stable’ formulations.” Pet. 44–45 (citing Ex. 1002 ¶¶ 154–55). With
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`respect to these arguments, we focus our analysis on independent claim 1 as our
`conclusions for that claim are applicable to the other challenged claims.
`1.
`Legal Standard
`35 U.S.C. § 112 requires that a patent’s specification “contain a written
`description of the invention . . . in such full, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains . . . to make and use the
`same.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
`(en banc). This provision ensures “the inventor actually invented the invention
`claimed” and “had possession of the claimed subject matter as of the filing date.”
`Id. at 1350–51. A patent specification can demonstrate possession of the claimed
`invention by providing a “precise definition” of the invention. Id. at 1350. “To
`provide this ‘precise definition’ for a claim to a genus, a patentee must disclose ‘a
`representative number of species falling within the scope of the genus or structural
`features common to the members of the genus so that one of skill in the art can
`“visualize or recognize” the members of the genus.’” Amgen Inc. v. Sanofi, 872
`F.3d 1367, 1373 (Fed. Cir. 2017) (quoting Ariad, 598 F.3d at 1350).
`2.
`Analysis
`Petitioner contends that the ’039 patent “does not pass the ‘representative
`species’ test” because “claim 1 is a broad genus claim and stability must be
`verified by empirical testing.” Pet. 45. Petitioner states that “[a]lthough the
`specification discloses dozens of additional test formulations, the only one that
`may be an embodiment of the claims is formulation D-12.” Id. at 46. Petitioner
`also asserts that despite the disclosure of formulation “D-12,” “empirical test data
`on a single species would not have described with reasonable clarity to a POSA
`which of the millions of possible species are stable enough to be members of the
`genus.” Id. at 46–47.
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`
`Petitioner further argues that the ’039 patent “does not earn a passing grade
`on the ‘common structural features test’” because the specification “does not
`correlate particular combinations and concentrations of the claimed ingredients . . .
`with the claimed stability.” Id. at 47. Particularly, Petitioner asserts that the test
`data for formulation “D-12” do not measure biological activity, as the claim term
`“stable” requires. Id. at 50–51. Petitioner argues that because biological activity is
`not measured by the testing methods, “the data, when viewed by a POSA as a
`whole, do not establish that any embodiment of the claims falls within the claimed
`stability range.” Id. 50.
`We agree with Patent Owner that Petitioner has not satisfied its burden of
`showing that it is more likely than not that claims 1–12 of the ’039 patent are
`unpatentable for lack written description. As Patent Owner correctly asserts, there
`is no legal requirement that a patent must include test results or working examples
`demonstrating stability for every possible composition that is covered by the
`claims. Prelim. Resp. 58; see Ariad, 598 F.3d at 1352 (stating that “the written
`description requirement does not demand either examples or an actual reduction to
`practice.”). Additionally, as acknowledged by Petitioner, at least one embodiment
`disclosed in the specification, the formulation “D-12,” “arguably falls within
`claim 1 since it has ‘adalimumab biosimilar,’ 10 mM phosphate buffer, 0.1%
`polysorbate 80, 240 mM trehalose sugar and a pH of 5.44, and does not contain
`mannitol or NaCal.” Pet. 18. Therefore, we are not persuaded by Petitioner’s
`“representative species test” arguments insofar as 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 the
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`claimed composition (i.e., mannitol, a citrate/phosphate buffer combination, and
`sodium chloride).
`We further agree with Patent Owner that Petitioner has failed to sufficiently
`show why a POSA could not determine that the ’039 patent “correlates the
`presence and absence of particular components and conditions with achieving the
`claimed stability.” Prelim. Resp. 59–60. Petitioner bases its argument on an
`incorrect construction of the term “stable” as requiring a range of stability, which
`includes a loss of no more than 5% activity over a period of two years. As
`discussed above, however, we do not construe the term “stable” recited in the
`claims to require the maximum stability disclosed in the Specification of the ’039
`as asserted by Petitioner. 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.
`Because Petitioner relies on an incorrect construction of stable and does not
`address the specification’s teachings that certain components and pH, including
`those explicitly recited in the claims, can impart stability, we are unconvinced
`
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`based on the present record by Petitioner’s argument that the inventors did not
`demonstrate possession of the claimed stable aqueous pharmaceutical composition.
`For the foregoing reasons, we agree with Patent Owner that Petitioner has failed to
`demonstrate that it is “more likely than not” that any of the challenged claims are
`unpatentable for lack of written description.
`E. Ground 2: Lack of Enablement
`Petitioner asserts that the challenged claims are unpatentable because the
`specification does not enable the full scope of the claims. Pet. 56. To support this
`assertion, Petitioner addresses a subset of the factors set forth in In re Wands, 858
`F.2d 731 (Fed. Cir. 1988), and argues those factors “confirm . . . the ’039 patent
`specification does not enable a POSA to practice the full scope of claims 1–12
`without undue experimentation.” Id. at 56. With respect to these arguments, we
`also focus our analysis on independent claim 1 as our conclusions for that claim
`are applicable to the other challenged claims.
`1.
`Legal Standard
`“Enablement requires that ‘the specification teach those in the art to make
`and use the invention without undue experimentation.’” Idenix Pharm. LLC v.
`Gilead Sci. Inc., 941 F.3d 1149, 1154 (Fed. Cir. 2019) (quoting Wands, 858 F.2d at
`737). The factors to be considered when determining if undue experimentation is
`required to practice the invention include: (1) the quantity of experimentation
`necessary; (2) the amount of direction or guidance presented; (3) the presence or
`absence of working examples; (4) the nature of the invention; (5) the state of the
`prior art; (6) the relative skill of those in the art; (7) the predictability or
`unpredictability of the art; and (8) the breadth of the claims. Wands, 858 F.2d at
`737.
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`
`Analysis
`2.
`Petitioner does not separately discuss each of the Wands factors, but instead
`focuses on the breadth of the claims, the amount of experimentation required, and
`the little guidance and lack of working examples provided in the specification to
`assert that a POSA would not be able to practice the full scope of the claimed
`invention without undue experimentation. Pet. 56–60.
`In particular, Petitioner contends that the scope of claims 1–12 “encompass
`millions of different formulations and those formulations will vary significantly in
`terms of stability.” Id. at 56. With respect to the quantity of experimentation
`necessary, Petitioner contends that a “POSA would need to test compositions
`covered by the claims to determine whether they met a particular claimed stability
`level,” and “[i]f they did not, the POSA would then need to make adjustments to
`the compositions and re-test as many times as necessary before achieving the
`required level.” Pet. 57 (citing Ex. 1002 ¶¶ 186–87) (internal citations omitted).
`Petitioner further contends that that “[a] POSA would have no way to evaluate if a
`formulation had the claimed range of stability, i.e., the claimed range of activity,
`with the tests measuring chemical degradation disclosed in the application.” Id.
`With respect to the guidance provided in the specification, Petitioner contends that
`the only example of a formulation that possibly contains the ingredients of claims
`1-4 is Formulation D-12, and the specification does not demonstrate that that is a
`“working” example, i.e., has the claimed stability. Id. at 58 (citing Ex. 1002 ¶¶
`159–63). Petitioner further contends that, “[t]he specification does not provide
`any examples of ingredient combinations set forth in claims 5-12, working or
`otherwise. Id. (citing Ex. 1002 ¶ 177).
`Petitioner contends that “to enable the full scope of the claims, the
`specification must enable a POSA to make sufficiently stable formulations
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`PGR2019-00064
`Patent 10,155,039 B2
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`containing hard-to-stabilize features, such as a high concentration of adalimumab,
`a pH at or near 4, a sugar like glucose that is a potent oxidizer, and buffers that the
`specification describes as being strong destabilizers, such as acetate,” and “must
`also enable a POSA to make formulations that meet the stringent 5% upper end of
`the claimed stability range.” Id. at 59. According to Petitioner, making and using
`the compounds covered by the claim would require undue experimentation because
`“a POSA would have to make and screen each candidate composition for stability,
`using a test of their own devising, to see whether it was stable for at least 3
`months.” Id. at 60.
`We are not persuaded by Petitioner’s arguments. As with its written
`description challenge, Petitioner’s arguments for lack of enablement are premised
`on an incorrect construction of the term “stable.” Contrary to Petitioner’s
`arguments, we do not find that the claims must necessarily be enabled for the
`“stringent 5% upper end” of the stability range insofar as 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. Pet. 59; Ex. 1001, 9:28–
`33. As discussed above, we 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 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. Moreover, even if a POSA would
`have needed to test whether a particular composition was stable, “[t]he fact that
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`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)).
`In sum, based on the current record, Petitioner has not demonstrated that
`achieving the claimed composition would require a POSA to undertake undue
`experimentation. For the foregoing reasons, we agree with Patent Owner that
`Petitioner has failed to demonstrate it is “more likely than not” that any of the
`challenged claims are unpatentable for lack of enablement.
`F. Ground 3: Indefiniteness
`1.
`Legal Standard
`“[A] patent is invalid for indefiniteness if its claims, read in light of the
`specification delineating the patent, and the prosecution history, fail to inform,
`with reasonable certainty, those skilled in the art about the scope of the invention.”
`Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014). The standard
`set forth by the Supreme Court “mandates clarity, whi