Case: 20-1074 Document: 132 Page: 1 Filed: 02/11/2021
`
`
`
`United States Court of Appeals
`for the Federal Circuit
`______________________
`
`AMGEN INC., AMGEN MANUFACTURING,
`LIMITED, AMGEN USA, INC.,
`Plaintiffs-Appellants
`
`v.
`
`SANOFI, AVENTISUB LLC, FKA AVENTIS
`PHARMACEUTICALS INC., REGENERON
`PHARMACEUTICALS INC., SANOFI-AVENTIS U.S.
`LLC,
`Defendants-Appellees
`______________________
`
`2020-1074
`______________________
`
`Appeal from the United States District Court for the
`District of Delaware in Nos. 1:14-cv-01317-RGA, 1:14-cv-
`01349-RGA,
`1:14-cv-01393-RGA,
`1:14-cv-01414-RGA,
`Judge Richard G. Andrews.
`______________________
`
`Decided: February 11, 2021
`______________________
`
`JEFFREY A. LAMKEN, MoloLamken LLP, Washington,
`DC, argued for plaintiffs-appellants. Also represented by
`SARAH JUSTINE NEWMAN, MICHAEL GREGORY PATTILLO, JR.;
`SARA MARGOLIS, New York, NY; ERICA S. OLSON, Amgen
`Inc., Santa Monica, CA; EMILY JOHNSON, STEVEN TANG,
`STUART WATT, WENDY A. WHITEFORD, Thousand Oaks, CA;
`KEITH HUMMEL, Cravath Swaine & Moore LLP, New York,
`
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`Case: 20-1074 Document: 132 Page: 2 Filed: 02/11/2021
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`AMGEN INC. v. SANOFI
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`NY; WILLIAM G. GAEDE, III, McDermott, Will & Emery
`LLP, Menlo Park, CA; CHRISTOPHER B. MEAD, Schertler
`Onorato & Mead LLP, Washington, DC; JAMES L. HIGGINS,
`MELANIE K. SHARP, Young, Conaway, Stargatt & Taylor
`LLP, Wilmington, DE. Plaintiff-appellant Amgen Inc. also
`represented by SARAH CHAPIN COLUMBIA, McDermott, Will
`& Emery LLP, Boston, MA; LAUREN MARTIN, Quinn Eman-
`uel Urquhart & Sullivan LLP, Boston, MA.
`
` MATTHEW WOLF, Arnold & Porter Kaye Scholer LLP,
`Washington, DC, argued for defendants-appellees. Also
`represented by VICTORIA REINES; DAVID K. BARR, DANIEL
`REISNER, New York, NY; DEBORAH E. FISHMAN, Palo Alto,
`CA; GEORGE W. HICKS, JR., NATHAN S. MAMMEN, CALVIN
`ALEXANDER SHANK, Kirkland & Ellis LLP, Washington,
`DC. Defendants-appellees Sanofi, Aventisub LLC, Sanofi-
`Aventis U.S. LLC also represented by STEPHANIE
`DONAHUE, Sanofi, Bridgewater, NJ. Defendant-appellee
`Regeneron Pharmaceuticals Inc. also represented by
`LARRY A. COURY, LYNDA NGUYEN, Regeneron Pharmaceu-
`ticals Inc., Tarrytown, NY.
`
` JORGE A. GOLDSTEIN, Sterne Kessler Goldstein & Fox,
`PLLC, Washington, DC, for amici curiae Bristol-Myers
`Squibb Company, Merck Sharp & Dohme Corp. Also rep-
`resented by KRISTINA CAGGIANO KELLY, ELDORA ELLISON,
`WILLIAM MILLIKEN.
`
` DUANE CHRISTOPHER MARKS, Eli Lilly and Company,
`Indianapolis, IN, for amicus curiae Eli Lilly and Company.
`Also represented by TONYA COMBS, MARK STEWART,
`GILBERT VOY.
`
` AMIT THAKORE, White & Case LLP, New York, NY, for
`amicus curiae Pfizer Inc. Also represented by DIMITRIOS T.
`DRIVAS; ELIZABETH K. CHANG, Palo Alto, CA; JEFFREY NEIL
`MYERS, Pfizer Inc., New York, NY.
`
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`AMGEN INC. v. SANOFI
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`3
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` STANLEY D. LIANG, Tarrytown, NY, as amicus curiae,
`pro se.
` ______________________
`
`Before PROST, Chief Judge, LOURIE and HUGHES, Circuit
`Judges.
`
`LOURIE, Circuit Judge.
`Amgen Inc., Amgen Manufacturing, Ltd., and Amgen
`USA, Inc. (collectively, “Amgen”) appeal from a decision of
`the United States District Court for the District of Dela-
`ware granting Judgment as a Matter of Law (“JMOL”) of
`lack of enablement of claims 19 and 29 of U.S. Patent
`8,829,165 (the “’165 patent”) and claim 7 of U.S. Patent
`8,859,741 (the “’741 patent”). See Amgen Inc. v. Sanofi,
`No. CV 14-1317-RGA, 2019 WL 4058927, at *1–2, *13 (D.
`Del. Aug. 28, 2019) (“Decision”). For the reasons set forth
`below, we affirm.
`
`BACKGROUND
`Elevated low-density lipoprotein (“LDL”) cholesterol is
`linked to heart disease. LDL receptors remove LDL cho-
`lesterol from the blood stream, thus regulating the amount
`of circulating LDL cholesterol. The proprotein convertase
`subtilisin/kexin type 9 (“PCSK9”) enzyme regulates LDL
`receptor degradation. PCSK9 binds to LDL receptors and
`mediates their degradation, thus decreasing the number of
`LDL receptors on a cell’s surface. Antibodies may bind to
`and block PCSK9, allowing LDL receptors to continue reg-
`ulating the amount of circulating LDL cholesterol.
`Amgen owns the ’165 and ’741 patents, which describe
`antibodies that purportedly bind to the PCSK9 protein and
`lower LDL levels by blocking PCSK9 from binding to LDL
`receptors. The ’165 and ’741 patents share a common writ-
`ten description. See Appellants’ Br. 10 n.2. The specifica-
`tion discloses amino acid sequences for twenty-six
`antibodies, including the antibody (designated as “21B12”)
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`AMGEN INC. v. SANOFI
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`with the generic name of evolocumab, marketed by Amgen
`as Repatha®. See ’165 patent col. 85 ll. 1–43; Appellants’
`Br. 11 n.3. As shown for example in Figure 20A of the ’165
`patent, the specification discloses three-dimensional struc-
`tures for the antibodies designated 21B12 and 31H4 and
`shows where those antibodies bind to PCSK9. The ’165 and
`’741 patents claim antibodies that bind to one or more of
`fifteen amino acids (i.e., “residues”) of the PCSK9 protein
`and block PCSK9 from binding to LDL receptors.
`The relevant ’165 patent claims are:
`1. An isolated monoclonal antibody, wherein, when
`bound to PCSK9, the monoclonal antibody binds to
`at least one of the following residues: S153, I154,
`P155, R194, D238, A239, I369, S372, D374, C375,
`T377, C378, F379, V380, or S381 of SEQ ID NO:3,
`and wherein the monoclonal antibody blocks bind-
`ing of PCSK9 to LDLR.
`19. The isolated monoclonal antibody of claim 1
`wherein the isolated monoclonal antibody binds to
`at least two of the following residues S153, I154,
`P155, R194, D238, A239, I369, S372, D374, C375,
`T377, C378, F379, V380, or S381 of PCSK9 listed
`in SEQ ID NO:3.
`29. A pharmaceutical composition comprising an
`isolated monoclonal antibody, wherein the isolated
`monoclonal antibody binds to at least two of the fol-
`lowing residues S153, I154, P155, R194, D238,
`A239, I369, S372, D374, C375, T377, C378, F379,
`V380, or S381 of PCSK9 listed in SEQ ID NO: 3
`and blocks the binding of PCSK9 to LDLR by at
`least 80%.
`’165 patent col. 427 l. 47–col. 430 l. 23.
`The relevant ’741 patent claims are:
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`AMGEN INC. v. SANOFI
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`1. An isolated monoclonal antibody that binds to
`PCSK9, wherein the isolated monoclonal antibody
`binds an epitope on PCSK9 comprising at least one
`of residues 237 or 238 of SEQ ID NO: 3, and
`wherein the monoclonal antibody blocks binding of
`PCSK9 to LDLR.
`2. The isolated monoclonal antibody of claim 1,
`wherein the isolated monoclonal antibody is a neu-
`tralizing antibody.
`7. The isolated monoclonal antibody of claim 2,
`wherein the epitope is a functional epitope.
`’741 patent col. 427 ll. 36–57. The claimed antibodies are
`defined by their function: binding to a combinations of sites
`(residues) on the PCSK9 protein, in a range from one resi-
`due to all of them; and blocking the PCSK9/LDLR interac-
`tion.
`This is the second time that these patents have been on
`appeal in our court. Amgen filed suit against Sanofi,
`Aventisub LLC, Regeneron Pharmaceuticals Inc., and
`Sanofi-Aventis U.S. LLC (collectively, “Sanofi”) on Octo-
`ber 17, 2014, alleging infringement of multiple U.S. pa-
`tents, including the ’165 and ’741 patents. Decision at *1.
`Amgen and Sanofi stipulated to infringement of selected
`claims (including ’165 patent claims 19 and 29 and ’741 pa-
`tent claim 7) and tried issues of validity to a jury in March
`2016. Id. During the trial, the district court granted JMOL
`of nonobviousness and of no willful infringement. Id. At
`the close of the trial, the jury determined that the patents
`were not shown to be invalid for lack of enablement and
`written description. Id.
`Sanofi appealed to this court. Relevant to the current
`appeal, we held that the district court erred in its eviden-
`tiary rulings and jury instructions regarding Sanofi’s de-
`fenses that the patents lack written description and
`enablement, and we remanded for a new trial on those
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`AMGEN INC. v. SANOFI
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`issues. Amgen Inc. v. Sanofi, 872 F.3d 1367, 1381–82
`(Fed. Cir. 2017). We also vacated the permanent injunc-
`tion. Id.
`On remand, the parties tried the issues of written de-
`scription and enablement to the jury. The jury again found
`that Sanofi failed to prove that the asserted claims were
`invalid for lack of written description and enablement.
`Sanofi moved for JMOL and, in the alternative, for a new
`trial. Decision at *1; J.A. 895. The district court granted
`Sanofi’s Motion for JMOL for lack of enablement and de-
`nied the motion for lack of written description. See Deci-
`sion at *17; J.A. 35. The court also conditionally denied
`Sanofi’s motion for a new trial. Id. Amgen timely ap-
`pealed, and we have jurisdiction pursuant to 28 U.S.C.
`§ 1295(a)(1). See J.A. 909–10.
`DISCUSSION
`Whether a claim satisfies the enablement requirement
`of 35 U.S.C. § 112 is a question of law that we review with-
`out deference, although the determination may be based on
`underlying factual findings, which we review for clear er-
`ror. See Alcon Research Ltd. v. Barr Labs., Inc., 745 F.3d
`1180, 1188 (Fed. Cir. 2014). The statutory basis for the en-
`ablement requirement is found in Section 112 of the patent
`statute, which provides in relevant part that a patent’s
`specification must “enable any person skilled in the art . . .
`to make and use” the patented invention. 35 U.S.C.
`§ 112(a). The purpose of the enablement requirement is to
`ensure that the public is told how to carry out the inven-
`tion, i.e., to make and use it. We have held that such dis-
`closure must be “at least commensurate with the scope of
`the claims.” Crown Operations Int’l v. Solutia Inc., 289
`F.3d at 1367, 1378–79 (Fed. Cir. 2002) (citing Nat’l Recov-
`ery Techs., Inc. v. Magnetic Separation Sys., 166 F.3d 1190,
`1196 (Fed. Cir. 1999)).
`“To prove that a claim is invalid for lack of enablement,
`a challenger must show by clear and convincing evidence
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`that a person of ordinary skill in the art would not be able
`to practice the claimed invention without ‘undue experi-
`mentation.’” Alcon Research, 745 F.3d at 1188 (quoting In
`re Wands, 858 F.2d 731, 736–37 (Fed. Cir. 1988)).
`“Whether undue experimentation is needed is not a single,
`simple factual determination, but rather is a conclusion
`reached by weighing many factual considerations.” Wands,
`858 F.2d at 737. Those factual considerations, which have
`come to be known as the “Wands factors,” are:
`(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.
`
`Id.
`
`As we have stated elsewhere, “[a]fter the challenger
`has put forward evidence that some experimentation is
`needed to practice the patented claim, the factors set forth
`in Wands then provide the factual considerations that a
`court may consider when determining whether the amount
`of that experimentation is either ‘undue’ or sufficiently rou-
`tine such that an ordinarily skilled artisan would reasona-
`bly be expected to carry it out.” Alcon Research, 745 F.3d
`at 1188 (quoting Wands, 858 F.2d at 737). Although a spec-
`ification does not need to “describe how to make and use
`every possible variant of the claimed invention, when a
`range is claimed, there must be reasonable enablement of
`the scope of the range.” McRO, Inc. v. Bandai Namco
`Games Am. Inc., 959 F.3d 1091, 1100 (Fed. Cir. 2020) (cit-
`ing AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244 (Fed. Cir.
`2003)) (internal citations omitted).
`On appeal, Amgen asks us to reverse the district court’s
`decision holding ’165 patent claims 19 and 29 and ’741 pa-
`tent claim 7 invalid for lack of enablement. Amgen
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`AMGEN INC. v. SANOFI
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`contends that, under a proper analysis of the Wands fac-
`tors, the claims at issue were enabled because no undue
`experimentation is required to obtain antibodies fully
`within the scope of the claims. Amgen points to expert tes-
`timony purportedly showing that a person of skill in the art
`can make all antibodies within the scope of the claims by
`following a roadmap using anchor antibodies and well-
`known screening techniques as described in the specifica-
`tion or by making conservative amino acid substitutions in
`the twenty-six examples. Amgen argues that the court
`erred by focusing on the effort required to discover and
`make every embodiment of the claims, see Appellants’ Br.
`32 (citing Decision at *7), while failing to recognize that
`Sanofi could not identify any antibody that cannot be made
`by following the specification’s teachings. See Reply Br. 4–
`5; see also McRO, 959 F.3d at 1104 (“[A] usual requirement
`[is] that the challenger identify specifics that are or may be
`within the claim but are not enabled.”). Amgen contends
`that the embodiments in the patent are structurally repre-
`sentative for the purpose of fulfilling the written descrip-
`tion requirement, and such evidence is sufficient to
`indicate a structure/function correlation establishing ena-
`blement. See Reply Br. 23–24.
`Sanofi responds that the district court properly con-
`cluded based on the Wands factors that the claims are not
`enabled because they require undue experimentation. As
`support for its position, Sanofi contends that there are mil-
`lions of antibody candidates within the scope of the claims,
`the disclosures do not provide sufficient guidance, antibody
`generation is unpredictable, and practicing the full scope of
`the claims requires substantial trial and error. See Appel-
`lees’ Br. 17–18, 56. According to Sanofi, the functionally
`defined claims cover a vast scope. See id. at 34–41. Sanofi
`argues that Amgen focused on “the number of antibodies
`actually known to satisfy the claims, when this court’s
`precedents require examining the number of candidates
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`AMGEN INC. v. SANOFI
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`9
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`that must be made and tested to determine whether they
`satisfy the claimed function.” Id. at 18.
`We begin by considering the Wands case itself, which
`has become the “go to” precedent for guidance on enable-
`ment, and which also involved claims relating to antibody
`technology. The broadest claim in Wands “involve[d] im-
`munoassay methods for the detection of hepatitis B surface
`antigen by using high-affinity monoclonal antibodies of the
`IgM isotype.” Wands, 858 F.2d at 733. The U.S. Patent
`and Trademark Office Board of Patent Appeals and Inter-
`ferences had found that undue experimentation would be
`required for one skilled in the art to make the claimed an-
`tibodies used in the methods because “production of high-
`affinity IgM anti-HBsAg antibodies [was] unpredictable
`and unreliable.” Id. at 735. We found, reviewing the facts,
`that the disclosure adequately taught using hybridoma
`technology to produce the needed claimed antibodies. See
`id. at 734. We stated that “no evidence was presented by
`either party on how many hybridomas would be viewed by
`those in the art as requiring undue experimentation to
`screen,” id. at 740, and we accordingly held that the speci-
`fication fully enabled the claimed invention, see id. at 736.
`Importantly, although Wands gave birth to its epony-
`mous factors, Wands did not proclaim that all broad claims
`to antibodies are necessarily enabled. Facts control and, in
`this court, so does the standard of review. In considering
`the Wands factors, the district court compared the present
`case to other cases in which we found lack of enablement
`due to the undue experimentation required to make and
`use the full scope of the claimed compounds that require a
`particular structure and functionality. For example, in Wy-
`eth & Cordis Corp. v. Abbott Laboratories, we held that
`claims covering methods of preventing restenosis with
`compounds having certain functionality requirements
`were invalid for lack of enablement. See 720 F.3d 1380,
`1385–86 (Fed. Cir. 2013). Of particular significance, we
`held that due to the large number of possible candidates
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`AMGEN INC. v. SANOFI
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`within the scope of the claims and the specification’s corre-
`sponding lack of structural guidance, it would have re-
`quired undue experimentation to synthesize and screen
`each candidate to determine which compounds in the
`claimed class exhibited the claimed functionality. Id.
`Similarly, in Enzo Life Sciences, Inc. v. Roche Molecu-
`lar Systems, Inc., we found that the claims were similar to
`those at issue in Wyeth in that they required both a partic-
`ular structure and functionality, and we held that the spec-
`ification failed to teach one of skill in the art whether the
`many embodiments of the broad claims would exhibit that
`required functionality. See 928 F.3d 1340, 1345–48 (Fed.
`Cir. 2019). And, in Idenix Pharmaceuticals LLC v. Gilead
`Sciences Inc., we affirmed the district court’s determina-
`tion that the claims had both structural and functional lim-
`itations, and that undue experimentation would have been
`required to synthesize and screen the billions of possible
`compounds because, given a lack of guidance across that
`full scope, finding functional compounds would be akin to
`finding a “needle in a haystack.” 941 F.3d 1149, 1160–63,
`1165 (Fed. Cir. 2019); see Idenix Pharms. LLC v. Gilead
`Scis., Inc., 2018 WL 922125 (D. Del. Feb. 16, 2018). The
`district court found that Wyeth, Enzo, and Idenix all sup-
`port its conclusion that the asserted claims lack enable-
`ment. See Decision at *9–13.
`What emerges from our case law is that the enable-
`ment inquiry for claims that include functional require-
`ments can be particularly focused on the breadth of those
`requirements, especially where predictability and guid-
`ance fall short. In particular, it is important to consider
`the quantity of experimentation that would be required to
`make and use, not only the limited number of embodiments
`that the patent discloses, but also the full scope of the
`claim. As we recently explained:
`[C]onducting the Wands analysis has routinely in-
`volved concrete identification of at least some
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`AMGEN INC. v. SANOFI
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`11
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`embodiment or embodiments asserted not to be en-
`abled—including what particular products or pro-
`cesses are or may be within the claim, so that
`breadth is shown concretely and not just as an ab-
`stract possibility, and how much experimentation
`a skilled artisan would have to undertake to make
`and use those products or processes.
`McRO, 959 F.3d at 1100. We then elaborated in a footnote
`that:
`In cases involving claims that state certain struc-
`tural requirements and also require performance of
`some function (e.g., efficacy for a certain purpose),
`we have explained that undue experimentation can
`include undue experimentation in identifying, from
`among the many concretely identified compounds
`that meet the structural requirements, the com-
`pounds that satisfy the functional requirement.
`Id. at 1100 n.2 (citations omitted).
`That reasoning applies here. While functional claim
`limitations are not necessarily precluded in claims that
`meet the enablement requirement, such limitations pose
`high hurdles in fulfilling the enablement requirement for
`claims with broad functional language. See, e.g., Wyeth,
`720 F.3d at 1384 (finding that practicing the full scope of
`the claims would require excessive experimentation); Enzo,
`928 F.3d at 1345 (finding that the specification failed to
`teach whether the many embodiments would be both hy-
`bridizable and detectable upon hybridization); Idenix, 941
`F.3d at 1155–56 (finding that the broad functional limita-
`tion of having efficacy against hepatitis C virus increased
`the number of nucleoside candidates that would need to be
`screened).
`Each appealed claim in this case is a composition claim
`defined, not by structure, but by meeting functional limita-
`tions. We agree with the district court’s finding that the
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`AMGEN INC. v. SANOFI
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`specification here did not enable preparation of the full
`scope of these double-function claims without undue exper-
`imentation. See Decision at *13. The binding limitation is
`itself enough here to require undue experimentation.
`Turning to the specific Wands factors, we agree with
`the district court that the scope of the claims is broad.
`While in and of itself this does not close the analysis, the
`district court properly considered that these claims were
`indisputably broad. The parties dispute the exact number
`of embodiments falling within the claims. However, we are
`not concerned simply with the number of embodiments but
`also with their functional breadth. Regardless of the exact
`number of embodiments, it is clear that the claims are far
`broader in functional diversity than the disclosed exam-
`ples.1 If the genus is analogized to a plot of land, the dis-
`closed species and guidance “only abide in a corner of the
`genus.” AbbVie Deutschland GmbH & Co. v. Janssen Bio-
`tech, Inc., 759 F.3d 1285, 1299–300 (Fed. Cir. 2014). Fur-
`ther, the use of broad functional claim limitations raises
`the bar for enablement, a bar that the district court found
`was not met.
`We also agree with the district court that this invention
`is in an unpredictable field of science with respect to satis-
`fying the full scope of the functional limitations. One of
`Amgen’s expert witnesses admitted that translating an an-
`tibody’s amino acid “sequence into a known three-dimen-
`sional structure is still not possible.” J.A. 3910; see also
`Decision at *9. Another of Amgen’s experts conceded that
`“substitutions in the amino acid sequence of an antibody
`can affect the antibody’s function, and testing would be
`
`1 For example, there are three claimed residues to
`which not one disclosed example binds. See J.A. 4283; Ap-
`pellees’ Br. 52. And although the claims include antibodies
`that bind up to sixteen residues, none of Amgen’s examples
`binds more than nine. See id.
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`13
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`required to ensure that a substitution does not alter the
`binding and blocking functions.” J.A. 3891; see also Deci-
`sion at *9. And while some need for testing by itself might
`not indicate a lack of enablement, we note here the conspic-
`uous absence of nonconclusory evidence that the full scope
`of the broad claims can predictably be generated by the de-
`scribed methods. Instead, we have evidence only that a
`small subset of examples of antibodies can predictably be
`generated.
`Although the specification provides some guidance, in-
`cluding data regarding certain embodiments, we agree
`with the district court that “[a]fter considering the dis-
`closed roadmap in light of the unpredictability of the art,
`any reasonable factfinder would conclude that the patent
`does not provide significant guidance or direction to a per-
`son of ordinary skill in the art for the full scope of the
`claims.” Decision at *11. Here, even assuming that the
`patent’s “roadmap” provided guidance for making antibod-
`ies with binding properties similar to those of the working
`examples, no reasonable factfinder could conclude that
`there was adequate guidance beyond the narrow scope of
`the working examples that the patent’s “roadmap” pro-
`duced.
`As the district court noted, the only ways for a person
`of ordinary skill to discover undisclosed claimed embodi-
`ments would be through either “trial and error, by making
`changes to the disclosed antibodies and then screening
`those antibodies for the desired binding and blocking prop-
`erties,” or else “by discovering the antibodies de novo” ac-
`cording to a randomization-and-screening “roadmap.” Id.
`Either way, we agree with the district court that the re-
`quired experimentation “would take a substantial amount
`of time and effort.” Id. at *12. We do not hold that the
`effort required to exhaust a genus is dispositive. It is ap-
`propriate, however, to look at the amount of effort needed
`to obtain embodiments outside the scope of the disclosed
`examples and guidance. The functional limitations here
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`AMGEN INC. v. SANOFI
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`are broad, the disclosed examples and guidance are nar-
`row, and no reasonable jury could conclude under these
`facts that anything but “substantial time and effort” would
`be required to reach the full scope of claimed embodiments.
`We therefore conclude that, after weighing the Wands
`factors, the court did not err in concluding that undue ex-
`perimentation would be required to practice the full scope
`of these claims.
`Finally, Amgen is incorrect that the district court’s de-
`cision is inconsistent with Wands or that our affirmance
`here would overrule Wands. Wands, as indicated above,
`does not hold that antibody screening never requires undue
`experimentation. The holding in Wands was based on the
`facts of that case and the evidence presented there. Here,
`the evidence showed that the scope of the claims encom-
`passes millions of candidates claimed with respect to mul-
`tiple specific functions, and that it would be necessary to
`first generate and then screen each candidate antibody to
`determine whether it meets the double-function claim lim-
`itations. See Decision at *7–13. The facts of this case are
`thus more analogous to those in Enzo, Wyeth, and Idenix,
`where we concluded a lack of enablement.
`CONCLUSION
`We have considered Amgen’s remaining arguments but
`find them unpersuasive. For the reasons above, we affirm
`the district court’s determination that the asserted claims
`are invalid for lack of enablement.
`AFFIRMED
`
`