# 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 No s . 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 1 1 , 2021

______________________
J EFFREY A. L AMKEN , MoloLamken LLP, Washington, DC, argued for plaintiffs

- appellants. Also represented by S ARAH J USTINE N EWMAN , M ICHAEL G REGORY P ATTILLO , J R

. ; S ARA M ARGOLIS , New York, NY; E RICA S. O LSON , Amgen Inc., Santa Monica, CA; E MILY J OHNSON , S TEVEN T ANG , S TUART W ATT , W ENDY A. W HITEFORD , Thousand Oaks, CA; K EITH H UMMEL , Cravath Swaine & Moore LLP, New York, Case: 20-1074 Document: 132 Page: 1 Filed: 02/11/2021AMGEN INC

. v. SANOFI 2

NY; W ILLIAM G. G AEDE , III , McDermott, Will & Emery LLP, Menlo Park, CA; C HRISTOPHER B. M EAD , Schertler Onorato & Mead LLP, Washington, DC; J AMES L. H IGGINS , M ELANIE K. S HARP , Young, Conaway, Stargatt & Taylor LLP, Wilmington, DE. Plaintiff

- appellant Amgen Inc. also represented by S ARAH C HAPIN C OLUMBIA , McDermott, Will & Emery LLP, Boston, MA ; L AUREN M ARTIN , Quinn Emanuel Urquhart & Sullivan LLP, Boston, MA.

M ATTHEW W OLF , Arnold & Por ter Kaye Scholer LLP, Washington, DC, argued for defendants

- appellees. Also represented by V ICTORIA R EINES ; D AVID K. B ARR , D ANIEL R EISNER , New York, NY; D EBORAH E. F ISHMAN , Palo Alto, CA; G EORGE W. H ICKS , J R ., N ATHAN S. M AMMEN , C ALVIN A LEXANDER S HANK , Kir kland & Ellis LLP, Washington, DC. Defendants

- appellees Sanofi, Aventisub LLC, Sanofi

Aventis U.S. LLC also represented by S TEPHANIE D ONAHUE , Sanofi, Bridgewater, NJ. Defendant

- appellee Regeneron Pharmaceuticals Inc. also represented by L ARRY A. C OURY , L YNDA N GUYEN , Regeneron Pharmaceuticals Inc., Tarrytown, NY.

J ORGE A. G OLDSTEIN , Sterne Kessler Goldstein & Fox, PLLC, Washington, DC, for amici curiae Bristol

- MyersSquibb Company, Merck Sharp & Dohme Corp. Also represented by K RISTINA C AGGIANO K ELLY , E LDORA E LLISON , W ILLIAM M ILLIKEN

.

D UANE C HRISTOPHER M ARKS , Eli Lilly and Company, Indianapolis, IN, for amicus curiae Eli Lilly and Company. Also represented by T ONYA C OMBS , M ARK S TEWART , G ILBERT V O Y

.

A MIT T HAKORE , White & Case LLP , New York, NY, for amicus curiae Pfizer Inc. Also represented by D IMITRIOS T. D RIVAS ; E LIZABETH K. C HANG , Palo Alto, CA ; J EFFREY N EIL M YERS , Pfizer Inc., New York, NY. Case: 20-1074 Document: 132 Page: 2 Filed: 02/11/2021AMGEN INC

. v. SANOFI 3

S TANLEY D. L IANG , Tarrytown, NY, as amicus curiae,

pro se.

______________________

Before P ROST , Chief Judge

, L OURIE and H UGHES , Circuit Judges

. L OURIE , Circuit Judge

. Amgen Inc., Amgen Manufacturing, Ltd. , and Amgen USA, Inc. ( collectively, “Amgen”) appeal from a decision ofthe United States District Court for the District of Delaware 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

. B ACKGROUND

Elevated low

- density lipoprotein (“ LDL ”) cholesterol is linked to heart disease

. LDL receptors remove LDL cholesterol from the blood stream

, thus regulating the amount of circulating LDL cholesterol. The p roprotein convertase subtilisin/kexin type 9 ( “ PCSK9 ” ) enzyme regulates LDL receptor degr adation. 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

, allow ing LDL receptor s to continue regulating the amount of circulating LDL cho lesterol

. Amgen owns the ’165 and ’741 patents, which describe antibodies that purportedly bind to the PCSK9 protein and lower LDL levels by block ing PCSK9 from binding to LDL receptors. The ’165 and ’741 patents share a common written description

. See Appellants’ Br. 10 n.2. The specification discloses amino acid sequences for twenty

- six antibodies , including the antibody (designated as “21B12”) Case: 20-1074 Document: 132 Page: 3 Filed: 02/11/2021AMGEN INC

. v. SANOFI 4

with the generic name of evolocumab, mark eted 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, t he specification discloses three

- dimensional structures for the antibodies designated 21B12 and 31H4 and show s 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 c laims 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 where in the monoclonal antibody blocks binding 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 isolatedmonoclonal 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 and blocks the binding of PCSK9 to LDLR by at least 80%.

’ 165 patent c ol

. 427 l. 47

– col. 430 l. 23

. The relevant ’ 741 patent claims are: Case: 20-1074 Document: 132 Page: 4 Filed: 02/11/2021AMGEN INC

. v. SANOFI 5

1. An isolated mo noclonal 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 neutralizing antibody.
7. The isolated monoclonal antibody of claim 2, wherein the epitope is a functional epitope.
’741 patent col. 427 ll. 36

– 57

. T he claimed antibodies are defined by their function: binding to a combinations of sites(residues) on the PCSK9 protein, in a range from one residue to all of them ; and blocking the PCSK9/LDLR interaction

. This is the second time that th ese paten t s ha ve 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 October 17, 2014, alleging infringement of multiple U.S. patents, 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 patent 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, t he jury determined that the patents

were not shown to be in valid 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 evidentiary rulings and jury instructions regard ing Sanofi’s defenses that the patents lack written description and enablement, and we remanded for a new trial on those Case: 20-1074 Document: 132 Page: 5 Filed: 02/11/2021AMGEN INC

. v. SANOFI 6

issues

. Amgen Inc. v. Sanofi , 872 F.3d 1367, 1381

– 82 (Fed. Cir. 2017). We also vacated the permanent injunction. Id

. On remand, the p arties tried the issues of written description 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, f or a n ew t rial. Decision at *1 ; J.A. 895. The district court grantedSanofi’s Motion for JMOL for lack of enablement and denied the motion for lack of written description. See Decision at *17 ; J.A. 35. The court also conditionally denied Sanofi’s motion for a new trial. Id. Amgen timely appealed, and we have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1). See J.A. 909

– 10.

D ISCUSSION
Whether a claim satisfies the enablement requirement of 35 U.S.C. § 112 is a question of law that we review without deference, although the determination may be based onunderlying factual findings, which we review for clear error. See Alcon Research Ltd. v. Barr Labs., Inc. , 745 F.3d 1180, 1188 (Fed. Cir. 201 4). The statutory basis for the enablement requirement is found in S ection 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 patent ed 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 invention, i.e. , to make and use it. We have held that such disclosure 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 Recovery Techs., Inc. v. Magnetic Separation Sys. , 166 F.3d 1190, 1196 (Fed. Cir. 1999) )

.

“ To prove that a claim is invalid for lack of enableme nt, a challenger must show by clear and convincing evidence Case: 20-1074 Document: 132 Page: 6 Filed: 02/11/2021AMGEN INC

. v. SANOFI 7

that a person of ordinary skill in the art would not be able to practice the claimed invention without ‘ undue experimentation. ’” 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 consider ations

, 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 sta te 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 experi mentation is either ‘ undue ’ or sufficiently routine such that an ordinarily skilled artisan would reasonably be expected to carry it out. ” Alcon Research , 745 F.3d
at 1188 (quoting Wands , 858 F.2d at 737 ). Although a specification does not need to “ descr ibe 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) (citing AK St eel 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 patent claim 7 invalid for lack of enablement

. Amgen Case: 20-1074 Document: 132 Page: 7 Filed: 02/11/2021AMGEN INC

. v. SANOFI 8

contends that, under a proper analysis of the Wands factors, 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 testim ony 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 specification or by making conservative amino acid substitutions in the twenty

- six examples. Amgen argues that the court

err ed by focusing on the effort required to discover and make every embodiment of the claims

, s ee Appellants’ Br. 32 (citing Decision at *7 ), while failing to recognize that Sanofi could not identify an y antibody that cannot be made by following the specification’s teachings. See Reply Br. 4

– 5; s ee 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 representative for the purpose of fulfilling the written description requirement, and such evidence is sufficient to indicate a structure / function correlation establish ing enablement. See Reply Br. 23

– 24. Sanofi responds that the district court properly concluded based on the Wands factors that the claims are not enabled because they require undue experiment a tion

. As support for its position, Sanofi contends that t here are millions of antibody candidates within the scope of the claim s , the disclosures do not provide sufficient guidance, antibody generation is unpredictable, and practicing the full scope of the cla ims requires substantial trial and error. See Appellees ’ Br. 17

– 18, 56

. According to Sanofi, t he functionally defined claims cover a vast scope

. See i d. at 34

– 41. Sanofi argues that Amgen focused on “ the number of antibodies actually known to satisfy t he claims, when this c ourt’s precedents require examining the number of candidates Case: 20-1074 Document: 132 Page: 8 Filed: 02/11/2021AMGEN INC

. v. SANOFI 9

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, whichhas become the “go to” precedent for guidance on enablement, and which also involved claims relat ing to antibod y technology

. The broadest claim in Wands “ involve [d] immunoassay methods for the detection of hepatitis B surface antigen by using high

- affinit y monoclonal antibodies of the IgM isotype .” Wands , 858 F.2d at 733. The U.S. Patent and Trademark Office Board of Patent Appeals and Interferences had found that undue experimentation would berequired for one skilled in the art to make the claimed anti bodies 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 t he disclosure adequately taught using hybridoma technology to produce the need ed claimed antibodies. See i d. at 734. We stated that “ n o evidence was presented by either party on how many hybridomas would be viewed by those in the art as requiring undue experimentation to

screen , ” i d. at 740
, a nd w e accordingly held that the specification fully enabled the claimed invention

, s ee i d. at 736. Importantly, although Wands gave birth to its eponymous factors, Wands did not proclaim that all broad claims to antibodies are necessarily enabled

. Facts control and, in thi s court, so does the standard of review. In considering the Wands factors, the district court compared th e 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 Wyeth & Cordis Corp. v. Abbott Lab oratories

, we held that claims covering method s of preventing resteno sis with compound s 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 Case: 20-1074 Document: 132 Page: 9 Filed: 02/11/2021AMGEN INC

. v. SANOFI 10

within the scope of the claim s and the specification’s corresponding lack of structural guidance , it would have required undue experimentation to synthesize and screen each candidate to determine which compounds in the claimed class exhibited the claimed functionalit y. Id.
Similarly, in Enzo Life Sci ences , Inc. v. Roche Molecular Sys tems , Inc.

, we found that the claims were similar to those at issue in Wyeth in that they required both a particular structure and functionality, and we held that t he specification fail ed 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 Pharm aceuticals LLC v. Gilead Sci ences Inc.

, we affirmed the distric t court’s determination that the claims had both structural and functional limitations, 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, 116 0

– 63, 1165 (Fed. Cir. 2019 ); see Idenix Pharms. LLC v. Gilead Scis., Inc. , 2018 WL 922125 (D. Del. Feb. 16, 2018)

. T he district court found that Wyeth

, Enzo , and Idenix all support its conclusion that the asserted claims lack enablement

. See Decision at *9

– 13

. What emerges from our case law is that the enablement inquiry for claims that include functional requirements can be particularly focused on the breadth of those requirements , especially where predictability and guidance 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 involved concrete identification of at least some Case: 20-1074 Document: 132 Page: 10 Filed: 02/11/2021AMGEN INC

. v. SANOFI 11

embodiment or embodiments asserted not to be enabled

— including what particular products or processes are or may be within the claim, so thatbreadth is shown concretely and not just as an abstract possibility, and how much experimentation a skilled artisan would hav e to undertake to make and use those products or processes.

McRO , 959 F.3d at 1100

. We then elaborated in a footnote that:

I n cases involving claims that state certain structural 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 compoundsthat meet the structural requirements, the compounds that satisfy the functional requ irement.

Id

. at 1100 n.2 ( citations omitted)

. That reasoning applies here. While f unctional 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 practic ing the full scope of the claims would require excessive experimentation ); Enzo

, 928 F.3d at 1345 (finding that the s pecification failed toteach whether the many embodiments would be both hybridizable and detectable upon hybridization); Idenix , 941 F.3d at 1155

– 56 (finding that the broad functional limitation of having efficacy against hepatitis C virus increased the nu mber of nucleoside candidates that would need to be screened).
Each appealed claim in this case is a composition claimdefined, not by structure, but by meeting functional limitations

. We agree with t he district court ’s f inding that the Case: 20-1074 Document: 132 Page: 11 Filed: 02/11/2021AMGEN INC

. v. SANOFI 12

specification here did not enable preparation of the full scope of these double

- function claims without undue experimentation. See Decision at *13. The binding limitation is itself enough here to require undue experimentation.
Turning to the specific Wands factors, w e agr ee with the district court that the scope of the claims is broad

. While in and of itself this does not close the analysi s , t he 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 di versity than the disclosed examples. 1 If the genus is analogized to a plot of land, the disclosed species and guidance “only abide in a corner of the genus.” AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. , 759 F.3d 1285, 1299

– 300 (Fed. Cir. 2014 ). Further, t he 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 t his invention is in an unpredictable field of science with respect to satisfying the full scope of the functional limitations

. One of Amgen’s expert witnesses admitted that translating an antibody’s amino acid “sequence into a known three

- dimensional structure is still not possible.” J.A. 3910; see also De cision at *9. Another of Amgen’s expert s 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 no t one disclosed example binds. See J.A. 4283; Appellees ’ Br. 52. And although the claims include antibodies that bind up to sixteen residues , none of Amgen’s examples bind s more than nine. See id. Case: 20-1074 Document: 132 Page: 12 Filed: 02/11/2021AMGEN INC

. v. SANOFI 13

required to ensure that a substitution does not alter the binding and blocking functio ns. ” J.A. 3891; see also Decision at *9. And while some need for testing by itself mightnot indicate a lack of enablement, we note here the conspicuous absen ce of nonconclusory evidence that the full scope of the broad claims can predictably be generate d by the described methods . Instead, we have evidence only that a small subset of example s of antibodies can predictably be generated.
Although t he specification provides some guidance, including data regarding certain embodiments , we agree with the distr ict court that “[a] fter considering the disclosed roadmap in light of the unpredictability of the art, any reasonable factfinder would conclude that the patentdoes not provide significant guidance or direction to a person of ordinary skill in the art for the full scope of the claims

. ” Decision at *1 1

. Here , even assuming that thepatent’s “roadmap” provided guidance for making antibodies 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 wo rking examples that the patent’s “roadmap” produced.
As the district court noted, the only ways for a personof ordinary skill to discover undisclosed claimed embodiments would be through either “trial and error, by making changes to the disclosed antibodi es and then screeningthose antibodies for the desired binding and blocking properties,” or else “by discovering the antibodies de novo ” according to a randomization

- and

- screening “roadmap.” Id. Either way, we agree with the district court that the requi red 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 appropriate , however, to look at the amount of effort needed to obtain embodiments out side the scope of the disclosed examples and guidance . T he functional limitations here Case: 20-1074 Document: 132 Page: 13 Filed: 02/11/2021AMGEN INC

. v. SANOFI 14

are broad, the disclosed examples and guidance are narrow, 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, a fter weighing the Wands factors, the court did not err in concluding that undue experimentation would be required to practice the full scope of the se cla ims

. Finally, Amgen is incorrect that the district court’s decision is inconsistent with Wands or that our affirmance here would overrule Wands

. Wands

, as indicated above, does not hold that antibody screening n ever requires undue experimentation. The holding in Wands was ba s ed on the facts of that case and the evidence presented there. H ere, the evidence showed that the scope of the claims encompasses millions of candidates claimed with respect to multiple specific function s , and that it would be necessary to first generate and then screen each candidate antibody to determine whether it meets the double

- function claim limitations

. 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

. C ONCLUSION
We have considered Amgen ’s remaining arguments but find them unpersuasive. For the reasons above, we affirm th e district court’s determination that the asserted claims are invalid for lack of enablement

. AFFIRMED Case: 20-1074 Document: 132 Page: 14 Filed: 02/11/2021