Lindis Biotech, GmbH v. Amgen Inc.

Filing 155

MEMORANDUM ORDER: IT IS HEREBY ORDERED that: 1. Amgen's Motion to Dismiss Count I and Count II of Plaintiff Lindis' Complaint for Failure to State a Claim (D.I. 13) is GRANTED-IN-PART and DENIED-IN-PART. The Court grants dismissal of all claims of contributory infringement in Count I and Count II, with leave for Lindis to Amend. Amgen's Motion to Dismiss Count I and Count II is otherwise denied. 2. Amgen's Motion to Dismiss Count III of Plaintiff Lindis' Complaint for Failure to State a Claim (D.I. 13) is GRANTED. Signed by Judge Gregory B. Williams on 3/27/24. (ntl)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

LINDIS BIOTECH, GMBH,
Plaintiff,

C.A. No. 22-35-GBW

V.

AMGEN, INC.,
Defendant.

MEMORANDUM ORDER

Pending before the Court is Defendant Amgen Inc.' s ("Defendant" or "Amgen") Motion
to Dismiss Plaintiff Lindis Biotech, GMBH's ("Plaintiff' or "Lindis") Complaint under F.R.C.P.
12(b)(6) (the "Motion"). D.I. 13. Defendant's Motion raises several grounds challenging each of
the following counts of the Complaint: (1) Count I, which asserts direct and indirect infringement
of U.S. Patent No. 8,709,421 (the '"421 Patent") (D.I. 1, ,i,i 69-72); (2) Count II, which asserts
direct and indirect infringement of U.S. Patent No. 10,071,158 (the "'158 Patent") (D.I. 1, ,i,i 7578); and (3) Count III, which asserts direct and indirect infringement of U.S. Patent No. 10,576,149
(the '" 149 Patent") (D.I. 1, ,i,i 81-84). Having considered Defendant' s Motion and all related
briefing (D.I. 14, D.I. 23, D.I. 25), the Court finds that the Motion is GRANTED-IN-PART and
DENIED-IN-PART. Defendant's Motion to Dismiss is GRANTED as to any contributory
infringement claims alleged in Counts I and II, with leave for Plaintiff to amend. With respect to
Count III, Defendant's Motion to Dismiss is GRANTED with prejudice. The Motion is otherwise
DENIED.

I.

LEGAL STANDARDS
To state a claim on which relief can be granted, a complaint must contain "a short and plain

statement of the claim showing that the pleader is entitled to relief . ... " Fed. R. Civ. P. 8(a)(2).
Such a claim must plausibly suggest "facts sufficient to ' draw the reasonable inference that the
defendant is liable for the misconduct alleged. "' Doe v. Princeton Univ., 30 F.4th 335, 342 (3d
Cir. 2022) (quotingAshcroftv. Iqbal, 556 U.S. 662, 678 (2009)) (citing Bell At!. Corp. v. Twombly,
550 U.S. 544, 557 (2007)). "A claim is facially plausible 'when the plaintiff pleads factual content
that allows
the court to draw the. reasonable inference that .the defendant is liable for the
.
. misconduct
alleged. " ' Klotz v. Celentano Stadtmauer & Walentowicz LLP, 991 F.3d 458, 462 (3d Cir. 2021)
(quoting Iqbal, 556 U.S. at 678). But the Court will '"disregard legal conclusions and recitals of
the elements of a cause of action supported by mere conclusory statements. " ' Princeton Univ. , 30
F.4th at 342 (quoting Davis v. Wells Fargo , 824 F.3d 333, 341 (3d Cir. 2016)). Under Rule
12(b)( 6), the Court must accept as true all factual allegations in the Complaint and view those facts
in the light most favorable to the plaintiff. See Fed. Trade Comm 'n v. Abb Vie Inc, 976 FJd 327,
351 (3d Cir. 2020).
"The issue is not whether a plaintiff will ultimately prevail but whether the claimant is
entitled to offer evidence to support the claims." In re Avandia Mktg. , Sales Pracs. & Prod. Liab.

Litig. , 804 F.3d 633, 638 (3d Cir. 2015) (internal citation omitted). "A motion to dismiss [under
Rule 12(b)(6)] 'may be granted only if, accepting all well-pleade~ allegations in the complaint as
true, and viewing them in the light most favorable to plaintiff, plaintiff is not entitled to relief. '"

McCrone v. Acme Markets, 561 F. App' x 169, 172 (3d Cir. 2014) (quoting In re Burlington Coat
Factory Sec. Litig., 114 F.3d 1410, 1420 (3d Cir. 1997)).

2

II.

DISCUSSION
Amgen presents five (5) grounds for dismissal:
(1) Count I should be dismissed in its entirety because "the Complaint does not allege that
Blincyto® is a 'trifunctional, bispecific immunostimulatory antibody' as recited in all
claims of the '421 [P]atent." D.I. 14 at 1.
(2) Count III should be dismissed in its entirety because "the Complaint does not allege
that Blincyto® is used or directed for use to treat subjects with 'lymphoma' as recited
in all claims of.the ' 149 [P]atent." Id.
(3) All claims of direct infringement in Counts I-III should be dismissed because "the
Complaint does not allege that Amgen itself performs any of the claimed methods of
the Asserted Patents." Id.
(4) All claims of contributory infringement in Counts II-III should be dismissed because
"the Complaint concedes that Blincyto® is suitable for a substantial non-infringing
use." Id.
(5) To the extent that Counts I-III assert infringement based on the purported performance
of methods outside of the United States, Amgen argues they should be dismissed
because "such acts neither constitute infringement nor serve as a basis for indirect
infringement." Id.

The Court will review each argument in turn.
A. Trifunctional, bispecific immunostimulatory antibody (Count I, the '421
Patent)
Amgen contends that Count I of the Complaint should be dismissed because, unlike the
'421 Patent, the Complaint fails to allege that the accused product includes an antibody that is
trifunctional. D.I. 14 at 8-9.
3

Count I asserts patent infringement of the '421 Patent. Independent claim 1 of the '421
Patent is representative:
A method for reducing the non-specific release of a cytokine in a subject which is
associated with a treatment of a cancer or tumor with an antibody comprising
administering to the subject at least one glucocorticoid immediately before or
immediately after administering at least one trifunctional, bispecific
immunostimulating antibody directed against a tumor antigen and a CD marker,
which glucocorticoid reduces the non-specific release of the cytokine associated
with the treatment of the cancer or tumor, wherein the CD marker is selected from
the group consisting of CD2, CD3, CD4, CDS , CD6, CD8, CD28, and CD44.
D.I. 1, Ex. A (the '421 Patent), claim 1. 1
According to Amgen, Count I fails because the Complaint does not allege that the
infringing

product,

Blincyto®,

requires

administration

of a

trifunctional,

bispecific

immunostimulating antibody. D.I. 14 at 8-9. In response, Lindis contends that it is only required
to plead a "short and plain statement of the claim" to meet the Iqbal/ Twombly pleading standard.
D.I. 23 at 7. Lindis maintains that the Complaint satisfies this standard. Id. Amgen disagrees and
argues that the complexity of the subject matter involved in this dispute requires Lindis to plead
more than mere conclusory allegations of infringement. D.I. 25 at 2-3 ("Lindis cannot just 'flatly
stat[e]-without more-that Defendants' accused products have or perform [every] limitation.'").
While the Court agrees that the Complaint must plead facts explaining how Amgen infringes the
Asserted Patents, the Court finds that the Complaint meets the applicable pleading standard.

1

Following a claim construction hearing, this Court construed "trifunctional, bispecific
immunostimulating antibody" to mean "a bispecific antibody having a function in addition to
two specific binding functions, namely 1) binding to a target antigen, and 2) binding to a CD
marker." D.I. 95 ("Markman Order") at 2. With the benefit of claim construction, Plaintiff need
only plead that the bispecific immunostimulating antibody contains some third function. Id.
Thus, the Court will not address Amgen's arguments that are contrary to the Court's
construction. See D.I. 14 at 5 ("Unlike typical antibodies and the "trifunctional, bispecific
antibodies" recited in the claims, Blincyto® lacks an Fe region.").
4

1. Given the Complexity of the Technology Involved, Lindis Must Allege More
than a Short and Plain Statement of the Claim.

Amgen correctly notes that the relevant pleading standard in an infringement claim
depends, in part, on wh~ther the Asserted Patents involve "simple" or "c01nplex" technology. Id.
In Disc Disease Sols. Inc. v. VGH Sols., Inc., 888 F.3d 1256 (Fed. Cir. 2018), the Federal Circuit
held that, in cases involving "simple technology," allegations are sufficient under the plausibility
standard of Iqbal/ Twombly if the complaint identifies the accused products, provides information
"akin to including photos" of the products, and alleges that the accused products met "each and
.
.
.
.
every element of at least one claim" of the Asserted Patents, either literally or equivalently. Disc
Disease, 888 F.3d at 1260. However, in cases that do not involve such "simple technology," a

plaintiff "must [] do more than assert that the product infringes the claim." Bos. Sci. Corp. v.
Nevro Corp., 415 F. Supp. 3d 482,489 (D. Del. 2019).

In other words, in matters involving complex technology, the plaintiff"must show how the
defendant plausibly infringes by alleging some facts connecting the allegedly infringing product
to the claim elements." Id. (emphasis in original). To satisfy this standard, "[t]here needs to be
something set out beyond a legal conclusion-i.e., some facts alleged that shows why it is plausible
that the products infringe," and "[t]he patentee cannot meet its obligation to assert a plausible claim
of direct infringement under the Twombly/Iqbal standard by merely copying the language of a
claim limitation, and then flatly stating-without more-that Defendant[' s] accused products have
or perform such a limitation." DIFF Scale Operation Rsch., LLC v. MaxLinear, Inc., C.A. No. 192109-LPS-CJB, 2020 WL 2220031, *2 (D. Del. May 7, 2020), report and recommendation
adopted, 2020 WL 6867103 (D. Del. Nov. 23, 2020).

While the Court agrees that the asserted technology in this matter concerns subject matter
that is more complex than Disc Disease, the Court finds that Count I is not, as Amgen claims,
5

"based solely on conclusory allegations." See D.I. 25 at 3. Rather, as discussed in more detail
below, the Complaint properly pleads "some facts [] that show[] why it is plausible that the
[accused] product[] infringe[s]." DIFF, 2020 WL 2220031 , at *2.
2. The Complaint Meets the Heightened Pleading Standard.

"At the pleading stage, a plaintiff alleging patent infringement need not 'plead facts
establishing that each element of an asserted claim is met . . . ."' ID Image Sensing LLC v.
OmniVision Techs., Inc., No. CV 20-136-RGA, 2020 WL 6888270, at *6 (D. Del. Nov. 24, 2020),
report and re.commendation adopted, No. CV 20-136-RGA, 20~1 WL 602438 (D. Del. F_eb. 16,

2021 ). Rather, as Amgen notes, the Complaint must only allege facts that plausibly indicate that
Amgen' s accused product infringes each limitation of the asserted claims. Id. The Court finds
that Lindis has met this pleading standard.
Claim 1 of the '421 Patent discloses a method for administrating "at least one
glucocorticoid" and "at least one trifunctional, bispecific immunostimulating antibody" to treat
patients suffering from cancerous diseases. ' 421 Patent, claim 1. The patent specification notes
that the intended goal of the invention is to "provide a new system for the most extensive possible
alleviation of the side-effects" from immunotherapeutic cancer treatments.

Id. at 2:20-25.

According to the specification, immunostimulating antibodies are commonly used to target and
treat tumor antigens and/or CD makers.

Id. at 2:50-55.

In many cases, however, the

immunostimulating antibodies cause the cells of the body' s immune system to over-secret a
regulatory protein called cytokines, and these cytokines, in turn, cause patients to experience
intense side-effects, including vomiting, allergic reactions, and even fatal circulatory failure. See
id. at 1:41-58. Thus, to combat the side-effects, the invention discloses a method for administering

a glucocorticoid alongside the immunostimulating antibodies to "reduce the non-specific release

6

of a cytokine."

Id. at 3:27-44.

The method disclosed in Claim 1 requires the use of an

immunostimulating antibody that is trifunctional and bispecific. Id. at claim 1. Claim 1 further
discloses that the trifunctional, bispecific immunostimulating antibody must be administered to
the patient "immediately before or after" the glucocorticoid. Id.
In its Complaint, Lindis alleges that Amgen infringes the '421 Patent by manufacturing,
selling, and marketing an immunotherapy drug, Blincyto®, both in and outside the United States,
and instructing physicians to administer Blincyto® in a manner that mirrors the method disclosed
in Claim. 1. D.I. 1 ,r,r 27-36. Speci_fically, Lindis alleges, th'1;t physicians are instructeq by Amgen
to administer Blincyto®, which Lindis contends is a bispecific recombinant antibody, in
conjunction with a glucocorticoid (hereinafter, the "Amgen- Blincyto® Regimen"). Id.

,r 46.

Lindis claims that the instructions require that the patient be premedicated with glucocorticoid to
reduce cytokine secretion. Id.

,r 47.

When read as a whole, Lindis asserts sufficient facts to support its claim that the AmgenBlincyto® Regimen plausibly infringes the '421 Patent. In fact, Lindis draws significant parallels
between the elements of Claim 1 and the Amgen- Blincyto® Regimen. Lindis alleges, for instance
that, like Claim 1, the Amgen- Blincyto® Regimen seeks to reduce the non-release of ctyokines in
patients with Lymphoblastic Leukemia, a type of cancer, by instructing physicians to administer a
glucocorticoid before they administer Blincyto®. Id.

,r,r 47-49.

Also like Claim 1, the Complaint

reveals that Blincyto® is bispecific (i.e., it binds a cancer antigen to a T-Cell). Id.

,r 28.

Indeed,

Lindis contends that Blincyto® "link[s] the same specific cancer antigen (CD 19) to the same type
ofT-cell (CD3 positive) as does the [Claim 1] regimen." Id. (emphasis added).

While Lindis does not allege that Blincyto® is trifunctional, Amgen concedes that Lindis
is not required to establish every element of Claim 1 to survive dismissal. D.I. 25 at 3. Further,

7

as noted above, the Complaint connects elements from the ' 421 Patent to elements of Amgen's
accused product. The Court finds that, by doing so, the Complaint puts Amgen on notice as to
what activity is being accused and how that activity infringes the ' 421 Patent. Cf SIPCO, LLC v.
Streetline, Inc., 230 F. Supp. 3d 351 , 353 (D. Del. 2017). At this stage of the pleading, nothing

more is required.
Accordingly, Amgen's Motion to Dismiss Count I on grounds that the Complaint fails to
allege the tri-functionality of Blincyto® is DENIED.
B. Lymphoma (Gount III, the '149 Patent)

The Court issued its Memorandum Opinion and corresponding order regarding claim
construction on July 27, 2023. In its Opinion, the Court construed "lymphoma" to have its plain
and ordinary meaning, which is a cancer of the lymphatic system. D.I. 94 at 21-25. The Court
also found that the plain and ordinary meaning of lymphoma excluded leukemia. Id.
The ' 149 Patent expressly claims methods of treating lymphoma. See D.I. 1, Ex. Cat claim
1 ("A method of using a bispecific antibody for treating lymphoma in a subject .. ."); claim 5 ("A
method for administering a bispecific antibody to a subject having lymphoma . .. ); claim 14 ("A
method of antibody therapy for treating a subject having lymphoma.. ."). The parties agree that
the claim preambles for claims 1, 5, and 14 of the ' 149 Patent were limiting. D.I. 86 at 7.
Following the entrance of this Court' s Claim Construction Order, Plaintiff withdrew its
opposition to Defendant Amgen's Motion to Dismiss Count III in its entirety. D.I. 98. Thus, the
Motion to Dismiss Count III is GRANTED. 2

2

In granting the motion to dismiss Count III, the Court will not address the arguments made
against Count III going forward.
8

C. Performance of Claimed Methods of Asserted Patents (All Counts)

Amgen contends that all allegations of direct infringement should be dismissed because
"[t]he Complaint does not allege any facts to support claims that Amgen directly infringed the
Asserted Patents by ' administering' certain therapeutic antibodies 'to [a] subject. " ' D.I. 14 at 14
(internal citation omitted). Rather, Amgen argues that "Lindis solely relies on statements in the
Complaint that Amgen . . . 'instructs' physicians by virtue of its FDA-approved prescribing
_information." Id. These ~structions, according to _Amgen, are "insufficient ~o show direction or
control" as required under binding precedent to hold a third-party directly liable for the conduct of
another. D.I. 25 at 7. While the Court agrees that "instructions" alone are generally insufficient
to support a finding that a party directs or controls the infringing conduct of another, the Complaint
alleges that Amgen provides physicians with more than mere "instruction."
"[F]or a party to be liable for direct patent infringement under 35 U.S.C. § 271(a), that
party must commit all the acts necessary to infringe the patent, either personally or vicariously."
Aristocrat Techs. Australia Pty Ltd. v. Int'! Game Tech. , 709 F.3d 1348, 1362 (Fed. Cir. 2013).

Under the so-called "single actor" rule, " [d]irect infringement under § 271(a) occurs where all
steps of a claimed method are performed by or attributable to a single entity." Akamai Techs. , Inc.
v. Limelight Networks, Inc., 797 F.3d 1020, 1022 (Fed. Cir. 2015). "[A] defendant may be directly

liable for infringing a claimed method where a third party carries out all steps of the method to
obtain a benefit conditioned by the defendant and the defendant controls the manner or timing of
that performance." Sentius Int'!, LLCv. Apple Inc., No. 4:20-CV-00477-YGR, 2020 WL 6081775,
at *4 (N.D. Cal. Oct. 15, 2020).

9

According to the Complaint, Amgen manufactures and sells the Accused Product,
Blincyto®, D.I. 1 , 27, provides prescribing information instructing physicians how to use
Blincyto® in an infringing manner, id. , ,, 29, 46, 57, and explains that performing the instructions
will allow the user to receive the same treatment benefits as the Asserted Patents (i.e., the reduction
of Cytokine secretion). Id. , ,, 46-49, 57-60.
Additionally, the Complaint alleges that Amgen requires Blincyto® to be administered by
a physician, not the patient, id. , 36, and details the manner in which administration must occur.

See id. ,, 33 ("Aµlgen ' s prescribing info!Il).ation for Blincyto® _instructs physicians to .
'[p ]remedicate with prednisone or equivalent dexamethasone. "'); Id. ("For adult patients,"
physicians must "premedicate with 20 mg dexamethasone 1 hour prior to the first dose of
[Blincyto®]"). The Complaint also alleges that Amgen places several visible warnings on the
boxes and product labels for Blincyto® cautioning patients and physicians of "CYTOKINE
RELEASE SYNDROM." Id., 29. The Complaint notes that the prescribing instructions similarly
contain warnings that Cytokine Release Syndrome may be "life-threatening or fatal" to patients
taking Blincyto® and inform patients that, "[b ]efore [they] receive BLINCYTO, [they] will be
given a corticosteroid medicine to help reduce infusion reactions." Id. , 33.
When viewed in the light most favorable to Lindis, the alleged facts support a claim that
Amgen intended to control and direct the method in which Blincyto® is administered. In fact,
requiring Blincyto® to be administered by physicians supports a finding that Amgen does not offer
the prescribing instructions as mere guidance. Because of their training and the duties that they
have to their patients, physicians are more likely to understand and appreciate the need to
administer Blincyto® as instructed and approved by the FDA. When coupled with detailed
instructions specifying exactly when and how Blincyto® should be administered and the

inconspicuous warnings highlighting the fatal risks of Cytokine Release Syndrome in patients
taking Blincyto®, the asserted facts "support a finding that [Amgen] cross[ es] the line from merely
guiding or instructing . .. to conditioning treatment" on abiding by the prescribing instructions.
See Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357, 1366 (Fed. Cir. 2017).
Thus, Amgen's Motion to Dismiss Counts I and II on grounds that "[t]he Complaint does not allege
any facts to support claims that Amgen directly infringed the Asserted Patents" is DENIED.

D. Non-infringing Use (Counts 1-11, the '421 and '158 Patents)

Amgen argues that Counts I and II should be dismissed for the additional reason that "the
Complaint itself identifies a substantial non-infringing use for Blincyto®: its co-administration
with prednisone" instead of Dexamethasone. D.I. 14 at 16. Specifically, Amgen contends that
"[t]he Complaint expressly concedes that Blincyto® may be administered with the glucocorticoid
'prednisone' instead of 'dexamethasone' as follows: "Amgen's prescribing information for
Blincyto® gives the instruction to '[p]remedicate with prednisone or equivalent dexamethasone. "'

Id. (quoting D.I. 1 11 29, 46). Thus, Amgen argues that the Complaint, on its face, precludes
Lindis from alleging contributory infringement. Id. The Court agrees.
To state a claim for contributory infringement, the Complaint must "plead facts that allow
an inference that the components sold or offered for sale have no substantial non-infringing uses."
In re Bill of Lading Transmission & Processing Sys. Pat. Litig., 681 F.3d 1323, 1337 (Fed. Cir.
2012). "Where the product is equally capable of, and interchangeably capable of both infringing
and substantial non-infringing uses, a claim for contributory infringement does not lie." Id. at
1338. As the Supreme Court has recognized, this limitation on contributory infringement is of
"critical importance" given that "a finding of contributory infringement is normally the functional
equivalent of holding that the disputed article is within the monopoly granted to the patentee."
11

Sony Corp. of Am. v. Universal City Studios, Inc., 464 U.S. 417,441 (1984). Thus, to prevent a
patentee from "extend[ing] his monopoly beyond the limits of his specific grant," the Supreme
Court warned that a claim of contributory infringement would not survive unless the patentee can
show that the unpatented articles are '" unsuited for any commercial noninfringing use."' Id
(citing Dawson Chemical Co. v. Rohm & Hass Co., 448 U.S. 176, 198, (1980)). By alleging that
Blincyto® can be co-administered with prednisone, the Complaint fails to meet this standard.
While Lindis cites Sanofi-Aventis US. , LLC v. Watson Labs. Inc., 875 F.3d 636 (Fed. Cir.
2017), for the proposition that there is_"liab[ility] for inducing aµ infringing use of a prod1=1ct even
if the product has substantial noninfringing uses," D.I. 23 at 14, the language highlighted by Lindis
concerned an infringement claim for inducement and thus is inapplicable to claims for contributory
infringement. In fact, in finding that a non-conforming use would not defeat liability under an
inducement theory, the Court in Sanofi explained that its holding was consistent with the Patent
statute, since "Section 271(b), on inducement, does not contain the 'substantial noninfringing use '
restriction of section 271(c), on contributory infringement." Id at 646 (emphasis added).
Additionally, Lindis argues that "Amgen' s use of Blincyto® also infringes under the
doctrine of equivalents." D.I. 23 at 15. Lindis is barred, however, from raising the doctrine of
equivalents in support of its contributory infringement claims because "Lindis dedicated coadministration with equivalent prednisone to the public." D.I. 25 at 8. That is, the disclosurededication doctrine holds that, "when a patent drafter discloses but declines to claim subject matter,
... this action dedicates the unclaimed subject matter to the public." Eagle Pharms. Inc. v. Slayback

Pharma LLC, 958 F.3d 1171, 1175 (Fed. Cir. 2020) (internal citation omitted). "To determine
whether the disclosure-dedication doctrine applies in a given case, we ask whether the
specification discloses unclaimed subject matter with 'such specificity that one of ordinary skill in

12

the art could identify the subject matter that had been disclosed and not claimed."' Id. (citing PSC
Comput. Prods., Inc. v. Foxconn Int'!, Inc., 355 F.3d 1353 , 1360 (Fed. Cir. 2004)). Here, Lindis

does not dispute that the '421 and ' 158 Patents teach prednisone as an equivalent of
dexamethasone. See, e.g., ' 158 Patent, 2:47-52. Because prednisone is disclosed by both patent
specifications, the disclosure-dedication doctrine holds that Lindis cannot assert a claim for
contributory infringement which relies on an equivalency argument.
Finally, Lindis contends that "Arngen's argument is factually wrong, because its
prescrib_ing information for adult~ does not provide the option to premedicate with prednisone."
D.I. 23 at 14. The relevant provision of the Complaint asserts:
Amgen's prescribing information for Blincyto® instructs physicians to
"[p]remedicate with prednisone or equivalent dexamethasone. (2.1)." In
addition, the prescribing information states "[p ]remedicate with
dexamethasone: For adult patients, premedicate with 20 mg dexamethasone
1 hour prior to the first dose ofBLINCYTO®."
D.I. 1 , 29 (emphasis added). While the Complaint highlights the dexamethasone instruction "[f]or
adult patients," the language disclosing from the adult instruction does not, on its face,
"discourage" or "foreclose" the use of prednisone for adults. See Sanofi v. Glenmark Pharms.
Inc. , USA, 204 F. Supp. 3d 665, 684 (D. Del. 2016), afj'd sub nom. Sanofi v. Watson Lab'ys Inc.,

875 F.3d 636 (Fed. Cir. 2017) ("The proposed labels are written broadly enough so as to arguably
render on-label uses in accordance with the E/A trials and certainly do not discourage such a use
in any way. Numerous pieces of evidence also demonstrate that Sanofi advertises uses ofMultaq®
based upon the results of the E/A studies."). In fact, the Complaint introduces the adult instruction
only after recognizing that physicians are instructed to premedicate with "prednisone or equivalent
dexamethasone." D.I. 1 , 29. The Complaint does not allege that the instruction to "premedicate
with 20 mg dexamethasone" is a requirement rather than a preferred method of treatment or a mere

13

example. See In re Bill ofLading Transmission & Processing Sys. Pat. Litig., 681 F .3d 13 23, 13 38
(Fed. Cir. 2012) (internal citation omitted) ("That practicing the patented method may be the most
logical or useful purpose for Appellees' products does not render the alternative uses 'unusual, farfetched, illusory, impractical, occasional, aberrant, or experimental."'). Thus, the Court cannot
find that the prescribing information, as pled in the Complaint, reveals that "the option to
premedicate with prednisone" is not available for adults. See D.I. 23 at 14.
Accordingly, Amgen's Motion to Dismiss Counts I and II on grounds that "the Complaint
itse.l f identifies a substantiat non-infringing use for _Blincyto®" is GRANTE_D.

Because an

amendment clarifying the adult instruction may not be futile, the Court dismisses the contributory
infringement claims of Counts I and II without prejudice and with leave for Lindis to amend. See
EIS, Inc. v. WOW Tech Int'! GmbH, C.A. No. 19-1227-LPS/GBW, 2020 WL 7027528, at *13 (D.

Del. Nov. 30, 2020).

E. Purported Performance of Methods Outside of the U.S. (All Counts)
Amgen also contends that the Complaint incorrectly claims infringement based on the use
ofBlincyto® by, or sale ofBlincyto® to, third parties outside of the U.S. D.I. 14 at 17-18. Amgen
thus argues that "those portions of Counts I, II, and III that seek relief based on the alleged use of
Blincyto® outside the U.S." must be dismissed. Id. While the Court agrees that infringement of
a method claim under§§ 271(a)-(c) requires that each infringing step occur in the United States,
the Court finds ~at foreign sales or distribution of Blincyto® to foreign users are relevant to
damages calculations.
A party directly infringes a patent when it "makes, uses, offers to sell, or sells any patented
invention, within the United States or imports into the United States any patented invention during
the term of the patent." 35 U.S.C. § 271(a). Direct infringement of a method patent in particular
14

requires that the infringer utilize and complete all steps of the method. NTP, Inc. v. Rsch. In

Motion, Ltd , 418 F.3d 1282, 1318 (Fed. Cir. 2005) ("A method or process consists of one or more
operative steps, and, accordingly, it is well established that a patent for a method or process is not
infringed unless all steps or stages of the claimed process are utilized.") (internal citation omitted).
Further, "[t]he use of a patented method does not infringe unless ' each of the steps is performed
within this country."' F45 Training Pty Ltd v. Body Fit Training USA Inc. , No. CV 20-1194WCB, 2022 WL 17177621 , at *16 (D. Del. Nov. 17, 2022), dismissed, No. 2023-1304, 2023 WL
. 2965590 (Fed. Cir. Apr.

p , 2023) (citing NTP, 41~ F.3d at 1318).

Thus, to prove its infringement

claims, Lindis must show that each step of the Asserted Patents was practiced in the U.S. Id.
The Complaint asserts that Amgen infringes the Asserted Patents by "manufacturing,
marketing, distributing and selling the immunotherapy drug Blincyto® in the United States" and,
in some instances, either "selling Blincyto® outside of the United States" or "ship[ping] Blincyto®
from the US to other countries for distribution, sale and use, together with the prescribing
information for Blincyto®." D.I. 1 at ,r,r 70, 76, 82. Because the Complaint pleads that Blincyto®
is, at times, sold and distributed in the United States and that "Amgen has induced and continues
to induce infringement in this district and elsewhere in the United States," the Court finds that
Lindis pleads sufficient facts to support a claim that, in some instances, each step of the infringing
method is practiced within the United States.
While Lindis cannot rely on foreign uses of the patented method to prove infringement, the
use and sale of Blincyto® to parties outside of the United States is relevant to patent damages.
That is, a patentee who proves infringement may recover against "whoever without authority
makes, uses, offers to sell, or sells any patented invention, within the United States." 35 U.S.C. §
271(a) (emphasis added). Because§ 271 (a)' s use of the disjunctive "or," courts have recognized

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that "the sales of products that use the methods to foreign users can be used to measure damages
for acts of infringement in the United States." See Archerdx, LLC v. QIAGEN Scis. , LLC, No. CV
18-1019 (MN), 2021 WL 3857460, at *1 (D. Del. Aug. 30, 2021). In Carnegie Mellon University
v. Marvell Technology Group, Ltd., the Federal Circuit found that foreign sales could be used in

calculating the royalty base of a damages award where the patentee demonstrates (1) an infringing
act occurred within the United States (i.e., making, using, or selling), and (2) a substantial
connection exists between the domestic infringing act and the foreign sale. 807 F.3d 1283, 130608 (Fed. Cir. 2015).. When "a physical prqduct is being employed _to measure damages for .
infringing use of patented methods," for instance, the patentee may recover for foreign sales "only
when any one of those domestic actions for that unit (e.g., sale) is proved to be present, even if
others of the listed activities for that unit (e.g., making, using) take place abroad." Carnegie
Mellon Univ., 807 F.3d at 1306; Cal. Inst. ofTech. v. Broadcom Ltd., 25 F.4th 976, 992 (Fed. Cir.

2022).
Thus, while Lindis alleges that, in some instances, the accused products are practiced by
users outside of the United States, these foreign uses or sales may be relevant to a royalty rate
calculation. 3 To recover for foreign sales, however, Lindis will be required to show a substantial
connection between a domestic action (e.g., the production of Blincyto®) and the alleged
infringing act (e.g., the sale or use ofBlincyto® abroad). See Carnegie Mellon Univ., 807 F.3d at

3

Of course, to be entitled to damages, Lindis must first prove infringement, and as the Court
noted, infringement of a method patent requires that all infringing steps occur in the United
States. Nothing in this opinion shall be read as "expanding the statutory requirement for
infringement." See Archerdx, 2021 WL 3857460, at *2 (instructing the jury that, "[d]amages . . .
may [] be awarded on sales of products that practice the patented methods in their normal
intended use outside of the United States if, for those products, you find that (1) QIAGEN's
infringement in the United States was a substantial cause of the sale of that product, and (2)
QIAGEN made or sold the product within the United States").
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1306. Because the foreign sales may be relevant to damages, Amgen' s Motion to Dismiss Counts
I and II on grounds that Lindis cannot recover for "infringement based on the purported
performance of methods outside of the United States" is DENIED.
III.

CONCLUSION

For the foregoing reasons, the Motion to Dismiss is granted-in-part and denied-in-part.
***
WHEREFORE, at Wilmington this 27th day of March, 2024, IT IS HEREBY
ORDERED that:

1. Amgen' s Motion to Dismiss Count I and Count II of Plaintiff Lindis' Complaint for
Failure to State a Claim (D.I. 13) is GRANTED-IN-PART and DENIED-IN-PART.
The Court grants dismissal of all claims of contributory infringement in Count I and
Count II, with leave for Lindis to Amend. Amgen's Motion to Dismiss Count I and
Count II is otherwise denied.
2. Amgen' s Motion to Dismiss Count III of Plaintiff Lindis' Complaint for Failure to
State a Claim (D.I. 13) is GRANTED.

GREGORY B. WILLIAMS
UNITED STATES DISTRICT JUDGE

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