Promega Corp. v. Life Technologies Corp.

United States Court of Appeals
for the Federal Circuit
______________________
PROMEGA CORPORATION,
Plaintiff-Cross-Appellant,
AND
MAX-PLANCK-GESELLSCHAFT ZUR FORDERUNG
DER WISSENSCHAFTEN E.V.,
Plaintiff,
v.
LIFE TECHNOLOGIES CORPORATION,
INVITROGEN IP HOLDINGS, INC., AND APPLIED
BIOSYSTEMS, LLC,
Defendants-Appellants.
______________________
2013-1011, -1029, -1376
______________________
Appeals from the United States District Court for the
Western District of Wisconsin in No. 10-CV-0281, Chief
Judge Barbara B. Crabb.
______________________
Decided: December 15, 2014
______________________
SETH P. WAXMAN, Wilmer Cutler Pickering Hale and
Dorr LLP, of Washington, DC, argued for plaintiff-cross-
appellant. With him on the brief were THOMAS G.
SAUNDERS and DINA B. MISHRA; and MARK C. FLEMING,
2 PROMEGA CORP v. LIFE TECHNOLOGIES CORP.
PROSHANTO MUKHERJI and ERIC F. FLETCHER, of Boston,
Massachusetts. Of counsel was SUSAN R. PODOLSKY, Law
Office of Susan R. Podolsky, of Alexandria, Virginia.
EDWARD REINES, Weil, Gotshal & Manges LLP, of
Redwood Shores, California, argued for defendants-
appellants. With him on the brief was DEREK C. WALTER.
Of counsel on the brief was CARTER G. PHILLIPS, Sidley
Austin LLP, of Washington, DC.
______________________
Before PROST, Chief Judge, MAYER and CHEN, Circuit
Judges.
Opinion for the court filed by Circuit Judge CHEN.
Dissenting-in-part opinion filed by Chief Judge PROST.
CHEN, Circuit Judge.
Life Technologies, Applied Biosystems, LLC, and Invi-
trogen IP Holdings, Inc. (collectively, LifeTech) appeal
from the district court’s grant of a motion for summary
judgment that the asserted claims of United States Pa-
tent Nos. 5,843,660 (’660 patent), 6,221,598 (’598 patent),
6,479,235 (’235 patent), and 7,008,771 (’771 patent) (col-
lectively, the Promega patents) are not invalid for lack of
enablement and obviousness. Promega Corp. and Max-
Planck-Gesellschaft zur Förderung der Wissenschaften
E.V. (collectively, Promega) appeal from a grant of a
motion for judgment as a matter of law (JMOL) that
LifeTech’s accused products do not infringe either the
Promega patents or U.S. Patent No. RE 37,984 (the Tautz
patent), a motion that resulted in the vacatur of a jury’s
verdict of damages and willful infringement. Finally,
LifeTech appeals from the district court’s oral ruling that
it is not licensed for all uses of the asserted patents under
a license agreement with Promega (2006 Cross License).
PROMEGA CORP v. LIFE TECH 3
For the reasons discussed herein, we conclude that
the asserted claims of the Promega patents are invalid for
lack of enablement. We also find substantial evidence
that LifeTech is liable for infringement of the Tautz
patent under both 35 U.S.C. § 271(a) and 35 U.S.C.
§ 271(f)(1). Finally, we affirm the district court’s finding
that the 2006 Cross License does not cover all of Life-
Tech’s sales of the accused products. We therefore reverse
the grant of LifeTech’s motion for JMOL and remand to
the district court for a determination of damages based on
LifeTech’s infringement of the Tautz patent.
I. BACKGROUND
DNA is a double-stranded molecule that encodes ge-
netic instructions for living organisms. It consists essen-
tially of two complementary strands of nucleotides.
Particular nucleotide sequences may be repeated within a
region of a DNA strand. For example, the DNA sequence
ATT (adenine-thymine-thymine) may be repeated ten
times in a row in a particular location. Such repeating
sequences are called “short tandem repeats” (STR), and
the region of the DNA strand in which they occur is called
an STR “locus.”
STR loci occur frequently in the human genome. The
number of repeated sequences within an STR locus varies
highly from person to person. For example, one individu-
al’s DNA may have eleven ATT repeats at a given STR
locus, while another individual may have fourteen at the
same locus. These variations are referred to as “alleles,”
or markers, of the particular locus. Alleles are responsi-
ble for “polymorphism,” or genetic differences between
individuals.
No one allele varies enough to differentiate one person
from another to a statistically significant degree. A
particular set of alleles at multiple loci within an individ-
ual’s DNA, however, can be used to create a DNA “finger-
print” unique to that individual. This method of
4 PROMEGA CORP v. LIFE TECHNOLOGIES CORP.
identification is called “STR profiling” and is useful in
many fields, including forensic science.
STR profiling may require making copies of the loci of
interest in order to obtain a detectable amount of DNA for
analysis. This process is called “amplification,” and can
be accomplished with polymerase chain reaction (PCR).
In PCR, a pair of “primers” effectively “flanks,” or marks
the start and finish of, the locus to be copied. Strands of
DNA are then replicated between the primer pair by a
DNA polymerase. This process is repeated until a suffi-
cient number of copies of the desired STR locus are gener-
ated.
It is highly beneficial to amplify multiple STR loci
simultaneously, creating a “multiplex” reaction or a co-
amplification. Joint Appendix (J.A.) 1381. Multiplexing,
however, is more complicated than performing a series of
individual, or “monoplex,” amplifications. J.A. 1371. This
is because a successful multiplex reaction depends on the
selection of a set of primer pairs for which each primer
pair not only flanks its respective target locus, but does
not overlap—and thus interfere—with primer pairs for
other targeted loci. Id. at 1372.
Identification of STR loci sets and primer pairs that
successfully co-amplify is a trial and error process. In the
early 1990s—the time of invention of the patents-in-suit—
it is undisputed that scientists could not predict with any
certainty, absent a preexisting publication or teaching,
whether a given set of loci would successfully co-amplify.
Id. This was true even when adding a new locus to an
already successful multiplex, as skilled artisans could not
predict “how the loci would interact with each other or
how effectively and efficiently the primers would work in
a single reaction [multiplex] environment.” Id. It is also
undisputed that the greater the number of STR loci
sought to be amplified in a single reaction, the more
complicated the process of creating a successful multiplex
PROMEGA CORP v. LIFE TECH 5
for that loci set. Id. For example, adding an eighth locus
to a seven-loci multiplex (7-plex) was “more complicated”
than adding a seventh locus to a six-loci multiplex (6-
plex). Id. This was because in order to determine wheth-
er the loci would co-amplify successfully, it was necessary
to “develop primer pairs that would co-amplify together
and not interfere with each other[,] avoid undesirable
results such as nonspecific amplification or primer-dimer
formation[,] and adjust a number of reaction parameters
such as temperature, the number of amplification cycles,
and the concentration of primers, enzyme, buffer, dNTP,
etc.” Id. at 1372–73.
A. Patents-in-Suit
This case involves five patents that relate to multiplex
amplification of STR loci. Promega owns the four
Promega patents outright and is the exclusive licensee of
the Tautz patent. The Promega patents claim methods or
kits for simultaneously determining the alleles present in
a set of STR loci from DNA samples, comprising: (a)
obtaining a DNA sample; (b) selecting a set of loci of the
DNA sample to amplify, including at least the specific loci
recited in the claim; (c) co-amplifying the selected loci in a
multiplex amplification reaction; and (d) evaluating the
amplified alleles to determine the number of STR that are
present at each loci. See, e.g., ’660 patent, claim 5; ’235
patent, claim 1; ’598 patent, claim 23; ’771 patent, claim
5.
Each of the asserted claims1 in the Promega patents
includes a limitation that recites the phrase “a set of . . .
1 Promega asserted infringement of claims 25, 27–
31 of the ’660 patent, claims 18–19 and 21–23 of the ’235
patent, 10, 23–24, 27, and claim 33 of the ’598 patent,
claim 5 of the ’771 patent, and claim 42 of the Tautz
6 PROMEGA CORP v. LIFE TECHNOLOGIES CORP.
loci” followed by a list of particular STR loci multiplexes
of varying complexity, ranging from a 3-plex to a 14-plex.
During claim construction, the district court construed
the asserted claims with the transitional phrase “a set of
. . . loci . . . consisting of” in the relevant limitation as
“limited to products that use no loci other than those
listed in the claims” (i.e., “closed loci set” claims), 2 and
patent. Promega Corp. v. Max-Planck-Gesellschaft zur
Forderung der Wissenschaften E.V., No. 10-cv-0281-bbc,
ECF No. 345, slip op. at 32 (W.D. Wis. Nov. 29, 2011)
(hereinafter, Promega I).
2 The district court granted LifeTech’s motion for
summary judgment of noninfringement of the “closed loci
set” claims (claims 25 and 27–31 of the ’660 patent), a
decision that Promega did not appeal. Promega I, slip op.
at 22. Representative claim 25 of the ’660 patent recites:
25. A kit for simultaneously analyzing short tan-
dem repeat sequences in at least three loci, com-
prising a container which has oligonucleotide
primers for co-amplifying a set of at least three
short tandem repeat loci, wherein the set of loci
are selected from the sets of loci consisting of:
D3S1539, D19S253, D13S317;
D10S1239, D9S930, D20S481;
...
D16S539, D7S820, D13S317, D5S818,
HUMCSF1PO, HUMTPOX, HUMTH01,
HUMvWFA31; and
D16S539, D7S820, D13S317, D5S818,
HUMF13A01, HUMFESFPS, HUMBFXIII,
HUMLIPOL.
PROMEGA CORP v. LIFE TECH 7
other claims with the transitional phrase “a set of . . . loci
. . . comprising” in the relevant limitation as not so lim-
ited (i.e., “open loci set” claims). Promega I, slip op. at 2–
3. Claim 23 of the ’598 patent is one such claim with an
“open loci set” limitation:
23. A kit for simultaneously analyzing short tan-
dem repeat sequences in a set of short tandem re-
peat loci from one or more DNA samples,
comprising:
A single container containing oligonucleotide pri-
mers for each locus in a set of short tandem repeat
loci which can be co-amplified, comprising
HUMCSF1PO, HUMTPOX, and HUMTH01.
’598 patent, 40:22–28 (emphasis added).
This claim recites an STR profiling kit with primers
that can successfully co-amplify a set of three specific STR
loci. Both parties agree that the claim requires successful
co-amplification of every locus in the claimed “a set of . . .
loci.” Because Promega used the word “comprising” in the
“a set of . . . loci” limitation, the district court concluded
that claim 23 covers not only the three loci recited in the
claim, but also any other loci combination containing
those three recited loci—whether that combination in-
cludes 13, 1,300 or 13,000 STR loci. Promega I, slip op. at
27. The district court’s construction of the “a set of . . .
loci” limitation in claim 23 and the other asserted claims
is not disputed on appeal.
The Tautz patent is likewise directed to a process for
examining polymorphism in DNA samples. For example,
the Tautz patent claims a kit for testing at least one STR
locus that contains: (1) a mixture of primers; (2) a poly-
’660 patent, 67:35–68:13 (emphasis added).
8 PROMEGA CORP v. LIFE TECHNOLOGIES CORP.
merizing enzyme such as Taq polymerase; (3) nucleotides
for forming replicated strands of DNA; (4) a buffer solu-
tion for the amplification; and (5) control DNA. Claim 42
of the Tautz patent recites:
42. A kit for analyzing polymorphism in at least
one locus in a DNA sample, comprising:
a) at least one vessel containing a mixture of pri-
mers constituting between 1 and 50 of said primer
pairs;
b) a vessel containing a polymerizing enzyme
suitable for performing a primer-directed poly-
merase chain reaction;
c) a vessel containing the deoxynucleotide tri-
phosphates adenosine, guanine, cytosine and
thymidine;
d) a vessel containing a buffer solution for per-
forming a polymerase chain reaction;
e) a vessel containing a template DNA comprising
i) a simple or cryptically simple nucleotide se-
quence having a repeat motif length of 3 to 10 nu-
cleotides and ii) nucleotide sequences flanking
said simple or cryptically simple nucleotide se-
quence that are effective for annealing at least
one pair of said primers, for assaying positive per-
formance of the method.
Tautz patent, 16:43–61.
B. Accused Products
LifeTech manufactures genetic testing kits that pro-
vide components for carrying out a multiplex amplifica-
tion of STR loci from DNA samples. The kits contain a
number of components, including: (1) a primer mix; (2)
Taq polymerase; (3) PCR reaction mix including nucleo-
tides; (4) a buffer solution; and (5) control DNA. Each of
PROMEGA CORP v. LIFE TECH 9
these kits is designed to successfully co-amplify STR loci
combinations that include the recited loci listed in the
asserted claims of the Promega patents as well as loci
that are not listed in the claims. J.A. 1233–36. LifeTech
manufactures one component of its kits in the United
States, the Taq polymerase, which it ships overseas to a
LifeTech manufacturing facility in the United Kingdom.
J.A. 6288. This offshore facility assembles and sells the
kits worldwide. Relevant here, LifeTech’s STR kits are
used by law enforcement agencies for forensic identifica-
tion, and by clinical and research institutions for purposes
such as analyzing cancer cells. J.A. 2265–66.
C. 2006 Cross License
In 2006, Promega and defendant Applied Biosystems 3
entered into a non-exclusive cross license agreement that
granted Applied Biosystems the right to use the alleged
inventions in the Promega patents and the Tautz patent
for “Forensics and Human Identity Applications.” 4 The
2006 Cross License limited Applied Biosystems’ use of the
patents-in-suit to, inter alia, activities relating to legal
proceedings. J.A. 1868–69.
D. Procedural History
In 2010, Promega sued LifeTech for infringement of
the Promega and the Tautz patents, alleging that Life-
Tech sold STR testing kits not covered by the 2006 Cross
License. LifeTech responded that it was licensed to
practice all of the patents-in-suit and filed counterclaims
3 Applied Biosystems was then part of Applera Cor-
poration, but is now a wholly owned subsidiary of Life-
Tech.
4 The actual language of the 2006 Cross License is
confidential and subject to a protective order, so we refer
to the agreement only in broad terms.
10 PROMEGA CORP v. LIFE TECHNOLOGIES CORP.
that the asserted claims of the Promega patents were
invalid. In September 2011, both parties cross-moved for
summary judgment on infringement and invalidity. The
district court rejected LifeTech’s license defense to direct
infringement, orally ruling that the license was limited to
use in live forensic investigations conducted by police
officers, and thus LifeTech’s sales outside this field of use
were infringing. See J.A. 1792.
The district court also ruled on summary judgment
that LifeTech’s sales of its STR kits for uses other than
live forensic investigations conducted by police officers
directly infringed claim 42 of the Tautz patent and the
claims of the Promega patents containing the “open loci
set” limitation. Promega I, slip op. at 32. In addition, the
district court rejected LifeTech’s enablement and obvious-
ness challenges to the Promega patents. LifeTech did not
challenge the validity of the Tautz patent. Id. at 30–32.
The case proceeded to a jury trial on willfulness and
damages. During the trial, both parties stipulated that
LifeTech grossed $707,618,247 in worldwide sales of its
accused STR kits during the relevant five-and-a-half year
period of infringement. J.A. 5478; 202. At the close of
Promega’s case-in-chief, a dispute arose between the
parties about what Promega was required to prove during
trial. Promega believed the issue of infringement was
decided and it merely needed the jury to determine an
appropriate amount of damages. LifeTech contended that
Promega had confused the stipulated worldwide sales
amount with actual damages available under the Patent
Act, and that Promega had failed to satisfy its burden of
proof as to which products and sales were eligible for
damages under 35 U.S.C. § 271(a). 5 J.A. 5735–36. The
5 35 U.S.C. § 271(a) states: “Except as otherwise
provided in this title, whoever without authority makes,
PROMEGA CORP v. LIFE TECH 11
district court acknowledged that there had been “a mis-
communication between counsel, and that included me.”
J.A. 6190. It determined that although Promega “thought
that it didn’t have to put in any more [evidence about
damages] than it already had,” Promega’s belief was “not
correct.” Id. However, it allowed Promega to present
additional evidence in its rebuttal case in order to attempt
to correct this deficiency. Id.Following the close of evidence, the district court
asked the jury to answer the question: “[W]hat is the total
dollar amount of Defendant’s sales of STR kits that were
United States sales as that term has been defined for you
in the instructions?” J.A. 189. Over LifeTech’s objection,
the district court asked the jury to consider liability for
both § 271(a) and § 271(f)(1), explaining that “United
States sales” included “all kits made, used, offered for
sale, sold within the United States or imported into the
United States, as well as kits made outside the United
States where a substantial portion of the components are
supplied from the United States.” Id. LifeTech chal-
lenged the inclusion of the § 271(f)(1) language and ar-
gued that that an alleged patent infringer (i.e., LifeTech
and its foreign manufacturing facility) could not induce
itself within the meaning of the statute.
The jury returned a verdict of willful infringement
and found that: (1) all of LifeTech’s worldwide sales were
attributable to infringing acts in the United States;
(2) ten percent of those sales were for unlicensed uses;
and (3) Promega was entitled to $52 million in lost prof-
its. See J.A. 202–03. After the entry of judgment, Life-
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 therefor,
infringes the patent.”
12 PROMEGA CORP v. LIFE TECHNOLOGIES CORP.
Tech moved for JMOL on the ground that Promega “failed
to prove the applicable damages for patent infringe-
ment.” Id. at 2296. The district court granted LifeTech’s
motion, finding that Promega failed to present sufficient
evidence to sustain a jury verdict under § 271(a) and
§ 271(f)(1). The district court vacated the prior finding of
infringement and denied Promega’s motion for reconsid-
eration, or in the alternative, a new trial.
Both parties appealed. Promega challenges the dis-
trict court’s vacatur of the jury’s verdict of willful in-
fringement and award of damages, and in the alternative,
the denial of its motion for a new trial. LifeTech chal-
lenges the district court’s finding that the Promega pa-
tents are both enabled and nonobvious. LifeTech also
challenges the district court’s finding that it is not li-
censed to practice the patents-in-suit under the 2006
Cross License. We have jurisdiction under 28 U.S.C.
§ 1295(a)(1).
II. ANALYSIS
A. Standards of Review
Under the Seventh Circuit’s standard, we review a
grant of summary judgment de novo. Dempsey v.
Atchison, Topeka & Santa Fe Ry. Co., 16 F.3d 832, 836
(7th Cir. 1994). Summary judgment is only proper when
there are no disputed issues of material fact, even after
viewing all reasonable inferences drawn from the record
in the light most favorable to the non-movant. Id. at 836.
Whether a claim satisfies the enablement require-
ment of 35 U.S.C. § 112, ¶ 1 is a question of law reviewed
de novo. 6 AK Steel Corp. v. Sollac, 344 F.3d 1234, 1238–
6Paragraph 1 of 35 U.S.C. § 112 was replaced with
newly designated § 112(a) when § 4(c) of the America
PROMEGA CORP v. LIFE TECH 13
39 (Fed. Cir. 2003). Any facts underlying the enablement
determination are reviewed for clear error. Id. A party
must prove invalidity based on non-enablement by clear
and convincing evidence. Microsoft Corp. v. i4i Ltd.
P’ship, 131 S. Ct. 2238, 2242 (2011).
We review motions for JMOL and for a new trial un-
der regional circuit law. Finjan, Inc. v. Secure Computing
Corp., 626 F.3d 1197, 1202 (Fed. Cir. 2010). In the Sev-
enth Circuit, a grant of JMOL is reviewed “without defer-
ence, while viewing all the evidence in the light most
favorable to the nonmoving party.” Trading Techs. Int’l v.
eSpeed, Inc., 595 F.3d 1340, 1357 (Fed. Cir. 2010) (citing
Harper v. Albert, 400 F.3d 1052, 1061 (7th Cir. 2005)).
Denial of a motion for a new trial is reviewed for the
abuse of discretion. Huff v. Sheahan, 493 F.3d 893, 899
(7th Cir. 2007).
Finally, the licensing issues on appeal are governed
by California law, pursuant to the choice of law clause in
the 2006 Cross License. Under California law, interpreta-
tion of a contract is a judicial function reviewed de novo.
Cachil Dehe Band of Wintun Indians v. California, 618
F.3d 1066, 1073, 1075 (9th Cir. 2010).
B. Enablement of the Promega patents
The district court construed the asserted claims in the
Promega patents with the “open loci set” limitation broad-
ly, finding that the language of the claims “makes it clear
that they are not limited to the recited loci because they
all use the word ‘comprising’ when listing the loci.”
Promega I, slip op. at 21. Thus, the district court conclud-
Invents Act, Pub. L. No. 112-29, took effect on September
16, 2012. Because the applications resulting in the pa-
tents at issue in this case were filed before that date, we
will refer to the pre-AIA version of § 112.
14 PROMEGA CORP v. LIFE TECHNOLOGIES CORP.
ed that “all of the asserted [open loci set] claims allow for
unrecited loci.” Id.
For example, claim 23 of the ’598 patent recites an
STR loci combination that comprises three specific loci.
Under the district court’s construction, claim 23 encom-
passes not only the 3-plex co-amplification recited in the
claims, but it also encompasses any other larger, more
complex multiplex reaction, so long as it includes the three
recited loci. Based on this construction—which is not
disputed on appeal—LifeTech moved for summary judg-
ment of invalidity of the asserted claims of the Promega
patents for lack of enablement under § 112, ¶ 1. The
district court denied LifeTech’s motion, concluding that
the asserted claims need not enable “unrecited elements.”
Promega I, slip op. at 21, 28.
The enablement requirement is set forth in 35 U.S.C.
§ 112, ¶ 1:
The specification shall contain a written descrip-
tion of the invention, and the manner and process
of making and using it, in such full, clear, concise,
and exact terms as to enable any person skilled in
the art to which it pertains, or with which it is
most nearly connected, to make and use the same.
The enablement requirement ensures that “the public
knowledge is enriched by the patent specification to a
degree at least commensurate with the scope of the
claims.” Nat’l Recovery Techs., Inc. v. Magnetic Separa-
tion Sys., Inc., 166 F.3d 1190, 1195–96 (Fed. Cir. 1999).
The scope of the claims must be “less than or equal to the
scope of enablement.” Id. at 1196.
Here, we disagree with Promega’s characterization
that unrecited STR loci combinations in the “open loci set”
limitation of the asserted claims are merely “unrecited
elements”; under the undisputed claim construction, they
are part of the claim scope. In this field of technology,
PROMEGA CORP v. LIFE TECH 15
introducing even a single STR locus to an existing loci
multiplex significantly alters the chemistry of, and has an
unpredictable effect on, whether the resulting multiplex
will successfully co-amplify.
There is no genuine dispute that identifying STR loci
multiplexes that will successfully co-amplify is a complex
and unpredictable challenge, and as a result, undue
experimentation may be required to identify a successful-
ly co-amplifying multiplex that adds even a single new
locus to an existing loci combination. To illustrate,
Promega repeatedly argued to the United States Patent
and Trademark Office (Patent Office) during prosecution
that its then-pending claims were patentable because the
prior art did not disclose “methods for selecting, co-
amplifying, and evaluating the specific sets of short tan-
dem repeat loci” recited in the claims. J.A. 1012 (empha-
sis added). 7 According to Promega, this lack of disclosure
was critical, as the state of the art in this technology area
“d[id] not disclose or suggest that any arbitrary combina-
tion of loci can be co-amplified without undue experimen-
tation.” J.A. 1225. Promega also stated that “multiplex
amplification” of specific STR loci combinations disclosed
in the prior art “cannot be extended to predict the success
of multiplexing unrelated combinations of loci.” Id. at
1224. Promega explained that this was because the prior
art “clearly indicate[d] that each individual [STR] locus
responds differently when subjected to the PCR using
locus-specific primers.” Id. at 1226. As a result, Promega
stated that the prior art could not “provide any direction
as to which of many possible [STR loci combination]
choices is likely to be successful.” Id.7 LifeTech collected over seventy similar represen-
tations to the Patent Office made by Promega during
prosecution of the Promega patents. J.A. 1223–31.
16 PROMEGA CORP v. LIFE TECHNOLOGIES CORP.
More specifically, Promega represented to the Patent
Office that the addition of even a single locus to an exist-
ing loci combination rendered that new loci combination
patentable. See, e.g., J.A. 1226 (arguing a claim was
patentable because “[o]ne of those four loci [disclosed in
the prior art] is not included in the list of loci of claim 1 [of
the ’660 patent].”). For example, Promega argued that a
claim reciting a 3-plex loci combination was patentable
over prior art that disclosed only two of the three loci.
J.A. 1230 (“No more than two of the STR loci disclosed in
the [prior art reference] are included in any of the sets of
at least three loci listed in step (b) of claim 21 [of the ’598
and ’235 patents] as amended.”); see also J.A. 1227 (“[The
prior art reference] fails to disclose the suitability of more
than two of the loci listed in claim 1 [of the ’660 patent].”).
Thus, Promega argued that “the disclosure of some of the
individual loci in the various [recited] sets of loci co-
amplified” was insufficient to render a claim unpatenta-
ble. See id.Promega pressed the same position when defending
the validity of the Promega patents in this action. In
particular, Promega argued that the loci multiplexes
recited in its claims were new inventions even though
they “comprised” prior art loci combinations that are
subsets of its claimed STR loci. Promega justified its
position by repeatedly describing the identification of new
successfully co-amplifying STR loci combinations as
“unpredictable.” E.g., Cross Appellant’s Br. 8; 25, 61–62.
In addition, Promega’s expert opined that at the time of
filing the parent application to the ’598 patent, “any new
STR multiplex . . . was inventive, even where one added a
single new locus to a pre-existing multiplex (e.g. adding a
new locus to a multiplex of two loci to make a triplex;
adding a new locus to a multiplex of three loci to make a
quadruplex, etc.).” J.A. 715. Thus, Promega explained
that without a preexisting publication or teaching, a
skilled artisan “could not predict with any certainty . . .
PROMEGA CORP v. LIFE TECH 17
whether a given set of loci would co-amplify successfully
together.” J.A. 1358. Promega urged that “[t]he lack of
these novel and unobvious locus combinations in the prior
art, together with the unpredictable nature of this art, is
fatal to [LifeTech’s] obviousness arguments.” Id. at 1360.
But when describing the scope of its claims for pur-
poses of infringement, Promega sings a different tune.
Despite the overwhelming evidence that the addition of a
single locus to an existing loci combination can fundamen-
tally transform the character of the resulting multiplex
reaction, Promega argues that LifeTech’s STR kits in-
fringe its claims because any and all co-amplifying loci
combinations that include the STR loci recited in the
claims are encompassed by the claims. Promega has
chosen broad claim language “at the peril of losing any
claim that cannot be enabled across its full scope of cover-
age.” MagSil Corp. v. Hitachi Global Storage Techs., Inc.,
687 F.3d 1377, 1381 (Fed. Cir. 2012). Our previous deci-
sions in MagSil and Wyeth & Cordis Corp. v. Abbott
Labs., 720 F.3d 1380 (Fed. Cir. 2013), are instructive.
In MagSil, a patentee asserted infringement of a
claim directed to a device used in computer hard drive
disks that required a “change in resistance by at least
10%” between two electrodes on the device. 687 F.3d at
1379–80. The specification disclosed information suffi-
cient to enable a skilled artisan to achieve a change in
resistance of 11.8%, and at the time of the invention,
those in the field aspired to achieve changes in resistance
of around 24%. Id. at 1381, 1383. Instead of tying the
key claim limitation to what the specification enabled, the
patentee sought to extend its scope in order to cover later-
invented devices that achieved greater than 600% chang-
es in resistance. Id. at 1383. To do so, the patentee
contended that its claims encompassed the entire range of
changes in resistance from 10% up to infinity because it
had used standard “open claim” language that “d[id] not
exclude additional, unrecited elements.” Id. We rejected
18 PROMEGA CORP v. LIFE TECHNOLOGIES CORP.
the patentee’s argument because the specification of the
patent “d[id] not contain sufficient disclosure to present
even a remote possibility that an ordinarily skilled arti-
san could have achieved the modern dimensions of this
art.” Id. at 1382. We determined that “the specification
enabled a marginal advance over the prior art,” but did
not support the infinite range of resistive changes encom-
passed by this claim limitation. Id.
Although the Promega patents recite specific sets of
STR loci instead of an open-ended range as in MagSil, the
claims at issue here are similar in that they cover the
successful co-amplification of a virtually unlimited num-
ber of STR loci combinations (so long as they include the
recited loci) through recitation of the “open loci set” limi-
tation. And as in MagSil, we need not delineate the
precise boundary at which Promega’s claims are no longer
enabled. It is sufficient to conclude, based on Promega’s
own statements, that the teachings of Promega’s patents
would not have enabled a skilled artisan at the time of
filing to identify significantly more complicated sets of
STR loci combinations that would successfully co-
amplify—such as those found in LifeTech’s STR kits—
without undue experimentation. Thus, like the patentee
in MagSil, Promega’s “difficulty in enabling the asserted
claims is a problem of its own making.” 687 F.3d at 1384.
In Wyeth, the patentee asserted infringement of
claims covering a broad class of drug compounds with
certain structures and properties. 720 F.3d at 1384–85.
Although the specification disclosed only one species of
the compound having these particular characteristics, the
patentee nevertheless contended that its claims encom-
passed tens of thousands of other species within the genus
that were not disclosed by the patent. Id. at 1382, 1384–
85. The undisputed evidence, however, was that a skilled
artisan could not determine whether a particular com-
pound would exhibit the claimed properties without
PROMEGA CORP v. LIFE TECH 19
synthesizing and screening that compound, a “laborious”
and “iterative” testing process. Id. at 1385.
Even if this testing process for any one compound
would have been routine to a skilled artisan, we deter-
mined that practicing the full scope of the claims required
“more than routine experimentation” because the specifi-
cation disclosed “only a starting point for further iterative
research in an unpredictable and poorly understood field.”
Id. at 1385–86. In particular, we noted that the specifica-
tion was “silent” as to how to modify the disclosed com-
pound “in a way that would preserve the recited utility.”
Id. at 1385. Further, even the patentee conceded that
because of the unpredictable nature of the art, practicing
the full scope of the claims would require testing each of
the tens of thousands of potential species within the
claimed genus. Id. As a result, we concluded that undue
experimentation would have been required in order to
practice the full scope of the claims and thus the claims
were invalid for lack of enablement. Id. at 1386.
While the claims of the Promega patents are not di-
rected to a genus of compounds as in Wyeth, the claims at
issue here similarly cover potentially thousands of undis-
closed embodiments in an unpredictable field. And simi-
lar to Wyeth, the specification of the Promega patents
provides only a starting point—specific STR loci combina-
tions that successfully co-amplify—with no disclosure that
would have allowed a skilled artisan, absent laborious
testing, to add new loci to these recited STR loci combina-
tions that would still successfully co-amplify. Undue
experimentation is a matter of degree, and even “a con-
siderable amount of experimentation is permissible,” so
long as it is “merely routine” or the specification “provides
a reasonable amount of guidance” regarding the direction
of experimentation. Johns Hopkins Univ. v. CellPro, Inc.,
152 F.3d 1342, 1360–61 (Fed. Cir. 1998) (internal quota-
tion omitted). But permissible routine experimentation
“is not without bounds.” Wyeth, 720 F.3d at 1386 (citation
20 PROMEGA CORP v. LIFE TECHNOLOGIES CORP.
omitted). As the extensive evidence here demonstrates,
undue experimentation would have been required in order
to enable the full scope of coverage sought by Promega—
the successful co-amplification of potentially thousands of
unrecited STR loci combinations.
Promega argues that its “open loci set” limitations
“permit” its claims to encompass a potentially limitless
number of primers and multiplex reactions that are not
enabled by the specification. Cross Appellant’s Br. 55.
Promega then seeks to shift the focus away from the
particular facts of this case by contending that nearly
every claim using the transitional phrase “comprising”
would be invalidated if we were to reject its position and
agree with LifeTech. These fears are unfounded.
It is true that when used in the preamble of a claim,
the term “comprising” permits the inclusion of other
steps, elements, or materials in addition to the elements
or components specified in the claims. See In re Bax-
ter, 656 F.2d 679, 686 (CCPA 1981). As we stated in
Gillette Co. v. Energizer Holdings, Inc., 405 F.3d 1367,
1371 (Fed. Cir. 2005), open claims “embrace technology
that may add features to devices otherwise within the
claim definition” (emphasis added). But the relevant
usage of “comprising” here is not the one recited in the
preamble. Rather, it is within the specific claim limita-
tion that lists combinations of successfully co-amplifying
STR loci, combinations whose identification and discovery
Promega itself asserts is a complex and unpredictable
endeavor. While the term “comprising” in a claim pream-
ble may create a presumption that a list of claim elements
is nonexclusive, it “does not reach into each [limitation] to
render every word and phrase therein open-ended.” See
Dippin’ Dots, Inc. v. Mosey, 476 F.3d 1337, 1343 (Fed. Cir.
2007). Promega’s claims differ from customary “open-
ended” claims in that Promega’s usage of “comprising” in
its “open loci set” limitation, as construed, expands the
claims at a key limitation in order to cover what are
PROMEGA CORP v. LIFE TECH 21
indisputably advances in this unpredictable art. Under
the circumstances here, the numerous embodiments
covered by Promega’s claims cannot be merely regarded
as “unrecited elements” in a standard “open-ended” claim.
Since the Promega patents do not enable a skilled ar-
tisan to practice the full breadth of this claim scope with-
out undue experimentation, the challenged claims of the
Promega patents are invalid for lack of enablement.
Accordingly, we reverse the district court’s denial of
LifeTech’s motion for summary judgment of invalidity of
the four Promega patents for lack of enablement under
§ 112, ¶ 1 and vacate the district court’s grant of
Promega’s motion for summary judgment of infringement
for the Promega patents. 8
C. Infringement under 35 U.S.C. § 271(f)(1)
Since the four Promega patents are invalid for lack of
enablement, we need only address the district court’s
grant of LifeTech’s motion for JMOL of noninfringement
of the Tautz patent. As mentioned supra, LifeTech’s
accused genetic testing kits include a primer mix, a PCR
reaction mix, a buffer solution, control DNA, and a poly-
merase (Taq), which is necessary for the PCR amplifica-
tion. LifeTech manufactures this Taq polymerase
component in the United States. LifeTech then ships this
component to its facility in the United Kingdom for incor-
poration into its accused genetic testing kits, which are
sold worldwide, including in the United States. See J.A.
2265–67.
8 Because the asserted claims of the Promega pa-
tents are invalid for lack of enablement, adjudication of
LifeTech’s obviousness challenge under 35 U.S.C. § 103 is
unnecessary.
22 PROMEGA CORP v. LIFE TECHNOLOGIES CORP.
As discussed infra, LifeTech admits that sales of these
accused kits in the United States infringe the Tautz
patent under 35 U.S.C. § 271(a). At trial, the jury also
awarded lost profits to Promega based on worldwide sales
of LifeTech’s accused STR kits under 35 U.S.C. § 271(f)(1).
The district court, however, granted LifeTech’s motion for
JMOL under Rule 50(b) of the Federal Rules of Civil
Procedure that Promega failed to prove infringement
under § 271(f)(1) as a matter of law. In particular, the
district court held that (1) § 271(f)(1) requires the in-
volvement of another, unrelated party to “actively induce
the combination of components” and that no other party
was involved in LifeTech’s assembly of the accused kits,
and (2) a “substantial portion of the components” requires
at least two components to be supplied from the United
States and that LifeTech supplied only a single compo-
nent—the Taq polymerase—from the United States.
Promega Corp. v. Max-Planck-Gesellschaft zur Forderung
der Wissenschaften E.V., No. 10-cv-0281-bbc, ECF No.
684, slip op. at 7–19 (W.D. Wis. Sept. 13, 2012) (hereinaf-
ter, Promega II). On this narrow issue, we disagree with
the district court’s reading of § 271(f)(1). Moreover,
substantial evidence supports the jury’s finding that
LifeTech’s activities infringe the Tautz patent under a
proper understanding of that statutory provision. There-
fore, the district court erred in granting LifeTech’s motion
for JMOL.
Under 35 U.S.C. § 271(f)(1), a party may infringe a
patent based on its participation in activity that occurs
both inside and outside the United States. Section
271(f)(1) states:
Whoever without authority supplies or causes to
be supplied in or from the United States all or a
substantial portion of the components of a patent-
ed invention, where such components are uncom-
bined in whole or in part, in such manner as to
actively induce the combination of such compo-
PROMEGA CORP v. LIFE TECH 23
nents outside of the United States in a manner
that would infringe the patent if such combination
occurred within the United States, shall be liable
as an infringer.
1. “Actively induce the combination”
We first address whether “to actively induce the com-
bination” requires involvement of a third party or merely
the specific intent to cause the combination of the compo-
nents of a patented invention outside the United States.
We conclude that no third party is required.
To begin, we acknowledge that the word “induce” can
suggest that one is influencing or persuading “another.”
However, induce also encompasses the more broad con-
cept of “to bring about, to cause.” See Promega II, slip op.
at 16 (citing http://www.merriam–webster.com/dictionary/
induce); see also VII Oxford English Dictionary 888 (2d ed.
1989) (“[t]o bring about, bring on, produce, cause, give rise
to”); Am. Heritage Coll. Dictionary 894 (4th ed. 2000)
(“[t]o bring about or stimulate the occurrence of; cause”).
The object of the transitive verb “induce” can either be a
person or a thing, such as an activity or result. The
statute is written such that an activity—“the combina-
tion”—is the object of “induce,” not a person. Had Con-
gress wanted to limit “induce” to actions completed by two
separate parties, it could easily have done so by assigning
liability only where one party actively induced another “to
combine the [patented] components.” Yet, “another” is
absent from § 271(f)(1). 9 Instead, the focus of the statute
9 In this respect, § 271(f)(1) discusses inducement
unlike other areas of the law, where statutes describe the
inducement of “another person,” “any individual,” or a
third party. See, e.g., statutes involving extortion (NY
State Penal Law § 155.05(2)(e) (“A person obtains proper-
24 PROMEGA CORP v. LIFE TECHNOLOGIES CORP.
is to induce “the combination of the components of the
patented invention.”
Nor does the concept of a third party appear in the
legislative history for the § 271(f) amendment, which
focuses on the would-be infringer’s action of supplying
components overseas. The legislative history explains:
“In order to be liable as an infringer under paragraph
(f)(1), one must supply or cause to be supplied ‘all or a
substantial portion’ of the components in a manner that
would infringe the patent if such combination occurred
within the United States.” Section-by-Section Analysis:
Patent Law Amendments of 1984, 130 Cong. Rec. 28,069
(1984) as reprinted in 1984 U.S.C.C.A.N. 5827, 5828
(hereinafter, “Legislative History”).
Congress enacted § 271(f) in response to a “loophole”
brought to its attention by the Supreme Court’s decision
in Deepsouth Packing Co. v. Laitram Corp., 406 U.S. 518(1972). Legislative History, 1984 U.S.C.C.A.N. at 5828.
In Deepsouth, the Fifth Circuit affirmed an injunction
barring use of an infringing shrimp deveining machine
ty by extortion when he compels or induces another person
to deliver such property to himself or to a third person
. . . .”) (emphasis added)); pandering (D.C. Code § 22-2705(“(a) It is unlawful for any person, within the District of
Columbia to: (1) Place or cause, induce, entice, procure, or
compel the placing of any individual in the charge or
custody of any other person, or in a house of prostitution,
with intent that such individual shall engage in prostitu-
tion”) (emphasis added)); child delinquency (FL Act
§ 827.04 (“Contributing to the delinquency or dependency
of a child; penalty.—(1) Any person who: (b) Induces or
endeavors to induce, by act, threat, command, or persua-
sion, a child . . . .”) (emphasis added)).
PROMEGA CORP v. LIFE TECH 25
within the United States. 406 U.S. at 519. The infringer
subsequently began making the parts of its enjoined
shrimp deveining machine in the United States, then
exported those parts to its foreign buyers, who would
ultimately assemble and use the completed machines
abroad. Id. at 523–24. The Supreme Court found that
the unassembled export of the elements of the infringing
shrimp deveining machine did not infringe the patent,
which required the completed combination of those ele-
ments. Id. at 528–29. The Court determined that with-
out a “clear and certain signal from Congress,” it was not
prepared to expand the rights of patent holders to include
an “extraterritorial effect.” Id. at 531.
Congress responded to Deepsouth by enacting § 271(f).
Section 271(f) closed the Deepsouth “loophole” by expand-
ing the reach of the patent statute to capture certain
domestic precursors to extraterritorial activity not previ-
ously considered as infringing. In terms of its policy
goals, § 271(f)(1) sought to “prevent copiers from avoiding
United States patents by supplying components of a
patented product in this Country so that the assembly of
the components may be completed abroad.” Legislative
History, 1984 U.S.C.C.A.N. at 5828.
To achieve these goals, Congress chose language for
§ 271(f)(1) broader than the particular facts of Deepsouth.
For example, although Deepsouth involved the supplying
of patented components to unrelated third party custom-
ers, Congress did not limit the reach of § 271(f)(1) to
“third parties” or “another.” In addition, although
Deepsouth involved the supply of all the components of a
patented invention, Congress chose to expand liability to
the supply of “all or a substantial portion” of the compo-
nents, discussed infra. Given Congress’ choice of broaden-
ing language—which focuses solely on the activity abroad
(“the combination”) rather than the actor performing the
combination—and acknowledgment of “the need for a
legislative solution to close a loophole” identified in
26 PROMEGA CORP v. LIFE TECHNOLOGIES CORP.
Deepsouth, Legislative History, 1984 U.S.C.C.A.N. at
5828, it is unlikely that Congress intended § 271(f)(1) to
hold companies liable for shipping components overseas to
third parties, but not for shipping those same components
overseas to themselves or their foreign subsidiaries. 10
LifeTech argues that “to actively induce the combina-
tion” requires involvement of a third party based on its
interpretation of the phrase “actively induces infringe-
ment” in the context of 35 U.S.C. § 271(b). See, e.g.,
Global-Tech Appliances, Inc. v. SEB SA, 131 S. Ct. 2060,
2065 (2011). In Global-Tech, the Supreme Court, in
deciding a different issue, uses language that assumes the
presence of a second person as a direct infringer where
there was such a person. 11 That assumption is quite
natural for induced infringement under § 271(b), since a
single party who causes the infringement of a patent
would already be strictly liable for infringement under
§ 271(a). However, because § 271(f)(1) lacks such a strict
liability companion statute, comparisons to § 271(b) are of
limited value.
2. “Substantial portion of the components of a patented
invention”
We next address whether infringement under
§ 271(f)(1) requires at least two components to be supplied
from the United States. Section 271(f)(1) assigns in-
10 We are mindful of the fact that the Supreme
Court has cautioned against the extraterritorial applica-
tion of United States laws. See, e.g., Deepsouth, 406 U.S.
at 531. But in this instance, Congress’ chosen language
assigns liability to LifeTech’s conduct within the United
States, based on its extraterritorial effect.
11 None of the cases cited by the dissent had to con-
front the question of statutory construction we face here.
PROMEGA CORP v. LIFE TECH 27
fringement to anyone who supplies or causes to be sup-
plied “all or a substantial portion of the components of a
patented invention.” We hold that there are circumstanc-
es in which a party may be liable under § 271(f)(1) for
supplying or causing to be supplied a single component for
combination outside the United States. And based on the
facts of this particular case, we conclude that substantial
evidence supports the jury’s verdict that LifeTech is liable
for infringement under § 271(f)(1) for shipping the Taq
polymerase component of its accused genetic testing kits
to its United Kingdom facility.
As with our analysis for “to actively induce the combi-
nation,” we begin by examining the ordinary meaning of
the text of the statute. See FDIC v. Meyer, 510 U.S. 471,
476 (1994). The dictionary definition of “substantial” is
“important” or “essential.” Webster’s Third New Int’l
Dictionary 2280 (2002); XVII Oxford English Dictionary
67 (2d ed. 1989) (“essential; material”); see also Am.
Heritage Coll. Dictionary 1727 (4th ed. 2000) (“considera-
ble in importance . . .”). A “portion” is defined as a “sec-
tion or quantity within a larger thing; a part of a whole.”
Am. Heritage Coll. Dictionary 1066 (4th ed. 2000); XII
Oxford English Dictionary 155 (2d ed. 1989) (“[a] part of
any whole”). Nothing in the ordinary meaning of “por-
tion” suggests that it necessarily requires a certain quan-
tity or that a single component cannot be a “portion” of a
multi-component invention. Rather, the ordinary mean-
ing of “substantial portion” suggests that a single im-
portant or essential component can be a “substantial
portion of the components” of a patented invention.
None of LifeTech’s arguments persuade us otherwise.
First, LifeTech contends that the reference to “compo-
nents” in its plural form in the statute indicates that more
than one “component” must be supplied outside the Unit-
28 PROMEGA CORP v. LIFE TECHNOLOGIES CORP.
ed States for § 271(f)(1) to apply. 12 Promega II, slip op. at
10. LifeTech ignores, however, that the statute assigns
infringement liability when a party supplies “all or a
substantial portion of the components of a patented
invention”—not merely the “components of a patented
invention.” Subsequent references within the statute to
“such components” are clearly references to “the compo-
nents of a patented invention,” not to what must be
“supplied” by the alleged infringer. To illustrate, the
statute assigns liability to a party who “actively induce[s]
the combination of such components outside of the United
States in a manner that would infringe the patent if such
combination occurred within the United States.” The
term “such components” must refer to the components “of
a patented invention,” and not to what is “supplied,” as
only the combination of all “components of a patented
invention” results in infringement. In order to reference
what must be “supplied” by the alleged infringer within
the natural grammatical structure of the statute, Con-
gress would have had to reference “such all or a substan-
tial portion,” not “such components.” In short, LifeTech’s
reading of “such components” is inconsistent with the
grammatical structure of the statute.
LifeTech next compares § 271(f)(1) with § 271(f)(2),
arguing that Congress used the plural “components” in
subsection (f)(1) and the singular “component” in subsec-
tion (f)(2) for a reason. 13 However, these two subsections
12 We note that LifeTech’s interpretation ignores the
Dictionary Act, which instructs that “words importing the
plural [can] include the singular.” 1 U.S.C. § 1.
13 Section 271(f)(2) recites: “Whoever without au-
thority supplies or causes to be supplied in or from the
United States any component of a patented invention that
is especially made or especially adapted for use in the
PROMEGA CORP v. LIFE TECH 29
employ the terms in different contexts, and thus the use
of “component” in § 271(f)(2) does not control the meaning
of “components” in § 271(f)(1). The focus of the infringe-
ment inquiry under § 271(f)(1) is whether one or more
components supplied by a party constitutes “all or a
substantial portion of the components of a patented
invention” and if so, whether the alleged infringer “active-
ly induce[d] the combination” of those components. On
the other hand, the focus of the infringement inquiry
under § 271(f)(2) is whether a party has supplied any
component “especially made or especially adapted for use
in [a patented] invention” that is not a “staple article or
commodity of commerce suitable for substantial nonin-
fringing use.” 14
LifeTech also contends that Microsoft v. AT&T Corp.,
550 U.S. 437 (2007), supports its interpretation of
§ 271(f)(1). In Microsoft, an alleged infringer exported the
“master version” of its accused operating system software
overseas with the intent that the software would be
copied by and installed on foreign manufacturers’ com-
puters, computers that were eventually sold to foreign
customers. 550 U.S. at 445–46. This operating system
invention and not a staple article or commodity of com-
merce suitable for substantial noninfringing use, where
such component is uncombined in whole or in part, know-
ing that such component is so made or adapted and
intending that such component will be combined outside
of the United States in a manner that would infringe the
patent if such combination occurred within the United
States, shall be liable as an infringer” (emphasis added).
14 Promega does not assert infringement under
§ 271(f)(2) because Taq polymerase is “a staple article or
commodity of commerce suitable for substantial nonin-
fringing use.” See J.A. 6289.
30 PROMEGA CORP v. LIFE TECHNOLOGIES CORP.
software incorporated a speech processing function that
allegedly infringed the patentee’s claims. Id. at 441. On
the facts before it, the Supreme Court addressed two
specific questions: (1) “when, or in what form, does soft-
ware qualify as a ‘component’ under § 271(f)”; and (2)
whether “components” of the foreign-made computers
were “supplie[d]” from the United States. Id. at 447. The
Supreme Court held that abstract software code “de-
tached from an activating medium” such as a CD-ROM
was not a “component” that could trigger infringement
liability under § 271(f) because it was merely an “idea
without physical embodiment.” Id. at 449. The Court
also held that the copies of the accused software made by
foreign manufacturers outside the United States were not
“supplied” from the United States for purposes of § 271(f).
Id. at 453–54.
LifeTech points to two footnotes of the Supreme
Court’s opinion comparing the language of § 271(f)(1) with
§ 271(f)(2). First, the Court observed that the two subsec-
tions “differ, among other things, on the quantity of
components that must be ‘supplie[d] . . . from the United
States’ in order for liability to attach.” Microsoft, 550 U.S.
at 454 n.16. LifeTech ignores the next two sentences of
the Court’s opinion, however, which state: “Paragraph (2),
like (1), covers only a ‘component’ amenable to ‘combina-
tion’” and “Paragraph (2), like (1), encompasses only the
‘suppl[y] . . . from the United States’ of ‘such [a] compo-
nent’ as will itself ‘be combined outside of the United
States.’” Id. (emphases added). This language tends to
support the conclusion that § 271(f)(1) may apply when a
single “component” is involved.
Second, the Supreme Court observed that Ҥ 271(f)(2)
applies to the export of even a single component if it is
‘especially made or especially adapted for use in the
invention and not a staple article or commodity of com-
merce suitable for substantial noninfringing use.’” Mi-
crosoft, 550 U.S. at 454 n.18. LifeTech appears to argue
PROMEGA CORP v. LIFE TECH 31
that the Court’s use of the phrase “single component” in
§ 271(f)(2) by implication means that § 271(f)(1) applies
only to multiple components. But LifeTech ignores the
preceding sentence of the opinion, in which the Supreme
Court observes that, in contrast, Ҥ 271(f)(1) applies to the
supply abroad of ‘all or a substantial portion of’ a patent-
ed invention’s components.” Id. Again, this footnote does
not suggest that § 271(f)(1) differs from § 271(f)(2) in that
it necessarily requires the export of more than one com-
ponent.
Moreover, LifeTech’s interpretation of these two foot-
notes is undermined by the very facts of Microsoft. In
Microsoft, the patented invention involved the combina-
tion of at least two components: operating system soft-
ware and a computer. 550 U.S. at 441–42. The alleged
infringing activity under § 271(f) was a party’s export of a
single component of this two-component invention—either
a “master disk” or an “electronic transmission” containing
the accused operating system software. Id. at 446. The
patentee did not specify which subsection of § 271(f) was
triggered by the alleged infringer’s activity, and for “clari-
ty’s sake,” the Supreme Court focused its analysis on the
text of § 271(f)(1). Id. at 447 n.7. Although the “electronic
transmission” was determined not to be a “component,”
neither party argued—and the Supreme Court never
suggested—that liability under § 271(f)(1) did not attach
merely because the single component of a master disk or
electronic transmission could not be a “substantial por-
tion” of the components of the patented invention. In
short, the Supreme Court in Microsoft could have decided
the patentee’s challenge by finding, or at least instructing,
that liability under § 271(f)(1) requires the export of more
than one component of a patented invention. It did not.
In the absence of express guidance by the Supreme Court,
we will not contravene the ordinary reading of the statute
and categorically exclude the “supply” of a single compo-
nent of a patented invention from the scope of § 271(f)(1).
32 PROMEGA CORP v. LIFE TECHNOLOGIES CORP.
Our determination that liability under § 271(f)(1) may
attach for export of a single component does not end the
inquiry, however. According to the statute, this compo-
nent must be “a substantial portion” of the components of
the patented invention. Here, we find substantial evi-
dence to support the jury’s conclusion that the Taq poly-
merase supplied by LifeTech from the United States to its
foreign facility is a “substantial portion” of the compo-
nents of the LifeTech’s accused genetic testing kits.
Claim 42 of the Tautz patent recites five components:
a primer mix, a polymerizing enzyme (such as Taq poly-
merase), nucleotides, a buffer solution, and control DNA.
Tautz patent, 16:43–61. LifeTech’s domestic arm sup-
plies 15 the Taq polymerase to its facility in the United
Kingdom, which both manufactures the remaining four
components and assembles all the components into the
accused STR kits. J.A. 2265–67, 6288. Taq polymerase is
an enzyme used to amplify the DNA sequences in order to
obtain enough replicated sample for testing. J.A. 6281.
Without Taq polymerase, the genetic testing kit recited in
the Tautz patent would be inoperable because no PCR
could occur. LifeTech’s own witness admitted that the
Taq polymerase is one of the “main” and “major” compo-
nents of the accused kits. J.A. 6290–91. In short, there is
evidence in the record to support the jury’s finding that a
polymerase such as Taq is a “substantial portion” of the
patented invention.
In sum, we disagree with the district court that a sin-
gle component supplied from the United States, no matter
how important or central to the invention, can never
constitute “a substantial portion of the components of a
15 LifeTech either purchases Taq polymerase from a
third-party in the United States or produces Taq poly-
merase itself in an Austin, Texas facility. J.A. 6281–83.
PROMEGA CORP v. LIFE TECH 33
patented invention.” The evidence demonstrates that
LifeTech supplied a substantial portion of the patented
invention—the polymerase—to its overseas facility as a
component of its accused genetic testing kits. Further,
whether LifeTech exhibited the necessary knowledge and
intent to combine the Taq polymerase with the remaining
components of its genetic testing kit “in a manner that
would infringe” the Tautz patent if that combination
occurred within the United States is not contested and is
presumed. There is substantial evidence in the record to
support the jury’s finding that LifeTech is liable for in-
fringement under 35 U.S.C. § 271(f)(1).
D. Infringement under 35 U.S.C. § 271(a)
The district court also granted LifeTech’s motion for
JMOL of noninfringement of the Tautz patent under
§ 271(a) because it believed Promega did not offer evi-
dence that LifeTech’s accused products were made, used,
offered for sale, or sold in the United States. Though the
district court acknowledged that Promega had introduced
evidence that at least some of LifeTech’s accused products
infringed under § 271(a), it granted LifeTech’s motion
because Promega had not shown that all its sales were
infringing. We reverse the district court.
At trial, LifeTech admitted that some of the sales of
its accused genetic testing kits in the United States were
“technically an infringement” of Promega’s patents. J.A.
5127. LifeTech also admitted that Promega was “entitled
to be compensated for [LifeTech’s] infringement.” Id.
Promega presented evidence to the jury showing sales of
LifeTech’s accused kits in the United States. See J.A.
7031–7170, 7362–7744, 7906–8002 (LifeTech sales rec-
ords); J.A. 6249–68 (LifeTech testimony explaining the
sales records). Based on LifeTech’s own admissions,
which are supported by evidence in the record, we con-
clude that LifeTech’s kits made, used, or sold in the
United States infringe the Tautz patent under 35 U.S.C.
34 PROMEGA CORP v. LIFE TECHNOLOGIES CORP.
§ 271(a). Because substantial evidence supports the jury’s
finding that LifeTech’s accused kits infringe the Tautz
patent under both § 271(a) and § 271(f)(1), we reverse the
district court’s grant of LifeTech’s motion for JMOL of
noninfringement of the Tautz patent.
E. 2006 Cross License
The 2006 Cross License is a limited field-of-use li-
cense for “Forensics and Human Identity Applications.”
Appellant’s Br. 9. California state law provides: “The
language of a contract is to govern its interpretation, if
the language is clear and explicit, and does not involve an
absurdity.” Cal. Civ. Code § 1638. During a hearing
before trial, the district court issued an oral ruling that
the scope of the 2006 Cross License was limited to sales of
LifeTech’s STR kits used during “live” forensic investiga-
tions conducted by law enforcement agencies, and did not
cover sales of the STR kits used for forensic research,
education, and training at universities and other non-law
enforcement bodies. J.A. 1792.
LifeTech contends that because forensic research, ed-
ucation and training are necessary parts of any “live”
forensic investigation by a law enforcement agency, the
2006 Cross License also covers STR kits used by universi-
ties and other parties for any purpose related to forensic
research, education, and training. 16 For example, Life-
Tech argues that any educational use of its STR kits is for
“Forensics and Human Identity Applications” of law
enforcement agencies because “the forensics student is
learning specifically how to use the very kits that will be
16 In its Reply Brief, LifeTech argued for the first
time that it has broader licensing rights to the Tautz
patent based on a 1996 agreement. Reply Br. 8. We will
not consider this untimely argument.
PROMEGA CORP v. LIFE TECH 35
used for legal proceedings, and cannot use those kits in
legal proceedings if he or she has not been trained on
them.” Appellant’s Br. 59.
We are not persuaded by LifeTech’s creative interpre-
tation of the 2006 Cross License. LifeTech’s desire to
expand the scope of the license to authorize certain un-
specified applications contradicts the express language of
the agreement, which grants LifeTech a limited field-of-
use license for “forensics and paternity.” J.A. 1868–69.
The district court correctly determined that the plain
language of the 2006 Cross License’s “Forensic and Hu-
man Identity Applications” field-of-use provision does not
extend to research, education, and training. As the dis-
trict court summarized in its oral ruling, “defendants
want [the 2006 Cross License] to apply to every research
project going on in the world that had anything to do with
genetics, no. No. Doesn’t work.” Id. at 1792.
* * *
We have considered all other arguments presented by
the parties and find them unpersuasive.
III. CONCLUSION
For the foregoing reasons, we conclude that the chal-
lenged claims of the four Promega patents are invalid
under 35 U.S.C. § 112, ¶ 1 for lack of enablement, and
thus reverse the district court’s denial of LifeTech’s mo-
tion for summary judgment of invalidity. Because sub-
stantial evidence supports the jury’s finding that LifeTech
infringed the Tautz patent under both 35 U.S.C. § 271(a)
and 35 U.S.C. § 271(f)(1), we reverse the district court’s
grant of JMOL of noninfringement as to the Tautz patent.
We affirm the district court’s ruling that certain sales of
LifeTech’s accused STR kits are not covered by the 2006
Cross License. Since the challenged claims of four of the
five asserted patents on which the jury based its damages
verdict are invalid, we vacate the jury’s damages award.
36 PROMEGA CORP v. LIFE TECHNOLOGIES CORP.
We also vacate the district court’s denial of Promega’s
motion for a new trial, and we remand to the district court
to determine damages due to LifeTech’s infringement of
the Tautz patent.
AFFIRMED-IN-PART, REVERSED-IN-PART,
VACATED-IN-PART, AND REMANDED
COSTS
No costs.
United States Court of Appeals
for the Federal Circuit
______________________
PROMEGA CORPORATION,
Plaintiff-Cross-Appellant,
AND
MAX-PLANCK-GESELLSCHAFT ZUR FORDERUNG
DER WISSENSCHAFTEN E.V.,
Plaintiff,
v.
LIFE TECHNOLOGIES CORPORATION,
INVITROGEN IP HOLDINGS, INC., AND
APPLIED BIOSYSTEMS, LLC,
Defendants-Appellants.
______________________
2013-1011, -1029, -1376
______________________
Appeals from the United States District Court for the
Western District of Wisconsin in No. 10-CV-0281, Chief
Judge Barbara B. Crabb.
______________________
PROST, Chief Judge, dissenting-in-part.
While I join Sections I–II.B and II.D–II.E of this opin-
ion, I respectfully dissent from Section II.C in which the
majority determines that LifeTech can be held liable for
infringement of the Tautz patent under 35 U.S.C
§ 271(f)(1). The opinion concludes that LifeTech “actively
induce[d]” itself (i.e., its U.K. subsidiary) to make the
2 PROMEGA CORP v. LIFE TECH
patented combination in the U.K. See Majority Op. at 23–
26. However, I read § 271(f)(1) and its requirement of
active inducement to necessarily mean inducement of
another. Indeed, we have never before held—in the
context of either § 271(f) or § 271(b)—that a party can
induce itself to infringe. And for good reason: this conclu-
sion runs counter to unambiguous Supreme Court prece-
dent. Therefore, contrary to the majority, I conclude that
LifeTech cannot be held liable for infringing the Tautz
patent under § 271(f)(1). 1
Twice the Supreme Court has held that inducement
liability requires a third party. In interpreting the phrase
“induces infringement” in § 271(b), the Supreme Court
wrote that it requires “that the inducer lead another” or
“persuade another.” Global-Tech Appliances, Inc. v. SEB
SA, 131 S. Ct. 2060, 2065 (2011) (emphases added).
Additionally, in Metro-Goldwyn-Mayer Studios Inc. v.
Grokster, Ltd., a case in the analogous copyright context, 2
the Supreme Court stated that inducement is defined as
“entic[ing] or persuad[ing] another” to infringe. 545 U.S.
913, 935 (2005) (emphasis added). The majority cannot
point to a single case—from the Supreme Court or other-
1 Because I find that the district court properly de-
cided that LifeTech is not liable under § 271(f)(1) for
active inducement, I would not reach the alternative
argument that LifeTech is not liable under § 271(f)(1)
because it only supplied a single component.
2 The Supreme Court has explained it is most ap-
propriate to draw an analogy between copyright cases and
patent cases “because of the historic kinship between
patent law and copyright law.” Sony Corp. of Am. v.
Universal City Studios, Inc., 464 U.S. 417, 439 (1984); see
also Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d
1276, 1295 (Fed. Cir. 2011) (“[T]he most analogous area to
patent law is copyright.”).
PROMEGA CORP v. LIFE TECH 3
wise—that supports its contrary interpretation of in-
ducement.
Our en banc court has also made similar statements
regarding inducement under § 271(b). For example, in
DSU Medical Corp. v. JMS Co., we ruled that inducement
requires proof: (1) “of culpable conduct, directed to en-
couraging another’s infringement”; (2) that the defendant
“actively and knowingly aid[ed] and abet[ted] another’s
direct infringement”; and (3) “that the alleged infringer
knowingly induced infringement and possessed specific
intent to encourage another’s infringement.” 471 F.3d
1293, 1305–06 (Fed. Cir. 2006) (en banc) (emphases
added). And in Lucent Technologies, Inc. v. Gateway, Inc.,
we stated that “inducement requires evidence of culpable
conduct, directed to encouraging another’s infringement.”
580 F.3d 1301, 1322 (Fed. Cir. 2009) (emphasis added);
see also Wordtech Sys. v. Integrated Networks Solutions,
609 F.3d 1308, 1315 (Fed. Cir. 2010) (same).
The majority rests its analysis on the legislative his-
tory surrounding the enactment of § 271(f). Even assum-
ing that reliance on legislative history is appropriate in
this circumstance, the majority ignores the most relevant
part of the legislative history: “the term ‘actively induce’”
in § 271(f)(1) was expressly “drawn from existing subsec-
tion 271(b)[.]” 130 Cong. Rec. 28,069 (1984) (statement of
Rep. Kastenmeier, inserting a section-by-section analysis
of H.R. 6286). It is a “standard principle of statutory
construction that identical words and phrases within the
same statute should normally be given the same mean-
ing.” Powerex Corp. v. Reliant Energy Servs., Inc., 551
U.S. 224, 232 (2007). As Congress expressly based
§ 271(f)(1) on § 271(b), that principle of statutory con-
struction has special force here.
Further, the majority focuses on the fact that it is il-
logical to hold companies liable for shipping components
to third parties overseas while simultaneously permitting
4 PROMEGA CORP v. LIFE TECH
companies to ship those same components overseas to
either itself or its subsidiaries. The majority states that it
is “unlikely” that Congress intended this result. See
Majority Op. at 26. Maybe. Maybe not. More important-
ly, however, the majority imputes from Congress’ sup-
posed intent to close the Deepsouth loophole a much
broader legislative intent to close all loopholes related to
extraterritorial liability. This is improper. Congress
replaced Deepsouth with the statutory language of
§ 271(f), not some amorphous “intent.” In these circum-
stances it is hardly our role as judges to surmise or divine
what Congress may or may not have foreseen or desired,
and to act as its surrogate.
Indeed, the Supreme Court rejected such an aggres-
sive methodology when it resolved Deepsouth Packing Co.
v. Laitram Corp, 406 U.S. 518 (1972). Facing a loophole
in the statutory scheme, the Supreme Court in Deepsouth
held that no law prohibited an entity from avoiding
infringement by shipping components of a patented device
for assembly outside the United States. And what hap-
pened next? Congress stepped in and superseded
Deepsouth by enacting § 271(f). See 130 Cong. Rec.
28,065–69 (1984).
But I need not even look to Deepsouth. I also follow
the clear guidance from the Supreme Court in Limelight
Networks, Inc. v. Akamai Technologies, Inc, 134 S. Ct.
2111 (2014). There, the Court explained that “when
Congress wishes to impose liability for inducing activity
that does not itself constitute direct infringement, it
knows precisely how to do so. The courts should not
create liability for inducement of non-infringing conduct
where Congress has elected not to extend that concept.”
Id. at 2118.
Finally, the Supreme Court has cautioned against
employing a policy-oriented approach to judicial decision
making when it would cause law to have extraterritorial
PROMEGA CORP v. LIFE TECH 5
application. Specifically, in Microsoft Corp. v. AT&T
Corp., the Supreme Court noted that Congress did not
address all gaps when it drafted § 271(f) and, therefore,
the Supreme Court chose to “leave in Congress’ court” the
broader, extraterritorial “patent-protective determina-
tion” the patentee sought in that case. 550 U.S. 437, 458
(2007). The Supreme Court warned that “[i]f the patent
law is to be adjusted[,] . . . the alteration should be made
after focused legislative consideration, and not by the
Judiciary forecasting Congress’ likely disposition.” Id. at
458-59. Because we are limited by the language of the
statute, Supreme Court precedent, and our own prece-
dent, I respectfully dissent from the portion of the majori-
ty’s opinion addressing § 271(f)(1).