Streck v. Research & Diagnostic ( 2012 )

United States Court of Appeals
for the Federal Circuit
__________________________
STRECK, INC.,
Plaintiff-Appellee,
v.
RESEARCH & DIAGNOSTIC SYSTEMS, INC. AND
TECHNE CORPORATION,
Defendants-Appellants.
__________________________
2011-1044
__________________________
Appeal from the United States District Court for the
District of Nebraska in Case No. 06-CV-0458, Chief Judge
Joseph F. Bataillon.
_________________________
Decided: January 10, 2012
_________________________
FLOYD R. NATION, Winston & Strawn LLP, of Hous-
ton, Texas, argued for plaintiff-appellee. With him on the
brief was MERRITT D. WESTCOTT. Of counsel on the brief
was RICHARD L. STANLEY, of Houston, Texas.
KURT J. NIEDERLUECKE, Fredrikson & Byron, P.A., of
Minneapolis, Minnesota, argued for defendants-appellants.
With him on the brief was GRANT D. FAIRBAIRN. Of counsel
on the brief was MARTIN M. ZOLTICK, Rothwell, Figg, Ernst
& Manbeck, of Washington, DC.
STRECK v. RESEARCH & DIAGNOSTIC 2
__________________________
Before NEWMAN, O’MALLEY, and REYNA, Circuit Judges.
O’MALLEY, Circuit Judge.
In this patent case, Streck, Inc. (“Streck”) filed suit
against Research & Diagnostic Systems, Inc. and Techne
Corporation (collectively, “R&D”) in the United States
District Court for the District of Nebraska alleging that
R&D infringed three of Streck’s patents for hematology
control technology: U.S. Patent Nos. 6,200,500 (“the ’500
Patent”), 6,221,668 (“the ’668 Patent”), and 6,399,388
(“the ’388 Patent”) (collectively, “the patents-in-suit”).
R&D counterclaimed for declaratory judgment of nonin-
fringement and invalidity.
R&D appeals from the district court’s: (1) dismissal of
R&D’s invalidity counterclaims with respect to claims
Streck did not include in its infringement allegations (the
“unasserted claims”); (2) denial of summary judgment for
R&D and grant of summary judgment for Streck on
written description; (3) denial of judgment as a matter of
law (“JMOL”) for R&D and grant of JMOL for Streck on
enablement; (4) denial of R&D’s renewed motion for
JMOL and motion for a new trial on priority; and
(5) issuance of a permanent injunction. Streck, Inc. v.
Research & Diagnostic Sys., Inc., 658 F. Supp. 2d 988 (D.
Neb. 2009) (“Summary Judgment Order”); Streck, Inc. v.
Research & Diagnostic Sys., Inc., No. 8:06cv458, 2010
U.S. Dist. LEXIS 104461 (D. Neb. Sept. 30, 2010) (“Denial
of Renewed JMOL Order”). Because we conclude that the
district court did not err in refusing to address the valid-
ity of the unasserted claims and correctly denied R&D’s
written description and enablement defenses as a matter
of law, and because the issue of priority is controlled by
3 STRECK v. RESEARCH & DIAGNOSTIC
this court’s resolution in Appeal No. 2011-1045, 1 we
affirm the district court’s judgment against R&D and its
decision granting a permanent injunction in favor of
Streck.
BACKGROUND
A. Factual Background
The technology involved in this case relates to hema-
tology controls. These controls are used to monitor and
test the accuracy and consistency of hematology analyz-
ers, which clinical laboratories use to analyze patient
blood samples. Specifically, hematology analyzers meas-
ure the various components of whole blood, including red
blood cells, white blood cells, platelets, and reticulocytes, 2
and the information gathered is used to diagnose and
treat diseases. Both Streck and R&D manufacture and
sell hematology control products.
Prior to 1996, hematology instruments measured re-
ticulocytes and white blood cells separately and thus
required separate stand-alone hematology controls – i.e.,
those that measured only a single component of blood.
Stand-alone controls using true reticulocytes 3 and reticu-
locyte analogs were well-known in the art before the
applications that matured into the patents-in-suit were
filed. Dr. Alan Johnson, a senior scientist at R&D, is a
1 Streck, Inc. v. Research & Diagnostic Sys., Inc.,
659 F.3d 1186 (Fed. Cir. 2011).
2 Reticulocytes are “anucleate immature red blood
cells containing some ribonucleic acid.” Streck, Inc. v.
Research & Diagnostic Sys., Inc., No. 8:06cv458, 2008
U.S. Dist. LEXIS 91865 (D. Neb. Nov. 12, 2008) (“Claim
Construction Order”).
3 The terms “true reticulocytes” and “natural reticu-
locytes” are used interchangeably to refer to naturally-
occurring reticulocytes. For consistency, we refer to them
as “true reticulocytes.”
STRECK v. RESEARCH & DIAGNOSTIC 4
named co-inventor on U.S. Patent No. 5,736,402 (“the ’402
Patent”), which claims stand-alone true reticulocyte
controls. In the mid-1990s, Dr. Wayne Ryan, the majority
owner and Chief Executive Officer of Streck, invented and
patented a method for making reticulocyte analogs and
using those analogs in a stand-alone control. See U.S.
Patent No. 5,432,089 (“the ’089 Patent”). The ’089 Patent
explains that reticulocyte analogs “exhibit a reticulocyte
continuum and distribution that is similar to that of
normal human reticulocytes.” ’089 Patent col.8 ll.36-39.
Hematology instrument manufacturers began devel-
oping a hematology analyzer that could measure both
reticulocytes and white blood cells simultaneously in the
same blood sample. Accordingly, there was a need for an
integrated hematology control containing at least: (1) a
stabilized reticulocyte component; and (2) a fixed and
stabilized white blood cell component. Over time, both
R&D and Streck began working on projects aimed at
developing an integrated hematology control.
On August 20, 1999, Streck filed a patent application
directed to an integrated reticulocyte control. That appli-
cation became the ’500 Patent, which issued on March 31,
2001. Ryan is the named inventor on the ’500 Patent.
The ’668 Patent, which issued on April 24, 2001, and the
’388 Patent, which issued on June 4, 2002, are continua-
tions of the ’500 Patent. Ryan and John Scholl, Streck’s
research and development manager, are named as co-
inventors on the ’668 and ’388 Patents. Both Ryan and
Scholl assigned their rights in the patents to Streck.
The parties agree that Claim 1 of the ’668 Patent is
representative for this appeal. It claims “[a] hematology
control composition comprising: a) a stabilized reticulo-
cyte component; and b) a fixed and stabilized white blood
cell component capable of exhibiting a five-part differen-
5 STRECK v. RESEARCH & DIAGNOSTIC
tial.” ’668 Patent col.16 ll.41-45. The specification ex-
plains that:
the control may suitably contain stabilized reticu-
locytes (that is, immature anucleate red blood
cells containing some ribonucleic acid) or an ana-
log thereof. For example, among possible em-
bodiments, the reticulocyte component may
comprise true mammalian reticulocytes prepared
for instance by mammalian (e.g. human) red blood
cell encapsulation or by isolation from whole
blood. The reticulocyte component is prepared in
any suitable manner. See, e.g., [the ’089 Patent].
Alternatively, it is possible to obtain suitable re-
ticulocytes by obtaining blood from an anemic
animal (e.g., a pig, goat, rabbit or the like).
’668 Patent col.3 ll.14-25. The district court construed the
patents-in-suit to encompass an integrated reticulocyte
control using either true reticulocytes or reticulocyte
analogs.
On October 18, 1999, roughly two months after Streck
filed its application, R&D filed its own patent application
relating to integrated reticulocyte controls. Dr. Johnson
is the named inventor of the control composition in R&D’s
application. In 2003, after some of Streck’s patents had
issued, R&D copied claims from Streck’s patents into its
still-pending application and asked the United States
Patent and Trademark Office (“the PTO”) to declare an
interference to determine priority of invention. Facts
relating to the parties’ priority dispute are set forth in
companion Appeal No. 2011-1045, which was previously
decided by this court. To the extent necessary, those facts
are incorporated by reference herein.
While R&D’s interference request was pending, R&D
began manufacturing and selling integrated hematology
STRECK v. RESEARCH & DIAGNOSTIC 6
controls, the first of which was referred to as CBC-XE.
R&D subsequently began producing controls under the
names CBC-4K Plus Retics and CBC-5D Plus Retics as
well. It is undisputed that Ryan used his reticulocyte
analog as the reticulocyte component of the integrated
control when he reduced his invention to practice. In
contrast, R&D’s integrated controls use true reticulocytes
as the reticulocyte component.
B. Procedural History
On June 29, 2006, Streck filed suit against R&D in
the District of Nebraska alleging willful infringement of
the patents-in-suit. R&D counterclaimed seeking a
declaration that the asserted claims of the patents-in-suit
are invalid and not infringed.
1. Identification of the Asserted Claims
On December 14, 2006, the parties agreed to be bound
by the Patent Local Rules of the United States District
Court for the Northern District of California. Summary
Judgment Order, 658 F. Supp. 2d at 993. Patent Local
Rule 3-1 requires that, “[n]ot later than 10 days after the
Initial Case Management Conference, a party claiming
patent infringement shall serve on all parties a ‘Disclo-
sure of Asserted Claims and Preliminary Infringement
Contentions’” which sets forth, among other things,
“[e]ach claim of each patent in suit that is allegedly
infringed by each opposing party.” N.D. Cal. Patent L.R.
3-1(a). 4 Likewise, Rule 3-3 provides that “[n]ot later than
45 days after service upon it of the ‘Disclosure of Asserted
Claims and Infringement Contentions,’ each party oppos-
4 The Patent Local Rules for the Northern District
of California were revised in 2008. The versions cited
herein were in effect from January 1, 2001 to February
29, 2008.
7 STRECK v. RESEARCH & DIAGNOSTIC
ing a claim of patent infringement, shall serve on all
parties its ‘Invalidity Contentions’” identifying each item
of prior art that allegedly anticipates a claim or renders it
obvious. Patent L.R. 3-3(a). The parties agreed that,
consistent with Rule 3-7, supplementation of invalidity
contentions “was allowed only by order of [the] court on a
showing of good cause.” Summary Judgment Order, 658
F. Supp. 2d at 994.
Pursuant to the Patent Local Rules, in a document
dated December 15, 2006, Streck provided its “Disclosure
of Asserted Claims and Preliminary Infringement Con-
tentions,” which identified the following “claims asserted
to be infringed”:
R&D directly infringes, induces others to infringe,
and/or contributes to third-party infringement of
at least claims 28 and 29 of the ’500 patent, claims
1, 4, 5, 6, 8-9, 13, 15, and 26-29 of the ’668 patent,
and claim 13 of the ’388 patent literally and/or
under the doctrine of equivalents through the
manufacture, use, sale, offer to sell (including
R&D’s related promotion and advertising), and/or
importation of R&D’s hematology controls desig-
nated “CBC-XE” and “CBC-4K Plus Retics.”
Streck, Inc. v. Research & Diagnostic Sys., Inc., No.
8:06cv458 (D. Neb. Apr. 16, 2007), ECF No. 32-4 at 2-3.
In response, on January 19, 2007, R&D submitted its
“Preliminary Invalidity Contentions” stating that the
“Johnson Inventions anticipate each claim asserted by
Streck, including at least claims 28 and 29 of the ’500
patent, claims 1, 4, 5, 6, 8-9, 13, 15, and 26-29 of the ’668
patent, and claim 13 of the ’388 patent.” Id. ECF No. 32-5
at 3. On December 16, 2008, Streck informed R&D that it
was asserting only the following ten claims: Claims 28-29
of the ’500 Patent; Claims 1, 4, 5, 6, 8, 9, and 13 of the
STRECK v. RESEARCH & DIAGNOSTIC 8
’668 Patent; and Claim 13 of the ’388 Patent. Summary
Judgment Order, 658 F. Supp. 2d at 994. Subsequently,
in March 2008, R&D amended its invalidity contentions
to assert that all claims of the patents-in-suit, except
Claim 20 of the ’388 Patent, were invalid for failure to
satisfy enablement and written description require-
ments. 5
2. Claim Construction and Final Invalidity Contentions
On June 5, 2008, the district court conducted a hear-
ing pursuant to Markman v. Westview Instruments, Inc.,
517 U.S. 370, 372 (1996). The court issued its claim
construction order on November 12, 2008. In that order,
the court noted that the “claims of the patents make it
clear that the reticulocyte component of the control com-
position can be either a reticulocyte or an analog of a
reticulocyte.” Claim Construction Order, 2008 U.S. Dist.
LEXIS 91865, at *23. The court construed “reticulocyte
analog” to mean “particles made from a source other than
naturally occurring reticulocytes, such particles appearing
to the instrument as reticulocytes that naturally occur in
the whole blood for which the instrument is intended.” Id.
at *33.
On January 2, 2009, R&D served its final set of inva-
lidity contentions alleging that: (1) Johnson’s inventions
anticipated each of Streck’s asserted claims; (2) each
claim of the patents-in-suit, except Claim 20 of the ’388
Patent, was invalid for failure to satisfy enablement and
written description requirements; and (3) Claim 3 of both
the ’500 and the ’668 Patents was invalid for indefinite-
5 In its summary judgment order, the district court
states that R&D amended its invalidity contentions in
March 2007, but R&D admits, and the record reflects,
that the amendment did not occur until March 2008.
Appellants’ Reply Br. 3; J.A. 43368.
9 STRECK v. RESEARCH & DIAGNOSTIC
ness. See Summary Judgment Order, 658 F. Supp. 2d at
994.
3. Summary Judgment Motions
On March 27, 2009, the parties filed cross-motions for
summary judgment. Streck’s motion requested judgment
that: (1) its asserted claims were valid and contained
sufficient written description; and (2) R&D had infringed
the asserted claims.
R&D’s motion asserted that: (1) Claim 3 of the ’500
and ’668 Patents was invalid as indefinite, inoperative, or
not enabled; (2) all claims of the patents-in-suit (except
Claim 20 of the ’388 Patent) were invalid for lack of
written description and lack of enablement; (3) the ’388
Patent was invalid for misjoinder 6 ; and (4) there was no
evidence to support a finding of willful infringement.
Specifically, with respect to invalidity, R&D argued that
the patents-in-suit described an integrated control with
reticulocyte analogs and did not adequately describe an
integrated control with true, naturally occurring reticulo-
cytes.
On September 9, 2009, the district court denied
R&D’s motion for summary judgment on its written
description defense and granted Streck’s cross-motion.
First, the court held that, as a matter of law, Streck’s
patents adequately described an integrated control with
true reticulocytes. Summary Judgment Order, 658 F.
Supp. 2d at 999. The court noted that R&D’s arguments
focused primarily on enablement, rather than written
description, and that R&D relied heavily on Claim 3 of
’500 Patent, which was not asserted in Streck’s initial
6 The misjoinder issue related to whether Dr. John
Scholl was properly listed as an inventor on one of
Streck’s patents.
STRECK v. RESEARCH & DIAGNOSTIC 10
disclosures. Id. The court further found that the level of
skill in the art was high, and that a person of such skill
would understand that the patents were meant to encom-
pass both natural and analog reticulocytes. The court
denied R&D’s motion for summary judgment on enable-
ment, finding that “there is a genuine issue of material
fact with respect to the enablement issue.” Id. at 999-
1000.
Next, the court dismissed R&D’s invalidity counter-
claims with respect to Claim 3 of the ’500 and ’668 Pat-
ents. The court found that Streck did not assert
infringement of those claims, and that R&D had “no
‘reasonable apprehension’ it will face an infringement suit
on any claims other than those that Streck asserts it has
infringed in this action.” Id. at 1000. Finally, the court
found that R&D had, as a matter of law, literally in-
fringed the claims at issue, and that there was evidence
from which a jury could find willfulness. 7 Id.
4. Motions in Limine
On September 4, 2009, both parties filed motions in
limine. R&D sought, among other things, to exclude
evidence relating to Streck’s conception prior to 1997, on
grounds that conception is irrelevant to the question of
the priority of invention. Streck sought to exclude any
evidence challenging the validity of the seventy-four
unasserted claims of the patents-in-suit. Streck explained
7 The district court also dismissed R&D’s misjoin-
der claim (relating to inventorship) on grounds that R&D
failed to raise that claim in its final invalidity contentions
and that even if it had, R&D failed to provide clear and
convincing evidence that the inventorship was incorrect.
Summary Judgment Order, 658 F. Supp. 2d at 1000.
Misjoinder is not an issue on appeal.
11 STRECK v. RESEARCH & DIAGNOSTIC
that it had informed R&D that it was only asserting
infringement with respect to nine out of the total eighty-
three claims of the patents-in-suit and that R&D should
be prohibited from presenting evidence or testimony
relating to the seventy-four unasserted claims. 8 On
October 15, 2009, the district court denied R&D’s motion,
without prejudice to reassertion at trial, on grounds that
it “involve[d] the weight rather than the admissibility of
the evidence.” Streck, Inc. v. Research & Diagnostic Sys.,
Inc., No. 8:06cv458, 2009 U.S. Dist. LEXIS 96196, at *9
(D. Neb. Oct. 15, 2009). The court also denied Streck’s
motion:
Although the court finds the subject of the motion
is more properly viewed as an objection to be
raised at trial, the court notes it will generally
sustain such an objection. . . . The validity of
claims other than those alleged to have been in-
fringed is not an issue in this case and evidence
with respect to those claims is generally not rele-
vant. That said, some evidence that touches on
the unasserted claims could be relevant for some
purpose. Accordingly the court finds that the mo-
tion in limine should be overruled at this time,
without prejudice to its reassertion via timely ob-
8 As noted above, in its December 2006 infringe-
ment contentions, Streck identified fifteen asserted
claims. In its December 2008 correspondence to R&D,
Streck reduced the number of asserted claims to a total of
ten (Claims 28-29 of the ’500 Patent; Claims 1, 4, 5, 6, 8,
9, and 13 of the ’668 Patent; and Claim 13 of the ’388
Patent). In May 2009, Streck removed Claim 4 of the ’668
Patent from the list of asserted claims, thus reducing the
number to a total of nine claims. Streck, Inc. v. Research
& Diagnostic Sys. Inc., No. 8:06cv458 (D. Neb. Sept. 4,
2009), ECF No. 236-5 at 2.
STRECK v. RESEARCH & DIAGNOSTIC 12
jection to the admissibility of such evidence at
trial.
Id. at *3-4. Prior to trial, however, the district court
excluded R&D’s evidence on the unasserted claims.
Specifically, the court orally ruled that, “[t]here is an
issue about the declaratory judgment and jurisdiction
over the unasserted claims of the patents. The validity of
the unasserted claims will not go to the jury. That’s the
way I intend to proceed.” J.A. 45134.
5. Jury Trial and JMOL Motions
Beginning on October 19, 2009, the court conducted
an eight-day jury trial to address priority of invention,
enablement, damages, and willfulness. At the close of the
evidence, both parties moved for JMOL on the issues of
enablement and priority. The court noted that it had
permitted the presentation of enablement evidence to the
jury so that the court could get a clear understanding of
the issue. Based on the evidence adduced at trial, and
before submitting the case to the jury, the court granted
JMOL for Streck on enablement, explaining that
“[e]verybody agrees that if you use encapsulated reticulo-
cytes that you could use Dr. Ryan’s invention to describe
that.” J.A. 46724. The court further explained that “a pig
reticulocyte is not a human reticulocyte, so it’s obviously
an analog of a human reticulocyte.” Id. Finally, the court
stated that, according to the evidence, it would make no
difference whether analog or true reticulocytes were used
in Ryan’s claimed invention. With respect to priority, the
court found that Ryan was the first to conceive, but that
there were substantial factual disputes as to whether
Johnson was the first to invent. Accordingly, the only
issues submitted to the jury were R&D’s priority counter-
claim, and Streck’s damages and willful infringement
claims.
13 STRECK v. RESEARCH & DIAGNOSTIC
On October 28, 2009, the jury found that: (1) R&D had
not proven, by clear and convincing evidence, that it was
the first to invent; and (2) R&D had not willfully infringed
Streck’s patents. The jury found that Streck was entitled
to a royalty for R&D’s infringing sales and awarded
damages of 12.5%, which amounted to $92,298.88 plus
costs and interest. The court entered judgment in favor of
Streck on October 29, 2009.
6. The Concurrent Interference Proceedings and
Streck’s § 146 Action
While the infringement litigation was progressing,
R&D’s interference request was pending with the PTO,
and, on March 21, 2007, the PTO declared an interference
(“the PTO Interference”) between five of Streck’s patents
(the patents-in-suit as well as U.S. Patent Nos. 6,403,377
and 6,406,915) and R&D’s pending patent application.
The sole count in the PTO Interference was Count 1,
which corresponded to Claim 1 of Streck’s ’668 Patent,
and is identical to the representative claim in this ap-
peal. 9 On August 14, 2007, the district court denied
R&D’s motion to stay the infringement suit pending
resolution of the PTO Interference, and the two cases
proceeded concurrently.
The PTO Board of Patent Appeals and Interferences
(“the Board”) heard the parties’ arguments regarding
priority of invention in February 2009. On November 2,
2009, just four days after the district court entered judg-
ment in this case, the Board issued its priority decision.
Unlike the jury in this case, which found priority for
9 The sole count in the PTO Interference recited a
“hematology control composition comprising: (a) a stabi-
lized reticulocyte component; and (b) a fixed and stabi-
lized white blood cell component capable of exhibiting a
five-part differential.”
STRECK v. RESEARCH & DIAGNOSTIC 14
Streck, the Board found that R&D had proven, by a
preponderance of the evidence, that Johnson was the first
to invent the claimed integrated control.
On November 13, 2009, Streck appealed the Board’s
interference decision to the district court under 35 U.S.C.
§ 146. The § 146 appeal was assigned to the same judge
who presided over the infringement case. Because there
was a complete evidentiary record on the issue of priority
– between the trial and the proceedings before the Board
– the parties agreed to submit the § 146 action to the
district court on the admitted record without further
discovery or offers of proof.
7. Renewed Motion for JMOL, Motion for a New
Trial, and Injunctive Relief
Following the jury verdict and the Board’s priority de-
cision, the parties filed three motions on November 12,
2009. First, R&D filed a renewed motion for JMOL and
motion for a new trial. In the motion, R&D argued that
the court should enter judgment as a matter of law on its
counterclaim for invalidity because there was “insufficient
evidence as a matter of law to sustain the jury’s verdict
that Defendants did not meet their burden of proving that
Dr. Johnson was the prior inventor by clear and convinc-
ing evidence.” J.A. 45059. Second, in light of the Board’s
decision in the PTO Interference proceedings, R&D moved
to vacate the judgment in this case, stay proceedings, and
hold a new trial. Finally, Streck filed a motion for per-
manent injunction against R&D to prevent future in-
fringement of the patents-in-suit. The parties agreed to
defer judgment on Streck’s motion for injunctive relief
and R&D’s motion for a new trial until the district court
ruled on the § 146 action, so both could be appealed
together to this court.
15 STRECK v. RESEARCH & DIAGNOSTIC
The district court issued three decisions on September
30, 2010. First, in the co-pending § 146 action, the court
reversed the Board’s decision and found priority for
Streck. As discussed below, the § 146 action was at issue
in a companion appeal – Appeal No. 2011-1045 – which
was previously decided by this court. See Streck, Inc. v.
Research & Diagnostic Sys., Inc., 659 F.3d 1186 (Fed. Cir.
2011). Second, in this case, the court denied R&D’s
renewed motion for JMOL and motion for a new trial.
The court found, in relevant part, that the evidence at
trial supported: (1) “the jury’s finding that R&D did not
prove by clear and convincing evidence that Dr. Johnson
was the first to invent an integrated reticulocyte control
composition”; and (2) “the court’s finding as a matter of
law that Streck’s patents were adequately enabled.”
Denial of Renewed JMOL Order, 2010 U.S. Dist. LEXIS
104461, at *32. Finally, the court granted Streck’s motion
for a permanent injunction and assessed additional dam-
ages of $36,690.18 for infringement occurring since the
jury trial. The court then enjoined R&D from making,
using or selling the products at issue in this case “as well
as any hematology control products that are only colora-
bly different therefrom in the context of the infringed
claims . . . and from otherwise infringing the asserted
claims of [the patents-in-suit] until the expiration of the
last to expire of the Patents-in-Suit.” J.A. 40047.
The district court denied R&D’s motion to stay the in-
junction pending appeal to this court. Specifically, the
court held that R&D: (1) did not demonstrate a likelihood
of success on the merits regarding enablement, priority,
or lack of written description; (2) did not show it would be
irreparably harmed absent a stay because hematology
controls are only a small part of their business; and (3)
did not show that an injunction would hurt the public
interest because there was no showing that Streck would
STRECK v. RESEARCH & DIAGNOSTIC 16
be unable to meet the industry’s demands for controls.
R&D was, however, granted a sixty-day grace period to
clear its inventory because hematology controls are per-
ishable products.
R&D timely appealed the September 30, 2010 district
court decisions to this court. This opinion relates solely to
the infringement action. We have jurisdiction pursuant to
28 U.S.C. § 1295(a)(1).
DISCUSSION
On appeal, R&D does not challenge the district court’s
decision that its accused products literally infringe the
patents-in-suit as a matter of law. Instead, R&D argues
that the district court erred when it: (1) dismissed R&D’s
invalidity counterclaims relating to the unasserted
claims; (2) granted summary judgment to Streck and
denied R&D’s cross-motion on written description;
(3) granted JMOL for Streck and denied R&D’s cross-
motion on enablement; (4) denied R&D’s motion for
renewed JMOL and motion for a new trial on priority; and
(5) issued an overbroad permanent injunction.
For the reasons set forth below, we find that: (1) the
district court did not err in limiting the action to the
claims Streck asserted, given R&D’s failure to establish a
case or controversy with respect to the other claims;
(2) the patents-in-suit satisfy the written description
requirement as a matter of law, because the specification
clearly discusses true reticulocytes as well as analogs;
(3) R&D’s evidence failed to create a jury question on the
issue of whether the patents-in-suit failed to enable one
skilled in the art to make the claimed integrated controls
using true reticulocytes; (4) the priority issue is controlled
by this court’s ruling in Appeal No. 2011-1045, and R&D’s
related evidentiary challenges are without merit; and
17 STRECK v. RESEARCH & DIAGNOSTIC
(5) properly construed, the language in the permanent
injunction is not overbroad. Accordingly, we affirm the
district court in full.
A. Jurisdiction Over the Unasserted Claims
R&D sought summary judgment of invalidity with re-
spect to all claims of the patents-in-suit. In its summary
judgment order, the district court noted that: (1) Streck
did not assert infringement with respect to Claim 3 of the
’500 and ’668 Patents; (2) R&D “has no ‘reasonable appre-
hension’ it will face an infringement suit on any claims
other than those that Streck asserts it has infringed in
this action”; and (3) there is “nothing in the record to
suggest any intent to sue on the nonasserted claims.”
Summary Judgment Order, 658 F. Supp. 2d at 1000.
Although the district court initially denied Streck’s mo-
tion in limine to exclude argument and evidence regard-
ing the unasserted claims, just before trial, the court
stated that: “[t]here is an issue about the declaratory
judgment and jurisdiction over the unasserted claims of
the patents. The validity of the unasserted claims will
not go to the jury.” J.A. 45134.
R&D argues that the district court erroneously dis-
missed its written description and enablement challenges
with respect to the unasserted claims. In support of this
argument, R&D submits that the court applied an out-
dated “reasonable apprehension of suit test” and that
Streck’s withdrawal of claims “more than two years into
this case” does not deprive the court of jurisdiction over
its invalidity counterclaims. 10 Appellant’s Br. 34. R&D
10 As noted below, R&D’s discussion of timing with
respect to the unasserted claims ignores the fact that
Streck served its preliminary infringement contentions,
which narrowed significantly the scope of the asserted
claims, only months after the action was filed.
STRECK v. RESEARCH & DIAGNOSTIC 18
also argues that its counterclaim was sufficient to put
Streck on notice that all claims were at issue.
In response, Streck argues that the district court cor-
rectly dismissed R&D’s challenges to its unasserted
claims. Specifically, Streck contends that R&D’s counter-
claim only sought a declaration of invalidity with respect
to the “asserted claims” and, therefore, the court had
jurisdiction only over claims asserted at the time the
relevant motions were filed. For the reasons that follow,
we conclude that the district court did not err in finding
that it lacked jurisdiction over the unasserted claims.
It is well-established that, in patent cases, the exis-
tence of a “case or controversy must be evaluated on a
claim-by-claim basis.” Jervis B. Webb Co. v. So. Sys., Inc.,
742 F.2d 1388, 1399 (Fed. Cir. 1984) (citations omitted).
A party claiming declaratory judgment jurisdiction has
the burden of showing “that the facts alleged, ‘under all
the circumstances, show that there is a substantial con-
troversy, between the parties having adverse legal inter-
ests, of sufficient immediacy and reality to warrant the
issuance of a declaratory judgment.’” Benitec Austl., Ltd.
v. Nucleonics, Inc., 495 F.3d 1340, 1343 (Fed. Cir. 2007)
(quoting MedImmune, Inc. v. Genentech, Inc., 549 U.S.
118, 127 (2007)). The party seeking a declaratory judg-
ment must establish that jurisdiction “existed at the time
the claim for declaratory relief was filed and that it has
continued since.” Id. at 1344. (citing Steffel v. Thompson,
415 U.S. 452, 459 n.10 (1974)). In other words, jurisdic-
tion must exist “at all stages of review, not merely at the
time the complaint [was] filed.” Id. at 1345 (quoting
Steffel, 415 U.S. at 459 n.10).
Prior to the Supreme Court’s decision in MedImmune,
this court applied a two-part test to determine whether
there was an actual controversy in a declaratory judg-
19 STRECK v. RESEARCH & DIAGNOSTIC
ment action. Under the prior test, a declaratory judgment
plaintiff had to show: (1) an explicit action by the patentee
that creates the “reasonable apprehension” of an in-
fringement suit; and (2) present activity by the declara-
tory judgment plaintiff that could constitute infringement
or steps taken with intent to infringe. Gen-Probe Inc. v.
Vysis, Inc., 359 F.3d 1376, 1380 (Fed. Cir. 2004). In
MedImmune, the Supreme Court rejected strict reliance
on the “reasonable apprehension of suit” prong of the test.
549 U.S. at 132 n.11; see also Sandisk Corp. v. STMicro-
electronics, Inc., 480 F.3d 1372, 1380 (Fed. Cir. 2007)
(“The Supreme Court’s opinion in MedImmune represents
a rejection of our reasonable apprehension of suit test.”)
The Court held that there is no bright-line rule for deter-
mining whether an action satisfies the case or controversy
requirement and, instead, what is required is:
that the dispute be definite and concrete, touching
the legal relations of parties having adverse legal
interests; and that it be real and substantial and
admit of specific relief through a decree of a con-
clusive character, as distinguished from an opin-
ion advising what the law would be upon a
hypothetical state of facts.
MedImmune, 549 U.S. at 127 (citations and quotations
omitted). After MedImmune, courts must look at “all the
circumstances” to determine whether a declaratory judg-
ment plaintiff has shown a case or controversy between
the parties. As this court has explained, moreover, al-
though the Supreme Court rejected the reasonable appre-
hension of suit test as the sole test for jurisdiction, “it did
not completely do away with the relevance of a reasonable
apprehension of suit.” Prasco, LLC v. Medicis Pharm.
Corp., 537 F.3d 1329, 1336 (Fed. Cir. 2008) (citing Caraco
Pharm. Labs., Ltd. v. Forest Labs, Ltd., 527 F.3d 1278,
1291 (Fed. Cir. 2008)). Instead, in the wake of MedIm-
STRECK v. RESEARCH & DIAGNOSTIC 20
mune, “proving a reasonable apprehension of suit is one of
multiple ways that a declaratory judgment plaintiff can
satisfy the more general all-the-circumstances test” to
establish jurisdiction. Id. (citing Caraco, 527 F.3d at
1291).
Post-MedImmune, at least one district court has found
that it lacked declaratory judgment jurisdiction over
patent claims that were initially asserted in a broad
complaint and subsequently not included in the narrower
scope of claims alleged to be infringed. See Hoffman-La
Roche Inc. v. Mylan Inc., No. 2:09cv1692, 2009 U.S. Dist.
LEXIS 114784, at *17-18 (D.N.J. Dec. 9, 2009). In Hoff-
man, the plaintiff alleged infringement of a patent that
encompassed six claims. Id. at *8. After filing the com-
plaint, the plaintiff served its infringement contentions
pursuant to the local patent rules and asserted infringe-
ment with respect to only one of the six claims. Id. at *9.
The district court found that, with respect to claims that
were no longer asserted, the counterclaimant seeking
declaratory judgment “must meet its burden under
MedImmune and show that a live case or controversy
exists and continues to exist on a claim-by-claim basis
and at every stage of the litigation.” Id. at *17. The court
concluded that the plaintiff’s decision to change its posi-
tion did not automatically divest the court of jurisdiction,
but the counterclaimant must show that jurisdiction
continues to exist with respect to the now unasserted
claims. Id. at *18. Because the counterclaimant failed to
make that showing, the court found that it lacked juris-
diction over those discrete claims. Id. at *20. Although
Hoffman is not binding on this court, we find its analysis
persuasive and agree that, consistent with MedImmune, a
counterclaimant must show a continuing case or contro-
versy with respect to withdrawn or otherwise unasserted
claims.
21 STRECK v. RESEARCH & DIAGNOSTIC
Citing Scanner Technologies Corp. v. ICOS Vision
Systems Corp., 528 F.3d 1365, 1382-83 (Fed. Cir. 2008),
R&D argues that “a patentee cannot dictate the scope of a
duly filed counterclaim simply by withdrawing some, but
not all, of the asserted patent claims from the lawsuit.”
Appellants’ Br. 34. As Streck argues, however, R&D’s
reliance on Scanner Technologies is misplaced, particu-
larly since the circumstances here are readily distin-
guishable.
In Scanner Technologies, the patent holder filed suit
alleging infringement, and the defendant counterclaimed
seeking a declaration that both of the patents-in-suit were
invalid, unenforceable, and not infringed. 528 F.3d at
1371. The parties stipulated that the case “would rise
and fall” on one claim of one of the patents, and, based on
that stipulation, the district court analyzed only that one
claim in its infringement analysis. Id. The district court
then found that the claims of both patents-in-suit were
invalid as obvious and entered summary judgment of
noninfringement. Id. at 1373. The patentee appealed,
arguing, among other things, that the district court lacked
jurisdiction to adjudicate and invalidate claims other than
the single claim at issue in the infringement analysis. Id.
at 1383. Although the parties had stipulated that the
case would be tried on a representative claim, we found
that the district court nonetheless had jurisdiction over
all of the claims because the defendant asserted a coun-
terclaim seeking declaratory judgment on all claims of the
patents-in-suit. Id. at 1383-84. Specifically, we found
that the “pleadings represented that ‘the case’ constituted
allegations of infringement of both patents, and a declara-
tory judgment action seeking invalidity, noninfringement,
and unenforceability of all the claims of the patent in
suit.” Id. at 1383-84. As such, the district court had
STRECK v. RESEARCH & DIAGNOSTIC 22
jurisdiction to invalidate the claims of both patents-in-
suit.
Unlike the situation in Scanner Technologies, where
the parties stipulated that the court need only analyze
one “representative” claim to decide infringement, and the
patentee never affirmatively disclaimed its allegations of
infringement as to the other claims, here, as in Hoffman,
the patentee narrowed the scope of its claims at the start
of litigation pursuant to the local patent rules and did so
even further before any dispositive rulings by the court.
Streck filed its Complaint in June 2006, alleging in-
fringement of “one or more claims” of each of the patents-
in-suit. In December 2006, Streck served its preliminary
infringement contentions, which narrowed the scope of
claims at issue to fifteen specific claims. 11 In response,
R&D’s counterclaim was limited to the “asserted claims,”
and its initial invalidity contentions, which were served
on January 19, 2007, addressed the same fifteen claims
identified in Streck’s infringement contentions. The
number of asserted claims was narrowed again, moreover,
by no later than May 2009, this time to only nine claims.
Therefore, unlike the situation in Scanner Technologies,
where all of the claims were at issue and were never
withdrawn or altered by either party, here, both parties
were on notice from the start of litigation that the scope of
claims at issue was only a subset of the full patents-in-
suit and, significantly, did not include Claim 3 of any
patent. And, the parties knew precisely which claims
were at issue well before the court ruled on the parties’
summary judgment motions or conducted trial.
11 R&D’s assertion that Streck did not narrow its as-
serted claims until 2008 is wrong. Although neither party
cites to the preliminary infringement and invalidity
contentions, a careful examination of the docket clarifies
that the timing described here is, in fact, the correct one.
23 STRECK v. RESEARCH & DIAGNOSTIC
R&D relies primarily on its assertion that, under
MedImmune, it need not prove reasonable apprehension
of an infringement suit to vest jurisdiction over its inva-
lidity counterclaims in the district court. Though R&D is
correct that the reasonable apprehension of suit test is no
longer the exclusive test for declaratory judgment juris-
diction, MedImmune does not stand for the proposition
that an Article III case or controversy exists automati-
cally whenever a competitor desires to mount a validity
challenge. Under MedImmune, a party seeking declara-
tory judgment still “has the burden of establishing the
existence of an actual case or controversy.” 549 U.S. at
140. Thus, although the district court relied on pre-
MedImmune case law in its summary judgment order,
and incorrectly relied on the absence of a “reasonable
apprehension” of suit to defeat jurisdiction, considering
the totality of the circumstances, we agree with the dis-
trict court’s determination that it lacked jurisdiction over
the unasserted claims. Importantly, there is no evidence
that R&D met its burden of showing a continuing case or
controversy with respect to the unasserted claims. In-
deed, R&D does not seriously argue here that it did so,
relying instead only on the district court’s misstatement
of current governing law. 12 Because, applying MedIm-
mune, we find that the district court did not have jurisdic-
tion over the unasserted claims, we affirm its decision not
to address them.
B. Written Description
The district court found that Streck’s patents-in-suit
satisfied the written description requirement as a matter
of law. Summary Judgment Order, 658 F. Supp. 2d at
12 The fact that R&D amended its invalidity conten-
tions in March 2008 and January 2009 does not alone
create a case or controversy.
STRECK v. RESEARCH & DIAGNOSTIC 24
999. In support of this conclusion, the court found that:
(1) Claim 4 of the ’500 patent discloses a composition
“wherein the reticulocyte component comprises reticulo-
cytes prepared by isolation from whole blood”; and (2) the
’668 and ’388 Patents “contain additional disclosure of the
use of reticulocytes isolated from the blood of anemic
animals.” Id.R&D argues that the district court erred because
“[t]he patents-in-suit failed to provide sufficient details for
[a] person of ordinary skill in the art to understand that
Ryan was in possession of a true reticulocyte integrated
control.” Appellants’ Br. 35. R&D asks this court to grant
its motion for summary judgment that Streck’s patents
are invalid for lack of written description or, in the alter-
native, remand the written description issue for a jury
trial.
Streck responds by pointing to specific disclosures in
the patents-in-suit as evidence that the asserted claims
are adequately described. In light of these disclosures,
which are discussed below, Streck argues that the district
court correctly found that the claims and specifications of
the patents-in-suit are sufficient to satisfy the written
description requirement as a matter of law. We agree.
Written description is a statutory requirement set
forth in 35 U.S.C. § 112. Section 112 provides, in relevant
part, that:
The specification shall contain a written descrip-
tion of the invention, and of the manner and proc-
ess 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 . . .
25 STRECK v. RESEARCH & DIAGNOSTIC
35 U.S.C. § 112, para. 1 (emphasis added). The written
description “must clearly allow persons of ordinary skill in
the art to recognize that [the inventor] invented what is
claimed.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d
1336, 1351 (Fed. Cir. 2010) (en banc) (citation and quota-
tions omitted). The test is whether the disclosure “con-
veys to those skilled in the art that the inventor had
possession of the claimed subject matter as of the filing
date.” Id. This test requires an “objective inquiry into the
four corners of the specification from the perspective of a
person of ordinary skill in the art.” Id. Given this per-
spective, in some instances, a patentee can rely on infor-
mation that is “well-known in the art” to satisfy written
description. Boston Sci. Corp. v. Johnson & Johnson, 647
F.3d 1353, 1366 (Fed. Cir. 2011). Where, however, the
“four corners of the specification directly contradict infor-
mation that the patentee alleges is ‘well-known’ to a
person of skill at the effective filing date, no reasonable
jury could conclude that the patentee possessed the
invention.” Id.It is well-established that the “hallmark of written de-
scription is disclosure.” Ariad, 598 F.3d at 1351. The
level of detail required to satisfy the written description
requirement depends, in large part, on the nature of the
claims and the complexity of the technology. Id. As we
explained in Ariad, the written description requirement
“does not demand either examples or an actual reduction
to practice; a constructive reduction to practice that in a
definite way identifies the claimed invention can satisfy
the written description requirement.” Id. at 1352 (citing
Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1366-67
(Fed. Cir. 2006)). That said, a “mere wish or plan” to
obtain the claimed invention is not sufficient. Centocor
Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1348
(Fed. Cir. 2011) (citing Regents of the Univ. of Cal. v. Eli
STRECK v. RESEARCH & DIAGNOSTIC 26
Lilly & Co., 119 F.3d 1559, 1566 (Fed. Cir. 1997)). “Com-
pliance with the written description requirement is a
question of fact but is amenable to summary judgment in
cases where no reasonable fact finder could return a
verdict for the nonmoving party.” PowerOasis, Inc. v. T-
Mobile, Inc., 522 F.3d 1299, 1307 (Fed. Cir. 2008).
The pivotal issue here is whether the patents-in-suit
provide adequate written description for integrated
controls using either true reticulocytes or reticulocyte
analogs. According to R&D, the patents-in-suit fail to
demonstrate that Ryan possessed and invented an inte-
grated control using true reticulocytes. In support of this
argument, R&D asserts that: (1) “Ryan was unable to
locate any description of the use of true reticulocytes in
his own patents” when asked to do so during his deposi-
tion; (2) Ryan did not consider true reticulocytes to be
part of his invention; and (3) “Streck had never attempted
to make a true reticulocyte integrated control.” Appel-
lants’ Br. 36.
R&D mischaracterizes Ryan’s testimony, however.
Although Ryan initially testified that he did not know if
he could point to anything specific in the ’500 Patent
describing the use of true reticulocytes rather than ana-
logs in an integrated control, he subsequently reviewed
the patent and pointed to language providing that “the
reticulocyte component may comprise true mammalian
reticulocytes prepared for instance by mammalian red
blood cell encapsulation or by isolation from whole blood.”
J.A. 43601:2-13. Based on this language, Ryan clarified
that the Patent specifically “covers both kinds” of reticulo-
cytes. Id. And, the mere fact that Ryan chose to reduce
his invention to practice using a reticulocyte analog
rather than a true reticulocyte is not relevant to the
written description inquiry. Although R&D contends that
Streck “did not posses true reticulocyte integrated con-
27 STRECK v. RESEARCH & DIAGNOSTIC
trols,” Streck is not required to prove an actual reduction
to practice as to all disclosures. See Ariad, 598 F.3d at
1352. Instead, to satisfy written description, Streck need
only show that the specification itself demonstrates “a
constructive reduction to practice that in a definite way
identifies the claimed invention.” See Id. at 1352. The
relevant inquiry, therefore, is whether a person of ordi-
nary skill in the art would reasonably find that the patent
sufficiently described the invention using true reticulo-
cytes. R&D’s expert, Dr. Simson, testified that, in this
case, a person of ordinary skill in the art is “someone with
an advanced degree like an M.D. or a Ph.D. and with
experience in the field.” J.A. 46608:10-12.
Looking to the specifications, the patents-in-suit refer
to several types of true reticulocytes:
[T]he control may suitably contain stabilized re-
ticulocytes (that is, immature anucleate red blood
cells containing some ribonucleic acid) or an ana-
log thereof. For example, among possible em-
bodiments, the reticulocyte component may
comprise true mammalian reticulocytes prepared
for instance by mammalian (e.g. human) red blood
cell encapsulation or by isolation from whole
blood. The reticulocyte component is prepared in
any suitable manner. See, e.g. U.S. Pat. No.
5,432,089, incorporated by reference. Alterna-
tively, it is possible to obtain suitable reticulocytes
by obtaining blood from an anemic animal (e.g., a
pig, goat, rabbit or the like).
’668 Patent col.3 ll.17-25 (emphases added). Likewise, the
’500 Patent provides that: “Among possible embodiments,
the reticulocyte component may comprise true mammal-
ian reticulocytes prepared for instance by mammalian
(e.g. human) red blood cell encapsulation or by isolation
STRECK v. RESEARCH & DIAGNOSTIC 28
from whole blood.” ’500 Patent col.2 ll.37-42. These
disclosures demonstrate that Ryan invented the claimed
integrated control using both true reticulocytes and
reticulocyte analogs. Further, as Streck points out in its
brief, this is not a case where a patentee attempts to
claim a broad genus without defining specific species.
Instead, as noted, Streck listed several specific true
reticulocytes in its specifications.
According to R&D, Ryan testified that true reticulo-
cytes were not part of his invention. Contrary to R&D’s
suggestion, however, Ryan never said that the claimed
integrated controls could not be made using true reticulo-
cytes. To the extent Ryan testified about the difficulty of
using true reticulocytes in controls, the district court
found that his testimony “relate[d] to the commercial
practicalities of use of true reticulocytes on a large scale
and not to the feasibility or viability of true reticulocytes
in a control.” Summary Judgment Order, 658 F. Supp. 2d
at 999. We agree with the district court that Ryan’s
testimony, when taken in context, merely reflected his
personal preference for using analogs in integrated con-
trols.
The district court properly concluded that one skilled
in the art would have recognized that the claimed inte-
grated controls could be made using either true reticulo-
cytes or reticulocyte analogs. This is particularly true
given the evidence that analogs are designed to mimic
true reticulocytes and that use of true reticulocytes in
stand-alone controls was well-known in the prior art.
Given the language in the patents-in-suit, coupled with
the well-known use of true reticulocytes in the prior art, a
person of ordinary skill would understand the patent to
include integrated controls using true reticulocytes.
Accordingly, we affirm the district court’s decision grant-
29 STRECK v. RESEARCH & DIAGNOSTIC
ing Streck’s motion for summary judgment on written
description.
C. Enablement
At the close of the evidence, but before the case went
to the jury, the district court granted JMOL that the
patents-in-suit enabled the claimed integrated hematol-
ogy control using both true reticulocytes and reticulocyte
analogs. When reviewing a district court’s grant or denial
of a motion for JMOL, this court applies the procedural
law of the relevant regional circuit, here the Eighth
Circuit. Trading Techs. Int’l, Inc. v. eSpeed, Inc., 595 F.3d
1340, 1357 (Fed. Cir. 2010). The Eighth Circuit reviews a
district court’s grant or denial of JMOL de novo, applying
the same standard as the district court. Synergetics, Inc.
v. Hurst, 477 F.3d 949, 956 (8th Cir. 2007) (citation omit-
ted). To grant judgment as a matter of law, the court
must find that there is “no legally sufficient basis to
support a jury verdict in the non-moving party’s favor.”
Id. (citing Fed. R. Civ. P. 50(a)(1)). All factual inferences
are drawn in favor of the non-moving party. Id.Although R&D concedes that the patents-in-suit en-
able the use of reticulocyte analogs in an integrated
control, it argues that they do not enable true reticulocyte
integrated controls. First, R&D argues that the district
court erred by failing to assess whether the patents-in-
suit enable the novel aspect of the claimed invention:
making and using true reticulocytes in an integrated
control. According to R&D, the court improperly relied on
prior art and knowledge of those skilled in the art to “fill
in the missing disclosure as to the novel aspect of inte-
grating true reticulocytes into whole blood controls.”
Appellants’ Br. 43. In support of this argument, R&D
points to the testimony of one of Streck’s experts, James
Janik, who testified that the patents-in-suit mention use
STRECK v. RESEARCH & DIAGNOSTIC 30
of true reticulocytes in an integrated control but do not
“discuss it in any other detail.” J.A. 45879:18-22. Second,
R&D submits that the court erred in granting JMOL in
favor of Streck because the patents-in-suit do not enable a
true reticulocyte integrated control without “undue ex-
perimentation.” R&D asks this court to grant its motion
for JMOL, or, in the alternative, remand the enablement
issue for a jury trial.
In response, Streck claims that: (1) the “novel aspect”
of the patents-in-suit is “an integrated reticulocyte con-
trol, i.e., a single control containing both a reticulocyte
component and a white blood cell component capable of
exhibiting a five-part differential”; (2) the patents-in-suit
enable the use of true reticulocytes in such integrated
controls because true reticulocytes are “virtually indistin-
guishable” from analogs; (3) R&D failed in its burden to
prove invalidity by clear and convincing evidence; and
(4) R&D’s expert testimony was conclusory and legally
insufficient to preclude JMOL. Appellee’s Br. 35, 37. For
the reasons articulated below, we find Streck’s arguments
well-taken.
Enablement “is a legal determination of whether a
patent enables one skilled in the art to make and use the
claimed invention.” Hybritech Inc. v. Monoclonal Antibod-
ies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986) (citation
omitted). To be enabling, a patent’s specification must
“teach those skilled in the art how to make and use the
full scope of the claimed invention without ‘undue ex-
perimentation.’” Alza Corp. v. Andrx Pharm., LLC, 603
F.3d 935, 940 (Fed. Cir. 2010) (citations omitted). It is
well-established, however, that a specification need not
disclose what is well-known in the art. See Hybritech, 802
F.2d at 1384 (“[A] patent need not teach, and preferably
omits, what is well known in the art.”). It is true, how-
ever, that, “the rule that a specification need not disclose
31 STRECK v. RESEARCH & DIAGNOSTIC
what is well known in the art is merely a rule of supple-
mentation, not a substitute for a basic enabling disclo-
sure.” Alza, 603 F.3d at 940-41 (quoting Auto. Techs.
Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 1282
(Fed. Cir. 2007)).
The enablement requirement is met where one skilled
in the art, having read the specification, could practice the
invention without “undue experimentation.” In re Wands,
858 F.2d 731, 736-37 (Fed. Cir. 1988) (“Enablement is not
precluded by the necessity for some experimentation such
as routine screening.”). Whether undue experimentation
is required “is not a single, simple factual determination,
but rather is a conclusion reached by weighing many
factual considerations.” Alza, 603 F.3d at 940 (citing
Wands, 858 F.2d at 737). In Wands, this court set forth
the following factors to consider when determining
whether a disclosure requires undue experimentation:
(1) the quantity of experimentation necessary,
(2) the amount of direction or guidance presented,
(3) the presence or absence of working examples,
(4) the nature of the invention, (5) the state of the
prior art, (6) the relative skill of those in the art,
(7) the predictability or unpredictability of the art,
and (8) the breadth of the claims.
858 F.2d at 737. “[I]t is not necessary that a court review
all the Wands factors to find a disclosure enabling. They
are illustrative, not mandatory.” Amgen, Inc. v. Chugai
Pharm. Co., 927 F.2d 1200, 1213 (Fed. Cir. 1991).
“Enablement is a matter of law that we review with-
out deference; however, this Court reviews the factual
underpinnings of enablement for substantial evidence.”
Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d
1363, 1378 (Fed. Cir. 2009) (quotations and citation
omitted). Because patents are presumed valid, lack of
STRECK v. RESEARCH & DIAGNOSTIC 32
enablement must be shown by clear and convincing
evidence. Alza, 603 F.3d at 940 (citing Auto. Techs., 501
F.3d at 1281).
R&D relies on Automotive Technologies for the propo-
sition that, “when the patentee broadly claims two dis-
tinct species, it must enable both.” Appellants’ Br. 43.
Automotive Technologies involved a side-impact crash
sensor for an automobile airbag, and the district court
construed the claims to include both mechanical and
electronic side-impact sensors. One of the defendants
moved for summary judgment that the claims covering an
electronic sensor were invalid for lack of enablement.
Auto. Techs., 501 F.3d at 1279-80. The district court
granted the motion on grounds that the specification
failed to provide adequate detail to teach a person of skill
in the art to make an electronic sensor without undue
experimentation. Id. at 1280.
On appeal, this court found that the electronic sensors
were novel for side-impact crash sensing and agreed with
the district court that the patentee had not disclosed
sufficient detail to make a side-impact electronic sensor.
Id. at 1283-84. In reaching this conclusion, we reviewed
the specification and noted that, although it detailed
mechanical side-impact sensors, there was only one short
paragraph and one figure showing an electronic sensor.
Id. at 1282. We explained that “[e]lectronic side impact
sensors are not just another known species of a genus
consisting of sensors, but are a distinctly different sensor
compared with the well-enabled mechanical side impact
sensor that is fully discussed in the specification.” Id. at
1285. We disagreed with the patentee’s argument that
the knowledge of one skilled in the art could supply the
missing information regarding how the electronic sensor
operates, and reiterated that the specification, not the
knowledge of those skilled in the art, “must supply the
33 STRECK v. RESEARCH & DIAGNOSTIC
novel aspects of an invention” to satisfy the enablement
requirement. Id. at 1283 (citing Genentech, Inc. v. Novo
Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997)).
Although R&D argues that “Streck presented no evi-
dence that the preparation and stabilization methods
used for true reticulocyte stand-alone controls would work
with integrated reticulocyte controls,” the burden was on
R&D to show invalidity by clear and convincing evidence.
See Appellants’ Br. 47. The question here is whether
there was a legitimate issue of fact regarding enablement
– i.e., regarding whether the specification contains suffi-
cient information to enable a person skilled in the art to
make integrated hematology controls using either true
reticulocytes or reticulocyte analogs. After full review of
the record, we agree with the district court that, consider-
ing its burden at trial, R&D failed to submit sufficient
evidence from which a jury could reasonably conclude that
one skilled in the art could not have followed Streck’s
specification to substitute true reticulocytes for Ryan’s
reticulocyte analog in the claimed control.
Unlike the situation in Automotive Technologies,
where the electronic sensors differed in structure and
operation from mechanical sensors, here, there was
unrebutted evidence that true reticulocytes and Ryan’s
reticulocyte analogs “work in exactly the same way in a
hematology control, and are virtually indistinguishable,
even to one skilled in the art.” Appellee’s Br. 39. Indeed,
the patents-in-suit incorporate by reference Ryan’s prior
patent for a stand-alone control using reticulocyte ana-
logs: U.S. Patent No. 5,432,089 (“the ’089 Patent”). See
’668 Patent col.3 ll.16-23. The ’089 Patent describes how
reticulocyte analogs are made and explains that the
“synthetic reticulocytes which are used in the reference
control of the invention exhibit a reticulocyte continuum
and distribution that is similar to that of normal human
STRECK v. RESEARCH & DIAGNOSTIC 34
reticulocytes.” ’089 Patent col.8 ll.35-43. As such, the
specification, and the ’089 Patent incorporated by refer-
ence therein, support Streck’s position that true reticulo-
cytes and reticulocyte analogs work in the same way in a
hematology control.
At trial, moreover, Ryan testified that “I would dare
say hardly anyone I know could tell the difference be-
tween [analog] and standard reticulocytes.” J.A. 45587:6-
7. Similarly, another Streck expert, Mr. Scholl, testified
that “under a microscope [analogs] are very similar to
human reticulocytes.” J.A. 45518:21-24. In other words,
the enabling disclosure in Streck’s patents for use of
reticulocyte analogs is equally enabling with respect to
true reticulocytes, and, importantly, R&D failed to offer
evidence to the contrary.
R&D also failed to produce adequate evidence that the
experimentation required to create a true reticulocyte
integrated control would be unduly laborious for one of
ordinary skill in the art. R&D relies primarily on its own
expert, Dr. Simson, who testified that “the patents do not
enable a person of ordinary skill in the art to make . . . an
integrated control preparation containing naturally
occurring reticulocytes.” J.A. 46613:9-12. Simson further
testified that “there is no real description in the patent
itself enabling one to do it” and there were no examples
“of how to make this material using natural occurring
reticulocytes” in the patents. J.A. 46610:25-46611:5. As
Streck argues, however, conclusory expert assertions do
not give rise to a genuine issue of material fact. Although
Simson testified that “a large amount of experimentation”
would be necessary, on cross-examination he admitted,
after he was presented with his own conflicting deposition
testimony, that he has never been involved in developing
controls. See J.A. 46611:19-24; 46621:13-46622:20.
35 STRECK v. RESEARCH & DIAGNOSTIC
Although R&D argues that Ryan and Scholl admitted
that the quantity of experimentation to make and use a
true reticulocyte integrated control would be high, R&D
mischaracterizes this testimony. Indeed, when taken in
context, most of the testimony R&D cites was referring to
the difficulty that would have been experienced in at-
tempting to combine a reticulocyte into an integrated
control prior to Ryan’s disclosure. For example, when
asked about developing a control, Ryan responded that:
“sometimes it’s pretty hard . . . I think that usually when
we have to make a control, three or four of us will work on
it and it may take us anyway [sic] from one to two years.
So it doesn’t happen instantaneously.” J.A. 45596:5-9.
Ryan clarified that statement, however, when he noted
that development and testing for a true reticulocyte
integrated control would be “a lot less for the obvious
reason that I have already gone through the process once.
Going through with a different analog, with an animal
analog, shouldn’t be that much harder.” J.A. 45714:14-17.
Ryan further testified that a person skilled in the art
knew that true reticulocytes could be used in controls and
that he had, in fact, previously developed stand-alone
controls using animal cells.
During cross-examination, when asked whether any-
one at Streck ever tried to make an integrated control
using a true reticulocyte, Scholl testified that, although he
was not aware of any instances, “we knew that we could if
we wanted to.” J.A. 45539:12. Scholl then testified that
“some testing” would be required to use a true reticulocyte
in an integrated control but that “the same technology
would be involved with either one of the two types of
reticulocytes.” See J.A. 45539:16-45540:17. Likewise,
when asked whether it would be difficult to use a true
human reticulocyte cell in the integrated control, Janik
testified that, “[e]ven if [Ryan’s patent] gave you the exact
STRECK v. RESEARCH & DIAGNOSTIC 36
formula you would have to test it” but “it doesn’t seem
like it’s a huge amount of effort.” J.A. 45844:6-14. And,
when asked whether a person skilled in the art would
have to conduct “extraordinary experimentation” rather
than “just routine testing,” Janik testified that:
the reticulocyte analog that was made even looked
like a real reticulocyte under the microscope . . .
You can’t predict everything, but, you know, if the
question was would you predict that using animal
retics would work pretty much as well? The an-
swer would be yes, because they both look the
same and probably act the same to some degree,
but would still have to be tested with the different
instruments and understand that.
J.A. 45844:21-45845:7. Finally, Streck’s expert, Dr.
Langley, testified as follows:
Q. With regard to the state of the art, as you un-
derstood it as one of ordinary skill in the art in
1999, there were a number of complications
that you would need to overcome in order to
take a reticulocyte-only control and use it in
an integrated control; isn’t that correct?
A. I remember giving that opinion when I was
asked to analyze the other patent. Yes.
* * *
Q. Dr. Langley, is it correct that I asked you: In
fact, on the next page of paragraph 39, you lay
out a number of complications that would need
to be overcome in order to take a reticulocyte-
only control and use it in an integrated con-
trol, isn't that right? And you said yes, correct?
A. That’s what it says.
37 STRECK v. RESEARCH & DIAGNOSTIC
Q. And then I asked you: To overcome those, you
would have to do a substantial amount of test-
ing, correct?
A. That’s --
Q. You said, "I think so, yeah."
A. That’s what it says.
Q. That’s what I thought.
J.A. 46013:9-46014:17. According to R&D, this testimony
is evidence of Langley admitting that “there would be a
number of complications to overcome in order to use a
true reticulocyte stand-alone control in an integrated
reticulocyte control.” Appellants’ Br. 54. Streck accu-
rately responds, however, that Langley was “discussing
the difficulties in combining any reticulocyte component
(true or analog) into an integrated control before Ryan
disclosed his invention.” Appellee’s Br. 45. Langley did
not say that making an integrated control using true
reticulocytes would be more difficult than making it with
analogs. Nor did he testify that, after reading the pat-
ents-in-suit, a person of ordinary skill would have to
conduct the same level of experimentation Ryan already
completed to make the claimed invention using reticulo-
cyte analogs.
The foregoing testimony, when taken in context, es-
tablishes that no undue experimentation would be neces-
sary once the teachings in the patents-in-suit were
known. In light of this testimony, the district court
correctly concluded that there was no evidence showing
that it would make any difference whether true reticulo-
cytes or reticulocyte analogs were used in the claimed
integrated control. Importantly, there was no testimony
from which a jury could find that using true reticulocytes
STRECK v. RESEARCH & DIAGNOSTIC 38
would require “undue experimentation.” 13 Because R&D
failed to offer any evidence showing that one skilled in the
art could not follow the patent’s teachings to use a true
reticulocyte in the claimed integrated control, a reason-
able jury could not have found the patents invalid for lack
of enablement by clear and convincing evidence. 14 As
such, the district court did not err in granting Streck’s
JMOL with respect to enablement.
D. Priority and Evidentiary Rulings
The jury found in favor of Streck on the issue of prior-
ity. R&D filed a renewed motion for JMOL, which the
court denied on grounds that the evidence adduced at
trial “supports the jury’s finding that R&D did not prove
by clear and convincing evidence that Dr. Johnson was
the first to invent an integrated reticulocyte control
13 In its order denying R&D’s renewed motion for
JMOL and motion for a new trial, the district court spe-
cifically found that “Streck presented undisputed evidence
that its invention was properly enabled” and that R&D
failed to show that a person skilled in the art would have
to undergo “undue experimentation” “to create a control
composition with other reticulocyte analogs than those
described in the patent.” Denial of Renewed JMOL Order,
2010 U.S. Dist. LEXIS 104461, at *36.
14 While we believe the evidence clearly supports a
finding of enablement, the standard of review imposed
upon us by the district court’s decision to take this fact-
laden inquiry away from the jury is an exacting one.
Despite careful application of that standard of review, we
ultimately conclude that the district court’s JMOL ruling
should be affirmed. See Fed. R. Civ. P. 50(b) advisory
committee’s note on the 1991 amendments (“[T]he court
may often wisely decline to rule on a motion for judgment
as a matter of law made at the close of evidence, and it is
not inappropriate for the moving party to suggest such a
postponement of the ruling until after the verdict has
been rendered.”).
39 STRECK v. RESEARCH & DIAGNOSTIC
composition.” Denial of Renewed JMOL Order, 2010 U.S.
Dist. LEXIS 104461, at *32.
In Appeal No. 2011-1045, we affirmed the district
court’s award of priority to Streck in the § 146 action.
Streck, 659 F.3d at 1196. It is undisputed that resolution
of priority in that appeal controls the priority issues here,
where R&D’s burden was higher and this court’s defer-
ence to the jury verdict is substantial. Specifically, in the
§ 146 action, R&D had to establish priority by a prepon-
derance of the evidence whereas in this appeal, R&D had
to show its priority defense by clear and convincing evi-
dence. As such, our decision in Appeal 2011-1045 that
R&D failed to establish priority by a preponderance of the
evidence necessarily means that R&D could not meet the
clear and convincing burden required in this case. And,
because the priority defense here was decided by a jury,
on appeal R&D has to show that the jury’s findings were
not supported by substantial evidence. In addition, as
Streck argues, because the § 146 appeal involved the
same parties, the same evidence, and the same priority
issue presented in this appeal, R&D is barred by the
doctrine of collateral estoppel from challenging this
court’s priority determination in Appeal No. 2011-1045.
In the alternative, R&D argues that this court should
overturn the jury verdict and remand for a new trial on
priority because the district court “abused its discretion
and materially prejudiced R&D’s priority case by commit-
ting several errors relating to the presentation of evi-
dence.” Appellants’ Br. 63-64. In particular, R&D argues
that the court erred when it: (1) denied R&D’s motion in
limine regarding conception and diligence; (2) failed to
control the order of proof by allowing Streck “to preemp-
tively rebut R&D’s case-in-chief on invalidity”; and
(3) submitted a misleading question to the jury on the
verdict form. Each of these arguments relates to priority,
STRECK v. RESEARCH & DIAGNOSTIC 40
which, as previously discussed, is controlled by this
court’s prior decision in the companion appeal. Resolution
of that appeal renders R&D’s arguments regarding prior-
ity moot.
To the extent R&D’s evidentiary challenges can be
construed to relate to anything other than priority, we
have considered them and find that they are without
merit, particularly given the level of deference afforded to
district courts with respect to motions in limine, and the
order of proof and presentation of evidence.
E. Injunction
After the jury trial, Streck moved for a permanent in-
junction. The district court applied the four-factor test for
injunctive relief set forth in eBay, Inc. v. MercExchange,
LLC, 547 U.S. 388, 391 (2006), and concluded that all four
factors favored entry of an injunction. Specifically, the
court ordered that R&D is prohibited from:
making, using, offering to sell, selling, or import-
ing into the United States, or supplying from the
United States, or causing to be made, used, of-
fered for sale, sold, imported into the United
States, or supplied from the United States the in-
fringing hematology control products presently
designated CBC-XE, CBC-4K Plus Retics, and
CBC-5D Plus Retics, as well as any hematology
control products that are only colorably different
therefrom in the context of the infringed claims,
whether individually or in combination with other
products or as a part of another product, and from
otherwise infringing the asserted claims of [the
patents-in-suit] until the expiration of the last to
expire of the Patents-in-Suit.
41 STRECK v. RESEARCH & DIAGNOSTIC
J.A. 40047 (internal statutory citations omitted). We
review the district court’s decision entering an injunction,
as well as the scope of the injunction, for abuse of discre-
tion. i4i Ltd. P’ship v. Microsoft Corp., 598 F.3d 831, 861
(Fed. Cir. 2010) (citation omitted).
R&D argues that the district court erroneously en-
tered the injunction and that the injunction itself is
overbroad because it prohibits R&D “from otherwise
infringing the asserted claims of [the Patents-in-Suit]
until the expiration of the last to expire of the Patents-in-
Suit.” Appellants’ Br. 69. Specifically, R&D asks this
court to vacate the injunction or replace it with one lim-
ited to “the adjudicated CBC-XE, CBC-4K Plus Retics,
and CBC-5D Plus Retics products, and products not more
than colorably different therefrom.” Id. at 70. Streck
responds that “the injunction already prohibits exactly
what R&D proposes by expressly listing the three adjudi-
cated products and extending only to products that are
‘only colorably different therefrom.’” Appellee’s Br. 64.
We agree with Streck.
R&D does not challenge any of the court’s underlying
eBay findings. As such, R&D’s sole argument on appeal
relates to overbreadth. After careful consideration, we
find that R&D’s argument is without merit, particularly
given the language in the injunction referring to the
specific products at issue in this case. Mere inclusion of
the phrase “from otherwise infringing the asserted
claims,” when taken in the context of the entire order and
record on which it was entered, does not render the in-
junction overbroad. See Signtech USA, Ltd. v. Vutek, Inc.,
174 F.3d 1352, 1359 (Fed. Cir. 1999) (holding that, in
light of the “detailed record” on which it was entered, an
injunction prohibiting “any further infringement . . . of
the patent” complied with the specificity requirements set
STRECK v. RESEARCH & DIAGNOSTIC 42
forth in Fed. R. Civ. P. 65(d)). Simply put, we read the
injunction to contain the very limitations R&D now seeks.
CONCLUSION
For the foregoing reasons, and because we find that
R&D’s remaining arguments are without merit, we affirm
the district court’s judgment against R&D and its decision
entering a permanent injunction in favor of Streck.
AFFIRMED