NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
FOREST LABORATORIES, INC., FOREST
LABORATORIES HOLDINGS, LTD., ADAMAS
PHARMACEUTICALS, INC.,
Plaintiffs-Appellants
MERZ PHARMA GMBH & CO. KGAA, MERZ
PHARMACEUTICALS GMBH,
Plaintiffs
v.
TEVA PHARMACEUTICALS USA, INC.,
Defendant-Appellee
______________________
2016-2550, 2016-2553
______________________
Appeals from the United States District Court for the
District of Delaware in Nos. 1:14-cv-00121-LPS, 1:14-cv-
00686-LPS, Chief Judge Leonard P. Stark.
______________________
Decided: December 11, 2017
______________________
GEORGE FRANK PAPPAS, Covington & Burling LLP,
Washington, DC, argued for plaintiffs-appellants. Also
represented by JEFFREY B. ELIKAN, JEREMY D. COBB,
BRADLEY KEITH ERVIN, ERIC RITLAND SONNENSCHEIN;
2 FOREST LABS., INC. v. TEVA PHARMS. USA, INC.
DAVID SCOTT DENUYL, San Francisco, CA; PETER J.
ARMENIO, Quinn Emanuel Urquhart & Sullivan, LLP,
New York, NY.
MARK DAVID SCHUMAN, Carlson, Caspers, Vanden-
burgh, Lindquist & Schuman, P.A., Minneapolis, MN,
argued for defendant-appellee. Also represented by M.
JEFFER ALI, JENNELL CHRISTINE BILEK.
______________________
Before LOURIE, REYNA, and TARANTO, Circuit Judges.
Opinion for the court filed by Circuit Judge TARANTO.
Concurring opinion filed by Circuit Judge LOURIE.
TARANTO, Circuit Judge.
Forest Laboratories, Inc.; Forest Laboratories Hold-
ings, Ltd.; and Adamas Pharmaceuticals, Inc. (collective-
ly, Forest) filed patent infringement actions against Teva
Pharmaceuticals USA, Inc., in the U.S. District Court for
the District of Delaware. During claim construction, the
district court determined that all of the asserted patent
claims are invalid for indefiniteness and on that basis
entered judgment against Forest. We affirm. 1
I
A
Adamas is the owner, and Forest Laboratories Hold-
ings, Ltd., is the exclusive licensee, of six related patents:
1 Merz Pharma GmbH & Co. KGAA and Merz
Pharmaceuticals GmbH were plaintiffs in one of the two
civil actions now before us, namely, No. 1:14-cv-00121-
LPS. Their asserted claims (against parties other than
Teva) were eventually resolved by stipulation. See J.A.
281, 288.
FOREST LABS., INC. v. TEVA PHARMS. USA, INC. 3
U.S. Patent No. 8,168,209;
U.S. Patent No. 8,173,708;
U.S. Patent No. 8,283,379;
U.S. Patent No. 8,329,752;
U.S. Patent No. 8,362,085; and
U.S. Patent No. 8,598,233.
The patents describe and claim pharmaceutical composi-
tions, and methods of administering pharmaceutical
compositions, that contain extended-release formulations
of memantine, an N-methyl-D-aspartate (NMDA) receptor
antagonist. ’209 patent, col. 1, lines 23–25. 2
The NMDA receptor, which contains a calcium ion
channel, is activated by the neurotransmitters glutamate
and glycine.
Id., col. 1, lines 40–43. In patients with an
overactive NMDA receptor, the calcium channel will
remain open longer than necessary and calcium will build
up, causing symptomatic and neurodestructive effects in
the patient.
Id., col. 1, lines 51–56. NMDA receptor
antagonists such as memantine can be used to prevent
such calcium build-up and detrimental effects.
Id., col. 1,
lines 57–63.
Memantine was traditionally administered in an im-
mediate-release formulation, which, when administered,
quickly released the active ingredient for absorption by
the body. See
id., col. 1, lines 63–64;
id., col. 2, lines 38–
42. For a patient newly taking the drug, introducing the
active ingredient so quickly could lead to troublesome side
effects; to temper those side effects, treatment with an
immediate-release formulation required starting with a
low dose, administered frequently, with increases of the
dose level over time.
Id., col. 1, lines 64–67. Problems
with such a dosing regimen are that starting with low
2 The ’209, ’708, ’752, ’085, and ’233 have materially
the same specification. The specification of the ’379
patent is slightly different, but the parties rely entirely on
the shared specification for their arguments on appeal.
For simplicity, we refer only to the specification of the
’209 patent.
4 FOREST LABS., INC. v. TEVA PHARMS. USA, INC.
doses delays the achievement of a therapeutically effec-
tive, steady-state level of the drug and that many patients
find the complex dosing schedules hard to follow. See
id.,
col. 1, line 67 through col. 2, line 4.
An extended-release memantine formulation can ad-
dress those problems. Upon administration to a patient,
the memantine in such a formulation “is released into a
subject sample [such as by entering a patient’s blood-
stream] at a slower rate than observed for an immediate
release . . . formulation.”
Id., col. 4, lines 24–26, 39–41.
According to the specification, the rate that the meman-
tine in a particular formulation enters a patient’s blood-
stream is measured in terms of a ratio: “dC” designates
the change in concentration of memantine in blood during
a specified time; “dT” designates the length of the speci-
fied time; and “dC/dT” (despite its similarity to the usual
notation for a derivative) simply designates dC divided by
dT.
Id., col. 4, lines 24–26, 36–38.
The change in memantine concentration in blood over
time can be portrayed graphically to generate a curve
known as a concentration profile. See
id., col. 4, lines 17–
22 & Figs. 1A, 2D. Figures 1A and 2D are graphs of
concentration profiles for immediate- and extended-
release formulations of memantine, where the numbers
are generated by a computer. For the same 20 mg dose,
the figures show the plasma memantine concentration of
the immediate-release formulation starting from zero at
time zero and increasing more quickly than the plasma
memantine concentration of the extended-release formu-
lation.
The specification describes comparing the dC/dT of an
immediate-release formulation to the dC/dT of an extend-
ed-release formulation containing an equivalent amount
of memantine, and the specification focuses particularly
on comparing the two when measured between time zero
(when the formulations are administered) and Tmax
FOREST LABS., INC. v. TEVA PHARMS. USA, INC. 5
(when the immediate-release formulation reaches its
maximum concentration in the blood).
Id., col. 4, lines
29–30, 34–47. For that time period, the dC/dT is higher
for the immediate-release formulation than for the ex-
tended-release formulation, because at the time the
memantine in the immediate-release formulation reaches
its maximum concentration in the blood, the memantine
in the extended-release formulation has not yet been fully
released into the blood. See
id., col. 4, lines 39–50. Un-
like the immediate-release formulation, the extended-
release formulation does not require starting at a low dose
followed by dose escalation but instead allows patients to
achieve desirable steady-state concentration levels soon
after the start of therapy with a simple dosing schedule
and decreased side effects.
Id., col. 2, lines 19–25; see also
id., col. 4, lines 55–60.
B
Forest Laboratories, Inc., holds New Drug Application
No. 22–525 covering Namenda XR® (Namenda Extended
Release formulation), a memantine hydrochloride formu-
lation “indicated for the treatment of moderate to severe
dementia of the Alzheimer’s type.” J.A. 524 (Namenda
XR® prescribing information). Six patents are listed as
covering Namenda XR® in the Food and Drug Admin-
istration’s publication Approved Drug Products with
Therapeutic Equivalence Evaluations, commonly known
as the “Orange Book.”
In December 2013, Teva filed an abbreviated new drug
application seeking approval to sell a generic version of
Namenda XR® and provided Forest with its Paragraph IV
certification stating that the six patents were invalid or
will not be infringed by Teva’s generic. See
21 U.S.C.
§ 355(j)(2)(A)(vii)(IV). Forest then sued Teva in the U.S.
District Court for the District of Delaware for infringe-
6 FOREST LABS., INC. v. TEVA PHARMS. USA, INC.
ment of the six patents pursuant to
35 U.S.C. §§ 271(e)(2),
281. 3
When the parties addressed issues of claim construc-
tion, they disputed the construction of a term appearing,
with slight variations, in the claims at issue on appeal:
claim 1 of the ’209 patent; claims 1 and 6 of the ’708
patent; claim 1 of the ’379 patent; claim 1 of the ’752
patent; and claim 1 of the ’085 patent. Forest Labs., Inc.
v. Teva Pharms. USA, Inc., Nos. 14-121, -200, -508, -686,
-1058, -1271,
2016 WL 54910, at *8 & n.7 (D. Del. Jan. 5,
2016). The parties agreed that the language in claim 1 of
the ’209 patent is representative.
Id. at *8 n.7. With the
language at issue highlighted, claim 1 reads:
1. A solid pharmaceutical composition in a
unit dosage form for once daily oral administra-
tion comprising an extended release formulation
of 5 to 40 mg memantine or pharmaceutically ac-
ceptable salt thereof, wherein administration of a
dose of the composition to a human subject pro-
vides a plasma memantine concentration profile,
as measured in a single-dose human PK [pharma-
cokinetic] study, characterized by a change in
memantine concentration as a function of
time (dC/dT) that is less than 50% that of an
immediate release dosage form comprising
the same dose of memantine as the composi-
tion, wherein the dC/dT is measured between the
3 In addition to the six patents, Teva filed a Para-
graph IV certification regarding
U.S. Patent No.
8,039,009, which is owned by Forest and is also listed in
the Orange Book as covering Namenda XR®. Forest
included the ’009 patent in the infringement suit. The
parties settled the infringement case regarding that
patent in June 2016.
FOREST LABS., INC. v. TEVA PHARMS. USA, INC. 7
time period of 0 to Tmax of the immediate release
form of memantine.
’209 patent, col. 37, lines 11–22.
Forest proposed that the highlighted language either
be left unconstrued or be construed to mean a “change in
plasma memantine concentration of the extended [sus-
tained] release dosage form as a function of time (dC/dT)
that is less than 50% that of an immediate release dosage
form comprising the same dose of memantine as the
extended [sustained] release dosage form.” Forest Labs.,
2016 WL 54910, at *8 (emphases added to indicate For-
est’s proposed changes to the plain language) (brackets in
original).
Teva contended that the claim term is indefinite un-
der
35 U.S.C. § 112, ¶ 2 (2006). 4 According to Teva, the
term requires the comparison of a concentration profile of
an immediate-release formulation and a concentration
profile of an extended-release formulation, as measured in
human pharmacokinetic studies. But, Teva asserted,
neither the claim language nor the specification adequate-
ly describes how to conduct the studies to obtain those
concentration profiles, and differences in study design
lead to variable results in the claim-required comparison.
In response, Forest argued that, under the claim lan-
guage, the dC/dT of the extended-release formulation is to
be derived from a human study, and then compared to the
dC/dT from the computer-derived curve of the immediate-
release formulation shown for Namenda 20 mg in Figures
1A and 2D of the specification.
4 The Leahy-Smith America Invents Act (AIA),
Pub. L. No. 112–29 (2011), changed paragraph 2 into
subsection (b), but it did not change the indefiniteness
standard. The AIA amendment does not apply to this
case.
8 FOREST LABS., INC. v. TEVA PHARMS. USA, INC.
Teva also proposed an alternative construction if the
court did not find the language at issue to be indefinite.
This alternative construction would call for both the
immediate-release and extended-release profiles to be
measured in the same human study. The relevant claim
language would be read to refer to a
change in mean plasma concentration of meman-
tine as a function of time (dC/dT) that is less than
50% that of an immediate release dosage form
comprising the same dose of memantine as the ex-
tended release composition, where the plasma
concentration of the extended release and the im-
mediate release memantine are measured in the
same PK [pharmacokinetic] study conducted in
human subjects.
Forest Labs.,
2016 WL 54910, at *8. Forest expressly
opposed that construction, arguing that it would be im-
proper to read into the claim a requirement that the
dC/dT of both the extended- and immediate-release for-
mulations be measured in the same human study. E.g.,
J.A. 502–03 (Forest’s opening claim construction brief:
“The claims do not include this [same human study]
requirement; the proposed insertion of this limitation is
merely an attempt—by certain Defendants [including
Teva]—to rewrite this portion of the asserted claims.”).
The district court construed the claim to require that
the concentration profile of the extended-release formula-
tion and the concentration profile of the immediate-
release formulation be measured in human pharmacoki-
netic studies. Forest Labs.,
2016 WL 54910, at *8. The
court concluded that the intrinsic evidence does not
disclose a specific human-study design or provide guid-
ance as to how to design a human study.
Id. at *8–9; see
also ’209 patent, col. 5, lines 14–17 (“The precise slope for
a given individual will vary according to the NMDA
[receptor] antagonist being used, the quantity delivered,
FOREST LABS., INC. v. TEVA PHARMS. USA, INC. 9
or other factors, including, for some active pharmaceutical
agents, whether the patient has eaten or not.”). The court
also found that the extrinsic evidence of how a person of
skill in the art would understand the language at issue,
including undisputed expert testimony, showed that
“measurements from human [pharmacokinetic] studies
vary widely in terms of the concentration profiles they
generate” for any particular memantine formulation.
Forest Labs.,
2016 WL 54910, at *9; see also J.A. 553
(Namenda package insert reports Tmax of “about 3-7
hours”); J.A. 660–61 (New Drug Application data shows
Tmax values ranging from 1.6 hours to 9.8 hours). Be-
cause “[a] person of ordinary skill in the art would not
know, with reasonable certainty, which ‘human [pharma-
cokinetic] study’ on which to rely when considering
whether a formulation of memantine might infringe” and
because human-study results are so variable, the court
ruled, claim 1 and the other claims it represented are
indefinite. Forest Labs.,
2016 WL 54910, at *8–9. The
court did not address whether the claim required that the
profiles be measured in the same human study, as pro-
posed in Teva’s alternative construction but opposed by
Forest, and whether such a construction would render the
claims indefinite. See
id. at *8–9.
The court entered a final judgment of invalidity based
on indefiniteness. Forest timely appealed. 5 We have
jurisdiction under
28 U.S.C. § 1295(a)(1).
5 The appeal is limited to the claims listed above.
Forest has not appealed the district court’s judgment of
invalidity as to claims 10 and 15 of the ’708 patent, claim
1 of the ’379 patent, claim 9 of the ’752 patent, claim 7 of
the ’085 patent, and claim 1 of the ’233 patent. See Forest
Labs.,
2016 WL 54910, at *9–10.
10 FOREST LABS., INC. v. TEVA PHARMS. USA, INC.
II
A
We review de novo a district court’s determination of
indefiniteness, but we review for clear error any of the
district court’s underlying findings of fact based on extrin-
sic evidence. Sonix Tech. Co., Ltd. v. Publ’ns Int’l, Ltd.,
844 F.3d 1370, 1376 (Fed. Cir. 2017); UltimatePointer,
L.L.C. v. Nintendo Co., Ltd.,
816 F.3d 816, 826 (Fed. Cir.
2016). A patent claim must “particularly point[] out and
distinctly claim[] the subject matter which the applicant
regards as his invention.”
35 U.S.C. § 112, ¶ 2 (2006).
“[A] patent is invalid for indefiniteness if its claims, read
in light of the specification delineating the patent, and the
prosecution history, fail to inform, with reasonable cer-
tainty, those skilled in the art about the scope of the
invention.” Nautilus, Inc. v. Biosig Instruments, Inc.,
134
S. Ct. 2120, 2124 (2014).
B
Forest contends that the district court erred by con-
struing the claim to require that both of the concentration
profiles being compared—the profiles of the extended- and
immediate-release formulations—be derived from meas-
urements in human pharmacokinetic studies. Forest
argues that, under the proper construction, while the
profile for the extended-release formulation must be
measured in a human study, the profile to which it is
being compared—the profile for the immediate-release
formulation—must be the computer-generated profile
shown in Figures 1A and 2D. We agree with the district
court in rejecting Forest’s argument.
The language of claim 1 requires “a plasma meman-
tine concentration profile, as measured in a single-dose
human PK [pharmacokinetic] study.” ’209 patent, col. 37,
lines 16–17. While it is grammatically possible to read
that phrase as referring to only the profile of the extend-
FOREST LABS., INC. v. TEVA PHARMS. USA, INC. 11
ed-release formulation, such a reading is unreasonable in
the context of the intrinsic evidence.
The specification describes Figures 1A and 2D as
showing concentration profiles of a 20 mg memantine
immediate-release formulation and a 20 mg memantine
extended-release formulation generated by a predictive
pharmacokinetic software program called GastroPlus.
’209 patent, col. 6, lines 58–65 (“F[igure] 1A is a graph
showing the memantine plasma concentration over a
period of 24 hours, as predicted by Gastro-Plus software
package v.4.0.2, following the administration of a single
dose of an immediate release (IR) formulation of meman-
tine (Namenda) or a sustained release formulation of
memantine (NPI-6701). The sustained release formula-
tion exhibits a dC/dT during the initial phase that is
about 20% of that for the immediate release (IR) formula-
tion.”);
id., col. 7, lines 26–32 (same description, in all
material respects, of Figure 2D). 6 Those descriptions of
Figures 1A and 2D are the only intrinsic evidence high-
lighted by Forest to support its argument that the imme-
diate-release profile in those figures supplies the
immediate-release profile recited in the claim. That is not
enough to support the argument.
The descriptions of the figures are no more than what
they purport to be: descriptions of the figures. They do
not constitute a definition and are not even directed to the
meaning of the claim terms. Elsewhere, the specification
does expressly define terms, such as “dC/dT,” e.g., col. 4,
lines 36–38, but it does not use such language for the
6 Forest equates the “sustained release” language of
the specification with the “extended release” language of
representative claim 1 of the ’209 patent. (Other claims
at issue use “sustained release” language.) We proceed on
Forest’s premise that the difference is immaterial to the
issue before us.
12 FOREST LABS., INC. v. TEVA PHARMS. USA, INC.
immediate-release concentration profile. Indeed, the
merely illustrative character of the figures is confirmed by
the fact that the figures show profiles only for particular
doses, not profiles for the full range of doses covered by
the claims—for which immediate-release profiles are
needed but not found in those figures.
In addition, the figures and the accompanying de-
scriptions supply the same amount of detail for the imme-
diate-release profile as for the extended-release profile.
But it would make no sense to say that the figure descrip-
tions “define” the extended-release formulation profile—
which must be generated for any given potentially infring-
ing product by (as Forest agrees) a human pharmacoki-
netic study. The figures are computer-to-computer
comparisons that merely illustrate a possible relation
between an immediate-release and extended-release
formulation. See ’209 patent, col. 29, lines 50–67 (Exam-
ple 16: “Predicted Plasma Profile of Memantine Sustained
Release”).
Nor do Figures 1A and 2D define a fixed baseline for
the claim-required comparison simply because they
provide the only immediate-release concentration profile
disclosed in the specification. Forest points to Liberty
Ammunition, Inc. v. United States,
835 F.3d 1388, 1393
(Fed. Cir. 2016), in which this court rejected an indefi-
niteness challenge to a claim term requiring a “reduced
area of contact” between the “interface” and “rifling” of a
firearm. The court concluded that the claim language
“necessarily calls for a comparison against some baseline.”
Id. at 1395. The specification narrowed “the ambiguity by
disclosing that the patent’s proposed projectile has a
‘reduced contact area as compared to conventional projec-
tiles’” and also “identifie[d] the M855 round as a specific
conventional projectile that the invention seeks to im-
prove upon.”
Id. at 1396. On that basis, the court deter-
mined that the specification’s disclosure of one
conventional round “strongly suggest[ed] that the M855
FOREST LABS., INC. v. TEVA PHARMS. USA, INC. 13
round is the point of comparison for the claims.”
Id. at
1396. In this case, by contrast, the basic descriptions of
Figures 1A and 2D do not provide a clear point of compar-
ison to narrow the claim language at issue.
The prosecution history also provides no support for
Forest’s proposed construction. The inventor declaration
submitted during prosecution describes the results of a
human pharmacokinetic study from which both immedi-
ate-release and extended-release profiles were derived.
The inventor compared those two profiles measured in the
human study; he did not compare the extended-release
profile from the human study to the immediate-release
profile in Figures 1A and 2D.
For those reasons, Forest’s claim construction is con-
trary to the intrinsic evidence. And Forest does not argue
that extrinsic evidence—about usage or other facts exter-
nal to the patent—requires its reading of the claims as
calling for a comparison of a human-study profile to a
computer-generated profile. We therefore conclude, in
agreement with the district court, that human-study
comparisons are required.
C
The district court, having concluded that the claims
require human-study comparisons, determined that there
is no study design specified in the patents, that the pa-
tents are not limited to the particular human study
reported in the prosecution history, that Forest’s extrinsic
evidence did not persuasively identify particular human
studies a relevant skilled artisan would know to use, and
that different human pharmacokinetic studies produce
widely varying concentration profiles for particular for-
mulations. Forest Labs.,
2016 WL 54910, at *8–9. In
these circumstances, the district court’s indefiniteness
ruling is supported by precedents that hold claims indefi-
nite in particular circumstances where the claims require
measured quantities (absolute or relative), different
14 FOREST LABS., INC. v. TEVA PHARMS. USA, INC.
techniques for such measurements are known in the art
and some produce infringing results and others not, the
intrinsic evidence does not adequately specify the tech-
nique or techniques to use, and extrinsic evidence does
not show that a relevant skilled artisan would know what
technique or techniques to use. See, e.g., Dow Chem. Co.
v. Nova Chems. Corp. (Canada),
803 F.3d 620, 633–35
(Fed. Cir.), rehr’g denied,
809 F.3d 1223 (Fed. Cir. 2015);
Honeywell Int’l, Inc. v. Int’l Trade Comm’n,
341 F.3d
1332, 1339–42 (Fed. Cir. 2003).
Forest makes only one argument for setting aside the
indefiniteness ruling if this court agrees with the district
court’s rejection of its human-to-computer comparison
construction. In that event, Forest argues, this court
should adopt the claim construction that Teva presented
in the alternative in the district court. Specifically, Forest
argues that, if the claim requires that both the extended-
and immediate-release profiles be measured in a human
study, the claim requires that both profiles be measured
in the same study.
Forest affirmatively opposed this very position in the
district court when Teva raised it. Forest argued repeat-
edly that it would be improper to read into the claim a
requirement that the dC/dT of both the extended- and
immediate-release formulations be measured in the same
human study. E.g., J.A. 502–03 (Forest’s opening claim
construction brief: “The claims do not include this [same
human study] requirement; the proposed insertion of this
limitation is merely an attempt—by certain Defendants—
to rewrite this portion of the asserted claims. . . . That
construction is unduly restrictive, particularly where, as
here, there is nothing in the claim language, specification,
or prosecution history that remotely suggests the inven-
tors intended to so limit the claims.”); Pls.’ Reply Claim
Constr. Br., Forest Labs., Inc. v. Teva Pharms. USA, Inc.,
No. 1:14-cv-121, Dkt. No. 125, at 7–8 (D. Del. July 15,
2015) (“In reaching his conclusion[] . . . [that the immedi-
FOREST LABS., INC. v. TEVA PHARMS. USA, INC. 15
ate and extended release profiles should be derived from
the same human pharmacokinetic study], [Teva’s expert]
was not informed of the claim construction principle that
limitations from the specification should not be read into
claims. [His] opinions are premised on incomplete legal
standards; they are unreliable and should not be credit-
ed.”) (internal citation omitted); Claim Constr. Hr’g Tr.,
No. 1:14-cv-121, Dkt. No. 158, at 58 (D. Del. Aug. 3, 2015)
(Forest’s counsel: A same study requirement would im-
pose on Forest “an onerous burden that we [would] have
to go take their generic drug, take branded Namenda, and
then go out and find human beings that are willing to
participate in a study like that to prove infringement.”);
see also J.A. 1147–48 (declaration of Forest’s expert, Dr.
James Polli: “I also disagree with [Teva’s expert] that the
person of ordinary skill would understand the claims as
requiring comparison of the [immediate-release] and
[extended-release] dosage forms in the ‘same’ single dose
human [pharmacokinetic] study.”).
In many cases we have barred an appellant from urg-
ing a new claim construction on appeal. See, e.g., Interac-
tive Gift Exp., Inc. v. Compuserve Inc.,
256 F.3d 1323,
1346 (Fed. Cir. 2001) (collecting cases). This case involves
a particularly extreme situation, because the position
Forest now proposes is not just different from any it urged
the district court to adopt but is one that Forest affirma-
tively and unequivocally urged the district court to reject.
Cf. N. Telecom Ltd. v. Samsung Elecs. Co.,
215 F.3d 1281,
1290 (Fed. Cir. 2000) (noting that “we look with extreme
disfavor on appeals that allege error in claim construc-
tions that were advocated below by the very party now
challenging them.”) (internal quotation marks omitted).
The important interests in judicial efficiency support
finding waiver in these circumstances.
16 FOREST LABS., INC. v. TEVA PHARMS. USA, INC.
III
For the foregoing reasons, we affirm the judgment of
the district court.
AFFIRMED
NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
FOREST LABORATORIES, INC., FOREST
LABORATORIES HOLDINGS, LTD., ADAMAS
PHARMACEUTICALS, INC.,
Plaintiffs-Appellants
MERZ PHARMA GMBH & CO. KGAA, MERZ
PHARMACEUTICALS GMBH,
Plaintiffs
v.
TEVA PHARMACEUTICALS USA, INC.,
Defendant-Appellee
______________________
2016-2550, 2016-2553
______________________
Appeals from the United States District Court for the
District of Delaware in Nos. 1:14-cv-00121-LPS, 1:14-cv-
00686-LPS, Chief Judge Leonard P. Stark.
______________________
LOURIE, Circuit Judge, concurring.
I fully join the thorough opinion of the court finding
certain claims indefinite. We decide appeals based on the
decision of the lower tribunal and the arguments raised
before us. Thus, the opinion of the court properly and
correctly addresses those issues and arguments.
2 FOREST LABS., INC. v. TEVA PHARMS. USA, INC.
However, Claim 1 is indefinite for a much more basic
reason than the opinion recites, or the parties have
briefed. Claim 1 of this patent recites a “solid pharma-
ceutical composition . . . comprising an extended release
formulation of 5 to 40 mg memantine . . ., wherein admin-
istration of a dose . . . provides a plasma memantine
concentration profile, as measured in a single-dose human
PK study, characterized by a change in memantine con-
centration as a function of time (dC/dT) that is less than
50% that of an immediate release dosage form.” U.S.
Patent 8,168,209 col. 37 ll. 11–19.
Pharmaceutical dosage forms containing memantine
are old. This claim attempts to encompass an extended
release formulation of memantine, but it does so without
including any materials that cause the extended release.
It attempts to serve that function by defining a result, a
concentration profile. Claiming a result without reciting
what materials produce that result is the epitome of an
indefinite claim. Such a claim fails to delineate with any
reasonable certainty the requirements of the formulation.
The claim is thus indefinite irrespective of the twisting
narrative that is recited concerning how the result is
measured. It is a hollow claim.
In dependent claims 7–9, the patent does recite, in
more definite terms, how to achieve the claimed result.
Claim 7 focuses on an extended release coating. I will not
appraise the definiteness of that claim, but at least it
makes an attempt at definiteness by reciting some struc-
ture to cause extended release. Claim 8 then recites an
insoluble matrix polymer and a water soluble material.
And finally, claim 9 gets to the point, reciting ethyl cellu-
lose and polyvinylpyrrolidone.
But it is claim 1 that is before us and, while I join the
majority opinion finding claim 1 indefinite in the recita-
tion of the means for determining the result, and admire
its unwinding of that tortuous recitation, claim 1 is indef-
FOREST LABS., INC. v. TEVA PHARMS. USA, INC. 3
inite for the principal and simple reason that it claims a
result without reciting how to achieve that result, as the
subsequent dependent claims perhaps do. The measure-
ment of that result is secondary to the basic defect of the
claim.
