Pfizer Inc. et al v. Teva Pharmaceuticals USA, Inc. et al
Filing
113
MEMORANDUM OPINION detailing the court's claim construction; outlining the operative language of Claims 25 and 26. Signed by District Judge Rebecca Beach Smith and filed on 3/17/11. (mwin, )
UNITED STATES DISTRICT COURT FOR THE
EASTERN DISTRICT OP VIRGINIA
Norfolk Division
PFIZER INC., PFIZER LTD.,
and
PFIZER IRELAND PHARMACEUTICALS,
Plaintiffs, Vm
TEVA PHARMACEUTICALS Defendant. USA, INC.,
Civil
No.
2:10cvl28
MEMORANDUM
OPINION
This matter comes before the court for claim construction.
On
December 13, 2010, the court conducted a hearing pursuant to Markman
v. Westview Instruments, Inc., 517 U.S. 370, 372 (1996) ("Markman
hearing"), and heard argument from all parties as to the meaning of
the
terms
in the disputed claims
Opinion details the
of
the patent at
claim
issue.
This
and
Memorandum
court's
construction
explains its reasoning.
1323, 1329 (Fed. Cir.
See MercExchange LLC v. eBay, Inc., 401 F. 3d
2005).
I. Procedural History
This case involves the alleged infringement of United States
Patent No. 6,469,012 (filed May 13, 1994) (issued Oct. 22, 2002) ("the
'012
patent").
Pfizer
Inc.,
Pfizer
"Pfizer")
Ltd.,
and
Pfizer
Ireland
Teva
Pharmaceuticals
(collectively
filed
suit
against
Pharmaceuticals
USA,
Inc.
("Teva")
on March 24,
2010, 1
seeking
injunctive and declaratory relief against imminent infringement of
Pfizer's '012 patent entitled "Pyrazolopyrimidinones for the
Treatment of Impotence. "
The '012 patent claims a number of chemical
("ED"), one of
compounds for the treatment of erectile dysfunction
which is the active ingredient in the drug Viagra.
Pfizer alleges
that Teva will infringe the
%012 patent by manufacturing a generic
version of Viagra.2
On April 29, 2010, Teva answered the complaint
and filed a counterclaim against Pfizer seeking a declaration that
the claims will not of the v012 patent are invalid and Teva's planned drug any patentable
2010.
infringe
claim.
Pfizer
answered Teva's
counterclaim on May 20,
Pursuant to this court's scheduling order and a subsequent order
extending filing times,
the parties
submitted their initial claim
construction
briefs
on
August
30,
20,
2010,
2010,
their
and their
reply
joint
claim
claim
construction briefs
on September
construction brief on September 27, 2010.
On September 8 , 2010, this
1 Pfizer brought suit against two defendants:
Industries, Ltd., and Teva Pharmaceuticals USA, Ltd.
the parties
Teva Pharmaceutical
Inc. The complaint
2010.
against Teva Pharmaceutical Industries,
prejudice upon agreement of
was dismissed without
on May 4,
2 As evidence,
Pfizer cites Teva's filing of an Abbreviated New Drug
The the application in April 2007.
Application with the FDA for the sale of such a generic drug. FDA granted tentative approval of
court scheduled a Markman hearing for December 13,
2010,
to aid the
court in construing the disputed terms of the patent.3
Subsequently, on November 12, 2010, Teva moved to amend its
answer and counterclaim to add an allegation of invalidity because
of inequitable conduct. Pfizer responded in opposition to Teva's
motion on November 29,
On December court, 8, 2010,
2010,
Pfizer
and Teva replied on December 6,
filed a supplemental
2010.
the
notice with
alerting the court to the execution of a covenant not to sue
Teva on the animal claims of the patent,
Claims 1-23,
which claims
are
the
subject
2010,
of
Teva's
inequitable
conduct
assertion. 4
On
December 8,
this court notified the parties that it would hear
that motion at
the same time as
the Markman hearing.
2010, and
The court held the Markman hearing on December 13,
heard argument on both the issue of claim construction and amendment
of pleadings by Teva.
At the end of the hearing, the court took both The court granted Teva's motion to amend
file a revised amended
issues under advisement.
on January 18, 2011,
but ordered that Teva
answer and counterclaim within ten days reflecting only the claims
3 On October 13,
hearing.
2010,
this court entered the joint consent order
concerning the procedures that would be followed during the Markman
4 A copy of the covenant not to sue was attached to the notice filed
with the court. See Docket # 64.
at issue before the court, Claims 25 and 26.5
26, 2011, and
2011. II.
Teva did so on January
counterclaim on
Pfizer
answered
the
amended
February 2,
Factual Background
The
'012
patent
is
entitled
"Pyrazolopyrimidinones
for
the
Treatment of Impotence" and consists of twenty-six claims,6 all of
which claim certain chemical compounds for the treatment of
impotence.
read:
Claims 25 and 26, the claims at issue in this proceeding,
25. A method of treating erectile dysfunction in a male human, comprising orally administering to a male human in need of such treatment an effective amount of a compound
selected from:
[listing nine different chemical compounds]
or a pharmaceutically acceptable salt thereof; or a pharmaceutical composition containing either entity.
26. A method as defined in claim 25, wherein said compound is [listing a chemical compound] or a pharmaceutically acceptable salt thereof, or a pharmaceutical composition
containing either entity.
*012
patent
col.
10,
11.
1-39.
One
of
the particular
chemical
compounds claimed in Claim 25 is called "sildenafil."
Sildenafil
5 See Docket #77.
In its Memorandum Order,
the court ordered that
all references to the "animal claims" be removed from Teva's answer
and counterclaim,
were at issue.
as the parties agreed that only Claims 25 and 26
6
Claim 24
was
ruled
invalid by
the
Patent
and Trademark Office
("PTO")
and is not asserted by Pfizer here.
citrate is the active ingredient in Viagra.7
to expire on October 22, 2019.
The l012 patent is set
In the late 1980s, Pf izer researchers in the United Kingdom were
working on a new drug, which they aimed to use to treat angina,
heart condition.
a
During the first phase of human testing of the drug
in 1992, male volunteers in the study reported penile erections as a side effect. This led to the discovery that the chemical compounds As a result, Pfizer
Pfizer was testing could be used to treat ED.
began human testing of one such compound, sildenafil, in 1993,8 which
in March 1998 was approved by the FDA as the drug Viagra to treat
ED.
As it is currently approved for use by the FDA, a dose of Viagra
is to be taken in anticipation of sexual activity on an as-needed,
single dose basis.9
Sildenafil works to treat ED by inhibiting an enzyme known as
PDE5.
An erection is caused by the relaxation of the arterial smooth
7 Pfizer also holds another patent specifically for sildenafil in United States Patent No. 5,250,534, which expires on March 27, 2012. 5,250,534 {filed May 14, 1992) {issued Oct. 5, 1993) ("the *534 patent") . This patent is different than the '012 patent because the 4012 patent is a method patent for a number of different chemical compounds for the treatment of ED, while the '534 patent is a compound patent that claims sildenafil as a newly discovered chemical
compound.
Pyrazolopyrimidinone Antianginal Agents,
United States Patent No.
8 Multiple dose testing began in July 1993, while single dose clinical
trials commenced in early 1994.
9 As approved by the FDA, a dose of Viagra is 25 mg, 50 mg, or 100 mg taken once per day before anticipated sexual activity. See infra
note 11.
muscle tissue of the penis which allows more blood to flow into the
organ.
The increased blood flow signals to the rest of the smooth
muscle tissue, composed of two hollow tubes on each side of the penis
called the corpora cavernosa, to relax and fill with blood. As the
penis fills with blood, the vein therein is pinched, preventing blood
from flowing out and causing an erection.
To initially relax the smooth muscle tissue, which in turn sets
off the chain reaction, the nervous system reacts to sexual stimuli
by producing nitric oxide. cyclase, ("cGMP"). an enzyme, This nitric oxide reacts with guanylate cyclic guanosine monophosphate
producing
cGMP is the activator on the smooth muscle tissue that
cGMP can be inhibited, however, by another enzyme,
cues it to relax.
PDE5.
Thus,
if there is too much PDE5,
cGMP can be inhibited and
the whole process of smooth muscle tissue relaxation can be thwarted.
This is where Viagra comes in, when an individual's ED is caused by
this imbalance in PDE5 and cGMP.10
The way Viagra works,
then,
is
to inhibit excess PDE5 so that cGMP can work the way that it is
supposed to.
ED has many causes, both psychological and physical. In regard to physical causes, when ED is not the result of by any particular physical injury to the body, such as paralysis or certain lower back injuries, then it is often caused by an imbalance at the cellular
10
level
between
PDE5
and
cGMP.
In
6
this
type
of
case,
Viagra
is
effective.
III.
Claim Construction
Claim construction is a matter of law to be decided by the court.
Markman,
517 U.S.
at
372. [a]
The goal
of
such construction [the]
is
to
"discern the meaning of
and field of art. "
term in the context of
invention
Curtiss-Wright Flow Control Corp. v. Velan, Inc.,
438 F.3d 1374, 1379 (Fed. Cir. 2006).
In performing this function,
the court need only construe disputed terms of disputed claims of
the patent to the extent necessary to resolve the controversy. See
NTP, Inc. v. Research In Motion, Ltd., 418 F.3d 1282, 1311 (Fed. Cir. 2005)
795,
(citing Vivid Techs., Inc. v. Am. Sci. & Eng'g, Inc., 200 F.3d
803 (Fed. Cir. 1999)) .
Sitting en bane, the Federal Circuit gave an overview of claim
construction in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005).
Overall, claim construction aims to determine the "meaning that the
term would have to a person of ordinary skill in the art in question
at the time of the invention, i.e., as of the effective filing date
of the patent application." instances, IcL_ at 1313 (emphasis added) . In some
a term's ordinary meaning "may be readily apparent even
to lay judges, and claim construction in such cases involves little
more than the application of the widely accepted meaning of commonly
understood words."
Id. at 1314.
However,
when the term's meaning
is not readily apparent, courts must consult "those sources available
to the public that show what a person of skill in the art would have
understood disputed claim
language to mean."
Id.
(citation and
internal
quotation marks
omitted).
Those
sources
include both
intrinsic
evidence,
such
and
as
the
claims,
evidence,
specification
such as
and
prosecution history,
dictionaries,
extrinsic
technical
treatises and expert testimony.
Chamberlain Group,
inc. v. Lear Corp. , 516 F.3d 1331, 1335 (Fed. Cir. 2008).
Intrinsic
evidence is considered to be "more reliable" than extrinsic evidence,
id., and thus it should be the court's "primary focus in determining
the ordinary and customary meaning."
Corp., 441 F.3d 991, 996 (Fed. Cir.
Atofina v. Great Lakes Chem.
2006).
The claim construction process begins with the words of the
claims themselves, Old Town Canoe Co. v. Confluence Holdings Corp.,
448 F.3d 1309, 1315 (Fed. Cir. 2006) , focusing on the context in which
the term is used. Phillips, law that 415 F.3d at 1314. "It is a bedrock
principle of patent
the claims of a patent define the
invention to which the patentee is entitled the right to exclude."
Id. at 1312
(citation and internal quotation marks omitted).
Each
disputed term is to be given its "ordinary and customary meaning."
Id. In seeking the plain meaning, the court is concerned with fair
Johnson
notice to the public concerning the scope of the claims.
& Johnston Assoc,
1052 (Fed. Cir.
Inc. v. R.E. Service Co.,
Because claim
Inc.,
285 F.3d 1046,
2002) .
terms
are normally used
consistently throughout the patent, other claims, both asserted and
8
unasserted, may be instructive as to the meaning of the disputed term.
Phillips, 415 F.3d at 1314. Differences among claims may also be
helpful,
as
limitations
in
dependent
claims
Id.
can
at
clarify
the
independent claims
from which
they derive.
1314-15.
The claims, view of
however,
"do not stand alone" and must be "read in of which they are a part."
omitted). The
the specification,
Id.
at 1315
(citation and internal
quotation marks
entirety of
the specification is relevant to claim construction,
including the
abstract,
summary and preferred embodiment.
See generally Lucent
Techs.,
Inc.
v.
Gateway,
of
Inc.,
the
525
F.3d
1200
in
(Fed.
Cir.
2008)
claim
(examining
the
entirety
specification
performing
construction).
The specification "is always highly relevant to the
claim construction analysis.
Usually,
it is dispositive;
it is the
single best guide to the meaning of a disputed term."
F.3d at 1315 (citation and internal quotation
Phillips, 415
omitted).
marks
Further,
if the specification reveals "a special definition given to from the meaning it would
a claim term by the patentee that differs
otherwise possess," then "the inventor's lexicography governs."
at 1316; see, Edwards Lifesciences LLC v. Cook, Inc.,
Id.
582 F.3d 1322,
1329 that
(Fed. Cir. 2009). intent in
The patentee must, however, description."
F.3d 1379, 1381
"clearly express Bobrick
The
the written
Inc., 527
Helmsderfer v.
(Fed. Cir.
Washroom Equip.,
2008).
specification may also limit the scope of the invention through an
intentional disclaimer or disavowal.
Nevertheless, it is important that
Phillips,
court
415 F.3d at 1316.
the
"avoid the danger of
reading
"persons
limitations
of ordinary
from
skill
the
in
specification
the art
into
the
claim,"
as
rarely would confine
their
definitions of terms
embodiments." IcL_ at
to the exact representations depicted in the
1323. the court may also
In addition to the claims and specification,
consider
the prosecution history,
which "consists
of
the complete
record of the proceedings before the
and includes
Id.
of
[Patent and Trademark Office]
the examination of the
the
at
how
prior
1317.
the
art
cited
during
patent."
evidence
Although the prosecution history provides
and Trademark Office ("PTO") and the
Patent
inventor understood the patent,
the court must keep
in mind that
because it "represents an ongoing negotiation between the PTO and the
applicant,
rather
than
the
final product
of
that negotiation,
it
often lacks the clarity of the specification and thus is less useful
for claim construction purposes." As far as extrinsic evidence, Id. the court is not "barred from
considering any particular sources in any specific sequence, contradict claim meaning as
or required to analyze sources those sources are not used to unambiguous in light of the
long as is
that
intrinsic
evidence."
Id.
at
1324.
The
district
court,
in
its
discretion, may admit extrinsic evidence to help educate itself about
10
the
field of
the
invention in order
to determine how a person of
ordinary skill in the art would understand the claim terms.
Id. at
1319.u
IV. Claim Terms
The court construes the following five terms in Claims 25 and
26: 12
(1)
"erectile
(3)
dysfunction,"
(2)
"treating
erectile
(4) "an
dysfunction,"
"a male human in need of such treatment,"
effective amount, " and (5) "a method of treating erectile dysfunction
in ... a male human in need of such treatment."13
those claims read:
To reiterate,
11 The court notes one piece of extrinsic evidence that it does not consider in relation to the construction of the claim terms is the FDA approval of Viagra and its provisions on dosage, method of usage, and purpose. The reason for this exclusion is that the filing of the v012 patent application predated the application to and approval by the FDA, and the court considers the state of the art and the meaning of the terms at the time the patent is filed. See Phillips, 415 F.3d at 1313. Thus, the FDA approval is not relevant to the court's instant task, though the court notes that such information may become relevant at trial as regards secondary considerations of non-obviousness. See Graham v. John Deere Co., 383 U.S. 1, 17-18
(1966) .
12 Claim 26 is a dependent claim of Claim 25, as it refers to the method
in Claim 25 and then relates it to another chemical compound, so the
construction that the court must engage in for both claims is the same. See Felix v. Am. Honda Motor Co. , 562 F.3d 1167, 1177-78 (Fed. Cir. 2009) (noting that normally the same terms have the same meaning
throughout the patent).
13 The parties do not agree on what language in the claims should be considered a "term" for construction purposes. Pfizer initially
argued that Term 3 ("a male human in need of such treatment") is not a claim term, and Teva submitted the same for Term 5 ("a method of
11
25. A method of treating erectile dysfunction in a male human, comprising orally administering to a male human in need of such treatment an effective amount of a compound
selected from:
[listing nine different
chemical compounds]
or a pharmaceutically acceptable salt thereof; or a pharmaceutical composition containing either entity. 26. A method as defined in claim 25, wherein said compound
is [listing a chemical compound] or a pharmaceutically acceptable salt thereof, or a pharmaceutical composition
containing either entity.
'012 patent col.
10,
11.
1-39.
At the outset, the court sets forth the contours of the parties'
fundamental disagreement, as this disagreement informs how each
party approaches
the construction of each term.
At a base level,
the parties disagree as to the scope of the patent.
Pfizer argues
that the "012 patent covers all dosing regimens, including daily use
or on an as-needed basis, using the chemical compounds claimed as
method for treating ED.
By contrast,
Teva argues that Pfizer only
patented the method of using the chemical compounds claimed like the
drug Cialis, that is to say by taking a dose every day to
prophylactically prevent ED at all times.14
Thus, Teva argues that
treating erectile dysfunction in ... a male human in need of such treatment"). However, each party proposed a construction of the
respective term in its reply brief in response to the opposing party's
construction,
and the court considers all
five terms.
14 This suit does not concern the drug Cialis, and the court has no specialized knowledge concerning how Cialis operates and differs
12
making a generic version of Viagra for as-needed use would not
infringe the '012 patent because that method was not claimed.
this background framing the analysis,
With
the court now turns to the
specific terms of the patent requiring construction.
A. "Erectile dysfunction"
As to the first term for construction, "erectile dysfunction,"
Pfizer proposes
"an inability to obtain or sustain an erection Teva proposes "an inability to obtain
adequate for intercourse."
or sustain an erection adequate for sexual intercourse when sexually
stimulated, also known in the art as impotence."
its analysis by looking at the claims
The court begins
However, no
themselves.
description of what is meant by "erectile dysfunction" is to be found therein, so the court must turn to other intrinsic evidence.
derives its definition directly from the language
Pfizer
of the
specification, which provides "erectile impotence or dysfunction may be defined as an inability to obtain or sustain an erection adequate
for intercourse."
'012 patent col.
1,
11.
11-14.
Pfizer argues
that the court need look no further,
expressly provided by the patent.
given that the definition is
Teva is in agreement that the
explicit definition should be adopted, but urges that the definition
be expanded to reflect what a person of ordinary skill in the art
from Viagra. However, both of the parties referenced Cialis as an example of an everyday, prophylactic treatment for ED, and the court references it only for this limited, illustrative purpose.
13
understood about
ED at
the
time
of
filing.
In particular,
Teva
argues that reference should be made to sexual stimulation because
the scientific community agreed that ED only occurred when sexual
stimulation was present.
of the filing of the
Additionally, Teva argues that at the time
patent, erectile dysfunction was used
interchangeably with impotence and thus it should be included in the
term definition.
Looking to the specification,
the court agrees with Pfizer, as
it is clear that the explicit definition stated in the patent should be used and no further construction is necessary. As the Federal
Circuit held in
definition for
Phillips,
a term in
if
the patent
the
itself
gives
"the
a
special
specification,
inventor's
lexicography governs."
415 F.3d at 1316.
Here, the patentee has met
the requirement that the intent to create a specialized definition be clear. The definition of ED,
for
"an inability to obtain or sustain
is introduced in the
erectile
an erection adequate
patent by the words
intercourse,"
'012
or
"[m]ore
specifically,
impotence
dysfunction may be defined."
col.
1,
11.
11-12
(emphasis added).
What a person of ordinary skill in the art would understand the term
to mean is easily answered here,
because any concerns about prior
art and scientific consensus are obviated by the patentee's specific
limitation of the definition. Thus, the addition of "when sexually
14
stimulated" to the express definition is contrary to the law of claim
construction.
Similarly, the addition of "also known in the art as impotence"
is not supported by the intrinsic evidence.
patent refers to impotence in
It
is
true that
and indeed
the
the
the specification,
patent title.
However,
in doing so it defines the larger category
of dysfunctions,
which involves both ED and failure to ejaculate.
The patent defines impotence as
"a lack of power,
in the male,
to
copulate and may involve an inability to achieve penile erection or
ejaculation,
added).
above,
or both."
*012
patent
col.
1,
11.
9-11
(emphasis
The patent
namely,
then continues with the definition discussed
specifically, erectile impotence or
"[m]ore
dysfunction may be defined as an inability to obtain or sustain an
erection adequate for intercourse."
(emphasis added). It is
'012 patent col.
1,
11.
11-14
therefore apparent that the patent draws
a distinction between the overall umbrella of "impotence," which it defines first, and the specific disorder of ED, which it introduces with the words "more specifically."
the state of the art at the time of
As above, any understanding of
filing, upon which the court
expresses no opinion,
is again beside
the point when the patentee
has provided the definition of a term in the specification itself.
Thus, this court holds that "erectile dysfunction" means "an
inability to obtain or sustain an erection adequate for intercourse. "
15
B. "Treating erectile dysfunction"
As
to
the
second
term
for
construction,
"treating erectile
is not necessary
dysfunction,"
Pfizer proposes
that
construction
because the plain meaning of the term is clear.
However,
Pfizer the
argues that if the court finds that construction is required,
term should be defined as
erectile dysfunction."
"medically caring
for or dealing with
Teva proposes "preventing an inability to
obtain or sustain an erection adequate for sexual intercourse from
returning whenever sexually stimulated."15
Turning first to the
claims themselves, there is no indication therein as to what is meant
by "treating" in the case of erectile dysfunction.16
Pfizer argues
that the claim language "treating erectile dysfunction" is readily
understandable to both the court and a person ordinarily skilled in
the art and requires no construction, so the court must use the plain
meaning of contrast, the terms. argues that See Phillips, the 415 F.3d at 1313. evidence of Teva, by
intrinsic
the
patent
prosecution history demonstrates that "treating" has a specialized
15 At the outset of the discussion of this term, the court notes that it need not consider the part of Teva's construction concerning sexual stimulation. As settled in the construction of "erectile
dysfunction" above, sexual stimulation is not part of the definition
of
IV.
ED
A.
in
the patent,
per
its
express
definition.
See
supra
Part
15 The court primarily discusses the meaning of "treating" in this section, as "erectile dysfunction" has already been construed. See
supra Part IV. A.
16
meaning given to it by the patent.
Specifically, Teva points to a
submission by Pfizer to the PTO in 1996 after the PTO had rejected
several proposed claims for a method of curing ED. Therein, Pfizer
defined its understanding of "treating" as keeping ED from returning,
or preventing it. Teva concludes that this represents an express
definition by the patenting party which overrides the ordinary and
customary meaning of the word. Pfizer counters that the language
that
Teva cites
was
merely a reservation of
rights
in case of
reconsideration, and the final patent included only claims for the
treatment of ED, not prevention or curing.
The court looks first to Teva's express definition argument.
It is clear from the law concerning patentee as lexicographer,17 that
the evidence pointed to by Teva does not establish the intent to
express
a
special
meaning.
A patentee's
understanding
of
the
an
definition of a term in a pre-approval submission to the PTO,
understanding which is not embodied in the final patent, cannot form
the basis of a "special definition given to a claim term by the
patentee that differs from the meaning it would otherwise possess."
Phillips, 415 F.3d at 1316. The court is well-advised in this
instance to remember that communications between the patentee and
the PTO are part of an ongoing negotiation, id. at 1317, and there
17 See supra Part III.
at 9.
17
is no other evidence that suggests Pfizer intended "treating" to have
the particular specialized meaning suggested by Teva in the patent
as approved by the PTO.18
E.g., Glaxo Group Ltd. V. Teva Pharm. USA,
inc.,
No.
07-713,
2009 WL 1220544,
at *3
(D.
Del.
Apr.
30,
2009)
(unpublished) 1313, 1327
(citing Liebel-Flarsheim Co. v. Medrad, Inc., 299 F. 3d (noting that the court should not read
(Fed. Cir. 2002))
a restriction into a patent's terms unless the restriction has been
clearly
demonstrated) .
Indeed,
Pfizer
specifically
deleted
Those
references
meanings
in patented claims
to curing or preventing ED.
the patent.
cannot be read back into
The court next looks to the specification.
The patent states
its
purpose:
"[T]hese
disclosed
compounds
are
useful
in
the
treatment of erectile dysfunction,"
l012 patent col. 1,
11. 61-63,
and can be used "for the manufacture of a medicament for the curative
or prophylactic treatment of erectile dysfunction." v012 patent
col.
2,
11.
55-57.
The patent again repeats this,
stating "[t]hus
the invention includes a pharmaceutical composition for the curative
Even if the court were to accept that the single piece of evidence pointed to by Teva demonstrates an express definition, Pfizer's submission itself does not support Teva's conclusion. In its response to the PTO, Pfizer states that when it used the words "cure" and "prevent," they were not used in the sense of curing "for all time." Pfizer Reply Claim Construction Br. 13 (citing Teva Opening Claim Construction Br. Ex. 25 at 2 (Ex. 25 being Pfizer's Apr. 23, 1997, amendment in response to PTO Office Action of Oct. 9, 1996)). Thus, Teva's suggestion that "treating" should mean "preventing" ED "whenever sexually stimulated," is not borne
18
out by the record.
18
or prophylactic
treatment
of
erectile dysfunction."
'012 patent
col.
6,
11.
10-12.
No further elucidation is given as to what is
meant by
"curative or prophylactic treatment."
Teva argues embodiment in
that this meaning is clarified by the preferred specification, which states: The "preferred
the
dosing regimen for a typical man is 5 to 7 5 mg of compound three times
daily." '012 patent col. 5, 11. 65-67. Teva thus concludes that
"treating" means administering daily multiple doses to keep ED from
occurring at all times. The Federal Circuit's precedent, however,
is conclusive on this issue:
"When the specification describes a
single embodiment to enable the invention, this court will not limit
broader claim language to that single application unless the patentee
has demonstrated a clear intention to limit the claim scope using
words or expressions of manifest exclusion or restriction." Abbott
Labs, v. Sandoz, Inc. , 566 F.3d 1282, 1288 (Fed. Cir. 2009) (citation
and internal quotation marks omitted). The court therefore
considers
the
preferred
but such
embodiment,
embodiment is
as
not
it
does
the
entire
of the
specification,
determinative
claimed method of treating.
Instead the court is of
the opinion that
"treating erectile
dysfunction" does not require construction because its ordinary and
customary meaning would be clear to a person ordinarily skilled in
the
art
reading
the
entirety of
19
the patent which describes
the
invention, its purpose, and its use.
Sys. , Inc., 558 F.3d 1368, 1374
ICU Med. , Inc. v. Alaris Med.
Cir. 2009) (citation and
{Fed.
internal quotation marks omitted)
("[T]he person of ordinary skill
in the art is deemed to read the claim term not only in the context
of the particular claim in which the disputed term appears, but in
the context of the entire patent,
Phillips,
including the specification."
(emphasis added));
415 F.3d at 1313.
The
court,
therefore,
holds
that
"treating
erectile
dysfunction"
requires no construction.
[animal] in need of such treatment"
C. "A male human
For the third term,
"a male human
[animal]
in need of such
treatment," Pfizer proposes the construction to be "a male human in
need of treatment for erectile dysfunction." Teva proposes "a male
human [animal] who requires a pharmaceutical composition to prevent
an inability to obtain or sustain an erection adequate for sexual
intercourse from returning whenever sexually stimulated." Teva's
definition of this term is dependent on its definitions of "treating"
and "erectile dysfunction" as discussed above. Having defined those
terms,19 this discussion does not bear repeating in the construction of this term.
dysfunction"
As the court has already held that "treating erectile
requires no construction and should receive its
19 See supra Part IV.
A.
& B.
20
ordinary and customary meaning,20
"such treatment"
in this
term
refers back to "treating erectile dysfunction" and itself requires
no construction.
The court, therefore, is of the opinion that the meaning of the
term is clear and adopts the construction "a male human in need of
treatment for erectile dysfunction."
D. "An effective amount"
As
to
"an
effective
amount,"
Pfizer
proposes
that
no
construction is necessary because the plain meaning of the term is clear. If the court does find that the term must be construed, Pfizer
Teva
proposes "an amount sufficient to produce the desired effect."
proposes "an amount sufficient to prevent an inability to obtain or
sustain an erection adequate for sexual intercourse from returning
whenever sexually stimulated." Teva and Pfizer agree that "an
effective amount" generally means an amount sufficient to have the desired effect, but they differ on whether and how the construction should take account of that desired effect,
desired effect is. on its
and indeed what the
Teva's construction of this term is dependent "treating erectile dysfunction," as such
construction of
treatment
is
the desired effect,
and Teva
again points
to
the
preferred embodiment as evidence that an effective amount must mean
20 See supra Part IV.
B.
21
an amount sufficient to prevent ED at all times.21
The court has
already found these arguments to be unavailing.22
The court holds that "an effective amount" requires no
construction because a person ordinarily skilled in the art reading the patent would understand its ordinary and customary meaning.
E. WA method of treating erectile dysfunction in ... a male human
in need of such treatment"
As to the final term, "a method of treating erectile dysfunction
in ... a male human in need of such treatment," Pfizer proposes
"a
method
practiced
Teva,
for
the
purpose
of
treating
erectile
dysfunction."
though it maintains that the term proposed by
Pfizer is not actually a claim term, appears to agree with this logic
in general, as its definition sets out what it believes the purpose
to be.
Teva proposes "a method that prevents an inability to obtain
or sustain an erection adequate for sexual intercourse from returning
in a male human whenever sexually stimulated."
Again, the parties'
interpretations are dependent on their earlier construction of the
claim terms.
Pfizer
argues
that
prior
cases
have
held
that
this
claim
language states the purpose of the invention,
and this term should
21
Tellingly,
Teva does not take the next logical step and propose '012 patent col.
IV. B. at 19.
22
that "an effective amount" be "5 to 75 milligrams of compound three
times daily."
22 See supra
5,
11.
65-66.
Part
be interpreted accordingly.
See,
e.g.,
Jansen v. Rexall Sundown,
Inc.,
342 F.3d 1329,
1333
(Fed. Cir. 2003)
(holding that a method
of treating ... a male human in need of such treatment means a method
practiced
for
the
stated
purpose). 23
The
court
given
finds
the
this
entire
purposiveness
argument
persuasive,
especially
context of the patent which consists of method claims. Thus, the court
...
holds
that
"a method
of
treating erectile
dysfunction in
a male human in need of such treatment" means
"a
method
practiced
for
the
purpose
of
treating
erectile
dysfunction." V. Conclusion
Therefore,
given the construction of the disputed terms,
the
operative language of Claims 25 and 26 reads:
A method practiced for the purpose of treating an inability to obtain or sustain an erection adequate for intercourse in a male
human, comprising orally administering to a male human in need
of treatment for erectile dysfunction an effective amount of
a compound selected from:
[listing chemical compounds]
or a pharmaceutically acceptable salt thereof;
or a pharmaceutical composition containing either entity.
23
Pfizer additionally argues
that
the court should look to
the
prosecution history.
the PTO's concern that the earlier patent for sildenafil, the '534 patent, see supra note 7, inherently disclosed the inventions of the x012 patent. Pfizer did so by successfully arguing that while sildenafil had been previously patented, the '012 patent was unique because it patented sildenafil, along with other chemical compounds, specifically as a method claim for treating ED.
23
During the prosecution, Pfizer had to overcome
The court DIRECTS the Clerk to send a copy of this Memorandum
Opinion to counsel for the parties.
IT IS SO ORDERED.
/S/
Rebecca Beach Smith United States District Judge
Rebecca Beach Smith ... United States District Judge
Norfolk,
Virginia
March
\f\ ,
2011
24
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