Motorola Mobility, Inc. v. Apple, Inc.

Filing 158

NOTICE by Apple, Inc., Motorola Mobility, Inc. of Filing Supplemental Authority on Claim Construction (Attachments: # 1 Exhibit 1, # 2 Exhibit 2, # 3 Exhibit 3, # 4 Exhibit 4, # 5 Exhibit 5, # 6 Exhibit 6, # 7 Exhibit 7, # 8 Exhibit 8)(Giuliano, Douglas)

Exhibit 2

Page 1

4 of 5 DOCUMENTS
PFIZER INC., PFIZER LTD., and PFIZER IRELAND PHARMACEUTICALS,
Plaintiffs, v. TEVA PHARMACEUTICALS USA, INC., Defendant.
Civil No. 2:10cv128
UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF
VIRGINIA, NORFOLK DIVISION
2011 U.S. Dist. LEXIS 27886

March 17, 2011, Decided
March 17, 2011, Filed
SUBSEQUENT HISTORY: Motion denied by,
Dismissed by, in part Pfizer, Inc. v. Teva Pharms. USA,
Inc., 2011 U.S. Dist. LEXIS 90021 (E.D. Va., Aug. 12,
2011)
PRIOR HISTORY: Pfizer Inc. v. Teva Pharms. USA,
Inc., 2011 U.S. Dist. LEXIS 90762 (E.D. Va., Jan. 18,
2011)

COUNSEL: [*1] For Pfizer Inc., Pfizer Limited, Pfizer
Ireland Pharmaceuticals, Plaintiffs: Aaron Stiefel, Alan
Michael Fisch, Marc Nathan Zubick, Soumitra Deka,
PRO HAC VICE, Coke Morgan Stewart, Daniel Peter
DiNapoli, Kaye Scholer LLP, New York, NY; Brett
Alexander Spain, Conrad Moss Shumadine, Willcox &
Savage PC, Wells Fargo Center, Norfolk, VA; Roy
William Sigler, Kaye Scholer LLP, Washington, DC.
For Teva Pharmaceuticals USA, Inc., Defendant, Counter
Claimant: Gregory N. Stillman, LEAD ATTORNEY,
Brent Lee VanNorman, PRO HAC VICE, Hunton &
Williams, Norfolk, VA; Brian Prew, Charles Wizenfeld,
David Hashmall, John Paul Hanish, Joshua Aaron
Whitehill, Keith Adam Zullow, Kevin James Culligan,
Goodwin Procter LLP (NY-NA), The New York Times
Building, New York, NY; David Michael Young,
Goodwin Procter LLP (DC), Washington, DC; Elaine

Herrmann Blais, John Thomas Bennett, PRO HAC
VICE, Goodwin Procter LLP (MA-NA), Boston, MA.
For Pfizer Inc., Pfizer Ireland Pharmaceuticals, Counter
Defendants: Aaron Stiefel, Alan Michael Fisch, Soumitra
Deka, PRO HAC VICE, Coke Morgan Stewart, Daniel
Peter DiNapoli, Kaye Scholer LLP, New York, NY; Brett
Alexander Spain, Conrad Moss Shumadine, Willcox &
Savage PC, Wells [*2] Fargo Center, Norfolk, VA; Roy
William Sigler, Kaye Scholer LLP, Washington, DC.
JUDGES: Rebecca Beach Smith, United States District
Judge.
OPINION BY: Rebecca Beach Smith
OPINION

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, 116 S. Ct. 1384, 134 L. Ed. 2d
577 (1996) ("Markman hearing"), and heard argument
from all parties as to the meaning of the terms in the
disputed claims of the patent at issue. This Memorandum

Page 2
2011 U.S. Dist. LEXIS 27886, *2

Opinion details the court's claim construction and
explains its reasoning. See MercExchange LLC v. eBay,
Inc., 401 F. 3d 1323, 1329 (Fed. Cir. 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 Ltd., and Pfizer Ireland Pharmaceuticals
(collectively "Pfizer") filed suit against Teva
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
compounds [*3] for the treatment of erectile dysfunction
("ED"), one of 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 of the '012 patent are invalid and Teva's
planned drug will not infringe any patentable claim.
Pfizer answered Teva's counterclaim on May 20, 2010.
1 Pfizer brought suit against two defendants:
Teva Pharmaceutical Industries, Ltd., and Teva
Pharmaceuticals USA, Inc. The complaint against
Teva Pharmaceutical Industries, Ltd. was
dismissed without prejudice upon agreement of
the parties on May 4, 2010.
2 As evidence, Pfizer cites Teva's filing of an
Abbreviated New Drug Application with the FDA
for the sale of such a generic drug. The FDA
granted tentative approval of the application in
April 2007.
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, 2010, their reply claim construction briefs on
September 20, 2010, and their joint claim construction
[*4] brief on September 27, 2010. On September 8, 2010,
this court scheduled a Markman hearing for December
13, 2010, to aid the court in construing the disputed terms
of the patent. 3
3 On October 13, 2010, this court entered the
joint consent order concerning the procedures that
would be followed during the Markman hearing.

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, 2010, and Teva replied on December 6,
2010. On December 8, 2010, Pfizer filed a supplemental
notice with the court, 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 of
Teva's inequitable conduct assertion. 4 On December 8,
2010, this court notified the parties that it would hear that
motion at the same time as the Markman hearing.
4 A copy of the covenant not to sue was attached
to the notice filed with the court. See Docket # 64.
The court held the Markman hearing on December
13, 2010, and heard argument on both the issue of claim
construction and amendment of pleadings [*5] by Teva.
At the end of the hearing, the court took both issues under
advisement. The court granted Teva's motion to amend
on January 18, 2011, but ordered that Teva file a revised
amended answer and counterclaim within ten days
reflecting only the claims at issue before the court,
Claims 25 and 26. 5 Teva did so on January 26, 2011, and
Pfizer answered the amended counterclaim on February
2, 2011.
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, as the parties agreed that only
Claims 25 and 26 were at issue.
II. 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. Claims 25
and 26, the claims at issue in this proceeding, read:
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
compounds]

different

chemical

Page 3
2011 U.S. Dist. LEXIS 27886, *5

or a pharmaceutically acceptable salt
thereof;
or a pharmaceutical composition [*6]
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 citrate is the active ingredient in
Viagra. 7 The '012 patent is set to expire on October 22,
2019.
6 Claim 24 was ruled invalid by the Patent and
Trademark Office ("PTO") and is not asserted by
Pfizer here.
7 Pfizer also holds another patent specifically for
sildenafil in United States Patent No. 5,250,534,
which
expires
on
March
27,
2012.
Pyrazolopyrimidinone
Antianginal
Agents,
United States Patent No. 5,250,534 {filed May
14, 1992) (issued Oct. 5, 1993) ("the *534
patent"). This patent is different than the *012
patent because the '012 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.
In the late 1980s, Pfizer researchers in the United
Kingdom were working on a new drug, which they aimed
to [*7] use to treat angina, a heart condition. 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 Pfizer was testing could be used to treat ED.
As a result, Pfizer 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
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.
Sildenafil works to treat ED by inhibiting an enzyme
known as PDE5. An erection is caused by the relaxation
of the arterial smooth 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 [*8] 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. This nitric
oxide reacts with guanylate cyclase, an enzyme,
producing cyclic guanosine monophosphate ("cGMP").
cGMP is the activator on the smooth muscle tissue that
cues it to relax. cGMP can be inhibited, however, by
another enzyme, 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.
10 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 level between PDE5 and
cGMP. In this type of case, Viagra [*9] is
effective.
III. Claim Construction
Claim construction is a matter of law to be decided
by the court. Markman, 517 U.S. at 372. The goal of such
construction is to "discern the meaning of [a] term in the
context of [the] invention and field of art."
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

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2011 U.S. Dist. LEXIS 27886, *9

resolve the controversy. See NTP, Inc. v. Research In
Motion, Ltd., 418 F.3d 1282, 1311 (Fed. Cir. 2005)
(citing Vivid Techs., Inc. v. Am. Sci. & Eng'g, Inc., 200
F.3d 795, 803 (Fed. Cir. 1999)).

Phillips, 415 F.3d at 1314. Differences among claims
may also be helpful, as limitations in dependent claims
can clarify the independent claims from which they
derive. Id. at 1314-15.

Sitting en banc, 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." IcL. at 1313 (emphasis added). In
some instances, a term's ordinary meaning "may be
readily apparent even to lay judges, and claim
construction in such cases involves [*10] 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 as the
claims, specification and prosecution history, and
extrinsic evidence, such as technical dictionaries, 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." Atofina v. Great Lakes Chem.
Corp., 441 F.3d 991, 996 (Fed. Cir. 2006).

The claims, however, "do not stand alone" and must
be "read in view of the specification, of which they are a
part." Id. at 1315 (citation and internal quotation marks
omitted). The entirety of the specification is relevant to
claim construction, including the abstract, summary and
preferred embodiment. See generally Lucent Techs., Inc.
v. Gateway, Inc., 525 F.3d 1200 (Fed. Cir. 2008)
(examining [*12] the entirety of the specification in
performing claim 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." Phillips, 415 F.3d at 1315
(citation and internal quotation marks omitted). Further,
if the specification reveals "a special definition given to a
claim term by the patentee that differs from the meaning
it would otherwise possess," then "the inventor's
lexicography governs." Id. at 1316; see, Edwards
Lifesciences LLC v. Cook, Inc., 582 F.3d 1322, 1329
(Fed. Cir. 2009). The patentee must, however, "clearly
express that intent in the written description."
Helmsderfer v. Bobrick Washroom Equip., Inc., 527 F.3d
1379, 1381 (Fed. Cir. 2008). The specification may also
limit the scope of the invention through an intentional
disclaimer or disavowal. Phillips, 415 F.3d at 1316.
Nevertheless, it is important that the court "avoid the
danger of reading limitations from the specification into
the claim," as "persons of ordinary skill in the art rarely
would confine their definitions of terms to the exact
representations depicted in the embodiments." Id. at
1323.

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, 415 F.3d at 1314. "It is a bedrock
principle of patent law that the [*11] 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 notice to the public concerning the scope of the
claims. Johnson & Johnston Assocs, Inc. v. R.E. Service
Co., Inc., 285 F.3d 1046, 1052 (Fed. Cir. 2002). Because
claim terms are normally used consistently throughout
the patent, other claims, both asserted and unasserted,
may be instructive as to the meaning of the disputed term.

In [*13] addition to the claims and specification, the
court may also consider the prosecution history, which
"consists of the complete record of the proceedings
before the [Patent and Trademark Office] and includes
the prior art cited during the examination of the patent."
Id. at 1317. Although the prosecution history provides
evidence of how the Patent and Trademark Office
("PTO") and the 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." Id.

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2011 U.S. Dist. LEXIS 27886, *13

As far as extrinsic evidence, the court is not "barred
from considering any particular sources or required to
analyze sources in any specific sequence, as long as those
sources are not used to contradict claim meaning that is
unambiguous in light of the intrinsic evidence." Id. at
1324. The district court, in its discretion, may admit
extrinsic evidence to help educate itself about the field of
the invention in order to determine how a person of
ordinary skill in the art would understand the claim terms.
[*14] Id. at 1319. 11

or a pharmaceutical
containing either entity.

composition

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.

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 '012 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, 86 S. Ct. 684, 15 L. Ed. 2d 545
(1966).
IV. Claim Terms
The court construes the following five terms in
Claims 25 and 26: 12 (1) "erectile dysfunction," (2)
"treating erectile dysfunction," (3) "a male human in need
of such treatment," (4) "an effective amount, " and (5) "a
method of treating erectile dysfunction in ... a male
human in need of such treatment." 13 To reiterate, those
claims read:
25. A method of treating erectile
dysfunction in a male human, comprising
orally administering [*15] to a male
human in need of such treatment an
effective amount of a compound selected
from:
[listing nine
compounds]

different

chemical

or a pharmaceutically acceptable salt
thereof;

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
treating erectile dysfunction in ... a male human in
need of such treatment"). However, each party
proposed [*16] 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.
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 making a generic
version of Viagra for as-needed use would not infringe
the '012 patent because that method was not claimed.
With this background framing the analysis, the court now
turns to the specific terms of the patent requiring
construction.

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2011 U.S. Dist. LEXIS 27886, *16

14 This suit does not concern the drug Cialis,
and the court has no specialized knowledge
concerning how Cialis operates and differs from
Viagra. However, [*17] 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.
A. "Erectile dysfunction"
As to the first term for construction, "erectile
dysfunction," Pfizer proposes "an inability to obtain or
sustain an erection adequate for intercourse." Teva
proposes "an inability to obtain or sustain an erection
adequate for sexual intercourse when sexually stimulated,
also known in the art as impotence." The court begins its
analysis by looking at the claims themselves. However,
no description of what is meant by "erectile dysfunction"
is to be found therein, so the court must turn to other
intrinsic evidence. Pfizer derives its definition directly
from the language 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, given that the
definition is expressly provided by the patent. Teva is in
agreement that the explicit definition should be adopted,
but urges that the definition be expanded to reflect [*18]
what a person of ordinary skill in the art 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. Additionally, Teva
argues that at the time of the filing of the 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 Phillips, if the
patent itself gives a special definition for a term in the
specification, "the 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, "an inability to obtain or sustain an
erection adequate for intercourse," is introduced in the
'012 patent by the words "[m]ore specifically, erectile
impotence or dysfunction may be defined." col. 1, 11.

11-12 (emphasis added). What a person of ordinary skill
in [*19] 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 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. It
is true that the patent refers to impotence in the
specification, and indeed the 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, or both." '012 patent col. 1, 11.
9-11 (emphasis added). The patent then continues with
the definition discussed above, namely, "[m]ore
specifically, 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
(emphasis added). It is therefore apparent that the patent
draws a distinction between the overall umbrella [*20] of
"impotence," which it defines first, and the specific
disorder of ED, which it introduces with the words "more
specifically." As above, any understanding of the state of
the art at the time 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. "
B. "Treating erectile dysfunction"
As to the second term for construction, "treating
erectile dysfunction," Pfizer proposes that construction is
not necessary because the plain meaning of the term is
clear. However, Pfizer argues that if the court finds that
construction is required, the term should be defined as
"medically caring for or dealing with erectile
dysfunction." 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 [*21] erectile

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2011 U.S. Dist. LEXIS 27886, *21

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
the terms. See Phillips, 415 F.3d at 1313. Teva, by
contrast, argues that the intrinsic evidence of the patent
prosecution history demonstrates that "treating" has a
specialized 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.
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" [*22] above, sexual
stimulation is not part of the definition of ED in
the patent, per its express definition. See supra
Part IV. A.
16 The court primarily discusses the meaning of
"treating" in this section, as "erectile dysfunction"
has already been construed. See supra Part IV. A.
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 definition of a term in a
pre-approval submission to the PTO, an 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 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 Pharms. USA, Inc., No. 07-713, 2009
U.S. Dist. LEXIS 37494, 2009 WL 1220544, at *3 (D.
Del. Apr. 30, 2009) [*23] (unpublished) (citing Teleflex,

Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1327 (Fed.
Cir. 2002)) (noting that the court should not read a
restriction into a patent's terms unless the restriction has
been clearly demonstrated). Indeed, Pfizer specifically
deleted references in patented claims to curing or
preventing ED. Those meanings cannot be read back into
the patent.
17 See supra Part III. at 9.
18 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 out by the record.
The court next looks to the specification. The patent
states its purpose: "[T]hese disclosed compounds are
useful in the treatment of erectile [*24] dysfunction,"
'012 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." '012
patent col. 2, 11. 55-57. The patent again repeats this,
stating "[t]hus the invention includes a pharmaceutical
composition for the curative 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 that this meaning is clarified by the
preferred embodiment in the specification, which states:
The "preferred 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 [*25]
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

Page 8
2011 U.S. Dist. LEXIS 27886, *25

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 embodiment, as it does the entire specification,
but such embodiment is not determinative of the 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 the patent which describes the invention, its
purpose, and its use. ICU Med., Inc. v. Maris Med. Sys.,
Inc., 558 F.3d 1368, 1374 (Fed. Cir. 2009) (citation and
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, including [*26] the specification." (emphasis
added)); Phillips, 415 F.3d at 1313.
The court, therefore, holds that "treating erectile
dysfunction" requires no construction.
C. "A male human [animal] in need of such
treatment"
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. As the court has already held that "treating
erectile dysfunction" requires no construction and should
receive its ordinary and customary meaning, 20 "such
treatment" in this term refers back to "treating erectile
dysfunction" and itself requires no construction.
19 See supra Part IV. A. & B.
20 See supra Part IV. B.
The court, therefore, is of the opinion that the
meaning of the [*27] 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 proposes "an amount sufficient to
produce the desired effect." Teva 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, and indeed what the desired effect is.
Teva's construction of this term is dependent on its
construction of "treating erectile dysfunction," as such
treatment is the desired effect, and Teva again points to
the preferred embodiment as evidence that an effective
amount must mean an amount sufficient to prevent ED at
all times. 21 The court has already found these arguments
to be unavailing. 22
21 Tellingly, Teva does not take the next logical
[*28] step and propose that "an effective amount"
be "5 to 75 milligrams of compound three times
daily." '012 patent col. 5, 11. 65-66.
22 See supra Part IV. B. at 19.
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. "A 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 for the
purpose of treating erectile dysfunction." Teva, 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.

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2011 U.S. Dist. LEXIS 27886, *28

Pfizer argues that prior cases have held that this claim
language states the purpose of the [*29] invention, and
this term should 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 finds this
purposiveness argument persuasive, especially given the
entire context of the patent which consists of method
claims.
23
Pfizer additionally argues that the court
should look to the prosecution history. During the
prosecution, Pfizer had to overcome the PTO's
concern that the earlier patent for sildenafil, the
'534 patent, see supra note 7, inherently disclosed
the inventions of the '012 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.
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 [*30] 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
containing either entity.

composition

The court DIRECTS the Clerk to send a copy of this
Memorandum Opinion to counsel for the parties.
IT IS SO ORDERED.
Norfolk, Virginia
March 17, 2011
/s/
Rebecca Beach Smith
United States District Judge
Rebecca Beach Smith
United States District Judge