NOVEN PHARMACEUTICALS v. WATSON LABORATORIES, INC. et al
Filing
155
OPINION. Signed by Judge Dennis M. Cavanaugh on 11/26/2013. (nr, )
NOT FOR PUBLICATION
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
NOVEN PHARMACEUTICALS. INC..
Hon. Dennis M. Cavanaugh
Plaintiff,
OPINION
v.
WA I SON LABORM ORIES INC and
WATSON PHARMACEUTICALS. INC..
Civil Action No. 1 i-cv-5997 (DMC)(JBC)
DeF.ndants.
DENNIS M. CAVANAUGH, U.S.D.J,:
This matter comes before the Court upon the following Motions: i) the Motion of
DeIndants Watson Laboratories. Inc. and Actavis, Inc. (collectively Delndants’) for
Summar Judgment of Invalidity of Asserted Claims of US Patent No 6,210,705: ii) Defendants
Motion Ihr Partial Summary Judgment of Non-Infrmgement of US Patent No 6,348.211; iii) the
Cross—Motion of Plaintiff Noven Pharmaceuticals. Inc. (“Plaintiff) for Leave to File Amended
Infringement Contentions and For Additional Claim Constructiom and iv) Plaintiffs CrossMotion for Summary Judgment of No Invalidity of the Asserted Claims of U.S. Patent No.
6.210,705. Pursuant to FED. R. Civ. P 78, no oral argument was heard. Based on the following
and for the reasons expressed herein, Defendants’ Motion for Summary Judgment of Invalidity
of Asserted Claims of US Patent No 6,210,705 is granted, Defendants’ Motion for Partial
Summary Judgment of Non-Infringement of US Patent No 6,348211 is granted, Plaintiffs
Effective January 24, 2013, the entity name of Watson Pharmaceuticals.
Inc.
was changed to Actavis. Inc.
Cross-Motion for Leave to File Amended Infringement Contentions
and For Additional Claim
Construction is denied, and Plaintiiis Cross—Motion for Summary Judgm
ent of No Invalidity ol
the Asserted Claims of U.S. Patent No. 6.210.705 is denied.
I.
2
HACKGROUNI)
A. The Patents-in-Suit
The instant Motions stem from the following two patents that are lawfully owned
by
Plaintiff: i) United States Patent No, 6,210,705, entitled Compositions and
Methods bor
Treatment of Attention Deficit Disorder and Attention DefIcit/Hyperactivity Disord
er With
Methvlphenidate (the “‘705 Patent”). and ii) United States Patent No. 6.348.
211. also entitled
‘Compositions and Methods For Treatment of Attention i)eficit [)isorder and Attent
ion
Deficit/Hyperactivity Disorder With Methylphenidate’ (the “‘211 Patent”). Both patents
claim.
in/er a/ia. compositions and methods for treatment of attention deficit disorder
and attention
deficit/hyperactivity disorder (collectively “ADHD”) with transdermal methyipheni
dale delivery
systems.
1) The ‘705 Patent
The ‘705 Patent was duly issued by the United States Patent and Trademark Of/ice
(‘USPTO’) on April 3, 2001. Claims 1. 16, 18. and 25 of the ‘705 Patent include a limitat
ion that
requires that the composition compromise of no more than about 5 vt % of acid functio
nal
monomers. The claims are as follows:
1. A composition for topical application of methvlphenidate compr
ising
methylphenidate in a flexible, finite system, wherein the methyiphenidate is presen
t
in a therapeutically effective amount sufficient to achieve substantially zero
order
kinetics lbr delivery to the skin or mucosa of a patient in need thereof over a period
of Itime] at least 10 hours, and i’herein the colnposition COfllJ)1iSCS nO iflOiC thou
((bout .3 wt % of acid functional monomers.
The facts from this section are taken from the parties’ pleadings.
2
16. A method of treating attention deficit disorder and attention deficit/hyperactivit
y
disorder comprising topically administering methyiphenidate in a flexible, finite
system, wherein the methylphenidate is present in a therapeutically effective amount
sufficient to achieve substantially zero order kinetics for delivery to the skin or
mucosa of a patient in need thereof over a period of time at least 10 hours, and
wherein acidfunctional monomers are present in an amount ofno more than aboui
Swt%.
18. A composition for topical application of methylphenidate comprising
methylphenidate in a flexible, finite system, wherein the methylphenidate is present
in an amount sufficient to permit a therapeutically effective dose in a patient over a
total duration of 24 hours, wherein the total delivered amount of methylphenidate is
from about 0.5 mg to about 100 mg, and wherein acidfunctional monomers are
present in an amount ofno more than about 5 wi %.
25. A method oftreating attention deficit disorder and attention deficit/hyperactivity
disorder comprising topically administering methylphenidate in a flexible, finite
system, wherein the methylphenidate is present in an amount sufficient to permit a
therapeutically effective dose in a patient over a total duration of 24 hours, wherein
the total delivered amount of methylphenidate is from about 0.5 mg to about 100
mg, and wherein acidfunctional monomers are present in an amount qf no more
than about 5 WI %.
Additionally, claims 15, 17,24, and 26 include limitations of I wt % of acid functional
monomers. The claims containing the 5 wt % limitations and the claims containing the I wt %
limitations will be referred to collectively as the “705 Claims.”
During claim construction proceedings, Plaintiff argued that the wt % limitations
compare the weight of acid functional monomers to the total monomer content. After a Markman
hearing held on December 6, 2012, this Court adopted Plaintiff’s construction for the wt %
limitations as follows:
Wherein, for the monomers in the flexible, finite system. no more than about 5 wt
% are acid functional.
Wherein, for the monomers in the flexible, finite system, no more than about 1 wt
% are acid functional.
(ECF No. 91, Jan. 4, 2013).
3
2) The ‘211 Patent
The ‘211 Patent was duly issued by the USPTO on iebruarv 19. 2002. Claims 1-2. 0-7.
11 -14, 16-21. and 28 of the ‘21 1 Patent (the “‘211 Claims”) recite or incorporate the
flllo wing
limitation: “wherein the proportion of methvlphenidate:silicone adhesive:acrylic adhesive
(wt (4)
dry) is about 5-30:0-70:0-70, respectively” (hereinafter ‘the proportion limitation”). During
claim construction proceedings, Plaintiff argued that the term ‘about” allows for ranges
of 080% or 0-90% acrylic adhesive. However, this Court agreed with Defendants’ construction
and
held that the term about” onlY allows for the additional margin appropriate for rounding
decimals to whole numbers.
B. The Watson ANI)A Product
The accused product is Abbreviated New Drug Application No. 200147 (the “\\atson
ANDA Product”), submitted by Defendants on August 3 1. 2009. The Watson ANDA Product is
a methylphenidate transdermal system that is indicated for the treatment of A1)l-li). Plaintiff
believes that the Watson ANDA Product infringes various claims of the ‘705 and ‘211 Patents.
C, The Motions
On July 8, 2013, Defendants filed a Motion for Summary .ludgment of Invalidity of
Asserted Claims of US Patent No 6,210,705 (“Def.’s ‘705 Mot.,” ECF No. 120) and a Motion for
Partial Summary Judgment of Non-Infringement of US Patent No 6,348,211 (ECF No. 121). On
August 9, 2013, Plaintiff filed an Opposition to Defendants’ Motion for Partial Summary
Judgment of Non—Infringement of US Patent No 6,348,211 and a Cross—Motion
for
I eave to
File Amended Infringement Contentions and 1 or Additional Claim Construction (1ECF No. I 2
On August 1 0. 201 3. Plaintiff liled a Cross-Motion for Summary .Tuclginent of \o Inval iditv a!’
the Asserted Claims of U.S. Patent No. 6,210,705 (“Pl.’s ‘705 Mot..” ECF No. I 34). On August
4
30, 2013. Defendants filed a Combined Reply Brief in Support of their Motion
for Partial
Summary Judgment of Non-Infringement of US Patent No 6.3482l 1 and
Opposition to
PlaintifPs Cross—Motion br Leave to File Amended Infringement Conten
tions and for
Additional Claim Construction (ECF No, 139) and a Combined Reply in
Support of their Motion
h)r Summary Judgment of Invalidity of Asserted Claims of US Patent No 6,2
1 0705 and
Opposition to Defendants Cross-Motion for Summary Judgment of No Invalid
ity (‘Def’s ‘705
Reply.” ECF No. 140).
[1.
STANDARD OF REVIEW
Pursuant to Fed. R. Civ. P. 56(c). summary judgment must be granted “if the pleadin
gs.
depositions. answers to interrogatories, and admissions on file, together with the affidav
its, if any.
show that is no genuine issue as to any material fact and that the moving party is entitle
d to a
judgment as a matter of law.” The moving party “hears the initial responsibility of inform
ing the
district court of the basis for its motion, and identifying those portions of the [the record which
it
1
believes demonstrate the absence of a genuine issue of material fact.” ç otexCor.vCatr
ett, 477
U.S. 317, 323 (1986). A genuine issue of material fact exists only if sufficient eviden
ce is presented
favoring the nonmoving party for a jury to return a verdict for that party. Anders
on v.Liherty
Lobby, Inc., 477 U.S. 242, 248 (1986). “Thus, to withstand a properly supported
motion for
summary judgment, the nonmoving party must identify specific facts and affirma
tive evidence that
contradict those offered by the moving party.” Red Roof Franchisinc. LLC
v. AA Hospitality
Northshore, LLC, 877 F. Supp. 2d 140. 147 (D.N.J. 2012) (citing Anderson. 477
U.S. at 256-57).
To do so. “[aj party opposing summary judgment must do more than just rest
upon mere
allegations, general denials, or vague statements.” j. (citing
anav.1ai1Corp., 260 F.3d
228, 232 (3d Cir. 2001 )). Accordingly, “[w]here the record taken as a whole could
not lead a
rational
trier of fact
to find for the
non—moving
party, there is no genuine issue thr trial”
Matsushita Flee, Indus. Co. v. Zenith Radio Corp., 475 U.S. 574,
587 (1986).
ilL
DISCUSSION
A. The ‘705 Patent
1)efendants move for Summary Judgment
of
invalidity of the ‘705 Claims. arguing thai.
the claims are invalid for lack of adequate written description. Plaintiff
opposes Defendani.s
Motion and simultaneously moves fbr Summary Judgment of no invalid
ity.
A claim is invalid if it lacks written description support in the specilication
as required by
35 U.S.C.
§
112. To comply with this requirement, “the specification must describe an invent
ion
understandable to [the] skilled artisan and show that the inventor actually invent
ed the invention
claimed.” Ariad Pharm.. Inc. v. Eli Lilly & Co.. 598 F,3d 1336, 1351 (Fed. Cir.
2010): see also
Carnegie Mellon Univ. v. Hoffmann—La Roche Inc., 541 F.3d 1115. 1122 (Fed.
Cir. 2008) (“To
satisfy the written description requirement, the applicant does not have to utilize
any particular
form of disclosure to describe the subject matter claimed, but the description must
clearly allow
persons of ordinary skill in the art to recognize that he or she invented what is claime
d.’ (internal
quotations and citation omitted)). Although compliance with this requirement
is a question of
fact, it “is amenable to summary judgment in
cases
where no reasonable fact tinder could return
a verdict for the non-moving party.” Boston Scientific Corp. yJoJi oi
Johnson, 647 F.3 d
1353. 1361 (Fed. Cir. 2011) (citation omitted).
1) The 5 wt % Limitations
Defendants assert that the ‘705 Claims containing the 5 wt % limitation are invalid
.
arguing that these claims lack written description support because this Court
construed the 5 ut
% limitations as referring to the amount of acid functional monomers by the weight
oft/ic
6
monomer content, but the ‘705 Patent specification refers to the amount of acid functional
monomers hi wekht
0/ acri
lie
monomer
(Def ‘s ‘705 Mot. at I ). Thus. Defendants claim that
the specification does not convey to a person of ordinary skill in the art ‘that the acrylic adhesive
may contain an excess of about 5 wt% acid functional monomers provided that the acid
functional monomers [do] not exceed about 5 wt% of the total monomer content of the
composition” (Id. at 8). Essentially. Defendants argue that the invention claimed is broader than
the invention described in the specification.
In response, Plaintiff first argues that this Court should rule against Defendants because it
already rejected Defendants’ written description arguments when it adopted Plaintiffs
construction of the wt % limitations after the Markman hearing. However, Plaintiff is mistaken
in believing that the ‘705 Claims are necessarily valid simply because this Court adopted
Plaintiff’s broad interpretation of the vi % limitations during claim construction proceedings. In
Liehel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 1383 (Fed. Cir, 2007), one of the terms at
issue was “physical indicia.” In claim construction proceedings, the district court agreed with the
plaintiff’s broad interpretation of the term. Id. at 1376. However, the district court subsequently
found that the plaintiffs patent claims were invalid because the limited written description did
not sufficiently convey the breadth of the patent. Id. The Federal Circuit affirmed and noted that
the plaintiff “argued for a broad meaning, and succeeded, but suffers a Pyrrhic victory.”
at
1383. Thus, this Court will not deny Defendants’ Motion and grant Plaintiff’s solely because it
ruled for Plaintiff during claim construction proceedings.
Second, Plaintiff points to portions of the ‘705 Patent specification and argues that they
show that the degradation of methyiphenidate is reduced by minimizing acid functional groups,
regardless of the source. For example, the specification states that “methylphenidate, in
7
particular the base form, can be unstable and undergoes degradation in the presence of acid
functional groups which are contained in adhesives.
.
.
and other components of the topical
composition” and discloses that the degradation of methylphenidate increases with each 1%
increase of acid functional component. However, Defendants persuasively argue that although
this language describes the effect of reducing acid functional groups in general, it “provides no
blaze marks that would lead a person of ordinary skill to compositions having no more than 5 wt
% acid functional monomers by weight of the total monomer content” (Def.’s ‘705 Reply at 9).
Third, Plaintiff contends that the ‘705 Patent specification includes the original claims
filed, and that a number of these claims “demonstrate ample written description beyond the
specific preferred 5 wt % acrylic embodiment” (Pl.’s ‘705 Mot. at 9). However, during the
prosecution of the ‘705 Patent, the Examiner rejected these claims as not reasonably provid[ing]
enablement for a composition wherein the amounts and proportions are not claimed,” leaving a
person of ordinary skill unable to obtain the “desired flux rate for the desired period of time”
based on the patent’s teachings. Plaintiff acquiesced in the rejection and amended the original
claims to include the 5 wt % limitations. Thus, Plaintiff cannot argue that the original claims
render the specification sufficient.
Fourth, Plaintiff points to the following language in the ‘705 Patent specification and
argues that it shows that aS wt % functional acrylic polymer is only a prqferred embodiment:
In view of the foregoing, acrylic polymers that are non-functional, hydroxyl
functional, or minimally acidfunctional are preferred.
A preferred embodiment for attaining at least 10 hours of substantially zero-order
delivery is to include in the composition the polymers described above, such as the
acrylics having no or minimalfunctional groups.
Plaintiff contends that it is improper to consider only the preferred embodiments in assessing the
scope of a patent’s written description. This Court finds that nothing in the above quoted
8
language relates to a person of ordinary skill that Plaintiff
Possessed other embodiments having
an acrylic adhesive with more than 5 wt % acid functional monom
ers. Thus, contrary to
Plaintiffs assertion, the scope of the ‘705 Claims cannot be “derive
d’ from the teachings of the
spec itcation (Id. at 1 3).
Fifth, Plaintiff claims that Defendants’ overbreadth argument defies
logic and
common sense because nothing in the ‘705 Patent supports the
contention that “the
degradation of methyiphenidate changes substantially if the same
overall level of acid
functional monomers came from just one acrylic, instead of comin
g from two different
acrylics” (Id. at 14). Plaintiff argues that Defendants’ expert, Dr. Walter
s. testified that he
did not know i fit would make a difference if the overall acid functional
monomer level
was the preferred 5 wt % or less, hut
one of more
of the acrylic components was above the
5 wt % criterion. However, at issue is what Plaintiffs specification disclos
ed, and Dr.
Walters concluded that a person of ordinary skill would not understand that
the inventors
possessed the full breadth of the invention covered by the 5 wt % limitation.
ge 1CLJ Med.,
iicx.J Mc4Sy1Lnc, 558 F.3d
1368, 1377-78 (Fed. Cir. 2009) (affirming a finding
of invalidity when the patent specification only included valves with spikes
but the claims
covered valves both with and without spikes). This Court finds that this conclu
sion is sound
for the reasons discussed above. Further, this Court agrees that the
testimony ol Dr.
Enseore. Plaintifrs expert, is suspect, as Dr. Enscore admitted at his
deposition that his
opinions were based on inserting the word “acrylic” into the Court’s claim
construction
—
a word that is completely absent from the construction that the court
upheld after the
Markman hearing.
Finally, this Court finds that it is telling that not a single one of the twenty
nine examples
9
in the ‘705 Patent specification include an acrylic adhesive having more than 5 wt % acid
functional monomers by weight of the acrylic polymer. Although Plaintilf correctly asserts that it
is not required that the patent specification disclose every example that falls within the claims.
the lack of any example including an acrylic adhesive having more than 5 wt % acid functional
monomers by weight
of
the acrylic polymer weighs against Plaintiffs constant argument that
‘705 Patents’ “general teachings” show that such a composition is included. Thus. this Court
finds that Defendants have adequately shown that the ‘705 Claims are broader than the
disclosure in the specification
Accordingly, Defendants’ Motion for Summary Judgment is granted and Plaintiff’s
Cross-Motion for Summary Judgment is denied.
2) The 1
wt
% Limitations
In its Motion for Summary Judgment. Defendants assert that “[cllaims 1 5. 1 7. 24 and 20
of the ‘705 patent, which contain the 1 wt % limitations, fail to satisfy the written description
requirement for the same reasons as the claims containing the 5 wt % limitations” (I)ef. ‘s 705
Mot. at 1 9). Defendants do not elaborate on this argument because “Drs. \Valters and Enscore
are
in agreement that the analysis for the 5 wt % limitations applies equally to the I wt %
limitations” (Id.). In its Cross-Motion and Opposition, Plaintiff claims that Defendants’ Motion
should be denied because it did not address the 1 wt % limitations and states that “[Defendants’
overbreadth concerns do not apply to the I wt % limitations” (Pl,’s ‘705 Mot. at 22-23).
Plaintiff cannot
argue
that a different analysis applies to the I vt % limitations alter
consistentk agreeing that the analysis for the I wt % limitations
the 5 wt % limitations. (See Lydisgen Dec., Ex. 7
¶
is
the same as the analysis for
135 (“The same analysis applies
to
Dr.
Walters’ assertions concerning the 1 wt % limitation.”); 2nd Lydisgen Dec., Ex 18 at 153 (“The
10
claims containing the 1 wt % acid functional monomer limitations have adequate support for the
same reasons as discussed, supra. for the 5 wt % acid functional monomer limitations.”)),
Accordingly. this Court rules in favor of Defendants with respect to the claims containing the 1
wt % limitations for the same reasons as discussed for the claims containing the 5 wt
limitations.
B. The ‘211 Patent
Defendants seek partial Summary Judgment of non-infringement of the 2l I Claims,
arguing that the Watson ANDA Product does not literally infringe these claims. Plainti I’!’ Cross-
Moves for leave to file amended infringement contentions and for additional claim construction.
1) Non-Infringement
A determination of patent infringement involves two steps. “The first step is determining
the meaning and scope of the patent claims asserted to be infringed. The second step is
comparing the properly construed claims to the device accused of infringing.” Markman v.
52 F.3d 967, 976 (Fed. Cir. 1995). A patentee must present proof
that “the accused product meets each and every claim limitation.” Lorest_L..1igbb
Labs., 239 F.3d 1305, 13 1 0 (Fed Cir. 2001). If even one limitation is missing in the accused
product, there is no literal infringement. See Dolly, Inc. v. Spaulding & E mflo Cos,. 1 6 l.3d
394, 397 (Fed. Cir. 1994); Kraft Foods, Inc. v. Int’l Trading Co., 203 F.3d 1362, 1370 (Fed. Cii’.
2000). Therefore, the second step may be decided on summary judgment “when no reasonable
jury could find that every limitation recited in the properly construed claim either is or is not
found in the accused device.” Bai v. L & L Wings, Inc., 160 F.3d 1350. 1353 (Fed. Cir. 1998).
Defendants assert that the Watson ANDA Product does not infringe the ‘2 ii Claims
because all dosage strengths of the Watson ANDA Product include methvlphenidate:silicone
11
adhesive:acrylic adhesive (wt % dry) in the following proportion: 21:0:7
9. Thus, Defendants
argue that because this Court found that the term “about” in the propor
tion limitation only allows
for the rounding of decimals to whole numbers, the 79% acrylic adhesi
ve present in the Watson
ANDA product does not literally fall within the “0-70” claimed range for
the acrylic adhesive
required by the proportion limitation. Plaintiff; however, contends that the
temis “proportion”
and “ratio” refer to the total weight of the composition (which includes compo
nents other than
methylphenidate, silicone adhesive, and acrylic adhesive). Therefore, accord
ing to Plaintiff,
because the Watson ANDA Product contains 18.3 % methylphenidate and
68.7 % acrylic
adhesive, it literally infringes the ‘211 Claims.
This Court finds no support for the proposition that the terms “proportion” and
“ratio”
refer to the entire composition rather than to the dry weight of the three compo
nents. Plaintiffs
expert even admitted that “Watson’s ANDA Products contain a slightly differe
nt ratio of
methylphenidate:silicone adhesive:acrylic adhesive (wt % dry) [than the propor
tion limitation],
namely the ratio of 2l%:0%:79%,” and went on to assert that the use of 79%
acrylic adhesive in
the Watson ANDA Product is nonetheless equivalent to the proportion limitat
ion under the
doctrine of equivalents (Pe Decl., Ex. 10 ¶ 115-117). As discussed below,
the doctrine of
equivalents arises when a claim element is not literally present in the accuse
d product. Further.
the language used by Plaintiff throughout this action shows that Plaintiff unders
tood
that
“proportion” refers to the ratio of the three components based on their combin
ed dry weight, not
the weight of the entire composition. For example, in its Amended Infringement
Contentions.
Plaintiff asserts that “Watson’s ANDA Products contain methylphenidate:sili
cone
adhesive:acrylic adhesive (wt % dry) in the ratio of 21%:0%:79%” (Lydis
gen Dec., Ex. 5)
(emphasis added).
12
This Court finds no need to conduct additional claim construction regarding the word
“proportion,” Plaintiff was free to raise this issue during claim construction proceedings. it
seems that Plaintiff is attempting to find an alternative way
to
show literal infringement after its
interpretation of the word “about” was denied. Additionally, this Court finds that Plaintiff has not
been diligent in seeking to amend its infringement contentions. as it has known of the
composition of the Watson ANDA Product since November 4, 2011, the date that Defendant
produced its i-\NDA to Plaintiff. Further, allowing Plaintiff to amend its infringement contentions
would prejudice Defendants, as T)efendants have already gone through the claim
construction
process, engaged in expert discovery, and filed a motion for summary judgment in reliance upon
the interpretation of the word “proportion” that has been used by both parties. Accordingly,
Plaintifis Cross—Motion for Leave to File Amended Infringement Contentions and for
Additional Claim Construction is denied.
2) The Doctrine of Equivalents
The doctrine of equivalents allows a plaintiff to establish, in certain instances, that a
claim element, though not literally present, is nevertheless met by demonstrating that the missing
element has been replaced by a structure that performs the
same function in
the same wa to
achieve the same result as the claim element in the patented device. gg Warner—Jenkinson Co.
v Hilton Dais Chem
(.o
520 U S 17 35 (1997) lhc doctnne of equivalents howcver is an
“equitable” tool that is applicable “only when the changes rin the accused product] are so
insubstantial as
to result
in a fraud on the patent.’ Slimfold Ml. Co. v. Kinkead Indus.. Inc.. 932
F.2d 1453, 1457 (Fed. Cir. 1991).
The doctrine of equivalents has limitations. When a patentee “originally claimed the
subject matter alleged to infringe but then narrowed the claim in
13
response to a rejection,
he may
IlOt
argue that the surrendered territory comprised unforeseen subject iattei’
thai should he
deemed equivalent to the literal claims ofthe issued patent.”
Kogyo Kabushiki Co., Ltd., 535 U.S. 722, 733-34 (2002). A narrow
ing amendment that is made
to comply with any requirement of the Patent Act can evoke estoppel.
at 736. For example. if
a § 112 amendment is necessary and narrows the patent’s scope even
if only for the purpose of
-
better description estoppel may apply. Id. at 737. However, the Suprem
e Court also held that
—
there are three exceptions to this rule:
II] The equivalent [was] unforeseeable at the time of the application; [21 the
rationale underlying the amendment
bear[s] no more than a tangential relation
to the equivalent in question; or [3] there [is] some other reason
that the patentee
could not reasonably be expected to have described the insubstantial substit
ute in
question.
.
.
.
.
.
.
ld at 740-41.
Defendants assert that Plaintiff is barred from relying on the doctrine of equiva
lents
because during the prosecution
of the
‘211 Patent, Plaintiff added the proportion limitation by
amendment in order to overcome enablement rejection. Plaintiff however, conten
3
ds that the
second Festo exception applies because the Examiner’s rejection related to
the methylphenidate
range, not the acrylic range. and thus the 79 wt % acrylic in the Watson
L\NDL\
Product is only
‘tangential” to the narrowing amendment. To support this argument. Plaintiff points
to the lhct
that it argued only as to the proportion of methylphenidate in response to the
Examiner’s
rejection. However, the Examiner’s rejection stated that the claims of the ‘211
Patent were
insufficient because, among other things, “the claims are silent with regard
to the composition of
the flexible finite system” and “[t]he amounts and/or propoi’tions and the carrier
4 are both
’svstem
Defendants also claim that Plaintiff is barred from relying on the doctrine of equiva
lents based on the disclosure
dedication doctrine, Because this court finds that Plaintiff is barred from relying
on the doctrine of equivalents due
to prosecution history estoppel, it need not address the disclosure dedication
doctrine.
It is clear from the language of the ‘211 Patent that an adhesive is a preferred
type of
carrier (ç Lydisgen Dec.,
14
critical to the invention” (Lydisgen Dec.. Ex. 7). Further, Defendants
correctly argue that the fact
that the Examiner’s rejection called for the recitation of “proportions”
shows that the rejection
pertained not only to methylphenidate hut to other components as well.
Finally, Plaintiff’s
amendment defined not only the amount of methvlphenidate. but the relativ
e quantity of silicone
and acrylic adhesive. This weighs against Plaintiff’s argument that the 79 xvt
% acrylic in the
Watson ANDA Product is only “tangential” to the narrowing amendment.
See Felix v. Am.
Honda Motor Co., Inc., 562 F.3d 1167, 1184 (Fed. Cir, 2009) (“[T]he inquiry
into whether a
patentee can rebut the Festo presumption under the ‘tangential’ criterion
focuses on the
patentees objectively apparent reason for the narrowing amendment[, which
must bel discernible
from the prosecution history record” (citation omitted)). Therefore, this Court
finds that Plaintiff
is barred from relying on the doctrine of equivalents. Accordingly. Defendants Motion
for
Summary Judgment of non-infringement of the ‘2 11 Patent is granted.
IV.
CONCLUSION
For the foregoing reasons Defendants’ Motion for Summary Judgment of invalid
ity of
Asserted Claims of US Patent No 6,210,705 is granted, Defendants’ Motion for
Partial
Summary Judgment of Non—infringement of US Patent No 6.348211 is granted. Plainti
ff’s
Cross—Iviotion for Leave to File Amended Infringement Contentions and For Additi
onal Claim
Construction is denied, and Plaintiffs Cross-Motion for Summary Judgment
of No Invalidity of
the Claims of U.S. Patent No. 6,210,705 is denied. An appropriate or
follows this Opinion.
Dennis M. Cavanaugh. U.S.l .1.
Date:
Original:
cc:
NovembcrC. 2013
Clerks Office
I-Ion. James B. Clark U.S.M.J,
All Counsel of Record
File
Ex. 6) (‘in a preferred embodiment, the carrier comprises an adhesive.”).
15
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